Valeo

PENTRU UZ DIDACTIC

SUMMARY

INTRODUCTION Page 1

PART 1 : TOTAL QUALITY Page 2

PART 3 : SECURITY AND ENVIRONMENT Page 7

PART 2 : QUALITY ASSURANCE Page 15

GLOSSARY Page 76

VALEO 1000

PART 1

TOTAL QUALITY ORGANIZATION

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For Valeo, Total Quality is the permanent involvement of all the company's members to improve :

- the quality of its strategical choices and of its objectives ;- its functioning quality ;- product and services quality in relation with its environment.

Total Quality is a culture based on : a language, methods and common tools. Its objective is to satisfy customers at least cost. It ensures of the company profitability.

SUMMARY

1. MANAGEMENT'S COMMITMENT

2. TOTAL QUALITY ORGANIZATION

3. TOTAL QUALITY DISPLAY

3.1. Information3.2. Detailed objectives3.3. Training3.4. Communication3.5. Measure3.6. Recognition

4. MONITORING TOTAL QUALITY DISPLAY

VALEO 1000 Juillet 1994

1. MANAGEMENT'S COMMITMENT

Management shall communicate clearly its total quality policy and be personally and resolutely involved.

This policy is based on VALEO'S OPERATING STRATEGIES and on the elements fitted to the mission statement of each branch. It is detailed in the Total Quality charter which is displayed, known and understood by everyone.

Management shall define precise objectives related to this policy which shall include both group objectives and their specific objectives.

2. TOTAL QUALITY ORGANIZATION

Management shall implement an adequate Total Quality organization. This organization shall be defined. It shall be based on the work of multifunctional groups and shall allow the complete involvement of all personnel.

Therefore, management shall :

- evaluate if the system ensures objectives are attained, and analyses deviations ;

- define an action plan for each function for the global quality improvement process. And shall monitor the results ( person in charge, dealines...),

- communicate this plan to all personnel ;- ensure that all the necessary requirements for achieving objectives

are clearly identified, valued and budgeted ;- forecast the availability of personnel and equipment resources to

attain the company's objectives.

Management shall define communication, delegation and operational rules (attitude, upward flow of information, definition of multifunctional teams...)

Management shall ensure that positive and quick consideration is given to any improvement proposal from personnel.

It shall ensure :

- that there are no obstacles to the flow of information ;- the improvement proposals are implemented.

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3. TOTAL QUALITY DISPLAY TO ALL FUNCTIONS

3.1. Information

After having been trained (training cessions, seminars...) management shall:

- inform all personnel of the launching of a Total Quality approach ( distribution of the charter...) ;

- communicate to all personnel the Total Quality policy and its objectives,

- ensure that the Total Quality policy is known and understood by everyone ( including newly employed personnel) ;

- frequently remind personnel of all information related to the Total Quality policy.

3.2. Detailed objectives

Management's Total Quality objectives shall be displayed to each function (both internal customer/supplier relations).

Each function shall define its own Total Quality objectives in compliance with management's objectives as well as the action plans linked to it.

Management shall :

- ensure that these objectives are summarized in a document which foreshadows the policy display plan ;

- ensure objectives are consistent with company's policy.

3.3. Training

A monitored training plan, developed in a manner consistent with company objectives, shall take into account all necessary needs for displaying the policy in each department.

The training plan is assessed :

- for the quality level of the training ; - for the personnel's views on training.

Training shall lead to progressive changes and to a change of Total Quality Culture personnel.


3.4. Communication

Information related to the progress achieved in the Total Quality display shall be regularly communicated to all personnel staff (eg : meetings, postages, informal meetings...).

In parallel with the traditional networks of communication, the company shall

develop a visual communication approach which is formalized in a plan.

Furthermore, personnel shall be given meeting space and order that they can freely display their problems and analyze the causes.

This system shall encourage personnel to put forward suggestions for improvement.

3.5. Measure

To monitor its performances, each function shall monitor and develop a precise system to measure the quality of its work.

For each general objective that is specific to a function, comparative methods shall exist, they shall be regularly displayed and monitored.

Progress actions shall be implemented in accordance with the results to ensure that objectives are reached.

3.6. Recognition

A recognition system (merits, improvements...) shall be formally integrated into a Total Quality improvement approach, based on the results obtained or on attitudes (eg : improvement proposal, validated solution, reactions, team spirit, regularity of an attitude or of a well-performed work...).

This formal or informal recognition, either individual or collective shall ensure the involvement of all personnel.

4. MONITORING TOTAL QUALITY DISPLAY

Management shall periodically conduct a review of the Total Quality policy display and shall :

- assess the adequacy between the budget and the objectives ;- compare the indicators to the objectives and stipulate improvement

and progress actions ;- define new objectives in accordance with the actual situation.

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VALEO 1000

PART 2

SECURITY AND ENVIRONMENT


SUMMARY

1. VALEO CHARTER FOR SECURITY AND ENVIRONMENT

2. SECURITY

2.1. Management and organization2.2. Audits2.3. Security actions

3. ENVIRONMENT

3.1. Management3.2. Audits

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2. SECURITY

A programme to manage the security of people and goods shall be developed, understood, implemented and maintained at all levels in the organization.

This programme shall consist of the identification of potential risks and a plan designed to reduce or eliminate them.

2.1. Management and organization

2.1.1. Organization grids

The security management shall be defined in the organigramme at all levels of the organization. This organization shall show the relationships between the security function and those of production, human resources and its relationship to management.

2.1.2. Management responsibilities

Each Branch, Division or Plant Manager shall adhere to the regulatory standards in the country in which he operates, and shall also adhere to the Valeo's standards for the protection of goods (FM/NFPA).

2.1.3. Identification of resources

The security programmes of each Branch and Division shall ensure that there are adequate resources in terms of personnel and equipment to attain Valeo's objectives.These programmes shall involve local authorities, the assurers and external contractors as necessary, in conjunction with the Valeo personnel responsible for the previously defined functions.

2.1.4. Position of the Risk Manager

Each Branch, Division and Plant Manager shall be responsible for the security of people and goods in his charge. He shall delegate routine management to a Risk Manager. The Security Function for personnel and goods can be separated if there is a regular system of communication in place between them. These persons responsible shall guide the security programme and associated activities, in coordination with Risks Management policy of the Group. The Branch Division and Plant Managers are regularly informed of problems and corrective actions implemented by the use of a formal reporting system.


2.2. Audits

Management shall ensure that plants are regularly audited by specialist external auditors, by regulatory bodies and by assurance companies, these auditors shall be approved by Valeo's Risk Management.Internal inspections shall be conducted more frequently by the Responsible Security personnel.Regulatory bodies, authorities and the assurance companies' technical services shall be associated with project which can potentially modify the risks encountered.

2.3. Security actions

Branch Managers in coordination with Division, Plant and Head Office Managers shall ensure that action plans are established to optimize the security of people and goods.

2.3.1. Security of people

A prevention and improvement policy for the security of people shall be defined by Branch, Division and Plant Managers in conjunction with those Responsible for Security at sites, Hygiene, Security and Work Conditions Comities and the Medical Works Doctor.They shall ensure that regulatory requirements for security at the work place (training of personnel, display of security requirements). they shall, in collaboration with the associated services carefully ensure that machines equipment and products used conform to regulatory requirements' standards.The permanent awareness of personnel to these problems is continually brought to their notice by information on the number of accidents occurring at work.

2.3.2. Security of goods

Branch, Division and Plant Managers, in conjunction with the Risk Management ensures that :- new investments and projects integrate the necessary security measures ;- the production sites are protected in an adequate manner or have an action plan to attain the desired levels, as other Valeo units and customers ;- personnel shall receive regular training.

A well-protected establishment is one with the HPR qualification (Highly Protected Risk) according to the security standards FM/NFPA.This qualification is given by the Assurers Technical Management after the priority recommendations have been implemented following the regular technical audits.

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2.3.3. Back-up plan

Branch Managers shall ensure that a back-up plan has been established for the Branch and regularly updated.A back-up plan shall enable production to continue totally or partially with the shortest possible delay in the event of a major accident occurring in production.This plan shall prioritize the use of Branch or Group resources, the use of temporary sub-contracting, as well as the potential for re-supplying in equipment and critical production materials.

2.3.4. Security of supplies

Branch, Division and Plant Managements shall verify that supplier apply an optimum security policy, related to their dependance on the supply (one or 2 suppliers).

Management shall verify that the Purchasing Function produces an updated list of potential suppliers capable of delivering in a short time, in the event of a failure of a regular supplier.


3. ENVIRONMENT*

An environmental management programme shall be developed, understood, implemented and maintained at all levels of the organization. The programme shall consist of an organization and a plan for managing environmental activities.

3.1. Management and Organization

3.1.1. Organization chartThe environmental management programme shall be defined in organigrammes at all levels of the organization. These charts shall show the relationship of the environmental function to quality and production control functions, and indicate the reporting system to management.

3.1.2. Management responsibilityEach Branch, Division and Facility Manager shall adhere to Valeo compliance standards and incorporate Valeo environmental policies and procedures to the operations of the branch or division.

3.1.3. Identification of resourcesThe environmental management programme of each branch and division shall ensure that adequate resources are available in terms of human resources and equipment, to achieve the Valeo environmental objectives. Appropriate and qualified outside contractors may be used in support of Valeo personnel responsible for the functions outlined below.

3.1.4. Environmental program activitiesThe environmental management programme of each branch and division shall consist as a minimum, of the following types of activities :

. Development of management directives to implement Valeo environmental policies and procedures. (See "Environmental

Guidance Document" Ed. 1 April 1992) ;. Incorporation of environmental considerations into all aspects

of Valeo operations, including research and development, design, planning, production or assembly, maintenance, procurement,

property management, personnel, training and management, and customer relations ;

. Establishment of an environmental data management program from the data base defined in appendix A of the document "Environmental Guidance Document") ;

. Preparation of plans and studies for reducing environmental liabilities in the long run

("Environmental Guidance Document" chapter 7) ;. Emergency plan and Communication plan ("Environmental Guidance Document" chapters 6 and 8).

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_______________________* This chapter is applicable to all Valeo sites. The choice for its eventual application to a

supplier is under the initiative of Valeo purchasing department.


3.1.5. Environmental Coordinator position Each Branch, Division and Facility Manager shall be responsible for the Environment of the site in his charge. He shall delegate routine management to an Environmental Coordinator to monitor compliance with the Valeo environmental management programme, and undertake planning, data collection, monitoring, inspection, training, and documentation activities required to implement Valeo environmental policies and procedures. The managers or coordinators shall cooperate and communicate with the contractors working with the Valeo corporate office to initiate the environmental management programme. Managers and Coordinators work in collaboration and communicate with Valeo's contractors to initialize the programme for managing the environment.

3.2. Audits

Management shall ensure that a routine programme of environmental facility audits and site assessment is established and maintained for all Valeo properties. Full audits and site assessments shall be performed only by qualified external environmental contractors approved by the Valeo Risk Manager. More frequent self-audits and self-inspections shall be performed by qualified and trained plant personnel.External audits shall be regularly conducted to a schedule defined for each plant by the audit function.

