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D 16

ISO/TS 16949 readiness

Goal 1 Quality approach

1.1 Background 1.2 Scope

2 Principles and steps 3 Process approach

3.1 Definitions 3.2 Process

3.2.1 Management process 3.2.2 Realization process 3.2.3 Support process

3.3 Process mapping 3.4 Process approach

4 Quality management system (QMS) requirements 4.1 General requirements 4.2 Documentation

5 Management responsibility 5.1 Commitments 5.2 Management review

6 Resource management 7 Product realization

7.1 Planning 7.2 Customer 7.3 Design and development 7.4 Purchasing 7.5 Production 7.6 Monitoring and measuring

8 Measurement, analysis and improvement 8.1 General 8.2 Internal audit 8.3 Nonconforming product 8.4 Analysis of data 8.5 Improvement

8.5.1 Continual improvement 8.5.2 Corrective action 8.5.3 Preventive action

Annexes

Goal of the module: Readiness for implementation, certification, maintenance and improvement of your quality management system for automotive production (ISO/TS 16949)

in order to:

increase the satisfaction of stakeholders improve economic and financial results

meet customer, statutory and regulatory requirements

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1 Quality approach 1.1 Background

The quality management systems (QMS) ISO 9000 standards have appeared in:

1987: ISO 9000 first edition: ISO 9001; ISO 9002; ISO 9003; ISO 9004 1994: ISO 9000 first revision: ISO 9001; ISO 9002; ISO 9003; ISO 9004 – more

understandable, customer focus better determined, preventive actions added 2000: ISO 9000 second : ISO 9000; ISO 9001; ISO 9004 – simplified structure (8

clauses), priority to process approach and customer satisfaction 2008: third revision (fourth edition of ISO 9001): clarification of the requirements (no

new requirement), better alignment with ISO 14 001

The ISO standards (more than 15 600) are used in countless fields and are recognized all over the world. ISO is the international organization for standardization and was created in 1947. ISO comes from the Greek "isos" (equal).

The ISO 9000 family of standards contains three core booklets:

ISO 9000 (2005): Quality management systems - Fundamentals and vocabulary

ISO 9001 (2008): Quality management systems - Requirements

ISO 9004 (2009): Managing for the sustained success of an organization - A quality management approach

A specialised laboratory standard:

ISO 17 025 (2005): General requirements for the competence of testing and calibration laboratories

All these standards and many more can be ordered on the ISO site.

The automotive standards have appeared in the 1990s (AVSQ = FIAT, VDA = BWM + VW + Daimler, Valéo…):

1994: EAQF (PSA + Renault); QS 9000 (Chrysler + Ford + GM)

1998: QS 9000 third version

1999: ISO/TS 16949 first version

2002: ISO/TS 16949 second version

2009: ISO/TS 16949 third version

The role of the IATF (International Automotive Task Force) was essential to replace the existing standards in different countries with a single technical specification:

ISO/TS 16949: Quality management systems. Particular requirements for the application of ISO 9001: 2008 for automotive production and relevant service part organizations

This allows a single certification recognized worldwide for any organization linked to automotive production. The requirements of ISO/TS 16949 and the specific requirements of customers are the basis of any quality management system for automotive manufacturers.

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The technical specification ISO/TS 16949 fully resumes the 8 clauses of ISO 9001: 2008 (boxed text) and adds the specific requirements for the automotive industry (81 sub-clauses, 49 notes and one normative annex). Some of these requirements:

business plan

special characteristics

Advanced Product Quality Planning (APQP)

analysis of potential risks (Failure Mode and Effects Analysis, FMEA)

control plan

laboratory control

product acceptance process (Production Part Approval Process, PPAP)

measurement systems analysis (MSA)

statistical process control (SPC) For more information on these core tools you can consult the following manuals:

Production Part Approval Process (PPAP), 2006, AIAG

Analysis techniques for system reliability. Procedure for failure mode and effects analysis (FMEA), 2006, IEC

