Process Audits VDA 6.3 – “Management“ 2-day introduction

© VDA QMC Revision 17-11

Process Audits VDA 6.3 – “Management“2-day introduction training

LE05-001

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• Overview of the contents of the VDA 6.3 method

• Knowledge about other VDA 6.x methods

• Understanding of the ”Turtle Model” for process approach.

• Understanding of relationship to IATF 16949 and ISO 9001

• Power of using VDA 6.3 as a standardised tool

• Potential analysis as tool for in the supplier development process

• Process for performing internal audits.

• Understanding of evaluation scheme for VDA 6.3

Purposes and objectives

1410-LE10-TF000-001

VDA 6.3 – Länkar till andra krav

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During the audit of your supplier MUDA SWEDEN AB your are assigned to audit the project performance for development of energy cells for battery production to the new premium car Excelsior Crown. You interview the project manager and the project team and establish following:

• A project management established with a project organisation!

• Is there a project plan and has this been agreed with the customer!

• Structured resource planning based on the progress of the project has not yet been carried out!

• Change management within the project ensured by the project organisation!

• An escalation process established and is this effectively implemented!

HOW DO YOU DETERMINE THE SITUATION ?

SIMPLE CASE??

NON-CONFORMITY ?NON-CONFORMITY ? MAJORMAJOR MINORMINORFår ej

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During the audit of your supplier MUDA SWEDEN AB your are assigned to audit the project performance for development of energy cells for battery production to the new premium car Excelsior Crown. You focus on change management during developmentor products and processes. You sample four different projects and find one case wherea change specification initiated by the top management has not been validated (and approved) at the the product and project was transferred to production.

HOW DO YOU DETERMINE THE SITUATION ?

10p – Completely compliant with requirements. (No risk)

8p - Partially compliant. Minor Non-Conformity (Low risk)

6p – Partially compliant. Medium Non-Conformity (Medium Risk)

4p – Not complaint. Major Non-Conformity (High risk)

0p – Non existing (Extremly high risk)

SIMPLE CASE 2

QUIZ TIMEQUIZ TIME

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Carry out process audits systematically and effectively

Content:

• Classification international

Quality standards

• Overview of VDA 6.3 volumes

• Other monitoring systems

• Work safety and environmental

protection

Classification and demarcation

LE10-001

VDA 6.3 – Connection to other requirements

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Automotive Specific Requirements for Quality Management

LE10-002

International Requirements

Industry Sector Requirements

Customer Specific Requirements

QM-Handbook

QM-Handbook

Approach and responsibility

Who, what, when

How

Results, evidence,effectiveness

EU-Laws & EU StandardsDIN EN ISO 9001

VDA Volumes & IATF 16949

QAA, Special Terms,..

Legal Requirements National Legislation

VDA 1Documentation and ArchivingVDA 2Quality Assurance for SuppliesVDA 3 (Part 1 und 2)Zuverlässigkeitssicherung bei Automobilherstellern u. LieferantenVDA 4 Loose-leaf BinderQuality Assurance in the Process LandscapeVDA 5Capability of Measurement ProcessesVDA 6Certification Requirements forVDA 6.1, VDA 6.2 and VDA 6.4VDA 6.3Process AuditVDA 6.4QM-System audit Production EquipmentVDA 6.5Product auditVDA 6.7Process audit – Unit ProductionVDA 19.1Technical CleanlinessVDA MLAMaturity Level AssuranceVDA RPPRobust Production ProcessVDA FFAField Failure AnalysisAutomotive SPICEProcess assessment model

Note: List is not complete!(see VDA QMC Webshop)

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Automotive specific

Development of QM Standards

LE10-003

1999 2000

ISO 9001:1994(Basic Standard)

QS-9000 3rd Edition

ISO/TS 169491st Edition

2002

Industry Newtral

2008


2006

ISO/TS 169492nd Edition

20152009


VDA6.2 (2004) VDA6.1 (2010) VDA6.1 (2016) VDA6.2 (2017)


ISO/TS 169493rd Edition

2016

IATF 169491st Edition


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9.2.2.2 Quality management system audit

• Audit all processes over a three year's calendar period, according to one annual plan

• Apply process direction

• Include customer specific requirements

• Audit all production processes over a three year's calendar period, according to an annual plan

• Determine effect and effectiveness

• Use a procedure for process audits specified of customer

• Production processes are audited on all shifts

• Appropriate numbers samples of shift changes

• Audit of efficiently introducing of the risk analysis for the process (PFMEA/Control plan)

9.2.2.3 Manufacturing process audit

• At appropriate stages during production and delivery

• Verify compliance with specified requirements

• Using of customer specific methods

9.2.2.4 Product audit

IATF

IATF 16949-9.2.2 Internal audits

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Overview of the VDA 6.x Volumes

LE10-006

Rules

Process

Product

System

Serial Production Single ProductionServices

VDA 6

VDA 6.1 VDA 6.4VDA 6.2

Material Products – VDA 6.3 – Services VDA 6.7

VDA 6.5


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The interface between hardware and software for products withintegrated software is included in the questionnaire.

For a detailed evaluation of software development assessments using Automotive SPICE®, CMMI can be applied additionally .

Questions concerning environmental protection and occupational safety are not explicitly included, since there are specific monitoring systems and normative guidelines.

VDA 6.3 – Boundaries with other monitoring systems

LE10-007

EMAS²

ISO 14001

ASiG, ArbSchG, DGUV¹

OHSAS 18001


ASiG, ArbSchG, DGUV¹ - example for country specific legislation (German), EMAS² - Eco-Management and Audit Scheme

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Obvious issues that affect the “product and/orenvironment” must be documented and taken into account in the evaluation.

Dealing with environmental issues and work safety in the audit

LE10-008

6.1.3 Are incoming materials stored appropriately?

6.4.4 Are the work and inspection stations appropriate for the needs?

6.4.5 Are tools, equipment and test equipment stored properly?

Other possible related questions: 6.6.4* / 7.1 / 7.3*


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Carry out process audits systematically and effectively

Contents:

• Definition and audit objectives

• Basics of the audit

• Definition of audit types

• System audit

• Process audit

• Product audit

Overview of Audit Types

LE20-001

VDA 6.3 – Types of Audits

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• DIN EN ISO 19011 defines an audit...

... „systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.“

• The altitude has to be remembered during audits…

How deeply do we have to enter the process chain as auditors?

Audit definition und Audit objectives

LE20-002


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• Audits are always random checks.

• The auditor has to take appropriate samples.

• Internal audits are carried out by independent, adequately qualifiedemployees.

• External audits are carried out by customers, their representatives or certification bodies. The auditor must be independent and comprehensively qualified.

• The auditor must align the findings to the requirements of the checklist and make a comprehensible assessment.

