VDA Band 06.3 EN

23.08.2010

10:07 Uhr

Seite 1

6

Quality Managment in the Automotive Industry Process Audit

Part 3

Product Development Process / Serial Production Service Development Process / Providing the Service

VDA Volume 6 Part 3

Band_06_3_2nd_engl:Umschlag_rot

Dokument wurde bereitgestellt vom 2nd completely revised edition, June 2010 VDA-QMC Internetportal am 10.11.2010 um 14:27

Nur zur internen Verwendung für Flextronics Automotive GmbH&CoKG bestimmt.

Process Audit

Product Development Process / Serial Production Service Development Process / Providing the Service

2nd completely revised edition, June 2010 Verband der Automobilindustrie e.V. (VDA)

Dokument wurde bereitgestellt vom VDA-QMC Internetportal am 10.11.2010 um 14:27


ISSN 0943 9412 Printed 08/2010 Copyright 2010 by Verband der Automobilindustrie e.V. (VDA) Quality Management Center (QMC) Behrenstraße 35 10117 Berlin Germany Overall production : Henrich Druck + Medien GmbH Schwanheimer Straße 110 60528 Frankfurt am Main Germany Printed on chlorine free bleached paper



Preface Greater demands in the whole chain of customer and supplier processes present the quality management of companies with new and ever more complex tasks. Higher expectations of products require robust processes which must be secure throughout the entire manufacturing and supply chain. The time between the concept of a new product and its manufacture is becoming ever shorter and this means that work processes in all the various areas of the company need to operate in parallel to an ever greater degree. This in turn places greater demands on the organisations involved, their work processes and their personnel. Organisational processes must therefore be continually monitored and improved so that they are secure and, if deviations occur, to use appropriate control loops to introduce corrective measures. An important instrument in the monitoring of processes is the process audit. This is an integral part of the VDA strategy : "Quality standard for the German automotive industry (VDA 6)" as can be seen from the following illustration. QUALITY STANDARD OF THE GERMAN AUTOMOTIVE INDUSTRY (VDA 6)

VDA 6

VDA 6 QM system audit VDA 6 QM system audit Part 1 Products Part 2 Services

Quality audit

VDA 6 Process audit Part 3 Serial production / Services

VDA 6 Part 7

VDA 6 QM system audit Part 4 Production equipment Process audit Production equipment

Fundamentals VDA 6 Product audit (material and non material) Part 5

There is agreement between automobile manufacturers and suppliers on the execution of audits in accordance with this publication.


3


We thank the organisations involved and their employees for their contributions to the preparation of this publication. The following firms have cooperated in drawing up the publication :

Audi AG, Ingolstadt Continental AG, Ingolstadt Daimler AG, Stuttgart Dr. Ing. h.c. F. Porsche AG, Stuttgart Harman Becker Automotive Systems GmbH, Karlsbad Knorr Bremse Systeme für Nutzfahrzeuge GmbH, Münich Robert Bosch GmbH, Stuttgart Rollax GmbH & Co. KG, Bad Salzuflen Volkswagen AG, Wolfsburg ZF Sachs AG, Schweinfurt

Our thanks go also to all who have given us suggestions in the preparation and improvement of this publication.

Berlin, May 2010

VERBAND DER AUTOMOBILINDUSTRIE E.V. (VDA)

4



Page

Contents Preface

3

1

Introduction

7

2 2.1 2.2 2.3

Guidance on the use of a process audit Area of application for a process audit Limits of a process audit – potential analysis Identifying process risks (risk analysis)

8 8 9 9

3 3.1 3.2

Requirements regarding auditors Auditor qualifications Code of behaviour for auditors

11 11 12

4 4.1 4.2 4.3 4.4 4.5 4.6 4.7

The audit process Audit programme Audit contract Preparation Execution Assessment Presentation of results Final evaluation and closure

13 14 16 19 24 27 29 32

5

Potential analysis ( Process element P1) Objective and purpose of the potential analysis Pre conditions Preparation Operational sequence of a potential analysis

35 35 35 35 36

5.1 5.2 5.3 5.4 6 6.1 6.2 6.2.1 6.2.2

Assessment Assessing the potential analysis Assessing a process audit for material products Assessing the individual questions Assessing sub elements in the process analysis of production and generic baselines 6.2.3 Overall assessment 6.2.4 Assessing product groups and process stages 6.3 Assessing service processes 6.3.1 Individual assessment of questions & process elements Dokument wurde bereitgestellt vom VDA-QMC Internetportal am 10.11.2010 um 14:27

37 37 39 39 40 41 42 43 43 5


6.3.2 Overall assessment of the audit result 6.3.3 Classification 7

6

Using the questionnaire (process elements P2 to P7)

44 45 47

8 8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8

Questionnaire Questionnaire overview Project management (P2) Planning the product & process development (P3) Carrying out the product & process development (P4) Supplier management (P5) Serial production (P6) Customer support, customer satisfaction, service (P7) Services (PD)

49 49 54 60 66 75 82 112 119

9 9.1 9.2 9.3

Assessment forms & overviews (examples) Process audit for material products Process audit for services Potential analysis

144 144 150 151

10 10.1 10.2 10.3

Best Practice / Lessons Learned Example of information provided by the supplier Assessment guidelines Data stores

161 161 170 172

11

Technical terms

175

12

Downloads

176



1

Introduction

The established Audit Standard VDA 6.3 1998 has been completely revised. The objective was to re organize the process audit, making it more precise and adapting it to changing requirements in the automotive industry. Processes must be analysed in such a way that risks and weaknesses are detected in the work processes and in their interfaces. Part A of the 1998 issue has been fully revised and expanded to include further process elements such as potential analysis and project management. The contents of Part B of the 1998 issue have been made more precise and expanded with the aim of achieving maximum repeat recognition. The rules for determining classification levels have been extended, questions with particular product and process risks are identified by (*) and the classification levels have been reduced to A, B and C. In addition to the questions set out in this VDA 6.3 publication, it is recommended that databases be established in order to provide adequate support for relevant product and process specific requirements. Other assessment methods (such as software assessments using Automotive SPICE) are useful, depending on the product and can be used as supplementary systems. Explicit questions regarding environmental protection and health & safety at work are not covered, as these have their own monitoring systems, including standards covering requirements. A further objective in drawing up this new issue was to take account of existing VDA publications, in particular "Maturity level assurance for new parts" and "Robust production process (RPP)“.


7


2

Guidance on the use of a process audit

2.1

Area of application for a process audit

Process audits can be used internally as well as externally throughout the entire product life cycle. The list of questions is constructed in such a way that it can be used for small and medium sized companies as well as for large concerns. As can be seen from Fig. 1, the way of looking at the product life cycle in the supply chain varies according to different phases. Issue contract Cutomer

Pre select suppliers; Potential analysis

Def. and Draft, Product & process development

SOP

Quotation process (contract review)


Serial production

Customer service (After Sales)

Receive Issue SOP contract contract

Supplier

Fig. 1:

Implementation Product / process development

Pre select suppliers; Potential analysis

Customer service After Sales

SOP

Issue contract

Receive contract Organisation

Serial production


Phases of the product life cycle in the supply chain

Fig. 2 shows how individual questions regarding process elements can be aligned with the product life cycle, independent of the position within the supply chain. This illustration may vary, depending on the specific organisation. Receive contract Quotation process (contract review)


Issue contract Pre select suppliers; Potential analysis

SOP


Serial production

Customer service (After Sales)

P1

Allocation of questions

P2 P3 P4 P5 P6 P7

P1: Potential analysis (new)

P5: Supplier management

P2: Project management (new)

P6: Process analysis / production

P3: Planning the product & process development

P7: Customer support, customer satisfaction, service

P4: Carrying out product & process development

Fig. 2:

8

Allocation of process elements to the product life cycle Dokument wurde bereitgestellt vom VDA-QMC Internetportal am 10.11.2010 um 14:27


2.2

Limits of a process audit

potential analysis

As will be seen from Fig. 2, an analysis of potential (P1) can be carried out before a project is launched. In this, a process audit of reduced scope can be used to assess potential suppliers who are suitable as serial production suppliers. Because these are merely potential suppliers, the audit must be based on other processes / products which should be comparable with the product to be supplied. The analysis of potential can likewise be accepted by all parties, where the products and technologies are comparable (see Section 5). 2.3

Identifying process risks (risk analysis)

In a process audit, the effect of the individual processes on the product is decisive and the assessment must therefore be made from the stand point of the product risks involved. For this reason, the potential risks within the process must be determined as early as the preparations for the audit (see also Section 4.3), so that they may be assessed adequately in the process audit itself. One method of determining the product risk is the "turtle" model : see Fig. 3.

What functions / areas / persons support the process ?

What material facilities are used to carry out the process ?

Material resources

Process support

Equipment; facilities

Training, knowledge, ability, authority

What goes into the process ?

I

PS1

O

Input

What is the intended result of the process ?

Process PS2 stage stage

Output

Interface

PS3

O

Interface

How does the process operate ?

Work content

Control of execution : instructions, procedures, methods

Fig. 3:

I

How effectively is the process carried out ?

Level of effectiveness

Performance indicators

"Turtle" model


9


Firstly an explanation is given of what "input" is converted into an "output" by the process. This is expanded by considering the following questions : how does the process operate ? (work content) what functions/areas/personnel support the process ? (process support) what means are employed to carry out the process " (material resources) how effectively is the process executed (level of effectiveness) In a second stage the potential risks arising from these questions are determined. These potential risks must then be evaluated in the audit, to ensure that they are assured to a reasonable degree.

10



3

Requirements regarding auditors

3.1

Auditor qualifications

The quality of the results of an audit is influenced critically by the qualifications of the auditors. The qualification criteria for auditors are as follows : Internal process auditor Carrying out internal process audits with no interfaces to outside suppliers or customers : Technical requirements Basic knowledge of quality management (familiarity with current regulations and standards) and knowledge of the specific product/ processes. Certification of successful participation in a VDA 6.3 training course. Career experience At least 3 years' industrial experience, preferably in manufacturing companies in the automobile industry, including at least one year in quality and/or process management. Process auditor in the supply chain Carrying out internal and external process audits with interfaces to outside suppliers or customers. Technical requirements Well grounded knowledge of quality and process management, as well as knowledge of the specific product/ processes. Certification of an auditor qualification (e.g., based on EOQ systems). Certification of successful participation in a VDA 6.3 training course. Career experience At least 5 years' industrial experience, preferably in manufacturing companies in the automotive industry, including at least 2 years in quality and/or process management.


11


3.2

Code of behaviour for auditors Process auditors must exercise their professional capabilities and their judgement, taking account of the law and maintaining the principles of honesty and plain dealing. Process auditors must continue to develop their technical expertise and maintain their knowledge of the latest developments. Process auditors must behave at all times in such a manner that the standing and reputation of the organisation (the company) are not placed in jeopardy. Process auditors must not accept contracts which represent a conflict of interests in regard to their contractual duties. Process auditors undertake to maintain strict secrecy regarding confidential information (for example, know how) which they have gained in the course of their professional activities. This duty of confidentiality does not apply where the law requires information to be divulged. Process auditors must not use in a dishonest manner the information they have gained in the course of their activities, neither to their own advantage nor to the advantage of third parties.

12



4

The audit process

This section describes the procedure for carrying out internal and external audits, as well as the analysis of potential suppliers. Process oriented auditing Audit Audit contract

Preparation

Execution

Assessment

Presentation of results

Final evaluation and closure

programme

Internal audit External audit (suppliers) Potential analysis (suppliers)

Fig. 4:

Audit process

Details covering the execution of a potential analysis are set out in Section 5.


13


4.1

Audit programme Audit Audit contract

Preparation

Execution


Assessment


programme

Generate the audit programme from the audit requirements Input ! Audit requirements ! Time frame ! Auditor pool ! Current audit programme ! Experience from previous years

Rolling adjustments to the audit programme as new requirements emerge Process stage Generate the audit programme from the audit requirements

Output ! Audit programme

Objective Audits are planned in accordance with their priority and the company's in house requirements. Qualified auditors are used to achieve the objective. Responsibility The person responsible for the audit programme draws up an audit programme for a defined period. Description The number of audits is determined and prioritized by the person responsible for the audit programme. From this, this person works with the audit client (and, where appropriate, the operation to be audited) to set out the following details regarding the audit : ! ! ! !

The main emphasis of the audit The calendar week of the audit The number of days required for the audit Details of the auditors, in particular the process experts

In addition to technical qualifications and the necessary neutrality, the choice of auditors should also take account of a knowledge of language and inter cultural aspects. A process expert should be provided to assess process specific questions beyond the competence of the process auditor. This process expert need not necessarily be a VDA process auditor. Thereafter the audit programme is approved by the relevant management.

14



Method / documentation Audit programme Input !

Process stage Events based need for an audit

Output

Rolling adjustments to the audit programme as new requirements emerge

Current audit programme Up dated resource planning

Objective The audit programme is always current as a result of continuous adjustment. Responsibility The person responsible for the audit programme continually adjusts the audit programme and plans resources accordingly. Description Current quality problems in production and / or at the supplier's premises, new product launches or changed priorities can create new audit requirements at any time. During the whole course of validity of the audit programme, the person responsible for the audit programme must ensure that these additional audits are included in the programme. The existing resources must be adapted to meet the new requirements. To achieve this, the person responsible for the audit programme up dates the existing programme and resource planning before agreeing them with the organisations to be audited and the body placing the contract for the audit. Management must be involved in up dating the audit programme. Method / documentation Up dated audit programme


15


4.2

Audit contract Audit Audit contract

Preparation

Execution

Assessment Presentation of results


!"#!$%%&

Clarify initial situation with the client

Input Reason for audit Audit programme

Draw up the audit contract

Process stage

Output

Clarify initial situation with the client

Audit contract

Objective To implement the requirements set out by the body placing the contract in the form of a precisely detailed audit contract. Examples of audit contracts : determine / assess / approve the current status analyse / estimate risks qualify / encourage / improve check the effectiveness of actions from a prior audit escalation Responsibility Person responsible for the audit programme (audit leader) with the support of the client.

16



Description The auditor must know the reason for drawing up the audit contract. Reasons for an audit can be :

Process audit

Potential analysis

X

X X

X X

X X

X

X

X X

X

Special audit (e.g.. technical revision)

External

X X

Internal

New supplier New technology New location (transfer of production) Requirements (client; standards; legislation) Changes to management, core and support processes Changes caused by outside processes To secure a product launch and process approval Organisational changes (change of company name, ownership, ..) Continuous monitoring of production and organisation Target criteria not achieved Customer complaints / rejects Production breakdown Escalation stages (e.g., red or yellow from VDA publication "Maturity level assurance for new parts") Periodic monitoring as part of current audit programme Continuous improvement process

Audit variant

Events based

Planned

Reason for an audit

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

X

Method / documentation


17


Input initial situation reason for audit

Process stage

Output

Draw up the audit contract

Audit contract

Objective Draw up an audit contract with all the information required for a structured execution of the audit Responsibility The audit client, with support from the person responsible for the audit programme Description The following factors must be taken into account in an audit contract : ! ! ! ! ! !

Reason for the audit Audit objective Audit variant Audit location Audit team (provisional) Extent of the audit

!

Client

! ! ! !

Audit date Date of the contract Comments Essential documents

!

History

see previous table Assessment; process release; status examination; etc. Internal/external audit, potential analysis, special audit Internal, external Auditor, process expert(s) Processes, products, manufacturing locations, interfaces, outside processes Person responsible for the audit programme, management, person responsible for the product Desired date; audit period; shifts Background information Test/inspection regulations; contracts; important agreements, cost stipulations, etc. Complaints; rejects; delivery performance; project status

Method / documentation Audit contract form

18



4.3

Audit preparations

Audit Audit contract

Preparation

Execution

Assessment



programme

Specify the audit team

Gather information

Input

Limit the Processes and set points of emphasis for the audit

Process stage

Audit contract Process documents

Draw up check lists and audit plan and agree these with the organisation

Output


Audit team

Objective Select a suitable audit team with appropriate qualifications Responsibility The audit leader specifies the final audit team and organises the audit. Description The audit team is appointed on the basis of the audit contract, any other relevant information and by the planning in the audit programme. In addition to the personal aptitude of the auditors and any technical experts (see Section 3.2 : "Code of behaviour for auditors") the qualifications for the audit must be taken into account, particularly technical knowledge. A process expert should be provided to assess process specific questions beyond the competence of the process auditor. This process expert need not necessarily be a VDA process auditor. Method / documentation Code of behaviour; audit contract


19


Process stage

Input Audit contract Audit team Information

Gather information

Output ! Documents ! Assembled information

Objective The team of auditors obtain all the information required to plan the audit Responsibility Audit team with the support of the client and the organisation to be audited Description The information collected for the audit must be capable of displaying the process, as well as the interplay and interfaces between processes. The following documents can be taken into account : organisation charts process flow plans production control plans (internal audit) FMEAs (internal audit) Standards specifications customer specific requirements target requirements (ppm, for example) process descriptions quality control charts audit results action plan from the previous audit results of supplier quality assessments (quality performance) complaints / rejects layouts project plans etc… Method / documentation

20



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22



Process stage

Input

Output

Draw up check lists and audit plan and agree these with the organisation

Audit contract Process limits Process stages Audit points of emphasis

Audit plan Check lists

Objective The specific check lists are specified on the basis of the agreed audit contract. Responsibility Audit team Description From the information obtained and the company's own database, the audit team extends and completes the minimum requirements covering assessments set out in the VDA 6.3 audit question listings. If any item cannot logically be assigned to an existing question, further questions can be added. However, this means that the results will no longer necessarily be comparable. In such cases the assessment matrix will need to be adapted. In agreement with the organisation being audited, the audit team sets out the audit plan, which will contain the following as a minimum : the participants the names of the auditors the audited organisation/functional unit the duration of the audit the time required for documenting each audit operation must be taken into account (for example, 10 minutes for documentation for every hour of the audit) audit locations process operations/product groups Breaks in production (lunch breaks, etc.) must be taken into account when drawing up the audit plan, as well as the use of foreign languages, inter cultural aspects, changes in shifts and transfer times. Changes on site are possible. Method / documentation Audit plan, check lists


23


4.4

Execution Audit Audit contract

Preparation

Execution

Assessment



programme

Opening discussion to communicate the audit objectives and timing plan Input Audited organisation (on site) Audit plan Audit team Specific check lists