Potential Failure Mode and Effects Analysis (FMEA), 2008, AIAG

Advanced Product Quality Planning (APQP), 2008, AIAG

Measurement Systems Analysis (MSA) - 2010, AIAG

Statistical Process Control (SPC) - 2005, AIAG

Effective Problem Solving Guideline - Continuous Quality Improvement (CQI -10) - 2006, AIAG

ISO/TS 16949:2009 Guidance Manual - Continuous Quality Improvement (CQI -16) - 2009, AIAG

The standards of the series ISO 10 001 to ISO 10 019 are guidelines for quality management systems and will help you find many answers (cf. ISO 9004:2009, Bibliography).

All these standards and many more can be ordered in electronic or paper format on the ISO site. More than 28 000 standards (in English and other languages) are available on the Public.Resource.Org site.

1.2 Scope

The ISO/TS 16949 technical specification is applied voluntary to the management system of any organization (without limitations about size) manufacturing automotive products in the scope of design, development, production and relevant service.

Some requirements of clause 7.3 can be excluded when the responsibility of product design and development is outsourced. This is possible when these exclusions:

do not affect in any case product conformity linked to: o customer requirements o applicable regulation requirements

do not release the organization of its responsibilities are justified in the quality manual do not concern design manufacturing processes

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2 Principles and steps

Quality is anything that can be improved. Masaaki Imai

Quality approach is a state of mind which starts with top management as a priority strategic decision and extends to all employees. Top management sets the quality policy which determines the quality objectives, themselves applicable to all activities. The tool used to achieve the objectives is the quality system. The prevention concept is generalised.

The purpose of a Quality Management System is to increase the satisfaction of customers (both external and internal) by meeting their needs and expectations through permanent improvement of the effectiveness of the processes.

Quality is almost free when the customer is satisfied: he remains loyal to us. It’s only when the customer is not fully satisfied that quality becomes very expensive to us: sooner or later the customer will go to a competitor.

Quality stays long after the price has been forgotten

The eight quality management principles (cf. figure 2-1) will help us achieve sustained success (ISO 9000, sub-clause 0.2, ISO 9004, Annex B and the free ISO brochure “Quality management principles”).

Figure 2-1. The 8 quality management principles

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A well-prepared approach is half successful

The approach to implementing a quality management system starts with the preparation. An example is shown in figure 2-2.

Figure 2-2. QMS preparation

Step 1 contains the determination of the needs and expectations (requirements) for the customers (internal and external). The involvement of top management at its highest level is truly indispensable. The advice of a consultant is often solicited. A status of the management system (whole or partial) would be welcome at this stage. An external certification body is chosen.

One of the key questions which comes up quickly (step 2) is the need for this decision. If this is really unnecessary or if the estimated costs of the certification approach exceed the available resources, it is better to give up the idea right now.

The ISO 9000 family of standards will stop you making promises you can't fulfil and help you keep those you can. David Hoyle

The benefits of implementing a quality management system are often:

improved image of the organization

one step ahead of the competition

enhanced customer satisfaction

better economic results

increased daily efficiency

staff is aware, consulted, motivated and proud

best practices valorised

formalization of knowledge

process control

legal requirements updated

reduced production costs

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commitment benefits everybody

The benefits of the certification of a quality management system are often:

new customers

increased market share

increase in sales

better financial performance

More than one and a half million businesses worldwide can not be wrong!

The internalization of the spirit of the principles and requirements of an ISO standard significantly improves the overall performance of your business, especially when it is not considered as a constraint.

The third step shall determine whether this approach receives the approval of the staff. A communication campaign is launched in-house on the objectives of a quality management system (QMS). The staff is aware and understands that without their participation the project cannot not succeed.

Have confidence, success will come with the involvement and effort of all!

