Professional Documents
Culture Documents
Product Manufacturing
and Delivery
Robust Production Process
Pre-requisites, Standards, Controlling, Examples
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Joint Quality Management
in the Supply Chain
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ISSN 0943-9412
English edition printed: 2011/12
Reprint: 2020/01
Overall production:
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Non-binding VDA recommendation
Exclusion of Liability
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the time of issue. Implementation of VDA recommendations relieves no one
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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
In addition, the OEMs are faced with ever-greater product complexity and
ever-shorter development and test lead-times.
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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.
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
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These matters should be clarified in appropriate contractual regulations. The
volume at hand makes no claim to be complete.
Our thanks also go to all who have given us encouragement and assistance
in generating and improving the document.
Withdrawn VDA volumes have been removed from notes and overview
tables.
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Dokument wurde bereitgestellt vom
8 VDA-QMC Internetportal am 14/10/2022 um 11:31 AM
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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
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.
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
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
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
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Fig. 1.3-2 Assignment of influencing factors in the ISO model
(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
(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
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.
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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").
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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:
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
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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:
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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
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
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2.2 The four control loops of the Robust Production Process
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.
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"
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
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:
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).
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.
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.
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
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
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
(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.
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
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
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
See also Chapter 5.1.1: Standard 1: Control loops and IATF 16949 Chapter
10.3.
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
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).
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.
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3.2.2 Parts from a new manufacturing location
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
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
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)
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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.
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
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Fig. 5.0-1 Standards in production
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5.1 Basic standards for internal production processes
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….
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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
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
Continuous.
4) Benefits
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
Basic rules:
6) Examples
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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.
Failure
e
Review elimination
Not OK
Production process
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5.1.1 Continued:
Standard 1: Control loops for monitoring and measuring
the production process and products
FEP
FEP Section
ele
release
!
Process step 1 Process step 2 Process step 'n'
-
Failure origination Failure detection
Failure
Review elimination
Process step 1
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5.1.2 Standard 2: Internal quality agreements
2) Areas of application
3) Threshold criteria
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)
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
7) Key data
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5.1.3 Standard 3: Internal release procedure (product & process)
Securing the quality of the product and process for new starts, restarts
and changes.
2) Area of application
Production.
4) Benefits
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5.1.3 Continued:
Standard 3: Internal release procedure (product & process)
6) Examples
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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
To enable employees at all levels to carry out correctly the tasks given to
them.
2) Area of application
3) Threshold criteria
4) Benefits
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5.1.4 Continued:
Standard 4: Employee qualification
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
7) Key data
8) References
x ISO 9001
7.1.2 People
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5.1.5 Standard 5: Communication, reporting, escalation
2) Area of application
3) Threshold criteria
4) Benefits
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5.1.5 Continued:
Standard 5: Communication, reporting, escalation
6) Examples
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5.1.5 Continued:
Standard 5: Communication, reporting, escalation
7) Key data
8) References
x ISO 9001
7.4 Communication
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5.1.6 Standard 6: Comprehensive equipment management /
maintenance / service
2) Area of application
3) Threshold criteria
4) Benefits
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5.1.6 Continued:
Standard 6: Comprehensive equipment management /
maintenance / service
Plan Do
Act Check
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5.1.6 Continued:
Standard 6: Comprehensive equipment management /
maintenance / service
6) Examples
7) Key data
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
2) Area of application
3) Threshold criteria
4) Benefits
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5.1.7 Continued:
Standard 7: Risk management / contingency plan
6) Examples
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
2) Area of application
Production.
3) Threshold criteria
4) Benefits
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5.1.8 Continued:
Standard 8: Problem-solving methods
6) Examples
7) Key data
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
2) Area of application
Production.
3) Threshold criteria
Fundamental.
4) Benefits
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
6) Examples
7) Key data
8) References
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5.1.10 Standard 10: Change management
To secure the quality of product and process where changes are made,
to ensure no failures due to changes.
2) Area of application
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
Supplier involvement
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5.1.10 Continued:
Standard 10: Change management
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
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5.1.10 Continued:
Standard 10: Change management
6) Examples
7) Key data
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
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5.2.1 Supplier selection
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
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
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.
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.
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 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.
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
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5.3 Monitoring & controlling
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.
