Vda process auditing

DRIVING WORLDWIDE
BUSINESS EXCELLENCE
VDA 6.3 Management
Overview
R. Dan Reid
ASQ Fellow and Certified Quality Engineer
Omnex Director of Consulting
October 30, 2014 Webinar

2014 Omnex, Inc.
325 East Eisenhower Parkway, Suite 4
Ann Arbor, MI 48108
734-761-4940
This publication is protected by Federal Copyright Law, with all rights reserved. No part of this publication may be
reproduced, stored in a retrieval system, translated, transcribed, or transmitted, in any form, or by any means
manual, electronic, electro-magnetic, mechanical, chemical, optical, or otherwise, without prior explicit written
permission from Omnex, Inc.
Copyright 2014 Omnex, Inc. All Rights Reserved.2

Omnex provides training, consulting and software solutions to the
international market with offices in the USA, Canada, Mexico, China (PRC),
Germany, India, the Middle East, and SE Asia. Omnex offers over 400
standard and customized training courses in business, quality,
environmental, food safety, laboratory and health & safety management
systems worldwide.
Email: info@omnex.com
Web: www.omnex.com

Omnex Introduction
• International consulting, training and software development
organization founded in 1985.
• Specialties:
– Integrated management system solutions.
– Elevating the performance of client organizations.
– Consulting and training services in:
• Quality Management Systems, e.g. ISO 9001, ISO/TS 16949, AS9100, QOS
• Environmental Management Systems, e.g. ISO 14001
• Health and Safety Management Systems, e.g. OHSAS 18001
• Leader in Lean, Six Sigma and other breakthrough systems and
performance enhancement.
– Provider of Lean Six Sigma services to Automotive Industry via AIAG
alliance.

About Omnex
• Headquartered in Ann Arbor, Michigan with offices in major global markets.
• In 1995-97 provided global roll out supplier training and development for
Ford Motor Company.
• Trained more than 100,000 individuals in over 30 countries.
• Workforce of over 400 professionals, speaking over a dozen languages.
• Former Delegation Leader of the International Automotive Task Force
(IATF) responsible for ISO/TS16949.
• Served on committees that wrote QOS, ISO 9001:2000, QS-9000 and it’s
Semiconductor Supplement, ISO IWA 1 (ISO 9000 for healthcare).
• Member of AIAG manual writing committees for FMEA, SPC, MSA, Sub-tier
Supplier Development, Error Proofing, and Effective Problem Solving (EPS).

Omnex Worldwide Offices
Omnex is headquartered
and operates from the
United States through
offices in Michigan.
The company maintains
international operations in
many countries to provide
comprehensive services to
clients throughout Western
Europe, Latin America
and the Pacific Rim.
www.omnex.com
info@omnex.com
Omnex Global Head Quarters (Michigan, USA)
West Coast Operations (San Jose, CA)
Asia Pacific HQ (Chennai, Pune, Delhi, Bangalore)
China (Shanghai, Guangzhou, Wuhan)
Canada (Mississauga)
Europe (Berlin, Germany)
Middle East (Dubai, Saudi Arabia, Bahrain)
Thailand (Bangkok)
Mexico (Monterrey)
Singapore
Malaysia (Kuala Lumpur)

R. Dan Reid
• Company Experience
– Omnex, Director of Consulting
– AIAG, Program Development Manager, Quality
– Baxter Healthcare, BioScience Division, Director of Supplier Quality
– General Motors, Various Materials Management, Purchasing and Supplier Quality positions
• Accomplishments
– ASQ Fellow and ASQ Certified Quality Engineer (CQE)
– Member of U.S. Technical Advisory Groups for Quality, Environmental and OH&S Management Systems
– The first Delegation Leader of the International Automotive Task Force (IATF)
– Author of QS-9000, ISO Technical Specification (TS) 16949, ISO 9001:2000, ISO International Workshop
Agreement (IWA 1), AIAG Business Operating Systems for Healthcare Organizations (HF-2); author with
McGraw Hill, ASQ Press and others; ASQ Quality Progress Administrative Committee/Reviewer
– Worked on the Chrysler, Ford and GM Potential Failure Mode and Effects Analysis, Production Part
Approval Process and Advanced Product Quality Planning projects and IAQG APQP/PPAP Project
– Led AIAG Projects for Effective Problem Solving, Cost of Poor Quality, Supplier Management and others
– Registered VDA 6.3 Auditor Trainer; ISO 9000, ISO 14000, AS 9100 Trainer
– A2LA Board of Directors
• Awards include
– 2010 Quality Coaching Excellence for Primary Care Practices, Michigan Primary Care Consortium
– 2006 Automotive Industry Action Group (AIAG) Healthcare Focus Group Chairs’ Award
– 2007, 2005, 2004, 1993 Cecil C. Craig Awards, ASQ Automotive Division
– 2004 ASQ Automotive Division Quality Leader of the Year
– 2003 Leadership Award from the ISO9000 International Conference
– 2002 AIAG Outstanding Achievement Award8