The vision (what we want to be), the mission (why we exist) and the business plan of the organization are determined. The following step (4) includes adding the specific automotive requirements in the quality policy. If you do not have a copy of the ISO/TS 16949 specification, now is the time to get it (cf. ISO).

Planning is the last step (5) of the project preparation for obtaining ISO/TS 16949 certification. The resources (financial and people) are confirmed by top management. A management representative (it is often the quality manager) is appointed as project leader. Top management commitment is formalized in a document communicated to all staff.

The establishment and implementation of a quality management system are shown in figure 2-3.

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Figure 2-3. QMS implementation

Step 1 aims to identify and determine the processes and in establishing the specific automotive requirements in the processes and the documents. New documents are created (control plans, FMEA, quality plans). The quality manual is updated.

The necessary resources to achieve the quality automotive objectives are determined in step 2. Planning tasks, responsibilities and time frames are established. Training to automotive requirements of internal auditors is taken into account.

Step 3 allows you to set and implement methods for measuring the effectiveness and efficiency of each process (indicators). Internal audits help to evaluate the degree of implementation of the automotive requirements.

Nonconformities of all kinds are listed in step 4. A first draft for dealing with waste is established. A sort of corrective and preventive actions is introduced.

A first encounter with the specific automotive tools and application areas of continual improvement is made in step 5. A table with the main costs of obtaining quality (COQ) is filled by people with the information at hand. An approach to preventing nonconformities and eliminating causes is established.

To conduct the pre-audit of the QMS (step 6) documents such the quality manual, procedures and others are checked and approved by the appropriate people. A management review allows evaluating whether applicable requirements are met. The quality policy and objectives are finalized. A quality manager from another company or a consultant can provide valuable feedback, suggestions and recommendations.

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When the system is accurately implemented and followed, the certification of the QMS by an external body is a breeze, a formality (step 7).

An appropriate method for evaluating the performance of your quality management system is the RADAR logic model of excellence EFQM (European Foundation for Quality Management) with its 9 criteria and overall score of 1000 points.

The Deming cycle (figure 2-4) is applied to control any process. The PDCA cycles (Plan, Do, Check, Act) are a universal base for continual improvement.

Figure 2-4. Deming cycle

Plan – develop and establish the strategy, the customers, the policy, the resources, the objectives, the documentation, the products, the processes, the trainings, the deadlines to meet (clauses 4, 5 and 6 of ISO/TS 16949)

Do – implement processes, indicators, realize the product (clause 7 of ISO/TS 16949)

Check – compare, inspect, analyse data, verify if objectives are achieved, validate, audit (clause 8 of ISO/TS 16949)

Act – improve, adjust, adapt, react with actions and find new improvements (new PDCA), (sub-clauses 5.6, 8.3 and 8.5 of ISO/TS 16949)

For more information on the Deming cycle and his 14 points of management theory (cf. table 2-1) you can consult the classic book "Out of the crisis" W. Edwards Deming, MIT press, 2000. Table 2-1. The 14 Deming points

Points Description

1 Create constancy of purpose for permanent improvement of products and services, in order to become competitive, stay in business and provide jobs

2 Adopt the new philosophy in the new economic age. Western management must accept its responsibilities and lead for change

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3 Don't be dependent on inspection to achieve quality. Eliminate mass inspection by including quality in the product in the first place

4 Stop buying just on the basis of a low price. Minimize further total costs by cutting down the number of suppliers and build long-term relationships of loyalty and trust with them

5 Improve permanently the production system, improve quality and productivity to obtain costs decrease

6 Establish training for all

7 Establish leadership. The purpose of supervision is to help people, equipment and tooling to do a better job

8 Keep fear out of sight, everybody's work will be more efficient

9 Break down barriers between departments. Teamwork is needed throughout the whole organization to foresee potential problems

10 Eliminate slogans and targets asking for zero defects from the work force. Most of the causes of low quality and productivity belong to the system