3.2.1. Self-audits and self-inspectionsThe corporate audit programme is a key component of Valeo's overall environmental compliance strategy.However, an equally important programme is a system of self-audits and self-inspections at the facility level. All Valeo operations and facilities shall conduct periodic self-audits on environmental issues. The responsibility for ensuring that the self-audits are completed shall rest with facility management, although the actual audits are conducted by the facility environmental coordinator.Although the frequency of the self-audits will depend on the complexity of the environmental issues at the facility, weekly self-audits are expected at most operations.

3.2.2. Scope of the Self-AuditsAlthough the self-audits are not to the level and details as the corporate audits, the audits shall be of sufficient detail to provide facility management with a true picture of the compliance status for the facility (in compliance with the "Environmental Guidance Document").

3.2.3. Reporting of Self-Audiditing ResultsOn a monthly basis, the Facility Environmental Coordinator shall prepare an environmental compliance report to the facility management with copy to the Branch Environmental Coordinator. This report shall communicate and document the status of environmental compliance as well as note exceptions to compliance such as those issues can be given proper attention and priority by facility management.The report shall also cover other environmental indicators such as governmental agency activities on the site, significant environmental

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activities being conducted, community complaints about facility emissions, and summaries of environmental monitoring.

3.2.4. Document managementAt all levels, Valeo management shall develop, maintain and manage applicable environmental documents in a manner which optimizes their use, provides the necessary security from misuse, and protects the confidentiality of privileged information.Documents and revisions shall be controlled as directed by the Branch or Division/Facility Environmental Coordinators.All primary or original copies of environmental documents, permits and correspondence shall be kept in a central environmental filing location within a facility.In addition, each facility shall maintain back-up files to build up a data information system.Document management is established in compliance with appendix A "Environmental Guidance Document" chapters 3 and 4. 3.2.5. Control and monitoring operationsAll control and monitoring operations shall be conducted in compliance with the "Environmental Guidance Document".

3.2.6. Non-conformance Corrective ActionEnvironmental problems identified by the audit team, by ambient monitoring or by self-audits shall be understood, corrective actions shall be identified by a monitored and budgeted environment improvement plan.


VALEO 1000

PART 3

QUALITY ASSURANCE

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The Valeo 1000 standard is structured according to the ISO 9001 standard and contains its entire requirements.

Each chapter contains the related ISO 9001 text (framed).Valeo 1000 incorporates the standards recognized by French and German car manufacturers and equipment suppliers (EAQF 94 and VDA 6 respectively).The document also includes the requirements of other Valeo customers from Europe, North America and Japan. Last, Valeo 1000 incorporates the recommendations of the ISO 9004 standard as well as the requirements specific to Valeo.

Complements compared to the former issue are in bold-faced characters.

The ISO 9001 standard specifies the applicable Quality system requirements when a contract between two parties (Customer/Supplier) implies that the supplier can demonstrate his aptitude to design and supply a product destined to the customer.

On the other hand, Valeo 1000 is not only placed at the Customer/Supplier interface but specifies the applicable Quality system requirements to an organism (Valeo or its suppliers) including the relation with its own customers and suppliers.

Therefore, we shall read in the ISO 9001:- for supplier, organization;- for sub-contractor, supplier;

according to this diagram:

ISO 9001Customer Supplier Sub-

contractor

VALEO 1000

Customer Organization

Supplier

(ex: Valeo)

ISO 9001:" Quality System - Model for quality assurance in design/development, production, installation and servicing" (1994 issue).

N.B.: The ISO 9002 standard is part of the ISO 9001 standard applicable to a "Model for quality assurance in production and installation".

ISO 9004 "Quality management and quality system elements-

Guidelines"VALEO 1000 Juillet 1994

VDA: Verband der Automobilindustrie ( Automotive industry union)Part 6: "Audit of the Quality Assurance System - questionnaire / assessment of results".(1993)

EAQF 94 : Evaluation de l'aptitude qualité Fournisseur 1994

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CONTENTS

Page

1. Management responsibility

2. Quality system

3. Contract review

4. Design control5. Document and data control

6. Purchasing

7. Control of customer supplied product

8. Product identification and traceability

9. Process control10. Inspection and testing

11. Inspection, measuring and test equipment12. Inspection and test status

13. Control of non-conforming product

14. Corrective and preventive action15. Handling, storage, packaging, preservation and delivery

16. Control of quality records17. Internal quality audits18. Training

19. Servicing

20. Statistical techniques


1. MANAGEMENT RESPONSIBILITY

1.1. Quality policy

The supplier's1 management with executive responsibility for quality shall define and document its policy for quality including objectives for quality and its commitment to, quality. The quality policy shall be relevant to the supplier's organizational goals and the expectations and needs of its customers. The supplier shall ensure that this policy is understood, implemented and maintained at all levels in the organization.1: read organization

In addition, the following points shall be satisfied:

Management sets up a system and methods for managing Quality.

The total quality policy:

- integrates continuous improvement of all processes and is consistent

with other policies (economic, social, environmental);

- emphasizes prevention against defect detection (right first time);

- applies itself to reduce recurrences in all fields and to reduce variations in

all processes (technical and administrative).

A Quality Improvement Plan is applied systematically and continuously. It is used by all functions of the company and is regularly reviewed (see 1.3).

Objectives pertaining to key elements of the quality policy (e.g.: performance, reliability, security, etc.) are defined and the measure is controlled by management. They are detailed into short and long-term objectives, and are documented for each department. They are based on measurable criteria and the target is zero defect at all levels.

The actions needed to achieve the objectives whether what they are (training, supplier actions or organisation...) are specified and monitored.

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1.2. Organization

1.2.1. Responsibility and authority

The responsibility, authority and the interrelation of personnel who manage, perform and verify work affecting quality shall be defined and documented; particularly for personnel who need the organizational freedom and authority to:

a) initiate action to prevent the occurrence of any nonconformities relating to product, process and quality system;

b) identify and record any problems relating to the product, process and quality system;

c) initiate, recommend or provide solutions through designated channels;

d) verify the implementation of solutions;

e) control further processing, delivery or installation of a nonconforming product until the deficiency or unsatisfactory condition has been corrected.

In addition, the following points shall be implemented:

The defined objectives are achieved through the organization which is defined through continuously updated flow charts.

The composition of project teams, their status and responsibilities within the organization are defined. Responsibilities of the entire personnel shall be defined and nominated deputies shall be designated. If management chooses to delegate the responsibilities for activities related to quality assurance, the persons so delegated shall be independent of the activities they report on.

A suitable, qualified person responsible for the coordination and management of control/security standards and other regulatory constraints shall be nominated.This person manages legal information, trains and informs managers of their responsibilities concerning the risks of defective products.He/she shall be responsible for:

. the definition system and identification of security items, the documented characteristics and procedures to identify all risks linked to the product;. identification of security standards;. carrying out design evaluation tests and prototype testing for security and documenting test results;. labeling compliance, user manuals, etc.;. specific method of traceability;. contacts with the concerned suppliers.


The application of procedures dedicated to security standard/regulatory items is audited regularly.The organization shall ensure that the resources are identified to control manufacturing and delivery processes.

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1.2.1.1. Responsibility and authority of the Quality Function

The primary roles of quality are defined:

- The Quality Function represents the customer in ensuring that requirements are met for Quality and lead time;- In cooperation with the Management, it defines the Quality policy, objectives and general quality organisation;- It organizes and coordinates Quality actions (in cooperation with other departments), from Marketing to after-sales service;- It promotes preventive action;- It ensures that corrective actions are applied, that quality action plans progress to reach pre-defined objectives and targets;- It ensures that new Quality methods are developed and used (QFD, FMEA, Design of experiment, Forecast reliability, etc.);- It ensures that the Quality system is developed and respected at all times. It regularly audits the application of the system;- It plays a role in picking out important product and process characteristics;- It guarantees the quality of supplier products (subcontractors).

1.2.2. Resources

The supplier1 shall identify resource requirements and provide adequate resources, including the assignment of trained personnel.(see 18.) for management, performance of work and verification activities including internal quality audits.1: read organization


The quality system shall:

- ensure adequate quality resources conforming to function definitions and calculated using a formalized method;- ensure that the training needs for the entire personnel including management are met;- ensure that all needs are clearly identified, calculated and budgeted (taking account of actual surveillance plans, resources, and volumes to be produced, customer programs in terms of personnel and equipment (including computing facilities to manage quality), in order to meet company objectives).

Furthermore, if there is no quality function during the entire production period, a procedure shall give the same guarantees as the regular schedule.

The surveillance plan is set up taking account of these restrictions. It organizes different levels of surveillance and guarantees the authority of the Quality Function.


1.2.3. Management representative

The supplier's1 management with executive responsibility shall appoint a member of the supplier's1 own management who, irrespective of other responsibilities, shall have defined authority for:

a) ensure that quality system requirements are established, implemented and maintained in accordance with this International Standard,

b) report on the performance of the quality system to the supplier's1

management for review and as a basis for improvement of the quality system.

NOTE: The responsibility of a management representative may also include liaison with external parties on matters relating to the supplier's1 quality system.1: read organization's


The management representative has the same status as the production managers and is independent from them.The Quality manager has the authority to stop production or delivery for non conforming parts.

1.3. Management review

The supplier's1 management with executive responsibility shall review the quality system at defined intervals sufficient to ensure its continuing suitability and effectiveness in satisfying the requirements of this International Standard and the supplier's1 stated quality policy and objectives (see 1.1).Records of such reviews shall be maintained.(see 16)1: read organization's


A documented procedure is established to ensure that the review is respected (dates/duration) and to guarantee its frequency (at least once per year).1. In the existing area, management examines the following:

- Product performance (quality, reliability, internal and external returns);

- Elements from analyses of customer satisfaction;- Results of audits (internal and external) including audits of safety and

the environment;- The status of procedures- The quality action plan- The Quality performance chart;- Information regarding preventive action;- The Quality Improvement Plan.

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Management measures the pertinence of the Quality system and of the Quality improvement plan (malfunctions identified - techniques, organisation and planning of corrective actions).2. Management validates necessary changes in the Quality system (new procedures, new resources and equipment, expanded workforce, etc.) in order to deal with new products, new suppliers, new technologies, new legislation, and new methods and organisation.


2. QUALITY SYSTEM

2.1. General

The supplier1 shall establish, document and maintain a quality system as a means of ensuring that product conforms to specified requirements. The supplier's1 shall prepare a quality manual covering the requirement of this International Standard. The quality manual shall include or make reference to the quality system procedures and outline the structure of the documentation used in the quality system.

NOTE: Guidance on quality manuals is given in ISO 10013.

2.2. Quality System Procedures

The supplier1 shall:

a) prepare documented procedures consistent with the requirements of this International Standard and the supplier's1 stated quality policy,

b) effectively implement the quality system and its documented procedures.

For the purpose of this International Standard, the range and detail of the procedures that form part of the quality system shall be dependent upon complexity of the work, the methods used, and the skills and training needed by personnel involved in carrying out the activity.

NOTE : Documented procedures may make reference to work instructions that define how an activity is performed.

