Advanced Product Quality Planning
APQP
QUALITY PRODUCTIVITY MANAGEMENT CONSULTANCY
(QPMC)
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Advanced Product Quality Planning (APQP) Synopsis: Advanced Product Quality Planning (APQP) is the technique, adopted by most of the companies, which helps to establish the steps necessary to assure that a product satisfies the customer. The goals of product quality planning are effective communication in a team with everyone involved, on time completion of all required steps, minimal or no quality problem. APQP should be used as a guideline to utilize the resources towards customer satisfaction, to identify the required changes early, to provide a quality product on time at competitive cost. Effective product quality planning depends on a company’s top management commitment to the effort required in achieving customer satisfaction.
Purpose The purpose of this workshop is to provide individuals and teams with the knowledge and skills to the different phases of APQP requirement. The training program covers Plan and Define program, Product design and development, Process design and development, Product and Process validation, Feedback assessment and Corrective action.
Objectives: After completion of this workshop, participant will be able to: 1. Explain the importance of thinking. 2. Understand different stages of APQP 3. Able to take decision fast
Precaution: The participant manual was designed for use in the context of an instructor-led workshop and as a reference outside the workshop. All presentations are in transparent sheet material. It was not designed as a self-study text. This material should not be photocopied without the permission of author. Also this material should not be shown or given to any Consultant or Consultancy Organization.
Dr. S Bhuniya
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Advanced Product Quality Planning (APQP) What is APQP? Advanced Product Quality Planning (APQP) is a structured method of defining and establishing the steps necessary to assure that a product satisfies the customer. Effective product quality planning depends on a company’s top management commitment to the effort required in achieving customer satisfaction. Objectives of APQP The goals of product quality planning are * effective communication in a team with everyone involved * on time completion of all required steps * minimal or no quality problem. * minimal product launch quality risk Benefits of APQP * Resources are directed towards customer satisfaction * Required changes are identified early * A quality product on time at competitive cost. Phases of APQP
Phase I- Plan and Define program Phase II- Product design and development Phase III- Process design and development Phase IV- Product and Process validation Phase V- Feedback assessment and Corrective action.
Phase –I ( Plan and Define the Program) 1. Organization will interface with the customer& get all the necessary customer inputs like customer drawings, specifications, sample parts etc. to enable to do a preliminary feasibility study. 2. An initial feasibility study, preliminary process flow & risk assessment are done based on the checklist to evaluate the suitability of designing and manufacturing the new product. This initial feasibility and risk assessment will be done in a team. 3. In some cases, when the customer requires some sample parts before submitting the quotation, the same is submitted. 4. Based on the initial feasibility studies, the new product development will be considered. The cost estimation will be done for the new product. 5. The quotation package will be prepared & submitted to the customer for acceptance. The qualities planning activities starts once the customers conforms the orders either verbally or give it in writing.
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6. The team will do a detailed contract and feasibility review based on the customer confirmation and order placement. 7. Organizer will conduct a Quality system requirements review with the customer to ensure that all TS 16949:2002 system requirements are clarified and any additional customer specific requirements are required. Organizer will ensure that all customer standards like packaging standards, engineering standards; inspection standards are received from the customer. 8.
Organizer will combine feasibility review & quality system requirements review.
9. Organizer will prepare a detailed Product quality planning and introduction Gantt chart. This chart will show all the activities of APQP in detail along with the responsibilities, start-date and end-date. The progress of the product introduction is also monitored using this chart. 10. Organizer will initiate the APQP Status reporting form. The program need dates and the supplier timing dates are planned depending on when the customer requires the product. If the customer requires the APQP status reporting form to be sent to him at a determined frequency, Organizer will ensure that the status reporting form are sent to the customer as per the agreed frequency. 11. Organizer will prepare the Bill of Material for the new product. Based on the BOM and the similarity of the new product components with the existing ones, Organizer will review the existing Family data sheet and decide the part families for the new product for all components made in-house. 12. Organizer will select the subcontractors from the Approved subcontractors list. If any new subcontractors are required, then the selection will be done. Quality system development of existing subcontractors will be done. Product development with the subcontractors (new/existing) will be done. 13. The following are the outputs are the end of phase-1 of APQP: * Customer inputs like drawings, specs, and correspondences * Initial feasibility and risk assessment checklist * Quotation * Customer’s Purchase order * Contract and feasibility review checklist * Quality system review checklist * New product planning and introduction Gantt chart * Bill of Material * Family data sheet * APQP status reporting form * List of subcontractors * Customer specified special characteristics 14. Management review will be conducted by organizer to ensure the adequacy of all the activities conducted during Phase-1.
