Quality Manual
CONTROLLED/UNCONTROLLED copy (delete as applicable) Controlled Copy No:
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This document may not be copied or reproduced in any way without the prior written permission of XXX
XXX Quality Manual
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Table of Contents Page Number 3 4 5 5 6 8 9 9 11
Section Number 1 2 3 4 5 6 7 8
XXX Quality Manual
Title
Amendment record Introduction Scope and exclusions Quality policy Quality management system Management responsibility Resource management Product realisation Measurement, analysis and improvement
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Amendment Record Issue No.
Section/Page No.
XXX Quality Manual
Brief Description of Change
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Date
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Section 1 Introduction Goes in here
Contact Information
Offices: Goes in here Telephone: Fax: Web site:
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Section 2 Scope & Exclusions The scope of our quality management system is: The design and delivery of tunnelling solutions for the water, road, rail and utilities industries, plus research and development of tunnelling techniques and materials. Due to the nature of our business, there are no exclusions from ISO 9001:2008.
Section 3 Quality Policy It is the quality policy of XXX to:
Establish itself as a Centre of Excellence for the design of tunnelled solutions to the construction industry in the UK.
Undertake research for new and innovative design solutions incorporating the development of materials, design and construction methods.
Offer technical guidance and management services to underground construction schemes with select clients in chosen markets.
Implement our management system in accordance with ISO 9001:2008 and provide adequate resources for its maintenance.
Invest in and involve all personnel in order to ensure that they develop within the company in order to achieve their strategic targets.
Ensure that our contractual and regulatory objectives are fulfilled, promote collaborative working with our clients and effect continual improvement of our management system.
This policy will be reviewed periodically in order to ensure that it remains effective and realises our strategic targets.
Authorised by: Engineering Director
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Section 4 Quality Management System 4.1
General Requirements
XXX’s quality management system has been developed around the processes of its business activities – the diagram below shows the main processes and their interrelationships. These processes will be implemented and maintained in order to achieve our objectives and we will actively seek to continually improve the system. Organisational Processes
Core Processes
System Processes
Enquiry received
Can XXX conduct the work?
Internal Audit and Management Review
Nonconforming Product and Customer Complaints
No Reject
Yes
Conduct site visit
Select tender team
Site investigation
Human Resources
Produce outline tender design Corrective Action
IT
Issue bid/tender Preventive Action Business Development No Bid accepted? Control of Documents
End
Yes Calculations, drawings, specifications
Finance Conduct detail design
Research and development
Control of Records Testing
Contractor performs work
Support
Calibration of Equipment
Commissioning, testing and validation
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4.2
Documentation Requirements
XXX’s quality management system is structured in 4 main tiers as shown below:
Quality Manual Procedures Method Statements Forms etc.
The quality manual (this document) outlines our approach to quality and is designed to help the reader to understand how we meet the requirements of ISO 9001 at policy level and to point the reader in the direction where further information can be found. Our procedures take these policies and turn them into practical information on how to operate our processes in a defined manner. Some of these procedures are unique to XXX and will be identified by the prefix XXX, whilst others are common to the parent body’s quality system and will be identified by the prefix ZZ. A list of our procedures is contained in appendix 1 of this manual. Method statements, where they are required, provide further detail of how to perform a particular task.
The lowest layer contains all of our standard forms which are used to record and control our activities and also contains other documents such as standards, codes of practice, etc. 4.2.3 Control of Documents
Ensuring that our employees have ready access to correctly authorised, up to date documents is fundamental to our ability to meet requirements. This applies to paper and electronic documents, whether they have been created by ourselves or supplied by an external source. As such, we have developed and implemented documented procedures to control these activities and satisfy this clause. See procedure XXX 09 & XXX 10 4.2.4 Control of Records
Records are created during the operation of most of our processes. These may be paper and/or electronic records and they will be managed in such a manner as to ensure that they are legible, identified, stored, protected and retrievable. Timescales for their retention will be established and a suitable method of disposal employed at the end of this period. Where records are retained electronically, appropriate back-up XXX Quality Manual
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systems will be used to achieve the above. In order to achieve the above requirements we have developed and implemented a documented procedure to control these activities and satisfy this clause. See procedure XXX 11
Section 5 Management Responsibility The head of XXX is the Engineering Director whose ultimate responsibility it is to ensure that quality and customer satisfaction are, as a minimum, achieved and wherever possible, exceeded through the use of our QMS. His duties include ensuring that all staff understand their role in achieving quality and meeting customer, statutory and regulatory requirements. We have established a quality policy (see section 3) and quality objectives are set to enable us to manage and improve our processes. Reviews of the system will be integrated into regular business meetings and the need for resources considered and provided as necessary. Quality objectives are set on a ‘project by project’ basis and include such elements as completion on time, completion to cost and number of nonconformities raised. These are contained in the project documentation and reviewed as the project progresses. Also included will be the planned methods of achieving these objectives which will be used as key tool for the improvement of our services to customers.