2.3. Quality Planning

The supplier1 shall define and document how the requirements for quality will be met. Quality planning shall be consistent with all other requirements of a supplier's1 quality system and shall be documented in a format to suit the supplier's1 method of operation. The supplier1 shall give timely consideration to the following activities, as appropriate, in meeting the specified requirements for products, projects or contracts:

a) the preparation of quality plans;

b) the identification and acquisition of any controls, processes, equipment (including inspection and test equipment), fixtures, resources and skills that may be needed to achieve the required quality;

c) ensuring the compatibility of the design, the production process, installation, servicing, inspection and test procedures and the applicable documentation;

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d) updating, as necessary, of quality control, inspection and testing techniques, including the development of new instrumentation;

e) the identification of any measurement requirement involving capability that exceeds the known state of the art in sufficient time for the needed capacity to be developed;

f) the identification of suitable verification at appropriate stages in the realization of product;

g) the clarification of standards of acceptability for all features and requirements, including those which contain a subjective element;

h) the identification and preparation of quality records. (see 4.1).

NOTE: The quality plans referred to (see 2.3a) may be in the form of a reference to the appropriate documented procedures that form an integral part of the supplier's1 quality system.

1: read organisation


All services and all personnel of the company shall be involved in the quality system (quality loop). It shall be understood by all personnel and give the appropriate emphasis on its efficiency.A quality audit system verifies its implementation and corrective actions are implemented in case of failure.

Quality plans shall define:

. the applicable items in the Quality manual and the specific project requirements,. the quality objectives to be attained;. the specific allocation of responsibilities and authority during the different phases of the project;. the specific procedures, methods and work instructions to be followed;. suitable testing, inspection, examination and audit programs at appropriate stages (e.g. design, development);. a method for changes and modifications in a quality plan as projects proceed; . other measures necessary to meet objectives (including resource acceptance criteria);. the chronological order of specific Quality-related activities.


2.4. Product conformity to specified requirements

Specified requirements apply for product and service; they consist of customer stated and implied demands and are documented.

The quality system shall:

- define the product and process significant characteristics and make the communication to the relevant functions;

- define quality acceptance limits by compliance with customer requirements;

- define reliability test requirements in terms of method and frequency, at least in line with customer requirements;

- identify and define control/security items within the procedures, work instructions, specifications and drawings;

2.5. Quality communication system (moved from chapter 18 to chapter 2)

An information and communication system shall be set up to ensure quality information to management and the sectors concerned.

A quality performance chart is established for each level, and daily, weekly and monthly results are consolidated.

An immediate information system exists for serious problems.

2.6. Measurement system for customer satisfaction (see chapter 19)

There is a documented approach and method for evaluating the degrees of customer satisfaction and dissatisfaction.

Trends and key indicators must be documented by objective data. The data are compared with competitors efforts and with benchmarks (best specialized sectors). The results are reviewed by management.

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2.7. Quality costs

A procedure shall be established for the analysis and reporting of QUALITY COSTS.

Factors to be considered are:

2.7.1. FAILURE cost (non-conformance product cost)

2.7.1.1 INTERNAL FAILURE COSTScrapsRepairsSortingNon-conformance of external suppliesDesign changesUnplanned operations (extra deliveries, etc.)

2.7.1.2 EXTERNAL FAILURE COSTCustomer returnsWarranty returnsRecall campaignsIncorrect deliveries

2.7.2. APPRAISAL costProduct verificationIncoming goods verificationMetrology

2.7.3. PREVENTION costStatistical Process ControlValidation testsTrainingSupplier Quality Assurance / Product Quality AssuranceInternal Quality AuditsFailure Mode Analysis and Effect analysis (FMEA)

The cost of resources involved in the above steps shall be reported.

Quality cost objectives shall be annually defined and a plan implemented to achieve them. Management results reviews are conducted and corrective actions are taken in case of deviations.

2.8. Back-up plan

A back-up plan shall be developed to ensure the continuity of supplies to customers in case random events disrupt production.


3. CONTRACT REVIEW

3.1. General

The supplier1 shall establish and maintain documented procedures for contract review and for the coordination of these activities.

3.2. Review

Before submission of a tender, or the acceptance of a contract or order (statement of requirement), the tender, contract or order shall be reviewed by the supplier1 to ensure that:

a) the requirements are adequately defined and documented. Where no written statement of requirement is available for an order received by verbal means, the supplier1 shall ensure that the order requirements are agreed before their acceptance;

b) any differences between the contract or order requirements and those in their tender are resolved;

c) the supplier1 has the capability to meet the contract or order requirements.1: read organization


The customer is either the final customer in a type P1 project (application project), or an internal customer (branch division, other branches, etc.) in a type P2 project (validated generic project).The customer shall be systematically informed that any new proposition shall be validated on existing references and that we can work in development only on the application of validated generic project (assured quality, best costs, shorter delays).Each new project development shall be subjected to a review of customer requirements to ensure that customer needs are fully understood and correctly translated into the organization's operational language. Customer needs shall be analyzed by an interactive questionnaire and/or by the Quality Function Deployment (QFD).

The functional specifications shall include critical functional (product) characteristics.All elements obtained from the customer are taken into consideration on product use test, to complete the definition of elements.The review report is approved by all the functions concerned (sales, marketing, design, process engineering, quality, etc...).

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3.2.1. Analysis of customer requirementsWhen the call for tender is received (P1), a project team is set up to analyze customer requirements and to ensure that they are correctly understood. All pertinent information (requirements) are conveyed to the project team.

Requirements for use in later design work are communicated to the department heads, especially:

- price objectives / investment;- development, production and equipment management requirements;- development criteria (deadlines, stages, planning, quality assurance, etc.);- all applicable standards, specifications, drawings, regulatory data (security, environment, etc.);- characteristics related to product's performances;- the required reliability characteristics;- installation, configuration or adaptation requirements;- fitness;- sensory characteristics (e.g.: style, aspect, color, etc.);- identification;- packaging, maintainability and inspection of product requirements;- any special requirements requested by the customer including Quality and Quality Assurance matters;- flow/delivery and sales administration (EDI, etc.);- requirements applicable to delivery times, first parts, quantities, etc.

If the customer has neglected to include certain requirements, the supplier uses an interactive questionnaire and specification to ensure the customer receives the degree of quality expected.The project team analyses needs and feasibility, and prepares specifications.

3.2.2. Review of customer needs shall include:

- Verification of feasibility using a structured and formalized process;- Satisfaction of customer special requirements;- Advanced Quality Planning for the quality stages (e.g.: FMEA, QFD, etc.);- Specific Quality plans are developed, understood and communicated within the organization and approved by the customer (upon demand);- for the organization's "in-house" designed and manufactured standard products, ensure that customer approval is obtained as necessary;- adequate capability of equipment, human resources within the organization to meet the contractual requirements including costs (project cost: resources, facilities, test equipment, etc.) and delivery schedule;- the manufacturing processes are planned effectively to meet the customers requirements for the final product.

3.3. Amendment to contract


The supplier1 shall identify how an amendment to a contract is made and correctly transferred to the functions concerned within the supplier's1

organization.1: read organization

3.4. Records

Records of such contract reviews shall be maintained. (see 16)

NOTE 1: Channels for communication and interfaces with the customer's organization in these contract matters should be established.

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4. DESIGN CONTROL

4.1. General

The supplier1 shall establish and maintain documented procedures to control and verify the design of the product in order to ensure that the specified requirements are met.1: read organization


Design control concerns projects P1 (customer application) and projects P2 (generic projects).

Procedures shall be established and maintained to control and verify the product and process design to ensure that the specified requirements are met. These requirements shall be inspected at the different stages of the product development.

All specifications, drawings and technical data shall be approved by the managers of the concerned functions.

4.2. Design and development planning

The supplier1 shall prepare plans for each design and development activity. The plans shall describe or reference these activities, and define responsability for their implementation. The design and development activities shall be assigned to qualified personnel equipped with adequate resources. The plans shall be updated, as the design evolves.1: read organization


Each project shall be developed into detailed elementary tasks and in a critical path analysis. These tasks shall be part of a plan which is formalized as the project develops. Critical paths shall be marked out and identified in a contractual manner with the customer. They shall be monitored, using a potential risk evaluation and improvement suggestions evaluation.

If the project starts to diverge, or if difficulties arise, the customer is informed so that a further action plan can be prepared.


Type P1 and P2 projects can include the following stages, in accordance with the development charter:

--> for a P1 project:- Pre-study

. project planning

. functional and technical specifications

. feasibility study

. contract review- Definition

. final specifications

. concept validation

. feasibility check using prototypes- Adaptation

. prototypes

. updating FMEA process

. etc.- Production preparation

. resistance and reliability qualifications

. initial samples

. etc.- Launch

. Operational confirmation of quality, reliability, performance and cost objectives. etc.

-- > for a P2 project- Concept

. functional specifications

. project planning

. etc.- Feasibility

. technical specifications

. choice of key suppliers

. etc.- Development

. prototypes

. product/process FMEA

. etc.

Project reviews shall be planned to perform critical examination of the project at each stage.

The methods of measurement and test, and the acceptance criteria shall be applied to evaluate the product and processes during both the design and production phases and should be specified.They shall take into account forecast performance values, limits and characteristics.Tests shall be conducted to failure.

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4.2.1 Activity assignment


Design requirements in terms of human resources (skills, training, experience, etc.) and equipment (CAD, Computer Aided Engineering) shall be available to meet the design planning requirements.

Design activities are qualified using the following techniques: QFD, DFM, DFA, Value analysis; design of experiment, FMEA, FTA, modeling, simulation, reliability, etc.).

Design responsibilities shall be defined for the various activities both inside and outside the organization to ensure that the personnel who contributes to design is fully aware of his responsibilities for achieving quality.

When studies are subcontracted, the purchasing function shall be involved. The ratio of subcontracted studies to total studies is monitored.

Specific responsibility shall be given to a nominated contact within the engineering / design function for control/security items and other regulatory items. This person shall have knowledge of appropriate regulations and responsibilities if product failure occurs.

4.2.2. Managing confidentiality

A confidentiality manager is named. He sets up and manages a system to:

- Protect know-how (patents, etc.);- Define levels of confidentiality;- Implement rules and structures to protect confidentiality (documents

on hard copy and computer);- Maintain confidentiality (with customers, co-contractors,

suppliers);- Protect prototypes.


4.3. Organizational and technical interfaces

Organizational and technical interfaces between different groups which input to the design process shall be defined and the necessary information documented, transmitted and regularly reviewed.


For each new development (P1 or P2 project) a project leader shall be nominated by management to control the project until the forecast objectives are achieved.

He shall be particularly responsible for preparing the Product Quality Assurance Plan, planning and budgeting.

He manages the Quality performance chart. He keeps team members and management informed. Risks are measured and controlled.

Close cooperation shall be established with the customer as soon as the project starts.Persons liaising with customers as part of their job shall have quality training. (They shall speak the customer's language).

A project team shall be multifunctional (simultaneous engineering) and include representatives of any involved function as necessary (Marketing, Business, R&D, Production, Manufacturing Engineering, Quality, Purchasing, etc.).The quality function validates movement from one phase to the next (see the development procedure).

