Risk-based Thinking in IATF 16949:2016

Transcription

1 Risk-based Thinking in IATF 16949:2016 Cathy Fisher President, Quistem, LLC ISO 9001/IATF QMS Expert Terry Onica Director, Automotive, QAD MMOG/LE Expert

2 Do you ever apply Risk-based Thinking in your life?

3 Risk-based Thinking is... Risk: effect of uncertainty Context + Risk = Basis for QMS planning Preventive actions are one result of risk based thinking Formal vs. informal approaches

4 Risk-based Thinking = Better Decision-making

5 Did You Know specific Requirements referencing RISK Plus several mentions in MMOG/LE!

6 Risk-based Thinking A Common Theme ISO 9001:2015 International Quality IATF 16949:2016 Automotive Quality MMOG/LE v4 Supply Chain

7 Automotive Risk-based Thinking Experts Cathy Fisher President, Quistem, LLC ISO 9001/IATF QMS Expert Terry Onica Director, Automotive, QAD MMOG/LE Expert

8 What we will cover in this session... Why Risk based Thinking supports effective Quality and Supply Chain Management Which IATF and MMOG/LE requirements refer to Risk based Thinking How Risk based Thinking is applied in IATF and MMOG/LE How to recognize Risk based Thinking in your organization

9 Intersection of Risk-based Thinking Requirements

10 Framework for Risk-based Thinking Issue/ Context Interested Parties Requirements Risks & Opportunities Priority Action Results

11 Business Ladder Satisfied Customer Risk-based Thinking can be applied to all levels of the business Product Mfg. Process Plan, (APQP) Mgt. System

12 IATF Risk-based Thinking Requirements IATF Description Requirement Business Ladder Level Risk Analysis Minimum inputs All Preventive Action Process to lessen impact of negative effects of risk All

13 Key Elements of Preventive Action Description of Risk and Results of Evaluation Determination of Risk Trigger/Cause Identification and Evaluation of Risk Elimination Actions Implementation Plan of Risk Elimination Actions Evidence of Risk Elimination Effectiveness

14 IATF Risk-based Thinking Requirements IATF a), b) Description Requirement Business Ladder Level Contingency Plans Contingency plans All

15 What could happen? How will we respond? How can we prepare in advance?

16 Need for Improved Contingency Plans Risk based thinking focus in ISO 9001/IATF quality management systems standards & MMOG/LE Complexity and diversity of automotive supply chain Critical supply chain disruptions Lack of organization wide contingency planning at suppliers Top IATF transition audit nonconformity

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18 In Reality, Plants are Assessing

19 Lack of Poor Risk Planning Results in... $2M $600K $500K

20 A Tale of Three Companies: 2011 Tsunami Case Study: Result: $615.3 Million Cost - Repairs - Inventory - Fixed assets - Inability to operate - Cancelled contracts Source: Renesas Annual Report 2011

21 A Tale of Three Companies: 2011 Tsunami Case Study: Result: Supply Chain Preparedness 6 weeks after 2011 tsunami GM was still locating suppliers Subsequently, GM implemented an event watch system 6 hours after the earthquake in Japan in 2016 GM understood the supplier impacts

22 A Tale of Three Companies: 2011 Tsunami Case Study: Xirallic Pigment used in paint Many OEMs rely on Xirallic Produced by a single source from a single factory in Japan Result: 4 month recovery advantage Already seeking alternatives Cut over to new supplier in 5 weeks Other OEMs didn t resume production for 5 months

23 Why is the Supply Chain not Prepared?

24 Contingency Planning Requirements (in IATF & MMOG/LE)

25 Requirement significantly enhanced from ISO/TS 16949:2009 More than just a documented plan Contingency planning as a process!