At any time, you may enter questions in
the [Enter a question for staff] field of
the GoTo Webinar control panel and it
will be answered at the end of the
webinar
Note: Today’s presentation is being
recorded and link in order to view it
will be available within 1 week.
An Omnex representative will
contact you within 3 business days
for your feedback and a PDF copy of
these slides can be provided at that
time.
Your Participation
Attendee Participation – Asking Questions

Webinar Agenda
• Who is VDA?
• Audit Approaches
• The Audit Process
• VDA 6.3 Themes
• Product Life Cycle
• Review of P2 – P7
• Questions
10 Copyright 2014 Omnex, Inc. All Rights Reserved.

The Manufacturer Groups Within the
German Automotive Industry Association

VDA Quality Management Center,
Berlin, Germany
Business fields
Employees
Founded: August 1997
Organization
• Separate department
• Not-for-profit
• Deliverables
- Training
- Seminars
- Publications
- Certification

VDA 6
Source: VDA 6.3, 2nd Edition, pg. 3

Risk Management Process
(per ISO 31000:2009)
The 2010 VDA
6.3 revision
emphasizes
risk
identification
and mitigation!

Audit Approaches
• System Audit
– Has the management documented and implemented a QMS
conforming to the standard and is the system capable of giving
assurance to the quality of product or service?
• Contract-Related Audit
– Carried out as a system audit but also covers the specific quality
requirements of a particular contract or series of contracts
• Process Audit
– Concentrate on the key processes as documented in procedures and
work instructions
• Product Audit
– An independent examination of the product determines whether or not
it meets the requirements of the established product specification

Basic Audit Principles
• Audits are always random sample checks
• The auditor must always take sufficient random samples
• Internal audits are carried out by independent, adequately
qualified employees
• External audits are carried out by customers, their
representatives and/or certification bodies
• The auditor must align their findings with the requirements in
and carry out a traceable assessment
• VDA 6.3 process audits will be classified in A, B or C
– A = Quality capable
– B = Conditionally capable
– C = Not capable

Final
Evaluation
and Closure
Presentation
of
Results
AssessmentExecutionPreparation
The Audit Process
Audit
Contract
Process-oriented Auditing
Internal Audit
External Audit (suppliers)
Potential Analysis (suppliers)
Audit
Program
Source: VDA 6.3, 2nd Edition, Fig. 4 pg 13

Process Focus
Versus Department Focus
Human
Resources
OperationsPurchasing Accounting Sales
General Management
Customer Satisfaction Metrics
Process Variation Outputs
Processes – not Departments – Drive PerformanceProcesses – not Departments – Drive Performance
TOP MANAGEMENT
Human
Resources
OperationsPurchasing Accounting Sales
General Management
Customer Satisfaction Metrics
Process Variation Outputs
Processes – not Departments – Drive PerformanceProcesses – not Departments – Drive Performance
TOP MANAGEMENT

Process Map – Sequence & Interaction
Business Planning
Training
Management
Review
Internal Audit
Process Planning
including APQP
CA/PA
Control N/C
Material
Customer
Complaints
Returned
Material
Customer
Satisfaction
Risk Management
Contract
Review
Create Job Order
Release to
Production
SchedulingPurchased Product
Production
Processes
Produce product
Shipping
Receiving
New Product Design
Including APQP
R & D
Product Realization Processes
QMS and Business Processes
Marketing Processes
Sales Processes
Billing
Supplier
Management
Technology
Roadmapping
Product
Roadmapping
Document ControlRecord Control
Support Processes
Resource Mgmt.PurchasingITProcess Control
Calibration Maintenance
Change
Management
Identification &
Traceability
Internal
Communications
External
Communications
Monitoring &
Measurement
Continual
Improvement
CUSTOMER
CUSTOMER
Scale Up
Quality
Laboratory Testing

VDA 6.3 “Themes”
• Supplier Involvement
• Qualified Resources
• Change Management
• Constraint Management (Bottle-necks)
• Evidence of Approvals, e.g. releases
• Formal Transfer

Product Life Cycle (VDA 6.3)