Carry out audit to the plan, using the check lists Process stage

Initiate immediate action if the audit detects crucial problems Output

Opening discussion to communicate the audit objectives and timing plan

Current timing plan Contact personnel

Objective Important features of the audit operation are specified in the opening discussion. Responsibility Audit leader Description The opening discussion takes place with the management of the organisation to be audited. The objectives of the audit are presented, together with the extent of the audit and the audit criteria. The audit plan is confirmed and the audit leader explains briefly the planned audit activities. The timing plan is checked, any necessary corrections are made and the date for the closing discussion is agreed. The units/processes to be audited can be presented by those responsible. The auditors introduce themselves and explain their roles in the audit. The contact personnel between the audit team and the organisation to be audited are specified. The sequence of drawing up reports is presented, with the assessment procedure to be used. Reference is made to the confidentiality of the information and results obtained. The organisation to be audited confirms the availability of the necessary facilities (rooms, printer, etc.) for the audit team. The question of any personal protection is clarified. Method / documentation

24



Input Check lists Timing plan Contact personnel Documents

Process stage Carry out audit to the plan, using the check lists

Output Audit evidences Audit records

Objective Verifiable determination of the quality situation, taking account of the audit plan and the situation on site Responsibility Auditor team Description The auditor analyses whether the audited area implements in practice the stipulations laid down by the organisation, customer requirements and the requirements set out in standards and in law. The investigation is carried out by asking questions based on the chronological sequence of activities within the process, using the question listing and any check lists which have been specifically drawn up. The auditor is required to ask open questions (see "sequence pyramid" in Section 7.1). Based on concrete cases and evidence the auditor must investigate the suitability and effectiveness of the processes. As a general rule, the discussion moves from general questions to concrete, detailed questioning. The auditor carries out random checks on the implementation of instructions and requirements relating to the products and processes, by examining appropriate documents and records. Findings relevant to the results are noted. The employees on site must be brought into the audit by questioning and their responses verified by inspection of the QM documentation. Any audit deviations must be communicated directly on the spot with the relevant personnel. The audit team should meet at specific intervals as required, in order to exchange information, assess the progress of the audit and (if necessary) to re allocate the distribution of tasks within the team. The audit plan must be verified regularly by the audit team regarding its timing and modified if necessary in agreement with the organisation being audited. Breaking off the audit An audit can be broken off at the discretion of the audit team, for example for the following grounds :

! ! !

refusal to provide necessary information during the audit clear infringements of the law refusal to allow access to areas relevant to the audit, despite previous agreement deficient preparations for the audit by the organisation presentation of clearly untrue information

Breaking off an audit must be justified by stating the reasons. Audit findings up to the point when the audit is broken off must be documented The organisation being audited will decide on the execution of a new audit. Dokument wurde bereitgestellt vom VDA-QMC Internetportal am 10.11.2010 um 14:27

25


Method / documentation Section 8 : Questionnaire Databases; check lists

Input Audit evidences Records Deviation report

Process stage Initiate immediate action if the audit detects crucial problems

Output Corrective actions which have been introduced

Objective To prevent the further spread of serious failures (customer complaints, broken down vehicles, loss of function, safety critical components, critical characteristics, etc.) Responsibility The audit leader is responsible for demanding immediate action if significant deficiencies arise Description Facts which identify a serious risk must be pointed out to the organisation without delay, so that it can specify appropriate immediate action. If serious failures occur, the organisation being audited must define immediate actions. Implementation of the actions must be confirmed and started before the audit is completed. Method / documentation Audit report

26



4.5

Assessment


Preparation

Execution

Assessment

Presentation Of results


programme

Assess in accordance with assessment plan

Input Findings Assessment plan Individual questions in the check lists

Process stage Assess in accordance with assessment plan

Decide on follow up audit

Output Findings Quantitative assessment

Objective The quantitative assessment reveals the quality capability status of the process under consideration. The comparability of the audit results is secured and changes in regard to previous audits are noted in the sense of a continuous improvement process Responsibility Audit leader, audit team Description Based on the findings of the audit the audit team evaluates the individual questions as described in the assessment procedure in Section 6. The basis of the assessment is whether or not the relevant requirements are achieved and the risks involved. If a question is not answered, a reason for this must be stated. The assessments of the individual questions lead to the overall audit assessment. Method / documents Assessment matrix – Section 9 Assessment guidelines – Section 10


27


Process stage

Input Audit assessment Classification Deviation report

Output

Decide on follow up audit

Decide on the need for a follow up audit

Objective The decision on a follow up audit is taken on the basis of the findings. Responsibility Audit leader Description The organisation must specify in what circumstances a repeat audit is necessary. Rules for a repeat audit can be : not reaching a defined level of achievement risks associated with a critical process not achieving required results (zero points) for one or more questions marked (*) red traffic light (analysis of potential) This repeat audit must be carried out within a specified time frame. Within this time frame the audited organisation must introduce actions to eliminate the deviations effectively. It is not sufficient for the repeat audit to check only that the deviations detected in the previous audit have been eliminated effectively Method / documentation Audit report

28



4.6

Presentation of results Audit Audit

contract

Preparation

Execution

Assessment Presentation of results


programnme

Hold a closing discussion

Input Findings Audit evidences Notes on documents which have been examined

Draw up the audit report

Process stage Hold a closing discussion

Release the audit report

Output Draw up report with emphasis on the audit contract Results / findings regarding quality capability Decide on follow up audit if necessary

Objective In the closing discussion a report, on the completed audit is presented to the body which has been audited and its representatives, with the emphasis on : advising the results and findings of the audit clarification of areas which were unclear specifying the next stages, such as dates for clearing the findings, or arranging a repeat audit if necessary motivating the personnel to carry out the proposed actions Responsibility Audit leader, auditor team Description The following are required in preparation for the closing discussion : invitations to the participants as set out in the audit plan sufficient space for all participants / availability of presentation facilities presentation of results The contents of the closing discussion are : presentation of the audit results presentation by the organisation of the status of immediate actions which have been taken specification of further procedure specification of the distribution of the audit report agreement on forwarding the data within the company and/or to third parties closing comments by the management of the unit which has been audited. Dokument wurde bereitgestellt vom VDA-QMC Internetportal am 10.11.2010 um 14:27

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Method /documentation

Input Notes on observations (positive / negative) Notes on documents whichhave been examined Personnel involved in the audit

Process stage

Output

Draw up the audit report

Audit report

Objective The audit report is a precise, summarized and clear record of the audit Responsibility Audit leader, auditor team Description The audit report is drawn up jointly within the auditor team. It consists of : a cover sheet the audit findings with regard to the documents which have been inspected explanations regarding the assessment schematic the audit timing plan / agenda process descriptions, if appropriate The cover sheet contains the following :

! !

the audit procedure fundamental internal and external requirements details of the unit and processes which have been audited, including products and customer requirements which have been checked the audit result a summary of the findings ! must be included : main deviation areas and need for handling ! can: be included : positive findings and potential for improvement Timing for the action plan

The audit report must not contain any findings other than those explained in the closing discussion. Method / documentation Audit report form

30



Input Audit report

Process stage

Output

Release the audit report

Released audit report

Objective The purpose of signing the audit report is : Internal The report becomes released and valid following its signature by the audit leader. Supplier audits The report becomes released and valid following its signature by the audit leader. It must also be signed by the supplier before it is circulated. Note : Signing the report confirms that the documentation is correct. Responsibility Audit leader Description Method / documentation Audit report form


31


4.7



Preparation

Execution

Assessment



programme

Audited organisation specifies corrective actions, inc. completion dates and responsibilities

Input Released audit report

Audit leader checks actions for plausibility and clarifies any inconsistencies

Process stage

Check on effectiveness and closure

Output

Audited organisation specifies corrective actions, inc. completion dates and responsibilities

Action plan with causes, timings and responsibilities

Objective Causes, actions, responsibilities and completion dates are allocated to the findings to a reasonable degree. Responsibility The audited organisational unit Description The action plan must be drawn up within a time frame agreed with the auditor. It contains all the activities involved, stating responsibilities and completion dates, to eliminate the deficiencies in the process on a permanent basis. Method / documentation Form / improvement program / action plan

32



Input Action plan with causes, timings and responsibilities

Process stage

Output

Audit leader checks actions for plausibility and clarifies any inconsistencies

Action plan (checked)

Objective To arrive at a plausible action plan. Responsibility Auditor Description The auditor checks the action plan for plausibility and to decide, in his estimation, the actions are appropriate for eliminating the deficiencies (a check on documents). Here the focus should be on the permanence of the actions taken, so that repeat failures are prevented. Approval by the auditor of the plausibility of the actions does not release the organisation from its responsibility for the effectiveness of the actions which have been taken. If there is any lack of clarity or disagreement, the auditor will call for improvements to the plan. If no response is received the auditor can launch an appropriate escalation procedure. NOTE : In particular in the case of supplier audits (2nd party supplier audits) the usual escalation procedures should be applied if action plans are not provided, or are withheld or are not plausible. However, these escalation procedures should have been agreed with the supplier as part of the contract before the audit takes place. Method / documentation Action plan


33


Process stage

Input

Output

Check on effectiveness and closure

Checked action plan

Corrective actions Contract for follow on audit Improved process Defect free product

Objective To close the control loop covering the implementation of actions, by carrying out a check on effectiveness Responsibility The organisational unit which has been audited is responsible for carrying out the actions. The person responsible for the process is responsible for carrying out the check on effectiveness. Description The audited organisation is responsible for implementing the actions and the person responsible for the process must monitor the implementation. Checking the effectiveness of the agreed actions is carried out primarily by the person responsible for the process. Confirmation of the effectiveness of the actions which have been taken is documented by a note in the action plan, with the date, by the person responsible for the process, who informs the auditor and the monitoring organisation unit of the result of the effectiveness check. Possible follow on actions if the effectiveness of the actions is not confirmed are : escalation procedure problem analysis follow on audit Method / documentation Among others, the following methods can be used for verification :

!

34

random sample checks product audit process audit capability studies on machinery and process intermediate status / extent of completion examination of the derived indicators before and after implementing the actions (ppm statistics; achievement of the objective; reject patterns)



5

Potential analysis (P1)

5.1

Objective & purpose of the potential analysis

A potential analysis is carried out in order to assess a new, not previously known potential supplier, new locations and technologies and, where appropriate, the new organisation's development and process potential, as preparation for a decision on whether to place a contract. The potential analysis examines the parts specifically stated and the specified processes involved in the particular sourcing process. The assessment judges the experience of the potential supplier in the manufacture of similar products and his potential in the creation of products and processes. An analysis of the supply market should be carried out beforehand, to reduce the number of potential suppliers to be investigated. The result of a potential analysis can result in any one of the following : a provisional release for the project a release with a time limit, covering a product group a release for a restricted quantity of products / small scale production A potential analysis with a positive outcome is not necessarily linked to a decision to place a contract with the company. A negative outcome eliminates the possibility of a contract. 5.2

Pre conditions

Because the supplier has no experience of the customer's specific requirements at this stage, an assessment of a similar process (if appropriate, a competitor's product) can be carried out to produce a forecast covering quality capability. In the enquiry and quotation stages there is no contract between the customer and the potential supplier and the following aspects must therefore be agreed as a minimum : confidentiality agreement on access forwarding of results to third parties 5.3

Preparation

Sourcing information in preparation for the analysis of potential is of particular importance. A valuable means of obtaining information is to ask for the supplier to provide a self assessment, in addition to one's own researches. Dokument wurde bereitgestellt vom VDA-QMC Internetportal am 10.11.2010 um 14:27

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The contents of a supplier's self assessment (SSA) can include : general supplier data (location; legal composition; size), general information on the current range of products from the proposed supply location, quality capability classifications by third parties and / or results of in house audits, internal value creation, sub suppliers, tool makers, joint venture developments, partners / know how, cooperation / core expertise, development / engineering department(s), project management, product development methods, design systems / innovation, laboratory facilities / test facilities, prototype and trial model building, patents etc.. An example of a supplier's information study is provided as an appendix.

5.4

Operational sequence of a potential analysis

The following diagram shows the sequence of an analysis of potential (P1). The questions to be examined in the P1 analysis are selected questions from the process elements P2 to P7. For an overview of the questions, see Section 8. A separate evaluation is required for the analysis of potential because the objective here is less to arrive at a classification in percentage terms and more to decide on "suitable" or "not suitable".

Issue contract

P1 Potential analysis Clarify the initial Request & assess situation and the supplier's restrict the information contract study (SIS) Unknown supplier Unknown location Unknown technology

Feedback to the supplier (obtain more information)

Compile a modular questionnaire

Client's own questions from his databases (for product and process requirements) and requirements specifications


Establish a team with experts, for example from the following sectors : • Quality • Dev'pment

On site visit

Prognosis/ recommend assessment ation/ based on a veto similar process or product (for other customers)

• Process

• Issue a report (inc. findings

• Purchasing and deviations) • Logistics • Presentation of results

• "Traffic lights" display

36

Risk assess ment

Clarify resources required for qualification Clarify the availability of in house resources (customer)

• e.g., inclusion in a supplier development program

End of auditor's responsibility



6

Assessment

6.1

Assessing the potential analysis

Each question is assessed in terms of responsible compliance with the requirement under review and the risk involved. As a basis, an audit should be carried out on a similar product, made with a similar process, in similar quantities. If a question is not answered (shown as "n.b."), a reason for this must be stated. No more than 3 questions can be shown as "n.b.". It must be noted that, in such cases, the comparability of results and the mutual acceptance of audit results by other parties may no longer apply. Each question in the potential analysis is assessed in terms of responsible compliance with the requirements under review and the risk involved. The assessment is marked, using the traffic light system of "red", "yellow" or "green". Assessment of individual questions The requirement in the question is not achieved The requirement in the question is achieved only to a certain extent (insofar as no product risk exists). The requirement in the question is achieved

Where questions are classified as "red" or "yellow" the reasons must be stated. Adding the assessments for each question results in an overall classification, which again uses the traffic light system : Classification Barred supplier Conditionally approved Fully approved supplier

Red :

Assessment by questionnaire Yellow Red More than 14

One question

max. 14

None

max. 7

None

The (potential) supplier is barred It is not possible to award (nominate the company for) the contract, product or product group in question Dokument wurde bereitgestellt vom VDA-QMC Internetportal am 10.11.2010 um 14:27

37


Yellow :

Conditionally approved supplier An award (nomination) can be made but is governed by defined conditions : The conditions to minimize the risk may be : restriction to a defined quantity (small scale production) restriction to a defined product restriction to part quantities of the overall enquiry the (potential) supplier receives a trial order on probation the (potential) supplier is included in a supplier development programme special treatment by supplier development teams with careful monitoring of the progress of the project. Note : Conditions must be specified by the relevant quality and sourcing departments.

Green :

Fully approved (potential) supplier It is possible for the customer to award (nominate the company for) the contract, product or product group in question, without any restrictions. A validation of quality capability in terms of approving a manufacturing location can be carried out only by a process audit in the development process or production process, based on customer related requirements and processes and/or the customer's own products.

38



6.2

Assessing a process audit for material products

6.2.1 Assessing the individual questions Each question is assessed in terms of responsible compliance with the requirement under review and the risk involved. The assessment of each question can result in the award of 0, 4, 6, 8 or 10 points, with the number of points awarded being based on proven compliance with the specified requirements. Points

Assessment of compliance with the requirements

10

Full compliance with requirements

8

Requirements mainly* satisfied; minor deviations

6

Requirements partially satisfied; significant deviations

4

Requirements inadequately satisfied; major deviations

0

Requirements not satisfied

(*) The term "mainly" means that all relevant requirements have been shown as achieved in more than ca. ¾ of all relevant cases and there are no special risks.

If a question is not assessed (shown as "n.b.") , a reason for this must be stated. At least 2/3 of the questions must be assessed. Bearing in mind the desirability of the comparability of results and the mutual acceptance of audit results by other parties, the entire list of questions should be covered in full. If complaints from previous audits are repeated, individual questions may be marked down when awarding points. Questions involving special product and process risks (* questions) In the process elements, questions involving special risks in terms of product and process are identified by an asterisk (*). In such cases, deviations from requirements must be classified more severely. There is the danger that the process is not sufficiently secure, or that the product may fail. The degree of achievement EE of a process element is calculated as : EE [%] =

Total number of points awarded for the relevant questions Total possible number of points for the relevant questions


[%]

39


6.2.2 Assessing sub elements in the process analysis of production and generic baselines The auditor analyses and assesses the process element P6 : "Process analysis of production" in accordance with the following sub elements : EU1 EU2 EU3 EU4 EU5 EU6 EU7

Process input Work content / process sequence Process support Material resources Level of effectiveness Process results / output Transport / parts handling (not separate questions; generated from identified questions in EU1 EU6)

In addition to the process analysis, an assessment is also made of the general requirements for a process, without which the function and effectiveness of the process in question is not guaranteed. Processes must also fulfil the following framework conditions (see also VDA publication 12 : "Process orientation") : 1)

There must be a person responsible for the process in question (process responsibility PR)

2)

Processes must be target oriented (TO), while taking account of the customer's requirements

3)

Important information (e.g., quality, problems, etc…) are communicated (CO) promptly and comprehensively to the appropriate people

4)

Risks in the processes are identified accordingly and taken into account (RI)

No separate questions are defined for the generic baselines. In the process elements P2 to P7 questions are identified, from which the assessment of the generic baselines are derived (see also Section 8.1).

40



6.2.3 Overall assessment Processes for material products Project management (P2)

EPM

Planning the product and process development (P3)

EPP

Carrying out the product and process development (P4)

EPR

Supplier management (P5)

ELM

Process analysis / production (P6)

EPG

Customer support / customer satisfaction / service (P7)

EK

The level of achievement ED before SOP (part A from the 1st edition) is calculated as follows : ED [%] =

EPM + EPP + EPR 3

[%]

The level of achievement EP at and after SOP (part B from the first edition) is calculated as follows : EP [%] =

ELM + EPG + EK 3

[%]

The overall level of achievement EG for the process audit is calculated as follows : EG [%] =

EPM + EPP + EPR + ELM + EPG + EK [%] 6

Overall level of achievement : Classification

Overall level of achievement EG [%]

Description of the classification

A

EG ≥ 90

Quality capable

B

80 ≤ EG < 90

Conditionally quality capable

C

EG < 80

Not quality capable


41


Rules covering downgrades The following rules covering downgrades must be used and be recorded in the audit report. Reasons for down grading from "A" to "B" despite an achievement level of EG ≥ 90% at least one of the process elements P2 to P7 or process stages E1 to En has been assessed as less than 80% the level of achievement of the sub elements of P6, such as process input, work content, process support, material resources, level of effectiveness, process output, transport/parts handling, is less than 80% at least one (*) question has been awarded 4 points at least one question from the process audit has been awarded 0 points assessments from the generic baseline, such as process responsibility, target orientation, communication and risk orientation are less than 70% Reasons for down grading to "C" despite an achievement level of EG ≥ 90% at least one of the process elements P2 to P7 or process stages E1 to En has been assessed as less than 70% the level of achievement of the sub elements of P6, such as process input, work content, process support, material resources, level of effectiveness, process output, transport/parts handling, is less than 70% at least one (*) question has been awarded 0 points Calculations in the assessment matrix are rounded off mathematically and used in the intermediate stages. The individual and overall levels of achievement are determined from the whole numbers. 6.2.4 Assessing product groups and process stages If required, the overall assessment of quality capability can be broken down into product groups and process stages. This procedure is used by the automotive manufacturers principally for classifying the quality capability of suppliers. In this way suppliers are given delivery approval/release restricted to product groups. Each product group involved is defined by one or more essential process operations.