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Phase II- Product design and development 15. Product design and development will be done ( only for design-responsibility organization) * Design FMEA * Design for manufacturability and assembly * Design Verification * Design reviews * Prototype build * Engineering Drawing * Engineering specification * Material specification * Drawing and specification changes 16. Organization prepares detailed drawing using customer drawing / sample wherever required and make tooling drawing accordingly. 17. A detailed plan for any new facilities, equipment or tool if required will be prepared by organization. Facilities planning and review will be done. 18. Organization will ensure that the existing gauges/measuring equipment is capable of measuring the characteristics for the new product made. If any new gauges/measuring equipment is required, then team will prepare a list of new gauges/measuring equipment for procurement and to be procured. 19. Organization will review whether any customer specified testing is needed and any additional test equipment are required for doing the testing. If any new test equipment is required, team will prepare a list of test equipment for procurement. 20. Organization will review the tooling/die/fixture requirements and identifies the existing tools/dies/fixtures and the tools/dies/fixtures to be manufactured for making the new product. This also includes any tooling/dies/fixtures, which have to be given to the subcontractor. 21. The following are the outputs at the end of Phase-2: * Drawings, specs * Design FMEA * Preliminary list of special characteristics * Prototype control plan (if contracted to produce prototype parts) * Design verification plan * Design verification test results * Design reviews * List of new equipment/facilities (if required) * List of new gauges/measuring equipment (if required) * List of new test equipment (if required) * List of tool /die/fixture 22. Management review will be conducted at the end of Phase-2 to ensure the adequacy of all the activities done during phase-2. 5
Phase III- Process design and development 23. The APQP team will prepare Process Flow Diagram, Process FMEA, Special characteristics & Pre launch Control, Tool/ Die/ Fixture Drawing. 24. Organization will prepare work / operation instructions based on the activities required 25. Process development and Qualification will be done. 26. Organization will prepare floor plant layout. 27. Packaging drawings and specifications will be done as per the customer specified packaging standard (if provided) or internal standards by organization. 28. Any training required for the operators as part of the new process are identified by team and provided. 29. Prepare sample and submit to customer for initial verification with dimensional report. 30. Conduct MSA study (Bias, Linearity, Stability, Gage R & R) for similar type of components or have the plan for those studies at the time of PPAP sample. 31. Prepare preliminary capability study plan for special characteristics. 32. At the end of Phase-3, Leader along with the APQP team ensures that the following are available for conducting the Production part approval process. TYPE Man Machine Method Measurement Material Atmosphere Documents
REQUIREMENTS 1. Trained operators 2. Facilities/equipment (including facilities at subcontractor) 3. Validated tooling (including tooling at subcontractor) 4. Calibrated gauges/measuring equipment 5. Test equipment 6. Raw materials 7. Subcontractor processes developed and qualified. 8. Packaging requirements 9. Good housekeeping 10. Any other environmental conditions (if any) 11. Drawings/specifications 12. Process flow chart 13. Process FMEA 14. Control plans/any other customer equivalents 15. Customer standards 16. List of special characteristics 17. Work / Operation instructions
33. Review is conducted at the end of Phase-3 to ensure the adequacy of all the activities done during phase-3. 6
Phase IV- Product and Process validation 34. Production Part Approval Process will be followed as per the PPAP reference manual after tool/die/fixture validation or those can be verified thoroughly by lay out inspection of component. If the customer wants a different process to be followed, then it will be agreed during Quality systems review with the customer. 35. PPAP sample (quantity as agreed or 300 nos minimum) will be produced as per Pre launch Control plan, Work/ Operations instruction. 36. MSA studies (Bias, Linearity, Stability, Gage R &R) to be carried out, if it was planned in Phase 3. 37. Preliminary process capability studies ( Pp, Ppk) will be carried for special characteristics as per plan. 38. Dimensional, Performance testing or Production validation testing will be carried out. 39. One master sample of PPAP, will be kept. 40. Packaging evaluation will be done 41. PPAP sample will be sent to customer for approval with PSW (Part submission warrant). 42. If customer approves the PPAP part for regular production, then APQP team prepares the Production control plan and releases it to the shop floor. 43. Quality Planning sign off will be done. 44. Changes for which as agreed with the customer during Quality systems review, PPAP has to be submitted Phase V- Feedback assessment and Corrective action. 45. If customer has not accepted the PPAP part, then relevant above activities have to be reviewed and make those effective for approval of customer. 46. Product quality planning data and experience will be used as an input for the future same type of product development. Common activities: 47. APQP timing plan initiated during Phase-1 will be reviewed and updated. and the progress of the product planning tracked. The review frequency will depend on the following: * Type of the new product * Difference in the processes from the existing processes * Customer requirement date