11 a. Eliminate work quotas on the shop floor. Substitute leadership b. Eliminate management by objectives. Eliminate management by numerical goals. Substitute leadership

12 a. Remove barriers that rob the worker of the pride of his workmanship b. Remove barriers that rob the people in management of the pride of their workmanship

13 Establish a vigorous training and self-improvement programme

14 Put everybody to work to accomplish the transformation. It’s everybody's job

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3 Process approach

3.1 Definitions

The beginning of wisdom is calling things by their proper names. Chinese proverb

In the ISO/TS 16949 (2009) specification the following terms in the supply chain are used:

Supplier (s) -> organization -> customer (s)

Customer: anyone who receives a product Organization: a structure that satisfies a need Process: activities which transform inputs into outputs Product (or service): every result of a process or activity Supplier: an entity that provides a product Some other definitions: Conformity: fulfilment of a specified requirement Customer satisfaction: top priority objective of every quality management system related to the satisfaction of customer requirements Effectiveness: capacity to realize planned activities with minimum efforts Efficiency: financial relationship between achieved results and used resources Indicator: value of a parameter, associated with an objective, allowing the objective measure of its effectiveness Management system: set of processes allowing objectives to be achieved Quality: aptitude to fulfil requirements Quality management: activities allowing the control of an organization with regard to quality Quality Management System: set of processes allowing achieving quality objectives Quality objective: quality related, measurable goal that must be achieved Quality policy: statement by the top management of an organization related to quality allowing the establishment of quality objectives Requirement: explicit or implicit need or expectation Stakeholder: person, group or organization that can affect or be affected by an organization System: set of interacting processes Some specific automotive terms are added: Control plan: document describing the specific measures to carry out the control of a product or process Fail safe devices: system allowing the prevention of errors by eliminating the human factor Special characteristic: characteristic of a product or process which could affect the safety of the product or compliance with regulations or could decrease customer satisfaction Examples of stakeholders: investors, customers, employees, suppliers, citizens, social or political organizations In the terminology of quality management systems do not confuse:

accident and incident o an accident is an unexpected serious event o an incident is an event which can lead to an accident

anomaly, defect, dysfunction, failure, nonconformity, reject and waste:

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o anomaly is a deviation from what is expected o defect is the non-fulfilment of a requirement related to an intended use o dysfunction is a degraded function which can lead to a failure o failure is when a function has become unfit o nonconformity is the non-fulfilment of a requirement in production o reject is a nonconforming product which will be destroyed o waste is when there are added costs but not value

audit, inspection, auditee and auditor o an audit is used to find deviations in relation to a standard o an auditee is the one who is audited o an auditor is the one who conducts the audit o an inspection is the verification of the conformity of a process or product

audit programme and plan o an audit programme is the annual planning of the audits o an audit plan is the description of the audit activities

calibration and gauging o calibration is the verification of a value found related to a standard (troy weight) o gauging is the positioning of reference marks

control and optimization o control is the attainment of the objective o optimization is the search for the best possible results

customer, subcontractor and supplier o a customer receives a product o a subcontractor provides a service or a product on which a specific work is

done o a supplier provides a product

effectiveness and efficiency o effectiveness is the level of achievement of planned results o efficiency is the ratio between results and resources

follow-up and review o follow-up is the verification of the obtained results of an action o review is the analysis of the effectiveness in achieving objectives

informing and communicating o to inform is to give someone an information o to communicate is to pass on a message, to listen to the reaction and discuss

objective and indicator o an objective is a sought after commitment o an indicator is the information on the difference between the pre-set objective

and the achieved result organization and enterprise, society, company

o organization is the term used by the ISO 9001 standard as the entity between the supplier and the customer

o enterprise, society, company are examples of organizations predictive and preventive maintenance

o predictive maintenance avoids the potential dysfunctions by forecast analysis o preventive maintenance avoids the unforeseen dysfunctions by regular

maintenance process, procedure, product, activity and task

o a process is how we satisfy the customer using people to achieve the objectives

o a procedure is the description of how we should conform to the rules o a product is the result of a process o an activity is a set of tasks

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o a task is a sequence of simple operations

Remark 1: the use of ISO 9000 definitions is recommended. The most important thing is to determine for everyone in the organization a common and unequivocal vocabulary.