4.4. Design input

Design input requirements relating to the product including applicable statutory and regulatory requirements shall be identified, documented and their selection reviewed by the supplier1 for adequacy. Incomplete, ambiguous or conflicting requirements shall be resolved with those responsible for imposing these requirements.

Design input shall take into consideration the results of any contract review activities.1: read organization


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4.4.1. Product

The design function shall:- ensure that the relevant customer's specifications/documents, applicable to the design project are available and communicated to all the relevant functions using items in the contract review;- ensure specified health and security requirements are detailed on the relevant specifications, procedures and work instructions;- analyze the state of technology (newspapers patents, etc.);- compare with competitive products;- analyze the possibility of patenting parts or the whole project;- use data from similar projects and customer feedback in order to avoid recurrence of problems;- find the physical items needed to test product use;- analyze the possible effects of misused products;- develop prevention measures against the misuse of products;- take into consideration product use, maintainability and maintenance and pollution constraints due to the removal of product;- ensure that manufacturing equipment is compatible with design requirements in terms of tolerances, targets, these requirements shall be respected for the manufacturing and installation;- ensure that customer reliability requirements are respected;- ensure that labeling, warning, identification, traceability and packaging requirements are satisfied.

4.4.2. Process

The project team shall design and develop the process in conjunction with the product design and manufacturing function.Management shall ensure that new productivity improvement techniques (current operations) are fully developed before their implementation.Production and inspection equipment shall be planned so they are operational before initial samples are presented.

Tools, machines and equipment shall be purchased according to defined specifications on a planned basis. (Plans and definition, equipment FMEA, Preventive maintenance processes, list of replacement parts and parts subject to wear and tear, etc.) Equipment and machine suppliers shall be chosen on Quality criteria (Audit, earlier supplies, etc.)with the cooperation of the purchasing department. The supplier shall provide initial samples from such equipment and SPC data (control diagrams, etc.). Documented evidence shall be maintained.

A process qualification procedure shall be developed and implemented (progress defined in the SQA procedure no. 01 02 18).

Non capable equipment shall be clearly identified and a corrective action plan (that may include temporarily a 100% check) shall be implemented and documented.

Systems shall be systematically developed to maintain quality (integrated inspections, poka yoke, locks, etc.).Traceability requirements are incorporated in process design.


4.5. Design output

Design output shall be documented and expressed in terms of requirements that can be verified and validated against design input requirements.

Design output shall:

a) meet the design input requirements;

b) contain or make reference to acceptance criteria;

c) identify those characteristics of the design that are crucial to the safe and proper functioning of the product (such as operating, storage, handling, maintenance and disposal requirements);

Design output documents shall be reviewed before release.


The design function shall give clear and definite technical data concerning:- definition of external supplies;- work execution- verification of product compliance to the specified requirements, including critical of characteristics;- acceptance and rejection criteria;- packaging and storage, handling, installation and use.

The corresponding recommendations are sent to the customer.

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4.5.1. Product

4.5.1.1. Quality Assurance Plan product

The design function in accordance with the Quality function shall:- develop a Quality Assurance File for a product, in compliance with the

Product Quality Assurance Plan (QAP.p), including the following for design:. Advanced Quality planning for the entire project;. Quality Function Deployment (QFD);. Functional analysis;. Value analysis; . Initial reliability and experimental validation of calculations;. Failure Mode Effects Analysis (FMEA) - critical points and corrective actions;. Surveillance plan for critical characteristics to be kept under control (Cpk1,67);. Plan for applying PQA to components. Design of experiments;. Project review;. Quality monitoring (all documents defining the specifications of all tests and product audits as well as test result analysis).;

- take into consideration project changes during development.

4.5.2. Process

4.5.2.1. Quality assurance plan for a specific process

The process design function in conjunction with the quality function shall develop a Quality Assurance Plan in accordance with Q.A.P.p:

. Advanced Quality Planning;

. Functional analysis;

. Value analysis;

. Estimated reliability;

. Failure Mode and Effects Analysis (FMEA)- critical points and corrective actions;. Design of experiments (testing and validation);. Machine and control capability (Cmk 2);. Surveillance plan including preventive maintenance and capabilities of critical process parameters (Cpk 1,67);. Quality monitoring;. Audits of equipment and machine suppliers.


4.5.2.2. Production and control equipment acceptance

Production and verification resources are clearly defined simultaneously. They are inspected and accepted before being used.

There are acceptance procedures for all new production equipment based on the specifications. This includes specifications for reliability, maintainability and capability.

Machine capability (Cm, Cmk) must be 2).

The capability of control equipment is confirmed once calibration and RR (Repeatability, Reproduce-ability) test results have been inspected.

Corresponding control reports are filed and available.

A maintenance program is planned. It is established for each of the resources by the department that designed it.

A maintenance schedule shall be provided by the design function/manufacturing engineering for all equipment.

In the event of non-measurable quality characteristics, master samples shall be taken from initial samples and used as reference.

4.5.2.3. Process qualification

According to the stages defined in the SQA procedure no. 01 02 18.

Pre-qualification is performed before initial sample are validated.

Capability, capacity and reliability are measured for one production day at full production capacity (Number of hours to be defined according to the product).

After three months of series production, the project's objectives (in terms of capability, capacity, reliability, costs, etc...) are satisfied.

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4.6. Design review

At appropriate stages of design, formal documented reviews of the design results shall be planned and conducted. Participants at each design review shall include representatives of all functions concerned with the design stage being reviewed as well as other specialist personnel, as required. Records of such reviews shall be maintained (see 16).

4.6.1. Product/process project review

The reviews shall ensure that all customers needs are complied with in terms of project requirements (specifications, timing and associated costs, etc.).A project review shall include design, planning and economic objectives reviews.

Mandatory project reviews shall take place at the end of each stage of the project (P1 or P2). All points analyzed during the project review shall be fully implemented as a condition to pass from one stage to another.

4.6.1.1. Design review

Formal, documented, systematic and critical reviews of the design output shall be conducted at various stages in the design development. These reviews shall be planned by the project manager and all participants shall be informed of the content and timing. The participants shall represent functions involved with quality (in some cases, the customer or supplier).The views of the specialists are crucial.

For example: marketing and sales, design, industrial engineering, purchasing, production, quality, etc.

The following activities shall be considered in conducting the reviews:- identification and anticipation of problem areas and inadequacy;- comparison of customer needs expressed in the product brief with technical specifications for materials, product and processes;- considerations of unintended uses and misuses;- ability to perform under expected conditions of use and environment;- security and environmental compatibility;- compliance with regulatory requirements, national and international standards, and corporate practices;- validation of the design through prototype tests;- comparisons with similar designs;- use of a data base for new projects to eliminate the recurrence of problems;- taking corrective actions to ensure that final design and corresponding documentation comply with customer requirements;- needs of customer- specification file and Product/process Quality Assurance file;- reliability and maintainability requirements;- permissible tolerances and comparison with process capabilities;- product acceptance/rejection criteria;


- installability, ease of assembly, storage needs, shelf-life and disposability;- benign failure and fail-safe characteristics;- aesthetic specifications and acceptance criteria;- labeling, warnings, identification, traceability requirements and user instructions;- review and use of standard parts;- manufacturability of the design, including special process needs;mechanization, automation, assembly and installation of components;- capability to inspect and test the design, including special inspection and test requirements;- specification of materials, components and sub-assemblies, including supplies, approved suppliers and availability;- packaging, handling, storage, and shelf-life requirements, especially security factors relating to incoming and outgoing items.

The approval of the responsible function shall be formalized at each stage of the design.

4.6.1.2. Planning review

The project leader shall ensure that the planning is respected. He implements the necessary actions in case of deviation.

4.6.1.3. Project economics

The project leader shall coordinate the monitoring and reporting of the financial aspect of the project.

4.6.2. Final design review

The final design review shall consider the following:- specifications and drawings that define the design baseline;- description of qualification test units "as built" and modified to correct deficiencies during the qualification test programs for configuration control throughout the production cycle.

The total document package that defines the design baseline shall be approved at appropriate levels of management affected by or contributing to the product. This approval constitutes the production release and signifies concurrence that the design can be realized.

Part of this review shall determine whether production capability and field support are adequate for the new or redesigned product. The review shall cover the following points, as appropriate:

- training of field personnel;- availability of spare parts;- field trials;- certification of the satisfactory completion of qualification tests;- physical inspection of early production units and their packaging and labeling;

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- evidence of process capability to meet specification on production equipment.


4.6.3. Periodic design re-qualification Periodic re-evaluation of product shall be performed in order to ensure that the design is still valid with respect to all specified requirements.

This shall include a review:- of customer needs and technical specifications in the light of field

experiences;- of field performance surveys, or new technology and techniques.

The review shall also consider process modifications. The quality system shall ensure that any production and field experience indicating design change(s) is fed back for analysis.

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4.7. Design verification

At appropriate stages of design, design verification shall be performed to ensure that the design stage output meets the design stage input requirements. The design verification measures shall be recorded (see 16).

NOTE: In addition to conducting design reviews (see 4.6), design verification may include activities such as:

- performing alternative calculations;

- comparing the new design with a similar proven design, if available;

- undertaking tests and demonstrations;

- reviewing the design stage documents before release.

The following activities shall be considered during the validation stage with critical specialists (design, Quality, process engineering, purchasing, etc..) :

- analysis using Quality methods, for example FMEA, Design of experiments;- check to ensure that all authorized design changes have been authorized, accomplished and recorded;

4.8. Design validation

Design validation shall be performed to ensure that product conforms to defined user needs and/or requirements.

NOTE 1: Design validation follows successful design verification (see 4.7).

NOTE 2: Validation is normally performed under defined operating conditions.

NOTE 3: Validation is normally performed on the final product, but may be necessary in earlier stages prior to product completion.

NOTE 4: Multiple validations may be performed if there are different intended uses.

The design process shall provide for periodic evaluations of the design at significant stages of its development (validation and qualification).


The following activities shall be considered during this evaluation stage:- evaluation of performance, durability, security, reliability and maintainability under expected and/or specified storage and operational conditions;- all results of tests and evaluations shall be documented regularly throughout the qualification test cycle;- review and analysis of internal and customer test results (analysis of defects and failures) and corrective actions (In particular, specifications will be updated if the functional definition is incomplete).

At the different stages of the product's design, especially at the prototype stage, the organization shall verify that requirements are in compliance with customer needs.A control report shall be sent with each prototype in accordance with the quality requirements. Traceability is guaranteed during test. An analysis is performed on test completion.A procedure for managing Initial Samples (presentation, reports, use of statistical data) shall be implemented and developed.

4.9. Design changes

All design changes and modifications shall be identified, documented, reviewed and approved by authorized personnel before their implementation.1: read organization


Care shall be taken that design changes do not cause product/quality degradation and that proposed changes are evaluated for their impact on all product characteristics in the design baseline definition.The management shall ensure that for all product/process modifications, the same development steps as for normal design are followed.

They shall establish procedures for the control and reporting of all modifications.These procedures shall define:

- change identification;- documentation;- appropriate review;- requalification and/or approval of the modified product;- removal of obsolete products.