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Failure Mode & Effects Analysis (FMEA) Definitions & Types FMEA is an analytical technique, which combines the technology and experience of several engineering disciplines in identifying foreseeable failure modes of a product or process and planning for its elimination. Mainly FMEA are Design FMEA and Process FMEA. What FMEA will do: * Identify known and foreseeable failure modes. * Rank failures according to relative impact on the product. * Help to establish priorities based on expected failures and severity of those failures. * Help to uncover oversights, misjudgments and errors that may have been made. * Help to reduce development time and cost of manufacturing process by eliminating many potential failure modes prior to operation of the process and by specifying the appropriates tests to prove the designed product. What FMEA will not: * Will not fix the identified problems. * Will not define the action that needs to be taken. * Will not replace the PDCA (Plan, Do, Check, Act) plan, which should be used to track major potential problems to resolution. How to get started: Select 4 to 8 people who are knowledgeable of the process or the design to be used for a new process. * Always best to include end users in the process. * Should be a team effort.
Customer
Assumptions
Design FMEA End user, Design responsible engineers or Higher assemblies or Mfg. Process responsible engineers in activities such as Mfg., Assembly, Service Takes the technical / physical limits of a Mfg. / Assembly process into consideration
Process FMEA End user, Subsequent or downstream Mfg. or Assembly operation
The product as designed will meet design intent
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PROCESS FMEA What is it? A process potential FMEA is an analytical technique, utilized primarily by Manufacturing Responsible Engineer / Team as a means to assure that, to the extent possible; potential failure modes and their associated causes / mechanisms have been considered and addressed. What it does? It - Identifies the process functions and requirements. - Identifies potential product and process-related failure modes. - Assesses the effects of potential failures on the customer. - Identifies the potential manufacturing or assembly process causes and identifies process variables on which to focus controls for occurrence reduction or detection of the failure conditions. - Develops a ranked list of potential failure modes, thus establishing a priority system for preventive /corrective action considerations. - Documents the result of the manufacturing or assembly process. Which customer is to be considered? “Customer” for a Process potential FMEA is seen as the ‘Next Process (NP)’, ‘Assembly’, ‘OEM’ and ‘Application / Vehicle’ or ‘government regulation’. Team Effort During the initial process potential FMEA process, the responsible engineer is expected to direct and actively involve representatives from all affected areas. Development of a Process FMEA FMEA begins by developing a list of what the process is expected to do and what it is expected not to do i.e. process intent. FMEA details should include: * FMEA Number * Item * Process Responsibility * Prepared by * Model Year (s) / Vehicle (s) * Key Date * FMEA Date * Core Team
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Process Function/ Requirements * What is the process? * What is it supposed to achieve? Potential Failure Mode * How can the process / part fail to meet the specification? * List each potential failure mode for the particular operation in terms of a component, subsystem, system or process characteristic. * Typical failure modes could be bent, Cracked, Handling damages, Surface too rough, Open circuited, Burred, Hole too shallow, Dirty, Deformed, Short circuited, Hole off-location, Hole missing, Hole too deep, Surface too smooth, Mis-labeled etc. Potential Effect (s) of Failure * In what form, would the customer define the failure? * What are the effects of this failure mode that the customer sees? * Typical failure effects could be - Noise, Erratic operation, Effort, Operation impaired, Intermittent operation, Leaks, Rework /Repairs, Scrap, Rough, Excessive, Unstable, Inoperative, Draft, Poor appearance, Vehicle control impaired, Customer dissatisfaction etc., in case of final operation. - Can not fasten, Does not fit, Does not connect, Does not match, Can not mount, Can not bore/tap, Cannot face, Damages equipment, Causes excessive tool wear, endangers operator etc., in case of customer being next operation or subsequent operation. Severity Severity is an assessment of the seriousness of the effect of the potential failure mode to the customer. Severity applies to the effect only. A reduction in Severity Ranking Index can be effected only through design change. Severity should be estimated on a “1” to “10”scale.