Remark 2: the customer can be also the user, the beneficiary, the trigger, the ordering party, the consumer.

Annex 10 specifies the frequency of use of certain keywords contained in the ISO/TS specification.

For other definitions, comments, explanations and interpretations which you don’t find in this module and in annex 06 you can consult:

ISO 9000: 2005 - Quality management systems. Fundamentals and vocabulary, (ISO, 2005)

Introduction and support package: Guidance on the Terminology used in ISO 9001 and ISO 9004 (Document ISO/TC 176/SC 2/N 526R2, 2008)

Quality management system – Indicators and synoptical tables (FD X50 - 171, ISO, 2000)

Books for further reading on quality:

Philip Crosby, Quality is free; the Art of Making Quality Certain, McGraw-Hill, 1979

Kaoru Ishikawa, What is Total Quality Control, The Japanese Way, Prentice-Hall, 1981

Edwards Deming, Out of the crisis, MIT Press, 1982

Eliyahu Goldratt, Jeff Cox, The Goal, A Process of Ongoing Improvement, North River Press, 1984

Masaaki Imai, KAIZEN, The key to Japan’s competitive success, McGraw-Hill, 1986

James Harrington, Poor-Quality Cost, Dekker, 1987

David Hoyle, Automotive Quality Systems Handbook, Elsevier, 2005

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Larry Webber, Michael Wallace, Quality Control for Dummies, Wiley, 2007

David Hoyle, ISO 9000 Quality Systems Handbook, Elsevier, 2009

Joseph M. Juran, Juran’s Quality Handbook, McGraw Hill, 2010

When I think of all the books still left for me to read, I am certain of further happiness. Jules Renard

3.2 Process

The word process comes from the Latin root procedere = go, development, progress (Pro = forward, cedere = go). Each process transforms inputs in outputs creating added value and potential nuisances. A process has three basic elements: inputs, activities, outputs. A process can be very complex (launch a rocket) and relatively simple (audit a product). A process is:

repeatable foreseeable measurable definable dependent on its context responsible for its suppliers

A process is determined among others by its:

title and type purpose (why?) beneficiary (for whom?) scope and activities initiators documents and records inputs outputs (intentional and not intentional) restraints people material resources objectives and indicators person in charge (owner) and actors (participants) means of inspection (monitoring, measurement) mapping interaction with other processes risks and potential deviations opportunities for continual improvement

A process review is conducted periodically by the process owner.

The components of a process are shown on figure 3-1:

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Figure 3-1. The components of a process

Figure 3-2 shows an example that helps answering some questions:

which materials, which documents, which tooling? (inputs)

which title, which activities, requirements, constraints? (process)

which products, which documents? (outputs)

how, which inspections? (methods)

what is the level of performance? (indicators)

who, with which competences? (people)

with what, which machines, which equipment? (material resources)

Figure 3-2. Some elements of a process

Often the output of a process is the input of the next process.

You can find some examples of process sheets in the document pack D 02.

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Any organization (company) can be considered as a macro process, with its purpose, its inputs (customer needs and expectations) and its outputs (products/services to meet customer requirements).

Our preference is to identify a process using a verb (buy, produce, sell) instead of a noun (purchases, production, sales) to differentiate the process from the company's department or procedure and recall the purpose of the process.

The processes are (as we shall see in the following paragraphs) of management, realization and support type. Do not attach too much importance on process categorizing (sometimes it's very relative) but ensure that all company's activities fall at least into one process.