Elements which shall be considered are:- the Quality Assurance Plan for a specific product/process;- specified points and times for implementing the changes (time-table);- removal of obsolete drawings, specifications and documents;- procedure for actions emergency changes to prevent the production of non-conforming product (concession procedure);- requirements, by specific customers, for initial sample approval are complied with when a process is to be changed;

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- summary of product/process changes, monitoring the Quality Assurance file;- known contact at customer plant to ensure that correct action is taken on modification/changes (good communication shall be maintained);- all relevant documents are correctly referenced (latest revision).


5 DOCUMENT AND DATA CONTROL

5.1. General

The supplier1 shall establish and maintain documented procedures to control all documents and data that relate to the requirements of this International Standard including, to the extent applicable, documents of external origin such as standards and customer drawings.

NOTE: Documents and data can be in the form of any type of media, such as hard copy or electronic media.

5.2. Document and data approval and issue

The documents and data shall be reviewed and approved for adequacy by authorized personnel prior to issue. A master list or equivalent document control procedure identifying the current revision status of documents shall be established and be readily available to preclude the use of invalid and/or obsolete documents.

This control shall ensure that:

a) the pertinent issues of appropriate documents are available at all locations where operations essential to the effective functioning of the quality system are performed;

b) invalid and/or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use;

c) any obsolete documents retained for legal and/or knowledge preservation purposes are suitably identified.

1: read organization


The system documented shall be minimal to ensure implementation and adequate control.All control/security items or other regulatory items are referenced on the relevant document (e.g.: specifications, drawings, procedures and work instructions);Documents specified as confidential and accessible to designated personnel listed and the confidentiality respected.

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5.3. Document and data changes

Changes to documents and data shall be reviewed and approved by the same functions/organizations that performed the original review and approval unless specifically designated otherwise. The designated functions/organizations shall have access to pertinent background information upon which to base their review and approval.

Where practical, the nature of the change shall be identified in the document or the appropriate attachments.


Document references and indexes (internal and external products and processes) are managed and controlled.

5.4. Keeping and recording documents

Documents (in-process and records) are stored in a safe location including computerized ones.Retention times shall be defined for each case.


6. PURCHASING

6.1. General

The supplier1 shall establish and maintain documented procedures to ensure that purchased product conforms to specified requirements.1: read organization


The Purchasing function is involved:- in the definition and the management of product/process quality;- in the measure of non-quality of external supplies;- in the implementation and monitoring of corrective actions.

The Purchasing function shall liaise with design on all aspects of product and process development, as necessary.The Purchasing function shall be involved in the resolution of problems resulting from the development of new products in conjunction with design and supplier. The Purchasing function and design function shall establish a standardization procedure for the rationalization of product in terms of sourcing.

6.2. Evaluation of sub-contractors2


a) evaluate and select sub-contractors2 on the basis of their ability to meet sub-contract4 requirements, including quality system and any specific quality assurance requirements;

b) define the type and extent of control exercised by the supplier1 over sub-contractors2. This shall be dependent upon the type of product, the impact of sub-contracted2 product on the quality of final product and, where applicable, on the quality audit reports and/or quality records of the previously demonstrated capability and performance of sub-contractors2.

c) establish and maintain quality records of acceptable sub-contractors2. (see 16)1: read organization 2: read supplier4: read order


The Purchasing function ensures that new suppliers develop a quality system based on prevention and the Supplier Quality Assurance manual (for Valeo sites: SQA ref. 010218).

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Suppliers are selected on their ability to meet the VALEO specified requirements.


For components and materials suppliers, purchasing shall:- ensure that the supplier quality system and preventive quality method is monitored in conformance with Valeo 1000 and Supplier Quality Assurance Standard (for Valeo suppliers: SQA ref. 010218).- maintain a list of approved suppliers which shall be classified according to the results of the audit procedure;- select supplier on the basis of their classification and on the basis of demonstrated capability to supply product, materials, components and services to the specified requirements and deliver them on time. It shall be established through the result of performance monitoring (Quality, Costs, Lead time, Management, Development).

6.3. Purchasing data

Purchasing documents shall contain data clearly describing the product ordered, including, where applicable:

a) the type, class, grade or other precise identification;

b) the title or other positive identification, and applicable issue of specifications, drawings, process requirements, inspection instructions and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment and personnel;

c) The title, number and issue of the quality system International Standard to be applied.

The supplier1 shall review and approve purchasing documents for adequacy of specified requirements prior to release.1: read organisation

In addition, he following points shall be satisfied:

The Purchasing department shall develop appropriate methods to ensure that the requirements for the supplies are clearly defined, communicated and, most importantly, completely understood by the supplier.

All purchasing documents shall clearly describe the product or service ordered and shall show:

- name, reference and applicable issue of specifications, drawings, process, requirements and work instructions.- requirements for approval of product, material or component, and the applicable quality methods.

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The Purchasing function shall apply PQA procedures to:

- determine the most important parameters and characteristics, including environmental and operating conditions, in association with suppliers, by means of an interactive questionnaire or similar method;

- ensure that the supplier has all the relevant specifications (including functional characteristics, delivered product environment, logistic instructions, etc.) drawings, process requirements and inspection instructions for the product, material, component or service under negotiation/development;

- ensure that the supplier has procedures, in operation, for the identification of batches of product, materials and components (signify any status of product, materials and components i.e.: convention for the use of certain colors);

- ensure that the supplier has been notified of any special requirements such as:

. prototypes and associated documents;

. significant characteristics are defined in an agreement between supplier and the customer;. process qualification;. initial sample testing and submission procedure;. pre-production sample testing and submission procedure;. control/security items or other regulatory items requirements including traceability;. any requirements for prior-approval by the organization's Quality specialists, before the start-up production.e.g.: Quality plans and potential capability studies.

Purchasing shall notify the supplier of any certification procedures which are required (pertinent statistical or laboratory data shall be submitted).

All documents and purchasing records are classified in an efficient and well-ordered manner.


6.4. Verification of purchased product

Supplier1 Verification at sub-contractors2 premises

Where the supplier1 proposes to verify purchased product at the sub-contractor's2 premises, the supplier1 shall specify verification arrangements and the method of product release in the purchasing documents.

Customer Verification of Sub-contracted2 Product

Where specified in the contract, the supplier's1 customer or the customer's representative shall be afforded the right to verify at the sub-contractor's2

premises and the supplier's1 premises that sub-contracted2 product conforms to specified requirements. Such verification shall not be used by the supplier1 as evidence of effective control of quality by the sub-contractor2.

Verification by the customer shall not absolve the supplier of the responsibility to provide acceptable product nor shall it preclude subsequent rejection by the customer.1: read organization2: read supplier


The Purchasing function or the nominated representative shall be afforded at source or upon receipt the right to verify that purchased product; material, components or services conform to specified requirements.

6.5. Product Quality assurance

The Purchasing function shall assist the supplier in the establishment of its product/process Quality Assurance Plan (SQA procedure no. 01 02 18).It shall ensure that a product/process Quality Assurance plan is applied by the supplier. (Process audit procedure no. 02 01 15)Suppliers' surveillance plan shall be approved by the organization and guarantee that the process can not be modified without the approval of the purchasing function.

6.6. Initial Samples

The acceptance of initial samples shall be a condition for the supply of new or modified items (product, process, production location).

Initial samples are produced on series production equipment.

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6.7 Measuring supplier performance

6.7.1. Quality received

Purchasing ascertains the quality of the products received from all suppliers through a series of measurements realized by suppliers.

6.7.2. Quality performance

Quality performance is monitored using the SQI indicator (SQA standard 01.02.18). The indicator is published with other QCD files.Quality and lead time files are available for consultation by the customer.

6.8. Supplier problem reporting

The Purchasing function shall be informed of any defects, even if only suspected, on the units delivered.The Purchasing function ensures that the supplier implements procedures for the isolation of non-conforming products, materials and components.

Purchasing shall establish with suppliers a communication system on problems encountered, products and deliveries. And shall validate corrective actions concerning:

- problems occurring at the different sites, (receiving inspection);- problems occurring "in the field";- problems occurring at the supplier which will affect scheduling within the organization.

6.9. Products supplied to supplier

The Purchasing function owns and respects a control procedure for units before they are sent to supplier to ensure that they are in compliance with the conditions previously defined.


7. CONTROL OF CUSTOMER SUPPLIED PRODUCT

The supplier1 shall establish and maintain documented procedures for the control of verification, storage and maintenance of customer supplied product provided for incorporation into the supplies or for related activities. Any such product that is lost, damaged or is otherwise unsuitable for use shall be recorded and reported to the customer (see 16).

Verification by the supplier1 does not absolve the customer of the responsibility to provide acceptable product.1: read organization

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8. PRODUCT IDENTIFICATION AND TRACEABILITY

Where appropriate, the supplier1 shall establish and maintain documented procedures for identifying the product by suitable means from receipt and during all stages of production, delivery and installation.

Where and to the extent that traceability is a specified requirement, the supplier1 shall establish and maintain documented procedures for unique identification of individual product or batches. This identification shall be recorded. (see16)1: read organization


All requirements related to the control/security items and other regulatory items' identification and traceability shall be clearly specified and respected.

A system will be define to make materials and units identifiable throughout the production cycle, from reception to delivery. This will make it possible to rapidly locate a group of defective products or components.


9. PROCESS CONTROL

9.1. General

The supplier1 shall identify and plan the production, installation and servicing processes which directly affect quality and shall ensure that these processes are carried out under controlled conditions. Controlled conditions shall include the following:

a) documented procedures defining the manner of production, installation and servicing, where the absence of such procedures could adversely affect quality;

b) use of suitable production, installation, and servicing equipment, suitable working environment;

c) compliance with reference standards/codes, quality plans and/or documented procedures;

d) monitoring and control of suitable process parameters and product characteristics;

e) the approval of processes and equipment, as appropriate;

f) criteria for workmanship which shall be stipulated, in the clearest practicable manner (e.g. written standards, representative samples or illustrations);

g) suitable maintenance of equipment to ensure continuing process capability.


In addition, the following points shall be identified:

Production scheduling shall be planned in conjunction with customer requirements as appropriate (just in time system, etc.)Production flows shall be reviewed at least once a year.A concession procedure shall exist, and be implemented when the defined processes do not meet specifications.

Work instructions define:

- what is to be controlled (critical characteristic, etc.);

- what exact event must occur to achieve control of the process;

- who is responsible for this control;

- why the control is needed;

- what special equipment is needed for measurement;

- who does the measurement and at what frequency;

- what type of process control chart is to be used and who plots it;

- what procedures are required to hold the process under control;

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- what corrective action is needed to bring an out of control process

back into control.


9.2. Special processes

Where the results of processes cannot be fully verified by subsequent inspection and testing of the product and where, for example, processing deficiencies may become apparent only after the product is in use, the processes shall be carried out by qualified operators and/or shall require continuous monitoring and control of process parameters to ensure that the specified requirements are met.

The requirements for any qualification of process operations including associated equipment and personnel (see 18) shall be specified.

NOTE: Such processes requiring pre-qualification of their process capability are frequently referred to as special processes.