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Effect
Criteria: Severity of effect (Customer Effect) Hazardous Very high severity ranking when a without potential failure mode affects safe warning vehicle operation and / or involves noncompliance with government regulation without warning Hazardous Very high severity ranking when a with potential failure mode affects safe Warning vehicle operation and / or involves noncompliance with government regulation with warning Very High Vehicle / item inoperable, with loss of primary function. High
Vehicle / item operable, but at a reduced level of performance. Customer very dissatisfied.
Moderate
Vehicle / item operable, but comfort / convenience item (s) inoperable. Customer dissatisfied.
Low
Vehicle / item operable, but comfort / convenience item (s) operable at reduced level of performance. Fit & Finish / Squeak & Rattle item does not conform. Defect noticed by most customers (greater than 75%). Fit & Finish / Squeak & Rattle item does not conform. Defect noticed by 50% of customers. Fit & Finish / Squeak & Rattle item does not conform. Defect noticed by discriminating customers (less than 25%) No discernible effect
Very Low Minor Very Minor None
Criteria: Severity of effect (Manufacturing / Assembly Effect) May endanger operator (machine or assembly) without warning
Rank
May endanger operator (machine or assembly) with warning
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100% of product may have to be scraped. Or Vehicle / item repaired in repair dept. with a repair time greater than one hour. Product may have to be sorted and portion (less than 100%) scrapped. Vehicle / item repaired in repair dept. with a repair time between a half-hour and an hour. A portion (less than 100%) of the product may have to be scrapped (no sorting) or Vehicle / item repaired in repair dept. with a repair time less than a half-hour. 100% of the product may have to be reworked. Or Vehicle / item repaired in offline but does not go to repair dept. The product may have to be sorted, with no scrap and a portion (less than 100%) reworked. A portion (less than 100%) of the product may have to be reworked with no scrap, on-line but out-of-station. A portion (less than 100%) of the product may have to be reworked with no scrap, on-line but in-station.
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Slight inconvenience to operation or operator, or no effect
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10
7
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5 4 3 2
Classification Classify any special product characteristics (e.g. Critical, Key, Major/ Significant) for components, subsystems or systems that may require additional process controls. If a classification is identified in the process FMEA, notify the design responsible engineer since this may affect the engineering documents concerning control item identification.
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Potential Cause (s) / Mechanism (s) of failure * What are the ways in which this process failure could occur? * Describe in terms of something that can be corrected / controlled. * Typical failure causes may be Improper torque (over, under), improper weld (Current, time, pressure), Inaccurate gauging, Improper heat treatment (time, temperature), Inadequate gating / venting, Inadequate or no lubrication, Part missing or mislocated, Worn locator, Worn tool, Chip on locator, Broken tool, Improper machine set up, Improper programming etc. Occurrence Occurrence is how frequently the specific failure cause / mechanism will occur. Occurrence should be estimated on a “1” to “10” scale. Probability of Failure Likely Failure Rate Very High: Persistent Failure ≥ 100 per thousand pieces 50 per thousand pieces High: Frequent Failures 20 per thousand pieces 10 per thousand pieces Moderate: Occasional Failure 5 per thousand pieces 2 per thousand pieces 1 per thousand pieces Low: Relatively Few Failures 0.5 per thousand pieces 0.1 per thousand pieces Remote: Failure is Unlikely ≤ 0.01 per thousand pieces
Ppk < 0.55 ≥ 0.55 ≥ 0.78 ≥ 0.86 ≥ 0.94 ≥ 1.00 ≥ 1.10 ≥ 1.20 ≥ 1.30 ≥ 1.67
Rank 10 9 8 7 6 5 4 3 2 1
Current Process Controls What are the existing process controls that: * Prevent to the extent possible the failure mode or cause/ mechanism of failure from occurring. * Detect the failure mode or cause / mechanism of failure Controls can be process controls such as error / mistake proofing or Statistical Process Control (SPC) or can be post-process evaluation. Two types of process controls to be considered * Prevent the cause / mechanism of failure or the failure mode from occurring, or reduce their rate of occurrence * Detect the cause / mechanism of failure or the failure mode, and lead to corrective action (s). Once the process controls have been identified, review all prevention controls to determine if any occurrence rankings need to be revised. Detection Detection is the rank associated with the best detection control listed in process control column. In order to achieve a lower ranking, generally the planned process control has to be improved. Detection should be estimated on a “1”to “10” scale.