3.2.1 Management processes

Management processes are also known as piloting, decision, key or major processes. They take part in the overall organization, elaboration of the policy, deployment of the objectives and all needed checks. They are the glue of all the realization and support processes.

The following processes can be part of this family:

develop strategy set policy manage risks plan the QMS acquire (human) resources establish process ownership conduct an audit carry out management review communicate improve negotiate contract measure customer satisfaction analyse data satisfy requirements

3.2.2 Realization processes

The realization (operational) processes are related to the product, increase the added value and contribute directly to customer satisfaction. They are mainly:

design and develop purchase components produce maintain equipment inspect production sell products implement traceability receive, store and deliver control nonconformities implement preventive and corrective actions monitor advanced product quality plan (APQP)

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carry out production part approval process (PPAP) carry out failure mode and effects analysis (FMEA) control laboratory implement control plan

3.2.3 Support processes

The support processes provide the resources necessary for the proper functioning of all other processes. They are not directly related to a contribution of the product's added value, but are still essential.

The support processes are often:

control documentation provide information acquire and maintain infrastructure provide training manage laboratory manage staff keep accountability

3.3 Process mapping

The process mapping (see figure 3-1) is par excellence a multidisciplinary work. This is not a formal requirement of the ISO 9001 standard (neither of ISO/TS 16949) but is always welcome.

The 3 types of processes and some interactions are shown in figure 3-3 and Annex 08:

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Figure 3-3. Process house

Interested party: person, group or company affected by the impacts from an organization

Examples of interested parties: investors, customers, employees, suppliers, society.

The mapping among other things lets you:

obtain a global vision of the organization

identify the beneficiaries (customers), flows and interactions

define rules (simple) for communication between processes

To obtain a clearer picture you can simplify by using a total of about fifteen core processes. A core process can contain several sub-processes, for example in a process "develop the QMS" can enter:

develop strategy

set policy

manage risks

plan the QMS

deploy objectives

acquire resources

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establish process ownership

improve

Two other process examples (design, figure 3-4 and produce figure 3-5):

Figure 3-4. Design process

Figure 3-5. Produce process

3.4 Process approach

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Simple solutions for now, perfection for later

The process approach contributes enormously to the efficient management of the organization.

Process approach: management by the processes to better satisfy customers, improve the effectiveness of all processes and increase global efficiency

The process approach integrated during development, implementation and continual improvement of a quality management system allows one to achieve objectives that are related to customer satisfaction as is shown in figure 3-6 (cf. ISO/TS 16949, clause 0.2).

Figure 3-6. Model of a Quality Management System based on process approach and continual improvement

Process approach:

emphasizes the importance of: o understanding and complying with customer requirements o prevention so as to react to unwanted elements such as:

customer returns scrap

o measuring process performance, effectiveness and efficiency o permanently improving objectives based on pertinent measurements o process added value

relies on: o methodical identification o interactions o the sequence and o process management which consist of:

determining objectives and their indicators

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piloting related activities analysing obtained results permanently undertaking improvements

allows one to: o better view inputs and outputs and their relationship o clarify roles and responsibilities o judiciously assign necessary resources o break down barriers between departments o decrease costs, delays, wastes

and ensures in the long run: o control o monitoring and o continual improvement of processes

Process approach is not:

crisis management ( "You will not solve the problems by addressing the effects")

blaming people (“Poor quality is the result of poor management." Masaaki Imai)

priority to investments (“Use your brain, not your money." Taiichi Ohno)

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4 QMS requirements

4.1 General requirements (requirements 1 to 19)

In the simplified diagram of figure 4-1 we can see the purpose of a quality management system ISO/TS 16949:

Figure 4-1. Purpose of a QMS ISO/TS 16949

The requirements of the ISO/TS 16949 specification in the sub-clauses of the clauses 4 to 8 and the Annex A are shown in figure 4-2.

Figure 4-2. The requirements of the ISO/TS 16949 specification

The requirements related to products are specified by the customer, the organization or a regulation.