Scope of VDA 6.3 – Sequence and Interaction

Questionnaire Structure
60 total questions P2-P7
Mandatory
requirements
Examples,
evidence
Links, inputs,
outputs,
references
Process
Element
Process
Sub-element

Review of VDA 6.3
Sections P2 to P5
25

P2 Requirements Summary
• There is a comprehensive project management
system (including quality planning and risk
management) both for planning and also for carrying
out the process and product development
• The project organization is equipped with the
necessary resources, its tasks, authority and expertise
are defined and known
• The customer is informed of the project planning
• A change management system involving the customer
is established

PR = process responsibility;
TO = target-oriented;
CO = communication;
RI = risk identification
P2 – Overview of Assessment Questions
27 Copyright 2014 Omnex, Inc. All Rights Reserved.27
PR TO CO RI
P2 Project Management
2.1
Is the project organization (project management) established and are tasks &
authorities specified for the team leader and team members?
X X X
2.2*
Are the resources required for the project development planned and available
and are all changes displayed?
X X X
2.3 Is there a proiect plan and has this been agreed with the customer? X X X
2.4 Is change management in the project ensured by the project organization? X X
2.5*
Are the responsible personnel within the organization and in the customer's
company involved in the change control system?
X X X
2.6
Is there a QM plan for the project? is this implemented and monitored regularly
for compliance ?
X X X
2.7* Is there an established escalation process and is this implemented effectively? X X X
Generic Baseline***Potential
Analysis**
Transport &
Parts
Handling
0 in any asterisk question is a “knock
out” punch, e.g. supplier rated “not
capable.”

• The requirements necessary for the product and
process development are known
• The feasibility of the products and processes to be
developed is assured
• With the product / process development plan it is
ensured that all essential activities are planned with
the customer's agreement
– Includes the need to take into account the necessary
technical and personnel resources
• Supplier management is taken into account for the
items which are to be obtained from outside sources

PR TO CO RI
P3 Planning the Product and Process Development
3.1 Are the product and process-specific requirements laid down? X X X
3.2*
Has manufacturing feasibility been assessed in a cross-functional manner,
based on the requirements which have been determined for product & process?
X X
3.3 Are there plans for the product and process development? X
3.4
Have the necessary resources been taken into account for the product and
process development?
X
3.5 Is QM planning arranged for sourcing bought-in products and services? X
Generic Baseline***Potential
Analysis**
Transport &
Parts
Handling
CO = communication;
capable.”

• In the execution phase all defined tasks from the
planning of the product and process must be carried
out
• Changes must be recognized and taken into account
in the planning
• Reviews must be carried out at specified intervals
during the execution phase
• If target requirements are not achieved, actions must
be specified and monitored for effectiveness

PR TO CO RI
P4 Carrying out the Product and Process Development
4.1
Have the Product FMEA / Process FMEA been drawn up ? Are they up-dated as the
project progresses and are corrective actions laid down?
X X
4.2
Are the stipulations arising from the plans for product and process development
put into effect?
X
4.3 Are the personnel resources in place and qualified? X X
4.4 Is the infrastructure in place and appropriate? X
4.5*
Based on the requirements, are the necessary evidence and releases available for
the various phases?
X X
4.6
Are the productions control plans used for the various phases and are
production, test and inspection documents derived from them?
X
4.7
Has a pre-production run been carried out under serial production conditions to
obtain production aoproval / release?
X
4.8
Are the planning activities associated with sourcing outside products and
services implemented effectively?
X X
4.9
Is the transfer of the project to production controlled in order to secure the
product launch?
X X X
Generic Baseline***
Transport &
Parts
Handling
Potential
Analysis**
CO = communication;
capable.”

• Only approved / released and qualified suppliers are
used for serial production processes
• Customer requirements are known throughout the
supply chain and are implemented
• Bought-in products comply with the customer
requirements which have been agreed

PR TO CO RI
P5 Supplier Management
5.1* Are only approved/released and quality-capable suppliers selected? X X
5.2 Are the customer's requirements taken into account in the supply chain? X X
5.3
Have target agreements for delivery performance been agreed with suppliers and
put into operation?
X
5.4*
Are the necessary approvals/releases available for the out-sourced products and
services?
X X
5.5* Is the quality of the out-sourced products and services ensured? X X
5.6 Are incoming goods stored appropriately? X
5.7 Are personnel qualified for the various tasks and are responsibilities defined? X
Generic Baseline***
Transport &
Parts
Handling
Potential
Analysis**
CO = communication;
capable.”