Basics of audits

LE20-003


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• Internal or external audit to determine the process capabilityfor selected products and their processes

• Check of the suitability and appropriatenessof the planned processes for the developmentand production of defect-free products

• Evaluation of the potential risk that productswill not meet the specifications or cause failure or problems at further production steps or during the usage phase

Process audit – Focus is on product quality and related processes

LE20-007


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Comparison of audit types

LE20-004


Audit Type Audited item Purpose

System audit QM System Assessment of the completeness and effectiveness of the basic requirements

Process audit(Service audit)

Realisation process for material products as well as the implementation of services (intangible)

Assessment of the Quality Capability

• For special products or product groups and their processes

• For services

Product audit Products Assessment of product quality characteristics

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Carrying out process audits systematically and effectively

Content:

• Overview

• Instructions for use

• Auditor requirements

• Audit process

• Potential analysis

• Evaluation

• Questionnaire

Overview of the content of VDA 6.3

LE30-001

VDA 6.3 – Structure

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Application of the process elements withina specific project

LE30-003

Chapter 2


Supplier

VDA 6.3

Customer

Definition ofProduct & Process

Preselectionof Suppliers;

Potential Analysis

Product / ProcessDevelopment

SerialProduction

CustomerService

(After Sales)

OfferProcessing(ContractReview)

Product-/ Process-

Development

SerialProduction

CustomerService

(After Sales)

Product/Process

Definition

Preselectionof Suppliers;

PotentialAnalysis

Issue Contract SOP

SOPReceive Order Issue Contract

P2/P3

P5-P7

P2-P4

Potential Analysis (P1)

P5-P7

X1

X2

X3

X4

X5

VDA-MLA Innovation Phase Ongoing Series

Innovationrelease forfull productequipment

Requirementsmanagement

for the contractissued

Specifiying thesupply chain andplacing the order

Release oftechnical

specifications

Completion ofproductionplanning

Product andprocessapproval

Parts fromproduction toolsand production

facilities areavailable

Project completion, transfer of

responsibilities toproduction. Start

requalification

ML0 ML1 ML2 ML3 ML4 ML5 ML6 ML7Får ej

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Scope of application in the supply chain

LE30-004

Chapter 2


Organisation

Supplier

Client

Product/ProcessDefinition

Preselectionof SupplierPotential Analysis

Product / ProcessDevelopment

SerialProduction

CustomerService

(After Sales)

Order Processing(ContractReview)

Product/ Process

Development

SerialProduction

CustomerService

(After Sales)

Product/Process

Definition

Preselectionof SupplierPotentialAnalysis

Award of Contract SOP

SOPReceive order Issue contract

SOPIssue Contract,Recieve Order,

Sub-Supplier Supplier Organisation Client

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Process orientated approach for the identification of risk

LE30-005

Chapter 2


I O I OO - OutputI - Input

Processstep 2

I . OPS1

Interface

Material Resources (P6.4)

What resources are used to complete the process?

e.g. machines, installations, equipment, …

I . OPS3

Interface

Personnel Resources (P6.3)

What areas, functions, persons support the process

e.g. capacity, competence, authority, …

Process Operation (P6.2)

How does the process work?

e.g. work sequence, methods, techniques, instructions

Effectiveness, Performance Indicators (P6.5)

How effectively is the process carried out?

e.g. effectiveness, efficiency, waste

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Audits the internal process chain without considering interfaces tosuppliers and/or customers:

• Good knowledge of quality tools and methods (e.g. VDA-MLA, DoE, FMEA, FTA, PPA, SPC, SWOT, 8D Method)

• Knowledge of the relevant customer specific requirements

• Knowledge of the relevant management system requirements (e.g. ISO/TS 16949 and respectively IATF 16949, DIN EN ISO 9001, VDA 6.1)

• Specific knowledge regarding the product and process

Professional experience

A minimum of 3 years professional experience (at least 1 year experience in QM).

Qualification of internal auditors

LE30-006

Chapter 3


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Audits the complete supply chain; the auditor carries out internal and external process audits with interface to suppliers and/or customers:

• Excellent knowledge of quality tools and methods (e.g. VDA-MLA, DoE, FMEA, FTA, PPA, SPC, SWOT, 8D Method)

• Auditor qualifications (negotiation, conflict management, audit procedure)

• Knowledge of the relevant customer specific requirements


• Specific knowledge regarding the product and process



Qualification of supplier auditors

LE30-007

Chapter 3


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Audits as an external service provider from an independent, third party organisation. Carries out the audit as a service for the organisation.

• Excellent knowledge of quality tools and methods (e.g. VDA-MLA, DoE, FMEA, FTA, PPA, SPC, SWOT; 8D Method)

• Auditor qualifications (negotiation, conflict management,audit procedure)Knowledge of the relevant customer specific requirements


• Specific knowledge of the product and process



Qualification of process auditors as external service providers

LE30-008

Chapter 3


examinationnecessary

!

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Detailed Description of the Audit Process

LE30-010

Chapter 4


Internal Audit

External Audit (Supplier)

Potential Analysis (Supplier)

Audit request PreparationConducting the audit

EvaluationPresentation of results

Follow up and closure

Audit

programme

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• Evaluation of potential new, unknown supplier (contender)

• Evaluation of unknown locationsor new technology or newProducts

• Classification of the potential for product development und production

Potential analysis

LE30-011

Chapter 5


Clarify resources needed for

qualification

Clarify the initial

situation and limit the contract

Award of contract

Request supplier self evaluation

and rate this

Compile questionnaire

module

Specify the audit team

On site visitRisk

evaluationFår ej

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VDA 6.3 – 2016 Process element

P2 Project management

P3 Planning the product and process development

P4 Implementation of the product and process development

P5 Supplier management

P6 Process analysis/production

P7 Customer care, customer satisfaction, service

58 questions

Breakdown of the questions in VDA 6.3

LE30-014

Chapter 7


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• Each question is assessed in terms of compliance with the requirements and the risk involved.

• The overall assessment is calculated from the individual evaluations taking into account:

Rules and hurdles for process steps, process elements and/or process sub-elements

Downgrading rules for use with *-questions

• Using the overall assessment, classification is given as A, B or C

Overall assessment

LE30-012

Chapter 6

VDA 6.33rd Edition 2016


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© VDA QMC 315TF000-35


Content:

• Identification of processrisks

• Knowledge database

Process orientated approach and risk analysis

LE40-001

Chapter 2

VDA 6.3 – Process orientated approach and knowledge database

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© VDA QMC 315TF000-36

Risk analysis, identification of risk in the product and process

LE40-004


O - OutputI - Input Process Step2I . OPS1 I . OPS3

What should the process produce?What goes into the process?

interface interface

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© VDA QMC 315TF000-37

Process terminology

LE40-002

Each process has a start and an end that are defined by two limit values

and a chain of activities between these two limit values!

Interface Interface Interface

Interfaces between process steps are potential risks!!!

VDA 6.3 - Process orientated approach and knowledge database

OutputCustomer with

requirement met

InputCustomer with requirement

Process

I . OPI . OP I . OPI . OP

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© VDA QMC 315TF000-38

Basic scheme of the turtle model

LE90-002

VDA 6.3 – Using the questionnaire

What goes into the process (input)?

What should be theresult of the process

(output)?

Process stepI


Material Resources

Which personnel is used in the process?

Personnel Resources


Process operation


Effectiveness

1.1 Which process elements (or sub-elements of P6) are part of

the example?

1.3 What should be the result of the process?

an abstract solution to the chosen process element

1.2 What goes into the process?

general listing of the selected process elements Får

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© VDA QMC 315TF000-39

Allocation of questions in the turtle model

LE40-003


I – Input O – OutputProcess Step 2I PS1 O PS3I O









e.g. work sequence, methods, techniques, instructions,…



e.g. effectiveness, efficiency, waste,…

1

2

3

4

5

6

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© VDA QMC 315TF000-40


Content:

• Risk analysis using the turtle model

• Structure of thequestionnaire

• Question and assessmenttechnique

Using the questionnaire

LE90-001

Chapter 6


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© VDA QMC 315TF000-41

Structure of the questions

LE90-006


Process element P6: Process analysis production

P6.1 What goes into the process?

Process input

P6.1.1 Has the project been transferred from development to serial

production and is a reliable start guaranteed?

