ISO062_Reid_TS16949 Automotive Supply Chain_PPT

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TS16949: Automotive Supply Chain Management

23rd Annual ISO 9000 ConferenceR. Dan Reid, ASQ Fellow, ASQ CQE

Session ISO-062

March 9, 2015

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• Purchasing Processes

• Supplier Assessment and Development

• ISO/TS 16949:2009 Key Related Clauses

• Material, Production Control & Logistics

Session Agenda

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PURCHASING PROCESSES

Supply Chain Risk


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• Supplier Qualification

• Supplier Selection

• Supplier Monitoring

• Supplier Development

Typical Purchasing Processes


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Supplier Risk Assessment Considerations

• Engineering, e. g. validation, technical

• Financial

• Quality, e. g. process capability/control, APQP/PPAP*

• Data/IP Security

• Single Sourcing

• Dependency/Leverage

• Geo‐political, e. g. geographical, political

• Sustainability, e. g. human rights, environmental, safety

• Material Compliance, e.g. Conflict Minerals

• Regulatory, e.g. export control, Customs‐Trade Partnership Against Terrorism (C‐TPAT)


*AdvancedProductQualityPlanningProductionPartApprovalProcess

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Supply Chain Risk Management

1. “Map” the supply chain for all direct productSuppliers and Sub‐Tier suppliers – Map should include supplier names, locations plus

other information as needed

2. Identify any risks – Risks should be qualitative, e. g. Red‐Yellow‐Green and

quantitative, e. g. Failure Mode and Effects Analysis (FMEA)

3. Develop a mitigation plan– Design to eliminate– Dual sourcing, – Extra inventory, e.g. buffer stock– Dual tooling

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SUPPLIER ASSESSMENT AND DEVELOPMENT


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AIAG* Sub‐tier Supplier Requirements

• ISO 9001 compliance (Certification preferred)

• AIAG Core Tools Implemented:

– Statistical Process Control (SPC)

– Failure Mode and Effects Analysis (FMEA)

– Measurement Systems Analysis (MSA)

– Advanced Product Quality Planning (APQP)

– Production Part Approval Process (PPAP)

• Determination / Documentation of Special and Pass Through Characteristics

• The Quality Department/Function is an integral part of the Supplier Selection process

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*AutomotiveIndustryActionGroup

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AIAG Sub‐Tier Supplier Requirements

• Supplier financial stability is reviewed before supplier selection– e.g. Dun and Bradstreet (D&B) risk analysis

• ISO 17025 (or equivalent) accreditation is required for any commercial laboratories used– Must be by a recognized body, e.g. A2LA, NAVLAP, L‐A‐B

• Supplier capacity and operating plan are verified before full production approval– For example, Run at Rate

• Supplier metrics include delivery and PPM, or an index that includes rejected and/or returned material

• AIAG certification as applicable, e.g. heat treat (CQI‐9)

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Main Audit Types• 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?

• 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


The audit program manager should have an audit program showing audit plans over time

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Supplier Operational Assessment


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Supplier Development

• Customer organizations should prioritize suppliers for

development based on supplier risk and supplier performance

– Also considering the importance of the purchased product to the

organization’s product(s)

• Top management is responsible provide sufficient resources

for supplier management activity including supplier

development (ISO 9001:2008, clause 5.1)

• Actions taken will result in either supplier performance

improvement or “escalation”


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Supplier Development • Examples of typical areas for supplier development

– Quick Set Up

– Lean Manufacturing

– Error proofing / Mistake proofing

– Process Controls

– Measurement System Capability

– Product Identification & Traceability

– Document / Records control

– Bottle neck / Constraint management

– Packaging / Labeling


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ISO/TS 16949:2009 KEY RELATED CLAUSES

Key Supplier Chain Issues


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ISO/TS 16949:2009

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Automotive Industry Agreed Requirements

ISO9001 Customer‐Specific Requirements

TS 16949 includes all ISO 9001 and applicable customer‐specific requirements

Customer‐Specific RequirementsCustomer‐Specific RequirementsCustomer‐Specific RequirementsCustomer‐Specific Requirements

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ISO/TS 16949:2009

Supplier Quality Management System Development (clause 7.4.1.2)

• The organization must perform supplier quality management system development with the goal of supplier conformity with this Technical Specification – conformity with ISO 9001:2008 is the first step in achieving this goal

– NOTE: The prioritization of suppliers for development depends upon, for example, the supplier’s quality performance and the importance of the product supplied

• Unless otherwise specified by the customer, suppliers to the organization must be third party registered to ISO 9001:2008 by an accredited third party certification body

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• The organization must determine and provide the resources needed:

– To implement and maintain the quality management system and continually improve its effectiveness

– To enhance customer satisfaction by meeting customer requirements

Clause 6.1 Provision of Resources


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• Clause 5.4.2 Quality management system planning– Top management shall ensure that… the integrity of the quality

management system is maintained when changes to the quality management system are planned and implemented…

• Clause 7.1.4 Change control– The organization shall have a process to control and react to changes that

impact product realization…– Any product realization change affecting customer requirements requires

notification to, and agreement from, the customer…

• Clause 7.3.7 Control of design and development changes– Design and development changes shall be identified and records

maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation…

Change Management Clauses


Change management must extend to the supply chain!

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• Clause 8.2.2 Internal Audit– The management responsible for the area being audited shall ensure

that any necessary corrections and corrective actions are taken without undue delay…

• Clause 8.2.3 Monitoring and measurement of processes– When planned results are not achieved, correction and corrective action

shall be taken, as appropriate…

• 8.2.3.1 Monitoring and measurement of manufacturing processes– A corrective action plan shall then be completed by the organization,

indicating specific timing and assigned responsibilities to assure that the process becomes stable and capable…

• 8.5.2 Corrective action– The organization shall take action to eliminate the causes of

nonconformities in order to prevent recurrence…(problem solving!)

Corrective Action Clauses


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• Clause 7.6.1 Measurement System Analysis– Statistical studies shall be conducted to analyze the variation present

in the results of each type of measuring and test equipment system…

– This requirement shall apply to measurement systems referenced in the control plan…

– The analytical methods and acceptance criteria used shall conform to those in customer reference manuals on measurement systems analysis…

Measurement Systems Analysis

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Measurement is a process!

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7.5.1.1 Control Plan

7.5.1.2 Work Instructions

7.5.1.3 Verification of Job Set‐Ups

7.5.1.4 Preventive and Predictive Maintenance

7.5.1.5 Management of Production Tooling

Process Control Clauses


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• The organization must establish and maintain documented procedures for identifying training needs to achieve competence of all personnel performing activities affecting product quality…

• Personnel performing specific assigned tasks must be qualified, as required, with particular attention to the satisfaction of customer requirements…

Clause 6.2.2.2 Training

An example of a Customer-Specific Requirement is the application of digitized mathematically-based data


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MATERIAL, PRODUCTION CONTROL AND LOGISTICS


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Automotive Industry Action Group (AIAG) and Odette International “Best Practices”


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• Supplier Management prioritization should be based on risk (supplier, product, process)– Qualitative, e. g. red‐yellow‐green ratings

– Quantitative, e. g. FMEA

• Organizations need effective supplier management processes– Supplier Qualification, Selection, Monitoring and Improvement

• Automotive industry has specified requirements for suppliers and sub‐tier suppliers

Session Summary


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734.761.4940

Questions?

Thank You!Dan [email protected]

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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 Award

ISO062_Reid_TS16949 Automotive Supply Chain_PPT

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