Records shall be maintained for qualified processes*, equipment and personnel as appropriate (see 16).* Recording of the process measured parameters.

9.3. Surveillance plan

All production processes shall be planned to ensure that the operating conditions are specified. A process control plan shall be developed which indicates the key variables in the process operation which have to be controlled (it contains a synopsis for the entire process, including repairs).

The surveillance plan shall contain all significant characteristics test/inspection requirements. (machines plans, regulating plan, instruction file plan, control plan, maintenance plan). Special requirements for control/security items may be requested by the customer. These shall be checked and complied with.

The process equipment shall be developed so that the designated significant quality characteristics, including control/security items requirements are met.

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9.4. Process control

Production programs shall exist.Before any product/process is launched into series, all process qualification stages shall have been satisfied and initial samples accepted.

Statistical tools shall be used to take into account important characteristics of initial sample presentation.

All personnel involved in the process shall be aware of the product and process characteristics to be controlled.All processes shall be controlled according to the specified requirements. Control shall be maintained on all jigs, fixtures and tooling to ensure conformity to specified measurements and records maintained.Additional methods and equipment shall be developed, if necessary, and implemented to maintain consistent quality of manufactured products (e.g.: Poka-Yoke, etc.).The minimum frequency of process audits is specified in the surveillance plan. The audits are performed during production in line with procedure 02.01.15.

9.5. Production equipment maintenance (equipment and machines)

A preventive maintenance procedure shall be established. This shall include reference to measurements obtained within the production process which affect the preventive maintenance operations.

A Total Productive Maintenance approach shall be developed.

There are files for the life cycle of equipment (set up date, changes, repairs, number of units produced, etc.).All production equipment has a maintenance program. The preventive maintenance schedule incorporates the different levels of maintenance (Levels 1, 2, 3, 4, 5..):

- verify testing equipment;- verify and exchange used parts;- verify operational cycle after maintenance;- cleaning;- change of ingredients (oiling, greasing requirements);- protection (security) and lighting checks;- verify active securities.

Management shall establish procedures to ensure that maintenance costs are known, analyzed and improvement plans are instituted.

The status for the verification of the material shall be identified during the production cycle (record sheets, etc.).

In case of a prolonged non-use, equipment shall be properly stored, inspected or standardized to ensure its preciseness and accuracy before re-use.


9.6. Statistical process control

A system shall be implemented to collect process parameters data for product and process, to evaluate causes of reported variability (cause and effect analysis, inspection card, etc.)

A written procedure for the measurement of the process technical capability shall be implemented. Capability studies shall be conducted to give a first assessment of the process ability to meet the specified requirements (Cp, Cpk); the process capability (Cpk) must be equal to or greater than 1.67.

If this is not so, a plan of action is drawn up to attain the appropriate capability and an appropriate measurement system is implemented to guarantee part quality (100% check, if necessary).

When a new product is to be produced on a current process then process capability data shall be taken and recorded.

Statistical process control is applied at operator level so that personnel can monitor and inspect the quality of their work.

9.7. Process capacity

The productivity of machines and processes shall be regularly checked and reported, the downtime due to non-quality (product processes and services) shall be measured and analyzed.

9.8. Supplies utilities and environments

Where important to quality characteristics, auxiliary materials and utilities, such as water, compressed air, electric power and chemicals used for processing, shall be controlled and inspected periodically to ensure uniformity of effect on the process.

Where a production environment, such as temperature, humidity and cleanliness, is important to product quality, appropriate limits shall be specified, controlled and inspected.

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10. INSPECTION AND TESTING

10.1. General

The supplier1 shall establish and maintain documented procedures for inspection and testing activities in order to verify that the specified requirements for the product are met. The required inspecting and testing, and the records to be established, shall be detailed in the quality plan or documented procedures.

When testing methods are common to many functions (Research, Manufacturing Engineering, Quality, etc.); tests related to the monitoring of quality shall be taken into account like those that are related to development.

A plan related to the testing methods shall exist, and include the tests related to developments and those related to quality monitoring.There shall be sufficient personnel, trained and in possession of the necessary equipment.

10.2. Receiving inspection and testing

10.2.1. The supplier1 shall ensure that incoming product is not used or processed (except in the circumstances described in 10.2.3.) until it has been inspected or otherwise verified as conforming to specified requirements. Verification of conformance to the specified requirements shall be in accordance with the quality plan and/or documented procedures.

10.2.2. In determining the amount and nature of receiving inspection, consideration shall be given to the amount of control exercised at the sub-contractor's premises and the recorded evidence of conformance provided

10.2.3. Where incoming product is released for urgent production purposes prior to verification, it shall be positively identified and recorded (see 16) in order to permit immediate recall and replacement in the event of nonconformity to specified requirements.1: read organization2: read supplier


On rates occasions, the incoming product for which production is launched before verification is processed by a special procedure.

10.2.4. Items/materials/parts requiring inspection

Procedures and work instructions shall be established which:

- define sampling, control schemes and ensure they are implemented;

- define action to be taken when non-conformity is found;


- ensure that the isolation (quarantine) areas are provided and that

non-conforming materials/parts, etc. is held in such areas, clearly

identified.

All tests shall be documented to monitor supplier performance trends.

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10.2.5. Items/materials/parts requiring supplier certification ( Product Quality Assurance)

Procedures and work instructions shall be established to:- define the certification system to be used by supplier including any particular requirements for statistical data/laboratory reports (e.g.: material analysis /dimensional data);- ensure that verification of supplier's certification and product shall be conducted by periodic audits.

The procedures and work instructions shall ensure that the two classifications of incoming materials/parts namely, those requiring inspection and those requiring certification, can be identified on receipt.

The frequency of inspections is tied to the progress made in PQA application.

The identification of product batches, materials and constituents shall be in compliance with the purchasing specifications.A periodical verification of certification data shall be established in a laboratory.

10.3. In-process inspection and testing


a) inspect the test product as required by the quality plan and/or documented procedures;

b) hold product until the required inspection and tests have been completed or necessary reports have been received and verified except when product is released under positive recall procedures (see 10.2.3.). Release under positive recall procedures shall not preclude the activities outlined in 10.3.a;

1: read organisation


10.3.1. General

First piece/set up inspection procedures to assure quality on start up shall be implemented.

Quality shall give its approval for the launching into series.

All requirements related to the in-process products' control and testing shall be integrated in work procedures and instructions.

Process control and monitoring methods shall be defined to establish product conformance requirements in compliance with the design specifications.

All non-conforming products shall be identified and isolated.

All the required tests/inspection shall be performed on control items/security items in accordance with engineering specification.

All records shall be maintained and recorded.

All testing/inspection shall be conducted by authorized personnel.

10.3.2. Control plan

Working procedures and instructions shall be established to ensure that all products are inspected in accordance with the Quality control/surveillance plan. The plan shall specify:

- parts to be tested or measured;

- process stage when control is performed;

- test frequency;

- sample size;

- method of analysis;

- testing or measurement means;

- standardization means;

- traceability;

- maintenance.

N.B.: Any special requirements for control/security items or other regulatory items shall be checked and complied with.

Where specified the Quality Standard and master samples shall be placed at or near work stations for use in verifying requirements.

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10.4. Final inspection and testing

The supplier1 shall carry out all final inspection and testing in accordance with the quality plan and/or documented procedures to complete the evidence of conformance of the finished product to the specified requirements.

The quality plan and/or documented procedures for final inspection and testing shall require that all specified inspection and tests, including those specified either on receipt of product or in-process, have been carried out and that the results meet specified requirements.

No product shall be despatches until all the activities specified in the quality plan or documented procedures have been satisfactorily completed and the associated data and documentation are available and authorized.1: read organisation


Working procedures and instructions shall be established for periodical audits of product performance to ensure that:

- all reliability/durability testing has been completed according to specified requirements;- all final identification requirements and all specific customers requirements shall be specified and checked.

The personnel shall have the relevant instructions on the use of the test and control equipment and interpretation of associated documents.

10.5. Inspection and test records

The supplier1 shall establish and maintain records which provide evidence that the product has been inspected and/or tested. These records shall show clearly whether the product has passed or failed the inspections and/or tests according to defined acceptance criteria. Where the product fails to pass any inspection and/or test, the procedures for control of nonconforming product shall apply (see 13).

Records shall identify the inspection authority responsible for the release of product (see16).1: read organization


It shall include all specified requirements, as defined in the control/quality/surveillance plan.

All documents related to, control and testing shall be monitored according to the product definition.The recording times of control and test results shall be defined and implemented.


These documents shall be systematically analyzed and corrective actions implemented to improve production, and can be consulted at any time.

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11. CONTROL OF INSPECTION, MEASURING AND TEST EQUIPMENT

11.1. General

The supplier1 shall establish and maintain documented procedures to control, calibrate and maintain inspection, measuring and test equipment (including test software) used by the supplier1 to demonstrate the conformance of product to the specified requirements. Inspection, measuring and test equipment shall be used in a manner which ensures that measurement uncertainty is known and is consistent with the required measurement capability.

When test software or comparative references such as test hardware are used as suitable forms of inspection, they shall be checked to prove that they are capable of verifying the acceptability of product, prior to release for use during production, installation or servicing and shall be re-checked at prescribed intervals. The supplier1 shall establish the extent and frequency of such checks and shall maintain records as evidence of control (see 16).

Where the availability of technical data pertaining to the inspection, measuring and test equipment is a specified requirement, such data shall be made available, when required by the customer or customer's representative, for verification that the inspection, measuring and test equipment is functionally adequate.

NOTE : For the purposes of this International Standard, the term "measuring equipment" includes measurement devices.

11.2. Control procedure


a) determine the measurements to be made, the accuracy required and select the appropriate inspection, measuring and test equipment that is capable of the necessary accuracy and precision;

b) identify all inspection, measuring and test equipment that can affect product quality and calibrate and adjust them at prescribed intervals, or prior to use, against certified equipment having a known valid relationship to internationally or nationally recognized Standards. Where no such Standards exist, the basis used for calibration shall be documented;

c) define the process employed for the calibration of inspection, measuring and test equipment including details of equipment type, unique identification, location, frequency of checks, check method, acceptance criteria and the action to be taken when results are unsatisfactory;

d) identify inspection, measuring and test equipment with a suitable indicator or approved identification record to show the calibration status;

e) maintain calibration records for inspection, measuring and test equipment (see 16);


f) assess and document the validity of previous inspection and test results when inspection, measuring and test equipment is found to be out of calibration;g) ensure that the environmental conditions are suitable for the calibrations, inspections, measurements and tests being carried out;h) ensure that the handling, preservation and storage of inspection, measuring and test equipment is such that the accuracy and fitness for use are maintained;i) safeguard inspection, measuring and test facilities, including both test hardware and test software, from adjustments which would invalidate the calibration setting.

NOTE : The metrological confirmation system for measuring equipment given in ISO 10012 may be used for guidance.1: read organization3: read customer


11.2.1. Documentation

Procedures shall be developed to maintain the accuracy of the measurement process using statistical methods.Personnel using calibration equipment shall be suitably trained.