Minimum requirements relevant for

assessment

Examples for

implementation

The project transfer to serial production has been carried out. If necessary, unresolved issues are followed up on and implemented on schedule. The responsibilities for the entire handover process are regulated and acknowledged.A complete production process and product release (PPA) including the documentation required must take place before the first production shipment.…

• Project status reports• Transfer reports• Milestone reports• Defined actions with

implementation schedule• Process FMEA and actions

…

12

3

4

5

1. Process element 4. Minimum requirements

2. Sub-element (if present)

5. Examples for practical use

3. Question

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© VDA QMC 315TF000-46


Content:

• Audit programme

• Audit request

• Preparation

• Conducting the audit

• Evaluation

• Presentation of results

• Follow up and closure

Audit process

LE50-001

Chapter 4

VDA 6.3 – Audit process

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© VDA QMC 315TF000-47

Process steps of an audit

LE50-003


Internal audit

External audit (supplier)

Potential analysis (supplier)

separate chapter

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© VDA QMC 315TF000-48

Audit programme

LE50-004


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© VDA QMC 315TF000-50

Awesome partsfor amazing cars

Nr. Vorgangsname Dauer Anfang Ende Ressourcen-namen

1 Projekt TK 123 65 Tage? Mo 11.01.10

FR 09.04.10

2 Entwicklung 10 Tage? Mo 11.01.10

Fr 22.01.10 Müller/Schulz

3 Freigabe/SOP 5 Tage? Mo 08.02.10

Fr 12.02.10 Meier

3 Serie 5 Tage? Mo 05.04.10

Fr. 09.04.10 Lehmann

5

3 Projekt DT 26B 35 Tage? Mo 25.01.10

Fr 12.03.10

7 Vorproduktion 5 Tage? Mo 25.01.10

Fr 29.01.10 Meier

8 Endmontage 5 Tage? Mo 08.03.10

Fr. 12.03.10 Lehmann

9

10 Projekt ABC 99 10 Tage? Mo 05.04.10

Fr 16.04.10

11 Auslagerung Druck 10 Tage? Mo 05.04.10

Fr 16.04.10 Peters

12

13 Projekt T1234 40 Tage? Mo 29.03.10

Fr 21.05.10

14 Vorfertigung 5 Tage? Mo29.03.10

Fr 02.04.10 Meier

15 Härterei 5 Tage? Mo26.04.10

Fr 30.04.10 Dr. Dieter

16 Galvanik 5 Tage? Mo 10.05.10

Fr. 14.05.10 Peters

17 Montage 4 Tage? Di 18.05.10 Fr. 21.05.10 Lehmann

18 Endprüfung 5 Tage? Mo 26.04.10

Fr 30.04.10 Müller

Projekt: Projekt 1

Datum: Mo 12.04.10

Vorgang

Unterbrechung

In Arbeit

Meilenstein

Sammelvorgang

Projektsammelvorgang

Externe Vorgänge

Externer Meilenstein

Stichtag

Seite 1

Current audit programme

• Acceptance of unrealized audits from existing audit programs

Experience from previous years

• Repeat audits

• Planned routine/approvals

• Layout inspection

• As part of a system audit

• Effectiveness test of new/changed processes

Audit programme

LE50-006


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© VDA QMC 315TF000-51

LE50-007


Audit request

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© VDA QMC 315TF000-53

LE50-009


Audit preparation

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© VDA QMC 315TF000-57

LE50-013


separate chapter

Evaluation

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© VDA QMC 315TF000-58

Auditte

am

festle

gen

• Findings

• Quantitative assessment

• Decision regarding follow up audit

• Audit findings

• Individual questions from the checklists


Evaluation

LE50-014

Description:

• Assign the audit findings to the questions of the questionnaire /checklists

• Carry out quantitative evaluation

o (10-8-6-4-0)

• Document deficits

• Create the overall rating

• Observe the grading rules

Description:

• Not reaching a defined level of compliance

• Risks associated with a critical process

• Not achieving required results (zero points) for one or more questions marked (*)

• Red traffic light at potential analysis

Responsibility:

• Lead auditor, audit team

Responsibility:

• Lead auditor, audit team

Decision about follow up audit

Evaluation in accordance with the evaluation scheme

Input Output

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© VDA QMC 315TF000-59

Points Assessment of compliance with the requirements

10 Full compliance with requirements

8 Requirements mainly¹ fulfilled; minor deviations

6 Requirements partially fulfilled; significant deviations

4 Requirements inadequately fulfilled; major deviations

0 Requirements not fulfilled

6.1 Evaluation of the individual questions

LE70-004

VDA 6.3 – Audit evaluation

•LE70-00

1) The term "mainly" means that the relevant requirementsare met in most instances and no special risks have been identified.

2) n.e. means not evaluated (not applicable)10

86

4

0

n.e.²

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© VDA QMC 315TF000-60

Risk assessment from the perspective of the process/process step: specific

Risk assessment from the perspective of the product; specific

Systematic view; abstract

10 Technical requirements and specifications

for the process are fulfilled

No product defects, the product meets

the technical standards

Requirements are completely

met

8 Small deviations in the process which do not

affect compliance with the customer

specifications or have an effect on following

process steps

Some product defects but no

influence on the function, use or

further process steps

Requirements are mainly

fulfilled;

minor deviations

6 The process does not always meet the

defined requirements. This has an impact on

the customer or following process steps

Product non-conformities do not affect

the function; however the failure has a

negative impact on the use or on


Requirements are partially

met;

significant deviations

4 The process does not meet the defined

requirements and has a significant impact on


Product non-conformities have an

impact on the function, the failure

leads to usage restrictions, significant

impact on the following process steps

Requirements insufficiently

met;

major deviations

0 The process is not capable of ensuring

compliance with the defined requirements

Product non-conformities, no function,

the use of the product is considerably

reduced, further process steps are not

possible

Requirements are not met

6.1 Evaluation guideline (Page 56)

LE70-005


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© VDA QMC 315TF000-61

Conversion of open questions to closed questions

Question and assessment technique

LE90-007


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Content:

• QuestionnaireProcess element P2Project management

Questionnaire

LE60-003

Chapter 7

VDA 6.3 – Questionnaire P2

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What is ensured?

• An integrated project management with project organisation has been established

• The project organization is equipped with the necessary resources. Tasks, powers and competencies are defined and known.

• The project planning is coordinated with the customer

• The advanced product quality planning and procurement activities are monitored for compliance

• Change management is ensured

• An escalation process is established and ensured

Process element P2 – Project management

LE60-004


OrganisationOffer

processing (contract review)

Product/ process

development

Serial production

Customer service (after sales)

Product/process

definition

Preselection of suppliers:

potential analysis


Allocation of questions P2

P3

P1

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2.1 Is a project management established with a project organisation?

Focus:

• The project organisation is specified and contacts are defined

• The responsibilities and authority of the project leader and team members are defined

• The team members of the project are qualified to carry out their tasks

• The project organisation meets the customer requirements

• Suppliers are involved in project management

LE60-005


T&H SWPOT*

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2.2 Are all resources required for the project implementation planned and available and are changes reported?

Focus:

• Resource planning takes the customer requirements into account

• The staff workload has to be considered

• Review and where necessary adjustment of resource planning is carried out when changes occur

• The critical path is given special consideration within the resource planning

• The necessary project budget for personnel and equipment is planned and released.

• Changes in the project organisation are reported

LE60-006


T&H SWPOT*

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2.3 Is there a project plan and has this been agreed with the customer?

Focus:

• A review is carried out at the milestones defined in the project plan

• All internal and customer defined milestones are fully incorporated in the project plan

• Internal and external communication is ensured when changes are made to the project plan

• Detailed quality-related project activities must be part of the project plan. The plans must take prototypes and pre-launch parts into account

• The project plan must include the detailed activities concerning procurement

LE60-007


T&H SWPOT*

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2.4 Is the advanced product quality planning implemented within the project and monitored for compliance?

Focus:

• Advanced product quality planning activities must meet the specific customer requirements

• Both product and process assurance measures are part of the advanced product quality planning

• Verification and validation of the customer requirements are contained within the planning

• The planning also addresses critical components and scope of supply

• The planning is regularly monitored for compliance and for target achievement

LE60-008


T&H SWPOT*

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2.5*Are the procurement activities of the project implemented and monitored for compliance?

Focus:

• The activities have to ensure that only approved and quality-capablesuppliers are used in production

• The level of activity depends on the risk classification of procured scope of supplies

• The transfer of customer requirements in the supply chain is ensured

• The activities also include customer required suppliers (directed suppliers) as stated within the agreement

• The suppliers for facilities, machinery, tools, test and measurement systems as well as services are integrated

• Dates for the assignment, supplier milestones and release have been laid down in the plan and coordinated with the overall schedule and the progress is monitored

LE60-009


T&H SWPOT*New

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2.6*Is change management within the project ensured by the project organisation?