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Detection
Criteria:
Insp Suggested Range of Detection Methods Types A B C Almost Absolute certainty X Cannot detect or is not checked Imposs of non detection ible Very Controls will X Control is achieved with indirect or random checks Remot probably not detect only e Remote Controls have poor X Control is achieved with visual inspection only chance of detection Very Low Controls have poor X Control is achieved with double visual inspection only chance of detection Low Controls may X X Control is achieved with charting methods, such as detect SPC. Moderate Controls may X Control is based on variable gauging after parts left the detect station, or Go / No Go gauging performed on 100% of the parts after parts left the station. Moderate Controls have a X X Error detection in subsequent operations, or gauging High good chance to performed on setup and first piece check (for setup detect causes only) High Controls have a X X Error detection in-station, or error detection in good chance to subsequent operations by multiple layers of acceptance: detect supply, select, install, verify, and cannot accept discrepant part. Very High Controls almost X X Error detection in-station (automatic gauging with certain to detect automatic stop feature). Cannot pass discrepant part. Very High Controls certain to X Discrepant parts cannot be made because item has been detect error-proofed by process/product design. A- Error Proofed, B- Gauging, C- Manual Operation
Rank 10 9 8 7 6 5 4 3
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Risk Priority Number (RPN) RPN = SEVERITY (S) * OCCURANCE (O) * DETECTION (D) Within the scope of the individual FMEA, RPN will be between “1” and “1000”. For higher RPN, the team must undertake efforts to reduce through corrective action. Regardless of the resultant RPN, special attention should be given when severity high. Recommended Action(s) Intent is to reduce the severity, occurrence, and / or detection ranking Action such as following should be considered - Only a design and or process revision can bring about a reduction in the severity ranking. - To reduce the probability of occurrence, process and / or design revisions are required. An action-oriented study of the process using statistical methods could be implemented for continuous improvement and defect prevention. 13
- To increase the probability of detection, use of error / mistake proofing / process and / or design revisions are required. Generally, improving detection controls is costly and ineffective for quality improvements. Increasing quality controls inspection frequency is not positive corrective action, should only be utilized as temporary measure, permanent corrective action is required. If engineering assessment leads to no recommended actions for a specific failure mode / cause/ control combination, indicate this entering “None” in this column. Responsibility (for recommended action) Enter the organization and individual responsible for the recommended action and the target completion date. Action taken After an action has been implemented, enter a brief description of the actual action and effective date. Resulting RPN Follow up The process responsible engineer is responsible for assuring that all the actions recommended have been implemented or adequately addressed. The process responsible engineer has several means of ensuring that concerns are identified and that recommended actions to be implemented. They include * Ensuring that process / product requirements are achieved * Reviewing engineering drawings, process /product specification, process flow * Confirming the incorporation of changes in assembly/ manufacturing documentation * Reviewing control plans and operation instructions.
______________X______________
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Guidelines for preparation of “Process Flow Diagram” 1. Mention Serial No. 2. Mention Operation Description . 3. Mention Flow diagram with symbol 4. Mention Operation Sketch 5. Mention incoming source of variation 6. Mention Process Characteristics 7. Mention Product characteristics Sl No.
