The document discusses Failure Mode and Effects Analysis (FMEA). It defines FMEA as a tool used to identify potential failures in products or processes, evaluate the effects of failures, and prioritize actions to address failures. The document outlines the types of FMEAs, including product design FMEA and process FMEA. It provides examples of FMEA tables and discusses how FMEAs are used in automotive standards.

1. March, 22th 2010 Quality Tool Meeting Failure Modes and Effects Analysis (FMEA)

2. What is FMEA? Automotive Standards Types of FMEA FMEA Examples Conclusion Summary

3. Core Tools & Quality ISO/TS Requirements Could be audited by External Automotive Auditor (March, 29 th 2010) : FMEA Definition : Failure Mode and Effects Analysis or FMECA : Failure Mode, Effects and Criticality Analysis FE01J002_C (Guideline on Implementation and Operation of FMEA in MEED Doc db ) PSM Definition: Problem Solving Methods (Bone tools, Brainstorming, Functional Analysis,etc.) PDCA Definition : QCD Definition : Quality Costs Delays Continual Improvement Customers’ Satisfaction Please Don’t Change Anything Plan Do Check Act

4. 7.3.1.1 Approche pluridisciplinaire Exigée pour préparer le développement et la revue des analyses AMDEC et plans de surveillance ( Une approche pluridisciplinaire inclut typiquement la conception, la fabrication, les méthodes, la qualité, la production et tout autre personnel approprié de l'organisme) 7.2.1.1 Identification des caractéristiques spéciales du client 7.3.2.3 Caractéristiques spéciales L'organisme doit identifier les caractéristiques spéciales [caractéristiques spécifiées du produit essentielles pour son utilisation correcte et en toute sécurité] Note: Les caractéristiques spéciales peuvent inclure les caractéristiques du produit et les paramètres des processus. Exigences ISO/TS16949:2009

5. Exigences ISO/TS16949:2009 7.3.3.1 Éléments de sortie de la conception du produit - Supplément … une AMDEC produit , des résultats de fiabilité, les caractéristiques spéciales du produit, les spécifications,… 7.3.3.2 Éléments de sortie de la conception du processus de fabrication … les AMDEC de processus de fabrication, le plan de surveillance

6. Exigences ISO/TS16949:2009 7.5.1.1 Plan de surveillance Préciser les méthodes de surveillance utilisées pour maîtriser les caractéristiques spéciales Les plans de surveillance doivent être revus et mis à jour après toute modification du produit, du processus de fabrication, des méthodes de mesure, de la logistique, de la source d'approvisionnement ou de l'AMDEC. NOTE: L'approbation du client peut être nécessaire après la révision ou la mise à jour du plan de surveillance.

7. What is FMEA? An industrial-strength Risk Assessment tool A set of systemized group activities intended to: 1. Identify potential “failure modes” of a product or process 2. Evaluate the “effects” of each failure mode on the system 3. Define and prioritize action items to ∗ reduce the chance of failure mode to occurrence, or ∗ break the links between failure modes and effects 4. Track the progress of all action items 5. Document the entire process ∗ demonstrate “all due care” ∗ record the way of thinking of the designers

8. Types of FMEA and Coverage Two standard categories of FMEA - Product Design FMEA: ∗ addresses potential failure modes arising during design - Process FMEA: ∗ addresses potential failure modes arising during fabrication This method may be used for any type of process. (Sales, Logistics) where there is potential risk not to comply customers’ specific requirements or special characteristics. Control Plan : * defines mandatory controls to assure that product is conform to customer’s requirements (including measurement methods) Shared in three steps : Prototype, Pre series, Production where there is potential risk on three following steps before real product’s production in compliance with customers’ specific requirements or special characteristics.

9. Definitions Failure Mode = - Process FMEA: A problem or weakness in ∗ the process itself ∗ the assessment processes Effect = - Process FMEA: Degradation in the ability to: ∗ achieve one or more result(s) or ∗ assess one or more result(s)

10. (1) Identifying Failure Modes (Team works) Process FMEA - Assessment activities, links between processes or internal tools ∗ a few ad hoc or a periodic change Process FMEA - Analysis and evaluation of assessment instrument results ∗ Examine the problem items revealed by each instrument or a person ∗ Map each problem item to the affected result(s) - Each analysis becomes an Appendix of the Periodic FMEA (2) Evaluating the Effects (Team works)

11. (3) Define & Prioritize Actions (Team works) Process FMEA - Same Idea, Different Details (a) Prioritize the Problems using three parameters ∗ S = Severity of the problem, relative to outcomes ∗ C = Credibility of the instruments that identified the problem ∗ R = Recurrence likelihood (Probability) for the problem if no corrective action is taken (b) Rank each parameter (S, C, R) on a [1 ...10] scale (RPN : Risk Priority Number) ∗ again, 10 = worst ∗ Each ranking level has a detailed verbal description ∗ Uses three items to define the levels

12. Severity (Gravité)

13. Recurrence (Occurrence)

14. Credibility or Detection

15. Delphi FMEA table

16. Delphi - AIAG FMEA table

17. Delphi FMEA table

18. Delphi FMEA table

19. MEF processes FMEA

20. Japanese FMEA & Control Plans Examples (1)

21. Japanese FMEA & Control Plans Examples (2)

22. Conclusion Thanks for your presence and you attention Mandatory tool to improve risks analysis