XXX operate a ‘flat’ management system which relies on selecting team members for projects based on their competence and availability. As such, there is no formal organisation chart but project based responsibilities and authorities are defined within each project’s documentation. The Engineering Director fulfils the role of the management representative and as such, takes responsibility for managing the QMS, reporting on its performance and ensuring that customer’s needs and expectations are fully understood by all staff. Regular project meetings take place to ensure that customer’s stat ed and changing requirements are fully communicated within XXX and with the customer. These meetings are supplemented by other communication methods such as email, letters, memo’s and design briefs to provide up to date information within the organisation.
Management review of the QMS takes place in a number of ways. As regular project meetings are held, many items are discussed and addressed at these meetings. In addition, an overview of the outcomes of these meetings will also be conducted at least annually. See procedure XXX 06
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Section 6 Resource Management Resources will be considered on 2 levels – a general business level and a project level. General business resources are reviewed on an ongoing basis and provided as required whereas project resources are determined and provided on a project by project basis and because our projects can last for a number of years, resources are continually reviewed throughout the life of the project. People will only be assigned to tasks for which they have a demonstrated competence. However, the development of our people is also one of our objectives so people will be encouraged to enhance their competence through training and other development activities. We will identify the competence requirements for tasks and wherever a ‘skills gap’ occurs, we will identify and implement a suitable method of bridging the gap and verify the effectiveness of the solution provided. In addition to specific technical competences, we will also ensure that all of our people are familiar with our QMS and the role it plays in achieving customer satisfaction. Records of training and reviews of training needs will be maintained. See procedure XXX 12 Our work is completed in both an office environment and outside, ‘on site’. In the offic e we will provide a suitable infrastructure and working environment which is appropriate to the work we perform and also the necessary hardware such as computers, software and supporting services such as communications.
Controlling the infrastructure and work environment for on site work is more difficult to manage but we will provide all the necessary equipment to ensure that we mitigate against the possibility of outside factors impacting negatively on our services.
Section 7 Product Realisation 7.1
Planning
Every project is subject to a planning phase, the outputs from which are project and design plans, which ensures that project requirements are clearly defined and communicated to all necessary parties. Where applicable, this will also include a risk assessment of the project. These plans are used to monitor and control the project and are reviewed and updated as the project progresses. They also contain or reference acceptance criteria for validation and acceptance testing and the records to be retained to demonstrate results obtained. See procedure XXX 04
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7.2
Customer related processes
Enquiries for work are received and reviewed to establish the customer’s requirements. If XXX decide to tender for the work a formal process is entered into which is described in procedure XXX 01. This includes the appointment of a project manager and suitable team and may entail a site investigation which ensures that all requirements can be identified and evaluated, be they stated, implied or statutory/regulatory.