Operation Flow description diagram
Flow Sketch
Incoming Source of Variation
Process Characteristic
Product Characteristic
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Guidelines to Carry out PFMEA Corrective action (CA) for existing problem Preventive action (PA) for potential problem (1) Failure Mode • Opposite of desired outcome of that process • Mention oversize / undersize in case of dimensional (if effect is same then no need to differentiate) • How much? • Last six months problem should be covered. (2) Effect • Effect to be written for o Next process (NP) o Assembly o OEM o Vehicle / Application o Government Regulation (3) Severity • Follow guide lines for ranking severity number • Circle the max no., which will be used for RPN calculation. (4) Class • Corresponds to product characteristic • For those product characteristic having effect on Application or Customer o Severity ranking 10, 9 - Critical , Safety, Government regulation o Severity ranking 8,7 – Significant / Major (5) Cause • Cause related to failure mode. • Write those, which are related Incoming source of variation, mentioned in Process Flow • Write those, which are related process characteristic (6) Occurrence • Check the data related to causes o If exists, then straightway go to the Occurrence table and rank accordingly o If it is not there, Depending on the probabilities, give the ranking Not able to take decision in the meeting / confusion, then go to failure mode data and give the same ranking to all causes • Check the rejection percentage corresponding to that failure mode o If it exists, then straightway go to the occurrence table and rank accordingly o If it is not existed, then go by probability • For each cause, there will be one occurrence no. (7) Current process Control • If the cause happens then what is the method, we have to detect the cause? • What is the method do we have to prevent the cause? • What is the method; do we have to detect the failure mode?
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Note: Difference between prevention and detection: Example: There is a sensor to stop the production process, if anything goes wrong- Detection If something goes wrong, but sensor doesn’t allow to stop the production or no inconsistency in production criteria, then it is ’Prevention’. (8) Detection • •
Whenever cause occurs, would it detect? Rank as per table
(9)Risk Priority Number (RPN) RPN = S X O X D (10) Recommended Action • To be taken, only when occurrence no. is more than 3, preferably; because our ultimate aim is to reduce the frequency of cause’s occurrence. • It should be completed within target date Outcome of the PFMEA • List of critical, significant or major and key characteristics of the part • List of recommended action to be implemented Customer Complaint & Rejection Analysis Customer Complaint Directly from customer
Rejection
Field failure Effect on Application / Vehicle
Failure Mode
Identify failure mode
Failure mode
Identify Causes Look for Preventive control Look for Detection control Corrective Action Corrective Action Impact ------------------------X------------------------
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Guideline to carry out CONTROL PLAN 1. Copy the Process No. and Process Description from Process Flow. 2. Write the Process machine/ Device/ Jig/ Tool used for doing that Process. 3. Go to the Process FMEA. Copy the first product characteristics for that process into Product characteristic column of Control Plan. 4. Copy the Potential Causes of FMEA into Process characteristics of Control Plan. 5. Copy the Class Column of FMEA into Special Characteristics column of Control plan. 6. Write Product specification from drawing against Product characteristic. 7. Write the Process specification if applicable in the same column. 8. Write the evaluation / Measuring Equipment used for controlling Product and Process characteristic. 9. Write control method (prevention and detection) used for controlling product and Process characteristic. 10. Write Reaction Plan for Product and Process characteristic when it goes out of specification.