Focus:

• Change management within the project meets the customer's specific requirements

• Changes lead to a new evaluation

• Changes are documented according to the specifications

• If changes affect product quality, the risk must be assessed with the customer

• Suppliers are actively involved in change management

LE60-010


T&H SWPOT*

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2.7 Is there an escalation process established and is this effectively implemented?

Focus:

• The escalation process in the project takes the specific customer requirements into account

• The criteria for escalation are defined, responsibilities and authorities are regulated and measures derived when deviations occur

• If risks have been identified in technologies, suppliers or supplied countries, these risks have to be considered within the escalation management

LE60-011


T&H SWPOT*

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Allocation of questions P2

P3

P1

What is ensured?

• The requirements necessary to submit an offer are known

• The feasibility is ensured

• The product and process development plan ensures that all necessary activities are planned and coordinated with the customer

• The activities to safeguard customer care and field complaint analysis are planned

• The necessary resources have been taken into account in the planning

Process element P3 - Planning the product and process development

LE60-021


OrganisationOffer


Product/ process

development

Serial production


Product/process

definition


potential analysis


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3.1 Are the specific product and process requirements available?

Focus:

• All requirements regarding the product to be developed are known or are systematically determined

• For products with embedded software, the requirements at interfaces between hardware and software are defined

• The organisation must take into account and use requirements on the product and the process known from previous experience

• Special characteristics are defined

• The quality requirements from the customer for the product and the process must be available

• Inquiry and contract documents are checked for completeness

• If customer requirements cannot be fulfilled the customer must be notified or deviations “allowed”/approved by the customer

• Quality agreements with directed suppliers are available

LE60-022


T&H SWPOT*

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3.2*Is the feasibility comprehensively evaluated according to the product and process requirements?

Focus:

• All determined product and process specific requirements must be checked for feasibility

• Material and personnel resources must be considered in the feasibility study

• The results of the feasibility study must be available before tendering

• The feasibility of critical purchased parts must be ensured

• If customer requirements cannot be fulfilled the customer must be notified or deviations “allowed”/approved by the customer

LE60-023


T&H SWPOT*

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3.3 Are the activities for the product and process development planned in detail?

Focus:

• When planning the product and process development the level of detail is dependent on the component, software and complexity of the process

• Suitable methods must be used to secure the product and process and minimise risk

• Risk analyses are part of the planning

• Requirements of the product operational conditions are considered

• The plans contain important milestones, times and periods

• Methods for development release meet customer requirements

• Activities related to the procurement scope are planned

• Outsourced processes and services are part of the project planning

LE60-024


T&H SWPOT*

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3.4 Are the activities planned for customer care/customer satisfaction/customer service and field failure analysis?

Focus:

• The customer requirements for the supply of parts across the product life cycle are taken into account

• Concepts to continually ensure series supply including a contingency plan are provided

• A fall-back concept is provided for product and process innovation

• The analysis process for 0-km and field complaints is planned and takes field failure analysis into account

• When introducing new technologies and products, employee training and the creation of the necessary infrastructure planned

LE60-025


T&H SWPOT* T&H SWPOT*New

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3.5 Have the necessary resources been taken into account for the product and process development?

Focus:

• Determination of resources refers to the availability of qualified personnel, budget, infrastructure such as building, test and inspection equipment including hardware and software

• Capacity for the implementation of prototypes and prototype construction, pilot-run, performance test and serial production must be planned and considered

• The resource planning is regularly adapted to changes in the project and potential bottlenecks are to be considered

LE60-026


T&H SWPOT* T&H SWPOT*

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What is ensured?

• All actions from the product and process development plans are implemented

• Reviews are carried out at defined intervals

• Personnel and material resources as well as approvals are available

• Changes are identified and taken into account in the planning, measures in case of non-compliance with specifications are defined and monitored for effectiveness

• A performance test is carried out and the project transfer has been regulated

Process element P4 - Implementation of the product and process development

LE60-034


Allocation ofquestions P2

P3

P1

P4

OrganisationOffer


Product/ process

development

Serial production


Product/process

definition


potential analysis


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4.1*Are the actions from the product and process development plans implemented?

Focus:

• The planning activities for the product and process are implemented

• Risk analysis e.g. FMEA for product and process are part of the development plan and take customer requirements into account

• Special characteristics are identified und taken into account in the FMEAs

• A test plan for components, assemblies, subassemblies, components, software and materials is available

• The overall plan must also include manufacturing processes from prototype and pre-launch phase

• Purchased products and services are taken into account in the supply chain

• Results from prototype phase and the pre-launch phase are documented and used as a reference in the series phase

• The requirements for test equipment are defined

LE60-035



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4.2 Are personnel resources available and are they qualified to ensure the start of serial production?

Focus:

• A staff schedule must be available and updated regularly

• Personnel must be qualified for their respective tasks. This also applies to the staff of external service providers

• Personnel resources are planned and qualified according to the project plan

• Processes that have been outsourced must be considered

LE60-036



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4.3 Are the material resources available and suitable to ensure the start of serial production?

Focus:

• A process to determine resources is available

• Resource determination related to test equipment, laboratory equipment, machinery, equipment, and the utilization of machinery and equipment is available

• The necessary infrastructure is taken into account

• A regular needs assessment is carried out

• Material resources for the realization of prototypes and sample building, pre-production, series start and serial production are available at the time determined in the project plan

• Outsourced and supporting processes must be considered

• The resources must be available with a suitable lead time before the start of serial production

LE60-037



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4.4*Are the required approvals and releases for the product and process development available?

Focus:

• Releases and verification of suitability are available for all items, assemblies, software versions and purchased products and services

• The material data is confirmed and released

• Actions from the FMEAs have been implemented and confirmed in their effectiveness

• The production process and product approval (PPA) is available at series start. For products with embedded software an additional software test report is available.

• Reference parts from sampling must be kept for the time stated in the customer requirements

• The verification and validation of the product and process are ensured before the customer SOP

LE60-038



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4.5 Are the manufacturing and inspection specifications derived from the product and process development and are they implemented?

Focus:

• The manufacturing and inspection specifications contain all characteristics from the product and process development including special characteristics

• Results of the risk analysis are considered

• The specifications include information for product control, manufacturing process control including reaction plans

• Product audits and “layout inspection and functional testing”¹ are defined and planned

• Specifications are available at the prototype phase (if required by the customer), pre-launch and series phase

Layout inspection and functional testing¹ - requalification

LE60-039



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4.6 Is a performance test carried out under series conditions for the series release?

Focus:

• The performance test has provided evidence that the quality capability of the entire production process is given under serial production conditions

Note: Depending on the time of the audit some parts of the relevant production test could still be at the planning stage!

LE60-040



This question is not relevant for the product development and is only evaluated for the process development!

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4.7 Are the processes established for securing customer care/customer satisfaction/customer service as well as the field failure analysis?

Focus:

• The customer requirements for the supply of parts during the product lifecycle are established

• The planned processes for the continuous series supply including safety margins for emergencies are available

• The analysis process for 0-km and field complaints is established andtakes customer requirements into account

• The requirements for the analysis capability at the site have been agreed with the customer

• If external sites are used for analysis, the interfaces are defined. Additionally, evidence of the presence of the required equipment and capacity is available

• New technologies and products are also taken into account in customer support

• The employees designated for these processes are qualified

• The infrastructure is available

LE60-041



This question is not relevant for the product development and is only evaluated for the process development!

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4.8*Is there a controlled method for the product handover from development to serial production?