Using the key data, the rating is determined as follows (see also Chapter
2.3.1: Classification using the traffic lights system):
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
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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:
For this, the following must be contractually regulated with the customer:
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.
Product classification:
For the requalification inspections, the following must be taken into account
with regard to planning, execution and documentation:
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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.
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5.4 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.
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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.
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 :
Source/Source reference
e Risk Management
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5.4.2 Reactive failure management
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
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
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
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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
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
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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
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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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95
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
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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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97
7 Appendix
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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
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7.1 Glossary and abbreviations
General terms
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General terms
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General terms
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7.1.2 Terms in the standards environment
Term Source
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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
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7.1.3 List of abbreviations
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7.1.3 Continued List of abbreviations
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7.2 Check-lists
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7.2.1 Continued
Check-list for production transfers and carry-over parts
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7.2.1 Continued
Check-list for production transfers and carry-over parts
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7.2.1 Continued
Check-list for production transfers and carry-over parts
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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
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7.2.3 Logistics concept check-list
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7.2.4 Check-point check-list
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7.2.4 Continued
Check-point check-list
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7.2.5 Quality assurance & logistics agreement (QALA) check-list
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
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7.2.5 Continued
Quality assurance & logistics agreement (QALA) check-list
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
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7.2.5 Continued
Quality assurance & logistics agreement (QALA) check-list
IATF 16949
Minimum contents Comments
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
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7.2.5 Continued
Quality assurance & logistics agreement (QALA) check-list
IATF 16949
Minimum contents Comments
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7.2.5 Continued
Quality assurance & logistics agreement (QALA) check-list
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
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7.2.5 Continued
Quality assurance & logistics agreement (QALA) check-list
IATF 16949
Minimum contents Comments
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!
- Material x x
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7.2.5 Continued
Quality assurance & logistics agreement (QALA) check-list
IATF 16949
Minimum contents Comments
- Design x x
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!
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7.2.5 Continued
Quality assurance & logistics agreement (QALA) check-list
IATF 16949
Minimum contents Comments
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7.2.6 Key data matrix check-list
Mini
Cock- Check-
Measurement criterion Comment / Definition cock-
pit point
pit
Complaints / reject x
management
Change management x
Logistics concept x
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7.2.6 Continued Key data matrix check-list
Mini
Cock- Check-
Measurement criterion Comment / Definition cock-
pit point
pit
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"
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
Mini
Cock- Check-
Measurement criterion Comment / Definition cock-
pit point
pit
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7.2.6 Continued: Key data matrix check-list
Mini
Cock- Check-
Measurement criterion Comment / Definition cock-
pit point
pit
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7.2.7 Example of cockpit for Robust Production Processes
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7.2.7 Continued:
Example of cockpit for Robust Production Processes
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
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
Probability of occurrence = O
Probability of detection = D
Possible cause of failure
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
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
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
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
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
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
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7.3.1 Continued Examples of standards for internal quality
agreements
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7.3.1 Continued Examples of standards for internal quality
agreements
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7.3.2 Examples of standards for release procedures
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7.3.2.1 Continued
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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
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7.3.2.1 Continued
2. Work flow-sequence
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7.3.2.1 Continued
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7.3.2.1 Continued
(The heading should show the production area and current date)
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7.3.2.2 Example 2: Quality evaluation
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)
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7.3.2.2 Continued Example 2: Quality evaluation
Comments
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7.3.2.2 Continued: Example 2: Quality evaluation
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
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7.3.3 Examples of standards for employee qualifications
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
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:
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
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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
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)
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 Tightening bolts
Cleaning = Inspection
TPM 3
Level 2:
Eliminating causes 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
TPM 5
Level 4:
Detect and correct minor facility deficiencies
x The machine operator gets to know the causes of failures and their
elimination.
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
TPM 7
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7.3.5.2 Example 2: TPM inspection plan (excerpt)
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7.3.5.2 Example 2 Continued: Total inspection plan (excerpt)
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7.3.5.3 Example 3: Training documents for TPM of robots
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.
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7.3.6 Examples of standards for risk management and contingency
plans
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.
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7.3.6.1 Continued: Example 1: Process risk filter
Total: 0
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
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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
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7.3.8 Examples of standards for work-place descriptions and
standard work-sheets
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
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7.3.8.3 Continued:
Example 3: Process illustrations and production operations
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
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7.3.9 Examples of standards for change management
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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
Available from:
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