11.2.2. Equipment

Such equipment includes:- gauges;- measuring instruments;- sensors;- special test equipment;- manufacturing jigs and fixtures;- process instrumentation;- weighing machines;- master samples.

11.2.3. Equipment control

The control of measuring and test equipment shall include the following factors:

- correct specification and acquisition;- range, bias, precision;- robustness;- durability (environmental requirements);- initial calibration prior to use;- periodic recall for adjustment and re-calibration;- calibration status of the equipment;- documented records of calibration;- traceability to reference standards (National standards);- accuracy;

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- reproducibility;- stability;- linearity.

The procedures shall make reference to any special requirements specified by the customer.


12. INSPECTION AND TEST STATUS

The inspection and test status of product shall be identified by suitable means, which indicate the conformance or non-conformance of product with regard to inspection and tests performed. The identification of inspection and test status shall be maintained, as defined in the quality plan and/or documented procedures, throughout production, installation and servicing of the product to ensure that only product that has passed the required inspections and tests (or released under an authorized concession (see 13.2)) is dispatched, used or installed.


Procedures and work instructions shall be established which define the methods by which the inspection and test status of the products/components are identified throughout the production cycle.

Particular attention shall be given to the identification of control/security items or other regulatory items.

Initial samples and pre-production sample requirements for identification shall be clearly specified in the procedures/work instructions.

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13. CONTROL OF NONCONFORMING PRODUCT

13.1. General

The supplier1 shall establish and maintain documented procedures to ensure that product that does not conform to specified requirements is prevented from unintended use or installation. This control shall provide for identification, documentation, evaluation, segregation (when practical), disposition of nonconforming product and for notification to the functions concerned.1: read organization


Procedures and work instructions shall be established to define the actions to be taken when tests/inspections show that product, components and/or materials do not conform to requirements as specified in the surveillance plan.The areas which shall be covered are:

- nonconformity at reception;

- nonconformity at production;

- nonconformity at delivery;

- nonconformity after delivery.

The following shall be defined and implemented:- identification of nonconformity, including at delivery and at the

customer's plant;- isolation of nonconforming product including clear identification of its

status;- evaluation of the importance of the problem, defining the potential impact on performance, quality costs, reliability, security and customer satisfaction.

Each nonconformity shall be recorded and communicated to the appropriate function/operation.


13.2. Review and disposition of nonconforming product

The responsibility for review and authority for the disposition of nonconforming product shall be defined.Nonconforming product shall be reviewed in accordance with documented procedures. It may be:

a) reworked to meet the specified requirements,b) accepted with or without repair by concession,c) regraded for alternative applications, ord) rejected or scrapped.

Where required by the contract, the proposed use or repair of product [see13.2.b)] which does not conform to specified requirements shall be reported for concession to the customer or customer's representative. The description of the nonconformity that has been accepted, and of repairs, shall be recorded to denote the actual condition (see 16).

Repaired and/or reworked product shall be re-inspected in accordance with the quality plan and/or documented procedure.3: read customer


The quality function shall:

- review of the non-conforming product are conducted by a designated responsible person to determine the action to be taken (e.g. scrap/sort)- determine whether the customer requires informing of the non-conformity- conduct quality meetings to monitor and follow-up concessions (they shall be authorized).

After repairs or rework, nonconforming products shall be systematically controlled according to the initial process to verify their compliance with requirements.

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14. CORRECTIVE AND PREVENTIVE ACTION

14.1. General

The supplier1 shall establish and maintain documented procedures for implementing corrective and preventive action.

Any corrective or preventive action taken to eliminate the causes of actual or potential nonconformities shall be to a degree appropriate to the magnitude of problems and commensurate to the risks encountered.

The supplier shall implement and record any changes in the documented procedures resulting from corrective and preventive action.

14.2. Corrective action

The procedures for corrective action shall include:

a) the effective handling of customer complaints and reports of product nonconformities;

b) investigation of the cause of nonconforming relating to product, process and quality system and recording the results of the investigation (see 16);

c) determination of the corrective action needed to eliminate the causes of nonconformities;

d) application of controls to ensure that corrective action is taken and that it is effective;


14.3. Preventive action

The procedures for preventive action shall include:

a) the use of appropriate sources of information such as processes and work operations which affect product quality, concessions, audit results, quality records, service reports and customer complaints to detect, analyze and eliminate potential causes of non-conformities;

b) determination of the steps needed to deal with any problems requiring preventive action;

c) initiation of preventive action and application of controls to ensure that it is effective;

d) ensuring that relevant information on actions taken is submitted for management review (see 1.3).


The supplier must apply a structured problem solving method to address real or potential non-conformity, whether internal or external:

- definition of the responsibility and authority for instituting corrective action;- investigation of the cause of the problem using quality analysis methods (e.g. cause and effect);- analysis of the causes of nonconformity to determine the major ones and corrective actions taken;- detailed analysis of the problem and related processes, operations and quality records;- all relevant functions shall be informed of the corrective action taken;- the person responsible for control/security items and other regulatory items shall be informed immediately of the problem and the corrective action taken;- method by which the corrective actions are efficiently completed to prevent recurrence of the problem.

Modifications due to corrective actions shall follow the normal treatment of modifications.

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15. HANDLING, STORAGE, PACKAGING, PRESERVATION AND DELIVERY

15.1. General

The supplier1 shall establish and maintain documented procedures for handling, storage, packaging, preservation and delivery of product.1: read organization


Procedures and work instructions shall be established to control the methods for handling, storage, packaging and delivery of the materials, products and components through all stages of the manufacturing process.

Packaging nonconformities and any damage due to transportation shall be treated just like any other nonconformity.

Audits of the transportation system, of the distribution centers and of delivery to the customer shall ensure that units are not damaged through the transportation cycle.

15.2. Handling

The supplier1 shall provide methods of handling product that prevent damage or deterioration.1: read organization


Control shall be maintained on all handling operations to avoid mixing of products.

The method of handling and storage of materials shall provide for the correct pallets, containers, conveyors and vehicles to prevent damage due to vibration, shock, abrasion, corrosion, temperature or any other condition occurring during handling and storage. Items in storage shall be checked periodically to detect possible deterioration.


15.3. Storage

The supplier1 shall use designated storage areas or stock rooms to prevent damage or deterioration of product, pending use or delivery. Appropriate methods for authorizing receipt to and despatch from such areas shall be stipulated.

In order to detect deterioration, the condition of product in stock shall be assessed at appropriate intervals.1: read organization


All storage areas shall be secured to prevent damage or deterioration of product component or materials in compliance with (components, primary units or material) suppliers specifications, as necessary.

The First in First out (FIFO) method shall be implemented regardless of the storage area.

Periodic verifications shall be conducted in these areas to determine condition of stock and facilities. Corrective action shall be taken and report issued if problem occurs.

If regardless of a security plan, a security stock remains, the same rules shall apply.

15.4. Packaging

The supplier1 shall control packing, packaging and marking processes (including materials used) to the extent necessary to ensure conformance to specified requirements.1: read organization


All packaging, preservation and marking processes including materials shall be specified with particular attention being given to specific customer requirements (e.g. specific labeling for new products, specific packaging materials).

The marking and labeling of materials shall be legible, durable and in accordance with the specifications. Marking shall be adequate to identify a particular product in the event that a recall or special inspection becomes necessary.All recyclable packaging that are used shall be clean and in good condition.

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15.5. Preservation

The supplier1 shall apply appropriate methods for preservation and segregation of product when such product is under the supplier's1 control.

15.6. Delivery

The supplier1 shall arrange for the protection of the quality of product after final inspection and test. Where contractually specified, this protection shall be extended to include delivery to destination.1: read organization


All requirements with respect to delivery responsibilities shall be respected complied with and any specific carrier regulations considered in planning transportation.

15.7. Housekeeping

Management shall ensure that housekeeping within the plant for all operations is maintained. The entire personnel is involved in this task. Particular attention being given to cleanliness (cleaning schedule), temperature, lighting, humidity and noise requirements in compliance with chapter 9.8.


16. CONTROL OF QUALITY RECORDS

The supplier1 shall establish and maintain documented procedures for identification, collection, indexing, access filing, storage, maintenance and disposition of quality records.

Quality records shall be maintained to demonstrate conformance to specified requirements and the effective operation of the quality system. Pertinent quality records from sub-contractors2 shall be an element of these data.

All quality records shall be legible and shall be stored and retained in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss. Retention times of quality records shall be established and recorded; Where agreed contractually, quality records shall be made available for evaluation by the customer or the customer's representative for an agreed period.

NOTE: Records may be in the form of any type of media, such as hard copy or electronic media.1: read organization 2: read supplier


Procedures shall be established and maintained for the control, storage and retention of quality records.

These shall include:- identification;- collection;- indexing;- filing (specific requirements may apply for control/security items and other regulatory items);- storage;- maintenance;- location (specified);- destruction.

Such quality records shall be maintained to demonstrate achievement of the required quality of product and the effective operation of the Quality System.The methods and retention times for critical characteristics data shall be defined.Retention times for product and system shall be defined in accordance with the customer requirements.

N.B.: Control/security items and other regulatory items shall be particularly taken into consideration. The particular reference shall be legible and identifiable to the product/process involved and shall be readily retrievable and shall be stored in a suitable environment to minimize deterioration, damage and prevent loss.

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Quality records on computers (discs, etc..) or microfilms back-up version shall be stored in a flame proof cabinet at a location away from the originals.


17. INTERNAL QUALITY AUDITS

The supplier1 shall establish and maintain documented procedures for planning and implementing internal quality audits to verify whether quality activities and related results comply with planned arrangements and to determine the effectiveness of the quality system.

Internal quality audits shall be scheduled on the basis of the status and importance of the activity to be audited and shall be carried out by personnel independent of those having direct responsibility for the activity being audited.

The results of the audits shall be recorded (see 16) and brought to the attention of the personnel having responsibility in the area audited. The management personnel responsible for the area shall take timely corrective action on the deficiencies found during the audit.

Follow-up audit activities shall record the implementation and effectiveness of the corrective action taken (see 16).

NOTE 1: The results of internal quality audits form an integral part of the input to management review activities (see 1.3).NOTE 2: Guidance on quality system audits is given in ISO 10011.1: read organization


Procedures shall be established, setting up a complete system of internal quality audits. The methods (tools) shall be standardized. Auditors shall receive specific training. A list of trained auditors shall be maintained. A monitoring system has been set up.An audit schedule shall be documented and communicated to all relevant functions.

Types of audit:

- System Audit ( the audit team shall be conducted by a

manager/responsible person);

- Product Audit;

- Process/compliance Audit (not restricted only to manufacturing

operations).

Audit schedule:

- the specific activities and areas to be audited and timing specified;

- audit (VALEO 1000);

- products/processes/procedures audits;

- reason for carrying out the audit.

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Performing the audit:

- an entry meeting with the relevant personnel shall be held;

- objective evaluation shall be made in a systematic manner;

- personnel conducting the audit shall be independent of the specific

area or activity being audited;

- nominated person (s) from the section/department being audited shall

accompany the auditors;

- reporting shall be defined in the above procedure.