Focus:

• A process exists for transferring work results from the project to the production

• A successful internal PPA process and series releases from the customer are available

• For products with embedded software, the results of the development are documented

• Proof of capability can be shown for all special characteristics

• Personnel resources are qualified, available and material resources available and approved in accordance with the planning

• Releases for procurement volumes are available

• Measures to secure the start-up of production are specified and introduced when necessary

LE60-042



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Audit evaluation

LE70-002

Chapter 6


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6 Evaluating a process audit for material products


6.2 Detailed evaluation and downgrading rules

6.3 Overall level of compliance and downgrading rules

6.4 Evaluation of product groups

6.5 Using the questionnaire (Process elements P2 toP7)

Evaluation – assessment

LE70-003


•LE70-001

Chapter 6

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Points Assessment of compliance with the requirements

10 Full compliance with requirements

8 Requirements mainly¹ fulfilled; minor deviations

6 Requirements partially fulfilled; significant deviations

4 Requirements inadequately fulfilled; major deviations

0 Requirements not fulfilled


LE70-004


•LE70-00

1) The term "mainly" means that the relevant requirementsare met in most instances and no special risks have been identified.

2) n.e. means not evaluated10

86

4

0

n.e.²

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Risk assessment from the perspective of the process/process step: specific

Risk assessment from the perspective of the product; specific

Systematic view; abstract

10 Technical requirements and specifications

for the process are fulfilled

No product defects, the product meets

the technical standards

Requirements are completely

met

8 Small deviations in the process which do not

affect compliance with the customer

specifications or have an effect on following

process steps

Some product defects but no

influence on the function, use or


Requirements are mainly

fulfilled;

minor deviations

6 The process does not always meet the

defined requirements. This has an impact on


Product non-conformities do not affect

the function; however the failure has a

negative impact on the use or on


Requirements are partially

met;

significant deviations

4 The process does not meet the defined

requirements and has a significant impact on


Product non-conformities have an

impact on the function, the failure

leads to usage restrictions, significant

impact on the following process steps

Requirements insufficiently

met;

major deviations

0 The process is not capable of ensuring

compliance with the defined requirements

Product non-conformities, no function,

the use of the product is considerably

reduced, further process steps are not

possible

Requirements are not met

6.1 Evaluation guideline

LE70-005


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Rule in the Volume:

If there are several findings for the assessment of a single question, the individual assessment which is the highest risk is decisive for the assessment of the respective question.

Example: Evaluation of question 6.3.1 in the process step assembly:

Evaluation of individual questions with several findings

LE70-006

1. Finding:

No assembly workers have any knowledge about the safety-relevant characteristics

Individual evaluation: 0 Points

2. Finding:

The training related to the last complaint was not signed by 2 out of 30 employees

Individual evaluation : 8 Points

highest risk!highest risk! Evaluation for

Question 6.3.1: 0 Points!

Define immediate action


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Rule in the Volume:

To ensure comparability the entire list of questions from the VDA 6.3 process element should be covered in full.

If a question is not evaluated (n.e.), the reason for this must be stated.

At least 2/3 of the questions for each evaluated process element, sub-elementor process step must be evaluated.

Example: Evaluation of P7 customer satisfaction

6.1 Comprehensive use of the questionnaire

LE70-007

1. 2/3 rule not met, no reason stated. 2. positive exampleInfo request displayed in tool!

P7

n.a

.

Customer care/customer satisfaction/service

gen

era

l

Min. questions: 4Questions answered: 3/5

7.1 Are all requirements related to QM-System, product and process fulfilled?

n.e.Evaluation not possible because lead auditor was sick.

7.2 Is customer service guaranteed? 6 Deviation

7.3 x Is the supply of parts guaranteed? 8 Deviation

7.4 x If there are deviations from quality requirements or complaints, are failure analysis carried out and corrective actions implemented effectively?

10No weak points identified

7.5 Are personnel qualified for their respective tasks and are responsibilities defined?

n.e.Please rate

gen

era

l

Min. questions: 4Questions answered: 4/5

n.e.Evaluation not possible because lead auditor was sick.

6 Deviation

8 Deviation

10 No weak points identified

8Deviation


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LE70-008

Rule in the Volume:

If non-conformities from previous audits are repeated, the lack of implementation of corrective actions can also be regarded as a deviation: e.g. “cause analysis”, “implementation of measures”, “meeting customer requirements”.

Example: Complaint “Marking D-compulsory not given”

In the process audit from 15.05.2015 the following non-compliance is documented:

The test report for non-flammability (internal cover) has not been marked as D-compulsory in the context of the verification of features requiring documentation (6 points)

In the process audit from 16.06.2016 the same non-compliance is observed.



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Procedure for the documentation of repeated non-conformities

1. Document deviation in corresponding question (6.2.3):Within the framework of verification of characteristics requiring documentation, the test report for non-flammability (internal cover) has not been marked as D-compulsory

2. Evaluation of risk -> identical risk = same evaluation Question 6.2.3 (6 points)(-> higher risk = lower evaluation)

3. Additional deviations noted in relevant questions, e.g.6.5.3-Cause analysis, 6.5.4-Implementation of measures, 7.1- Customer satisfaction

Measures from process audit 15.05.2015 “test report for non-flammability has not been marked as D-compulsory” has not been implemented


LE70-009


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LE70-010

Rule in the Volume:

In the process elements, questions involving special risks in terms of product and process are identified by an asterisk (*). The specific risks in the *-Questions are already taken into account by the classification rules (see section 6.3).

The evaluation is carried out analogously to the remaining questions, this means, *-Questions are not evaluated more severely than other questions.

Example – P6.4.3*: Can the quality requirements be effectively monitored with the measurement and test facilities in use?

…“One test instrument in the production is not calibrated. The deadline for the calibration was over 3 months ago. The test equipment is used for self-testing. The characteristic is monitored 100% automatically.“

Evaluation of the deviation= 6

Not rated more severely as a*-Question


6.2 Questions with special product & process risk(*-Question)

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Rule in the Volume:

All evaluated questions have the same weighting within the calculation of compliance.

The compliance EPn of a process element (P2, P3, …, P7) is calculated as:

6.2 Detailed evaluation and downgrading rules

LE70-011

EPn [%] =Total points awarded for the relevant questions

Total possible points for the relevant questions

Example– P2:

EP2 [%] =Total points awarded

=60

= 86 %Total possible points 70


=54





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Rule in the volume:

In process elements P3, P4 (separate results for product and process development) and P6 (results for each process step), several results for one question may be given. In this case the arithmetic mean of all results for the question must be calculated first. In calculations following this step, the average is rounded to two decimal places.These averages are used in place of “total points” when calculating the level of compliance of a process element. For each question only 10 points may be awarded for the total possible points –regardless of the number of results per question.

6.2 Exception: When more than one result is given for aquestion

LE70-012

Example– P3:P3 Planning the product and process development

Product Process


=35



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Rule in the Volume:

The evaluation of the sub-elements is carried out in the same manner as the process elements using the exception: more than one result is given for a question.

The questions from P6 are used for the evaluation of the individual process steps. All questions from P6 can be answered in each process step. The compliance level En of each process step can be calculated as follows:

6.2 Sub-elements of P6 and individual process steps

LE70-013

EUn [%] =

Total points awarded for the relevant questions in sub-elements of P6

Total possible points for the relevant questions in sub-element P6

En [%] =

Total points awarded for the P6 questions for this process step

Total possible points for the P6 questions for this process step


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6. 2 Evaluation of sub-elements for production processevaluation

LE70-014


O - OutputI - InputProcessstep 2

I . OPS1

Interface




I . OPS3

Interface










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I . OPS1

Interface




I . OPS3

Interface











I . OPS1

Interface




I . OPS3

Interface











I . OPS1

Interface




I . OPS3

Interface











I . OPS1

Interface




I . OPS3

Interface










6.2 Evaluation of sub-elements for production processevaluation

LE70-015

EU7 = Transport, handling of parts

The degree of compliance is generated fromdefined questions in EU1 to EU6

P6.1 = EU1 = Process input

P6.2 = EU2 = Process management

P6.3 = EU3 = Personnel resources

P6.4 = EU4 = Material resources

P6.5 = EU5 = Effectiveness

P6.6 = EU6 = Process output


1. The mean value of the individual questions of a sub-element with nprocess steps

2.

