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Joint Quality Management in the Supply Chain

Product Manufacturing
and Delivery
Robust Production Process
Pre-requisites, Standards, Controlling, Examples

1st edition, November 2007


Update reprint in November 2019
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Joint Quality Management
in the Supply Chain

Product Manufacturing and Delivery


x Robust Production Process

Pre-requisites, Standards, Controlling, Examples

1st edition November 2007 ‒ Updated reprint in November 2019

Verband der Automobilindustrie -


German Association of the Automotive Industry

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ISSN 0943-9412
English edition printed: 2011/12
Reprint: 2020/01

Copyright 2019 by:

Verband der Automobilindustrie e.V. (VDA)


Quality Management Center (QMC)
10117 Berlin, Behrenstr. 35
Germany

Overall production:

Henrich Druck + Medien GmbH


60528 Frankfurt am Main, Schwanheimer Straße 110
Germany

Printed on chlorine-free bleached paper

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Non-binding VDA recommendation

The Association of the German Automotive Industry (VDA) recommends its


members to apply the following guideline for the implementation and
maintenance of quality management systems.

Exclusion of Liability

VDA volumes are recommendations available for general use. Anyone


applying them is responsible for ensuring that they are used correctly in each
case.

This VDA volume takes into account state of the art technology, current at
the time of issue. Implementation of VDA recommendations relieves no one
of responsibility for their own actions. In this respect everyone acts at their
own risk. The VDA and those involved in VDA recommendations shall bear
no liability.

If during the use of VDA recommendations, errors or the possibility of mis-


interpretation are found, it is requested that these be notified to the VDA
immediately so that any possible faults can be corrected.

Copyright

This publication including all its parts is protected by copyright. Any use
outside the strict limits of copyright law, is not permissible without the consent
of VDA QMC and is liable to prosecution. This applies in particular to copying,
translation, microfilming and the storing or processing in electronic systems.

Translations

This publication will also be issued in other languages. The current status
must be requested from VDA QMC.

1
Note: references to DIN standards have been deleted in the 2017/05 reprint because they are no longer used in the
volume.

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Foreword

Industry in Germany and Europe, especially the automotive industry, is


currently experiencing great changes. Market globalization continues to
progress and the industry is now exposed to international competition. The
number of different automobile brands, which had been decreasing in recent
decades, has expanded in the last few years to include Asian competitors
who are now also internationally active. Their products are taking an ever-
larger market share due to the extensive fitment of products as standard and
a good ratio of price to performance.

Fig. 1.1-1 Initial situation for the automotive industry

In addition, the OEMs are faced with ever-greater product complexity and
ever-shorter development and test lead-times.

The percentage of electronic components involving complex software will


continue to increase and this will lead to additional challenges in terms of
essential validation and verification to achieve the high reliability and quality
levels required.

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At the same time cost pressures are enormous. By any international
comparison, production and manufacturing costs are clearly higher in Europe
and especially in Germany. These disadvantages can be countered only by
greater innovation and technology, as well as features which will catch the
customer's imagination.

The customer expects not only a vehicle providing excellent performance at


a reasonable price: he also expects an innovative, safe, premium-quality,
reliable vehicle. These expectations apply to the end-product – that is, the
vehicle with all its components. In addition, a defect-free supply chain for
manufacturing and production, servicing and the supply of replacement parts
must be guaranteed.
This present volume, Robust Production Processes, provides assistance
with the following topics:
x How are Robust Production Processes implemented?
x How are Robust Production Processes evaluated or measured?
x How are influencing factors and failures dealt with?
x How can existing production processes be improved?

3 5.4
Pre-requisites for a 5.1 Basic standards for
Failure
Robust Production internal production
management
Process processes
Management control loop
Customer control loop
Production control loop
Customer
Supplier control loop production
Internal process
Supplier production
production process
process

4
Checkpoint
5.2
Supplier´s Monitoring and
management controlling
5.3

Product development process


if necessary, with „Maturity Level Assurance“

ML0 ML1 ML2 ML3 ML4 ML5 ML6 SOP ML7

„Robust Production Process“

Fig. 1.1-2 The overall concept of the Robust Production Process.


The numbers refer to the chapters in this volume.

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These matters should be clarified in appropriate contractual regulations. The
volume at hand makes no claim to be complete.

We thank the participating organisations and their employees for their


contributions in the compilation of this document. The following companies
were involved in drawing up the volume:

x AUDI AG, Ingolstadt


x Daimler AG, Stuttgart
x Schaeffler KG, Herzogenaurach
x MAN AG, Münich
x Robert Bosch GmbH, Stuttgart
x Siemens VDO Automotive, Regensburg
x Volkswagen AG, Wolfsburg
x WABCO, Hannover
x ZF Friedrichshafen AG, Friedrichshafen
x Management Engineers GmbH & Co. KG, Düsseldorf

Our thanks also go to all who have given us encouragement and assistance
in generating and improving the document.

Oberursel, Nov. 2007

English version - Berlin, Dec. 2011

Foreword for updated reprint 2019


The DIN ISO standards, IATF and VDA-guidelines are in many cases
renewed or refined and are now incorporated in this reprint in their updated
form.

The cited content and references were adjusted accordingly.

Withdrawn VDA volumes have been removed from notes and overview
tables.

English version - Berlin, March 2020

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Table of Contents Page

1 Introduction 13
1.1 The initial situation 13
1.2 Objectives 13
1.3 Influencing factors 14
1.3.1 Complexity and Innovation 16
1.3.2 The human factor: management and employees 17
1.3.3 Resources 17
1.3.4 Planned and unplanned changes 17
1.4 Definition / “guide rails” of a Robust Production Process 18
2 Overview of the complete concept 21
2.1 Comments on navigation 22
2.2 The four control loops of the Robust Production Process 24
2.3 Links with VDA standard Maturity Level Assurance
for New Parts 25
2.3.1 Classification using the "traffic lights" system 27
2.4 Illustrations, check-lists and examples 27
3 Pre-requisites for a Robust Production Process 31
3.1 Corporate culture 31
3.1.1 Culture of trust, handling successes and failures 31
3.1.2 Process orientation and increased quality 32
3.1.3 Failure prevention / avoidance 33
3.1.4 Sustainability 33
3.1.5 Continuous Improvement 34
3.2 Product development and planning process 34
3.2.1 New parts 35
3.2.1.1 "A" parts 35
3.2.1.2 "B" and "C" parts 35
3.2.2 Parts from a new manufacturing location 36
3.2.3 Carry-over parts 36
3.3 Minimum requirements for the quality functions of a
production location 37
3.4 Logistics concept 37
3.5 Risk management – preventive failure management 37

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4 Check-point 38
5 Standards for Robust Production Processes 40
5.1 Basic standards for internal production processes 42
5.1.1 Standard 1: Control loops for monitoring and measuring
the production process and products 44
5.1.2 Standard 2: Internal quality agreements 48
5.1.3 Standard 3: Internal release procedure
(product and process) 51
5.1.4 Standard 4: Employee qualification 54
5.1.5 Standard 5: Communication, reporting, escalation 56
5.1.6 Standard 6: Comprehensive equipment management /
maintenance / service 59
5.1.7 Standard 7: Risk management / contingency plan 62
5.1.8 Standard 8: Problem-solving methods 64
5.1.9 Standard 9: Work-station description; standard work-sheets 66
5.1.10 Standard 10: Change management 68
5.2 Supplier management 72
5.2.1 Supplier selection 73
5.2.2 Contract validation, quality assurance & logistics agreement 75
5.2.3 Involvement of new suppliers 75
5.2.4 Monitoring the quality of deliveries 76
5.2.5 Escalation management 77
5.2.6 Communication and cooperation 78
5.2.7 Transfer to the complete supply chain 80
5.3 Monitoring & controlling 81
5.3.1 Key data cockpit 81
5.3.2 Communicaiton, display, reporting 83
5.3.3 Control loops 83
5.3.4 Requalification 84
5.4 Failure management 87
5.4.1 Preventive failure management / risk management 87
5.4.2 Reactive failure management 90

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6 Road map covering standards, guidelines and methods 91
6.1 Methods and guidelines road map for the VDA Volume
Robust Production Processes 93
7 Appendix 97
7.1 Glossary and abbreviations 100
7.1.1 General terms and expressions 100
7.1.2 Terms in the standards environment 103
7.1.3 List of abbreviations 105
7.2 Check-lists 106
7.2.1 Check-list for production transfers and carry-over parts 107
7.2.2 Check-list of minimum requirements for quality functions
at a production location 111
7.2.3 Logistics concept check-list 113
7.2.4 Check-point check-list 114
7.2.5 Quality assurance & logistics agreement (QALA) check-list 116
7.2.6 Key data matrix check-list 124
7.2.7 Example of cockpit for a Robust Production Processes 128
7.2.8 Example of a Robust Production Process mini-cockpit 129
7.2.9 Influencing factors check-list with an example of an
assessment matrix based on the FMEA Method 131
7.3 Examples of standards 138
7.3.1 Example of standard for internal quality agreements 138
7.3.2 Examples of standards for release procedures 141
7.3.2.1 Example 1: Overall assessment for a process release 141
7.3.2.2 Example 2: Quality assessment 147
7.3.3 Examples of standards for employee qualifications 151
7.3.3.1 Example 1: Qualification matrix 151
7.3.3.2 Example 2: Qualification and authorisation matrix 154
7.3.4 Examples of standards for communicating / reporting /
escalation 156
7.3.4.1 Example 1: Reporting and documentation 156
7.3.4.2 Example 2: Escalation monitoring 157
7.3.4.3 Example 3: Example showing quality key data and
execution 158
Example 4: Example of key data depiction 159
Example 5: Example of key data depiction 159

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7.3.5 Examples of standards covering comprehensive
equipment management, maintenance and service
7.3.5.1 Example 1: Training course material for TPM 161
7.3.5.2 Example 2: TPM inspection plan (excerpt) 165
7.3.5.3 Example 3: Training documents for TPM of Robots 167
7.3.6 Examples of standards for risk management and
contingency plan 168
7.3.6.1 Example 1: Process risk filter 168
7.3.6.2 Example 2: Flow chart for contingency management 170
7.3.6.3 Example 3: Quality reaction plan 171
7.3.7 Examples of standards for problem-solving methods 172
7.3.7.1 Example 1: Problem-solving sheet 172
7.3.7.2 Example 2: 8D Report 173
7.3.8 Examples of standards for work-place descriptions and
standard work-sheets 175
7.3.8.1 Example 1: Standard work-sheet 175
7.3.8.2 Example 2: Standard work-sheet 176
7.3.8.3 Example 3: Process illustrations and production
operations 178
7.3.9 Examples of standards for of change management 180
7.3.9.1 Example 1: Life-cycle planning 180
7.3.9.2 Example 2: Change request 182

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1 Introduction

1.1 The initial situation

Quality problems are normally associated with high costs. In addition, each
field return means a dissatisfied customer. The costs involved in guarantees,
warranty and goodwill are many times higher than the expenditure required
to remedy and to prevent failures at their point of origin. Furthermore, the
consequences, especially the costs and the loss of image for all the parties
involved, for example, in product recalls, are in the double-digit million Euro
range.

In order to meet technical, functional and logistics requirements, as well as


demands relating to quality and price, there is a need for closer, speedier
control loops and preventive measures to eliminate logistics problems and
complaints.

Communication in the supply chain, effective control loops, as well as the


use of preventive quality methods are often lacking or have not been
implemented adequately. Requirements covering these aspects are
described in a whole range of standards, regulations, specifications or
requirement specifications1 but in this jungle of standards there is a lack of
any adequate overview or control mechanisms.

This present publication sets out the pre-requisites needed in the future to
implement Robust Production Processes in a joint quality management
system operating through the complete supply chain.

1.2 Objectives

The objective is to ensure that minimum requirements are laid down for
production processes and to implement Robust Production Processes in the
future in order to assure market leadership by reducing quality costs. For this,
production processes must be planned and implemented in terms of their
performance capability, in such a way that defect-free products are
manufactured on schedule and in accordance with set requirements. Here
the emphasis is on the secure prevention of undesired negative influences
and on effective control loops.

1
See also VDA volumes, IATF 16949, ISO 9000 ff, customer specifications.

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Fig. 1.2-1 Objectives of the Robust Production Process

1.3 Influencing factors

In practice, very often people talk only of noise factors, instead of influencing
factors or factors. Depending on the way a company or an individual
production sector is organised and oriented, however, many influencing
factors are planned and incorporated in defined forms or even desired and
expected.

A noise factor is therefore an influencing factor which lies outside the planned
tolerance and has a negative influence on the performance capability of the
robust production process.2

Possible influencing factors relating to a production process can be combined


into major, or primary influencing factors. This can be done in different ways,
according to perception. The illustration in Fig. 1.3-1 shows a range of
influencing factors sorted by responsibility and how they may be assured3.

2
This sentence serves as the definition of the term “interference factor” in this volume.
3
These influencing factors were compiled in a benchmark of the companies involved in this
volume.

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Fig. 1.3-1 Sorting the primary influencing factors

This sorting of the main, or primary influencing factors into:


1. Complexity / innovation,
2. Human factors,
3. Resources,
4. Planned changes
5. Unplanned changes
(see also Fig. 1.3-2) illustrates the responsibility of management and this is
seen again in the assignment of these primary influencing factors for the
ISO 9000 process model (the basis for IATF 16949).

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Fig. 1.3-2 Assignment of influencing factors in the ISO model

1.3.1 Complexity and innovation

The complexity and degree of innovation of a product and its production


process are essential influencing factors affecting the robust production
process. These must be taken into account in the planning phase. Close
coordination between customer and supplier must be maintained throughout
the entire supply chain.

(See also chapter 3.2 and the VDA volume Maturity level assurance for new
parts)

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1.3.2 The human factor: management and employees

Non-compliance with regulations or specified work-sequences can generally


be attributed to the human factor.

The training and active involvement of employees is important in order to


control and to improve the human factor as an influencing variable.

(See also Chapter 3.1: "Corporate culture", Chapter 5.1: "Basic standards for
internal production processes" and Chapter 5.1.4: " Standard 4: Employee
qualification")

1.3.3 Resources

The planning and securing of necessary resources is a management


responsibility. Resource planning requires an exact knowledge of the
complexity and level of innovation of the products to be manufactured and
services to be provided, as well as the production process itself. The
management must make the means available – i.e. including the capital – so
that everything needed for a successful production process is available at the
right time, in the correct quantities and to the right quality. This includes the
necessary employees, facilities and production equipment, as well as the
necessary bought-in parts, energy supplies, etc. In the case of bought-in
parts, for example, it is essential to plan and implement a reliable supply
chain.

1.3.4 Planned and unplanned changes

Changes affect all the factors involved in establishing the production process.
This therefore includes resources and their provision, as well as rules
covering the item to be produced and the production process itself.

It is not possible to make a clear distinction between “planned” and


“unplanned” changes. A customer’s planned and intended change can often
have significant effects in the supply chain.

To ensure a Robust Production Process it is necessary to carry out timely


and complete verification, validation and release of the products and
processes with their layout inspection (see also Chapter 3.2: "Product
creation and planning process" and Chapter 5.1.10: "Standard 10: Change
management"). A comprehensive change management system is required in
order to maintain a Robust Production Process. This will cover all the

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products, processes and companies involved in the supply chain. Securing a
Robust Production Process requires intensive planning, which takes into
consideration the fluctuating influencing factors. It also includes a solid risk
assessment which focuses on prevention (see Chapter 5.4: "Problem
management").

1.4 Definition / "guide rails" of a Robust Production Process

A Robust Production Process is characterized by the fact that it is resistant


to all undesirable influencing factors. It ensures that production is aligned to
achieve timely shipments of quality products in accordance with delivery
schedules while complying with the planned economic expenditure.
Compared with assured, capable and controllable production processes, a
Robust Production Process therefore goes a step further toward the goal of
“zero-defects” with a simultaneous reduction in quality costs:

Fig. 1.4-1 Classification of a Robust Production Process

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In order to guarantee this and to define/classify a Robust Production Process,
Fig. 1.4-2 sets out the definition and guide rails of the Robust Production
Process.

At the same time, this definition of the Robust Production Process provides
the definition of the guide rails which describe and specify the course of
implementation.

These guide rails are roughly divided into the requirements / pre-requisites
and the objective of the Robust Production Process and are not a definition3
in the mathematical sense.

Fig. 1.4-2 Definition and guide rails of the Robust Production Process

3
A Definition (lat. de = about, concerning; finitio = similar, related to, adjacent, therefore
Definitio = concerning similar) is the compression of characteristics (for a term, a relation, a
function or a name) whose facts (Definiendum) subsequently lead back to characteristics
(Definiens).

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From the requirements (for example, “is dependent on a design which is
robust and capable of production”) it follows that the essential pre-requisites
for the production process must already be achieved in the preceding
maturity level process, which includes the phases of the product
development, product realization and product release up to SOP (start of
production).

All production processes which, at the present state of the art, cannot be
seen as stable and controllable – for example some manual production
processes and process operations – will be unable to reach the objective of
a Robust Production Process as long as they fail to comply with the pre-
requisites of product maturity and a stable, measurable, and controllable
process.

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2 Overview of the complete concept

The structure of the complete concept (see also Fig. 2.0-1) of a Robust
Production Process is divided into two areas: product development and
product manufacture, with a check-point in the area of transition. At this
check-point the pre-requisites for the Robust Production Process must be
checked. This corresponds to the chronological assignment of the activities
before and after SOP:

x Achieving the necessary pre-requisites


x The release and assessment of the Robust Production Process
at the checkpoint
x The subsequent production process with process monitoring and
control.

3 5.4
Pre-requisites for a 5.1 Basic standards for
Failure
Robust Production internal production
management
Process processes
Management control loop
Customer control loop
Production control loop
Customer
Supplier control loop production
Internal process
Supplier production
production process
process

4
Checkpoint
5.2
Supplier´s Monitoring and
management controlling
5.3

Product development process


if necessary, with „Maturity Level Assurance“

ML0 ML1 ML2 ML3 ML4 ML5 ML6 SOP ML7

„Robust Production Process“

Fig. 2.0-1 Complete concept of the Robust Production Process


(The numbering refers to chapters)

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2.1 Comments on navigation

As a first step the terms and their definitions are given and their sources are
given or are defined in the glossary.

The complete concept of the Robust Production Process forms the basis of
the make-up of the chapter and answers the following questions:

x Which pre-requisites must I achieve in order to operate a new


production process robustly, preferably from the start-up?
Chapter 2 references the VDA standard Maturity level assurance for
new parts which is closely associated with this volume. This VDA
standard defines essential pre-requisites for a Robust Production
Process which must be determined, planned and implemented in the
course of the product development process. Chapter 3 summarizes
these and the additional pre-requisites for a Robust Production
Process.
x How can I recognize before the start of production to what
degree the pre-requisites for robustness exist and which risks
are still present?
Chapter 4 describes the check-point, with the elements and pre-
requisites which must be checked there.
x How do I operate a Robust Production Process? Which
standards, methods and tools will help me with this?
Chapter 5 deals with the subject of the Robust Production Process
after SOP, together with the four control loops (see also Chapter 2.2).
It also covers the standards required for the operation of the
production process, supplier management, monitoring and control of
the four control loops, and failure management.
x “How do I achieve robustness?”
Chapter 5 gives recommendations as to how users of existing
production processes can develop these so that they become robust.
For ease of use and to simplify reference to additional standards and
documents, a guideline and methods "road map“ is provided in Chapter 6.
The structure of this "road map“ follows the chapter structure of this present
volume and the complete concept.

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Subject Chapter Page Check-list / example Chapter Page
Check-point 4 38 Check-point check-list 7.2.4. 114
Check-list from Maturity Level 2.3. 25 Check-list for production transfers 7.2.1. 107
and carry-over parts
Product development and 3.2. 34
planning process
Product / process releases 5.1.3. 51
Quality management 3.3. 37 Check-list of minimum require- 7.2.2. 111
ments for quality functions at a
production site
Basic standards 5. 40
– Control loops 5.1.1. 44
– Internal quality agreements 5.1.2. 48 Examples of internal quality 7.3.1. 138
agreements
– Internal release procedure 5.1.3. 51 Examples of release procedures 7.3.2. 141
(product and process)
– Employee qualification 5.1.4. 54 Employee qualification examples 7.3.3. 151
– Communication, reporting, 5.1.5. 56 Examples of communication/ 7.3.4. 156
escalation reporting / escalation
– Comprehensive equipment mgmt./ 5.1.6. 59 Examples of comprehensive 7.3.5. 161
maintenance / repairs equipment management
– Risk management / 5.1.7. 62 Examples of risk management/ 7.3.6. 168
contingency plan contingency plan
– Problem solving methods 5.1.8. 64 Examples of problem solving 7.3.7. 172
methods
– Job descriptions, standard process 5.1.9. 66 Examples of job descriptions 7.3.8. 175
sheets
– Change management 5.1.10. 68 Examples of change management 7.3.9. 181
Influencing factors and resources 5.4. 87 Influencing factors check-list with 7.2.9. 131
(failure management) example of assessment matrix
modelled on the FMEA method
Supplier management, QALA 5.2. 72 Quality assurance and logistics 7.2.5. 116
agreement check-list
Internal/external logistics concept 3.5. 37 Logistics concept check-list 7.2.3. 113

Monitored and managed by process controlling

Controlling and managing 5.3. 81 Key data matrix check-list 7.2.6. 124
Cockpit as an example for Robust 7.2.7. 128
Production Processes
Mini-cockpit as an example for 7.2.8. 130
Robust Production Processes

Fig. 2.1-1 Overview matrix of requirements for Robust Production


Processes with check-lists and examples

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2.2 The four control loops of the Robust Production Process

Four important control loops have been identified in order to achieve a


Robust Production Process in the supply chain. In their inter-action, these
control loops guarantee the success of the complete production process.