Audit reporting and follow-up:

- a final closing meeting with relevant responsible personnel shall be

held;

- results and conclusions of the audit findings shall be reported in

writing to the organization's management where they shall be reviewed

at the management review meeting;

- the implementation and effectiveness of corrective action suggested

in previous audits shall be assessed;

- corrective action recommendations shall be budgeted and reported in

the Quality Improvement Plan;

- budgets plan provision for financing corrective actions following the

audit.


18. TRAINING

The supplier1 shall establish and maintain documented procedures for identifying training needs and provide for the training of all personnel performing activities affecting quality. Personnel performing specific assigned tasks shall be qualified on the basis of appropriate education, training and/or experience, as required. Appropriate records of training shall be maintained (see16)1: read organization


18.1. Training

Ascertaining needs

Procedures shall be established and maintained for identifying the training needs and provide for the training of all personnel.

Training programs shall be developed to increase the awareness of all personnel on quality issues which affect customer satisfaction, operating cost and the economic well being of the organization.

Evaluation of needs and training plan

Needs for the training of personnel shall be evaluated and formalized in a budgeted annual training plan.This plan shall be developed to ensure that personnel are qualified to work at many work stations.Operators shall have appropriate, certified competence or formal qualifications when necessary (special processes, etc.).

All relevant personnel, especially management shall have a working knowledge of quality methods such as, for example: Statistical Process control, Failure mode Effects and Critical Analysis (FMEA), Quality Function Deployment, Pareto, Fishbone, charts and statistical methods, Design of experiment.Training on the knowledge of product shall be included in the training program for all personnel.Documents of training programs and an individual employee register of participation in these programs shall be maintained up to date and stored safely. Individual records are monitored for the training.

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18.2. Responsibilities and motivation of personnel

Management shall define the responsibilities of all personnel in a job description (mission, task, delegation of responsibilities) in accordance with the management organization chart.

A system shall be implemented to measure the deviation between the existing competencies and the needs for each function.

Management shall provide recognition of quality performance when satisfactory quality levels are achieved.Efforts to improve quality performance shall involve all personnel.

Information on product function, position on the vehicle, its environment, its use in the customer plant and the potential consequences of non quality products shall be communicated to all personnel (pictures, notice boards, meetings, customers visits, training, etc.)

A communication system shall be developed to ensure the exchange of information within the organization.For each service the quality achieved versus the objective shall be presented in a clear and understandable way.An adequate visual management system shall be implemented for an efficient and open communication.Multifunctional team work shall be developed, for example:project teams, problem solving and functional analysis, etc.

Induction training schemes shall be developed and implemented for both full time and part-time personnel.

The training program and its results shall be regularly assessed.


19. SERVICING

Where servicing is a specified requirement, the supplier1 shall establish and maintain documented procedures for performing, verifying and reporting that the servicing meets the specified requirements.1: read organization


19.1. Installation and after-sales service

The quality function after delivery includes technical advice to customer as well as an eventual training in the customer's production unit.

When new products are launched, the organization shall be at the customer's.

19.2. Market feedback and product surveillance

Working procedures and instructions shall be established to verify and ensure that quality after delivery conforms to specific requirements and to define the reporting of:

- line stoppages and returns;- warranty returns;- durability;- determination of the level of customer satisfaction builder and user.

All data shall be analyzed and reports issued to management and customer indicating actions being taken.

The customer shall be informed of the status and the result of implemented corrective actions.

A program of visits to customer plants shall be planned, respected and reported to management. It shall include all sites.

The analysis of performances enables to control product quality deviations throughout the life cycle.

A procedure shall be established which defines the method by which the after sales performance of product is analyzed and reported in terms of reliability and customer satisfaction. This information shall be reported to the design function for use in product development.

19.3. Spare part market

For all spare parts manufactured from the existing process, the quality assurance system shall be the same as normal production.For spare parts manufactured on different process than those used by normal manufacturing, the supplier shall present a product quality assurance plan to the customer.

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In all cases, the quality of the spare parts shall be identical to the quality required for original units.


20. STATISTICAL TECHNIQUES

20.1. Identification of need

The supplier1 shall identify the need for statistical techniques required for establish, controlling and verifying process capability and product characteristics.

20.2. Procedures

The supplier1 shall establish and maintain documented procedures to implement and control the application of the statistical techniques identified.1: read organization


Procedures shall be established for identifying and implementing the necessary statistical requirements.

Areas of application shall be:

- marketing;

- product design;

- reliability testing;

- durability predictions;

- process control studies;

- process capability studies;

- SPC (Statistical Process Control);

- machine capability studies;

- determination of quality limits/inspection plans;

- data analysis / performance assessment;

- defect analysis.

Statistical techniques which shall be available within the organization are:

- design of experiment/factorial analysis;

- security evaluation/risk analysis;

- quality control charts/custom techniques;

- statistical sampling techniques;

- reliability (Weibull method).

Management intends to implement these methods. Special attention is given to control of processes.

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VALEO 1000

GLOSSARY


Acronyms and their meanings

AMDEC

FMEA

Analyse des Modes de Défaillances de leurs Effets et de leurs

Criticité

Failure Modes and Effects Analysis

ANV

VA

ANalyse de la Valeur

Value Analysis

AQP

PQA

Assurance Qualité Produit

Product Quality Assurance

AVIEX Avis d'expédition

Delivery information

DFA Conception pour l'assemblage

Design For Assembly

DFM Conception pour la fabrication

Design For Manufacturing

DOE Design of experiment

EDI Echange de Données Informatiques

Electronique Data Interchange

PEPS

FIFO

Premier Entré/Premier Sorti

First In-First Out

FTA Analyse des arbres de défaillance

Fault Tree Analysis

IQF

SQI

Indicateur Qualité Fournisseur

Supplier Quality Indicator

ISO International Standard Organisation

P1 Projet P1 : pour application client

Project P1 : for customer application

P2 Projet P2 : projet générique validé

Project P2 : validated generic project

PAQp

QAPp

Plan d'Assurance Qualité produit

Quality Assurance Plan product

QCD Qualité, Coût, Délai

Quality, Cost, Lead time

QFD Quality Function Deployment

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Acceptance The acceptance is a control procedure enabling the supplier's quality services to verify that, after approval, a new supply produced under standard production conditions (initial sample) is in compliance with the defined requirements.

Approval Acknowledgement by the supplier that a product is fit for use.This product having achieved requirements :- for a unit or a group : by the functional plan and the specifications to which it is referred.- for a material : by the standard or a technical specification.

PSA Standard B200112 - May 1991

Quality Assurance All the planned and systematic activities implemented within the quality system and demonstrated as needed, to provide adequate confidence that an entity will fulfil requirements for quality.

ISO 8402 : 1991

Quality audit A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.

ISO 8402 : 1991

Quality loop A conceptual model of interacting activities that influence quality at the various stages ranging from the identification of needs to the assessment of whether these needs have been satisfied.

ISO 8402 : 1991

Capability A comparison of the real Quality performance of a machine/ process with the specified Quality performance.

Process capability Cp is a coefficient which enables to assess the capability of a process to produce units within the tolerances.

Machine capability Cm is a coefficient which enables to assess a machine's ability to produce units within the tolerances.


Critical characteristics Characteristics which if not controlled will lead to malfunction of the product.

Project head/leader Person responsible for all project aspects from the beginning until the series delivery. He ensures that the product meets the specifications. Furthermore, he is responsible for any delays and costs as well as the budget.

Quality cost It is equal to the sum of failure, detection and prevention costs.They are grouped into :- non-conformance costs (internal and external failure costs.- conformance costs (detection and prevention costs).

Job description A document which defines the objectives and the mission of a given person within the organization.

Initial samples Units manufactured by final production methods and under final production conditions. Their approval will validate the production equipment. After approval, IS are used as reference for the serial production.

Quality managementAll activities of the overall management function that determine the quality policy, objectives and responsibilities and implement them by means such as quality planning, quality control, quality assurance and quality improvement, within the quality system.

ISO 8402-1 : 1990

Specified ToleranceCapability indices Cm or Cp= --------------------------

Process spread

(process spread = 6 x mean deviation)

Quality manual A document stating the quality policy and describing the quality system of an organization.

ISO 8402-1 : 1990

Inspection plan A document setting out the specific provisions implemented to carry out the inspection of a given product or service.

ISO 8402 : 1986

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Quality plan (Quality A document setting out the specific quality practices, resources and

Assurance Plan for

sequence of activities relevant to a particular product, project or

product) contract.ISO 8402 : 1991

Surveillance plan A document which defines the methods, the process, products services conditions of implementation.

Sensitive points Characteristics which are affected by safety standards and all other

(control/regulatory mandatory regulations (legal).

items)

Special process A process which cannot be completely verified by final testing.It is necessary to control critical characteristics during processing.

P1 Project Development of a "customer programme" or "customer application " product; or Valeo internal improvement from an internal, validated product.

P2 Project Storage of a generical product ready for use for subsequent applications.

Prototype Representative sample of a part/component to be used for design qualification.

Qualification The process of demonstrating whether an entity is capable of fulfilling specified requirements.

ISO 8402 : 1991

Quality The totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs.

ISO 8402 : 1991

Total quality For Valeo, Total Quality is the permanent involvement of all the company's members to improve :- the quality of its strategical choices and of its objectives,- its functioning quality


- product and services quality in relation with its environment.Total quality is a culture based on : a language, methods, common tools. Its objective is to satisfy customers at least cost. It ensures of the company profitability.

Product liability A generic term used to describe the onus on a producer or others to make restitution for loss related to personal injury, property damage or other harm caused by a product.

ISO 8402 : 1991Design review A formal, documented, comprehensive and systematic

examination, to :- Assess this design, its requirements and its implementation - identify eventual problems and propose solutions;Note : design requirements include all the requirements applicable to the unit, at all stages of the quality loop and at all stages of the life cycle.

ISO 8402 : 1991

Management review A formal evaluation by top management of the status and adequacy of the quality system in relation to quality policy and objectives.

ISO 8402 : 1991

Project review It is conducted at the end of each project stage and includes a design, a planning and an economic objectives review.

Specification Document stating requirementsISO 8402-1 : 1991

Quality system The organizational structure, responsibilities, procedures, processes and resources for implementing quality management.

Total productive It leads to a maximization of the efficiency of installations and

Maintenance equipment for their entire life.TPM motivates the entire personnel, in each service to the maintenance of installations through voluntary activities.

Traceability The ability to trace the history, application or location of an entity, by means of recorded identifications.

ISO 8402-1 : 1990

Development of traceability means to facilitate the recall of a product undergoing security regulations, is

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part of the measure to take, to limit the responsibility risk linked to the product.

ISO 9004 : 1987

Validation Confirmation by examination and provision of objective evidence that particular requirements for a specific intended use are fulfilled.Notes :1. In design and development, validation concerns the process of examining a product to determine conformity with user needs.2.Validation is normally performed on the final product under defined operating conditions. It may be necessary in earlier stages.3. "Validated" is used to designate the corresponding status.4. Multiple validations may be carried out if there are different intended uses.Validation is decided by the quality service before it is submitted to the customer for its homologation, for a product in its use and real environment.