From this information an outline design is produced (see procedure XXX 02) and reviewed to ensure that the project is adequately defined, XXX can perform the work and any changes from the initial enquiry have been considered and addressed. The tender is then prepared and submitted to the customer for acceptance (see procedure XXX 01). Once the tender has been accepted, regular contact is maintained with the customer throughout all stages. This includes project meetings and an end of project review which also provide opportunities for customers to give feedback, including any problems encountered. 7.3
Design and Development
Design of the project is conducted in 2 stages – outline design and detail design - and would include any required temporary works. Design work is conducted in accordance with documented procedures (see procedure XXX 02 & Design Office Method Statement MS/01/T) and takes into account all applicable current codes and practices. The outputs from the design process are in the form of a design plan which includes drawings, calculations, specifications, etc., these outputs are reviewed and verified by an independent designer and the final design is issued. Due to the nature of our work, validation of the design cannot be conducted until the finished design is implemented. Validation takes the form of a post project review plus measuring and testing activities such as leak testing. The results of these activities are recorded and may be used as inputs for future, similar designs. Design changes may be initiated by the customer or XXX and are controlled via a design change application system which ensures that any changes are adequately reviewed, controlled and implemented. 7.4
Purchasing
Purchasing activities are limited to items such as software, laboratory equipment and the use of sub-contract services such as consulting engineers and electrical and mechanical contractors. A formal process exists within the parent body for selecting and evaluating suppliers and for placing purchase orders. This system will be adopted by XXX but we will be responsible for verifying that purchasing requirements have been satisfactorily met. See ZZ 06 & XXX 03 XXX Quality Manual
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7.5
Service Provision
The service provided by XXX is largely that of design so this element is mostly addressed within clause 7.3. However, other activities do exist such as research and development activities and on site support. The control of these activities is mostly achieved by the fact that they are conducted by competent people but this may be supplemented by method statements as required. Projects are identified by a project reference which is used on all documentation relating to the project. Documentation is controlled via a design issue sheet and signature blocks indicate the acceptance or not of each document. Customers supply documents, data and other information to XXX before and during a project. XXX verify the validity of this information, to the extent possible, and control it to ensure that confidentiality is maintained. Should problems occur with this information, XXX will formally report the fact to the customer. Design documents and data form the product produced by XXX. These may be distributed in paper and/or electronic format with care being exercised at all stages to ensure that they are not lost, damaged or corrupted. All equipment used for monitoring and measuring purposes will be controlled to ensure that it is adequate for the purpose and is calibrated. A documented procedure exists to control the calibration of equipment (see procedure XXX 13). Where appropriate, software used for calculation purposes, such as finite element analysis packages, will be verified to ensure its adequacy and accuracy.
Section 8 Measurement, Analysis Analysis and Improvement Monitoring and measuring activities will be conducted at various stages of a project to verify that the design meets requirements, that the quality management system is adequate and to seek improvements. The methods used to conduct these activities vary according to the circumstances and may include the use of statistical data where it would be beneficial. Customer satisfaction will be determined throughout the life of a project and is conducted through project meetings, including post project reviews. The information gathered will be reviewed and used to identify potential improvements to our services wherever possible. Regular internal audits will be conducted on the QMS and projects to identify conformance with the system and ISO 9001 as well as looking at the effectiveness of our processes. See procedure XXX 06
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Projects and the processes used to design and implement them are measured throughout their lifecycles in order to determine conformance with requirements and the effectiveness and efficiency of achieving them. Each finished design is subjected to a rigorous, pre-planned validation process which enables us to verify its effective implementation. Indicators such as nonconformities, complaints, project/budget overruns, internal audits and management review will also be used as a guide to the effectiveness of our processes. The tunnelling contractor is required to produce ‘as built’ drawings to confirm the final implementation of the design. The final validation of the project will be used as a method of final release and a handover certificate issued. Results of these testing activities will be retained and made available for future reference.
See procedure XXX 05 Nonconforming Product
Where a project, or part of a project, does not meet specified requirements, it will be identified as nonconforming. Nonconformities will be dealt with in accordance with a documented procedure. This includes responsibilities and authorities, actions to be taken and reporting mechanisms. It also addresses how nonconformities will be dealt with when they are identified after installation has been completed. See procedure XXX 07 Analysis of Data
Data will be collected and analysed from many sources to enable us to determine the effectiveness and conformity of our systems, processes and projects with the aim of improving them where possible. These include, but are not limited to the results from our monitoring and measuring activities and supplier performance. Improvement
Improvement of our products/services, systems and processes is one of our main objectives. We aim to enhance our performance for the benefit of our customers, ourselves and our people. We will use all means possible to achieve this including our quality policy, objectives, audits, management reviews, analysis of data, corrective and preventive actions. Corrective Action
Where nonconformities and customer complaints occur, we will take appropriate corrective action to resolve the situation and to prevent it from recurring. The method of conducting and recording corrective action is contained in a documented procedure. See procedure XXX 08
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Preventive Action
We acknowledge that prevention is better than cure and as such, we will consider preventive action at all stages of our processes as appropriate. These may include planning activities and techniques such risk assessments and the use of statistics to help identify where potential problems may occur. The method of conducting and recording preventive action is contained in a documented procedure. See procedure XXX 08
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Index to Procedures Procedure Number XXX 01 XXX 02 XXX 03 XXX 04 XXX 05 XXX 06 XXX 07 XXX 08 XXX 09 XXX 10 XXX 11 XXX 12 XXX 13
Procedure Title
Tendering Design Vendor Assessment Risk Assessment Monitoring & Measurement Internal Audits & Management Review Non-Conformance & Customer Complaints Corrective & Preventive Action Document Control - General Document Control - QMS Control of Records and Archives Training Measuring and Test Equipment
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