Fig. 2.2-1 Controlling and managing the four control loops


The first three control loops correspond to the classic process concept of ISO
9001. The fourth is a superordinate control loop used by management which
ensures the coordination of the other control loops:
1. Production control loop: This covers the internal production
process (from the standpoint of the relevant concept user),
2. Customer control loop: This loop operates between the user and
his customer4. It is installed by the customer at the interface between
his own organization and the point of product use - i.e., further
installation, use as production material for the customer’s production
process or use by the end-customer),
3. Supplier control loop5: This loop is at the interface with the
company's suppliers and the associated supply chain,
4. Management control loop: This loop operates at a super-ordinate
level to monitor and regulate the inter-action of the three inner control
loops.

4
For a Tier 1 supplier the customer is the OEM. For a Tier "n" supplier the customer is the
system supplier. For the OEM the customer is the purchaser of the vehicle.
5
This supplier control loop must encompass the complete upstream supply chain.

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2.3 Link with VDA standard: "Maturity level assurance for new
parts"

The Robust Production Process deals with the production process after the
start of production (SOP, see also Chapter 2: "Overview of the complete
concept"). The essential pre-requisites for a successful production process
are created in the upstream production development process, that is, the
planning and Maturity Level Assurance process.

Fig. 2.3-1 Product development process as a fundamental


pre-requisite for the Robust Production Process

The VDA volume Maturity level assurance for new parts, describes the
procedure for the classification of new parts. This requires that all new parts
(A-parts) classified as having a high risk must be clearly defined, as in this
VDA volume. At the check-point an assessment of the check-lists must be
carried out with green lights.

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In the case of production transfers the procedures set out in Chapter 3.2.2
and in the "Production transfers" check-list (Appendix 7.2.1) must be carried
out.
Carry-over parts (COP6) are parts which have already been released for use
in another system or sub-product. The planned use of carry-over parts for a
new application must be assessed in the product development stage of these
new systems or sub-products and will result in a risk classification there
(Chapter 3.2.3).

New parts are handled in accordance with their classification in the maturity level
assurance process and within the individually agreed product development proces s.
Check-lists for this are included in the VDA volume "Maturity level assurance for new
parts"

MATURITY LEVEL OF NEW PARTS

High Maturity level assurance


maturity level risk to VDA standard
"A" part (round tables, action
management) inc. RPP
requirements

Medium
maturity level risk
"B" part Product development
Risk classification of
process to VDA or
new parts
Low customer specification
maturity level risk
"C" part

Fig. 2.3-2 Classification of new parts

For all additional new parts (B and C parts with lower risk classification), the
essential pre-requisites for a Robust Production Process must be
demonstrated in the check-lists used at the check-point, by means of the
measurement criteria identified with “x” in chapter 5 Standards in the Process
of the volume Maturity level assurance for new parts.

6
“Carry-over parts ... this refers to the use of physical parts and components in a cross-
platform manner. The “carry-over" concept enables development concepts of complete
modules, through to complete car bodies, to be used across different vehicle platforms. It
combines the recycling of knowledge of structures and references to product life-cycle
management. By using a “top-down” approach, design engineering and engineering
changes are carried through the process overall in the distributed product structure, with
configuration and workflow / life-cycle being based on an internet-based architecture.”
source: http://www.prostep.org/de/events/symposium2006/abstracts/.

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2.3.1 Classification using the "traffic lights" system

The VDA volume Maturity level assurance for new parts, describes an
assessment method using a "traffic lights" system (see Chapter 3.4.2). In the
following chapter a similar assessment system is proposed, in which the
individual traffic light colours are directed contextually more toward
production than is the case with the maturity level model.
In both VDA volumes the traffic light assessment takes place according to
the following illustration:

Fig. 2.3-3 Traffic light assessment methods

The final traffic light colours of the maturity level check-lists are applied as
initial evaluations when an assessment of the Robust Production Process is
made at the check-point (see also Chapter 4).

2.4 Illustrations, check-lists and examples

An expanded "8-W turtle" model is normally used for illustrating and the
analysis of processes (see also Fig. 2.4-1). This is a useful tool for the
analysis, examination and design of standards, manufacturing procedures,
etc.

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The two most important principles of the concept of a process7 should always
be taken into account here:

x A process “is a set of inter related or inter acting activities that use
inputs to deliver an intended result” (ISO 9000, Chapter 3.4.1).
x The output of a process forms the direct input for the next process.
Therefore, a process whose results do not represent the input for a
subsequent process is superfluous.

Figure 2.4-1 The "8-W turtle" model

7
Understanding and managing interrelated processes as a system contributes to the
organization's effectiveness and efficiency in achieving its intended results., can be called a
“process approach” [Source: ISO 9001, 0.3 Process Approach].

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The "best practice" experience of the authors and the organizations involved
has been used as a basis for the check-lists and examples provided. These
data do not claim to be comprehensive and merely represent minimum
requirements8, serving as descriptive examples. They are intended as an aid
when starting with the subject matter and must be adjusted to the respective
processes and conditions.

All planned regular activities in the Robust Production Process must to be


subjected to continuous improvement, for example by using the "PDCA"
method according to Deming (Plan-Do-Check-Act).

PLAN DO
• Set the objective and plan • Implement and carry out the
actions for the introduction/ planned processes
improvement of the process

ACT CHECK
• Process improvements, • Continuous monitoring of
corrections, adjustments to effectiveness and
the objective and actions on achievement of the
the basis of the results objective. Measurement
obtained during monitoring and analysis of metrics

Fig. 2.4-2 The "PDCA" cycle

8
Minimum requirements are the contents listed in the check-lists (Chapter 7.2) and the
contents of the ten standards forms in Chapter 5.1.

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In order to achieve such an improvement it is necessary to carry out
appropriate planning, to determine the objectives for a process (“Plan” in Fig.
2.4-2) and to draw up a description of the work-processes (see also the "8-
W" model in Fig. 2.4-1). The next step is to implement and carry out the work-
processes, recording this as necessary (“Do” in Fig. 2.4-2). The effectiveness
of the specified work-processes is checked (“Check” in Fig. 2.4-2) by
continuous monitoring of the process (see also Chapter 7.3.4) – preferably
by measuring with key data (see also “What effect” in the 8-W model) and
their analysis, based on the established objectives,. The results determined
in the monitoring serve as the basis for the planned process optimization and
are input for determining new objectives (“Act” in Fig. 2.4-2).

1 Market

4 Machinery 6 Management
5 Materials 7 Manpower
Customer, Supplier

Customer
Process

8 9 Method
Measurement

2 Main competition

3 Mother nature (environment)

Figure 2.4-3 Cause / effect analysis using the "9-M turtle" model
A cause / effect analysis of processes can be created by drawing up an
expanded Ishikawa diagram. This “9-M Model” is shown in the turtle model
in Fig. 2.4-3. The core of the model is the process under examination and
this is influenced by the nine influencing factors: Market, Main competition,
Mother nature (environment), Machinery, Materials, Management,
Manpower, Measurement and Method.

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3 Pre-requisites for a Robust Production Process

3.1 Corporate Culture

The living corporate culture is the basis for functionally-capable quality


management.

Some of the most important elements are:

x Culture of trust, handling successes and failures,


x Process orientation and increased quality,
x Failure prevention / avoidance,
x Sustainability,
x Continuous improvement.

Management is just as responsible as the individual employees for the


implementation and further development of a living corporate culture. The
corporate culture is the basis of the strategy and objective, and must be the
guiding theme for management.

3.1.1 Culture of trust, handling successes and failures

In the organization’s culture of trust:

x trust is placed in the abilities of those involved,


x other opinions are accepted and respected
x realistic deadlines are set, in order to deal realistically with time and
resources,
x mutual appreciation is conveyed,
x employees are integrated via
o transparency,
o communication,
o displays,
o employee bonding to the organization through medium and
long-term planning and development.

(See also Standards, Chapter 5.1 and also Chapter 5.1.5 covering
Communication, Reporting, and Escalation.)

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Successes should be:
x displayed, communicated and personalized,
x appreciated.
Factors for success should be:
x recognized and standardized,
x oriented by reference to the best.
When failures occur:
x every employee knows that s/he will get help immediately,
x detection of the failure will be accepted.

Raising awareness of possible deviations and information regarding possible


failures must be aided and analyzed, since every failure carries the potential
for improvement.

3.1.2 Process orientation and increased quality

Process orientation refers to the:


x avoidance of unnecessary processes which do not add value,
x universal use of key data, taking account of process inter-actions,
x assignment of costs to causes and consideration of influences which
may be brought to bear.

Increased quality results from:


x controls based on key quality data,
x the continuous improvement process,
x bonus or penalty systems,
x thinking and acting in closed control loops,
x methods for evaluating further fundamental quality principles, such
as orderliness, cleanliness, safety, etc. (e.g. 5S9, or Muda, Mura,
Muri).

See also Chapter 5.3: Monitoring & Controlling, Chapter 2.2: Control Loops
and Chapters 5.1 and 5.1.1)

9
5S comes from the Japanese: 1. Seiri = Sorting, 2. Seiton= Simplifying, 3. Seiso= Organizing,
4. Seiketsu = Keeping the work-place clean, 5. Shituske = Complying.

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3.1.3 Failure prevention / avoidance

The objective is to:

x avoid failures instead of detecting them,


x apply the principle of “zero-defects” as a leitmotif,
x make preventive process assurance10 the focus for avoiding failures,
x reserve adequate capacity for the planning phase,
x guarantee product design and process design which are quality-
capable and suitable for production.

See also Chapter 5.1: Basic standards for internal production processes,
Chapter 5.1.8: Standard 8: Problem-solving methods and Chapter 5.4:
Failure management.

3.1.4 Sustainability

Sustainability is the permanent elimination of defects while preventing


recurring defects; this means:

x that quality is a leadership task (motivating the team to think: “I want


to, I can, I am allowed to”; on-site presence),
x the involvement of all those concerned,
x defect-resistant processes (e.g. by applying Poka Yoke),
x assessing the appropriateness and effectiveness of processes

See also Chapter 5.1.3: Internal release procedure and Chapter 5.1.8:
Standard 8: Problem-solving methods.

10
Focus on prevention, rather than on the “heroism” of "fire-fighting actions” required as the
result of inadequate prevention and which involve excessive demands on resources:
“preventive fire protection” instead of “fire-fighting action”.

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3.1.5 Continuous improvement

The production process is continuously improved by:

x constant control11 and reducing the "scatter" of product


characteristics and technical production parameters,
x the involvement of personnel at all levels,
x taking all individual processes into account.

Here, the management assessment has an essential role because, as an


output, it determines decisions and actions for the further improvement of the
quality management system, the processes, the products and the demand
on resources.

See also Chapter 5.1.1: Standard 1: Control loops and IATF 16949 Chapter
10.3.

3.2 Product development and planning process

For a Robust Production Process the essential pre-requisites are already


planned and implemented in the production development and planning
process – that is, before the start of production. A Robust Production Process
distinguishes between the parts to be produced (see also Chapter 2.3):

x New parts, classified by an appropriate assessment of the


development and maturity level risk into A, B and C parts (see also
Chapter 3.2.1),
x Existing parts produced at a different location (see also Chapter
3.2.2),
x Carry-over parts (see also Chapter 3.2.3).

The essential pre-requisites for a Robust Production Process are specified


according to this differentiation and the degree to which they are achieved is
assessed at the check-point (see also Chapter 4).

11
Control includes the specified value, measurement of the actual value, recording the
measurement, carrying out analysis (e.g. SPC) and implementing corrective controls or
action.

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3.2.1 New Parts

No matter what their classification (A, B or C level), new parts must comply
with the pre-requisites for Robust Production Processes.

The classification of new parts is described in the VDA volume Maturity level
assurance for new parts, Chapter 2.2.1

3.2.1.1 "A" parts

New parts with a high maturity level risk (so-called "A" parts) are subject to
the complete range of the maturity level assurance method set out in the VDA
volume Maturity level assurance for new parts. Compliance with the maturity
level criteria at the maturity level milestones ML0 to ML7 simultaneously
ensures essential pre-requisites for Robust Production Processes.

For "A" parts, the maturity level traffic light is adopted as the initial
assessment at the check-point (see also Chapter 4).

3.2.1.2 "B" and "C" parts

New parts with a medium-level or low-level maturity risk (so-called "B" and
"C" parts) are handled within the framework of the standard product
development process set out in VDA volume 4, or in accordance with the
relevant customer specifications.

In order to demonstrate compliance with the pre-requisites for Robust


Production Processes, "B" and "C" parts must comply with a reduced set of
measurement variables from the maturity level check-lists. These
measurement variables are identified with an “x” in the “Maturity Level
Checklists” in Chapter 5.2 of the VDA volume Maturity level assurance for
new parts, in the column “Relevant for RPP”. The maturity level assessment
of these measuring variables is carried out as the initial assessment at the
check-point (see also Chapter 4). Proof of compliance is required for the
measurement variables.

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3.2.2 Parts from a new manufacturing location

If the production of parts is transferred to a different location, it must be


demonstrated that the parts from the different location also comply with the
pre-requisites for Robust Production Processes after the relocation.

It is necessary to determine whether the transfer of production is carried out:

x within one factory,


x between two factories in a single organisation,
x between two organisations.

As a general principle, parts manufactured at a different production location


must conform to the same pre-requisites as new parts for the Robust
Production Process. However, the degree of processing and the level of
validation will depend on how the relocation process is integrated in the
processes of the organisation carrying out the transfer and what
technological and logistics effects are associated with the relocation (e.g.
installation of a completely new production line, relocation of tools and / or
production facilities). An appropriate risk assessment and classification
similar to the risk assessment and classification for new parts (see also
Chapter 3.2.1) must be carried out for the relocation at the start of the project.

To comply with the pre-requisites for Robust Production Processes, the


check-lists for production transfers (Appendix 7.2.1) should be used.

3.2.3 Carry-over parts

The criteria which a carry-over part must meet are defined by the product in
which the part is to be incorporated (for a new application). The effects on
production (e.g. changes in quantity, logistics, etc.) must be examined,
assessed, and if necessary appropriate measures must be taken.

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3.3 Minimum requirements for the quality functions
of a production location

As a general rule, a production location must have an accredited


certification12 to IATF 16949 or VDA 6.1. In addition to proof of a quality
management system which complies with the relevant standards, a
production location must have implemented further quality functions. These
include minimum requirements regarding data access or information and
cooperation from the production location in important quality tasks. These
minimum requirements are set out in the check-list Minimum requirements
for quality functions at a production location (Appendix 7.2.2).

These minimum requirements go beyond the typical testing within a


certification operation and are often handled by a remote supporting
location13 such as the company's headquarters. The check-list can be drawn
on as support in the assessment at the checkpoint (see Chapter 4).

3.4 Logistics concept

A Robust Production Process requires an adequate logistics concept which


is coordinated within the supply chain. Storage and transport of the parts
have a direct influence on downstream processes and the quality of the parts.
The logistics concept must comply with the requirements laid down for the
specific product and customer, in terms of in-house handling, transport,
storage and packaging, as well transferring the product to the customer.
Minimum requirements are listed In the check-list Logistics concept
(Appendix 7.2.3).

3.5 Risk management – preventive failure management

Preventive and reactive failure management is necessary for the


implementation of a Robust Production Process. The focus is placed on the
preventive assessment and avoidance of risks. With the remaining risk, an
appropriate contingency planning with emergency plans and thresholds for
triggering are necessary. The procedure is described in chapter 5.4.

12
By an IATF certified certification organisation. The link is on the VDA-QMC homepage
under www.vda-qmc.de or direct at
https://www.iatfglobaloversight.org/certification-bodies/under-contract/.
13
See IATF 16949 chapter 3.1 support function

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4 Check-point

In the transition from the product development process to the production


process, checks can be carried out at the checkpoint to determine whether
the essential pre-requisites for a Robust Production Process have been met.
Through this, any potential for improvement can be seen. In carrying out the
checks, seven essential main criteria must be taken into account:

Fig. 4.0-1 Main criteria at the checkpoint

The main criteria are described in the chapters shown in Fig. 4.0-1. They are
individually assessed and displayed with traffic light colours. The traffic light
colours represent the following assessment levels (see also Fig. 2.3-3)

x Green: complies with pre-requisites for stable and Robust


Production Processes
x Yellow: requirements partially complied with and risks
safeguarded against (action plan, safeguarding)
x Red: requirements partially or not complied with and risks not
adequately safeguarded against (action plan and
safeguarding are absent or are not adequate)

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In Appendix 7.2.4 an example is given of an assessment matrix for the check-
point with the complete measuring criteria. The traffic light assessment is
carried out as described in chapter 2.3.1.

In the overall assessment carried out at the check-point, the so-called


"hurdle" principle applies:

x the worst assessment of a partial criterion determines the


assessment of the main criterion
x the worst assessment of a main criterion determines the complete
assessment of the checkpoint.

This means that all traffic lights must show green in order for the check-point
to be assessed as green. If an assessment has any yellow or red lights,
actions and securitisation must be specified and carried out for the relevant
criteria. Only when all criteria are assessed as green and the check-point
therefore receives a green traffic light assessment overall, are all pre-
requisites complied with, so that a Robust Production Process can be
implemented

In the ongoing production process, the main criteria of the check-point are
regularly re-assessed and are part of the cockpit within the framework of
monitoring and controlling (see also chapter 5.3).

In addition there are further pre-requisites for the Robust Production Process,
such as a living corporate culture with the corresponding leadership and
responsibility provided by management (see also chapter 3.1) and the
specification of processes and work processes in a management system.
However, these additional pre-requisites should be assessed predominantly
only indirectly as “soft facts” at a check-point and are reflected partially in the
seven listed main criteria.

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5 Standards for Robust Production Processes

The Robust Production Process can only be implemented if all pre-requisites


and requirements have been fulfilled and a continuous improvement process
takes place (see also Chapter 1.4: Guide-rails of the Robust Production
Process and Chapter 2: Overview of the complete concept). To implement
these pre-requisites, there are “adjustment levers” which are represented in
the "8-W" turtle model (see also Chapter 2.4) by the four legs:
x “Who does it?”: authorized person, assignee and supporter,
x “in What manner is it done?”: method, work procedure, standard,
x “With what is it done?”: resources, production facilities,
x “What is the effect?”: controlling, key data.
Essential adjustment levers are analogous to the influencing factors
identified in Chapter 1.3:
x The design of the product and the production process (taking
account of complexity, innovation and the product development
process for “robust” products which can be produced). See also
Chapters 1.3.1 and 3.2,
x Advance quality planning with the securitisation of possible risks
(FMEA, control plan, risk management). See also Chapters 3.2 and
5.4),
x Adequate numbers and qualifications of the employees. See also
Chapters 1.3.2 and 5.1,
x Implementation of a living corporate culture by a responsible
management. See also Chapters 1.3.2, 2.2 and 3.1),
x Reliable supply chain (secure supply of necessary purchased parts,
services and resources). See also Chapters 1.3.3 and 5.2,
x Use of proven standards in the loops for production control, customer
control and supplier control, e.g. for change management, control
loops, job descriptions, problem-solving processes, qualification,
release procedure, etc. See also Chapters 1.3.4 and 5.1)
x Controlling with key data and objectives in short, closed control
loops. See also Chapter 5.3.3).

Standards are an essential factor for ensuring Robust Production Processes.