Review of VDA 6.3
Sections P6 and P7
34

The Turtle Diagram
• A structured document which fully describes a
process
• Made up of 6 sections
– Inputs – Suppliers
– Outputs – Customers
– Measurements – Variables & Effectiveness
– People – Competencies
– Equipment/Devices – Machines, fixtures, gages, technology,
tools
– Documents – Procedures, work instructions, job aids
• Each section describes a specific element of a process

“Turtle Diagram”
Copyright 2014 Omnex, Inc. All Rights Reserved.
PROCESS
REQUIREMENTS
REQUIREMENTS
Equipment /
Installations
(With what?)
Training
Knowledge
Skills
(With whom?)
Input
What should we
receive?
Output
What should we
deliver?
Controls,
Metrics
(Variables?)
Instructions
Procedures
Methods
(How?)
36

P6 Is Organized Around the Turtle
P6.1
P6.3P6.4
P6.6
P6.5P6.2

P6.1 Organized Around the Turtle
P6.1

P6.1 Requirements Summary
• What goes into the process ?
(process input)
– A transfer has taken place between the development
project and serial production
– The incoming materials required for production are stored
in the right quantities and quality, at the agreed time, at the
right place
• The materials are stored appropriately
– Process or product changes are documented and
communicated

P6.1 – Overview of Assessment Questions
PR TO CO RI
P6 Process Analysis / Production
6.1 What goes into the process? (process input)
6.1.1* Has the project been transferred from development to serial production? X X X
6.1.2
Are the necessary quantities / production batch sizes of incoming materials
available at the right time and at the right place (stores; work-station) ?
X X
6.1.3
Are incoming materials stored appropriately and are transport facilities /
packing arrangements suitable for the special characteristics of the incoming
materials?
X X
6.1.4
Are the necessary identifications / records / approvals available and allocated
appropriately to the incoming materials?
X X
6.1.5
Are changes to the product or process in the course of serial production tracked
and documented?
X
Potential
Analysis**
Transport &
Parts
Handling
Generic Baseline***
Transfer between the development project and serial production
CO = communication;
capable.”

P6.2

• Are all production processes controlled ?
(process sequence)
– The production processes are controlled and released
– It is ensured that the specific quality requirements are
achieved with the manufacturing facilities
– Scrap, rework and setting parts are separated so that they
cannot be used

PR TO CO RI
6.2 Are all production processes controlled? (process seauence)
6.2.1*
Are all the relevant details listed in the production and test/inspection
documents, based on the production control plan?
X X
6.2.2 Are production operations checked / approved and are setting data logged? X X
6.2.3*
Can the customer's specific product requirements be satisfied with the
production facilities used?
X X
6.2.4* Are significant characteristics controlled in production? X X
6.2.5 Are scrap, rework and setting parts kept separate and identified? X X
6.2.6 Is the flow of materials and parts secured against mixing / wrong items? X X
Potential
Analysis**
Transport &
Parts
Handling
Generic Baseline***
CO = communication;
capable.”

P6.3

• What functions support the process?
(personnel resources)
– Personnel have the necessary responsibility and authority
to monitor product / process quality
– The personnel available are suitable for the tasks involved
– The qualifications of the personnel are maintained

PR TO CO RI
6.3 What functions support the process? (personnel resources)
6.3.1
Are operators given responsibility and authority to monitor the quality of
product and process?
X
6.3.2*
Are the operators able to carry out their allotted tasks and are their
qualifications kept up-to-date?
X X X
6.3.3 Is there a personnel employment plan? X
Potential
Analysis**
Transport &
Parts
Handling
Generic Baseline***
CO = communication;
0 in any asterisk question is a
“knock out” punch, e.g. supplier
rated “not capable.”

P6.4

• What facilities are used to achieve the process?
(material resources)
– The quality requirements for the product are achieved with
the production facilities employed; preventive maintenance
is carried out
– Production operations and production batch sizes are
continuously aligned with each other
– Transport facilities are designed to suit the characteristics
of the incoming materials. Incoming materials are stored
appropriately
– The production level and inspection level of the parts are
ensured by appropriate identification

PR TO CO RI
6.4 What facilities are used to achieve the process? (material resources)
6.4.1
How are the maintenance and overhaul of production facilities / tools
controlled?
X
6.4.2*
Can the quality requirements be monitored effectively with the test, inspection
and measurement facilities employed?
X X
6.4.3 Are the work-stations and test/inspection areas suitable for requirements? X X
6.4.4 Are tools, equipment and test/inspection facilities stored correctly? X X
Generic Baseline***
Transport &
Parts
Handling
Potential
Analysis**
CO = communication;