42



Possible process stages

Product group Pressed & stamped parts Plastic injection mouldings Control devices

Stamping; drawing; forming

Galvanic plating

Plastic moulding Fitting components

Soldering

Painting Painting

Assembly

Functional check

Note : Additional process requirements should be generated in appropriate in house databases in order to assess process operations (see an example in the appendix)

In the assessment matrix (see appendix) the relevant process stages are allocated to the product group under consideration. The degree to which the product group fulfils the requirements of the production process analysis (process element P6) is derived from the arithmetic mean of the levels of achievement of the individual process stages which have been assessed (E1 to En ) : EProcess stage 1 + EProcess stage 2 + … + EProcess stage n Total number of process stages assessed

EPG [%]

[%]

Where EPG = the degree to which the product group fulfils requirements The overall degree of achievement by each product group EPN for the serial production process (part B from the first edition) is obtained from the arithmetic mean of the degrees of fulfilment ELM, EPG and EK (process elements P5, P6 and P7). 6.3

Assessing service processes

6.3.1 Individual assessment of questions & process elements Each question is assessed in terms of the relevant requirements and their consistent achievement in the service process. For each question the assessment can award 0, 4, 6, 8 or 10 points, with the degree of achievement providing the scale for the points awarded. Points

Assessment of achievement of individual requirements

10

Full compliance with requirements

8

Requirements mainly* satisfied; minor deviations

6

Requirements partially satisfied; significant deviations

4

Requirements inadequately satisfied; major deviations

0

Requirements not satisfied

(*) The term "mainly" means more than ca. ¾ of all requirements have been shown as achieved and there are no special risks. Dokument wurde bereitgestellt vom VDA-QMC Internetportal am 10.11.2010 um 14:27

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The degree of achievement EE for a process element is calculated as : EE [%]

Total of all points awarded for the relevant questions Total number of possible points for the relevant questions

[%]

6.3.2 Overall assessment of the audit result The following elements are assessed individually : Service processes

EG EDE

Planning (D1) Outside services (D2)

EZ

Service process (D3)

EPG

Customer satisfaction / customer support (D4)

EK

Because of the different process stages associated with the service groups in the service process element, a summary of the process stages (mean value EPG ) must be obtained for the relevant service group before the overall degree of fulfilment EP is calculated. This is also essential in order to ensure an equal weighting for all the elements. Here, different levels of achievement can be calculated for the individual service groups because of the selected process stages within the service process element. The mean value of all process stages EPG for each product group is calculated as : EPG [%] =

E1 + E2 +.......En ———————————————— [%] Number of process stages assessed

The overall level of achievement EG for the process audit is calculated as : EG [%] =

44

EDE + EZ + EPG + EK —————————————————— Number of process elements assessed

[%]



To complete this process assessment, the sub elements relating to the system in the service process element can also be shown and assessed separately. For services these are : EU1 [ %] EU2 [ %] EU3 [ %] EU4 [ %]

Personnel / qualification Provision of the service Communication / identification / information / data flow Elimination of errors / continuous improvement

By assessments covering several process stages the interfaces to the QM system are determined and deficiencies are highlighted. They are also of importance in the overall assessment (see "down grading criteria"). 6.3.3 Classification Overall level of achievement : Classification

Level of achievement EG [%]

Description of the classification

A

EG ≥ 90

Quality capable

B

80 ≤ EG < 90

Conditionally quality capable

C

EG < 80

Not quality capable

Rules covering downgrades : Reasons for down grading from "A" to "B" despite an achievement level of EG ≥ 90% One or more of the process elements D1 to D4 or process stages has been assessed as less than 80%. The level of achievement of the sub elements (provision of the service; communication; identification; data flow; failure analysis, corrections; continuous improvement process) is < 80%. At least one question from the process audit is assessed as 0 points. Reasons for downgrading to "C" despite an achievement level of EG ≥ 80% One or more of the process elements D1 to D4 or process stages has been assessed as less than < 70%. The level of achievement of the sub elements (provision of the service; communication; identification; data flow; failure analysis, corrections; continuous improvement process) is < 70%.


45


The rules for downgrading are to be used by the audit team and any downgrading must be recorded in the audit report. Calculations in the assessment matrix are rounded off mathematically and used in the intermediate stages. The overall and individual levels of achievement are determined from the whole numbers.

46



7

Using the questionnaire (process elements P2 to P7)

The questionnaire provided forms the basis for the auditor. The auditor selects the relevant process elements for the audit, depending on the phase in the product life cycle (see Fig. 2 in Section 2.1). Taking account of the identified product/process risks, additional specific requirements may be associated with the questions. The questions must be applied both to processes for material products and for auxiliary materials. Structure of the questionnaire The process element questions are structured as follows : questions asked minimum requirements / relevant for assessment possible examples of requirements and proof of compliance, depending on the product risk reference information The possible examples provide useful information on aspects which can be of particular significance, depending on the product/process. The relevant points must be selected on a product/process specific basis, expanded if necessary, analysed and evaluated. Here, the examples shown illustrate possible demonstrations of compliance which should be provided to a reasonable degree, depending on the product risk. An assessment is carried out, however, only with regard to minimum requirements, where assessment is relevant. For the auditor the audit consists of two mutually independent activities : 1.

The questions for the assessment are set out as closed questions which the auditor alone must answer, based on his findings.

2.

In order to obtain the answer regarding each requirement/question the auditor must ask open questions on the subject under review, based on the risks identified in the preparations for the audit.


47


Auditor alone

Assessment questions

Closed questions answered?

Assessed by auditor alone

yes / no

Fig. 6:

Open question 4

Open question 3

On site

Open question 2

Open question 1

Auditor in dialog

Audit questions On site Open questions

Audit pyramid

The process elements P3 and P4 are combined in terms of product and process to make the system easier for small and medium sized companies to use. If required, however, these two process elements can also be split so that product development and process development can be assessed separately. If process element P6 "Production" requires a breakdown into process stages, each process stage must be stated and must be assessed separately. In addition to the questions set out in this present VDA 6.3 document, it is worth creating databases in order to provide adequate coverage of the relevant product and process specific risks. The experience stored in such databases provides process specific support when considering the contents which require assessment. Based on the risk analysis described in Section 2.3, risks which are identified must be examined against the existing questionnaire and incorporated into the existing questions. If any item cannot logically be assigned to an existing question, further questions can be added. However, this means that the results will no longer necessarily be comparable. In such cases the assessment matrix will need to be adapted. A note must also be made on the cover sheet of the audit report, pointing out this fact.

48




49


3.5

3.3 3.4

P3 3.1 3.2*

2.7*

2.6

2.3 2.4 2.5*

2.2*

Planning the product and process development Are the product and process specific requirements laid down ? Has manufacturing feasibility been assessed in a cross functional manner, based on the requirements which have been determined for product & process? Are there plans for the product and process development ? Have the necessary resources been taken into account for the product and process development ? Is QM planning arranged for sourcing bought in products and services ?

Project management Is the project organisation (project management) established and are tasks & authorities specified for the team leader and team members? Are the resources required for the project development planned and available and are all changes displayed? Is there a project plan and has this been agreed with the customer? Is change management in the project ensured by the project organisation ? Are the responsible personnel within the organisation and in the customer's company involved in the change control system ? Is there a QM plan for the project ? is this implemented and monitored regularly for compliance ? Is there an established escalation process and is this implemented effectively ?

Questionnaire overview

8.1

P2 2.1

Questionnaire

8

x

x

x

x

x

x x

x

x

Potential analysis**

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

Transport Generic baseline*** & parts handling PR TO CO RI

50



5.5* 5.6 5.7

5.4*

P5 5.1* 5.2 5.3

4.8 4.9

4.7

4.6

4.3 4.4 4.5*

4.2

P4 4.1

Supplier management Are only approved/released and quality capable suppliers selected ? Are the customer's requirements taken into account in the supply chain ? Have target agreements for delivery performance been agreed with suppliers and put into operation ? Are the necessary approvals/releases available for the out sourced products and services ? Is the quality of the out sourced products and services ensured ? Are incoming goods stored appropriately ? Are personnel qualified for the various tasks and are responsibilities defined ?

Carrying out the product and process development Have the Product FMEA / Process FMEA been drawn up ? Are they up dated as the project progresses and are corrective actions laid down ? Are the stipulations arising from the plans for product and process development put into effect ? Are the personnel resources in place and qualified ? Is the infrastructure in place and appropriate ? Based on the requirements, are the necessary evidence and releases available for the various phases ? Are the productions control plans used for the various phases and are production, test and inspection documents derived from them ? Has a pre production run been carried out under serial production conditions to obtain production approval / release ? Are the planning activities associated with sourcing outside products and services implemented effectively ? Is the transfer of the project to production controlled in order to secure the product launch ?

x x

x

x x

x

x

x


x

x

x

x

x

x

x x

x

x

x

x

x

x

x

x

x

x



51


6.2 Are all production processes controlled ? (process sequence) 6.2.1* Are all the relevant details listed in the production and test/inspection documents, based on the production control plan ? 6.2.2 Are production operations checked / approved and are setting data logged ? 6.2.3* Can the customer's specific product requirements be satisfied with the production facilities used ? 6.2.4* Are significant characteristics controlled in production ? 6.2.5 Are scrap, rework and setting parts kept separate and identified ? 6.2.6 Is the flow of materials and parts secured against mixing / wrong items ?

Process analysis / production What goes into the process ? (process input) Has the project been transferred from development to serial production ? Are the necessary quantities / production batch sizes of incoming materials available at the right time and at the right place (stores; work station) ? 6.1.3 Are incoming materials stored appropriately and are transport facilities / packing arrangements suitable for the special characteristics of the incoming materials ? 6.1.4 Are the necessary identifications / records / approvals available and allocated appropriately to the incoming materials ? 6.1.5 Are changes to the product or process in the course of serial production tracked and documented ?

P6 6.1 6.1.1* 6.1.2

x

x

x x x x

x

x

x

x

x

x x x

x

x

x

x


x

x

x

x


52



How effectively is the process carried out ? (effectiveness, efficiency, elimination of waste) Are target requirements set for product and process ? Are quality and process data logged in such a way that they can be assessed ? In the case of deviations from product and process requirements, are the causes analysed and the corrective actions checked for effectiveness ? Are processes and products audited regularly ?

6.6 What should the process produce ? (process result / output) 6.6.1* Are the customer's requirements met in terms of product and process ?

6.5.4*

6.5.3*

6.5.1 6.5.2

6.5

6.4 What facilities are used to achieve the process ? (material resources) 6.4.1 How are the maintenance and overhaul of production facilities / tools controlled ? 6.4.2* Can the quality requirements be monitored effectively with the test, inspection and measurement facilities employed ? 6.4.3 Are the work stations and test/inspection areas suitable for requirements ? 6.4.4 Are tools, equipment and test/inspection facilities stored correctly ?

6.3 What functions support the process ? (personnel resources) 6.3.1 Are operators given responsibility and authority to monitor the quality of product and process ? 6.3.2* Are the operators able to carry out their allotted tasks and are their qualifications kept up to date ? 6.3.3 Is there a personnel employment plan ?

x

x

x

x

x

x

x

x

x


x

x

x

x

x

x

x

x

x

x

x

x

x

x

x



53


Customer support / customer satisfaction / service Are the customer's requirements satisfied regarding QM system, product (on delivery) and process ? Is customer support ensured ? Is the supply of parts ensured ? If there are deviations from quality requirements, are failure analyses carried out and corrective actions implemented effectively ? Is there a process which ensures that analysis of defective parts is carried out ? Are personnel qualified for the various tasks and are responsibilities defined ? X

x

x x

x

x

x

x x

x

x x

x

x

x

x


** questions in the questionnaire which must be audited at least within the framework of the potential analysis (P1) *** see Section 6.2.2 PR = process responsibility TO = target oriented CO = communication RI = risk oriented

Colour coding indicates a (*) question

Explanatory notes :

7.5 7.6

7.2 7.3* 7.4

P7 7.1*

6.6.2 Are quantities / production batch sizes aligned with requirements and are they forwarded to the next process stage in a targeted manner ? 6.6.3 Are products / components stored in an appropriate manner and are transport facilities / packing arrangements suitable for the special characteristics of the products / components ? 6.6.4 Are the necessary records / releases carried out and stored appropriately ?


54


Nur zur internen Verwendung für Flextronics Automotive GmbH&CoKG bestimmt. Process element P2 :

Project management (P2)

Possible examples of requirements and evidence, depending on product risk

Project management Notes (input output) and references

P2.1 Is the project organisation (project management) established and are tasks & authorities specified for the team leader and team members ? evidence of resources (specialists) internal sales The project management is in a position to meet the customer's customer requirements. for specific technologies internal specialist specification of tasks, expertise departments and responsibilities of the project A process for establishing the project management exists. suppliers leader / project team Internet portals project network for international The authority of the project leaders and team members is specified, together with links to the organisation. All the expertise projects (organisation) VDA vol. 4 project organisation chart required for implementation is established. VDA vol. 4 part 3 make up of the project team VDA vol. 4, Product & The suppliers are engaged in the project management customer's requirements Process FMEAs throughout. VDA vol. "Maturity level assurance for new parts " DIN 69901

Minimum requirements / assessment relevant:

8.2


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In particular the critical path is taken into account when planning resources.

Resource planning also takes account of suppliers.

Changes in the project must be notified at an early stage and agreed with the customer before they are implemented. If changes occur in the project (timings; extent of development, etc.) a check is made on resource planning and changes are made if necessary. This applies to changes caused by the customer, to in house changes and changes by suppliers.

The work load on personnel must be taken into account in the planning.

evidence of resources for specific technologies (specialists) evidence of resource planning (take account of other projects for other customers) planning takes account of the customer's project (short paths)

VDA vol. "Maturity level assurance for new parts"

customer Controlling department supplier internal specialist departments Personnel department

Are the resources required for the project development planned and available and are all changes displayed? *

Resource planning takes account of the customer's requirements, based on the contract covering the project. Resource planning (a cross functional, interdisciplinary team) for project management is established and implemented. The necessary project budget is planned and released. The technical personnel, with the relevant qualifications, are provided at the right time by the specialist departments.

P2.2

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A review is carried out at the milestones defined in the project plan to check that all planned activities are carried out and that the level of maturity required is achieved.

The QM plan must be part of the project.

A specified distribution system is in place to ensure that changes in the project plan are communicated internally. Changes to the project plan not initiated by the customer are discussed and agreed with the customer. The project takes account of critical delivery items. The critical path is generated from the project plan.

All in house and customer milestones are fully included in the project plan and are regularly adjusted to take account of changes.

Project plan with milestones Specific customer requirements regarding technologies and/or product groups Customer's project plan Customer's timing requirements Customer's milestones Customer's targets (metrics within the individual milestones) Milestone assessments (reviews) QM plan

Is there a project plan and has this been agreed with the customer ?

The project plan meets the customer's specific requirements.

P2.3

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customer suppliers internal specialist departments


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Nur zur internen Verwendung für Flextronics Automotive GmbH&CoKG bestimmt. Timing plans Process descriptions Change management Change request forms Change record Assessments of changes Change approvals

Is change management in the project ensured by the project organisation ?

Change management within the project meets the customer's specific requirements. Manufacturing feasibility checks on changes are carried out and documented. Changes are highlighted at the right time and agreed with the customer. All changes are documented using a defined process. Changes not initiated by the customer are discussed and agreed with the customer. Where changes have an influence on product quality the risks must be assessed with the customer. Suppliers are actively involved in change management (for critical aspects). Timings for changes to stop are defined and complied with. Any deviations from this rule are agreed in writing between customer and supplier. The period for changes before SOP does not jeopardize product quality. The implementation of changes must be assessed jointly, depending on the time remaining before SOP.

P2.4

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Nur zur internen Verwendung für Flextronics Automotive GmbH&CoKG bestimmt. Project plan Customer's milestones Customer's requirements regarding QM planning Customer's specifications Critical delivery items are taken into account in the QM plan Planned (status) reviews are carried out jointly, depending on the technology/product groups

VDA vol. 14 VDA vol. "Maturity level assurance for new parts"


Is there a QM plan for the project ? Is this implemented and checked regularly for compliance ?

A QM plan must be integrated in the project plan, covering all activities relevant to QM planning. The QM plan is drawn up in accordance with the customer's requirements/contract and contains both internal and external product securitisation criteria. The persons responsible for drawing up and maintaining the QM plan are defined and in place. The QM plan takes account of the timings in the overall project. It also contains critical delivery items. The QM plan takes account of all product and process specifications for verification and validation. Regular checks are made to ensure that the QM plan is implemented and achievement of the targets is monitored.

P2.6

Are the responsible personnel within the organisation and in the customer's company involved in the change control system ? * Persons responsible for change management and their customer Timing plans representatives, in the organisation, in the customer's suppliers Process descriptions Change management internal specialist organisation and at the suppliers are defined. There is a regulation covering dealing with changes (distribution, Specified responsibilities departments time permitted for processing and escalation paths. Change request forms Change record Customers' requirements for handling changes are complied VDA vol. 1 Assessments of changes with or specifically controlled and documented. VDA vol. 2 VDA vol. 4 VDA vol. 4 part 3 There is a defined regulation covering persons responsible for Change approvals VDA vol. 4 "Product & changes. Process FMEA" VDA vol. "Maturity level assurance for new parts"

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Nur zur internen Verwendung für Flextronics Automotive GmbH&CoKG bestimmt. Time periods for escalation are agreed, depending on the risk Contact personnel/ those making decisions in the escalation process are defined Escalation criteria and paths of communication are defined Reports of milestone assessments including actions

Is there an established escalation process and is this implemented effectively ? *

There must be an escalation model for deviations within the project which threaten the overall timing plan (risk management). An escalation process for the project is described & established. It takes account of specific customer requirements. The criteria for escalation are specified and responsibilities & authorities are regulated. The effectiveness of the function (escalation) is demonstrated by appropriate documentation. If special risks have been identified for technologies, suppliers and supply countries, this must also be taken into account in escalation management.