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Fig. 5.0-1 Standards in production

The following chapters (5.1 to 5.4) explain essential minimum requirements


for internal production (Chapter 5.1), supplier management (Chapter 5.2),
controlling (Chapter 5.3) and the failure management (Chapter 5.4). When
implementing a Robust Production Process it is essential to ensure, in
addition to the standards, relevant regulations and descriptions are available
which contain the minimum requirements. Existing process descriptions,
procedural instructions and similar things can be consulted for this. In
practice they usually include more than merely the minimum requirements in
terms of the standards.
The standards must be adapted to the processes in question and must be
implemented in binding form. They must also subject to a continuous
improvement process.
The 8-W model (Fig. 2.4-1) is an appropriate tool to describe a process
standard completely (see also Chapter 2.4) or to analyse existing
documentation to ensure it is complete regarding all the contents required.
When entering into an already existing production process, a recording of the
current status can be made by using an entrance "cockpit" (see also Chapter
5.3.1). This current status is assessed on the basis of the objectives for this
production process. Detected non-conformances are analysed and serve as
a support for beginning systematic improvements.

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5.1 Basic standards for internal production processes

Standards must be defined in order to secure internal production processes.


These standards will cover, for example:

1. Control loops
2. Internal quality agreements
3. Release procedures
4. Employee qualification
5. Communication / reporting / escalation
6. Comprehensive equipment management, maintenance and
service
7. Risk management and contingency plan
8. Problem-solving methods
9. Job descriptions, standard worksheets
10. Change management
11. Project management
12. Continuous improvement process (CIP)
13. etc….

Standards must also be drawn up to an appropriate extent for further


production-related topics (such as health & safety at work, environmental
protection, etc). The following pages provide forms for some of the standards
listed above. These forms describe the minimum contents required. In
addition, the appendix provides examples of procedures which have been
proven in practice.

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Fig. 5.1-1 Elements of a standard covering "Job description and
standard worksheets”, analogous to the 8-W model

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5.1.1 Standard 1: Control loops for monitoring and measuring
the production process and products

1) Objective of the standard

Incident-free manufacturing of the products,

Fast and reliable measuring of the process for process control and
improvement,
Early detection of trends, disturbances and failures,
Complete and sustainable implementation of measures for process
stabilization,
Lessons learned in production, to be applied to comparable and new
projects.

2) Areas of application

Production location and all further applicable business processes.

3) Threshold criteria for the use of the process

Continuous.

4) Benefits

Systematic process assurance including continuous improvement (CIP),


clearly defined tasks and responsibilities.

5) Elements and contents of the standard

Process description:
A control loop system consists of many control loops and checks. These
must be linked to each other at one point.
Control loops are defined for product, process, supplier and customer.
They are subject to the PDCA system.
Managers personally support the elimination of problems and ensure
compliance with standards through regular on-site inspections.

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5.1.1 Continued:
Standard 1: Control loops for monitoring and measuring
the production process and products

Control loop 3 Control loop 4


Control loop 1, e.g. Control loop 2, e.g. Product
Product
Released by operator Released by section release pta
acceptance
to
by customer

Basic rules:

1. Failures must be avoided as a matter of principle (for example:


through Poka Yoke or design for manufacturing for product and
process).
2. If failures still occur, control loops must be provided for monitoring
and measuring the production process and products in order to
detect the failure as soon as possible.
3. The following must be included in the control plan and process cycle:
x Measuring technology
x Random sample plans
x Acceptance criteria
x Reaction plans.

6) Examples

Example: control loop in a process step as additional security

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5.1.1 Continued:
Standard 1: Control loops for monitoring and measuring
the production process and products

7) Key data

x Failure rate,
x Effectiveness of the control loop (can defects slip though?),
x Cycle time,
x First time run / directional stability / FPY (first pass yield),
x Internal failure costs / scrap / re-work,
x Warranty costs.

8) References

IATF 16949
9.1 Monitoring, measurement, analysis and evaluation.

Addition 1: Control loop in an individual process operation


Failure elimination process

Failure
e
Review elimination

Not OK

Process step 'n'


n' OK
K.

Production process

Addition 2: Detailing of process elements

An explanation is provided in Chapter 5.1.9: "Work-station description",


using the turtle example

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5.1.1 Continued:
Standard 1: Control loops for monitoring and measuring
the production process and products

Addition 3: Control loop in a process section


FEP
FEP trigger

FEP

FEP Section
ele
release

!
Process step 1 Process step 2 Process step 'n'

-
Failure origination Failure detection

Failure
Review elimination

Process step 1

FEP: Failure Elimination


ina
na Process

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5.1.2 Standard 2: Internal quality agreements

1) Objective of the standard

Agreement of measurable parameters / influencing factors / items


between internal partners to secure and increase process and product
quality.

2) Areas of application

Internal customers, internal suppliers, e.g. factory to factory, trade to


trade, maintenance area to maintenance area, etc.

3) Threshold criteria

In failure-critical processes, between complete production operations


(e.g. pressing plant to paint shop), if the customer’s requirements are
not complied with.

4) Benefits
The requirements of the internal customer become transparent.
Standards are agreed and compared.
Non-conformances can be measured better.
Coordinated control loops and targeted failure elimination.
5) Elements and contents of the standard

A quality agreement builds on the contents of the control plan with test /
inspection planning.
Contents of the quality agreement:
Description of the customer's requirement,
The corresponding control variables with tolerances and control limits,
Measuring method and measurement points,
Relevant responsible person on both sides,
Description of the communication flow,
Description of the escalation levels with control limits,
Reaction plan for non-conformances,
Rules for carrying out actions.

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5.1.2 Continued:
Standard 2: Internal quality agreements

Process cycle:
Universal requirements when drawing up an internal quality agreement:
x Who draws up the agreement? (generally the customer)
x Who monitors?
x How often are new agreements made? (dynamic tolerance
adjustment)

P D C A Execute A Review and


Coordinate the Conclude the Compliance with actions if non- adapt quality
quality agreement agreement regular conformances agreement;
contents bindingly occur; escalate create new
monitoring if necessary agreement
Contents:
x Description of x Coordinated x Responsible x Reaction plan x Dynamical
customer's agreement of management, x Escalation adjustment of
requirement objectives x Management stages tolerances,
x Control variables review x Rules for frequency of
with tolerances monitoring new agreement
& control limits actions
x Measuring
method and
measurement
points
x Relevant
responsible
person on both
sides
x Communication
flow
x Escalation levels
with control limits
x Reaction plan for
non-conforman-
ces
x Rules for carrying
out actions

Responsibility
esponsibility:
x Who draws up
x Who monitors x Rules for
the agreement?
(e.g. QM) carrying out
(generally the
actions
customer)

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5.1.2 Continued:
Standard 2: Internal Quality Agreements

6) Examples

OEM Internal quality agreement form.

7) Key data

x Number of control limit over-runs per time unit (trend tracking),


x Result of internal process audit.

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5.1.3 Standard 3: Internal release procedure (product & process)

1) Objective of the standard

Securing the quality of the product and process for new starts, restarts
and changes.

2) Area of application

Production.

3) Threshold criteria for the use of the process

New starts, restarts and changes to the product and/or process.

4) Benefits

Quality risks are detected and safeguarded against.


Confirmation and proof of conformance with the requirements.

5) Elements and contents of the standard

Check-list with the relevant current/valid contents to check that:


Product:
x specifications have been complied with
x the customer's requirements have been fulfilled
x legal requirements have been complied with
x testing has been successfully carried out
x individual components and materials have been released
x manufacturing feasibility has been demonstrated
x etc…
Process:
As a general principle:
The necessary personnel in production must be available, qualified and,
depending on the work-place, trained regarding the following:
x Control plan has been created and is current & complete,
x The test concept (characteristics, severity of testing, capable test
equipment, test facilities) is available

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5.1.3 Continued:
Standard 3: Internal release procedure (product & process)

x Process parameters have been determined with tolerances and


control limits and are monitored
x Control loops have been defined,
x Special characteristics (safety, risk parts, critical parts, process
parameters, etc.) have been documented. Appropriate processes
have been implemented and are capable (proof of capability -
short-term capability - is available) or have been adequately
assured (e.g. Poka Yoke, 100% test, etc.),
x Standard work-sheets are available,
x Paths, work-sequences, and the flow of material and parts correspond
with requirements,
x Necessary load carriers have been released and are available,
x Machines, equipment and tools are to full production level,
x Technical release has been carried out,
x Production equipment and supplies have been released,
x Preventive maintenance has been determined and assessed
(effectiveness, etc.)
x Key data and target values have been determined (e.g. for quality,
performance, costs, personnel, etc.),
x Launches have been secured for new starts and restarts (in full
production and phase-out phase),
x Contingency plans are available
x Planning for proof of long-term capability and output capability,
x etc….

The release is confirmed and documented on site (not merely document


release).

6) Examples

Supplier quality evaluation


OEM process release (output, check-list, and action sheet).

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5.1.3 Continued:
Standard 3: Internal release procedure (product & process)

7) Key data
x Deviations from the target values of the quality planning:
e.g. regarding reworking, scrap, product defects
x Number of changes in the start-up.

8) References

x IATF 16949
8.3.4.4 Product approval process
x VDA volume 2 - Production Process and Product Approval (PPA).
x Change management standard.

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5.1.4 Standard 4: Employee qualification

1) Objective of the standard

To enable employees at all levels to carry out correctly the tasks given to
them.

2) Area of application

All sectors and levels of responsibility in the organization.

3) Threshold criteria

Non-fulfilment of the requirements matrix, results of work are inadequate


due to insufficient qualification Planned requalification on a preventive
basis.

4) Benefits

Improvement of the start of work and work safety.


Reduction of internal and external quality costs (e.g. scrap, rework, etc).
Strengthening of the robust process.

5) Elements and contents of the standard

x Planning to cover work-station, tasks and role-related qualifications,


x Prepare requirement matrix,
x Target/actual value comparison,
x Determine and schedule qualification requirements, including
arrangements for deputies,
x Determine and provide resources.
Responsible: supervisor.
x Carrying out of the employee qualification with regard to the finished
product and to practical anchoring by:
x theoretical training,
x Workshops,
x practical training (e.g. learning "islands", test line, training
workshop, etc).

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5.1.4 Continued:
Standard 4: Employee qualification

x Assessment and proof of effectiveness by:


x Testing with certification,
x Comparison / assessment of work results (check against targets).
Responsible: manager.
x Regular review of requirement-related qualification,
if necessary rescheduling. Responsible: manager.

P D C Evaluate the A
Carry out review
Plan the Carry out the success; Compare actual
qualifications qualification work demonstrate with
effectiveness requirement
Content
• Requirements matrix • Theoretical training • Test with • Regular review of
certification demand-related
• Compare actual with qualifications
• Workshops
requirements
• Compare
Suppliers Monitoring and
/evaluate results • New planning if
• Specify & plan • Practical training
management ofcontrolling
work (in relation required
needs, inc. (learning island, test
lines, trainee to the target)
deputising rules
workshop areas)

Responsibility:
C t t l
• Managers • Managers • Managers

6) Examples

Supplier qualification matrix


OEM qualification and authorization matrix.

7) Key data

x Degree of fulfilment of the qualification matrix targets,


x Level of improvement of work results, e.g. reduced rework / scrap.
In the case of black belts: saving volumes, etc.

8) References

x ISO 9001
7.1.2 People

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5.1.5 Standard 5: Communication, reporting, escalation

1) Objective of the standard

Quicker and more secure exchange of information. Transparency in


detecting trends for indicators and key data.

2) Area of application

All sectors, levels of responsibility and business processes in the


organization.

3) Threshold criteria

Regular communication and reporting, taking communication levels into


consideration.

Specific threshold criteria and/or control limits must be determined to


cover escalation.
For example:
x Severity of failure,
x Number of failures,
x Frequency of failures,
x Failure elimination time, etc.

4) Benefits

Early detection of trends.


Prompt decision-making and addressing of tasks (process control) to
secure the process.

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5.1.5 Continued:
Standard 5: Communication, reporting, escalation

5) Elements and contents of the standard

Specified communication and escalation structure (language, media,


and tools) across all levels and interfaces; adapted to the organization,
in order to assure the necessary flow of information.

Participants are specified (including their accessibility), as are the


authority to make decisions, key data and frequency (dynamic
adjustment).
Reports are made with standardized illustrations, e.g. forms, score-cards,
graphic processes, cockpit charts, etc.
The effectiveness of the actions implemented is also monitored (closing
the control loop) in regular communication meetings.
Appropriate key data must be continuously displayed and made
accessible (notice boards, monitor screens) to inform employees:
this information will cover the internal and external quality situation,
availability of resources, productivity, etc.
Regular reviews of the reporting and communication system.

6) Examples

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5.1.5 Continued:
Standard 5: Communication, reporting, escalation

Regular communication and standardized reports across the hierarchical


levels:
x on the status of the production process, e.g. productivity (directional
stability, availability of machines, etc), failure rates, main sources of
failures, etc.
x on key issues with development departments / planning departments/
outside organizations: e.g. aggregated key data (see above), project-
specific key data, etc.
Practical examples:
Supplier action plan,
Supplier ppm failure rate reporting.
Monitoring of OEM escalation.

7) Key data

Reliability of delivery of standard reports.

8) References

x ISO 9001
7.4 Communication

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5.1.6 Standard 6: Comprehensive equipment management /
maintenance / service

1) Objective of the standard

To improve the complete effectiveness of the production facilities through


the active participation of all employees.
To increase of the availability of facilities and provide preventive
assurance of the quality of product and process.
To achieve optimized machine scheduling through intensified
cooperation between planning, maintenance and production.

2) Area of application

All production processes as well as supporting technical processes.

3) Threshold criteria

Regular intervals (planned),


Exceeding of the control limits and tolerance limits (unplanned),
Number of defects,
The decrease in availability controls the intervals.

4) Benefits

Avoidance or reduction of:


x down times and minor disturbances/failures,
x adjustment work and setting parts,
x extended cycle time.
Improvements in:
x machine life,
x cleanliness and safety of the production equipment,
x availability,
x compliance with quality requirements,
x active integration of the staff,
x setting-up times and tool change times.

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5.1.6 Continued:
Standard 6: Comprehensive equipment management /
maintenance / service

5) Elements and contents of the standard

Production operators are trained in defined areas of maintenance and


closely integrated (production operators / machine operators and
maintenance personnel).
1. Cleaning, service and maintenance plans (schedules, check-lists)
are drawn up, taking account of the experience of machine
manufacturers, operators and maintenance personnel (see 4),
2. The causes of problems with facilities and defects are used to
achieve improvements in the machines,
3. Standards are laid down to reduce problems with the facilities
and to ensure regular maintenance,
4. Preventive integration into service and machine planning.

Plan Do

• Cleaning plan Carry out


utt m
maintenance according to
• Servicing plan sp ed plan
specified p and standard.
• Maintenance plan
• Planning must take account
oun
u of the
ex p
experience of
… machine manufacturers
… operators
p
… maintenance personnel

Act Check

• Determine the deviation from target


• Specify
p y measures
su for improvement
m • Monitor
Mo
on the equipment
nt parameters
ete
• Analyse
Anallys the causes off facility
fa disturbances/
ur
failures
ailurre

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5.1.6 Continued:
Standard 6: Comprehensive equipment management /
maintenance / service

6) Examples

Supplier's TPM 6-step description,


Supplier's TPM inspection plan,
Supplier's robot maintenance.

7) Key data

x Overall Equipment Effectiveness (OEE),


x Setting-up times,
x Planned and unplanned maintenance costs (total) / availability in
hours,
x Maintenance costs / replacement value of the equipment
x Output = first pass yield (course),
x Unplanned / planned shutdowns,
x TPM audit.

8) References

x IATF 16949
8.5.1.5 Total productive maintenance (TPM)

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5.1.7 Standard 7: Risk management / contingency plan

1) Objective of the standard

To avoid problems by carrying out preventive assessment of influencing


factors and disturbances/failures in the planning process.
To determine and implement remedial action and prepare contingency
plans for SOP.
To contain the effects of disturbances/failures.
To contain and eliminate disturbances/failures and their effect, quickly,
systematically and in a targeted manner.
(Definition: a disturbance/fault is an influencing factor which runs outside
the planned tolerance and has a negative influence on the capability of
the production process).

2) Area of application

Production (location, product, process).

3) Threshold criteria

Planning of new products, processes, locations,


Process release (SOP, restart),
Occurrence and review of disturbances/failures in the production process.

4) Benefits

Preventive securitisation of delivery performance and quality.

5) Elements and contents of the standard

Assessment of risks with a check-list of influencing factors

A contingency plan for influencing factors having a high risk assessment


must contain the following:
x The influencing factor / disturbance/fault.
x Control limits and tolerances.
x Responsible person (name, availability / phone, deputies [at two
levels]).
x Where must the plan be held and who must be aware of it?

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5.1.7 Continued:
Standard 7: Risk management / contingency plan

x Immediate actions (“first aid”, containment, damage containment) and


contingency concept (where necessary with escalation levels, e.g.
regarding local, regional and global disturbances/failures).
x Duty to inform: who must be informed, when and in what way,
about what (authorities, customer, insurances, public, media, etc).
x Action to ensure emergency operation.
x Controlled restart after the incident is eliminated.
x How the elimination of the disturbance/fault is confirmed (who is
responsible)?
x Review and documentation.

6) Examples

Check-list covering influencing factors,


OEM's risk filter process,
OEM's quality reaction plan,
Flow-chart covering suppliers in an emergency.

7) Key data

x Number of disturbances/failures,
x Duration of the disturbance/fault (from the beginning until confirmation
of the elimination),
x Supply performance,
x Failure rates,
x Severity (of damage) and regional relationship of the
disturbance/fault,
x Internal and external failure costs which can be traced back to
disturbance/fault,
x Are contingency plans up-to-date? (assessment from reviews).

8) References

x IATF 16949
6.1.2.3 Contingency plans

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5.1.8 Standard 8: Problem-solving methods

1) Objective of the standard

Rapid, complete and permanent elimination of problems / failures;


avoidance in production in the future (e.g. in the successor-product,
variants, etc.) through "lessons learned".

2) Area of application

Production.

3) Threshold criteria

N-times occurrence of the failure.

4) Benefits

Systematic analysis and thereby the permanent elimination of the failure.

5) Elements and contents of the standard

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5.1.8 Continued:
Standard 8: Problem-solving methods

6) Examples

OEM's problem-solving sheet,


Supplier's problem-solving sheet .

7) Key data

x Time from when the failure is reported, to the introduction of


immediate actions,
x Percentage of recurring failures to total failures.

8) References

x IATF 16949
10.2 Nonconformity and Corrective actions
8.7.1.2 Control of nonconforming products,
x Standard control loops.

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5.1.9 Standard 9: Work-station description; standard work-sheets

1) Objective of the standard

To secure the quality of the product and process by the obligatory


specification of a standardized work-sequence.

2) Area of application

Production.

3) Threshold criteria

Fundamental.

4) Benefits

An optimum work-sequence is documented and is traceable for managers


and employees. The risk of failures is reduced and efficient completion is
ensured.

5) Elements and contents of the standard

Use, for example, for:


x Operating procedures and their sequences,
x References to tools,
x Materials,
x Special characteristics
x etc.

Contents:
x Who must perform the task? (Q-matrix, assignment = authority, etc).
The following steps must be detailed, depending on the established
minimum qualifications:
x What do I have to do? (work-content)
x When must I do it? (time-scheduling, e.g. random sampling,
maintenance)
x With what? (work material, e.g. hardware, software, methods)

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5.1.9 Continued:
Standard 9: Work-station description; standard work-sheets

x How must I do it? (sequence of work operations, use of tools, etc)


x Why must I do it? (risk if the requirement is not met, the target, the
reason, and the relation to other tasks)
x How do I know that I have correctly conducted my work step?
(OK characteristics)
Descriptions and displays
As much content as possible should be conveyed with pictures, as little as
possible with text,
Employees are involved in the preparation and optimization of standards
(managerial function)!

6) Examples

OEM's work-sequence sheets,


OEM's forms for work-sequences,
OEM's standard work-sheet for bench drilling machines.

7) Key data

x Number of standardized work-sequences


(target: 100% of the necessary standards),
x Percentage of deviations from the standard (e.g. audits, 8D, etc),
x Work-station related failure,
x Scrap, rework.

8) References

IATF 16949 Chapter 8.5.1.2 Standardised work - operator instructions.

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5.1.10 Standard 10: Change management

1) Objective of the standard

To secure the quality of product and process where changes are made,
to ensure no failures due to changes.

2) Area of application

Production, development, supplier, logistics, sales, quality, service,


purchasing, etc.

3) Threshold criteria
In case of changes to:
Personnel, location, specification, production, test and inspection
processes, logistics, suppliers, production capacity, product software,
change of sub-supplier (process compliance is mandatory).

4) Benefits

Quality risks are detected and avoided or secured by additional measures.