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Production part Approval Process (PPAP) Purpose: To determine whether all customer engineering design record and specification requirements are properly understood by the organization & whether process has the potential to produce product consistently meeting the requirements during an actual production run as quoted production rate. Section I I.1 General Organization shall obtain full approval from the customer for • A new part or product • Correction of a discrepancy on a previous submitted part • Product modified by an engineering change to design records, specification or materials I.2 PPAP Process requirements: I.2.1 Significant Production Run: Product run shall be from 1 hour to 8 hours of production with 300 minimum consecutive parts or specified by customer. Run shall be manufactured at the production site using productionised tooling, gaging, process, materials and operators from the production environment. I.2.2 PPAP requirements Organization shall meet all specified requirements. Blanket statements of conformance are unacceptable for any test results. All records shall be in a PPAP part file or referenced in such file, which will be readily available. I.2.2.1 Design Records Organization shall have all design records. I.2.2.2 Any authorized Engineering Change Document Organizer shall have any authorized engineering change documents not yet recorded in the design record but incorporated in the product, part or tooling. I.2.2.3 Engineering Approval, when required Where specified by the design record, organization shall have evidence of customer engineering approval. I.2.2.4 Design FMEA (for design responsible) I.2.2.5 Process Flow Diagram Process flow diagram in organization-specified format that clearly describes the production process steps and sequence, as appropriate and meets the specified customer needs, requirements and expectation. I.2.2.6 Process FMEA As per PFMEA manual I.2.2.7 Dimension Results 19
Organization shall provide the evidence that dimensional verifications required by the design record (Layout inspection) and Control Plan has been completed and results indicate compliance with specified requirements. Organization shall identify one of the parts measured as the master sample. I.2.2.8 Record of Material / Performance test result Organization shall have records of material / performance/ functional test specified on design records or Control Plan. In Material test result, wherever chemical, physical or metallurgical requirements specified by design record or control plan to be verified form in-house laboratory or outside-accredited laboratories. Material test report shall indicate • Design record change level of parts tested, number, date, change level of specification • date on which the testing took place • material subcontractor’s name In Performance test result, whatever specified by design record or control plan to be verified form in-house laboratory or outside-accredited laboratories. Performance test report shall indicate • design record change level of parts tested, number, date, change level of specification • any authorized engineering change documents that have not yet been incorporated in the design record. • date on which the testing took place I.2.2.9 Initial Process Studies I.2.2.9.1 The level of initial process capability or performance to be evaluated for special characteristics only. Organization shall use calibrated measuring instrument with permissible measurement uncertainty. I.2.2.9.2 Quality Indices Cpk – Capability Index for a stable process Ppk performance index Short-term studies I.2.2.9.3 Acceptance Criteria for Initial Study For appearing stable process (Ppk) or stable process (Cpk) Results
Interpretation
>1.67
Process currently meets Customer requirements. After approval, begin production and follow control plan Process is currently acceptable, but may require some improvement
1.33 to 1.67 <1.33
Process does not currently meet the acceptance criteria
I.2.2.9.4 Unstable process An unstable process does not meet customer requirements. Supplier shall identify the nature of instability, evaluate and wherever possible eliminate special causes of variation prior to PPAP submission. I.2.2.9.5 Process with one-sided specification or Non Normal Distribution
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Organization shall establish an alternative acceptance criterion or different type of index or some method of transformation data for special characteristics which are not bilateral equidistant tolerance or non normal distribution. I.2.2.9.6 Strategy when acceptance criteria are not satisfied Organization shall submit corrective action plan and a modified control plan providing 100% inspection. Continue variation reduction efforts till Cpk greater than equal to 1.33. I.2.2.10 Measurement System Analysis Studies Organization shall carry our Bias, Linearity, stability, gage R & R for all equipment used for measurement or performance test. I.2.2.11 Qualified laboratory Requirements Organization shall have laboratory scope, policy and documentation as per QS 9000 (4.10.6 and / or 4.10.7) I.2.2.12 Control Plan I.2.2.13 Part Submission Warrant (PSW) Separate PSW shall be completed for each customer part number If production parts will be produced from more than one cavity, mould, tool, die, pattern or production process (e.g. line or cell) organization shall complete dimensional evaluation on one part from each with identified “Mold/ Cavity/ Production Process”. I.2.2.13.1 Part Weight Organization shall record part weight upto 4 decimal places unless otherwise specified by customer. I.2.2.14 Appearance Approval Report (AAR) Appearance approval report to be completed for each part or series of parts for which submission required for parts with color, grain or surface appearance requirements. I.2.2.15 Bulk Material Requirements checklist (apply only to bulk material only) I.2.2.16 Sample Production Parts: Organization shall provide sample product as requested by the customer and as defined by the submission request. I.2.2.17 Master Sample: Organization shall retain a master sample for the same period as the production part approval records, or until a new master sample is produced for the same customer part number for customer approval or where a master sample is required by design record, control plan or inspection criteria, as a reference or standard. Master sample shall be identified with approval date on the sample. Organization shall retain a master sample for each position of a multiple cavity die, mold, tool or pattern or production process unless otherwise specified by customer. I.2.2.18 Checking Aid: Organization shall certify that aspects of the checking aids agree with part dimensional requirements.
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I.2.2.19 Customer-Specific Requirement: Organization shall have the records of compliance to all applicable customer specific requirements.
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