P6.5

• How effectively is the process carried out?
(effectiveness, efficiency, elimination of waste)
– Target requirements are specified for products and
processes
– Quality and process data are logged and can be evaluated
– In the event of discrepancies, corrective actions are
checked for effectiveness
– Products and processes are audited regularly

PR TO CO RI
6.5
How effectively is the process carried out? (effectiveness, efficiency, elimination
of waste)
6.5.1 Are target requirements set for product and process? X X X
6.5.2 Are quality and process data logged in such a way that they can be assessed? X X
6.5.3*
In the case of deviations from product and process requirements, are the causes
analyzed and the corrective actions checked for effectiveness ?
X X
6.5.4* Are processes and products audited regularly ? X X
Generic Baseline***
Transport &
Parts
Handling
Potential
Analysis**
CO = communication;
capable.”

P6.6

• What should the process produce?
(process result / output)
– The customer's requirements for process and product are
achieved
– The products / parts are stored and transported in
accordance with requirements
– Product and process releases are carried out and archived

PR TO CO RI
6.6 What should the process produce? (process result / output)
6.6.1* Are the customer's requirements met in terms of product and process? X X X
6.6.2
Are quantities / production batch sizes aligned with requirements and are they
forwarded to the next process stage in a targeted manner?
X X
6.6.3
Are products / components stored in an appropriate manner and are transport
facilities / packing arrangements suitable for the special characteristics of the
products / components?
X X
6.6.4 Are the necessary records / releases carried out and stored appropriately? X
Generic Baseline***
Transport &
Parts
Handling
Potential
Analysis**
CO = communication;

• The product as delivered meets the customer's
requirements
• Customer support and the supply of parts are ensured
• There are effective and permanent failure elimination
processes in place in the event of complaints and
rejects

PR TO CO RI
P7 Customer Support / Customer Satisfaction / Service
7.1*
Are the customer's requirements satisfied regarding QM system, product (on
delivery) and process?
X X
7.2 Is customer support ensured? X
7.3* Is the supply of parts ensured? X X X
7.4
If there are deviations from quality requirements, are failure analyses carried
out and corrective actions implemented effectively ?
X X
7.5 Is there a process which ensures that analysis of defective parts is carried out? X X
7.6 Are personnel qualified for the various tasks and are responsibilities defined? X
Generic Baseline***
Transport &
Parts
Handling
Potential
Analysis**
CO = communication;
capable.”

Upcoming VDA 6.3 Training
• Auditing VDA 6.3
– December 15-17, 2014 – Ann Arbor, MI
– February 16-18, 2015 – Ann Arbor, MI
– February 16-18, 2015 – Mississauga, ON
– April 29-May 1, 2015 – Ann Arbor, MI
• Understanding VDA 6.3
– Only available for on-site training at your location
These classes can also be
delivered at your site.
Consulting and
Implementation
Assistance is also
available.

Upcoming Automotive Auditing Training
(ISO/TS 16949:2009)
Understanding and Documenting: 2 days
Internal Auditor Training: 3 days
Lead Auditor Training: 5 days
• December 8-12, 2014— Ann Arbor, MI
• December 8-12, 2014— Mississauga, ON
• January 12-16, 2015— Ann Arbor, MI
• January 12-16, 2015— Mississauga, ON
• January 19-23, 2015 — Dallas, TX
• January 26-30, 2015 — Los Angeles, CA
• February 23-27, 2015 — Ann Arbor, MI
• February 23-27, 2015 — Mississauga, ON
• March 23-27, 2015 — Mississauga, ON
• March 30-April 3, 2015 — Los Angeles, CA
• April 20-24, 2015— Ann Arbor, MI and San Jose, CA;
• April 20-24, 2015— Mississauga, ON
• April 27-May 1, 2015 — Dallas, TX
These classes can also be
delivered at your site.
Consulting and
Implementation
Assistance is also
available.
Certified Training Provider

Upcoming Webinars
• Ishikawa’s 7 Basic Tools – November 21, 2014 2-3pm EST
• Effective Problem Solving – November 24, 2014 2-3pm EST
• Linkages in the APQP Tools – TBD, December 2014
Contact us for information on how to register for these
webinars or to view recorded versions

info@omnex.com
734.761.4940
www.omnex.com
Questions?
Thank You!

Vda process auditing

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Viewers also liked

Viewers also liked (20)

Similar to Vda process auditing

Similar to Vda process auditing (20)

Recently uploaded

Recently uploaded (20)

Vda process auditing