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The requirements of the ISO/TS 16949 specification are exclusively about the Quality Management System and its processes:

the requirements of all interested parties are identified the Quality Management System (QMS) is established, documented and

implemented. The quality policy, the objectives, the resources and the work environment are set

the processes necessary for the QMS are identified, the required resources

guaranteed, the owners appointed, the interactions determined each process is measured, monitored, the objectives are established and analysed the actions for obtaining continual process improvement are established and

implemented

Pitfalls to avoid:

go overboard on quality

have the quality manager write all the procedures

overlook the specifics of the company mores

An externalised process is always under control (the requirements are met). When the product is externalised the supplier is under control.

Good practices

process mapping has enough arrows to show who is the customer (internal or

external)

for a process it is better to use a lot of arrows (several customers) rather to forget one

during the process review reveal the added value of the process

the analysis of processes performance is an example of continual improvement

evidence of the effectiveness of the QMS

Bad practices

some process outputs are not set correctly (customers not considered) process efficiency criteria not established process owner not formalized outsourced processes unidentified control of outsourced services not described sequences and interactions of certain processes are not identified criteria and methods for ensuring effective processes not determined monitoring the effectiveness of certain processes not established

4.2 Documentation (requirements 20 to 56)

The right document, at the right place, at the right moment

The QMS documentation (cf. figure 4-3) contains the quality policy, the quality objectives, the quality manual (QM), the procedures, the process sheets, the necessary documents to control processes and the required records. Included are documents of external origin (suppliers, customers, standards).

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Figure 4-3. The documentation pyramid

Each internal document is verified and approved. The obsolete documents are identified and their use is prohibited. The version before the last one of a document can become a record.

The technical report ISO/TR 10 013 (2006): "Guidelines for quality management system documentation" provides recommendations relative to the documentation of a QMS.

The quality manual (cf. Annex 01) describes, as a minimum, the scope of the QMS, the procedures (cf. Annex 02) or a reference to them, the interactions between processes (process mapping, cf. sub-clause 3.3) and the exclusions of clause 7 (cf. sub-clause 1.2). The quality manual is like the Traffic Regulations, it is mainly a guide, a tool, but does not

teach you how to drive.

Answers to all 524 requirements ("shall" in the text) of the clauses 4 to 8 and annex A of the ISO/TS 16949 specification are included in the documentation.

Procedure: set of actions to carry out a process Quality manual: document specifying the general measures taken by an organization to obtain products or services of quality Document: any support allowing the treatment of information Record: document providing objective evidence of achieved results

The 7 mandatory procedures of ISO/TS 16949 (cf. Annex 02) are:

control of documents (sub-clause 4.2.3). The procedure ensures: o verification (review of content and form) o approval (permission to distribute) o updating (verification and approval again) o relevant version at points of use o availability o control of external documents o prevention of use of obsolete documents o sustainability of its know-how

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o integration of hired people

control of records (sub-clause 4.2.4). The procedure ensures: o identification o classification o distribution o readability o protection o retention time and o disposal of records

Training (sub-clause 6.2.2.2)

internal quality audit (sub-clause 8.2.2)

control of nonconforming product (sub-clause 8.3)

corrective action (sub-clause 8.5.2)

preventive action (sub-clause 8.5.3)

You can combine several procedures into one. The documentation can be in any form and type of medium. The documentation, among other things, contributes to supply objective evidence and estimate the effectiveness and pertinence of the QMS.

Objective evidence: demonstrably true factual data

A procedure can be documented or not be (see ISO 9000: 2005, sub-clause 3.4.5). Our preference is for the documented solution (written), short, simple and relevant. Above all in cases where the absence of a procedure may lead to deviations in the policy or the quality objectives. A review of the documentation is conducted periodically by the quality manager.

True story At a third party audit the auditor asked to see the version history of three procedures and some instructions.