5) Elements and contents of the standard

Customer ISIR, PPPR


Customer release
agreement customer
ISIR / PPA release
Customer involvement

Proposal, Substantiation, Processing/ Implement-


trigger planning validation ation

Pre-filter, Verification and Assessment Production


e.g. the proposer release and release release
or technical team
leader Approval

Supplier involvement

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5.1.10 Continued:
Standard 10: Change management

Explanation of the elements and contents:

Proposer, trigger:
For example:
x Failure elimination measures
x Customer request or requirement (technical requirements;
IATF 16949, chapter 8.3.6.1)
x Cost reduction
x CIP, improvement suggestion
x Innovation
x Legal or regulatory requirements
x Increase in capacity
x Second supplier, supplier changes
x etc…
Pre-filter:
x Initial assessment of opportunities and risks
x Determine urgency

Substantiation, planning
x Risk examination (internal / customer / supplier)
Does the change have a risk in terms of the product (function;
reliability; appearance; noise; life expectancy) or the process
(capability; manufacturing feasibility, etc.)?
x Risk assurance planning (internal / customer / supplier)
The risk assurance plan includes:
Quality reliability tests, requalification, testing based on FMEA results
or experience, or FTA, etc, preventive quality assurance at the
suppliers' premises (see VDA volume Maturity level assurance),
Quality assurance of the ramp-up after introduction (e.g. additional
tests, proof of capability, etc.)

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5.1.10 Continued:
Standard 10: Change management

x Planning of timings, resources and costs for processing / validation /


implementation,
x Check whether, how & when customer involvement is to take place,
x Contextual detailing of the change,
x Determine which customers, technical departments, factories and
suppliers are affected.
Verification and release:
x Timing plan and quality assurance plan are available.
x Decision on customer involvement (whether, how, when).
x Bundling with other changes possible?
x Procedure with long-running products.
x Decision on whether to continue or stop work.
x Release the budget and resources.
Processing / validation:
x Preparation of samples / prototypes
x Product, process and testing validation
x Making documents available
Assessment and release:
x “OK” test has been provided
x All technical departments affected have been involved.
x Decision on whether to continue or stop work
x Quality improvement or at least maintaining previous quality level
Customer agreement:
x Declaration of consent to carry out change,
x If necessary, formulate further customer requirements
Implementation:
x Set-up full production process and securitisation
(e.g. capability, test / inspection planning, etc),
x If necessary 0-series, production approval according to planning
(e.g. 2DP),
x Preparation and test of initial samples.

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5.1.10 Continued:
Standard 10: Change management

Customer release ISIR, PPA / production release:


x Approved initial sample test report,
x Product satisfies quality requirements; process is capable.
Recommendations:
x Changes (releases) to be bundled on a time-basis,
x One responsible person for the complete procedure,
x Keep the scope and number of changes as low as possible.

6) Examples

OEM release planning,


Supplier change request form.

7) Key data

x Quality increase after change (e.g. 6 months after introduction),


x Processing time of the change in total and also in sub-steps
(e.g. time from first enquiry to the customer presentation, etc.),
x Number of disturbances/failures after change,
x Pareto cause of change (e.g. development, production, customer,
supplier, etc.),
x Recommended key data for the product,
x Change frequency per product after SOP (first 2 years),
x Course of the total number of changes per factory/product.

8) References

x IATF 16949
8.5.6.1 Control of changes - supplemental
8.3.6.1 Design and development changes,
x VDA volume 2 - Production Process and Product Approval (PPA)

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5.2 Supplier management

Suppliers of production material and services which influence quality have a


crucial influence on the Robust Production Process. Like every other
influencing factor, this has to be continuously planned, assessed, monitored
and controlled (see also Chapters 1.3 and 5.4). The supplier control loop is
therefore part of the overall concept of a Robust Production Process (see
also chapter 2.1).

Compared with the stipulations in VDA volume 2 Quality Assurance for


Supplies, additional requirements and pre-requisites in the field of supplier
management are necessary in the following areas for the implementation of
a Robust Production Process:

x Supplier selection (Chapter 5.2.1),


x Contract validation, quality assurance agreement and logistics
agreement (Chapter 5.2.2),
x Involvement of new suppliers (Chapter 5.2.3),
x Monitoring the quality of deliveries (Chapter 5.2.4),
x Escalation management (Chapter 5.2.5),
x Communication and cooperation (Chapter 5.2.6),
x Transfer to the complete supply chain (Chapter 5.2.7).

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5.2.1 Supplier selection

The objective of the supplier selection process must be to achieve to the


greatest possible degree the requirements laid down by the technical
departments14 involved (see Fig. 5.2.1-2). In order to ensure this, the
following measures must be taken:
x Before a quotation is submitted, it must be ensured that the supplier
knows the requirements regarding the product and the processes, so
that these can be taken into account in calculating the quotation (e.g.
the quotation should be submitted only after downloading the
guidelines, standards, etc; proof of participation in training courses
on the contents of the legal agreements, customer-specific
requirements, customer portals, etc).
x For suppliers already known, the current supplier assessment must
be taken into account (see also Fig. 5.2.1-1).

Fig. 5.2.1-1 Examples of key data for a supplier assessment

14
E.g. purchasing, quality, logistics, development, production.

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x The general and product-specific capability15 of new suppliers must
be checked and assessed regarding the requirements of all the
technical departments involved. With known suppliers, the existing
supplier assessment can be used if the performance of the supplier
complies with the requirements provided for a fresh award.
x The supplier's pre-requisites for the implementation of a Robust
Production Process must be checked as early as possible in the
awarding process, for example by using the check-list criteria (see
also Chapter 4).
x The technical departments involved should have the power of veto
in the inter-disciplinary selection of suppliers and subsequent
awarding of contracts.

2
Project personnel from:
4 • Purchasing
• Supplier assessment tool • Quality
• Technology-specific check-lists • Logistics
• Check-lists used at the check-point • Development
for Robust Production Processes • Production
5
Best possible achievement of
the requirements profile 1 8
List of suppliers
6 Supplier
approved to
selection
Release of part- receive
sections contracts

7 Key performance data from: 3


• Supplier evaluation for existing
• Purchasing
suppliers
• Quality
• Assessment of product-specific
• Logistics
capability
• Development
• Observe the pre-requisites for
• Production
Robust Production Processes
Compilation of the suppliers'
portfolios

Fig. 5.2.1-2 Supplier selection

15
Capability to produce a certain product or a product group/part family; for the definition of
capability, see ISO 9000 chapter 3.6.12.

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5.2.2 Contract validation, quality assurance & logistics agreement

When awarding a contract, a comprehensive contractual regulation of the


business relationship is of primary importance in order to avoid ambiguities
between the contracting parties. Essential requirements to secure the Robust
Production Process in the contract are contained in the quality assurance
and logistic agreement check-list (Appendix 7.2.5). These requirements must
be integrated in the contract documents, e.g. in purchasing conditions, quality
assurance agreements, agreements on objectives, etc. The check-list can be
used to check that existing contracts are comprehensive. In the upstream
supply chain, the requirements must also be known and contractually
secured.
Furthermore, responsibilities and persons responsible for matters such as
development, production, quality assurance and logistics, should be
determined in the contract phase.
5.2.3 Involvement of new suppliers

As already mentioned in Chapter 5.2.1: "Supplier selection" new suppliers


must be comprehensively assessed and informed of the requirements
involved. To further minimize the risk due to the new, previously unknown
business partner16, a comprehensive risk analysis should be carried out.
Additional safeguarding actions with new suppliers have proven themselves
in practice, such as:
x training on customer-specific requirements (e.g. quality guidelines,
requirements regarding quality management, customer-specific
methods of handling projects, etc),
x the awarding of trial orders, orders for part of the total demand and
restriction to a maximum number of projects in a fixed time period, in
order to gain initial experience with the supplier.
Increased controlling of these suppliers must be maintained up to and into
the production phase. New suppliers should be recognizable as such and
monitored more closely. If necessary, a quick and targeted securitisation of
the project should be feasible, e.g. with the development department and the
support of the new supplier.

16
Attention should also be paid to known suppliers if they apply for the awarding of a new
technology or a product group not previously delivered.

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5.2.4 Monitoring the quality of deliveries

When deliveries for full production begin, the supplier must have been
assessed at the check-point with a green light for the pre-requisites involved
(see also Chapter 4). If the result of the assessment is a yellow or red light,
the procedure is as described at the check-point.

Thereafter, a control system must be in place to monitor delivery quality on


an event-oriented basis, to ensure the quality of the parts delivered. Above
and beyond the delivery quality, this control system must integrate data and
information from the field (e.g., breakdowns, customer complaints, etc). The
monitoring (see also Fig. 5.2.4-1) must be regulated in such a way that
preventive and corrective actions17 can be deployed as early as possible.
This must be ensured via warning mechanisms through quickly closed
control loops with appropriate warning limits (see also Standard Control
Loops).

Fig. 5.2.4-1 Monitoring the quality of deliveries

17
See ISO 9000 Chapters 3.12.1 and 3.12.2

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Data and information should be handled in a company-wide, central data
recording and assessment system, in order to ascertain a complete picture
of the delivery quality (as part of the supplier assessment), and in order to be
able to react company-wide if the warning limits are exceeded. These
systems must make the relevant data available to the supplier as quickly as
possible.

The warning mechanisms must be aligned with the escalation management


so that they can quickly become active.

5.2.5 Escalation management

The objective of escalation management is to achieve the rapid and


sustainable elimination of failures and problem-solving. As the basis of
escalation management, measurement criteria and threshold values must be
established and must be made known to the supplier. The criteria used for
the supplier assessment are suitable as measuring criteria, since these are
known by both sides. The associated threshold values should, for example,
be recorded in the target agreement with the supplier.

In order to use the escalation system as early as possible, it is recommended


that the threshold values be divided into warning, action and tolerance limits,
based on statistical process monitoring and control. In this way, the
expenditure of time and effort can be kept low at the beginning of a problem.
The escalation starts, for example, with a message to the supplier, asking for
defect elimination actions to be introduced. This message is sent to the
person in charge at the customer’s within a defined time period.

As well as the measurement criteria and the threshold values, the following
must be defined in advance:
x Escalation stages,
x Actions which the customer demands or can take himself,
x Consequences for the supplier.
An example of monitoring an escalation is shown in the Appendix.

In the ongoing escalation process, the listed items must be set out in detail,
for example in talks with the supplier. In addition to specifying precisely the
actions and the consequences, this will include, for example, the defining of
time periods until the next decision-making meeting and the naming of
persons responsible at the supplier and the customer.
Each escalation management system should also include a defined de-

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escalation, in order to return to the desired “normal state”, i.e. to the Robust
Production Process. The de-escalation can take place when evidence has
been provided of the successful and sustainable elimination of the problem
and this evidence has been accepted by the customer, as well as when the
process can be classified as robust.

In principle, the following can be said for both escalation and de-escalation:
x Escalation is initiated and tracked by the responsible specialists of
the customer.
x The escalation model should be dynamic and, depending on the
severity of the failure, for example, allow individual escalation steps
to be skipped.
x The escalation process should also be traceable for the suppliers.
x The supplier must be informed of the classification in the escalation
model (for example, in writing).
x Deadlines must be defined for the duration of the established
escalation steps, actions and re-assessments.

The effectiveness of the complete escalation management system can be


measured, for example, by:
x The average duration of the period, in which the suppliers are in the
escalation process,
x the number of suppliers de-escalated to normal conditions,
compared with the number of escalated suppliers.

5.2.6 Communication and cooperation

The following points should be observed in order to achieve the best possible
communication and cooperation with the supplier:
x Contact persons on both sides must be clearly defined and declared
(consider the "one-face-to-supplier" principle). This can be, for
example, via a data-base made accessible to the supplier, in which
the supplier can maintain current contact data.
x The earliest possible integration18 of the supplier and the internal
technical departments responsible for the supplier and/or the parts,
as early as the product development phase (see also the volume
Maturity level assurance for new parts).

18
Depending on the component and the supplier’s share of development.

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x The customer’s requirements19 must be available to the supplier and
must be assessed in the course of the quotation preparation with
regard to feasibility. When awarding a contract, it must be assured
that the supplier complies with the customer’s requirements.
x In the contractual relationship, agreement must be reached on how
changes or newly added requirements (e.g. in the component
specifications, the test criteria, the quality guidelines, etc.) are
implemented in the supply chain.
x The requirements must be implemented in the supply chain. For this,
securitisation of sub-supplier management must be contractually
agreed with the supplier (e.g. transfer of specifications, rules of
access, etc).
x In the supplier assessment, account must be taken of the capability
assessments and performance assessments carried out by
purchasing, logistics, quality assurance, development and
production.
x The supplier must have access to the result of the supplier
assessment. It is useful to indicate to the supplier how he stands in
comparison with other competitors. Without being able to see any
names, the supplier should be able to access the most important
data from the supplier assessments for the ten best suppliers in a
product family or product type, for example, in order to motivate
himself through an overview of the market situation.

The supplier must have an incentive to improve quality: because


quality must pay off! The incentives can be, for example:
o long-term contracts (ideally: supply for the entire life-cycle of
the product),
o preferred awarding of contracts
o long-term cooperation.

19
Special attention should be paid to component specifications and associated test criteria.

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5.2.7 Transfer to the complete supply chain

The robustness of a production process is safeguarded or threatened not


only by the direct supplier but by the entire supply chain. In the future,
therefore, increased transparency in the supply chain must be the goal, in
order to achieve a better overview of the opportunities and risks in the
production and supply processes.

This transparency can be achieved by demanding and implementing the


systematic and continuous recording of sub-suppliers, even if the direct
contractual relationship exists only between the supplier and the customer.

Sub-suppliers should be preferably made known by name when a quotation


is submitted and, at latest, when initial samples are submitted. Sub-supplier
management must guarantee the customer’s requirements. Comprehensive
data recording, with linking to the respective products is necessary to cover
the administration and monitoring of sub-suppliers. For this, in future,
requirements will arise regarding the appropriate systems and tools used in
supplier management.

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5.3 Monitoring & controlling

As a general principle, important process parameters must at least be


monitored and recorded, and suitable measures must be taken if these
parameters are not complied with (for example, in the case of a production
process dependent on temperature and humidity and if the shop floor is not
air-conditioned, monitoring of the parameters should include a warning
system which will stop the process if the warning limits are exceeded and
identify clearly the parts affected).
The definition of measurement variables, key data and the measurement,
supervision and control of the control loops (see also Chapters 5.3.3 and
5.1.1) apply to the pre-requisites and also to the operation and control of the
production process in the supply chain.
To date it has not been possible to define conclusively the robustness of a
production process with a single key measurable or several measurement
variables, similar to the way capability indices for the assessment of
processes are defined using SPC. In this present volume it is possible to list
only the essential pre-requisites required in order to be able to implement this
kind of required robustness (see also "guide rails" and definitions of the
Robust Production Process in Chapter 1.4).
The key data listed in Chapter 5.3.1: "Key Data Cockpit" can therefore
represent in total only a dimension for a possible robustness, and the
individual key data serve only as an indicator. They do not assert a claim to
completeness.

5.3.1 Key data cockpit

Establishing key data and measuring criteria forms the pre-requisite for
detecting deviations from targets in production processes. For this reason, in
the early planning of a Robust Production Process it is necessary to define a
set of key data and measurement criteria (with the associated tolerances and
control limits) which will be appropriate in each individual case to provide
information on the current status of the production process. Meaningful key
data and measurement variables, customized to the individual production
process, must be selected, planned and recorded.
In the key data matrix check-list (see Appendix 7.2.6), a number of proven
key data and measurement criteria are suggested, from which the operator
of a production process can make a selection. Here the stati of the pre-
requisites for Robust Production Processes are taken into consideration as
measurement criteria.

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The example of a cockpit in Appendix 7.2.7 is divided into four main groups:

x Pre-requisites,
x Process quality,
x Resources,
x Personnel.

The illustration differentiates between the supplier, internal production


process and customer-relevant key data. The worst single rating of the
individual criteria determines the overall rating.

Using the key data, the rating is determined as follows (see also Chapter
2.3.1: Classification using the traffic lights system):

x A result within the warning limits corresponds to “green”,


x A result between warning limit and objective corresponds to “yellow”,
i.e., initial actions must be introduced to bring the process back into
the green area,
x A result outside the warning zones corresponds to “red”, i.e. the
process is probably not robust and product quality is possibly not
secured.

For an evaluation and/or visualization of the robustness of the immediate


production process (e.g. machine or group of machines), a reduced depiction
can be used, as in the mini-cockpit shown in Appendix 7.2.8.
If non-conformances are detected the process owner must select suitable
"adjustment levers" (see also Adjustment Levers in Chapter 5) and introduce,
track and document appropriate elimination actions.

Explanations of the key data used in these two examples are given in the
above-mentioned key data matrix check-list (see Appendix 7.2.6).

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5.3.2 Communication, display, reporting

A coordinated reporting system must exist at all points in the production


process in order to make available the information needed for essential
interventions, decisions and escalation. Features required are:

x agreed communication interfaces and tools,


x target groups for the reporting,
x the contents of the reporting by target group,
x reporting frequency and formats (display).

Details of this are shown in the standard: "Communication, reporting, and


escalation". Examples showing the display of key data in production are set
out in Appendix 7.3.4.3.

5.3.3 Control loops

The four essential control loops of the production (production, customer,


supplier and management control loops) have already been set out in
Chapter 2.1. Their regulation is carried out using the specific key data defined
for each control loop (see also Chapter 5.3.1). Control loops must be defined
and, if necessary, broken down into individual process operations so that
they are self-contained, summarize critical process elements as briefly as
possible, detect non-conformances quickly and allow for quick reaction.
Details of this are described in the standard: "Control Loops" (see also
Chapter 5.1.1: "Standard 1: Control loops").

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5.3.4 Requalification20

For the Robust Production Process, in addition to the release tests (see also
VDA volume Maturity level assurance for new parts and check-point) and in-
production routine tests and product audits, it is necessary to carry out an
appropriate and regular requalification of the bought-in parts and products
manufactured in-house. This must be implemented in the sense of periodical
inspections (to VDA 6.1 in 11.5 and 15.6) and the IATF 16949 requirement:

A layout inspection and a functional verification to applicable


customer engineering material and performance standards shall
be performed for each product as specified in the control plans.
Results shall be available for customer review.
Note: Layout inspection is the complete measurement of all
product dimensions shown on the design records.
(IATF 16949, Chapter 8.6.2)

For this, the following must be contractually regulated with the customer:

x The frequency and occurrence (when must an inspection be carried


out: e.g. every 12 months or the event of complaints or problems),
x Scope (what is to be inspected),
x Documentation,
x Procedure and methods for the requalification inspection.

The requalification inspections are planned in the course of the product


development process and are included in the control plan. For the
requalification, data from current product monitoring, product audits and from
new and resampling submissions can be drawn on.

The control plan derived from the FMEA serves as the basis of the
requalification.

20
The correct IATF-Term is: Layout inspection and functional testing or
functional verification (depending on context). It was decided not to
change the wording in this document because the term “requalification”
was established in this document in 2007.

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The extent of all inspections must be specified here, including release
inspections, in-production tests and inspections, product audits and
requalification, setting out the scope, frequency, execution and
documentation required. Requalification inspections must be taken into
account when calculating the quotation and in the contract review.

Using a logical classification, products can be combined into product groups


for the requalification. Requalifications involving such product groups or
product lines must be agreed with the customer.

Product classification:

x Requalification of all products having characteristics which:


o determine the function and/or
o are safety/legally relevant and/or
o are a special characteristic and/or
o determine the geometry (appearance, styling).
x Requalification must be contractually regulated between OEM and
supplier.

For the requalification inspections, the following must be taken into account
with regard to planning, execution and documentation:

x The number of characteristics to be inspected,


x The history of the part and the production process,
x Information from the field and shop floor
(ease of installation, ppm),
x Results and experience of the initial sample submission/inspection
(including any repeat sample submissions and special releases),
x The complexity of the part,
x The level of innovation with regard to the part and the
manufacturing process and/or its use,
x The assessment of the production process, e.g. according to
cockpit
x The supplier’s duty of disclosure to the customer and
x Scope and content of the documentation (reports etc),
x Production volume per time unit,
x Use: initial installation or replacement part,
x Legal requirements and customer-specific requirements.

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The following applies to all inspections:
In the case of subjective characteristics checking (i.e. wherever the
personnel has or can have a decisive influence on the output)
inspection/monitoring for requalification must be carried out by independent,
qualified personnel. Basically, subjective characteristic checking should be
avoided and replaced by objective inspections.

Fig. 5.3.4-1 Influencing factors affecting the production process

Test equipment without proof of capability for checking a specified


characteristic is an indicator for a Non-Robust Production Process => robust
processes can be expected only when characteristics are monitored with
capable test equipment (an exception: is where design/manufacturing is
carried out to proven Poka Yoke).
With demonstrably robust quality, the extent of testing can be reduced
accordingly. In other words, confirmation of the robustness of a characteristic
reduces the degree of testing.