P2.7

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Process element P3:

All requirements regarding the product to be developed are Product/process development known. Requirements specifications The organisation has implemented a process for identifying the (product; process) customer's general QM requirements and also development Customer requirements and process requirements. Legal requirements Enquiry and contract documents are checked to make sure Purchasing conditions they are complete. QM specific requirements If the requirements cannot be achieved, the customer must be Quality agreements informed. Deviations may be "released" / agreed by the Documentation requirements customer (in the event of a contract). Logistics requirements (JIT, JIS, Customer requirements regarding the choice of sub suppliers on consignment) and/or materials to be used must be documented. Timing plans; technical delivery Special characteristics must be identified on the basis of in conditions house requirements, customer requirements, legal Access to portals (customer / requirements, production technology and characteristics arising supplier) from the application/use of the product. Information platform in Internet There are interface agreements for suppliers (set suppliers) Definition of responsibilities for sub specified by the customer. suppliers / service providers jointly with the customer (e.g., qualification, sample submissions, approvals, tests,...) within the framework of a performance interface Test regulations Product / process characteristics Order documents with parts lists, timings

P3.1 Are the product and process specific requirements laid down ?


Planning the product and process development

Planning the product & process development (P3)

Minimum requirements / assessment relevant:

8.3

VDA vol. 4 : "Economical process design and process control" VDA vol. 4, part 3 VDA vol. "Maturity level assurance for new parts"

Benchmarking, comparison with practice

Standardised production systems :

Notes (input output) and references


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Nur zur internen Verwendung für Flextronics Automotive GmbH&CoKG bestimmt. suitability of facilities & tools test/inspection facilities layout of work places and test/ inspection stations handling, packing, storage identification

Process development

specifications, drawings, special characteristics experience with previous products

Product development

Legislation/regulations (country specific) Environmental aspects; recycling requirements Evidence of capability

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Has manufacturing feasibility been assessed in a cross functional manner, based on the requirements which have been determined for product and process ? * The procedure for assessing manufacturing feasibility must be Product/process development Standardised production controlled. system methods : customer requirements Contract and enquiry documentation must be checked for timings; time frames Benchmarking, manufacturing feasibility. Definition of responsibilities for comparison with practice A process must be implemented which ensures that all sub suppliers – customer quality sensor requirements relating to the product are determined, including regulations, standards, legislation re Experience with previous any not explicitly stated by the customer (e.g., legal regulations) environmental compatibility Experience (lessons learned) and forward looking expectations products customer regulations must be included in the study. Production programme product liability requirements The release process before a quotation is issued to a customer planning capacities must be controlled. availability of incoming materials All areas involved/with responsibility must confirm the feasibility VDA vol. 4: "Economical qualified development personnel of the customer's requirements (Buying, Development, process design and manufacturing facilities, production Production Planning, Production, QM Planning, Logistics, ...). process control" locations Consideration capacity required for making samples, VDA vol. 4 : buildings, space prototypes, etc. must be taken into account in the quotation "Manufacturing facilities, tools, production, test and phase. feasibility analysis" inspection equipment; auxiliary The requirements set out in "P7" : "Customer support / VDA vol. "Maturity level tools, laboratory facilities, transport customer satisfaction / service“ are taken into account. assurance for new parts " facilities, containers, stores Product/process CAM, CAQ innovations Innovation assessment SPICE

P3.2


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P3.3

Standardised production customer requirements system methods : customer timings (milestones, Quality management of premises) suppliers serial production date, dates for setting dates for sample submissions supply release, supplier dates for development phase approval and stop on samples, production tests, tools, changes lead times process audits to verify/ methods (QFD, DOE; FMEA; validate quality gates statistical test planning, ...) QM planning (reliability tests, function tests, trialling plan) VDA vol. 3, part 1 capacity studies VDA vol. 4 prototypes / pre production VDA vol. 4 : "Product & setting and monitoring targets for process FMEAs" maturity levels VDA vol. 4 part 3 regular status checks on the VDA vol. 13 progress of the development VDA vol. "Maturity level (reviews) assurance for new parts" Information / reporting to project management project plans for investment items, facilities (structures and equipment, production machinery, etc., ..) procedure if the customer changes dates and quantities Logistics planning covering dates, for supply approval, prototypes & pre production and start of full production tool timing plans

Are there plans for the product and process development ?

At a level below the project plan, specific plans are drawn up for the development of the product and process. These plans contain details of timing dates and periods for certain develop ment and planning activities, milestones, production tests, etc. The milestones are aligned with the customer's milestones. Metrics (RGA) are laid down for the individual milestones and the critical path is identified. The internal development plans are aligned with the relevant project timing plan, particularly with regard to metrics for the individual milestones. It is ensured that development plans are always up to date. QM planning must be integrated in the development plans, including test/inspection planning, the planning of test and inspection facilities and risk analyses. In the development phase, suitable methods must be used to secure the product development so that when the product goes into serial production it fulfils the installation conditions (function, reliability, safety, security). Product & process FMEAs are part of the QM planning. Experience in technology for serial production is demonstrated. External processes and services are an integral part of the project planning.

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Personnel qualification requirements and the facilities to be made available must be determined and documented before starting any development. Capacities for building prototypes, samples, 0 production, production tests and serial production must be planned. Regular demand analyses must be carried out during the development regarding possible bottlenecks & additional demand. Resource planning must be adapted regularly to changes in the project. Outside processes and services must be taken into account.

Production locations, tools, production, test & inspection facilities Test/inspection/laboratory equipment (internal & external) CAD, CAM, CAE equipment Availability of materials Availability of qualified personnel for the various tasks Communication facilities (e.g., remote data transmission) Resources for problem solving processes in the development phases Flow of information

VDA vol. "Maturity level assurance for new parts"

Standardised production system methods:

Have the necessary resources been taken into account for the product and process development ?

A procedure for determining resources must be controlled. This includes determining the availability of qualified personnel, budgets, infrastructure, test equipment, laboratory facilities, machines, plant, etc. (loading on machines and plant).

P3.4

provision of production, test and inspection facilities, software, packing security concept for changes (launch problems, etc.)


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P3.5 Make or buy decision Analysis of the supply market Activity plan for suppliers Description of supplier management Component classification Risk assessment for bought in parts / suppliers Definition (if relevant) jointly with the customer of responsibility for sub suppliers (supply chain) and service providers (e.g., covering qualification, sample submissions, releases, checks, etc.,..) within the framework of a performance interface agreement with the sub supplier. Particular attention to be given to suppliers specified by the customer Suppliers of services (development, laboratory, maintenance, etc.)

Is QM planning arranged for sourcing bought in products and services ?

A process must be implemented to plan and check essential supplier activities. This also includes the strategy for awarding the contracts, the extent of the contracts and the target date for the contracts. Potential suppliers are known, including those already appointed. The latest dates for awarding the contracts have been agreed across the various departments. Suppliers of plant, machinery, tools, services and procedures are integrated in the process development. It must be possible to trace the awards of contracts to suppliers via appropriate documentation. Timing dates for awarding contracts, reviews and acceptance checks are included in the process development plan.

VDA vol. 2 VDA vol. 4 VDA vol. 6, part 7 VDA vol. "Robust production process" VDA vol. "Maturity level assurance for new parts"

Standardised production system methods :

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Process element P4:

Carrying out the product and process development

Carrying out the product and process development (P4)

The effectiveness of the actions must be demonstrated.

Possible examples of requirements and evidence, Notes (input output) depending on product risk and references Minimum requirements / assessment relevant P4.1 Have the Product FMEA / Process FMEA been drawn up ? Are they up dated as the project progresses and are corrective actions laid down ? Customer requirements, special In the development phase it must be ensured by means of Standardised production characteristics, important FMEAs that the product and process meet the customer's system methods : parameters requirements in terms of function, reliability, etc. Functions, installation dimensions, Process FMEA Changes to the product and process must be evaluated afresh. If appropriate, a new analysis should be carried out in materials VDA vol. 4 agreement with the FMEA team and the project manager. Environmental aspects VDA vol. 4 : “Product Once actions have been completed, and up dated FMEA is Customer requirements for and Process FMEAs” required in regard to the probability of occurrence and the assessments VDA vol. 14 probability of detection, with the focus on the verification / Legal requirements VDA vol. “Maturity level validation of the Product in the project. Experience from previous projects assurance for new parts” The FMEA must be part of the development plan. Experience from similar products The start phase, the interface to the Process FMEA, up dating already in serial production loops, etc. must be clear from the Product FMEA. Product specific actions from the The execution of FMEAs must be controlled. Process FMEA Interfaces to customer and suppliers are defined. Process specific actions from the Any evaluation requirements set by the customer are Product FMEA (Design FMEA) documented and applied. Transport (internal / external) and Personnel from production planning and the future production its effect on product characteristics location are members of the FMEA team. Tracking actions When drawing up the Product FMEA the proposed production Documentation of FMEA meetings location must be involved. Change record Special characteristics (SCs) are identified, highlighted in the Lessons learned FMEA and secured by appropriate actions.

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Nur zur internen Verwendung für Flextronics Automotive GmbH&CoKG bestimmt. Project sequence planning Trial planning Methods (QFD, DOE; FMEA; statistical trial planning, ...) Fitment trials and system tests, more secure installation of individual components Use in the entire supply chain Poka Yoke principles Life / endurance tests Environment simulation test, ... Environmental compatibility investigations, inc. disposal Test/inspection plan Process description to permit QM planning

VDA vol. 4 VDA vol. 4 : "Product and Process FMEAs" VDA vol. 5 VDA vol. 14 VDA vol. : "Robust production process" VDA vol. "Maturity level assurance for new parts" DIN EN ISO 9000

Standardised production system methods : Product FMEA Process FMEA

Are the stipulations arising from the plans for product and process development put into effect ?

In the development of new products and processes, quality planning takes account of installation requirements for the product from the very earliest stages. The methods set out in the development planning for product development are used so that, after accumulated experience has been implemented and the product has gone into serial production, it will meet the specified installation conditions in terms of function, reliability and safety/security. The QM planning must include a trialling plan for the parts, sub assemblies and materials, including the manufacturing processes from the prototype and pre production phases. There is a QM plan (to DIN EN ISO 9000) for the prototype and pre production phases. There are records of knowledge gained from the prototype phase and pre production phase, to be taken into account in the serial production phase. The planning of test, checking and inspection equipment is part of the QM planning. Requirements covering this equipment have been laid down and implemented.

P4.2

Interfaces between Product and Process FMEAs are controlled There is a control loop for up dating FMEA s (frequency and reasons).

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Are the personnel resources in place and qualified ?

There must be a process covering general personnel planning. The personnel resources must be planned and available at the specified timing dates. Personnel must be qualified for the relevant tasks. This also applies to the service personnel employed in the product development process. Appropriate certification must be available. Determining resources is associated with the availability of qualified personnel. During product development a regular analysis must be carried out of possible bottlenecks and additional demand. Outside processes and services must be taken into account. There is capacity to achieve the prototype build, sample build, 0 production, production test and serial production

P4.3 Customer requirements Requirements profile for the relevant locations Determine the need for training Proof of training Knowledge in the various departments Project management DOE, QFD FMEA, Statistical trial planning Statistical process control(SPC) Suitability of test processes CAD/CAM, CAE Six Sigma Knowledge of foreign languages

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Is the infrastructure in place and appropriate ?

Note : Capacities must be available at an appropriate time before the customer's production launch.

There must be a process to determine resources. This refers to the availability of test equipment, laboratory facilities, machinery and plant and the loads on machinery and plant. An infrastructure (i.e., a system of facilities, process equipment and supporting services such as transport or communication) must be determined and provided. The capacities required must be taken into account in the calculations for the quotation. They must be available, or be planned to be available at the specified times. The facilities required for this must be set up in the project. Regular analyses of demand are carried out in the course of the product development, covering possible bottlenecks and additional demand. There must be transparency regarding the stages involved in determining the possible existence of bottlenecks (take account of variant structures !).

P4.4 Prototype builds Standardised production Planning of trials system methods : Trialling facilities/ test laboratory/ VDA vol. "Robust test equipment production process" Inspection facilities / equipment VDA vol. "Maturity level Buildings, space assurance for new parts" Factory structure plan Planning plant & machinery Customer requirements/ quantities Quantities per facility/ machine (max. quantity achieved in the process operation) Production cycle times Availability of incoming materials Down times Logistics capacity calculation Transport paths Transport facilities, containers & stores Availability of materials Capacity before production launch (system loading)

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Verification and validation for product and process are ensured.

PPAP (product and production process approval process) must have been carried out. PPAP is the final verification of the product, production and transport planning process and, if positive, results in release for serial production. Reference parts and products from sample submissions must be retained in accordance with the customer's requirements.

Specifications; drawings, customer's specifications FMEAs Product trials (e.g., fitment check, functional test, life/endurance test, environment simulation) Test/inspection reports Pre production parts Trial samples Commissioning Packing Logistics concept (e.g., suitability of the packaging checked by trial shipments) Tools, machines, settings, test and inspection facilities Proof of capability of significant product/ process characteristics Production tests Capacity studies Certification covering bought in items/ suppliers Legal releases Development releases from the customer Results of sample submissions Tooling acceptance checks

VDA vol. 2 VDA vol. 4 VDA vol. "Robust production process" VDA vol. "Maturity level assurance for new parts "

Based on the requirements, are the necessary evidence and releases available for the various phases ? *

Releases / evidence of suitability must be produced for all parts, sub assemblies and bought in items, in accordance with the development timing plans. Regular status reports are issued for the project, based on the project plan and the customer's milestones. Rules covering assessments/metrics must be defined.

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Nur zur internen Verwendung für Flextronics Automotive GmbH&CoKG bestimmt. Provision of facilities and equipment Timely, forward looking provision of measurement technology Checks at useful stages during the production of the product Clarification of acceptance check criteria Reaction plan Rework

Are the production control plans used for the various phases and are production, test and inspection documents derived from them ? The production control plan must The production control plan must contain the parts, sub Standardised production contain details of : assemblies, assemblies and materials, including the system methods : Section audits, manufacturing processes which are associated with the product. the sequence of the process Product audits, The production control plan must be drawn up for the following stages Production test phases : stipulation and identification of Serial production release special characteristics Prototype phase (if required by the customer) establishment of the test/ VDA vol. 4 : "Product inspection sequence plan, the & Process FMEAs" Pre production phase frequency of tests & inspection/ VDA vol. "Robust cycle production process" Serial production phase Gauges and test/inspection VDA vol. "Maturity level equipment to be used assurance for new parts" Documentation of test / The question is not relevant for product development ! inspection results

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Has a pre production run been carried out under serial production conditions to obtain production approval / release ? Customer requirements A pre production/ production test must be carried out in order to Standardised production Specify minimum quantities assess all production factors and influences at the appropriate system methods : Process audit Process capability study time and make any necessary corrections. Qualifications matrix Measurement equipment It should be possible to prevent bottlenecks and quality problems Rapid detection of capability in serial production. problems and elimination Production maturity of the The planning of a pre production run and the agreements for of defects production facilities and executing a pre production run are set out in P4.9 and P6.1.1. Eliminating failures equipment (measurement Critical product features are taken into account. Supplier management Proof that the agreed quantities can be achieved has been reports) Measurement equipment provided. Handling, packaging, capability checks Peak demands and agreed flexibility are taken into account. identification, storage Production programme Personnel qualification planning Note : Depending on the phase at which the audit is carried out, Work/inspection instructions certain production tests may still be in the planning stage ! Layout of work places and VDA vol. 2 inspection stations VDA vol. 4 The question is not relevant for product development ! Initial sample checks VDA vol. “Robust Planning the initial sample production process” submission sequence and its contents Production tests in accordance with the customer’s timing plan Detect errors in parts lists and scheduling

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Process development must define and verify the status of the products and processes to be used in the various phases.

Special characteristics, legal Standardised production requirements (e.g., materials system methods : Process audits requiring declaration) Process acceptance Reports of meetings to reach checks agreement, workshops, simultaneous engineering teams. APQP Supplier management Performance interface agreements VDA vol. 2 Items to be considered include : VDA vol. 4 Releases VDA vol. "Robust Identification of tools production process" Layout/quantity of tools Audit reports Visit reports Certification documents, Supplier's project reports Milestone assessments Demonstrations of capability Tolerance studies Load tests Reference samples QM plan

Are the planning activities associated with sourcing outside products and services implemented effectively ?

The organisation must monitor regularly the progress at the suppliers' premises with the execution of the project. Appropriate milestones and check lists are included in the project management of suppliers. Tracking activities at the suppliers' premises are carried out, deviations are detected and suitable actions are introduced.

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A procedure to secure the launch must be described and installed in order to secure the launch phase and a robust production process. A check on launch security must be carried out for all new and modified parts which need to be submitted for initial sample approval/release.

Proof is available of machine capability studies to cover all special characteristics. Tools, test, measurement and inspection equipment are available in sufficient quantities.

Specify responsibilities Standardised production Customer requirements system methods : Product FMEA Transfer report/check list Process FMEA Acceptance check report Specify additional, individual VDA vol. 2 checks which are not carried out VDA vol. 4 on the fully assembled product VDA vol. "Maturity level Specify test/inspection assurance for new parts" frequencies, quantities, VDA vol. "Robust parameters, duration production process" Specify a procedure for the immediate execution of failure analysis and introduction of corrective actions Definition of failure rates Specify the identification of parts from the launch phase

Is the transfer of the project to production controlled in order to secure the product launch ?

There must be a controlled process for the structured transfer of responsibility between the development team and production. The customer's requirements are taken into account. An internal production process release check must have been carried out in full before the first shipment of production items. A production test has been carried out at the production location in accordance with the customer's requirements. Actions arising from the production test have been completed on time.

