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: [email protected]

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

[email protected]

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

ManagementReview

Internal Audit

Process Planning including APQP

CA/PA

Control N/C Material

Customer Complaints

Returned Material

Customer Satisfaction

Risk Management

ContractReview

Create Job Order

Release toProduction

SchedulingPurchased ProductProduction Processes

Produce product

Shipping

Receiving

New Product DesignIncluding 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 MaintenanceChange

Management

Identification & Traceability

Internal Communications

External Communications

Monitoring & Measurement

Continual Improvement

CUST

OM

ER

CUST

OM

ER

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


21

Product Life Cycle

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

2.1Is 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

2.6Is 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

3.4Have 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




• 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

4.1Have the Product FMEA / Process FMEA been drawn up ? Are they up-dated as the

project progresses and are corrective actions laid down?X X

4.2Are 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

4.6Are the productions control plans used for the various phases and are

production, test and inspection documents derived from them?X

4.7Has a pre-production run been carried out under serial production conditions to

obtain production aoproval / release?X

4.8Are the planning activities associated with sourcing outside products and

services implemented effectively?X X

4.9Is 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**




• 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

5.3Have 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


Parts

Handling

Potential

Analysis**



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 process35 Copyright 2014 Omnex, Inc. All Rights Reserved.

“Turtle Diagram”

Copyright 2014 Omnex, Inc. All Rights Reserved.

PROCESS

RE

QU

IRE

ME

NT

S

RE

QU

IRE

ME

NT

S

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

6.1.2Are 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 facil ities /

packing arrangements suitable for the special characteristics of the incoming

materials?

X X

6.1.4Are the necessary identifications / records / approvals available and allocated

appropriately to the incoming materials?X X

6.1.5Are 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





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 l isted 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 facil ities 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***





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)

6.3.1Are 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***





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)

6.4.1How 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


Parts

Handling

Potential

Analysis**





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


6.5How 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


Parts

Handling

Potential

Analysis**





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

6.6.2Are 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


Parts

Handling

Potential

Analysis**




• 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

7.4If 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


Parts

Handling

Potential

Analysis**



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 daysInternal Auditor Training: 3 daysLead 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, TX59 Copyright 2014 Omnex, Inc. All Rights Reserved.

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


[email protected]

734.761.4940

www.omnex.com

Questions?

Thank You!

Engineering

Vda process auditing