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5.4 Failure management

5.4.1 Preventive failure management / risk management

In the introduction to this volume a noise factor was defined as an influencing


variable which lies outside the planned tolerances and has a negative influence
on the capability of the production process (see also Chapter 1.3).
The primary objective of risk and failure management must therefore be the
targeted recording, assessment and control of the possible influencing factors,
so that disturbances/failures do not occur.
The trigger for a risk assessment is any new development or a change of
process, product, or output from previous problems. The appendix to this
volume (Appendix 7.2.9: "Influencing factors check-list") contains an
example of the recording and assessment of influencing factors (similar to an
FMEA). Based on a collection of possible influencing factors on the
combination of production location and product, the variables can be
controlled as shown in the figure below.

Fig. 5.4.1-1 Elements of failure/problem avoidance


(preventive failure management)

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Once all risks have been minimized following the re-assessment, the design
of the process and the product can be called robust.

If it is impossible to exclude a residual risk from an influencing factor, a


contingency plan must be drawn up as the final step of risk management.
Warning limits and control limits must be defined, providing an early
indication of changes in the variable and thus permitting corrective control
actions.

Existing risks must be monitored further as part of the continuous


improvement process and must be checked at regular intervals to see if it is
possible to eliminate them entirely.

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A further means of assessing risks is shown in Fig. 5.4.1-2. Following an
assessment of the probability of occurrence and the effects, the risks are
communicated within the organization and actions to reduce the risk are
implemented. These actions depend on the risk classification.

Name R isk Management

Definition Risk management is a continuous activity which exists in order to identify and
(What?) analyse risks in the project. The potential risks can be minimized by appropriate
reaction.

Purpose of use The risk management tool helps to identify risks as early as possible, with the
(Why?) following procedure being defined :

x Assess the probability of occurrence


x Determine the extent of the oc
occurrence
x Communicate the risks in the
h project and/or to the manangement
he
x Implement control mechanisms to minimize the risks

Case study Classification of risks


(How?)
Prepare
Management
Decision
Define actions
within team
Monitor risk

Source/Source reference
e Risk Management

Fig. 5.4.1-2 Example showing the principle of risk management

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5.4.2 Reactive failure management

If there is nevertheless an incident, a quick, targeted and systematic


elimination has to be guaranteed.

4 Described in the 2 Crisis management


contingency plan
Customer, supplier

Customer
Contingency plan
comes into force 1
Normal 8
Failure elimination
condition
5 Threshold f(t) and
warning limits
exceeded

7 Severity / duration
of the problem 3 Emergency concept
. with escalation if needed
See standard

Fig. 5.4.2-1 Elements of failure/problem elimination


(Reactive failure management)

Fig. 5.4.2-1 shows the process of reactive failure management. As described


in the standard covering the failure management / contingency plan, the
contingency plan must contain all the information needed to eliminate the
disturbance/fault quickly, permanently and in a targeted manner. The crisis
management team designated in the contingency plan is responsible for
execution and has sole authority to confirm the end of the disturbance/fault.

If the consequences of the disturbance/fault may have an effect on the


customer or the environment, they must be informed immediately.

After the problem has been eliminated, an assessment is made of how the
disturbance/fault elimination process was carried out, so that the experience
and information gained can be incorporated into the process on a preventive
basis.

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6 Road map covering standards, guidelines and methods

The requirements and methods discussed here are taken up in various


places in the standards widely used in the automotive industry. To make it
easier for the reader to find the relevant locations and chapters, a method
overview with a reference to the chapter in this volume is given in the
following table. In this, the scope is limited to the VDA standards and IATF
16949.

Standard / Guideline
Methods
(Basis for certification and audits)
Title of the standard / guideline Title of the guideline
IATF 16949 Quality management system VDA Documented Information and
requirements for automotive production volume 1 Retention
and relevant service parts organizations
Guideline for control and retention of
documentation within the framework
of the product life cycle – particularly
their classification
VDA QM system audit VDA Quality assurance for supplies
volume 6.1 - Serial Production - volume 2 - Production Process and Product
Approval (PPA) -
VDA QM system audit VDA Reliability assurance of car
volume 6.2 - Services - volume 3.1 manufacturers and suppliers
- reliability management -
VDA Process audit VDA Reliability assurance of car
volume 6.3 - Product Development Process/Serial volume 3.2 manufacturers and suppliers
Production - reliability methods
- Service Development Process/ - tools
Providing the Service -
VDA QM system audit VDA Quality Assurance in the Process
volume 6.4 - Production euipments - volume 4 Landscape

VDA Product audit AIAG & VDA- Design FMEA


volume 6.5 FMEA- Process FMEA
Handbook Supplemental FMEA for Monitoring &
System Response

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Standard / Guideline
Methods
(Basis for certification and audits)
Title of the standard / guideline Title of the guideline
VDA volume 7 Exchanging quality data
QDX – Quality Data eXchange
VDA volume Automotive VDA Component
Component Requirement Specification Standard
Requirement Structure
Specification
VDA Preventive Quality Management
volume 14 Methods in the Pprocess Landscape

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6.1

Standards (basis for certification and audits) Methods


Chapter Chapter title Standard Chap. Title Guideline Chap. Title

1 Introduction
1.1 The initial situation
1.2 Objectives
1.3 Influencing variables VDA volume 4 QFD
1.4 Definition / "guide rails" of a
Robust Production Process

2 Overview of the complete


concept
2.3 Link with VDA standard VDA volume
"Maturity Level Assurance" Maturity Level
Assurance
3 Pre-requisites for a Robust IATF 16949 7.1 Resources
Production Process
Business processes and IATF 16949 7.1.3.1 Plant, facility and equipment planning
support processes
IATF 16949 8.1 Operational planning and control VDA volume 6.3 Process audit questionaire

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IATF 16949 8.2.1 Customer communication
IATF 16949 8.3 Design and development of products
and services

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IATF 16949 8.4 Control of externally provided
Methods and guidelines road map for the

processes, products and services


VDA Volume "Robust Production Process"

IATF 16949 8.5 Production and service provision

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93
94
Standards (basis for certification and audits) Methods
Chapter Chapter title Standard Chap. Title Guideline Chap. Title
3.1 Corporate culture VDA volume 3 Process description
Lessons learned
IATF 16949 7.2 / 7.3 Competence / Awareness
IATF 16949 5 Leadership
3.2 Product development and
planning process
3.2.1 New parts VDA volume 3.1 Reliability managent
VDA volume 3.2 all Reliability methods and tools

VDA volume 4 Development processes, QFD, FTA, DoE

AIAG & VDA all Design FMEA


FMEA- Process FMEA
Handbook Supplemental FMEA for Monitoring &
System Response

VDA volume Automotive VDA Component Requirement


Component Specification Standard Structure

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Requirement
Specification
VDA volume 14 DMU, manufacturing feasibility analysis,

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DFMA, SWOT, TRIZ
IATF 16949 8.2.3.1.3 Organization manufacturing feasibility
3.2.2 Parts from a new IATF 16949 8.4.1.3 Customer-directed sources
manufacturing location

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Standards (basis for certification and audits) Methods
Chapter Chapter title Standard Chap. Title Guideline Chap. Title
3.3 Minimum requirements for
the quality functions of a
production location
4 Check-point IATF 16949 8.3.4.2 Design and development validation VDA volume 2 Production Process and Product Approval
(PPA)
IATF 16949 8.3.4.4 Product approval process
VDA volume 3.4.2 Traffic light assessment of Maturity level
Maturity Level
Assurance
5 Standards for Robust VDA volume 6.3 Process audit questionaire
Production Processes
VDA volume 6.5 all Product audit
5.1 Basic standards for internal IATF 16949 5 Leadership
production processes
IATF 16949 10.3 Continual improvement
IATF 16949 10.2 Nonconformity and corrective action

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96
Standards (basis for certification and audits) Methods
Chapter Chapter title Standard Chap. Title Guideline Chap. Title
5.2 Supplier management IATF 16949 8.4 Control of externally provided

IATF 16949 8.4.2.3 Supplier quality management system


development
ISO 9001 8.4 Control of externally provided
processes, products and services
5.2.2 Contract validation, quality
assurance & logistics
agreement (QALA)
5.3 Monitoring and controlling IATF 16949 6.2 Quality objectives and planning to VDA volume 1 all Documented Information and Retention
achieve them

IATF 16949 7.1.5 Monitoring and measuring resources


IATF 16949 9.1 Monitoring, measurement, analysis
and evaluation
IATF 16949 9.1.3 Analysis and evaluation
VDA volume 4 Economical Process Design and Process
Control

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VDA volume 6.5 all Product audit
5.3.1 Key data cockpit

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5.3.2 Communication, display,
reporting

VDA volume 7 all Exchanging quality data


QDX – Quality Data eXchange
5.3.3 Control loops IATF 16949 10.2 Nonconformity and corrective action
5.3.4 Requalification IATF 16949 8.6.2 Layout inspection and functional VDA volume 6.5 all Product audit
testing

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Standards (basis for certification and audits) Methods
Chapter Chapter title Standard Chap. Title Guideline Chap. Title
5.4 Failure management IATF 16949 8.7 Control of nonconforming outputs
IATF 16950 8.5.1.1 Control plan
IATF 16951 9.1.1.1 Monitoring and measurement of
manufacturing processes
5.4.1 Preventive failure IATF 16949 6.1.2.3 Contingency plans AIAG & VDA all Design FMEA
management /risk FMEA- Process FMEA
management Handbook Supplemental FMEA for Monitoring &
System Response
6 Route map covering
standards, guidelines &
methods
7 Appendix
7.1 Glossary & abbreviations VDA volume 4. Terms
6.1
VDA volume 3. Terms
6.4
IATF 16949 3. Terms and Definition

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ISO 9000 QM-systems - Fundamentals and
vocabulary

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97
7 Appendix

7.1 Glossary and abbreviations


7.1.1 General terms and expressions
7.1.2 Terms in the standards environment
7.1.3 List of abbreviations
7.2 Check-lists
7.2.1 Check-list for production transfers and carry-over parts
7.2.2 Check-list of minimum requirements for quality functions
at a production location
7.2.3 Logistics concept check-list
7.2.4 Check-point check-list
7.2.5 Quality assurance and logistics agreement (QALA)
check-list
7.2.6 Key data matrix check-list
7.2.7 Example of cockpit for Robust Production Processes
7.2.8 Example of a Robust Production Process mini-cockpit
7.2.9 Influencing factors check-list with an example of an
assessment matrix based on the FMEA method
7.3 Examples of standards
7.3.1 Example of standards for internal quality agreements

7.3.2 Examples of standards for release procedures


7.3.2.1 Example 1: Overall assessment for a process release
7.3.2.2 Example 2: Quality assessment

7.3.3 Examples of standards for employee qualifications


7.3.3.1 Example 1: Qualification matrix
7.3.3.2 Example 2: Qualification and authorization matrix

7.3.4 Examples of standards for communication / reporting /


escalation
7.3.4.1 Example 1: Reporting and documentation
7.3.4.2 Example 2: Escalation monitoring
7.3.4.3 Example 3: Example showing quality key data and
execution
Example 4: Example of key data depiction
Example 5: Example of key data depiction

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7.3.5 Examples of standards covering comprehensive
equipment management, maintenance and service
7.3.5.1 Example 1: Training course material for TPM
7.3.5.2 Example 2: TPM inspection plan (excerpt)
7.3.5.3 Example 3: Training documents for TPM of robots

7.3.6 Examples of standards for risk management and


contingency plans
7.3.6.1 Example 1: Process risk filter
7.3.6.2 Example 2: Flow-chart for contingency management
7.3.6.3 Example 3: Quality reaction plan
7.3.7 Examples of standards for problem-solving methods
7.3.7.1 Example 1: Problem-solving sheet
7.3.7.2 Example 2: 8D Report
7.3.8 Examples of standards for work-place descriptions and
standard work-sheets
7.3.8.1 Example 1: Standard work-sheet
7.3.8.2 Example 2: Standard work-sheet
7.3.8.3 Example 3: Process illustrations and production
operations
7.3.9 Examples of standards for change management
7.3.9.1 Example 1: Life-cycle planning
7.3.9.2 Example 2: Change request

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7.1 Glossary and abbreviations

7.1.1 General terms and expressions

General terms

Term Definition Source

5S 5S comes from the Japanese:


1. Seiri = Sorting,
2. Seiton= Simplifying,
3. Seiso= Organizing,
4. Seiketsu = Keeping work-place
clean,
5. Shituske = Complying
5 x why Problem-solving method in which
“why?” should be asked five times in
order to get to the real cause of the
problem
8D 8D – Problem Solving in 8 Disciplines VDA volume 8D

Change The completion of a change results in a


new process / product specification
DFMA Design for Manufacture and Assembly:
a method for optimizing engineering
design and production costs, reducing
the number of parts, reducing the
development time, reducing assembly
expenditure and increasing quality.
Source: VDA volume 14
First Pass Yield Percentage of results which are correct www.quality.de
in the first process run-through and do
not require any rework

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General terms

Term Definition Source

First time run First process run-through

Ishikawa diagram Cause / effect diagram "Qualitätsmanagement


von A bis Z";
Kamiske, Brauer;
5th edition
ISBN 3-446-40284-5
Kanban Japanese for “sign”, a method to
reduce material inventories in the
production using demand-based control
according to the "pull" principle, e.g.
with cards.
Consignment stores Store for products which remain the
supplier's property until the customer
removes them
Short-term capability Can be used with a few available parts VDA volume 4
before start of production, for example,
for the approval of machines and
production facilities
Long-term capability Used to evaluate quality capability VDA volume 4
under real process conditions after
SOP over an appropriate time period.

Lessons learned Documentation and use of collected VDA volume “Lessons


experiences Learned”
Milestone Scheduled decision points in the course
of the project
Muda/ Mura/ Muri Starting points for improvements (part
of the Toyota Production System); the
English translations are: waste/
inconsistency/ overburden
0 km failures Failures which occur during delivery,
during installation in the vehicle or
during end-of-line inspection at the
OEM
Poka-Yoke (failure System for failure prevention and / or "Qualitäty management
avoidance) immediate detection of unforeseen from A to Z"; Kamiske,
failures Brauer; 5th edition
ISBN 3-446-40284-5
Process requalification See requalification (standard terms)

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General terms

Term Definition Source

Process validation See validation (standard terms)


Control loop System which continuously compares
its actual value with the targeted value
and can react correctively to changes
Maturity level Classification criterion used to VDA volume
determine the maturity of new, complex "Maturity level
products assurance for new
parts"

R-parts "Risk" parts


Run@rate Inspection of the production capacity
before SOP; e.g. customer-specific: the
2DP ( = 2 days' production).
ship-to-line Delivery directly to the production /
assembly line
Skip-lot-test Approval inspection on a sample basis;
see also DIN ISO 2859
Total productive Concept for the optimum use of
maintenance (TPM) production facilities on the basis of
preventive breakdown avoidance and
continuous improvement in regard to
equipment availability

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7.1.2 Terms in the standards environment

Term Source

Requirement DIN EN ISO 9000:2015 Chapter 3.6.4


Audit DIN EN ISO 9000:2015 Chapter 3.1.3.1
Customer DSQ document 11-04; 6th edition
Special characteristic IATF 16949 Chapter 3.1
Document DIN EN ISO 9000:2015 Chapter 3.8.5
Efficiency DIN EN ISO 9000:2015 Chapter 3.7.10
Initial sample DSQ document 11-04; 6th edition
Capability DIN EN ISO 9000:2015 Chapter 3.6.12
Failure DIN EN ISO 9000:2005 Chapter 3.6.2
Failure avoidance IATF 16949 Chapter 3.1.4
Release DIN EN ISO 9000:2015 Chapter 3.12.7
Competence DIN EN ISO 9000:2015 Chapter 3.10.4
Conformance DIN EN ISO 9000:2015 Chapter 3.6.11
Corrective actions DIN EN ISO 9000:2015 Chapter 3.12.2
Customer satisfaction DIN EN ISO 9000:2015 Chapter 3.9.2
Supplier DIN EN ISO 9000:2015 Chapter 3.2.5

Management DIN EN ISO 9000:2015 Chapter 3.3.3


Measurement process DIN EN ISO 9000:2015 Chapter 3.11.5
Rework DIN EN ISO 9000:2015 Chapter 3.12.8
Contingency plan IATF 16949 Chapter 6.1.2.3
Organization DIN EN ISO 9000:2015 Chapter 3.2.1
Product DIN EN ISO 9000:2015 Chapter 3.7.6
Production IATF 16949 Chapter 3.1.7
Control plan IATF 16949 Chapter 8.5.1.1
Project DIN EN ISO 9000:2015 Chapter 3.4.2
Inspection / check / test DIN EN ISO 9000:2015 Chapter 3.11.7
Qualification See "Competence"
Quality DIN EN ISO 9000:2015 Chapter 3.6.2

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Term Source
Layout inspection and functional testing
IATF 16949, Chapter 8.6.2
(Requalification)
Target value DSQ document 11-04; 6th edition
Special release DIN EN ISO 9000:2015 Chapter 3.12.5
Specification DIN EN ISO 9000:2005 Chapter 3.8.7
Incident / problem / failure DSQ document 11-04; 6th edition

Validation DIN EN ISO 9000:2015 Chapter 3.8.13


Verification DIN EN ISO 9000:2015 Chapter 3.8.12
Preventive actions DIN EN ISO 9000:2015 Chapter 3.12.1

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7.1.3 List of abbreviations

BPS Bosch Production System


CIP Continuous improvement process
COP Carry-over part
CP Control Plan
CpK Process Capability Index
DoE Design of Experiments
DRBFM Design Review By Failure Mode
ESD Electrostatic Discharge
FEP Failure Elimination Process
FIFO First In - First Out
FMEA Failure Mode Effect Analysis
FPY First Pass Yield
FTA Fault Tree Analysis
IMDS International Material Data System
ISI Initial Sample Inspection
ISIR Initial Sample Inspection Report
ML Maturity level
OEE Overall Equipment Effectiveness
OEM Original Equipment Manufacturer
PPAP Production Parts Approval Process
ppm parts per million
QM Quality Management
Q-Matrix Qualification matrix (for employees)
QMS Quality Management System

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7.1.3 Continued List of abbreviations

RPP Robust Production Process


RPN Risk Priority Number
SOP Start of Production
SPC Statistical Process Control
TPM Total Productive Maintenance
Verband der Automobilindustrie
VDA (English: Association of the Automobile Industry
2 DP Two days' production

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7.2 Check-lists

7.2.1 Check-list for production transfers and carry-over parts

No. Items to be checked Comments


1 Planning grounds
1.1 Trigger: customer / self / supplier? Who is the driver / customer?
1.1.1 Customer requirement
(e.g. due to costs, logistics, etc.)
1.1.2 Supplier
(e.g. production relocation, costs)
1.1.3 Self triggered
1.2 With / without tools
1.2.1 With / without production facilities
1.3 New production site is known / unknown
1.3.1 Assessment of influencing factors has
been provided
1.3.2 Contingency plans exist
1.4 New supplier is known / unknown
1.5 Standards, requirements, legal Also environmental regulations
regulations
1.6 Licenses, rights to products
2 Project concept
2.1 Project management
2.2 Feasibility study available? (feasibility:
logistics, technology, production, etc)
2.3 Deadlines
2.4 Contractual situation
2.5 Legal requirements Local import / export regulations / bans
2.6 Specified terms for releases and release
conditions
2.7 Sub-supplier management
2.8 Communication
2.8.1 Language (translations necessary, e.g.
for specifications, drawings, etc.?)

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7.2.1 Continued
Check-list for production transfers and carry-over parts

No. Items to be checked Comments


2.8.2 IT (systems, data, transfers)
2.9 Qualification
2.9.1 Qualification of the team handling the Personnel handling the execution;
relocation project contact person at the new location
2.9.2 Qualification concept for personnel at the Personnel for production, planning, etc;
new location contingency plan
2.10 Responsibilities, tasks
2.11 Customer information
2.11.1 Information to the customer Information to the customer that the
relocation is planned and how it is
planned
2.11.2 Information from the customer Requirements (procedure, release, etc.)
2.12 Customer releases
3 Logistics
3.1 Planning
3.2 Transport
3.3 Packaging, load carriers Packaging and transport trials
3.4 Handling of empty packaging Also circulation packaging and load
carriers
3.5 Storage conditions E.g. maximum storage times,
environmental conditions
3.6 IT connection For delivery schedules
3.7 Area planning
3.8 External service providers
3.9 Parts scheduling (lead time, packaging
materials)
3.10 Supplies of spares / replacement parts Must be clarified
after-market (who? concept?)