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Nur zur internen Verwendung für Flextronics Automotive GmbH&CoKG bestimmt. Process element P5: Possible examples of requirements and evidence, depending on product risk

Supplier management

supplier meetings/regular support existence of defined and documented selection criteria for selecting suppliers Evidence of support programmes for suppliers not meeting the selection criteria evaluation of the quality capability of the QM system – e.g., audit results / suppliers' certificates Quality capability assessments (self assessment, audits) by other customers / OEMs Assessment of quality perform ance on a cross functional basis (quality/costs/service) Releases (audits) for those suppliers who influence special characteristics. This also applies to : development suppliers and prototype suppliers suppliers of non material products such as software

Are only approved/released and quality capable suppliers selected ? *

Before suppliers are specified, an assessment of the QM system (certification / auditing) must be obtained. Evidence must be provided of the timely planning for selecting and assessing new suppliers, based on selection criteria meeting the customer's project plan. For serial production it must be ensured that only suitable suppliers are used. IF there are deviations from the organisation's own selection criteria, the further procedure must be decided on. Experience from evaluations of quality performance assessments must be taken into account for existing suppliers. Risks in the supply chain must be determined and assessed and must be reduced by appropriate action (strategy for emergencies) Process audits or comparable methods must be planned and executed in all phases for the suppliers selected (depending on the risk classification of the product). It must be ensured that the suppliers have sufficient capacities – this also applies to changes in quantities.

P5.1

Minimum requirements / assessment relevant

8.5 Supplier management (P5)

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Nur zur internen Verwendung für Flextronics Automotive GmbH&CoKG bestimmt. transmission of requirements (tolerances, timing tracks, process acceptance checks, releases, complaints, …) while ensuring change management Contract documents can contain reference information , such as requirements from the product or component specification, from QM agreements and other relevant regulatory documents evidence of other regular communication

Are the customer's requirements taken into account in the supply chain ?

Suppliers in the supply chain must be controlled and monitored in terms of their engagements and performance (depending o the risk classification of the product). Interfaces are recognized and secured. The forwarding of customer requirements must be controlled and traceable. Change management must also be taken into account.

P5.2

suppliers of plant, machines, tools service partners/external laboratories extended work benches (in house or outside companies)

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Nur zur internen Verwendung für Flextronics Automotive GmbH&CoKG bestimmt. VDA vol. 2 VDA vol. 4

Have target agreements for delivery performance been agreed with suppliers and put into operation ?

Workshops (inter disciplinary Target agreements must be agreed and implemented with working groups) suppliers to cover delivery performance, to ensure the continuous specify measurable targets for improvement of products and processes (quality control circle). In the event of discrepancies actions must be agreed and their quality, price & service such as : implementation monitored, including timing dates. • reducing the degree of inspection while simultaneously increasing process reliability • reducing scrap ((internal/external) • reducing work in progress • increasing customer satisfaction • reducing ppm rates within the framework of a zero defect strategy (on a yearly basis as a minimum) • eliminating special transport

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In the case of modules (unless otherwise agreed) the supplier has full responsibility monitoring the quality of all the individual components. Evidence must therefore be provided of comprehensive change management, from the customer to the sub supplier.

customer information (spec ifications, standards, test and inspection regulations) Approvals/releases for build samples, trials, … PPF reports in line with VDA vol. 2 Evidence of capability for special characteristics compliance with EU safety data sheets and "list of declarable materials in vehicles – contents of parts & materials" (IMDS/ REACh) Assessments of reliability Requalification checks & reports

VDA vol. 2 VDA vol. 4 VDA vol. “Maturity level assurance for new parts”

Are the necessary approvals/releases available for the out sourced products and services ? *

An approval/release must be issued for all out sourced products and services before they are used in serial production.

P5.4


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Test, inspection and measurement equipment must be stored in an orderly manner and associated work stations must be laid out appropriately (to prevent damage, contamination noise and to ensure good lighting conditions, tidiness, order and, if relevant, air conditioning).

Requalification checks are carried out to the customer's requirements.

For safety relevant parts, specific agreements must be made with the supplier regarding the handling of processes and tests/ inspection, as well as archiving the results.

To monitor the quality of the out sourced goods and services, regular checks are carried out, documented and evaluated.

QM agreements, inc. escalation mechanisms Reports of quality meetings Agreement and tracking of improvement programmes Evaluation of main failure areas/ problem suppliers ppm assessments, 8D reports Adequate test/inspection facilities (internal & external laboratory & test/checking equipment; tests to ISO/IEC 17025) for raw materials and finished parts Gauges/jigs provided by others Drawings, ordering regulations, specifications Alignment of test / inspection procedures, processes and frequencies Capability certification Requalification checks/reports Test certificates (also for parts made in house or on extended work bench basis)

Is the quality of the out sourced products and services ensured ? *

The capabilities and performance of a supplier must be checked at defined intervals and the results must be logged and evaluated in a report (supplier listing). In the event of negative results, qualification programmes must be laid down. Evidence must be provided that the actions have been implemented.

P5.5 VDA vol. 2 VDA vol. 4 VDA vol. 5

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Material stock figures in the stores administration system agree with the quantities actually in stock.

FIFO and batch traceability are ensured when the materials and goods are processed further.

Incoming materials and goods containers must be placed in stores in accordance with their release status so that they cannot be damaged or mixed up. "Suspect" and quarantined products must be stored securely to prevent access to them.

P5.6 Are incoming goods stored appropriately ? Packing Stores administration system Batch related usage Cleanliness and tidiness Climatic conditions Protection against damage, dirt, corrosion Identification (traceability, inspection status, work sequence, usage status) Mixing/false identification are prevented Quarantine stores; quarantine areas FIFO (first in/ first out)


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Are personnel qualified for the various tasks and are responsibilities defined ?

Knowledge is available of previous complaints regarding relevant out sourcing requirements.

Training needs must be determined for each employee in terms of the task and qualification must be provided accordingly.

A job description must be available for functions. Product / specifications/ special customer requirements Specialized knowledge of product characteristics and production operations for parts of modules Standards / legislation Packing Assessment methods (audits, statistics, …) Quality techniques (8D method, cause & effect diagrams, …) Complaints & corrective actions Foreign languages Maintaining qualifications

A description must be provided of what responsibilities, tasks and Knowledge must be available authority the employees have in their relevant task areas. regarding :

P5.7 VDA vol. 2

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Nur zur internen Verwendung für Flextronics Automotive GmbH&CoKG bestimmt. Process element P6 :

What goes into the process ? ( Process input)

Serial production (P6)


Serial production


Project status reports Standardised production Transfer reports system methods : Product FMEA Milestone reports Process FMEA specified actions with implementation timing plan VDA vol. 2 Approved/release suppliers VDA vol. 4 Process FMEA and actions VDA vol. "Robust Product FMEA and actions production process " Transfer report VDA vol. "Maturity level Production approval/release report assurance for new parts" IMDS material data sheet Customer approval/release (product release; process release) Special releases with time restrictions (if relevant) PPF (PPAP) report

Has the project been transferred from development to serial production ? *

A process is defined for transferring responsibility between development and production and is controlled. A complete production process and product approval/release with all the documentation required must take place before the first production shipment The PPF (PPAP) is the final verification of the product, production and transport planning process and a positive result lead to approval/release for serial production. Conditions for serial production release are agreed with the customer. Reference parts from sample submissions must be retained in accordance with the customer's instructions. The process for securing the launch of production is described and installed, in order to shorten the run up phase and ensure a robust production process. A process to secure the launch must be carried out for all new parts and modified products requiring initial sample submission and approval. A production test has been carried out to the customer's requirements and assessed positively. Actions arising from the production test have been completed on time. Production facilities/new parts have been sampled with positive results A process for the further development of the product and process FMEAs is defined and controlled.

P6.1.1


P6.1

8.6


83


Are the necessary quantities / production batch sizes of incoming materials available at the right time and in the right place (stores; work station) ? The right product (incoming material, part, component,...) must be Sufficiently appropriate transport Standardised production facilities provided to the agreed quality, in the right quantity and the right system methods : Standardised material Defined storage points packing, with the right documentation, at the agreed time and at stocks Minimum/no intermediate stores the agreed place. Parts/components must be available at defined Marking, identification, KANBAN Just in time store locations/work stations. lettering Stores administration This process must be controlled (KANBAN, Just in time, FIFO). Smoothed production/ Change status Order quantities/batch sizes must be taken into account in order pull production Only OK items to be forwarded to ensure that parts/materials are available to meet demand at Production flow Quantities to be logged and the relevant work place and must be aligned with upstream Types of wastefulness assessed processes. Information flow The return of unwanted parts (residual quantities) after the order Process FMEA Return of parts not required has been completed must be controlled, including a count of the VDA vol. "Maturity level (residual quantities) parts involved. assurance for new parts" Stock levels Production quantities tailored to VDA vol. "Robust the customer's requirements production process " Minimum stocks aligned with the production requirement (value flow analysis)

P6.1.2

Evidence of feasibility investigations has been provided for all special characteristics. Tools, test, inspection and measurement facilities are available in sufficient quantities. Responsibility for serial production has been transferred from the project team to the production plant.

84



Are incoming materials stored appropriately and are transport facilities / packing arrangements suitable for the special characteristics of the incoming materials ? Customer specific packing regulations must be taken into account Stock levels Standardised production Storage conditions / implemented throughout (including in production processes). system methods : Visual safety Approved special and standard During manufacture and internal transport and also when being instructions transport containers are available transported to and from service companies, suitable transport Material stocks Customer specific packing units must be used to protect the products from damage and "5W" method regulations contamination. Marking, identification, Internal transport containers Stores areas, work stations and containers must be appropriate lettering Protection against damage for the tidiness and cleanliness required for the parts/products. Set training Positioning of parts at the work Cleaning cycles are defined and monitored. station The supply of parts/materials at the work station/on the assembly Process FMEA Tidiness, cleanliness, no over line must provide for safe handling. VDA vol. "Maturity level filling (storage points; containers) Specified storage times and use by dates for special materials/ assurance for new parts " Monitoring of storage times parts must be monitored by appropriate methods (max. and min. Environmental / climatic effects VDA vol. "Robust storage times; specified intermediate storage times). production process " Critical operating and auxiliary materials for plant and machinery with a direct effect on the product/product quality must be monitored accordingly. Parts, incoming materials, critical operating and auxiliary materials must be protected against environmental/climatic influences.

P6.1.3


85


Are the necessary identifications / records / approvals available and allocated appropriately to the incoming materials ? Customer specifications and Released incoming materials must be clearly identified and Standardised production regulations for identification and system methods : recognizable. The release status must be clear from the traceability (legal requirements; identification. VDA vol. 1 product liability act) The release identification on bundles, batches, load containers VDA vol. 2 Process for the release of and parts must be specified. VDA vol. 4 products/materials Customer specific regulations for the release of products must be VDA vol. "Maturity level Identification of released parts/ taken into account. assurance for new parts " materials (adhesive or tie on It must be ensured that only released materials/parts are VDA vol. "Robust labels, tracking dockets, …) forwarded to production/the next process and used. production process" records of releases Traceability of releases must be ensured. Traceability system/concept The traceability of the units produced must be ensured within a Documentation of special reasonable framework (e.g., documentation covering the use of releases (quantity; duration; batches). type of identification, ..) Depending on the product risk, traceability must be guaranteed across the entire process chain, from sub supplier to the customer Special characteristics Production control plan Customer identification and traceability requirements must be VDA data sheets taken into account. Special requirements for the identification of spare pars must be taken into account. Legal requirements and the product liability act must be observed. Characteristics subject to special documentary and archiving requirements must be recorded accordingly.

P6.1.4

86



Are changes to the product or process in the course of serial production tracked and documented ?

The progress of a change from the initial change request through to implementation must be clearly described and responsibilities must be controlled. A process regulating the change release must be implemented.

Change release by the Standardised production organisation and the customer system methods : (feasibility; interface to components, effect on costs VDA vol. 2 and timing,…) VDA vol. 1 Forward changes to process Changes must be agreed, approved and released with the VDA vol. "Robust development, production areas, customer. If necessary a new PPF (PPAP) must be produced. production process " stores or to sub suppliers This refers both to product and process changes. VDA vol. "Maturity level Track the level of implement Documentation of change levels must be fully traceable assurance for new parts " ation of the change (overview throughout. with status) This requires the implementation of a suitable system which Documented change record controls the defined process sequence. (part life history) Up date documents involved This applies equally in the supply chain. (drawings; instructions, …) The effects of changes must be analysed, documented and Up date the FMEAs (product assessed, before the associated changes are implemented (risk and process) analysis, production control plan, …). Verification and validation of changes, including document Conformance with the customer's requirements must be checked ation before the change is released and implemented. Controlled introduction of It must be ensured that, at all times, the correct design level of the changes and modified incoming materials is used and the correct design level of the products/parts finished product is manufactured and shipped to the customer. Produce a security stock in advance of major changes Characteristics subject to special documentary and archiving which requirements must be tracked and documented accordingly. require production to stop for their implementation It is ensured that only current / valid documents are present at Throughput times for changes work stations. (customer's regulations, ...) Change levels of test/inspection equipment, gauges, tools and drawings

P6.1.5


87


Are all production processes controlled ? (process sequence)

Process analysis / production

Possible examples of requirements and evidence, Notes (input output) depending on product risk and references Minimum requirements / assessment relevant P6.2.1 Are all the relevant details listed in the production and test/inspection documents, based on the production control plan ? * Production control plans The production and test/inspection documents (production control Standardised production Process parameters (pressures, system methods : plan, work plan, manufacturing instructions) must be available at the work place / inspection station. Checking/inspection temperatures, times, speeds, ....) characteristics, facilities, methods, frequencies (cycles) and re Data regarding machines/tools/ Standard work sheets, qualifications must be described and defined in these documents. auxiliary aids (tool and machine station sheets Process parameters influencing product characteristics and/or numbers) Standardised work place quality must be fully stated. Inspection regulations (special Tolerances must be stated for process parameters and characteristics, attributive documentation checking/inspection characteristics. characteristics, inspection Metrics tables The control limits in process control charts must be specified, equipment, methods, inspection Section checks/ section recognizable and traceable. frequencies) audits Regulations regarding location/ Quality alarm / quality Non compliances and actions taken regarding process reference points stop / machine stop requirements and inspection characteristics must be documented. Control limits in process control Quality and production charts level information Data regarding machines/tools/auxiliary aids (tool and machine Machine and process capability Process security plan numbers) for critical products and processes must be stated in the certification Inspection equipment work plan, production control plan/inspection instructions. Operating instructions, handling monitoring / measure instructions ment device capability Conditions governing rework are specified and secured within the Work instructions studies process (parts identification; fresh checks/inspection, …). Checking/inspection instructions Quality store in the The quality checking/inspection concept complies with the Records and documentation assembly area customer's requirements/agreements made with the customer. covering checks/inspection and actions/corrections made in the process

P6.2

P6:

VDA vol. “Maturity level assurance for new parts “ VDA vol. “Robust production process” Information on current problems Maintenance instructions

88




89

Nur zur internen Verwendung für Flextronics Automotive GmbH&CoKG bestimmt. Release for production Standardised production Changed product/process system methods : Check lists Shut down of facilities/break in Process description process; repeat release for Qualification, production Qualifications matrix Repair, tool change On site measurements Change of material (e.g., a Release for full different batch) Changed production parameters production Process security plan First off parts checks with documentation VDA vol. 2 Up dated parameters VDA vol. 16 Special processes requiring VDA vol. 19 tidiness and cleanliness at the VDA vol. "Robust work place production process" Packing level, release level and VDA vol. "Maturity level change level for tools and assurance for new parts” inspection equipment Setting plans, setting aids, comparison aids Flexible tool change over devices Limit samples Machine capability studies

Are production operations checked / approved and are setting data logged ?

"Approval/release for serial production" is the contract related initial and repeat release for the start of production. The approval/ release is required for product and process and must be issued in writing by authorised personnel, based on acceptance criteria. At this point problem areas detected in previous serial production must be eliminated. The approval/release checks must be carried out to clear checking/inspection instructions to ensure repeatability. If production is to recommence after parts have been taken for test/inspection, the products must remain quarantined until these parts have been approved/released. Rework must be included in the approval/release processes. To ensure the constant quality of parts produced, fresh evidence must be produced of a secure production process after any break in production (e.g., night time shut down in the case of a 2 shift operation, a change of tool, material, batch or product). Corrective actions are also regarded as a break in production. A repeat release must always be carried out for the product and also for the process. Special processes (gluing, welding, soldering, ...) are controlled and require appropriate documentation in addition to the release. Responsibilities for the repeat release are specified. The repeat release for production must be documented and the quantity required for release must be defined. If it is not possible to carry out the release process immediately after a break or problem in production, access must be assured to all parts produced until the repeat release has been carried out. Setting plans (setting data, programmes, etc), product specific setting up plans and setting aids/reference parts must be available at the work place/at the station. For comparison purposes, inspection and limit samples must be available at the relevant work place. Non compliances and actions taken are documented.

P6.2.2

90



There is sufficient production capacity, taking into account levels of scrap and rework.

Cleanliness requirements for production are defined and implemented by reference to the product risk.

Evidence of machine/process capability for special character istics/ process determining parameters Compulsory control of important parameters Ishikawa cause & effect analysis Warning of deviations from limit requirements/parameters (e.g., a lamp, horn or automatic shut down) Feed and removal systems Poka Yoke solutions Inspection process capability Measurement equipment capability Measurement reports Inspection reports (e.g., measurement reports) Results of product audits Replacement tools Reproducibility of fixtures and fittings, ... Maintenance/overhaul level of tools/plant/machines (including planned maintenance) Planning for emergencies

VDA vol. 5 VDA vol. 6 Part 7 VDA vol. 19 VDA vol. "Robust production process" VDA vol. "Maturity level assurance for new parts "

MSA, manufacturing capability study "5W" method 8D method Ishikawa fish bone diagram Pareto analysis SPC Six Sigma Poka Yoke

Standardised production system methods : Failure prevention Failure avoidance SPC Machine stop if specified requirements are not achieved

Can the customer's specific product requirements be satisfied with the production facilities used ? *

It must be shown that the processes are implemented to the customer's requirements with the existing production facilities and that the resulting products comply with the customer's specifications. The production facilities, machines and equipment must be able to maintain the specified tolerances for the relevant characteristics. Process capability must be determined for significant product/ process characteristics and continually demonstrated. For short term process capability (machine capability studies) and provisional process capability, a figure of Cmk / PpK >= 1,67 must be achieved. For long term process capability (Cpk) the minimum requirement is Cpk >= 1,33. Note must be taken of customers' regulations, requirements for proof of capability of significant characteristics. In the case of significant characteristics where no capability level can be demonstrated, 100% inspection is required.