EUn [%] =„total points“

„possible points“


I . OPS1

Interface




I . OPS3

Interface











I . OPS1

Interface




I . OPS3

Interface










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Rule in the Volume:

These results (process element, sub-element of P6 or process step) are considered in the downgrading rules, but not used as intermediate results to calculate the percentage of the overall results.

6.2 Application of the downgrading rules

LE70-016

Downgrading rule

Processelement

Sub-elementfrom P6

Processstep

Result


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6.3 Overall level of compliance and downgrading rules

LE70-017

P2 = EP2

P3 = EP3

P4 = EP4

Project management

Planning the product and process development

Implementation of the product and process development

Supplier management

Process analysis/production

Customer care, customer satisfaction, service

P5 = EP5

P6 = EP6

P7 = EP7

Planning Product development= EPdP

Planning Product development = EPzP

Implementation product development = EPdR

Implementation product development = EPzR


Level of compliance

for the development

Level of compliance

for the series

All evaluated questionscarry the same weighting in the final result

Total points from all evaluated questions from P2, P3, P4, P5, P6, P7

EG [%] =Total of all possible points from these questions

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Rule in the Volume:

If the process elements P5, P6, P7 are evaluated (e.g. auditing of serial production) then the result is calculated as follows:

The designation EG(P5P6P7) are used to easily identify the process elements evaluated.

6.3 Overall level of compliance and classification

LE70-018

EG(P5P6P7) [%] =

Total points awarded for all evaluated questions from P5, P6 and P7

Total possible points from these questions


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6.3 Classification using the calculated result

LE70-019

Overall level of compliance EG [%]

Description of the classification

Classification

EG or EG(Pn) ≥ 90 Quality capable A

80 ≤ EG or EG(Pn) < 90 Conditionally quality

capableB

EG or EG(Pn) < 80 Not quality capable C


The final result is influenced through the application of the following downgrading rules.Får ej

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Downgrading from A to B even though the level of compliance is EG or EG(Pn)≥ 90%

• Process elements P2 to P7 Overall level of compliance < 80%

• Process steps E1 to En Overall level of compliance < 80%

• Sub-elements process analysis production EU1 – EU7 Overall level of compliance< 80%

• At least one *-Question is rated with 4 points

• At least one question from the process audit is rated with 0 points

LE70-020

The rules for downgrading are to be used by the audit team. The downgrading rule used is to be documented in the audit report.

6.3 Downgrading rules


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Downgrading to C even though the level of compliance is EG or EG(Pn)≥ 80%

• Process elements P2 to P7 Level of compliance < 70%

• Process steps E1 to En Level of compliance < 70%

• At least one *-Question is rated with 0 points

LE70-021

6.3 Downgrading rules


The rules for downgrading are to be used by the audit team. The downgrading rule used is to be documented in the audit report.

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For the assessment of quality capability after SOP for product groups

PG3 the level of compliance is:

6.4 Evaluation of product groups

LE70-022

The overall assessment of quality capability can be broken down into product groups!

E1 Injection moulding

E2 Painting

E3 Forming

E4 Assembly

E5 Punching

Product group PG1: Injection moulding parts

Product group PG2: Assembly injection moulding parts

Product group PG3: Cover parts

Example: overall level of compliance per product group series processes


Total points awarded from the questions for the evaluated process elements Pn (for each question in P6 the average value per question for each PG of the process step is

calculated)

Total of all possible points obtained from the P6 questions for the process steps of the product group PGn

EG(PGn) [%] =

Total of the points awarded for P5+P6 average(E4+E5) + P7

Total of all possible pointsP5+P6+P7

EG 5,6,7 (PG3) =Får

ej ko

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Audit report with VDA Excel® tool or VDA 6.3 Audit app

LE70-023


Content:

• Input template

• Evaluation matrix

• Corrective action

VDA 6.3 – Audit report

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Auditbericht (Excel®-Version)

Scope of input

• General data entry form

• Input sheep for evaluation and deviations

Scope of report

• Cover sheet

• Evaluation matrix

• Improvement programme

Import/Export functionality via CSV format

Report and evaluation

LE70-024

VDA 6.3 Audit App

• Export interface to Excel® tool

• Functions like Excel® tool including product groups and process steps

• Photo documentation

• Handwriting recognition

• Standard answer function

http://vda-qmc.de/publikationen/audit-manager-vda-63-audit-app/


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LE70-025

Input form

Audit report

Evaluation template

Evaluation matrix

Corrective action

Report generation with Excel®


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LE70-027

Table sheet: Input Form – Eingabe Maske

Input template for general information POT PA

Instructions for report generation:

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Cover sheet

LE70-032

Table sheet: Report – Bericht

Report sheet audit report VDA 6.3

Transfers the results of the evaluation

matrix and data input automatically

Text blocks for the addition of

management data

Signature fields

PA


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Development

Serial production


LE70-033

Table sheet: Evaluation – Bewertung

Evaluation matrix

Downgrading rulesResults of the

evaluation for product groups

Overall compliance

No manual input in the evaluation

matrix!

Results of classification (A,B,C) must be checked by

the auditor who takes the downgrading

rules into account!

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EP2 - EP7 und E1 - EN


LE70-034


Evaluation matrix: horizontal evaluation PA

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EU1EU7


LE70-035

EU2 EU3 EU4 EU5 EU6

1. Mean value of the individual questions of a sub-element over n process steps

2. EUn [%] = "Points awarded""Possible points"



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EG


LE70-036

Total points from all evaluated questions from Ep2, Ep3, Ep4, Ep5, Ep6 and Ep7

EG [%] =Total of all possible points from these questions



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Table sheet: Actionplan – Maßnahmenplan

Action plan

Tabellenblatt: Questions – Fragen

Entries from the input form for the individual

evaluations and appraisals are transferred to here

If weaknesses that require immediate action are detected during the audit, they must be identified in the action plan (X). The audited organisation is required to define immediate actions

and responsibilities (signed when necessary).

LE70-037


PA

xx

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Data from the Excel® tool and from the VDA 6.3 Audit App can be imported and exported. The standardized Excel format CSV is used for this purpose. This gives the possibility to use the data in various backend systems.

Within the Excel® tool there are three possibilities for data exchange:

1. Create CSV - Create a CSV file from the contents of the Excel® tool.

2. Import CSV - Import a CSV file created from the Excel® tool.

3. Importing a CSV App - A process audit created with the VDA 6.3 Audit App can be exported to a CSV file using the VDA 6.3 Audit App. Export this CSV export file back to the Excel® tool.

LE70-038

11

22

33

33

Table sheet: Input Form – Eingabe Maske

Import/Export Functions PA

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© VDA QMC 315TF000-131


Content:

• QuestionnaireProcess element P5Supplier management

Questionnaire

LE80-001

Chapter 7


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© VDA QMC 315TF000-132

Process element P5 – Supplier management

LE80-002


What is ensured?

• Only approved and quality-capable suppliers used in serial production

• Customer requirements are known and taken into account in the supply chain

• Target agreements for supplier performance been agreed upon and implemented

• Releases are available for purchased products and services

• The quality of purchased products meets the agreed upon criteria

• Incoming goods are delivered and stored appropriately

• Personnel is qualified for their respective tasks and their responsibilities are defined

Allocation of questions

P2

P3

P4

P5

OrganisationOffer


Product/ process

development

Serial production


Product/process

definition


potential analysis

SOPReceive order Issuecontract

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© VDA QMC 315TF000-140

Risk analysis using the turtle approach for supplier management in the process chain

LE80-010


Input OutputP5

Supplier management

I P4.x O P6.xI O

Interface Interface

Agreed upon quality of purchased products and services ensured?