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7.2.1 Continued
Check-list for production transfers and carry-over parts

Nr. Items to be checked Comments


4 Purchasing Purchasing department of the
organisation making the production
transfer
4.1 Purchasing concept Involve / inform the suppliers affected;
replacement part concept; special
agreements (e.g. stocks of raw
materials).
Clarification of build-up / reduction of
suppliers. Take account of procurement
lead times; contract situation
4.2 Plan for localization

4.3 New / changed supply chain? Sub-suppliers known?


Obligatory supply sources?
4.3.1 Releases exist (suppliers, part-related Sub-suppliers released by suppliers?
releases)
5 Production

5.1 Documented process status before the


relocation
5.2 Assessment of production (e.g. audit,
quality performance) before and after the
relocation
5.3 State of the technology => must not Obtain information about state of the
deteriorate in teems of quality capability technology in advance, make comparison
and quality performance possible
5.4 Extent of added value Planning and assessment of changes in
the extent of added value
5.5 Production process / technology / Before / after comparison
measurement technology (e.g. organization of the process, such as
inter-linking, single / multiple product
manufacturing, measurement / inspection
/ test technology)
5.6 Personnel at the new production location
5.6.1 Personnel in production Resources, qualifications in place?
5.6.2 Personnel with planning and Resources, qualifications in place?
management functions

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7.2.1 Continued
Check-list for production transfers and carry-over parts

No. Items to be checked Comments


5.7 Adoption of standards Standards for work-sequences,
environment and safety
5.8 Validation and release of the new
production process
5.8.1 Concept
5.8.2 Implementation
5.8.3 Expenditure at customer
5.8.4 Processes
6 Safety concept

6.1 Stocks e.g. consignment stores


6.2 Lead time Production and storage of stocks
6.3 Contingency concept Fall-back solution; contingency plans;
assessment of the influencing factors
(see influencing factors check-list, which
must be completed)
7 Inter-disciplinary topics
(e.g. information from 8Ds)
7.1 Transfer of "Lessons learned" After the project has been completed
7.2 Traceability concept
7.3 External service providers Availability, qualification, contractual
integration, etc.
7.4 Level of information at the location Up-to-date?
7.4.1 Data for transfer Transfer of data to new location
7.4.2 Drawings, parts lists, FMEA, PCP, work
instructions, procedural instructions, key
data, etc.
7.5 Ramp-up management at the new Planning, coordination, securitisation
production location
7.6 Run-out management at the previous Planning, coordination, securitisation
production location

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7.2.2 Check-list of minimum requirements for quality functions
at a production location

documentation
Cooperation
Execution

Access to
Quality function Comments

Certificate
Accredited automotive-specific certificate X X IATF 16949
or VDA 6.1
Prevention
Advance quality planning (fresh planning); X
Lessons learned
Supplier quality management Records of released
suppliers and parts
Initial sample submission X
Supplier assessment X Access to data
Audit X Access to information
Release X Access to lists
Supplier competence X Access to lists
Complaints / reject management X
Start-up support
Start-up process X
Product testing / inspection (internal)
Product release X X Additional: quarantine
Product audits X
Conformity test X X Additional: quarantine
Quality assurance in full production X
Requalification X X
System process controlling
Event-oriented process audits X
QM system and methods X
QM strategy X

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documentation
Cooperation
Execution

Access to
Quality function Comments

Process releases X X Additional: quarantine


Imposition of key data for process / product X
Failure analysis
Process / product analysis (cause) X
Location Q-data analysis X
Continuous improvement process X
Tracking / management of actions X
Escalation management X
Product quality (toward the customer)
Complaints / reject management X
Sample submissions X
Disturbance/ problem / failure management X

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7.2.3 Logistics concept check-list

No. Criterion Comment, Examples


1 Specify logistics systems E.g. ship-to-line, Kanban, consignment store,
FIFO; guarantee system support by the use of
appropriate facilities (hardware or software)
2 Specify internal logistics Intermediate storage, material flow
3 IT integration For delivery schedules
4 Transport Transportation infrastructure, transport facilities
etc.
5 Container management Determine quantity, return, cleaning, etc.
6 Packaging, load carriers Set the specification, check capability; packaging
and transport trials
7 Handling empty containers / Also circulation packaging and load carriers
packaging
8 Area planning
9 Protection from weather From Goods Inwards to the shipping area and to
the customer; also internal transport
10 Goods Inwards inspection e.g. dynamic skip lot inspection
11 Goods shipping inspection Supplier verification for the customer
12 Storage conditions Environment / climate, maximum storage times,
stackability, FIFO shelves, types of containers and
packaging, etc.
13 Quarantine store Quarantine store requirements: locked, inventory
list
14 Special requirements relating to ESD, clean room, air-conditioning where
ambient conditions necessary
15 Cleanliness and orderliness Inspection, for example through audits
16 Transport vehicles Compliance with specific requirements, e.g. ESD
(for internal transport)
17 Traceability / batch identification Determine type of identification and documentation
18 External service providers
19 Lead-time planning for parts,
packaging material
20 Supply of spares / replacement
parts / after-market (who?
concept?)

Check-list is support for/ example of the assessment at the check-point


Red / yellow / green assessment result becomes part of the check-point

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7.2.4 Check-point check-list

Check-point Comment / definition based Assessment


Comment
criteria on key data matrix basis
Procedure for A-parts is based Product releases Released without reservations:
on maturity level, specification is 100% fulfilled.
For B/C-parts: min. proof of Conditional: e.g. specification not
satisfaction of "X" questions; completely fulfilled but parts can be
product and process installed, documentation not
specifications complete. See also Chapter 5.1.3
Process releases
Control plan The control plan describes fully all
processes (inc. logistics) and
inspection operations, inc. planned
rework, from Goods Inwards to
shipping. It contains test / inspection
Product/ frequencies, a definition of random
process sampling, test equipment and
releases, method, documentation,
control plan, characteristics, full production
check-lists release (first-off parts), in-production
from maturity checks / inspection, product audit
level and requalification. There should be
a lead document which references
the necessary documents; “not
complete” can also mean: executed
incorrectly
Maturity level traffic See traffic light definition "Maturity
lights (A-parts) level assurance", also Chap. 2.3.1
Assessment status See traffic light definition "Maturity
of "X" questions level assurance", also Chap. 2.3.1
(B/C-parts)
Production transfers Assessment to be carried out by the
user. See also Chapter 7.2.1
Carry-over parts Assessment to be carried out by the
user
At least to VDA 6.1 or IATF Minimum QM Conditionally fulfilled means: risk
16949: a valid certificate is functions at the justifiable, e.g. cooperation only
required for the production production location instead of execution; document
location => integrated in the Q- access only instead of cooperation;
function check-list! Assign to not complete access. See also
QM system (question about Chapter 3.3
QM system certificate also included).
Minimum requirements for QM
of a production location is
included
Certificate for the
production location

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7.2.4 Continued
Check-point check-list

Checkpoint Comment / definition


Assessment basis Comment
criteria based on key data matrix
Planning and List of standards, minimum Standards required See Chapter 5.1
implementing requirements and examples
standards
Assessment to check-list of Influencing factors See also Chapter 5.4.1
influencing factors. If there is recorded and assessed
a high risk, there must be a (e.g. influencing factors
contingency plan with FMEA)
Influencing threshold values and
factors and tolerances for the influencing
resources factors
Necessary contingency
plans based on
assessment of
influencing factors
Quality Minimum contents to VDA Contents of quality See also Chapter 5.2.2
assurance & volume 2 and check-list from assurance & logistics
logistics the "Supplier Management" agreement
agreement / working group
contract
Logistics Planned & implemented See also Chapter 3.4
concept logistics concept
Complaints / Planned& implemented
rejects complaints / rejects
management management
Change Planned & implemented See also Chapter 5.1.10
management change management

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7.2.5 Quality assurance & logistics agreement (QALA) check-list

With involvement of customer


To be delivered to customer
To be kept ready at location
Can be managed centrally

IATF 16949
Minimum contents Comments
Index / version of the Specify the precise validity: as a rule the x x
QALA current index / version or the one ruling at
the time of the relevant agreements were
signed. Subsequent additional requirements
must be regulated.
Preamble / objective The objective is to assure the quality x
demanded by the customer, from the
planning of the product onward
(VDA volume 2).
Area of application, Fundamental business relationship, x x
subject of the contract products, product groups, etc.
Quality management Sub-suppliers should be named (at latest at x (x) x
system of the supplier the sample submission stage); changes in
(Tier 1) and sub-suppliers sources of supply must be declared; in the
case of special projects, the listing of names
is to be agreed on, possibly back to raw
material suppliers.
Suppliers (Tier 1): Alternative certification to VDA 6.1 (x) x
Minimum certification:
IATF 16949
Sub-suppliers: minimum Supplier also responsible for: proof of the (x) x Chapter 8.4.2.3
certification: ISO 9001 development of the sub-suppliers to IATF
16949 (e.g. timing for the certification
requirement) and evidence of the assurance
of customer-specific requirements which
extend beyond ISO 9001.
Minimum requirements for Robust Production Process check-list: also x
the quality functions of a to be assured in the supply chain
production location
Customer-specific Must at least be listed with a reference to x x e.g., special
requirements guidelines, manuals, requirement characteristics:
specifications, etc. see Chapters
3.1.2 / 7.3.2.3

0 = “optional”, x = “required”, (x) = “accessible on site”

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7.2.5 Continued
Quality assurance & logistics agreement (QALA) check-list

With involvement of customer


To be delivered to customer
To be kept ready at location
Can be managed centrally

IATF 16949
Minimum contents Comments
Auditing / verification Regarding supplier assessment procedure (x) Chapter 8.4.2.4
and regulations concerning sub-suppliers
and specified supply sources
Access rights after Specify access rights: who, when, how, x x
notification scope / depth, type of notification; specify
contractual assurances in the supply chain
through joint access rights to sub-suppliers
- short-term, 1 day e.g., Supplier technical revision,
beforehand problem analysis
- medium-term, 1 to e.g. audit
3 weeks beforehand
- immediately in the case Problem analysis
of severe problems

Product development and Must be specified, possibly through Maturity x Development


achievement process Level Assurance (milestones) Planning.
Chapter 8.3.2

Feasibility analysis Determine QM tools (e.g. FMEA, DoE) x


generally and project-specific

FMEA Process, product and system x

Preventive quality VDA volume 14: "Preventive Quality x


methods Management Methods in the Process
Landscape"

Proof of capability For processes, machines, and measurement x Chapter


equipment: specify the evidence to be 7.5.3.2.1
proven in the sample submission, to be
maintained in full production, and to be kept
ready for inspection.

0 = “optional”, x = “required”, (x) = “accessible on site”

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7.2.5 Continued
Quality assurance & logistics agreement (QALA) check-list

With involvement of customer


To be delivered to customer
To be kept ready at location
Can be managed centrally

IATF 16949
Minimum contents Comments

Initial sample/ Methods to be specified generally and / or x (x) x


sample submission for specific projects; e.g., to VDA, PPAP,
customer requirements, etc.

Run@rate Procedure / rules must be established; e.g., x x


2-day production, production approval
checks; rules for sub-suppliers are required

Full production release Process and product release x x Chapter 8.3.4.4

Internal audits Obligation to self-assessment, e.g. for x Chapter 9.2.2


product, process

Project management / Access for customer to view current status (x) x


time planning

Quality development and Target agreement, e.g. general objectives x x Chapter 6.2
objectives and those regarding product / project /
product families; consequences taking
bonus / penalties into consideration; process
cost optimization

Inspection plans Must be included in control plan; special x Chapter 8.5.1


regulations for parts wich are relvant for
(safety-relevance, legal and regulatory
requirements)

Maintenance Obligation to carry out preventive x Chapters


maintenance; planning and recording 8.5.1.5
(service manual)

Process layout / Current version to be submitted for x


production schedule inspection

0 = “optional”, x = “required”, (x) = “accessible on site”

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7.2.5 Continued
Quality assurance & logistics agreement (QALA) check-list

With involvement of customer


To be delivered to customer
To be kept ready at location
Can be managed centrally

IATF 16949
Minimum contents Comments

Capacities Production, personnel, tests / inspection, x Chapter 7.1


analyses, storage, logistics, etc.

Sub-supplier capacities Production, personnel, tests / inspection, (x) x


analyses, storage, logistics, etc.

Tool and measurement Obligation to carry out preventive x Chapter 7.1.5


equipment management maintenance / service; planning and records

Identification Tools and measurement equipment must be x


clearly labelled

Production facilities Maintenance, service, calibration and clear x Chapter 8.5.1


supplied by others ownership identification must be
(e.g., the customer) established; scrapping to be regulated; use
to be specified (e.g. not to be used to make
products for third parties)

Proof of capability Process, machine and measurement x


equipment: must be up-to-date, intervals for
reassessments must be specified; must be
fit for purpose

Test concept To be integrated in the control plan x

Calibration Test concept for calibration and adjustments x Chapter 8.5.1.6


must be specified

Evidence / evidence of Display data at the production location; x


quality assurance specify archiving and archiving period if
other than legal regulations; current, agreed
specifications must be available and
implemented; continuous monitoring

0 = “optional”, x = “required”, (x) = “accessible on site”

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7.2.5 Continued
Quality assurance & logistics agreement (QALA) check-list

With involvement of customer


To be delivered to customer
To be kept ready at location
Can be managed centrally

IATF 16949
Minimum contents Comments

Requalification See matrix and explanation sheets: must be (x) x Chapter 8.6.2
contractually regulated, general minimum
requirements and possibly project-specific
ones; regulate in control plan like product
audits

Change management See change management standard x

Continuous improvement Mandatory! Applies in all areas: x Chapter 10.3


process sub-suppliers, process, costs, logistics, etc.

Safety-relevant / special Regulation of responsibilities, regulate x (x) Chapter 3.1


product characteristics labelling of documentation / records

Handling complaints / Specify the complaints procedure: tools, (x) x


non-conforming / response times, delivery addresses for parts,
defective products type of report (e.g. 8D), etc.

Deviation approval / Specify responsibilities and regulations for x x Chapter 8.7.1.1


special release new sample submissions (times, costs),
specify the limits to special releases
(quantity, delivery period, etc.)

Cost absorption / provision Pre-requisites must be regulated, monetary x x


of resources / regression details are usually regulated by a purchase
analysis agreement

Identification, labelling, Pre-requisites x o o Chapter 7.5


documentation and
traceability

0 = “optional”, x = “required”, (x) = “accessible on site”

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7.2.5 Continued
Quality assurance & logistics agreement (QALA) check-list

With involvement of customer


To be delivered to customer
To be kept ready at location
Can be managed centrally

IATF 16949
Minimum contents Comments

Logistics: packaging, Qualitative and quantitative (e.g. ship-to-line, x x Chapter 8.5.4


transport, delivery Kanban, consignment stores, etc.) logistics
requirements; packaging audit, Goods
Inwards inspection & storage conditions,
internal logistics, cleanliness & orderliness,
minimum shelf life to be assured, special
requirements such as ESD, clean room,
storage climate, etc; incoming and outgoing
goods under roof (weather protection).
Specify requirements for logistics systems.
FIFO: manual is not normally adequate
(system support); traceability / batch
containment; labelling; container
management; internal flow of goods; interim
storage

Contact persons / List key functions by name (e.g. persons x x x Chapter 5.3
responsibilities / responsible for quality / logistics / technology
communication / orders); language, accessibility,
communication tools; need for notification of
both sides in the event of changes!

Duty of disclosure Procedure is to be coordinated from case to


case (e.g., fresh sample submission)

- Production relocation Processes transferred in the factory x x

- Out-sourcing / Value-adding processes, essential services x x


make or buy (e.g. laboratory)

- Process Essential process changes x x

- Material x x

0 = “optional”, x = “required”, (x) = “accessible on site”

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7.2.5 Continued
Quality assurance & logistics agreement (QALA) check-list

With involvement of customer


To be delivered to customer
To be kept ready at location
Can be managed centrally

IATF 16949
Minimum contents Comments

- Sub-suppliers Sources of supply x x

- Design x x

- Changes in Changes to corporate form / change of x x


management / ownership structure, significant restructuring
organisation affecting the sectors of production,
development, quality & logistics

Assurance of necessary Specify project-related targets; plan for x Chapter 7.2


staff qualification employee qualification

Environment; health & Recycling, reducing wastes, cost reduction x o o


safety at work

Declaration of constituent IMDS (to be assured via initial sample x


materials submission)

Failure / problem / incident See Failure FMEA, contingency plans: x Chapter 6.1.2.3
management explicitly require, or at least allow access to
contingency plans; require systematic
assessment and planning!

Failure analysis, Query filter, standard x


elimination measures

Obligatory insurance Product liability insurance, recall & service x x


actions

Obligation to carry out See IATF 16949; indicators such as after- x


market observation / market; regulation of information exchange
field observation from OEM in the supply chain

Electronic data processing Specify tools and interfaces o x x

0 = “optional”, x = “required”, (x) = “accessible on site”

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7.2.5 Continued
Quality assurance & logistics agreement (QALA) check-list

With involvement of customer


To be delivered to customer
To be kept ready at location
Can be managed centrally

IATF 16949
Minimum contents Comments

Confidentiality If appropriate, to be agreed separately x x x


before start of the project; need for security
in the sub-supplier chain

Appendices / additional List customer-specific documentation if x x x


documents appropriate

Handling documents and records:

0 = “optional”, x = “required”, (x) = “accessible on site”

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7.2.6 Key data matrix check-list

General for all key data:


The reference value is important: relating to time period, measurement scope, ACTUAL to TARGET, etc.

Mini
Cock- Check-
Measurement criterion Comment / Definition cock-
pit point
pit

Pre-requisites / check-point elements

Product/process release, Procedure for A-parts after maturity level, B and x x


PCP, checklists from Maturity C-parts at least proof of the x-queries; product
Level and process specifications

Quality assurance & logistics Minimum contents according to VDA volume 2 x x


agreement / contract and checklists from Supplier Management WG

Standards planning and List of standards and examples x x


implementation

QM system At least to VDA 6.1 or IATF 16949: a valid x x


certificate is required for the production location
=> integrated in the Q-function check-list!
Assign to QM system (question about certificate
also included). Minimum requirements for QM of
a production location is included

Complaints / reject x
management

Change management x

Logistics concept x

Influencing factors and Assessment based on influencing factors check- x


resources (7.2.9) list (7.2.9); if there is a high risk, a contingency
plan with threshold values and tolerances for
influencing factors must be provided

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7.2.6 Continued Key data matrix check-list

General for all key data:


The reference value is important: relating to time period, measurement scope, ACTUAL to TARGET, etc.

Mini
Cock- Check-
Measurement criterion Comment / Definition cock-
pit point
pit

Process quality / performance

Overall equipment Facility efficiency, level of use, overall x x


effectiveness (OEE) equipment efficiency, process efficiency,
unplanned maintenance times

Cycle time Duration of the production process cycle to


produce one unit

Run@rate / 2-day production Production approval under full-scale production x


conditions; proof of capability and capacities

Cp, Cpk, Ppk etc. Process capability key data for individual or x x
upstream production processes (e.g. within the
framework of the initial sampling submission);
source: VDA; volume 4.1 Chapter 10: "Quality
Management in the Automotive Industry"

Audit result Result of product, process, system and other x


types of audits. Can be a numerical value (e.g.
in %) or a classification (A/B/C)

Quantity per time period The quantity of units produced at the end of a
process per time period = production
performance, e.g. per shift, per working day.

Direct runs (First time run / Percentage of units produced which on the first x
first pass yield) process cycle and do not require any rework;
source: www.quality.de

Failure rate in a defined e.g., ppm; failure rates can also be, for example, x
recording period the number of sorting actions, factory incidents,
field failures, etc. Failure slippage: assessment
of the “failures which have slipped through”
(that is, found only at a later stage)
(Assigned to individual work / test stati)

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7.2.6 Continued: Key data matrix check-list

General for all key data:


The reference value is important: relating to time period, measurement scope, ACTUAL to TARGET, etc.

Mini
Cock- Check-
Measurement criterion Comment / Definition cock-
pit point
pit

Pre-requisites / check-point elements

Recurring / repeat failures Quantity, e.g. ratio of the number of recurring x


failures to number of failures

Pseudo failure These are failures which are assessed as OK x


after retesting; they are an indicator of test
equipment capability and test process drift

Rework Number of units produced needing another, x x


unplanned value-added operation before the
end-of-line release

Scrap Number of units to be discarded, related to the x x


total number of units; e.g. ratio of NOK parts to
be discarded, in relation to the total number of
units produced

Number of disturbances/ Process disturbances/failures occurred per time x


failures, period; to be specified, e.g. caused by supplier,
problems per time period logistics, etc; per shift, per working day, etc.

Complaints per time period Number of complaints per time period x

Delivery reliability / Ratio of deliveries to order regarding quantity, x


delivery performance / delivery date, number of pieces, quality,
delivery fulfilment packaging, shipping documents, etc; delivery
arrears, special transport, delivery reliability
does not match quality performance

Quality costs Internal and external expenditure for prevention, x


and processing failures. Internal failure costs:
e.g., key figures for debiting / charging back to
suppliers, test / inspection costs. External costs:
payments to the customer, e.g. guarantee,
warranty, goodwill

Number of changes per time Number of changes allocated to categories / x


period originator

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7.2.6 Continued: Key data matrix check-list

General for all key data:


The reference value is important: relating to time period, measurement scope, ACTUAL to TARGET, etc.