P6.2.3


91


Production processes are controlled and process capable. Quality records are specified for significant characteristics (type and duration of archiving) and are agreed with the customer. In the case of characteristics subject to special documentary and archiving requirements, customer specific requirements must be observed.

Product FMEA / Process FMEA Standardised production Production control plan system methods : Scrap/ separation of Quality records, statistical waste assessments Standardised equipment SPC assessments; quality Process security plan control charts VDA vol. 1 Proof of capability (Cpk, Cmk, VDA vol. 6 Part 5, production capability checks, …) Product audit Proof of suitability of inspection VDA vol. "Robust processes production process" Test/inspection results VDA vol. "Maturity level Results of product audits assurance for new parts " Independent of operators (Poka Yoke)

Are significant characteristics controlled in production ? *

Significant product characteristics and process parameters are identified in the production control plan and are monitored systematically (SPC). Control limits are defined and effective control action is taken in the event of deviations. Records are maintained of non compliances and corrective actions. Non compliances affecting the characteristics of the product must be approved by the customer.

P6.2.4

92



The storage and retention of setting parts, reference parts and tools must be displayed and identifiable.

Non released parts, defective parts and/or parts with defective characteristics must be separated and documented. They must be securely removed from production operations. Containers for scrap and rework must be appropriately identified. Quarantine stores and quarantine areas must be clearly recognizable (unauthorized access must be prevented).

Identification of scrap, rework Standardised production and setting parts system methods : Separation of scrap and Identification of containers for waste scrap, rework and setting parts Standardised equipment Defined scrap/rework stations in Process security plan production Quarantine stores & areas Identification of internal residual VDA vol. 4 quantities, including storage Records of rework and scrap VDA vol. "Robust (sorted by characteristic) production process" VDA vol. "Maturity level assurance for new parts "

P6.2.5 Are scrap, rework and setting parts kept separate and identified ?


93


Is the flow of materials and parts secured against mixing / wrong items ?

Internal residual quantities must be logged by quantity and suitably identified and stored.

Product / Process FMEA An appropriate and optimum flow of parts and materials must Poka Yoke actions ensure that mixing / confusion between similar items cannot occur. Poka Yoke or other methods may be used for this. The use Interrogation and checks in production equipment or fitment of an incorrect part or material must be immediately Parts identification detectable and must not proceed further in the value creation process. Suitable checks/actions must be carried out to guarantee Identification of work, inspection and usage status early detection and filtering out of items wrongly installed items. Batch identification, traceability Associated subjects and actions must be included and examined of use or production of batches in the Process FMEA and, if appropriate, in the Product FMEA. Use by dates for various materials There must be a clearly controlled process for handling residual Remove invalid identifications quantities, parts which have been separated out (for example, Work papers with master data stacked up because of a machine problem), re used parts from for parts/production. product audits, checking parts, etc. Design level of incoming Containers and parts must be adequately, appropriately and materials and finished products securely identified. Material flow analyses (value The process and/or inspection status must be clearly visible. flows) The use by date and longest storage time for materials must be observed.

P6.2.6

VDA vol. 4 VDA vol. "Robust production process" VDA vol. "Maturity level assurance for new parts"

Standardised production system methods : Marking, Identification, lettering Process security plan First In First Out (FIFO)

94


Nur zur internen Verwendung für Flextronics Automotive GmbH&CoKG bestimmt. Possible examples of requirements and evidence, depending on product risk


The quality consciousness of operators must be encouraged and maintained regularly by suitable means. All operators are trained in the consequences of carrying out work wrongly, as parts of product training (what tasks/functions does the product perform and what happens if these cannot be guaranteed because of incorrect assembly, etc.). A process must be implemented to determine to what extent personnel are aware of the significance and importance of their tasks. Employees regularly receive information on current quality levels achieved by the customers. Operators are engaged in the continuous improvement process. Feedback s provided on suggestions for improvements

Job descriptions and task Standardised production descriptions system methods : Job descriptions Participation in improvement Group tasks programmes Group work Operator self checks spokesperson Process release (setter release/ On site measurements checks on first off and last off Operator feedback parts Operator questioning Process control (interpretation of Recognition of operators control charts) Authority to quarantine products Assessment system Cleanliness & tidiness Team development Carry out or authorize repairs & activities maintenance Absenteeism Provide/store parts improvement Carry out/authorize setting up programme and alignment of inspection and Group discussions measurement equipment Group boards Product training Metrics boards Quality information (specified Continuous and actual figures) improvement workshop Zero defect programmes Improvement proposals VDA vol. "Robust production process"

Are operators given responsibility and authority to monitor the quality of product and process ?

A description must be provided of what responsibilities, tasks and authority the operators have in their individual areas of operation : who is responsible for process releases and checks on first off parts and who can distribute these. Checks carried out by the operators themselves must be described : when, how many, how often, with what, where, documentation. A description must be provided of who maintains the quality control charts and who has what authority in the event of non compliances (authority to quarantine parts, stop the line, etc...).

P6.3.1

Process analysis / production

What functions support the process ? (personnel resources)


P6.3

Process element P6 :


95


.

Voluntary special action (training, quality circles) Contribution to improvements in quality Self assessment Information flow, implementation in the organisation Workshops Product liability training

96



Training/instruction is given and documented in the event of changes to the product/process.

Induction, training, qualification Standardised production certification system methods : Qualification Knowledge of the product and Induction training for defects which can occur Training in health & safety at work employees Selection process for and environment aspects employees Training in the handling and Qualifications matrix dealing with "components/ Learning groups products requiring special Continuous improve documentary evidence" ment workshops Certificates of suitability – e.g., Group spokesperson welder's certificate, eye test, Employee feedback driving licence for fork lifts) Employee questioning Training planning to cover Recognition of changes in process and employees technologies Assessment system Product training motivation Team development Product liability training activities Quality information (specified and Absenteeism actual results) improvement Zero defect programmes programme Improvement proposals Group discussions Voluntary special actions Group boards (training; quality circles) Metrics boards Low sickness rates Contribution to quality VDA vol. "Maturity level improvements assurance for new parts" Self assessment Information flow; organisational implementation Workshops

Are the operators able to carry out their allotted tasks and are their qualifications kept up to date ? *

There must be a job description for each work station, including a requirements profile. Training needs must be determined individually for each operator based on the task and an appropriate personnel development plan drawn up. A record must be kept of who is qualified for what tasks and activities. This documentation must be taken into account when planning the use of personnel. Employees are trained in the processes and know of production errors which can potentially occur. All employees are trained in the consequences of carrying out work incorrectly (e.g., product training, what happens if the product is wrongly assembled; using checking / inspection equipment, …). Training in health & safety at work and work related environment aspects is provided regularly. Instruction must be given to employees regarding the handling and dealing with "components/products requiring special documentary evidence". Training, instructions and qualification evidence must be documented. There must be evidence of suitability to meet requirements regarding activities (e.g., fork lift driver licence; welding certificate, soldering certificate, eye test, hearing test, etc.). Induction plans must be available for new employees, replacement and temporary personnel. Induction phases must be demonstrated.

P6.3.2


97


Is there a personnel employment plan?

When planning the employment of personnel the qualifications of the employees must be taken into account (qualifications matrix). Absentee levels (sickness, holidays, training) are included in the employment planning. In the case of replacement personnel and personnel transferred on loan, it is important to ensure that they have the necessary qualifications. Rules regarding deputies are documented and are derived from the qualifications matrix for the relevant production operations.

P6.3.3 Shift plan (based on orders) Qualification certification (Qualifications matrix) Information flow; organisational implementation Documented rules regarding deputies

Standardised production system methods : Group spokesperson Group boards Rotation Qualifications matrix

98


Nur zur internen Verwendung für Flextronics Automotive GmbH&CoKG bestimmt. Process analysis / production

Clean working surroundings and work places are integral to an overall care for the facilities (GAB). A process has been effectively implemented to analyse and optimize down times, machine loadings and the life of tools.

Plant, equipment, machines and tools required for the problem free operation of key processes are identified and appropriate preventive maintenance intervals are allocated to them. Resources to carry out essential maintenance work are available. Essential maintenance work is systematically planned and carried out. Preventive maintenance of machines, plant and tools is carried out, documented and controlled (maintenance systems). Availability is assured for spares for production facilities, particularly for key processes reflecting the critical path.


planned/periodic maintenance Standardised production activities system methods : availability of spares/replacement Check lists & checks parts for production equipment Qualification covering key processes Qualification matrix comply with specified maintenance Overall plant and equipment support intervals (GAB, TPM) Planned and actual amount of work are the same VDA vol. 4 Documentation of maintenance VDA vol. : "Robust work completed Production Process" Qualifications of employees VDA vol. 19 involved Archiving of work certificates Regular plausibility checks on planned maintenance intervals Scheduling and availability of spares Contracts to external companies to carry out maintenance work

P6.4.1 Are the maintenance and overhaul of production facilities / tools controlled ?


What facilities are used to achieve the process ? (material resources)

Minimum requirements / assessment / relevant :

P 6.4



99


identification of usage status (OK / NOK / under repair) tool tracking card with all the changes made to the tool tool operating times protection from damage ownership details for the tool

Tools are covered by a tool management system containing the following points : Availability/use of associated technical documentation Facilities in the areas entrusted with maintenance work Preventive tool exchange programme for units subject to greater wear Quality of execution of maintenance work Logging, assessing & develop ment of maintenance targets Machinery to place items in or remove them from racking (for transport and storage, ....)

100



Can the quality requirements be monitored effectively with the test, inspection and measurement facilities employed ? * Production control plan The test, inspection and measurement facilities employed are Standardised production Checks to demonstrate reliability, system methods : suitable for the purpose and for handling in production. They are Statistical process function and corrosion resistance included in the production control plan. control (SPC) Measurement accuracy / Systematic and random causes of measurement errors are Monitoring of inspection capability of inspection equipment eliminated. Employees are trained in the use of measurement equipment and its Proof of the capability of equipment (exclusion of measurement errors). capability / capability inspection processes Capability studies are carried out on the measurement devices studies of measurement Data logging and suitability of and measurement systems employed. The accuracy of this devices data for assessment equipment is appropriate for the purpose and for the Evidence of the calibration of characteristics to be checked. VDA vol. 5 / MSA inspection equipment Certification is available covering the calibration of the Alignment of inspection equipment VDA vol. "Robust inspection equipment (inspection plates). production process" and measurement processes with A process for the periodic monitoring of measurement and VDA vol. "Maturity level the customer inspection equipment is installed and implemented assurance for new parts" (responsibility for collection and return is defined). This process also takes into account the calibration of process integrated measurement technology with an influence on the product characteristics. There is an identification system for measurement and inspection equipment. Administration of this equipment is based on the identification. Measurement and inspection equipment accessories having an influence on measurement accuracy and the measurement result are monitored in the same way.

P6.4.2


101


In addition, the work place layout is adapted ergonomically to the work to be carried out.

VDA vol. 4 VDA vol. 19 VDA vol. "Robust production process" VDA vol. "Maturity level assurance for new parts"

Standardised production Ergonomic work place layout system methods : Lighting Health & safety at work Cleanliness and tidiness and environmental Air conditioning awareness Clean rooms Standardised material Work place organisation stocks Surroundings / handling parts at Visual management the work place 5A Health & safety at work (national 7 ways of wasting legislation) 5 "why" Storage of parts at the work place Production system

Are the work stations and test/inspection areas suitable for requirements ?

Conditions for the work places and their surroundings (inc. rework areas) are appropriate for the products and the work carried out, in order to prevent / eliminate contamination, damage, mixing up of parts and misinterpretations.

P6.4.3

102



Storage is provided where the equipment is protected against damage and environmental effects, and cleanliness and tidiness are ensured. The issue and use of this equipment is controlled, specified and documented.

Stored free from damage Cleanliness and tidiness Defined storage location Issues are administered Environmental influences Status identification Identification showing customer's property, products/tools/devices provided on loan Defined release status and change level Machinery to place items in or remove them from racking (for transport and storage, ....

Are tools, equipment and test / inspection facilities stored correctly ?

Even tools, equipment and test/inspection devices not in use and/or not yet released must be stored and managed in an appropriate manner. All tools, equipment and test/inspection devices are identified with their current status and change level (released; under maintenance; maintenance required; quarantined).

P6.4.4

VDA vol. "Robust production process" VDA vol. "Maturity level assurance for new parts"

VDA vol. 4

Standardised equipment



103


Process and product metrics are defined and logged in order to control and monitor the organisation's processes. A regular comparison is made between specified and actual results. Target requirements are agreed and achievable; they are guaranteed to be up to date. Process specific targets are laid down, monitored and communicated (quantities produced; quality metrics such as failure rates, audit results, through times and process effectiveness figures (Cpk). Non conformances are analysed and subjected to suitable action leading to improvements to the product and process. Essential special action must be specified and implemented as necessary. The potential for improvement must be determined continuously from previous experience regarding quality, costs and service. Monitoring the metrics is ensured through regular management reviews and reported in associated committees.

P6.5.1 Are target requirements set for product and process ?


Presence & absence of personnel Standardised production Availability of plant and machines system methods : Target agreements Peak production figures under full Metrics boards production conditions and cycle Quality agreements times (some with escalation Scrap levels within the planned/ stages) estimated framework. Quantities produced Continuous Number of parts produced per improvement process time unit Rapid tool changes Rework; scrap Elimination of waste Run outs Six Sigma Quality metrics (e.g., failure rates, audit results) Throughflow times VDA vol. "Robust Non conformances (failure costs) production process" Process metrics (process VDA vol. "Maturity level capability). assurance for new parts" Cost improvements Criteria for establishing metrics Reduction of waste (e.g., scrap and rework, energy and process materials) Improved process security (e.g.,


How effectively is the process carried out ? (effectiveness, efficiency, elimination of waste)


P6.5


process sequence analysis) Improved tool change over times, increased machine availability Reduce throughflow times Reduce stock levels

104




105


Types and frequencies of failures are logged and assessed and actions are derived. The effectiveness of the actions introduced is verified. Failures resulting in a change to the process or product are also documented in the relevant FMEA with the associated actions. Failure costs are logged against those causing them (amount of scrap; rework items & consequences) and actions are allocated

SPC Pareto analyses Cause & effect diagrams FMEA

Original data charts Cumulative reject charts Control charts Data logging significant characteristics Writing device for process parameters (temperature, time, pressure, ...) Production data logging (e.g., plant down times, power failures, programme error messages) Parameter changes Process capability data Failure types & frequencies Failure costs (non conformance) Process parameters Scrap / rework Quarantine announcements/ sorting actions Cycle times; throughflow times Reliability / failure patterns

Are quality and process data logged in such a way that they can be assessed ?

Full quality data and process data must be available to demonstrate compliance with requirements and targets. The data must be capable of assessment. Special events must be logged (in a log book). Events and problems must be allocated to the areas responsible, where the associated improvements are generated and implemented. Quality control charts and monitoring charts are in use and are maintained in accordance with requirements. Process data and parameters (SPC) are monitored and used for the control of processes. In the event of a problem or non conformance, corrections are made automatically and/or an associated report is issued. Essential actions (action plan) for process problems are known and are introduced and documented by the responsible personnel. Non conformance with approved/released processes with an effect on the characteristics of the product must be approved by the customer. Process capabilities are checked regularly.

P6.5.2

VDA vol. 6, Part 1 VDA vol. 3.1; 3.2 VDA vol. "Robust production process" VDA vol. "Maturity level assurance for new parts"

Standardised production system methods : Process description Standardised work place documentation On site measurements SPC (statistical process control) Quality control circles in production Analysis of causes Problem solving processes PDCA 5W 8D

106



In the case of deviations from product and process requirements, are the causes analysed and the corrective actions checked for effectiveness ? * Additional dimensional material, If deviations from product and process requirements occur, Standardised production functional and endurance checks system methods : immediate containment actions must be taken to comply with Quality control circles in and tests the requirements, until the causes of failure are eliminated and production Cause & effects diagram evidence has been provided of the effectiveness of the Process FMEA Taguchi, Shainin corrective actions. PDCA FMEA / failure analysis Methods used for the analysis of causes are defined and in use. 8D Corrective actions are derived, their implementation is monitored Process capability analysis 5W Quality control circles and effectiveness is verified. 8D method In this, production control plans and FMEAs are taken into Analytical assessment methods VDA vol. 6, Part 1 account and are extended and up dated if required. VDA vol. 6, Part 5 Information flow to the customer Functioning quality control circles are implemented in production VDA vol. 14 5W method within the organisation. VDA vol. "Robust Problem downtime logging The status of the actions is transparent and communicated. production process"

P6.5.3


107


Are processes and products audited regularly ? *

Deficiencies in engineering and production are displayed, assessed from the customer's standpoint and appropriate actions are introduced.

Product audits are carried out and documented in production after production operations have been completed. They are carried out periodically and examine the finished product. Account is also taken of customer requirements and relevant functions, including ease and security of fitment.

Deviation reports must be issued to those responsible and improvement actions must be tracked. If quality requirements are not met (internal / external) additional audits referring to the specific event(s) must be carried out.

Reasons for an audit are : New projects, processes and/or products To provide evidence of compliance with quality requirements To indicate the potential for improvements

Audit plans (process audits, product audits) must be available for the product and its production processes.

P6.5.4

The capacity of checking and inspection devices, current inspection instructions, specified traceability documentation and responsibilities must be clearly controlled.

Specifications Standardised production Significant characteristics system methods : Sectional checks / Function section audit Process parameters / capability System audit / Identification, packing certification Specified process and procedural Process audit operations PDCA Controlling actions and timings Audit plans (for all areas; for VDA vol. 6 Part 5 product and process audits) inc. VDA vol. 6 Part 7 identification of planned and event related audits VDA vol. "Robust Frequency of product audits production process" Requirements for product audits VDA vol. "Maturity level Audit results; audit reports assurance for new parts" Auditor qualifications Audit results in the management review Developing metrics before and after implementing actions

108



Account must be taken of all requirements included in the customer's supplier assessment. Process specific targets (from the customer's requirements, if appropriate) must be laid down, including quantities produced, quality metrics such as failure rates, audit results, failure costs, throughflow times and process metrics (Cpk). Significant characteristics specific to the customer ("D" type characteristics) must be identified. Customer requirements must be audited in house (shipping audit, ...) A process is implemented, regulating the use of products supplied by the customer. This refers to products (setting parts), tools, inspection equipment and packaging. Test/checking/inspection instructions must be available (also covering endurance testing. Procedures must be agreed with the customer and documented accordingly. A process must be described and implemented, explaining how the areas of stores, scheduling, parts provision, shipping and the customer are informed in the event of a block on shipping.