26 What is MMOG/LE? Materials Management Operations Guideline Logistics Evaluation

27 What is MMOG/LE? Developed by AIAG/ Odette with OEMs, Suppliers and QAD Assessment tool to evaluate/select suppliers Completed at the site level Compare logistics capabilities against best practice Used for production and after sales Determines level of plant performance (e.g. A, B, C) Some OEMs require MMOG/LE in IATF customer specifics MMOG/LE = Delivery ISO 9001/IATF = Quality

28 Minimum Risks to Consider Per IATF 16949:2016 & SI #3 and MMOG/LE Internal Risks Key Equipment Failures Fire Utility Interruptions Infrastructure disruptions (e.g. EDI) Packaging External Risks Interruption from Externally Provided Products, Processes & Service Recurring Natural Disasters Labor Shortages Cyber attacks on Information Technology Systems Transportation

29 Additional Risks to Consider Internal Risks Security Chemical spills Financial Capacity interruptions Unexpected loss of organizational knowledge Project specific External Risks Regulatory issues Recalls Customer disruption Natural resource availability Political uncertainty Technology shifts

30 MMOG/LE Requirements Document risk management process Including prioritization Proactively manage/reduce risk Create action plans Review, train, test, and validate Lessons Learned Manage sub supplier risk Customer owned processes Require risk assessment and action plans

31 Contingency Planning Roadmap Review & Test Periodic evaluation Structured assessment 4 Update 5 Communicate & Implement Availability of Contingency Plans Communication Plan Awareness & Training 3 Lessons learned New/evolving risks Identify & Evaluate Risks Key issues & events Interested Parties requirements Evaluation criteria 2 Develop Plans Contingency Action process Contingency Plan content 1

32 Additional IATF 16949:2016 Risk-based Thinking Requirements and Methods

33 IATF Risk-based Thinking Requirements IATF Description Requirement Business Ladder Level Plant, facility & equipment planning (Note) Measurement systems analysis c) Calibration/verification records Risk identification & risk mitigation methods Prioritization of MSA studies Assessment of risk for out ofspecification conditions Plan, Process Process, Product Process, Product

34 Plant, Facility & Equipment Planning Optimize material flow, (synchronous material flow) Value added use of floor space Manufacturing feasibility assessments, ( ) input to management review Capacity planning input to management review Re evaluation relative to risk

35 IATF Risk-based Thinking Requirements IATF Description Requirement Business Ladder Level Awareness supplemental Organization manufacturing feasibility Design & Development planning Risks involved for customer with nonconforming product Feasibility analysis for new or changed products & processes Product design and manufacturing process risk analysis Product, Customer Plan, Process Plan, Process, Product

36 IATF Risk-based Thinking Requirements IATF Description Requirement Business Ladder Level Development of products with embedded software Prioritization based on risk and potential impact to customer Product design input Assessment of risks with input requirements & Product & manufacturing process design inputs Design alternatives Plan, Product Plan, Product Plan, Process, Product

37 IATF Risk-based Thinking Requirements IATF Description Requirement Business Ladder Level Manufacturing process design input Error proofing methods commensurate with risks encountered Special characteristics Based on risk analysis, (FMEAs) (Note) Monitoring Measurements include quality risks Plan, Process Plan, Process, Product Plan

38 8.3 Product & Manufacturing Process Design DFMEA & PFMEA Trade off analysis DFMA, (design for manufacturing and assembly) DFSS, (design for Six Sigma) Fault tree analysis Special characteristics

39 IATF Risk-based Thinking Requirements IATF Description Requirement Business Ladder Level & Design & Development and Manufacturing Process design outputs Supplier selection process Design risk analysis (FMEA), capacity analysis, manufacturing process FMEA Assessment of selected supplier s risk to product conformity, uninterrupted supply Plan, Process Plan

40 IATF Risk-based Thinking Requirements IATF Description Requirement Business Ladder Level Type & extent of control supplemental SI #8 Supplier QMS development Adjust type and extent of control based on supplier performance and assessment of product, material or service risks Using risk based model, define minimum acceptable and target QMS development level Plan Plan