Mini
Cock- Check-
Measurement criterion Comment / Definition cock-
pit point
pit

Resources (exc. personnel) Summarized assessment x

Machines, production facilities, ACTUAL AGAINST TARGET x


test / inspection equipment

Production materials ACTUAL AGAINST TARGET x

Operating (auxiliary) ACTUAL AGAINST TARGET x


materials

Energy (power supplies) ACTUAL AGAINST TARGET x

Areas, buildings ACTUAL AGAINST TARGET x

Logistics ACTUAL AGAINST TARGET x

External services ACTUAL AGAINST TARGET x

Personnel Summarized Assessment x

Qualification and number e.g., level of compliance with qualification x


matrix, with numbers and substitution
arrangements (ACTUAL against TARGET); for
details of further development; see qualification
standard

Attendance times Sickness levels, periods of absence; e.g. x


special leave, leave of absence, sabbatical

Accident rates Summarized assessment x

Fluctuation Adjustment to take account of x


"natural and planned fluctuation"

Overtime hours Adjustment to take account of x


“planned overtime hours”

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7.2.7 Example of cockpit for Robust Production Processes

Monthly survey Actual / target Suppliers


value Internal Customer
(unless otherwise specified) (examples) A B C D
Pre-requisites = Check-point
Product / process releases, control
Status green G G G G G
plan, check-lists from maturity level
QM system Status green Y G G Y Y
Planning and implementation of
Status green G G G G G
standards
Influencing factors and resources Status green G G Y R G Y
Quality assurance & logistics
Status green G G Y G
agreement / contract
Logistics concept Status green Y G G R Y Y
Complaints / rejects management Status green G G G R Y
Change management Status green G G G G G
Process quality / performance
Overall equipment efficiency
≥ 80% 82%
(OEE)
Cycle time (hrs) ≤ 24 22
Run@rate/2-day production Status green G G Y R Y
Cpk ≥ 1.33 1.97 2.14 1.05 1.41 1.84
Product audit result Status green G G Y Y G
Quantity produced per shift ≥ 2000 2012
(Direct run) First time run /
≥ 92% 95%
first pass yield
Failure rate (ppm) ≤ 50 10 10 38 120 20 12
Recurring / repeat failures ≤2 0 0 2 3 1
Pseudo failure ≤ 10% 2%
Rework ≤ 3% 1.8%
Scrap ≤ 1% 0.9%
Number of disturbances/failures
≤4 2.2
per shift
Complaints per month ≤1 0 0 1 5 1 0
Delivery reliability / delivery
Status green G G G R G
performance / delivery fulfilment
Q-costs (percent of turnover) ≤ 3% 2.8%
Number of changes per month ≤1 1 0 1 0 1 0

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7.2.7 Continued:
Example of cockpit for Robust Production Processes

Monthly survey Actual / target Suppliers


value Internal Customer
(unless otherwise specified) (examples) A B C D
Resources (exc. personnel)
Machines, production facilities,
Status green G
test equipment
Production materials Status green G
Operating (auxiliary) materials Status green G
Energy (power supplies) Status green G
Areas, buildings Status green G
Logistics Status green G G G Y G G
External services Status green G G G G G
Personnel
Qualification and number Status green Y G R Y G
Attendance times ≥ 96% 97.0%
Accident rates (employee days
=0 0
p.a.)
Fluctuation (p.a.) ≤ 8% 4.0%
Overtime hours ≤ 5% 4.5%

TOTAL Y G R R Y
G: Green Y: Yellow R: Red

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7.2.8 Example of a Robust Production Process mini-cockpit

New
Selec Respons-
Subject Value Target Actual Tools Deadline Status act-
tion ible
ual
Initial
Supplier complaint
process Ppk > 1.67
(internal / external)
quality
2.12 Process audit
Change of supplier
Poka Yoke
100% inspection
Process
Mainten-
cap- Repair z 05-2006
ance
ability
Tool optimization z AV 09-2006
Cpk > 1.33 1.27
Setting parameter
z AV 09-2006
optimization
100% inspection ‚
Poka Yoke z Production 05-2006
Process
perform- 6-shift incident analysis z Production 06-2006 88 %
ance
over
OEE 75 % Repair ‚
80%
Mainten-
Facility optimization z 07-2006
ance
Setting-up optimization
Rework Repair
Tool optimization
Setting parameter
% < 3% 2.40 %
optimization
100% inspection
Poka Yoke
Scrap Repair
Tool optimization
Setting parameter
% < 1% 0.50 %
optimization
100% inspection
Poka Yoke
Rejects Qty. <1 2 8D process z Production 06-2006 0
z: in specific case: selected tool for improvement

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7.2.9 Influencing factors check-list with an example of an
assessment matrix based on the FMEA method

Contingency plan see IATF 16949 Ch. 6.1.2.3


Concerns production location in general

Measurement variable, tolerances, control


Possible consequences of failure

limits, threshold value, impulse


Probability of occurrence = O

Probability of detection = D
Possible cause of failure
Avoidance actions
Concerns product

Detection actions
Significance = S
Possible failure

RPN = S*O*D
Possible influencing Examples of possible
variable / incident measurement variables
1 Resources Generally applicable:
availability, provision of
capital and security stock
1.1 Personnel
1.1.1 Qualification / Actual / target comparison
qualification matrix
1.1.1.1 Training / further Days per employee;
education / refresher Euros per employee
1.1.2 Quantity
1.1.3 Availability (vacation, E.g. absence rate
shift pattern, work
times, sick rate, etc.)
1.2. Services
1.2.1 Development / Man days, costs
engineering
1.2.2 Laboratory (testing Man days, costs
services)
1.2.3 Maintenance and Man days, costs
service
1.2.4 Calibration Costs / calibration
1.3 Production facilities
1.3.1 Machines, tools OEE
1.3.2 Testing equipment Capability, capacity
1.3.3 Auxiliary materials Qualification
(Grease, oil, etc.)

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7.2.9 Continued: Influencing factors check-list

Measurement variable, tolerances, control limits,


Contingency plan see IATF 16949 Ch. 6.1.2.3
Concerns production location in general
Possible consequences of failure

Probability of occurrence = O

Probability of detection = D
Possible cause of failure

threshold value, impulse


Avoidance actions
Concerns product

Detection actions
Significance = S
Possible failure

RPN = S*O*D
Possible influencing Examples of possible
variable / incident measurement variables
1.4 Production material,
also bought-in parts
if applicable (see
parts list)
1.4.1 Raw materials,
original materials
1.4.2 Bought-in parts Quality (failure rate in ppm),
costs, timings and quantities
(delivery reliability)
1.4.2.1 Change of supplier /
dual sourcing
(second supplier)
1.4.2.2 Supplier quality Quality capability (e.g. audit),
quality performance (failure
rate, initial sampling, etc.)
1.4.2.3 Supplier availability Yes / No
1.4.2.4 Logistics Must be positively assessed
1.4.2.4.1 Packaging Qualification
1.4.2.5 Setting parts / Yes / No; releases by
specified sources / customers
components
1.4.3 In-house Yes / No
manufacturing
1.4.3.1 Quality Failure rate, capability (Cpk,
state of technology f(t),
self-audit)
1.4.3.2 Timing / availability Yes / No
1.4.3.3 Volume Quantity per time interval

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7.2.9 Continued: Influencing factors check-list

Contingency plan see IATF 16949 Ch. 6.1.2.3


Concerns production location in general

Measurement variable, tolerances, control


Possible consequences of failure

limits, threshold value, impulse


Probability of occurrence = O

Probability of detection = D
Possible cause of failure
Avoidance actions
Concerns product

Detection actions
Significance = S
Possible failure

RPN = S*O*D
Possible
influencing variable Examples of possible
/ incident measurement variables
1.4.3.4 Logistics Must be evaluated positively
1.4.3.4.1 Packaging Qualification
1.5 Energy supplies
1.5.1 Electricity KWh; U; I; f; number of
phases
1.5.2 Thermal energy Heating value, amount,
(gas, coal, etc.) quality
1.5.3 Heat Target temperature
1.5.4 Lights / lighting Lux, illumination levels
1.5.5 Water Amount, temperature,
quality
1.5.6 Air-conditioning Temperature, humidity,
percentage of fresh air
1.5.7 Clean room Concentration of airborne
particles
1.5.8 Gas/ compressed Pressure, volume
air
1.6 Buildings, facilities E.g. surface, volumes,
and surfaces facility requirements
1.6.1 Special needs: Special flooring, chairs,
e.g., ESD transport facilities, etc;
protection occupational safety,
ergonomics
1.6.3 Cleanliness and E.g. audit, 5S
orderliness
1.7 Waste disposal Recycling quota, scrapping
(scrap, waste, quota, special audits
recycling, etc.)

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7.2.9 Continued: Influencing factors check-list

Contingency plan see IATF 16949 Ch. 6.1.2.3


Concerns production location in general

Measurement variable, tolerances, control


Possible consequences of failure

limits, threshold value, impulse


Probability of occurrence = O

Probability of detection = D
Possible cause of failure
Avoidance actions
Concerns product

Detection actions
Significance = S
Possible failure

RPN = S*O*D
Possible influencing Examples of possible
variable / incident measurement variables
1.8 Support (IT,
telecommunications,
postal service, etc.)
1.8.1 Software
1.8.2 Hardware
1.8.3 Services External / internal
1.8.4 Communication
facilities
2. Planned changes
2.1 Change of supplier Yes / No
2.2 Relocation of Yes / No
production
2.3 In-sourcing Yes / No
2.4 Out-sourcing Yes / No
2.5 Production Additional requirements /
requirements changes to previous
specification; these have
been agreed and are
complete and current (e.g.
drawing, specification)
2.6 Process Additional requirements /
requirements changes to previous
specification; these have
been agreed and are
complete and current (e.g.
drawing, specification)

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7.2.9 Continued: Influencing factors check-list

Contingency plan see IATF 16949 Ch. 6.1.2.3


Concerns production location in general

Measurement variable, tolerances, control


Possible consequences of failure

limits, threshold value, impulse


Probability of occurrence = O

Probability of detection = D
Possible cause of failure
Avoidance actions
Concerns product

Detection actions
Significance = S
Possible failure

RPN = S*O*D
Possible influencing Examples of possible
variable / incident measurement variables
2.6.1 Tooling trials Yes / No
2.6.2 Trial line Yes / No
2.7 Changes in Yes / No
resources (see 2.)
2.8 CIP / cost reduction Quality
3. Complexity / New processes, materials,
innovation products, assembly, etc.
3.1 Process maturity Available (e.g. green light,
(development times/ confirmed release)
release tests)
3.2 Product maturity Available (e.g. green light,
(development times/ confirmed release); quality
release tests) (failure rate, complaints, etc)
3.3 Complexity level
3.4 Product variance/ Variants per line, variants
mixed-model per product
production
3.5 Process innovation Benchmark for the state of
technology
3.6 Product innovation Number of patents,
percentage of new products

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7.2.9 Continued: Influencing factors check-list

Contingency plan see IATF 16949 Ch. 6.1.2.3


Concerns production location in general

Measurement variable, tolerances, control


Possible consequences of failure

limits, threshold value, impulse


Probability of occurrence = O

Probability of detection = D
Possible cause of failure
Avoidance actions
Concerns product

Detection actions
Significance = S
Possible failure

RPN = S*O*D
Possible influencing Examples of possible
variable / incident measurement variables
4. Unplanned
changes (i.e., to be
implemented at
short notice, run
conditionally only
via change
management)
4.1 Availability of See 2.
resources
4.2 Product Number of changes before /
requirements after / during SOP (number
of heroes per SOP)
4.3 Process Number of changes before /
requirements after / during SOP (number
of heroes per SOP)
4.4 Delivery schedule Quantity
fluctuations;
cancellation
4.5 Process deviations Quantity
4.6 Deviation from Quantity
process / customer
requirements /
agreements
4.7 Quality performance Number
deviations (disturbances/failures), failure
rate, external / internal failure
costs
4.8 Changes in Must be assessed; e.g. legal
peripheral conditions system, national budget
4.8.1 -political

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7.2.9 Continued: Influencing factors check-list

Contingency plan see IATF 16949 Ch. 6.1.2.3


Concerns production location in general

Measurement variable, tolerances, control


Possible consequences of failure

limits, threshold value, impulse


Probability of occurrence = O

Probability of detection = D
Possible cause of failure
Avoidance actions
Concerns product

Detection actions
Significance = S
Possible failure

RPN = S*O*D
Possible influencing Examples of possible
variable / incident measurement variables
4.8.2 -economic
4.8.3 -social e.g., keyword child labour
4.8.4 -logistical
4.8.5 Labour dispute,
strike
4.9 Environment / nature Must be assessed; e.g.
probability of occurrence,
advance warning time, etc.
4.9.1 Flooding 4.9.1
4.9.2 Storms 4.9.2
4.9.3 Fire 4.9.3
4.9.4 Earthquakes 4.9.4
4.9.5 Volcano 4.9.5
4.9.6 Roof loads (snow) Kg / area
4.9.7 Extreme weather
fluctuations
(temperature,
humidity, etc.)
etc…..

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7.3 Examples of standards

7.3.1 Examples of standards for internal quality agreements

Quality Agreement ….. (Identification)


Process / Process quality agreement …… page 1 / 5
(identification)
Customer: Supplier: Validity Date: Next review date(s):
<Date>
<Name> <Name> <Date>
<Position> <Position> Change Date: <Date>
<Department/Center> <Department/Center> <Date>
Customer Signature: Supplier Signature: Person responsible for
the agreement:
<Signature> <Signature> Superseded version:
<Name>
<Date>

1. Overview of the content of the agreement:

Control Variable (CV) /


Tolerance:
Customer Requirement: Communication: Escalation:
Tolerance Tolerance
1: 2:
1 <Concrete description of <Regular <Escalation levels
the customer requirement> <Tolerance <Tolerance communications, and occurrence
value 1> value 2> meeting dates> criterion>
2
3

2. Description of specified control variables & agreements on the


customer's individual requirements:

re Customer requirement 1-X


Tolerances: Persons responsible for the control variable
Measurement Target
variable unit: value: Tolerance Tolerance
Customer: Supplier:
1 2
<Unit, definition <Target value of <Value 1> <Value 2> <Foremen A, Dept.> <Foremen A, Dept.>
of the unit > measurement <Foremen B, Dept.> <Foremen B, Dept.>
variable>
Test
Test procedure: Calculation: Test documentation:
location:
<Test procedure <test loc. for <Calculation of <Documentation location, filing, system>
for measurement measurement measurement variable>
variable> variable>

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7.3.1 Continued Examples of standards for internal quality
agreements

re Customer requirement X-Y


Tolerances: Persons responsible for the control variable
Measurement
Target value: Tolerance Tolerance
variable unit:
1 2
<Unit, definition <Target value of <Value 1> <Value 2> <Foremen A, Dept.> <Foremen A, Dept.>
of the unit > measurement <Foremen B, Dept.> <Foremen B, Dept.>
variable>
Test procedure: Test location: Calculation: Test documentation:
<Test <test loc. for <Calculation of <Documentation location, filing, system>
procedure for measurement measurement variable>
measurement variable>
variable>

3. Specified escalation strategy and reaction plan

re Customer Requirement 1-X

Escalation Escalation Escalation Escalation De-escal-


Reaction plan Inform:
level value plan decision ation
<Occurrence <Information to <Escalation <Implementation of <Course of <Name>
criterion for the manager (name, decision by actions, start of the de- <Name>
escalation dept., position) whom, problem-solving escalation>
1 <Name>
level> by whom when, process / failure
(name, dept., where> elimination process by
position)> whom, when, where>
2
Persons responsible for escalation record <Name, department>

re Customer requirement X-Y

Escalation Escalation Escalation De-escala-


Escalation plan: Reaction plan: Inform:
level: value: decision: tion:
<Occurrence <Information to <Escalation <Implementation of <Course of <Name>
criterion of the manager (name, decision by actions, start of the de-
<Name>
escalation dept., position) whom, problem-solving escalation>
1
level> by whom (name, when, process / failure <Name>
dept., position)> where> elimination process by
whom, when, where>
2
Persons responsible for escalation record <Name, department>

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7.3.1 Continued Examples of standards for internal quality
agreements

4. Other agreements / further applicable documents

Further Applicable Documents:

<Reference to further applicable documents, appendix documents, etc.>

Other agreements / comments:

<Other agreements, comments>

5. List of contact personnel

Contact person for the


Employee Area of responsibility /
Department Position Phone no. following customer
involved role
requirements
<Name> <Department <Position> <Phone < Area of responsibility <Number of customer
abbreviation> no.> and role regarding QA> requirements to which the
person contributed>

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7.3.2 Examples of standards for release procedures

7.3.2.1 Example 1: Overall assessment for a process release

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7.3.2.1 Continued

Example 1: Overall assessment for a process release

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7.3.2.1 Continued: Check-list for a process release
(The heading should show the production area and current date)

1. Checks on documents

Completed

Parts N/A yes no Comment


1.1 Are the current drawings (assembly drawing,
unfinished and finished part drawings, etc) … … …
available?
1.2 Is an overview of the quality-relevant
characteristics available? … … …
1.3 Is the sample submission OK? (purchased and
in-house parts) (at least a grade of 3)
… … …
Process
1.4 Is the process capability check OK? … … …
1.5 Is a current production and test plan available? … … …
Measurement equipment
1.6 Is the test / inspection equipment capable and
recorded in the equipment monitoring system?
… … …
Facilities
1.7 Have the technical facilities been checked and
approved?
… … …
1.8 Do the measured machine capability
characteristics correspond to the … … …
requirements?
1.9 Define spares / replacement parts and items
subject to wear with regard to procurement
… … …
Employees
1.10 Are the qualifications of the employees aligned
with their jobs (production and quality … … …
management)?
1.11 Are the instructions documented (evidence of
training, flexibilization matrix)?
… … …
1.12 Has the personnel requirement (with defined
job specifications) been determined and
introduced in accordance with the production
… … …
plan?
1.13 Have groups and team-working been
introduced?
… … …

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7.3.2.1 Continued

2. Work flow-sequence

Bought-in materials / Goods Inwards N/A Yes No Comment


2.1 Incoming materials / storage / packaging: are
documents and specifications available (for … … …
example, packing instructions)?
2.2 Is the quality of bought-in parts appropriately
assured?
… … …
Facilities
2.3 Is production carried out with full production
tooling?
… … …
2.4 Have the facility and process parameters which
influence quality been listed (including setting
parameters with tolerances) and are they
… … …
complied with?
2.5 Have the parameters for critical characteristics
been statistically determined?
… … …
2.6 Does a maintenance plan (TPM) exist and has
it been implemented?
… … …
2.7 Availability of replacement parts? … … …
Work-places and measurement stations N/A Yes No Comment
2.8 Are all documents relevant to the production
processes available on site (work instructions,
test / inspection instructions, work sequence
… … …
plan, tool adjustment plan)?
2.9 Are screwed connections secured by line
attachments? … … …
2.10 Is suitable test / inspection equipment (or
alternatives) available at the right locations … … …
according to the test plan?
Labelling / traceability N/A Yes No Comment
2.11 Is comprehensive traceability of single
components assured? … … …
2.12 Is comprehensive traceability of single batches
assured? … … …
2.13 Are quarantine zones available?
… … …

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7.3.2.1 Continued

2.14 Is the flow of materials from rework areas


clearly defined and assured? … … …
2.15 Are production conditions for external process
steps assured? … … …

3. Quality data recording

N/A Yes No Comment


3.1 Are data and results documented in
accordance with specification?
… … …
3.2 Are the control results statistically evaluated? … … …
3.3 Is the quality control loop system used? … … …
3.4 Are there decision-making aids for functionally
important characteristics? (Test / inspection
and approval regulations; error listings; limit
… … …
samples)
3.5 Are NOK parts analysed? … … …

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7.3.2.1 Continued

Action sheet for the release report

(The heading should show the production area and current date)

To be completed by the auditor To be completed by the department To be completed by


the auditor
No. “ACTUAL” Analysis / Actions Responsible / deadline Completion notation
situation as suggestions;
discovered / recommend-
deviation ations
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.

Completion notation legend:

25% = Actions defined, 50% = Solution in progress,


responsibilities allocated,

75% = Solution tried / tested, 100% = Effectiveness of the


solutions verified.

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7.3.2.2 Example 2: Quality evaluation

Quality evaluation (QE)


Part number: Development dept.