Quality agreements with Standardised production customers system methods : Customer specific requirements Quality agreements (in (process requirements spec.) part with escalation Customer requirements for stages) identification of special, significant Customer quality sensor characteristics Quality control circle Shipping audits Production programme Endurance tests/long term trials planning (to determine failure reactions) Inspection regulations Storage/processing schedules/ VDA vol. 19 providing parts/shipping VDA vol. "Robust Function tests production process" Suitability of checking and VDA vol. "Maturity level measurement equipment assurance for new parts" Aligned checking procedures (measurement points, fixing concept, equipment, ...) Up to date specifications Target agreements to achieve

P6.6.1 Are the customer's requirements met in terms of product and process ? *


What should the process produce ? (process result / output)


P6.6



109


Are quantities / production batch sizes aligned with requirements and are they forwarded to the next process stage in a targeted manner ? Adequate, appropriate means of Parts/components must be forwarded to defined storage/holding Standardised production transport points using suitable means of transport. In this, attention must system methods : Standardised material Defined storage points be paid to the order quantity/batch size so that only the required stock levels KANBAN quantity of parts/materials is moved to the next work station (the Marking, identification, Just in time “pull” principle). lettering Stores management Logging and assessing quantities (number of OK parts, parts to Smooth production Change status be reworked and scrap parts) must be controlled and traceable. “Pull” production Logging/assessing quantities/ Parts identification must be specified (OK parts, rework parts Flow line production volumes and scrap). The identification must also indicate the current Types of waste Stock levels change status. Production quantities tailored to Process FMEA the customer’s needs It must be ensured that NOK parts cannot be forwarded or ESD protection for electronic processed further. VDA vol. “Robust parts Customer requirements for the identification of reworked parts production process” must be implemented and documented (quantity/volume, VDA vol. “Maturity level identification, life history and usage). assurance for new parts”

P6.6.2

zero defect objective Shipping audits Implement customer's demands for production tests under peak production conditions

110



Are products / components stored in an appropriate manner and are transport facilities / packing arrangements suitable for the special characteristics of the products / components ? Quantities in store Parts must be protected from damage by suitable storage and Standardised production Protection from damage packing. system methods : Positioning of parts Visual safety instructions Customer specific packing instructions must be available in Material stock levels shipping/goods outwards department and observed/implemented Cleanliness, tidiness, over filling Marking, identification, (storage points & containers) throughout (also in the various production operations). lettering Monitor storage periods The positioning of parts must ensure secure storage at the work Environmental and climatic place, including handling. influences Process FMEA Storage points/containers must meet essential requirements for Customer specific packing VDA vol. "Robust cleanliness & tidiness. This includes the parts at the work place instructions (inc. packing supplied production process" itself (no over filling). VDA vol. "Maturity level Specified storage times must be monitored (specified maximum, by the customer) assurance for new parts" minimum and intermediate storage times). Information on available stock Parts must be protected against environmental and climatic levels influences during storage and processing. Substitute packaging

P6.6.3


111

Nur zur internen Verwendung für Flextronics Automotive GmbH&CoKG bestimmt. Customer specifications Significant characteristics and customer's identification requirements Process descriptions Documentation matrix for storage times for various documents and records Customer's archiving requirements Archiving requirements/ regulations (EDI, paper, fire protection, legibility, ...)

Are the necessary records / releases carried out and stored appropriately ?

Releases for the shipment of products to the customer or the next process must be identifiable and documented. Special releases and releases under deviation must be traceable by appropriate identification and documentation. The documentation must cover the period and/or quantity of parts involved. These details must also be included in the parts life history, including the identification method. Traceability of releases, including documentation, must be generally guaranteed. Traceability of the parts produced must be ensured to a reasonable degree. The customer's requirements must be taken into account in determining archiving regulations and periods

P6.6.4

VDA vol. 1 VDA vol. 2 VDA vol. 19 IMDS VDA vol. "Robust production process"


112





It must be ensured that the product conforms with legal regulations.

Product requalifications are carried out to the customers' requirements.

Packing must meet the customers' requirements regarding suitability, fixing, cushioning and identification.

Customers' requirements for the supply of spares before, during and after serial production must be implemented and observed, including the acceptance and recycling of returned parts. The supply of spares must be considered in addition to serial production, including variants and changes, in terms of the resources required.

Quality agreements with the customer Completed shipping audits/ product audits Function checks Endurance tests (to determine failure reactions) Storage, scheduling, providing parts, shipping ppm figures, targets to achieve zero defects Incorrect deliveries Up to date specifications Requalification concept (frequency, extent, ...) Suitability of checking and measurement equipment Aligned test/inspection procedures, reliability tests, COP Audit plan to cover "D" characteristics Specify and track improvement programmes Involve sub suppliers Supplies of spares

VDA vol. 1 VDA vol. 2 VDA vol. 4 VDA vols. 6.x

Are the customer's requirements satisfied regarding QM system, product (on delivery) and process ? *

Take account of all requirements, particularly those included in the supplier assessment system used by the customer. Take account of the certification of the QM system in accordance with the customer's requirements. If appropriate, include evidence of significant characteristics when carrying out audits.

P7.1


Customer support, customer satisfaction, service

Customer support, customer satisfaction, service (P7)


8.7


113


Part shipments to provide spares/first fill before start of full production Duty to supply after end of full production Supply of spares to old levels following changes (tool management, ability to manufacture) Supply concept for small quantities of spares following changes / end of serial production Compliance with customer specific packing and identification regulations

114



Is customer support ensured ?

It must be ensured that competent contact personnel are available for the various areas in the customer's organisation. Communication in a language which the customer understands is essential. Customer support is also a measurement of active creative cooperation. The supplier has the obligation to examine his products at all stages of the creation and implementation stages and to improve them in agreement with the customer. A procedure is agreed with the customer for ensuring the security of new product/process launches.

P7.2 Reports of visits to customers and, if relevant, generating actions from these Knowledge of the product application Knowledge of problems with the product and complaints regarding the product or transport Implement new requirements Advise of improvement actions Advise of changes to product and process / change of production location (inc. those of suppliers) Initial & repeat sample submissions (trials / serial production) Information on non compliance with requirements (including packing and transport) Customer support in other countries Quality of logistics data from the supplier (e.g., statements of account covering container stocks) Access to customer portals (by agreement with the specific customer) Ensure problem free launches


115


Is the supply of parts ensured ? *

Concepts are in place, including security for emergencies to ensure supplies. These concepts must always be kept up to date in the serial production delivery phase. In this, consideration must be given to in house processes and also the suppliers' processes. Procedures must be in place which guarantee that the organisation informs the customer immediately when supply bottle necks are detected. The information must include the expected duration and extent of the bottlenecks and the actions which have been taken. The actions must be taken at the right time and in accordance with the customer's requirements

P7.3 Contingency plans (e.g., for alternative production, suppliers, transport) Capacity and reaction time for sorting actions Possible changes to equipment, special production facilities, tools, product specifications and sources of supply Use of external capacity Communication regarding supply bottlenecks Regulations covering authority to take decisions / escalation stages when introducing special actions Spares for assembly lines

VDA vol. "Standardized process for handing customers´ complaints "

116



If there are deviations from quality requirements, are failure analyses carried out and corrective actions implemented effectively ? Analysis facilities (laboratory, Independent detection and analysis of deviations from quality inspection and test equipment, requirements, with the rapid introduction of corrective actions personnel) including evidence of effectiveness are requirements demanded PARETO analysis of failure of the quality control circle. characteristics (internal/external) Involvement of all areas affected Timings agreed with the customer following complaints or (internal/ external) rejects must be maintained. Non conformances must be Use of problem solving methods communicated. Resolve deviations detected in sample submissions Deviations and the associated corrective actions must be Revise specifications placed in order of priority and integrated in existing risk Checks on effectiveness analyses (e.g., FMEAs). Product observation and improvement Introduce special actions to ensure the supply of products Flow of information, as far as the correct to specification (e.g., 100% inspection). customer, if deviations occur Knowledge data base, "lessons learned"

P7.4

Product FMEA Process FMEA VDA vol. "Standardized process for handing customers´ complaints "


117

Nur zur internen Verwendung für Flextronics Automotive GmbH&CoKG bestimmt. Checking specification for analysing field failures, with classifications based on standard checks and checks involving debit charges NTF guidelines Test/checking equipment and specialist personnel for analysing failures in defective parts Metrics for analysing defective parts (e.g., by average detection time) 8D reports Quality reports (including Pareto diagrams, Paynter charts)

Is there a process which ensures that analysis of defective parts is carried out ?

The process for analysing defective parts from the field is implemented and described throughout the organisation. Customer specific requirements are agreed. Test/inspection planning must be carried out for standard checking and checks involving debit charges. Initiation criteria must be agreed with the customer for the "NTF" (no trouble found) process. The characteristics to be checked and the specification for the checks must be documented and agreed with the customer. Capable checking equipment and the associated resources must be planned. Communication must be maintained with the contact personnel involved in analysing field failure returns. Personnel responsible for the findings, the NTF process, the reporting system and for controlling the failure elimination process must be clearly defined. Metrics for the field failures analysis process must be tracked in order to measure effectiveness. The standard reporting system for reporting on analyses (8D) and quality reports must be agreed with the customer. The effectiveness of the failed parts analysis is ensured by a continuous improvement process.

P7.5

VDA vol. "Field failures analysis"

118



P7.6

A job description, including requirements profile, must be provided for each function. Training needs must be determined for each person, depending on the task and appropriate personnel development planning must be drawn up and implemented.

Product / specifications / special customer requirements Standards / legislation Processing / usage Assessment methods (e.g., audits, statistics) Quality techniques (e.g., Pareto, 8D method, Ishikawa cause and effect diagrams) Knowledge of foreign languages in the following areas : Customer support Product checking Storage / transport Logistics Failure analysis

Evidence of knowledge of :

Are personnel qualified for the various tasks and are responsibilities defined ?

A description must be provided, setting out the responsibilities, tasks and authority of personnel in their respective task areas.


119


D 1.1

No.

D1

8.8 Planning

The following must be taken into account : The type and extent of the service Timings; locations Extent of guarantees Customer support / satisfaction (service actions) Pricing; quality requirements Confidentiality / discretion Environmental aspects The supplier's performance specification Specifying significant characteristics and process parameters Translating documents into the relevant language Benchmarking / competitor analyses



Terms & conditions of trading Specifications such as drawings, standards, etc. Company standards Purchasing conditions (inc. legislation / regulations) Customer requirements specifications Order / contract documents

These requirements and expectations are set out in the following, for example :

Notes (input output) and references Are the customer's requirements and expectations for this process / service logged and analysed in a consistent manner ? It is essential to consider all customer requirements in Customer requirements and expectations can be determined, planning a service / process. This includes the tasks for example, by asking customers, performed by sub suppliers. The supplier retains market research, etc. responsibility.

Use in phase

Services

120



D 1.2

Has a development plan been agreed with the customer for the services and service process and has this been implemented ? Up to date milestones, network plans or project plans The following points must be must be produced for the development plan. These must considered in planning the service : reflect all the activities involved, from the award of the Check the requirements to see if contract to the supply of the service itself. A person they are reasonable responsible for the project must be appointed and all the Clarity & comprehensiveness associated areas, with their respective tasks, must be Documentation of results known. A central, continuous monitoring function must Obtain and install the facilities be ensured. The monitoring must cover compliance with required for the services all the specified objectives, such as timings and Verify (check for compliance with qualifications (the type, extent and sequence of the requirements and expectations) service) with their costs. Approval/release in agreement with the customer Take account of changes and modifications Draw up operating and installation instructions. Flow of information to and from the customer during the planning of the services (regular meetings, conferences, remote data transmission) Work and process sequences (work sequence diagrams) Ensure compliance with timing requirements (milestones) Specifications (inc. tolerances) / extent of individual services Instructions Software / hardware, test facilities Extent of training (by supplier at customer's premises) Framework conditions


121


Definition of interfaces to other departments Specify the customer's obligation to cooperation Specify publicity and information policy Personnel required / temporary exchange of personnel Personnel qualification / point of performance Deviations from plan – actions and informing the customer Risk analyses Capability studies Controlling communication and information

122



D 1.4

D 1.3

The planned capacity must ensure that the contractually The following points should be specified customer requirements can be met. monitored, for example : Availability of production fixtures and facilities (information and communication facilities), buildings and documents Qualified personnel (training, capabilities, information) Health & safety at work; environment Release and guarantee the necessary investments.

Is sufficient capacity planned and is on time implementation ensured ?

The release stages can be traced, Release stages are to be planned in accordance with for example, in : the customer's requirements or the organisation's own Defined release stages and decisions. Release criteria and timings must be specified criteria for each release. The results must be documented. Milestones (release at the end of each phase) Review / verification / validation of contents and sequence of the service (test, comparison of performance; post calculations, Price comparison) Management of changes Risk assessment (compliance with future timing dates) Status report

Are release stages provided for all elements of the service at the time required ?


123


D 1.5

In this the following points must be considered : Function Safety/ security Reliability Traceability Availability Environmental aspects Qualification check to confirm individual requirements Problem areas Inadequacies Corrective / preventive actions

At each stage where matters are made concrete, improvement programmes must be introduced and implemented for the services / processes, with the emphasis being on the prevention of failures and not their elimination.

The following are examples of the methods employed : Risk analyses (System, Design and Process FMEAs) Function checks Reliability checks Feasibility analyses Pilot projects

Is a quality assessment made of the service / process and are further developments derived from this ?

124



D 2.1

No.

D2



Against what criteria are suppliers selected and are only approved / released suppliers used for this service / process ? Before suppliers are specified, an assessment must be Suitability can be demonstrated by, made by the customer. It must be ensured that only for example : suitable suppliers are used to provide the outside Supplier meetings / regular service. Experience gained from assessments of quality support performance must be taken into account. Assessments of quality capability (e.g., audit results) Assessments of quality performance Current results Preventive quality assurance actions.

Use in phase

Outside services Notes (input output) and references


125


D 2.3

D 2.2 The following may be used to evaluate outside services : Agreed assessment scales Adequate checking facilities Internal / external checks Specifications (e.g., requirements set out in the order/contract) QA agreements Agreement on checking procedures and sequences Assessment of main failure areas

As a result of the findings from the assessment (inadequate quality performance / quality capability) are qualification actions introduced and carried out with suppliers ? The capabilities and performance of a supplier should Evidence can be provided, for be checked over defined time periods and recorded in example, by : Discussion of fundamentals a listing / supplier questionnaire. If results are negative, with QA management / top qualification programmes must be specified. Their management of problem suppliers implementation must be demonstrated. Reports / findings on the state of improvement programmes Action plans Improved service process Audit results

Significant metrics, capable of assessment, must be generated in order to evaluate outside services, so that a classification can be made regarding the suitability of the outside service.

Is it ensured that the agreed quality of the outside services is guaranteed ?

126



D 2.5

D 2.4

A release procedure must be carried out for all services provided by a supplier before implementing new or modified services / processes

Release criteria include : Evidence of capability for significant characteristics Simulation checks Trial releases Results of preventive QA Compliance with regulations (e.g., legislation, standards, safety data sheets, EU standards).

Are the outside services to be used and their processes approved and released ?

Are target agreements / actions to improve processes and outside services agreed with the suppliers and implemented ? Improvements must be targeted towards objectives. The following points must be considered, for example : Continuous improvement Specified, measurable metrics Cost improvements


127


Use in phase

D 3.1.1


Are responsibilities and authority specified and implemented for personnel with regard to the quality of the service ? Responsibilities and authority must be defined in writing Responsibility / authority must be for employees involved in the service process specified for the following, for example : Cooperative work on improvement programmes Self checking Process release Process quarantining (release of quarantined units) Training on the significance and tasks associated with significant characteristics Process documents relevant to personnel include : Function description Authority matrix Description of task Job description Qualifications matrix (requirements profile) Information to and from managers (target agreement; process status).


Personnel / Qualification

D3.1

No.

Service process All the following questions must be assessed for each process stage

D3


128



D 3.1.2 Responsibilities / authority must be laid down and implemented for : Availability; maintenance System responsibility Operating instructions Work instructions Test/inspection instructions

Are responsibilities and authority for facilities and production equipment specified and implemented ?


129


D 3.1.3

Are personnel involved in the service process put in a position where they can carry out the allotted tasks and are qualifications regularly monitored ? Evidence must be provided for all personnel involved in The following points are some of the the service process, showing that training in the relevant employee qualifications : Leadership ability activity is planned and carried out and its effectiveness Instruction/training and proof of is checked regularly . qualifications for the process and service Legislation and guidelines (evidence requirement, storage periods for documents) Instruction in health & safety at work / environmental protection Process / service sequence (e.g., conditions and equipment at the work place and surroundings) Physical suitability Illustrations of targets and levels of achievement Encouragement of quality consciousness Knowledge of employee satisfaction Further training / qualification actions

130



D 3.1.4

Is the personnel requirement for the services / process determined / ensured and is alternative capacity secured ? The following are some of the The personnel required for each service must be aspects to be considered : determined and ensured. Risks regarding personnel Determine the personnel capacity must be determined and contingency plans requirement must be drawn up. Calculate the work involved Deputy arrangements for important positions


131


D 3.2.1

D3.2 No.

D3

Providing the service Minimum requirements / assessment / relevant : Possible examples of requirements and evidence, depending on product risk

An on site approval / release must be issued for all services before the introduction of new or modified services / processes. The release checks must be carried out to clear criteria to ensure repeatability. These criteria can be general or related to the specific process or service. The release must be issued in writing by "authorised" employees, based on acceptance criteria.

The following are some of the points to be examined in the release of services : Check list with specified criteria Comprehensive in terms of function / execution Availability of installation and operating instructions On the hand over (performance transfer) After a new version / new change level Complete paperwork at the work place Up to date requirements and expectations Cleanliness and tidiness at the work place Time frame for the introduction phase Log non conformances in a form which can be assessed

Is the service approved / released and are deviations from requirements handled ?

Use in phase

Service process All the following questions must be assessed for each process stage Notes (input output) and references

132



D 3.2.3

D 3.2.2

Improvement programmes from audits Information to the area causing the problem Interface discussions (internal/ external) Internal complaints, the principle of "the producer pays", logging costs Questioning customers Customers' complaints Risk analyses (FMEAs) Tracking actions

Corrective actions can arise from the following, for example :

The appropriate facilities and support must be available and the appropriate organisation must be selected in order to guarantee the specific quality requirements

Are the quality requirements applying specifically to the process guaranteed ?