The procedures had all more than 3 versions and instructions (in our case audit reports) on average 2 or 3 versions (actions and one or two follow-ups).

The auditor was comforted because he was afraid to come across inactive documents.

The documentation depends on the size and type of the organization, on the process complexity and on people’s competence. Only strictly necessary documents are mandatory in order to obtain a simplified documentation. Example of habitually used documents:

quality manual organizational chart procedures specifications work or test instructions documents containing internal communications production planning

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approved supplier list trial and monitoring plans quality plans

Specification: final description of system or product requirements in order to develop or validate it

Spoken words fly away, written ones stay. Latin proverb A process ensures the review, distribution, changes and implementation of technical specifications of the customer. Maintained records required by the QMS to prove conformity to the ISO/TS 16949

specification (sub-clauses):

process parameters (4.1) scope (4.2) dates of change implementations in production (4.2.3.1) management review (5.6.1) evidence of achieved objectives and customer satisfaction (5.6.1.1) competence, awareness and training (6.2.2 e) evidence that the realization processes and resulting product meet requirements (7.1

d) changes of product and production processes (7.1.4) evidence of control of special characteristics (7.2.1.1) results of the review of requirements of the product and following actions (7.2.2) production feasibility of proposed products (7.2.2.2) FMEA (7.3.1.1) product design and development inputs (7.3.2) process design and development inputs (7.3.2.2) design and development outputs (7.3.3.2) results of design and development review and necessary actions (7.3.4) results of design and development verification and necessary actions (7.3.5) results of design and development validation and necessary actions (7.3.6) results of control of design and development changes and necessary actions (7.3.7) results of suppliers evaluations and necessary actions (7.4.1) control plan (7.5.1.1) preventive and predictive maintenance (7.5.1.4) management of production tooling (7.5.1.5) validation of all processes (7.5.2.1) unique product identification when traceability is a requirement (7.5.3) customer property that is lost, damaged or found unsuitable for use (7.5.4) results of calibration, verification and validation of measuring equipment (7.6; 7.6.2) internal laboratory activities (7.6.3.1) results of internal audits and follow up actions (8.2.2) manufacturing process study capability and effective dates of process changes

(8.2.3.1) evidence of conformity with the product acceptance criteria including person(s)

authorizing product release (8.2.4) nature of nonconformities and actions taken (8.3) quantity and expiring dates of customer waiver (8.3.4) results of corrective actions (8.5.2 e) results of preventive actions (8.5.3 d)

ISO/TS 16949 readiness PQB D 16 S

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Every record is unique and usually cannot be changed. Every record provides proof of a task, an operation, an activity, a process or a requirement. The records are the data base essential to analyse process effectiveness and to contribute to continual improvement of the QMS. Examples of often used other records:

process capability studies

costs of obtaining quality

change requests

concession requests

customer complaints

Good practices

the quality manual is short and simplified (easy to read by all staff) the control of documents can clearly show the author, the verification and approval of

the original document and the subsequent versions managing changes to a document (the middle line of the old text, red) can quickly

show the history a list of dates for implementation of changes is available in production workshop methods of distribution of documents are outlined in the procedure "Control of

documents" the hierarchy of documents is logical and clear (manual, procedures, processes,

instructions, records) review of all the QMS documentation, conducted twice a year, is very well organized,

the actions are completed on time the master list of documents also includes the retention period for records external documents (standards, regulations, documents of customers, suppliers and

machines) are coded as internal documents and in a specific list the location of each external document is notified

Bad practices

the quality manual is not updated in the quality manual exclusions are neither detailed nor justified procedures are not updated the necessity for certain documents is not evaluated real activities are not identified in any process some documents are not codified documents are not in the place where needed instructions are not updated (before last version) documents are not approved prior to release at the project launch meeting the list of participants is not recorded protection of documents on the network is not determined external documents (customer, supplier) are not controlled (codified) retention period and methods of disposition of records are not identified