Material Resources

Personnel qualified for their respective tasks and are responsibilities defined?

Personnel Resources

Releases for purchasedproducts available?

Process Operation

Target agreements for supplier performance agreed upon and

implemented?

Effectiveness

P5.4*

P5.5* P5.7

P5.3

P5.1 P5.6

P5.2

Approved and quality capable suppliers

Consideration of customer requirements in

the supply chain

Goods received are OK and

stored appropriately?

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© VDA QMC 315TF000-141

Questionnaire

LE80-019


Content:

• QuestionnaireProcess element P6Process analysis Production

Chapter 7


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© VDA QMC 315TF000-142

Process element P6 – Process analysis / Production

LE80-020



P2

P3

P4

P5

P6

What is ensured?

• P6.1: What goes into the process – Process input

• P6.2: Are all production processes controlled – Process management

• P6.3: What functions support the process – Personnel resources

• P6.4: What means are used to implement the process – Material resources

• P6.5: How effective is the process being carried out – Effectiveness, efficiency, …

• P6.6: What should the process produce – Process result (output)

OrganisationOffer


Product/ process

development

Serial production


Product/process

definition


potential analysis


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© VDA QMC 315TF000-143

Layout of questions using the turtle approach

LE80-021


Input Output

P6

Process analysis/ Production

I P4.x O P6.xI O

Interface Interface

What means are used to implement the process?

Material Resources

Equipment, facilities

What functions, areas, personnel support the process?

Personnel Resources

Training, knowledge, skills, authorities

How dies the process run?

Process Operation

Implementation rules: instructions, procedures, methods

How effective is the process being carried out?

Effectiveness

Performance indicators, targets

6.2

6.4 6.3

6.5

6.1 6.6

What should be the result of the process?What goes into the process?

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© VDA QMC 315TF000-144

Sub-element P6.1 – Process input

LE80-023


Was soll das Ergebnis des Prozesses sein?

Input Output

P6

Processalyse/ Produktion

I P4.x O P6.xI O

Interface Schnittstelle

What means are used to implement the process?

Material Resources

Equipment, facilities

Welche Funktionen/Bereiche/ Personen unterstützen den Prozess?

Prozessunterstützung

Schulung, Wissen, Fähigkeit, Befugnisse

How dies the process run?

Process Operation

Implementation rules: instructions, procedures, methods

Wie wirkungsvoll wird der Prozess durchgeführt?

Wirkungsgrad

Leistungsindikatoren, Kennzahlen

6.2

6.4 6.3

6.5

6.1 6.6

What goes into the process?

P6.1 – What is ensured?

• A transfer of the project from development to serial production has been carried out

• The correct product (incoming material, part, component etc.) must be provided to the agreed quality, in the correct quantity and the correct packing, with the correct documentation, at the agreed time and at the agreed place

• Releases and approvals for incoming goods are available and identifiable

• Process or product changesare documented and communicated

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© VDA QMC 315TF000-150

Sub-element P6.2 – Process Management

LE80-035


P6.2 – what is ensured?

• Production processed are based on a control plan, regulated and released

• The repeat release of production processes is regulated

• Special characteristics are managed

• Non-approved and/or defective parts are managed

• The flow of materials and parts secured against mixing/wrong items

Process OperationFår ej

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© VDA QMC 315TF000-156

Sub-element P6.3 - Personnel resources

LE80-047


P6.3 – what is ensured?

• The employees able to fulfil their given tasks

• Employees know the responsibilitiesand authorities in the monitoring of the product and process quality

• The necessary personnel resources are available

Personnel Resources

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© VDA QMC 315TF000-160

Sub-element P6.4 - Material resources

LE80-055


I O P6.xI O

Schnittstelle

Welche Funktionen/Bereiche/ Personen unterstützen den Prozess?

Prozessunterstützung

Schulung, Wissen, Fähigkeit, Befugnisse

Wie wirkungsvoll wird der Prozess durchgeführt?

Wirkungsgrad

Leistungsindikatoren, Kennzahlen

6.3

6.5

6.6


• The product-specific requirements from the customer be met with the manufacturing equipment

• The maintenance of the manufacturing equipment and tools is controlled

• Test and measuring equipment/ facilities used are suitable, effective and monitored

• Work and inspection stations are appropriate for the products and the work carried out, in order to prevent or eliminate contamination, damage, mixing-up of parts

• Tools, equipment and test equipment are stored properly

Process OperationFår ej

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© VDA QMC 315TF000-166

Sub-element P6.5 – Effectiveness, efficiency, waste avoidance

LE80-067



• Targets are set for the manufacturing process

• Quality and process data is collected in a way that allows analysis

• In case of deviations the causes are analysed and corrective actions checked for effectiveness

• Products and processes are audited regularly

Personnel Resources

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© VDA QMC 315TF000-171

Sub-element P6.6 – Process result (Output)

LE80-077



• Quantities produced match the need and are systematically directed to the next process step

• Products/components are storedand transported in an appropriate manner

• Records and releases are documented and retained

• Customer requirements are met at the delivery of the final product

Personnel Resources

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© VDA QMC 315TF000-176

Questionnaire

LE80-089


Content:

• QuestionnaireProcess element P7Customer care, customer satisfaction, service

Chapter 7


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© VDA QMC 315TF000-177

Process element P7 – Customer care, customer satisfaction, service

LE80-090



P3

P4

What is ensured?

• Requirements on the QM system, product and process are fulfilled

• Customer service and the supply of parts is ensured

• Effective corrective actions are implemented if deviations or complaints occur

• Personnel are qualified for their tasks and responsibilities are defined

P5

P6

P7

OrganisationOffer


Product/ process

development

Serial production


Product/process

definition


potential analysis


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© VDA QMC 315TF000-183

Risk analysis using the turtle modelCustomer care, customer satisfaction, service

LE80-097


Input OutputP7

Customer careI P6.x O Customer

processesI O

interface interface

Is supply guaranteed?

Material Resources

Personnel qualified for their tasks and are responsibilities defined?

Personnel Resources

Customer service guaranteed.

Process Operation

Failure analysis and corrective actions in case of complaints?

Effectiveness

P7.2

P7.3* P7.5

P7.4*

P7.1 P7.2

Requirements related to QM-System, product and

process fulfilled

Product with agreed upon

Packaging and labelling

satisfied

customer

Field phase of use is monitored

Customer expectations

are met

P7.1

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Content:

• Purpose

• Time

• Procedure

• Initial situation

• Questionnaire

• Audit team

• Self-assessment

• Implementation

• Evaluation

• Report

• Risk analysis

• Project release andlocation release

Process element P1 – Potential analysis

LE110-001

Chapter 5

VDA 6.3 – Potential analysis P1

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Product/process

definitionProduct/process development

Serial production



potential analysi

SOPissuecontract

• A potential analysis is used to evaluate new and unknown supplier contenders, locations, technology in preparation for a contract award decision.

• The result of the potential analysis is a provisional quality rating given for the respective applicant.

• Furthermore, an estimation and risk assessment can be made as the basis of a contract award decision.