This applies before and during the process.

Are corrective actions checked for implementation and effectiveness ?


133


D 3.2.5

D 3.2.4 Monitoring can include the following : Efficiency metrics Simulation software Benchmarking (e.g., from data bank) Check lists (e.g., for audits) Measurement and inspection/ checking equipment Reliability / function checks Questioning customers Measurement accuracy / capability of checking/inspection equipment Logging and evaluation of data

If non conformances occur the actions taken must be documented

The relevant process requirements must be stated in descriptions of operations / process descriptions and similar documents.

Process requirements are factors which influence the process and which are used to control and regulate the process.

Service operations / process stages Process parameters / data Checking / inspection requirements (significant characteristics, checking and inspection equipment, methods, checking/inspection frequencies) Evidence of capability

Are the relevant requirements for the service process set out comprehensively at the work place and are they implemented in full ? Explanation of the term "requirements" in this context : Requirements can include :

Control mechanisms / systems must be introduced in order to monitor the effectiveness of the service process.

Is the effectiveness of the service process monitored ?

134



D 3.2.6

Work places and their surroundings must be appropriate for the work content of the services.

Reasonableness can be assessed in terms of : Lighting Ergonomics Cleanliness and tidiness Health & safety at work .

Is it ensured that work places and their surroundings are appropriate for requirements ?


135


D 3.3.1

D3.3 No.

D3 Communication, identification, information, data flow

Agreement must be reached between customer and supplier on ways and means of transmitting data and the exchange of information. The responsibilities and communication facilities to be used must be agreed. The service provider must ensure that confidentiality is maintained regarding the data / information provided to him and the services which he provides. Products used within the framework of service processes must always be current and available.



Notes (input output) and references Are the service products stored appropriately and is transport aligned with the special characteristics of the services in question ? It must be ensured that the service product is always stored and transported so that it is not damaged. In this connection there must be an effective system which takes account of the following aspects : Damage free storage (applies also to data carriers) Security against unauthorized access Effective protection against loss Appropriate transport and storage.

Use in phase


136



D 3.3.3

D 3.3.2

Information to the customer Information to those involved in the process Prevention of unauthorized use Ensure that corrections are made.

In the service process it must be ensured that, when non conformances are detected, information is given to the relevant locations and the non conforming products are separated and identified. In this the following must be observed :

Are non conforming products from services processes detected, separated carefully and identified ?

Is the extent of the service aligned with the demand and the process chain ? How have the interfaces to adjoining processes been taken into account ? The requirements which have been defined must be Points to be considered here taken into account in the service provider's planning include : tools. Business plan / marketing plan A regular check on implementation must be carried out Capacity planning and documented. Rights of access Interfaces / organisation plan.


137


D 3.3.4

The supplier must draw up operating or user instructions if applicable for the introduction of the service.

It must be ensured that access to the products and data is available at all times, in a manner which prevents mix ups and false identification. An error free method of data and information transfer is essential for the introduction of the service. In this connection there must be an effective system which takes account of the following aspects : Clear identification Current (change) status Security against unauthorized access Traceability Operating and user instructions

Are the services and their results sufficiently secured against mix ups and false identification ?

138



D 3.3.6

D 3.3.5

Defined contact points must be defined, which are responsible for the following aspects : Selection of suitable means of communication Up dating data Data protection Software safety copies Securing data against loss Transmission and comprehensiveness Archiving Changes Failure strategy.

It must be ensured that information arrives clearly and in full with the correct addressees.

Is the flow of information within the service process and to the customer controlled and ensured ?

It must be taken into account that, even after the introduction of new computer generations, access must still be provided to older data material.

Ways and means of storage must be agreed between customer and supplier. This includes agreement on the duration of the storage.

Facilities and applicable documents must be protected to a reasonable degree against ageing, damage and unauthorized access. Suitable storage areas must be selected for the purpose. Access which is not capable of being confused must be provided by clear identification.

Are facilities and applicable documents for the service process retained in an appropriate manner ?


139


D 3.4.2

D 3.4.1

D3.4 No.

D3

Eliminating errors and continuous improvement Minimum requirements / assessment / relevant : Possible examples of requirements and evidence, depending on product risk


Additional data can be displayed, such as : performance levels / levels of use throughflow times availability

Use of management methods such as : Continuous improvement TQM

Evidence must be provided of the following activities : Problem analysis / preventive actions / responsibility / timings Work sequence analyses Immediate containment actions

Are process problems reported and analysed and are corrective actions implemented effectively ?

Comparisons between specified and actual results relating to agreed targets Personnel statistics (sickness levels, absenteeism, holidays) Punctual delivery Identification of systematic errors

The following must be available :

Are work / test results logged consistently and quality patterns displayed in an understandable form ?

Use in phase


140



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141


D 4.1

No.

D4

Knowledge of current deficits / complaints Performance assessment by customers (quality, timings, prices, etc.) Intensive customer support (Buying, Engineering, Quality, etc.) Rapid reaction times to deficits / complaints in the service process Adequate individual advice (text replies are not enough)



Notes (input output) and references If deficits occur in the service process and if actual complaints arise, is information / support provided rapidly and comprehensively to the customer ? The term "customer" refers to internal and external customers.

Use in phase

Customer satisfaction / customer support (service)

142



D 4.3

D 4.2

The procedure covered by the 8D method is helpful. For details and a form, go to the VDA QMC home page (www.vda qmc.de)

Are causes of failure analysed in the long term for main problem areas ? Are improvement programmes derived and implemented for these and similar service processes ? Additional information can be Causes of failure can arise from : obtained from : asking customers deficiencies quality analyses problems on start up / introduction supply sources repeat failures data flow / transport change of suppliers without applying a security environmental influences concept corrective actions lack of traceability following recall actions continuous improvement process changes (e.g., processing guidelines) programmes

Log and circulate complaints Analysis of causes by the person(s) creating the problem Improvement programmes with responsibilities and timings Revision of specifications / documents Compliance with stated timings Checks on effectiveness of actions Derive preventive actions

Are current complaints for this service process analysed consistently and is there evidence that improvements have been carried out ? The following are required : Note :


143


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Assessment forms & overviews (examples)

Process audit for material products

9

9.1

Because of limited representation possible, due to the book format A5, all forms of this chapter will be made available as PDF download. Access chapter 12.

144




145


146




147


148




149


9.2

150

Process audit for services



9.3

Potential analysis (P1) as an extract from the VDA 6.3 questionnaire

Because of limited representation possible, due to the book format A5, all forms of this chapter will be made available as PDF download. Access chapter 12.


151


152



the layout of the questionnaire was simplified by the working group VDA 6.3, after publishing the German edition in July 2010

Ladies and Gentlemen,

Note:


153


154




155


156




157


158




159


160


Nur zur internen Verwendung für Flextronics Automotive GmbH&CoKG bestimmt. Timing 03.02.2010 17.02.2010 Open 12 wks before SOP

Contract: PY

________________________ Auditor

_________________

Auditor

Signed for and on behalf of the supplier / tenderer

________________________________________

Controlled suppliers / tenderers undertake to cooperate with an approved consultant organisation within the framework of an agreement to achieve improved qualifications. The costs of this will be borne by the supplier.

Improved qualification agreement

Self audit : In order to make a well founded assessment of the self audit we would ask you to advise the amount of time taken in man days and the time required for qualification of the auditors involved. We assume that the time for the self audit is at least equivalent to that of a certification audit. The self audit must be carried out in the 0 production phase of the project (parts from serial production tools and facilities). After we have received and checked these documents and provided that this results in an "A" status we shall agree with you on the date for our audit. If the result is a "B" status, please advise us of a realistic date when you expect to achieve an "A" status. We shall then expect you to send us the audit report at that time, covering the internal follow on audit, without our having to request this.

The actions must be implemented without delay. In the case of large scale improvement programmes this can be split into implementation phases.

Explanatory notes

Activities Improvement programs received I. Finalisation and agree timings for the improvement programme (14 days) II. Carry out the improvement programme (2 weeks from award of contract) III. Self audit to VDA 6.3 (only if contract awarded on the basis of a "GREEN" or "YELLOW" status)

Timing plan : Supplier / tenderer

Qualification timing plan

_________________________________________________________________________

10

Best Practice / Lessons Learned

10.1 Example of information provided by the supplier Information provided by the supplier

Customer

Date: Contact person Name Phone Email Fax General supplier information Supplier code Commodity/product of interest for customer Technology of interest for customer DUNS (Dun & Bradstreet) Code Company name Legal form Year of foundation

Address of headquarters Street City State Country Post code Phone Fax Dokument wurde bereitgestellt vom VDA-QMC Internetportal am 10.11.2010 um 14:27

161


Access to supplier portal for customer Name Phone Email Supplier Contact Name Phone Email Fax Languages spoken

Electronic data information (EDI) facilities Location System in use Communication standard Name of contact person Phone Email Products Main product groups

Current maximum capacity for each product

1. 2. 3. 4. 5. 6. 1. 2. 3. 4. 5. 6.

Tooling Percentage of in house tooling design

%

Percentage of in house tooling manufacturing

%

Tooling suppliers

%

162



Customers (by volume) All your customers (list names only) 4 biggest customers Industry (passenger cars, commercial vehicles, ...) Unit volume per year Sales per year Percent of total sales

%

%

%

%

Percent of sales exported

%

%

%

%

Production capacity utilization

%

%

%

%

Main Suppliers (by purchase volume) Supplier name

Product group

Product

Location/ country of origin

Distance to your plant


Annual quantity (€/$)

% of total purchasing volume (€/$)

163


Product quality Commodity/product of interest

Overall

Internal ppm Internal scrap rate First time capability (no rework) External ppm On time delivery For electric/electronic: Which statistical methods for early detection of failures (e.g. Part Average Analysis PAA) do you apply?

Location Name of location Total number of employees shopfloor/office Management R&D Engineering (Product) Engineering (Process)

164



Production Service Sales Purchasing Quality Toolshop and Maintenance Others Total facility area size Manufacturing Laboratory Engineering Administration Others possible expansion

Manufacturing facilities (only for processes used for commodity/product of interest) Type of machinery

Producer

Year of construction

Utilization % % % % % %


165


Manufacturing work pattern Shift model Working hours per shift Working days per week Union affiliation Working days per year Extra time possible

Competitors Company name

Market Share

1. 2. 3. 4. 5. 6.

% % % % % %

Quality Management Description QM certificates

ISO TS 16949

Environmental management certified

ISO 14001

Registration / certification body

Expiry date

In house laboratory certification Software development: ISO 15504 (SPICE) level?

166



Software development: CMM/CMMI level? List the laboratories used for validating commodity/product of interest: List supplier activities during customer ramp up

Ownership Parent company

Main owners

Participations

Joint Ventures

Cooperations / Alliances

List the parties from which you have received licenses for product and/or processes. List the parties you have given licences to for product and/or processes.

1. 2. 3. 4. 5. 1. 2. 3. 4. 5. 1. 2. 3. 4. 5. 1. 2. 3. 4. 5. 1. 2. 3. 4. 5. 1. 2. 3. 4. 5. 1. 2. 3. 4. 5.


167


Research & Development

Current customers during product creation phase

For commodity/product

Overall

Products in focus of R&D activities Brief description of prototype facilities Brief description of testing facilities CAD data processing

Business development (please attach your latest annual report) For each year listed (last four years) Total turnover Production utilization

%

%

%

%

Market share

%

%

%

%

Number of employees Export percentage Volume of purchased materials Expenditure on tooling/equipment

168



Expenditure on research and development Expenditure on wages/salaries

Explain your current logistics methods – (local / export) Delivery modes (JIT, Just in Sequence, Logistics centre, etc.)

Percentage of use for main customers

Percentage of use regarding parts supplied

% % % % %

% % % % %

IT processing Production "#$%&'%(#()%*$+&, interruptions Contingency plan exists ?

yes no

yes no

Transport interruptions yes no

Qualified personnel yes no

-.%#/% #$$#01 an up to date organisation chart a list of your suppliers (names, product, evaluation status) a complete list of all your manufacturing facilities a complete list of external developers/engineers


169


10.2 Assessment guidelines

170

Points 10

Product risks Product is free from complaints and meets technical requirements

Process risks Technical requirements / specifications covering product and process are met

8

Complaints regarding the product (no effect on function, use or further processing operations). Improvements required.

Minor problems in the production process Process weaknesses are present but are detected & eliminated immediately

6

Complaints regarding the product (no effect on function but defect leads to problems in use and/or further processing operations) Process capability (significant characteristics) is not achieved Defects are reworked in follow on processes Defects are detected by monitoring, non conforming items must be securely removed from production operations, separate rework required

4

Complaints regarding the product (defect affects function, leads to restrict ions in use and has a significant negative effect on further processing) Agreed process capability (special characteristics) is not achieved Defects lead to serious process difficulties Defects are not guaranteed to be detected, sorted or

Products cannot be made in a secure process; however, significant characteristics are within specification Significant characteristics are not monitored systematically Sorting action required Rework required Risk of damage to parts Process problems in overall flow of materials Inspection & measurement equipment not suitable for detecting the defect Employees have not been adequately informed Products cannot be made in a secure process; significant characteristics are in part outside tolerance Characteristics are not monitored systematically Sorting action required Rework required Risk of damage to parts Mixed up parts/ incorrect assembly leads to process problems Inspection &

QM system relevance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

-(34+0$*3& :#(#9%$%(/= *&/:%0$*3& (%<+*(%9%&$/ &3$ /%$ 3+$ *& (%,+.#$*3&/ C9:(3'%9%&$ :(3,(#9/ &3$ *&$(34+0%4 A??%0$*'%&%// 3? *9:(3'%>9%&$ :(3,(#9/ &3$ 4%93&/$(#$%4 E%'%(% 4%'*#$*3&/ ?(39 039:#&8>5*4% #&4 *&$%(&#. $#(,%$/ C%<+#$% 039:.*#&0% 5*$1 (%<+*(%9%&$/ ?3( 0(*$*0#. 01#(#0$%(*/$*0/



reworked in follow on processes High scrap levels and/or extensive separate rework required

0

Rules

Complaints regarding the product (function no longer guaranteed; use of the product is significantly restricted, further process ing by the customer is not possible) Defects not detected, sorted or reworked in follow on processes Rejects and field returns are to be expected Use of the product may represent a danger to the user

measurement equipment for detecting deviating characteristics are not suitable Employees are neither adequately trained no have they been informed of the defect pattern Machines, facilities and/or jigs & fixtures are unsuitable, incomplete or missing altogether Customer relevant characteristics cannot be achieved as a secure process Checks, inspection and measurement facilities to monitor customer relevant characteristics are not present Damage to customer relevant characteristics caused by parts handling Mixed up parts in house or when shipped restrict further processing by the customer

-%(/3&&%. $(#*&*&, ?3( ,(3+:/ */ &3$ 0#((*%4 3+$ C%<+#$% 039:.*#&0% 5*$1 (%<+*(%9%&$/ .%#4/ $3 ?+&0$*3&#. ?#*.+(%/ ?3( $1% 0+/$39%(

If there are deviations and the assessment score is 0 or 4, immediate actions must be specified and implemented. The auditor must assure him/herself of the effectiveness of the actions which are implemented If an assessment score is 0 the entire process chain must be checked. Suspect parts must not be shipped The scenarios in the above fields are merely framework examples. These examples are not always entirely applicable and may also be extended if required.


171


10.3 Data stores

Know how & Co. Ltd.

Version 1.2

Technology questions for process audits Criteria 1.

Suppliers / incoming materials Who

Granulate

What

How

Flow characteristics

Flow coil / melt flow index (MFI)

Melt temperature

Hot stage microscope

Density

Precision scales / density scales

Ash content

Muffle oven

Note In the case of coloured granulate batches, master batches are sometimes pre mixed. Granulates must be stored so that they remain dry (no moisture absorption). This must be taken into account in the case of external stores.

2. Production process and process security Granulate pre drying : essential and can be achieved with a circulating air dryer or high performance dryer. Recycled material (regrind) not permitted. Conditioning : required only for PA components and can be achieved with a heated water container and a monitored time period. Injection moulding : controlled and monitored parameters (temperature; pressure; cycle time; retention times to be constant as far as possible). Known temperature distribution in the tool. Spare parts – e.g., replacement/tempering equipment. Following a tool change or run up to production it is important to check first off parts to ensure heat up times are complied with and also to carry out fill studies, where appropriate, to assess the quality of the parts produced.

3. Checks on finished parts What

Comments

Visual check by operator

Dimensional stability

3D measurement machine; profile projector; standard measurement devices

Density

Scales

Moisture content

Direct moisture measurement or Moisture has an influence on shrinkage heater plate test

Reaction to heat / cold

Climate oven

Compare results before and after

Swelling in media

Storage in the test medium

The media have an influence on shrinkage

Issue : 1.2 Date : dd.mm.yyyy

172

How

Surface quality

Page : x of y By : (name)

Ensure adequate lighting

Release :



Data store for Know how & Co. Ltd. for product group covering pressed & stamped parts 1. Process operation : Stamping; drawing; bending 1.1 Requirements for incoming material Storage conditions are defined and maintained reasonably – e.g., requirements regarding protection against corrosion. Component*

Characteristic* / proof

Method*

Test bar / sheet

Tensile strength; expansion before breaking

Pull test machine

Sheet, wire, plate, coil

Dimensional stability; weight

Standard measurement equipment

Individual parts; bulk items

Weight; quantity

Standard measurement equipment; scales

Surfaces

Damage; splits; dents

Visual check

Material; composition

Material / melt analysis

Material test certificate

Surface coating / plating

Coating thickness

Coating thickness measurement device

Surfaces

Corrosion test

* These are examples only and not a complete list.

1.2 Equipment and processes Technology : machines with automatic controls; mechanical and hydraulic presses Stamping : crank presses; rapid run presses Bending : CNC controlled automatic wire bending machines Tools : hardened surfaces 1.3 Process parameters Parameter*

Measurement devices* / proof

Comments

Stroke; feed; press force

Optical display; digital; control

Interlocks in place

Tests / checks on the product : Characteristic* Variable characteristics

Checking equipment / proof*

Surfaces

Standard measuring equipment, 3D coordinate measurement machine, gauges, coating thickness measurement device Visual check

Strength test

Pull test machine

Comments*

Cp/Cpk

Long term development with graph showing measurement point results

x

Evaluation of main points

x

Measurement and destructive checks with proof

x

* These are examples only and not a complete list.

Author :

Checked :

Released :


173


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