41 Supplier QMS Development Ultimate objective become certified to this Automotive QMS standard IATF rd party certification MAQMSR or AIAG CQI-19 Only with customer approval: ISO nd party conformity IATF nd party conformity ISO 9001 registration + customer defined QMS ISO rd party registration Supplier s QMS Initial minimum acceptable level of QMS development

42 IATF Risk-based Thinking Requirements IATF Description Requirement Business Ladder Level Automotive productrelated software or products with embedded software Prioritization based on risk and potential impact to customer, require supplier software development capability self assessment Second party audits Supplier risk assessment; based on risk analysis, criteria for determining need, type, frequency, scope of 2 nd party audits Plan Plan

43 Types of 2 nd party Audits Initial supplier selection Management Systems review Quality Planning Project Kick-off Launch Readiness Verification/Validation Product Realization Release Ongoing Performance, (containment, change)

44 IATF Risk-based Thinking Requirements IATF Description Requirement Business Ladder Level Supplier development Determination for supplier development actions including risk analysis Control Plan Linkage and information from design risk analysis, manufacturing process risk analysis outputs; review and update control plans at a set frequency based on a risk analysis Plan Plan, Process, Product

45 IATF Risk-based Thinking Requirements IATF Description Requirement Business Ladder Level Identification & traceability supplemental Control of changes supplemental Temporary changes of process controls Develop traceability plans based on levels of risk or failure severity Evidence of related risk analysis Based on risk analysis, (e.g. FMEA), internal approvals prior to implementation Plan, Process, Product Plan, Process Process, Product

46 Product Traceability Plan Product markings Lot/batch Test results Outsourced process Manufacturing data Material certification Subassembly Finished product Interim process Component Component Raw material

47 IATF Risk-based Thinking Requirements IATF Description Requirement Business Ladder Level Control of reworked product Control of repaired product Identification of statistical tools Utilize risk analysis to assess risks in rework process Utilize risks analysis to assess risks in repair process Include in design risk analysis, (DFMEA), process risk analysis, (PFMEA) Process, Product Process, Product Plan, Process

48 IATF Risk-based Thinking Requirements IATF Description Requirement Business Ladder Level Internal audit program Manufacturing process audit Management review supplemental j) Management review inputs supplemental Audit program prioritized based on risk, etc. Audit effective implementation of process risks analysis, (PFMEA) Frequency of management review increased based on risk Potential field failures identified thru risk analysis System Process System System, Customer

49 Risk-based Thinking QMS Audit & Review Process Stability & Capability Product, Process, System Change Product Nonconformity New Developments Customer Satisfaction Audit & Management Review frequency QMS Performance

50 IATF Risk-based Thinking Requirements IATF Description Requirement Business Ladder Level d) Problem solving Consideration of impact on similar processes and products Error proofing Methods used documented in process risk analysis Continual improvement supplemental Include risk analysis (e.g. FMEA) Process, Product Process, Product All

51 Other Risk-based Thinking Resources ISO 31000:2018 Risk Management ISO 31010:2009 Risk Assessment Techniques ISO Guide 73:2009 Risk Management Vocabulary AIAG M 12 Business Continuity Planning for the Automotive Supply Chain AIAG/VDA FMEA manual in draft

52 Future Perfect What the future holds: Better transparency Increased Market opportunity Reduced costs More efficient supply chains Increased skills Less companies going bankrupt or becoming extinct

53 Implementing Risk-based Thinking Identify how your organization is applying Risk based thinking to key business processes Investigate Risk based Thinking methods appropriate for your organization Develop and implement processes to support Risk based Thinking in your business

54 Final Thought... How is your organization applying Risk based Thinking to ensure transition of your QMS to ISO 9001:2015/IATF 16949:2016 by the September 14, 2018 deadline?

55 Thank you for joining us for today s session Cathy Fisher President, Quistem, LLC ISO 9001/IATF QMS Expert Terry Onica Director, Automotive, QAD MMOG/LE Expert