Purpose and time of the potential analysis

LE110-002


Potential analysis when a supplier changes during the series

Potential analysis for new projects

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Clarify the provision of internal resources (customer)

e.g. taking part in a supplier development programme

Clarify the provision of external resources (Supplier)

If necessary addition of necessary resources in the nomination documents (e.g. construction of necessary infrastructure)

Clarify ressourcesneeded forqualification

Feedback to supplier (request any necessary additional information)

Create questions using the knowledge data-base (for product and process requirements) or for development of requirement specifications

Process evaluation based on a similar process or product (another customer)

Report

Presentation of results

Prognose

Recommendation

Veto

Clarify the initial

situation and limit the contract

End of auditorresponsibility

The audit team should be made up of experts in the following areas:

• quality

• development

• procurement

• logistics

• …

Award of contract

Unknownsupplier

Unknownfacility

Unknowntechnology

Request supplier selfevaluation

and rate this

Compilequestionnaire

module

Specify theaudit team

On site visitRisk

evaluation

Operational sequence of a potential analysis

LE110-003


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LE110-004

Reasons for a potential analysis can be:

Unknown supplier/contender

The applicant has not supplied the organisation either directly or indirectly

Unknowntechnology

Unknown location

Innovation: The applicant uses a new process or produces a new product

The applicant has never supplied the organisation from the location (development/series)

Initial situation

Clarify resources needed for qualification

Clarify the initial

situation and limit the

contract

Request supplier self assessmentand rate this


module


On site visitRisk

evaluation

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Supplier self evaluation

LE110-005

General data:

• General information about the current product range from the location under consideration

• Classification of quality capability by third parties and/or from the result of self-audits

• Internal value added, subcontractors, toolmakers

• Development:

• Joint Venture Partner

• Know-How, core capabilities

• Development department(s)

• Project lead, methods of project development

• Construction systems, innovation

• Laboratory and testing equipment, experimentaland prototype construction



Clarify the initial


contract



module


On site visitRisk

evaluation

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• 36 questions from the process elements P2 - P7

• Integration of knowledge database requirements into the questionnaire

• Integration of requirement specifications in the questionnaire

LE110-006

Questionnaire module



Clarify the initial


contract



module


On site visitRisk

evaluation

P6.4.1: Can the product-specific requirements from the customer be met with the

manufacturing equipment?*

Evidence must be shown that the processes are implemented in accordance with the customer requirements using the existing production facilities and that the resulting products meet the customer specifications.

Additional requirements from the customer specific knowledge database and requirement specifications e.g.

Important parametersImportant testsDefined toolingDefined measurement and testing equipment

No transfer of Know How

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Overview questionnaire potential analysis


2.1Project

management +-organisation

2.1Project

management +-organisation

2.2Project

resources

2.2Project

resources

2.3Projectplan

2.3Projectplan

2.4Implementation advanc. productquality planning

2.4Implementation advanc. productquality planning

2.5Procurement

activities of theproject

2.5Procurement

activities of theproject

2.6Change

management

2.6Change

management

2.7Escalationprocess

2.7Escalationprocess

P3 Planning the product and process development

3.1Product u. process

requirements

3.1Product u. process

requirements

P4 Implementation of the product and process development

4.1Implementation

of actions

4.1Implementation

of actions

4.4Approvals and

releasesavailable

4.4Approvals and

releasesavailable

P5 Supplier management

5.1Approved and

capablesuppliers

5.1Approved and

capablesuppliers

5.2Customer

requirementssupply chain

5.2Customer

requirementssupply chain

5.4Releases forpurchasedproducts

5.4Releases forpurchasedproducts

5.5Quality ofpurchasedproducts

5.5Quality ofpurchasedproducts

5.6Storage anddelivery of

incoming goods

5.6Storage anddelivery of

incoming goods

Process input

6.1.1Project transferfrom develop. toserial production

6.1.1Project transferfrom develop. toserial production

P6 Process analysis production

Process management

6.2.1Control plan

6.2.1Control plan

6.2.2Repeat releasefor the restartof production

6.2.2Repeat releasefor the restartof production

6.2.3Special

characteristicsmanaged

6.2.3Special

characteristicsmanaged

6.2.4Defective parts

managed

6.2.4Defective parts

managed

Personnel resources

6.3.1Employeesqualification

6.3.1Employeesqualification

Material resources

6.4.1Manufacturing

equipment

6.4.1Manufacturing

equipment

6.4.2Maintenance

6.4.2Maintenance

6.4.3Measurement

and testfacilities

6.4.3Measurement

and testfacilities

Process effectiveness + efficiency

6.5.3Root cause

analysis and eff. of corrective

actions

6.5.3Root cause

analysis and eff. of corrective

actions

Process result (output)

6.6.4Customer

requirements at delivery

6.6.4Customer

requirements at delivery

6.5.4Process u. productaudits

6.5.4Process u. productaudits

P7 Customer care, customer satisfaction, service

7.1RequirementsQM-system,

prod.,+ process

7.1RequirementsQM-system,

prod.,+ process

7.2Customer service

guaranteed

7.2Customer service

guaranteed


LE110-019

4.3Material

resourcesavailable

4.3Material

resourcesavailable

6.3.3Personnelresources

6.3.3Personnelresources

6.4.4Work andinspectionstations

6.4.4Work andinspectionstations

6.6.2Storage, transport, packaging

6.6.2Storage, transport, packaging

7.3Supply of parts

guaranteed

7.3Supply of parts

guaranteed

7.4Failure analysisand corrective

actions implem.

7.4Failure analysisand corrective

actions implem.

3.2Feasibilityevaluated

3.2Feasibilityevaluated

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Audit team


LE110-007

Assembly of a team with experts from the following areas:

• Quality• Development• Procurement• Logistic• Technology and process expert

Of particular importance is the support of technical experts in the fields of innovation and application of new technologies.


Clarify the initial


contract



module


On site visitRisk

evaluation

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• Process inspection through a similar process product

• Evaluation using the evaluation sheet (traffic lights)

• Presentation of results and reporting

1. Cover sheet (presentation of result)

2. Assessment sheet

3. List of deviations and potentials (improvement programme)

4. Site presentation (lay out, process flow, equipment, experience, references …)

5. Supplier self assessment

Procedure

LE110-008



Clarify the initial


contract



module


On site visitRisk

evaluation

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Evaluation of potential analysis

LE110-009

Evaluation of the individual questions:

RED: The requirements of the question are not met

YELLOW: The requirements of the question are partially met

GREEN: The requirements of the question are met


Classification

Evaluation based on questionnaire

Yellow Red

Barred supplier more than 14One or more

questions

Conditionally approved supplier

max. 14 none

Fully approved supplier

max. 7 noneFår

ej ko

pieras


Complete risk evaluation

Evaluation of the risk for the contract award

Interdisciplinary assessment by the appropriate departments:

• Purchasing (Procurement)

• Logistic

• Development

• Quality

Describe security concept (Fall-back alternative)

LE110-014



Clarify the initial


contract



module


On site visitRisk

evaluation

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Follow-up actions after a potential analysis

LE110-015

Clarify the provision of internal resources (customer)

• e.g. supplier development programme

Prognosis/ Recommendation

/veto

Process audit VDA 6.3Follow the improvement programmes

End of the auditor

Responsibility

Clarify the provision of external resources (supplier)

• If necessary, adding required resources in the nomination documents (e.g. measurement equipment, construction of necessary infrastructure

Product/process development

Serial processes

Clarify resourcesfor further

qualification

Riskanalysis

YesNO

Award of contract


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GREEN

Barred

Supplier:

No contractaward

Fully approved supplier:

Contract award possible

• e.g. scheduled release with escalation if deadline is exceeded• Only one product (limited scope see RPP)• Intensive monitoring (MLA) by customer (responsibility for parts)• Inclusion in a supplier development programme• Fall-back concept (using existing sites as fall-back)

A green or yellow potential analysis is not always coupled with and award of contract.

A red potential analysis excludes a contract award.

Conditionally approved supplier:

Conditional approval

YELLOW RED


LE110-016

Dealing with the results of the potential analysis

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Project release and location release

LE110-017

1. SOP

1. Project award

Carrying out process audit (P2 - P7)

2. Project award

2. SOP

Project n: qualification phase

Product/Process development

Serial production

n-ter SOP

n-te Project award

Project 2: qualification phase


Reference project: qualification phase


Project evaluation

Carrying out of a potential analysis (P1)

for project release

Serial production

Process/Product group/ material group approval

Process/Product group/ material group approval


A validation of quality capability in the sense of a release for series production can only be carried out using a PPA procedure for the corresponding customer specific procured volumes. For this purpose a process audit can be carried out as part of the customer process approval.

Serial production

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Documents

Process Audits VDA 6.3 – “Management“ 2-day introduction