Product information
Name of product: Part no.:
Performance specification: dated:
Timing plan: dated:
Preliminary drawing: dated:
Test sheet: dated:
Design FMEA: dated:
Process FMEA: dated:
Components / software with their own QE:
Reason for QE:
Fundamentally new development Critical / comprehensive change to a product
Changed useage condition with existing Ez Parts with mandatory documentation ("D" parts)
Changed production method, new materials New production location (factory or RG, or sub-
contractors)
Other reason: Restart after production ban
Levels of the QE
QE QE QE QE QE
(E.g. QE0 – Kickoff, QE1 – Draft,
QE2 – Development samples, QE3 – Final
review, QE4 – Production review)

Carried out on (date):


Signatures Development dept.:
Development mgmt. /
development mgmt. at
board level
Production department
Factory management /
Production mgmt. at
board level
Quality department
QE protocol Department
Date
Reference number

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7.3.2.2 Continued Example 2: Quality evaluation

Quality evaluation (QE)


Departments
Dept. abbreviation
involved
Development
Testing and
endurance run
Application
Technical sales
Customer
service
Quality assurance
Production
preparation
Production
execution
Purchasing
Prototyping
Central office

Comments

Individual evaluations / QE levels QE / Date: QE / Date: QE / Date: QE / Date: QE / Date:


(see QSP0304. Eval. symbols see below)
1 Function
1.1 Legal regulations, public standards
1.2 Customer requirements / requirements
specification / application
1.3 Own specification / performance
requirement
1.4 Project management
1.5 Costs for project and product
2 Reliability
2.1 Static and dynamic stability
2.2 Climatic resistance
2.3 Endurance test performance
2.4
2.5

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7.3.2.2 Continued: Example 2: Quality evaluation

Quality evaluation (QE)


3 Timing planning
4 Manufacturing feasibility
4.1 Security of production
(e.g. critical processes)
4.2 Testability, adjustability, etc (in factory)
4.3 Ext. procurement (order regulation, etc)
4.4 Security of transport
4.5
5 Use
5.1 Feasibility of assembly
(installation point)
5.2 Failure diagnostics (service work)

5.3 Test / inspection equipment


(RG, customer, service work)
5.4 Repair (software / hardware) /
maintenance / exchange
(service work)
5.5 Security against inappropriate use

5.6
6 Quality preview, prognosis of failure rate in ppm. If statement not possible, give reason under 8.
6.1 0 km / 0 hrs complaints
(Select customer/GB limit: ppm)
6.2 Field complaints during delivery
start-up (6 months)
6.3 Field complaints per year during
warranty period in year of SOP
(Select customer/GB limit: ppm,
Warranty period: years, costs in Euros)
6.4 Field complaints per year after end of
warranty period
7 Overall evaluation
7.1 Requirements are completely fulfilled
7.2 Requirements are fulfilled with
reservations (not customer-relevant)
7.3 Requirements are not adequately
fulfilled (customer-relevant)

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7.3.2.2 Continued: Example 2: Quality evaluation

Quality evaluation (QE)


8 Comments
(If the evaluation symbols “(+)”, “(–)” or “–” occur, actions must be specified with completion dates and persons
responsible. If necessary, attach an additional sheet.)

Evaluation symbols: Indicator:


(if necessary with additional “!” as reference to wear as a supplement to the symbols, e.g. “(+) 4/8”
and tear problems, e.g. “(-)!”.
1. Theoretical inspection
+ not problematic, will definitely be fulfilled 2. Design FMEA
(+) no positive statement can be made yet, 3. Functional sample(s)
but probably not problematic
4. Test prototype(s)
(–) no positive statement can be made yet,
but probably problematic 5. Release sample(s)
– very problematic, still no prospect of success 6. Process FMEA
7. Pre-production sample(s)
8. Initial sample(s)
9. Own testing
10. Customer testing / customer trials
11. Reference to comparable products
12. Reference to competitors
13. Full production
14. etc….

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7.3.3 Examples of standards for employee qualifications

7.3.3.1 Example 1: Qualification matrix

x = Participation is required,
SAP-VM (x) = Only when it applies Attainable level
i = Information-course, reduced content,
Structure participation required in % through
R = Recommendation training
i x Segment Work
Event group Topic Type of event BI
course course leader planner
QM + internal
Quality Management 80 R R
auditors
Basics
IATF16949 for
IATF 16949 60
operators
FMEA in
FMEA 20 40 i x
production
Advance product quality APQP 20 40 i x
planning (APQP) Test / insp. plan 80 x x
PPAP 40 x x
Product & process release
Release system 40 x x x
SPC 80
SPC for
40 x x x
supervisors
Quality
manage- SPC Main
40 R x
ment characteristics
methods Capability checks 80
Training to 6
80 R R
Sigma Green Belt
6 Sigma 6 Sigma
Champion 80 x
Training
8D, Ishikawa,
Failure avoidance, detection,
brainstorming 60 x
complaints
(e.g. 635)
Test / inspection methods 80
Reading work plans
80
and drawings
WSP Monitoring test / inspection.
80
equipment
Surface inspection 60
Conturograph 60
"Customized" interlocking
Interlocking 80 (x)
training
technique
Interlocking training 80 (x)
Document hierarchy at N
Documents 40 R x
location FN

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7.3.3.1 Continued: Example 1: Qualification matrix

x = Participation is required,
SAP-VM (x) = Only when it applies
i = Information-course, reduced content,
Structure participation required
R = Recommendation
Q Q Prod'n Prod'n Logistics Logistics
Event group Topic Type of Event fore- oper- fore- oper- fore- oper-
men ators men ators men ators
QM + internal
Quality management x R
auditors
Basics
IATF16949 for
IATF 16949 x
operators
FMEA in
FMEA x x x i
production
Advance product quality APQP x i
planning (APQP) Test / insp. plan x x x x
PPAP x x x x
Product & process release
Release system x
SPC x x x x
SPC for
supervisors
Quality
manage- SPC Main
x x x x x x
ment characteristics
methods Capability checks x x x x
Training to 6
x R
Sigma Green Belt
6 Sigma 6 Sigma
Champion
Training
8D, Ishikawa,
Failure avoidance, detection,
brainstorming x x x x x x
complaints
(e.g. 635)
Test / inspection methods x x R x
Reading work plans
x x R x
and drawings
WSP Monitoring test / inspection.
x x x x
equipment
Surface inspection x x (x) (x)
Conturograph x x (x) (x)
"Customized" interlocking
Interlocking training
technique
Interlocking training (x) (x) (x) (x) R R
Document hierarchy at N
Documents
location FN x x x x x x

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7.3.3.1 Continued: Example 1: Qualification matrix

x = Participation is required,
SAP-VM (x) = Only when it applies
i = Information-course, reduced content,
Structure participation required
R = Recommendation
Obligatory Info
Event group Topic Type of Event course course
Instructor Area duration duration
QM + internal
Quality management
auditors
Basics
IATF16949 for
IATF 16949 X Q1 4 hrs
operators
FMEA in
FMEA Y Q1 3 hrs
production 1.5 h
Advance product quality APQP Z Q1 3 hrs 1.5 h
planning (APQP) Test / insp. plan A/Y Q1/Q2 1 hr
PPAP B Q1 1 hr
Product & process release
Release system C Q3 2 hrs
SPC D Q1 16 hrs
SPC for
ext. 2 hrs
supervisors
Quality
manage- SPC Main
B Q1 1 hr
ment characteristics
methods Capability checks C Q1 5 hrs
Training to 6
ext.
Sigma Green Belt
6 Sigma 6 Sigma
Champion ext.
Training
8D, Ishikawa,
Failure avoidance, detection,
brainstorming Z/A Q4/Q1 2 hrs
complaints
(e.g. 635)
Test / inspection methods C Q1 6 hrs
Reading work plans
C Q1 5 hrs
and drawings
WSP Monitoring test / inspection.
D Q4 2 hrs
equipment
Surface inspection R Q4 2 - 4 hrs
Conturograph F Q4 2 hrs
"Customized" interlocking By arrange-
Interlocking G Q4
training ment
technique
Interlocking training D Q5 12 hrs
Document hierarchy at N
Documents H Q6
location FN

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7.3.3.2 Example 2: Qualification and authorisation matrix

Work-station / job description

Station 1 Station 2 Station 3 Station 4

Employee 1 ------------ ------------

Employee 2 ------------ ------------

Employee 3 ------------ ------------

Employee 4 ------------ ------------

Employee 5 ------------ ------------


Employees

Employee 6

Employee 7
P
Employee 8
P
Employee 9

Employee 10

Foreman A

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7.3.3.2 Continued: Qualification and authorisation matrix

Key:

------------ Application not planned, no training necessary

Employee not trained, training to be planned;


e.g. in 6-9 months.

P Employee not trained, training planned; e.g. in 3-6 months.

Employee trained, work according to instructions and with


1 supervision, intensified inspection of work results; e.g. 100%
inspection of seasonal and temporary workers
Employee trained, work according to instructions, random
2
inspection of work results
Employee trained, independent work, skip lot method for
3 inspection of work results
Employee trained, independent work, can train and supervise
4 other employees in jobs (foreman, team leader, etc)

Rules:
For categories 1 to 3:
- participation at least once a year in re-training
- assignment to the work-station at least once a year
Otherwise: reduce the qualification by 0.25
- at least 2 employees per work-station and shift
- at least one employee authorised to give instruction,
per work-station and shift
- each employee authorised to give instruction must have a deputy
(can also be from another sector or higher ranking)
Rework station must be defined:
Who? What is permitted? Which tools? Where?
Rules in case of quality problems: responsibilities, actions,
employee supervision / integration?
Tasks and contents of training courses must be documented and
accessible for every work-station

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7.3.4 Examples of standards for communication / reporting /
escalation

7.3.4.1 Example 1: Reporting and documentation

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7.3.4.2 Example 2: Escalation monitoring

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7.3.4.3 Example 3: Example showing quality key data and
execution

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7.3.4.3 Example 4: Example of key data depiction

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7.3.4.3 Example 5: Example of key data depiction

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7.3.5 Examples of standards covering comprehensive equipment
management, maintenance and service

7.3.5.1 Example 1: Training course material for TPM

TPM

Total Productive
Maintenance

TPM Levels
TPM LEVEL 6
Phase 3 Complete implementation of independent
maintenance, inspection and limited servicing

TPM LEVEL 5
Training employees in independent maintenance,
inspection and limited servicing
Phase 2
TPM LEVEL 4
Detection and correction of minor facility defects

TPM LEVEL 3
Generating standards for basic maintenance
(service and cleaning plans)

Phase 1 TPM LEVEL 2


Preventive measures against contamination

TPM LEVEL 1
Thorough cleaning of the machine / facility / equipment

TPM 2

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7.3.5.1 Continued: Example 1: Training course material for TPM

Level 1:
Thorough cleaning

Î Cleaning the facility


(dust, dirt, swarf, oil, etc.)

Î Tightening bolts

Î Detecting and correcting


deviations (e.g. oil level)

Î Identifying problem points

Cleaning = Inspection

TPM 3

Level 2:
Eliminating causes of contamination

Î Determining sources of contamination


Î Eliminating sources of contamination sources (repairs)
Î Reducing the amount of cleaning and lubrication work
 Use shields and screens
 Controlled collection of oil and filings
 Ensure easy access to problem areas
 Develop special cleaning devices

Prevent the spread of contamination

TPM 4

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7.3.5.1 Continued: Example 1: Training course material for TPM

Level 3:
Develop standards for basic maintenance

Î Ensure quick and safe cleaning, lubrication and checking through


standards (maintenance and cleaning plan)

Î Identify lubrication points, limit values, etc.


- oil levels;
- pressure ranges.

Î Specify the time frame for


basic maintenance
(e.g. 10 minutes a day,
30 minutes on Friday, etc.)

Prevent machine failures

TPM 5

Level 4:
Detect and correct minor facility deficiencies

The machine operator is able to independently monitor accident-prone


components and, in the event of a problem, can trigger the appropriate
corrective measures.

x The machine operator gets to know the causes of failures and their
elimination.

x The status of the machine is depicted by key data and analyses

x Additional maintenance points are made visible

x Training in simple maintenance tasks

x Creation of own maintenance documents

x Observation of health & safety at work

TPM 6

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7.3.5.1 Continued: Example 1: Training course material for TPM

Level 5:
Independent maintenance and limited servicing

The machine operator is able to independently service the machine


according to available check-lists and inspection plans, keep it in good
condition and carry out defined maintenance.

x All types of problems are illustrated by an appropriate action plan.

x Planned service is carried out on the machine, depending on the condition of


the machine.

x Personnel are trained in methods for monitoring


and eliminating disturbances/failures.

x In-depth training in the component parts of the


machine

TPM 7

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7.3.5.2 Example 2: TPM inspection plan (excerpt)

TPM – Total productive maintenance - Inspection plan (page 1)

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7.3.5.2 Example 2 Continued: Total inspection plan (excerpt)

TPM – Total productive maintenance - Inspection plan (page 2)

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7.3.5.3 Example 3: Training documents for TPM of robots

TPM – Total Productive Maintenance


Autonomous maintenance of robots

Despite intensive TPM training on the subject of lubrication, the


complexity and major responsibility involved in carrying out
robot maintenance makes it necessary to carry out additional
technical training for robots. The training is carried out by the
TPM coordinator.

Axle 5: Remove the plug screw for the


grease drain and screw in an adapter so
Axle 5 that the old grease does not drip onto
the drive belt when draining. Then
grease it.
Check the drive belt for wear, tear and
damage, replace if necessary.
Gear
mechanism
Gear Mechanism: Remove the plugs
Axle 1 from both sides and the internal plugs.
Screw in a bolt with a through bore-hole
(for the draining of excess grease) and
then pour the grease in through the
Axle 2 lubricating nipple.

Remove the screw from the drain hole


(across from the lubricating nipple) on
Axle 3 the axles 1-4 and pour grease in
through the lubricating nipple.

Axle 4

The axles 1-4 and the gear mechanism are to be greased with SK3 Harmonic grease
so long until visibly clean grease comes out of the drain side.
Attention: Grease Axle 1 with 5 stroke multi-purpose grease or Shell Alvania No. 2.

Attention: It is imperative that you use the right type of grease.

Axle 5 4 3 2 1 Gear mechanism

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7.3.6 Examples of standards for risk management and contingency
plans

7.3.6.1 Example 1: Process risk filter

The risk filter helps to estimate the risks involved in a process. This
simplifies the decision of whether a risk inspection should be carried out.

Author: --- Date: ---


Participants:
Model range: ---
Process: ---
1a Is it a new product concept (e.g. new component Yes No 0
geometry, new materials, etc)? 100 0
1b Is the process concerned already known or has Yes No 0
a comparable process already been used (also 0 200
regarding new requirements)?
1c Did problems caused by assembly occur with the Yes No 0
previous and/or the comparable process (e.g. 100 0
rework >1minute per vehicle over a longer time
period; process flow disturbances/failures on the
line; actions taken)?
1d Was additional time (planned extra time) Yes No 0
constantly needed with the previous process? 100 0
1e Is there a documentation obligation for the part Yes No 0
to be assembled / for the process parameter 100 0
(e.g. torque monitoring)?
1f Have potential process risks been detected in Yes No 0
prototype production or in a product FMEA? 200 0
2a In case of a large range of variants, is protection Yes No 0
against human error assured by clear detection 0 150
of the variants and their assignment to the
relevant vehicle (visually distinguishable; colour
labelling; Poka Yoke, etc.)?
2b Is there sufficient accessibility to permit a secure Yes No 0
assembly process? 0 50

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7.3.6.1 Continued: Example 1: Process risk filter

2c Is the fitment / assembly process sufficiently Yes No 0


visible to guarantee a secure assembly process? 0 50
2d Has damage to the vehicle / component (e.g., by Yes No 0
essential assembly tools / devices) been 0 100
excluded?
2e Can the possibility of injury from the component Yes No 0
or the assembly tools / devices be excluded? 0 100
2f Have major effects (e.g. production stop) on the Yes No 0
complete process been excluded if failures occur 0 100
in the individual process?
2g If a failure occurs, can risks to the customer and/ Yes No 0
or the environment be excluded? 0 200
3a Can the result of the assembly process be Yes No 0
detected by visual, acoustic or tactile feedback 0 150
characteristics? (e.g., stop position, latch, etc.)
3b If not: can the result of the assembly process be Yes No
checked in subsequent assembly operations? 0 150
3c If not: can the result of the assembly process be Yes No
checked by an adjustment or test specification? 0 200

Total: 0

Assessment: If the total figure from questions 1, 2 and 3 is greater than or


equal to a set threshold value, a process FMEA should be
carried out.

Comment:

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7.3.6.2 Example 2: Flow-chart for contingency management

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7.3.6.3 Example 3: Quality reaction plan

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7.3.7 Examples of standards for problem-solving methods

7.3.7.1 Example 1: Problem-solving sheet

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7.3.7.2 Example 2: 8D Report

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7.3.7.2 Continued: Example 2: 8D Report

See also VDA Volume 8D ‒Problem Solving in 8 Disciplines

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7.3.8 Examples of standards for work-place descriptions and
standard work-sheets

7.3.8.1 Example 1: Standard work-sheet

Occupational Machine: Bench drill Extra Information: Sheet 1


group: XY Operation: Drilling blanks of 1
No. 7.1 Main Steps Critical Items Q S P
1 Clamp the desired drill in the chuck. x
2 Turn on mains isolator switch. x x
3 Switch on machine. x
4 Set the desired drill speed with the manual x x
speed regulator.

5 Start the drilling process by turning the feed Take account of x


lever counter-clockwise. spring return
6 When the drilling process is finished, return the x
drill spindle to the upper position by turning the
feed lever clockwise.
7 Switch off the machine x
8 Take the drill out of the chuck x
9 Turn off mains isolator switch. x
10 Clean the machine. Vacuum up dust from x
metal blanks only with
a vacuum cleaner with
a micro-filter

Q = Quality
S = Safety
P = Profitability

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7.3.8.2 Example 2: Standard work-sheet

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7.3.8.3 Example 3: Process illustrations and production
operations

PROCESS ILLUSTRATIONS
Cost Center: 211.5 Production operation: Date: 04-07-2006
Station: 20 Install centerfill and Parktronic system Work Instruction No.:
(PTS) display

Mount PTS module in


WHAT the centerfill

1. Install centerfill in the


designated opening
using auxiliary tools
2. Connect the plugs to
the PTS module
HOW (observe position)
3. Push PTS module
uniformly into the
centerfill (ensure a
clean snap-fit)

1. Using the auxiliary tool guarantees damage-free installation of the centerfill


2. The PTS module must be correctly positioned to achieve an effective PTS
WHY display (signals must not light up towards the windscreen)
3. Since the PTS module is in the direct field of vision, the driver can
immediately detect a faulty assembly.

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7.3.8.3 Continued:
Example 3: Process illustrations and production operations

Production operation sheet


A0B Process Valid from Comment / explanation
no.
Page
Installation of 08-01-2006 LPA211.5
1 of 1
centerfill and PTS
display
No Main production Description Sym Quality characteristics /
operation . comments
1 Read code Check FIS record on code. OE Centerfill = production
Parktronic System = PTS display PTS = OE
Take out centerfill available.
Take centerfill out of box.
2 Install the Install the centerfill in the designated If the template is not used,
centerfill opening, using the template. the centerfill may be
damaged (dents).
3 Install the PTS Connect plugs to PTS module OE Position is very important.
(observe positions!). Wrong position Æcustomer
Push PTS module uniformly into the cannot see PTS display
centerfill (ensure a clean snap-fit). (diodes point to windshield
and not to driver).
Since the PTS module is in
the direct field of vision, the
driver can immediately detect
a faulty installation.
4

Tool Item no.


Template Special tool

Material Qty Item no.


PTS display 1 123 456 789

Shift manager
Additional documents REZEI. release Team leader release
Author release
MTM analysis, FPL) (initials) (initials)
(initials)
A-shift A-shift
B-shift B-shift
C-shift C-shift

Key: OE = Optional equipment

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7.3.9 Examples of standards for change management

7.3.9.1 Example 1: Life-cycle planning

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7.3.9.2 Example 2: Change request

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7.3.9.2 Continued: Example 2: Change request, page 1

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7.3.9.2 Continued: Example 2: Change request, page 2

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7.3.9.2 Continued: Example 2: Change request, page 2

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Quality Management in the Automotive Industry

The current issues of VDA publications covering quality management in the


automotive industry (QAI) can be viewed in the Internet under
http://www.vda-qmc.de.

You can also place orders on this home-page.

Available from:

Verband der Automobilindustrie e.V. (VDA)


Qualitäts Management Center (QMC)
Behrenstr. 35
10117 Berlin
Germany

Telephone: +49 (0) 30 89 78 42-235


Telefax: +49 (0) 30 89 78 42-605
E-Mail: info@vda-qmc.de
Internet: www.vda-qmc.de

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