WIXLIB

FMEA Dilemma andCountermeasuresGary Jing, PhDASQ World Conference – Session W06 – May 2, 2018

Learning Objectives This session is intended for experiencedpeople to discuss / exchange how to betterhandle the FMEA activities to get the bestout of it, by addressing challenges anddifficulties.– Interactions are encouraged & appreciated It’s not intended to teach basics tobeginners who have no experience.5/2/182018 WCQI W06 FMEA Gary Jing2

Agenda 5/2/18Speaker’s Connection to the TopicThe Challenges and DilemmaWhich Parts being DifficultTips to Deal With the DilemmaIntegration with Related ActivitiesAn Unique PracticeTakeawaysAppendix - More Discussions on Confusing Points2018 WCQI W06 FMEA Gary Jing3

Gary Jing’s BackgroundØ ASQ Fellow, MBA, PhD in IE, CQM / CQEØ Founding MBB @ Seagate TCO (1998 - 2005)Ø Sr. Mgr., Global LS / Founding MBB @ Entegris (2005 - 2009)Ø Global LSS Leader / MBB @ TE – ADC (2009 - 2015)Ø CI Director / MBB @ CommScope (2015 - Present)Ø US Delegation to ISO TC176 for ISO 9000 RevisionØ Editorial Review Board of Six Sigma Forum MagazineØ IQPC/PEX LSS Award Judge PanelØ Development of ASQ BB Certification Program (participant)Ø Delphi panel expert for SME/AME/Shingo Lean Certification ProgramØ Isixsigma DFSS Award (2011), Finalist of IQPC MBB of The Year (2008)Ø Two patents in disc drive modeling from his Sigma workØ Series publications on Lean SigmaØ More details on http://www.linkedin.com/in/ggaryjing.5/2/182018 WCQI W06 FMEA Gary Jing4

Foreword FMEA concept and practice can be appliedto almost anything. Most common ones are on design andproduction (process), which splits into:– Pre (production) release – easier to changedesign.– Post release – harder to change design.– Practice will be different b/w the 2 stages.– This session focuses on the Pre.5/2/182018 WCQI W06 FMEA Gary Jing5

Foreword The mechanism of FMEA is quitestraightforward, yet to do it well isn’t easy.So, what are the challenges?Gary Jing, FMEA Dilemma, Six Sigma Forum Magazine, May, 20145/2/182018 WCQI W06 FMEA Gary Jing6

What are the Biggest Challenges?Scenario 1: Cowboy under OSHA5/2/182018 WCQI W06 FMEA Gary Jing7

Example: Functions Identified for a Marker Cap20 “functions” identified.- Too much for FMEA.- Focus on NUD (new, unique,difficult) ones instead.5/2/182018 WCQI W06 FMEA Gary Jing8

A Fundamental Limitation of FMEA & RCAImpact / Return / RewardThe cost aspect needed for business decisionis usually not considered in FMEA (or lty / Effort / Cost5/2/182018 WCQI W06 FMEA Gary Jing9

What are the Biggest Challenges?Scenario 2: Everything is fine.5/2/182018 WCQI W06 FMEA Gary Jing10

So, What are the Biggest Challengesin doing FMEA?Effectiveness & Efficiency The quality of FMEA is hard to evaluate. No guaranty (or magic wand) 5/2/18With huge investment and no guaranty on results,people have the tendency to cut corner.2018 WCQI W06 FMEA Gary Jing11

Typical Ways to Boost FMEA Quality Experience- Ultimate pursuit Formality (& structure) - Less effective Right Focus- More effective Quantity- Trade efficiencyWill be elaborated in the remaining sections.5/2/182018 WCQI W06 FMEA Gary Jing12

Different Industries have Different Expectations onFMEA. More serious and formal in highly regulatedindustries– Medical Device, Aerospace, Automotive, etc.– Can be used as legal documents. Less formal in Telecom– Ad hoc in many cases. Less formal in Six Sigma activities– May be customized or use less formal form, e.g.Potential Problem Analysis (PPA).5/2/182018 WCQI W06 FMEA Gary Jing13

Agenda 5/2/18Speaker’s Connection to the TopicThe Challenges and DilemmaWhich Parts being DifficultTips to Deal With the DilemmaIntegration with Related ActivitiesAn Unique PracticeTakeawaysAppendix - More Discussions on Confusing Points2018 WCQI W06 FMEA Gary Jing14

Which Parts of FMEA are Difficult? Types of Failure Mode (FM) Types of Control– Prevention or Detection? Is it a Cause or Effect?– Cause – effect shifting Is it a process issue or design issue?– Some FMs may belong to both– Many process issues can be addressed by design Interaction between (sub-)structures (IBS)– IBS induced issues are hard to capture5/2/182018 WCQI W06 FMEA Gary Jing15

Which Parts of FMEA are Difficult? Types of Failure Mode (FM)– Failing to meet the specification Complete failureToo little (partial, uneven or not complete)Too much (over)IntermittentFailure over time– Incorrect or inappropriate requirements Wrong, missing, hidden, unstated, assumed)– Unintended use, application, or environment– Does harm to others5/2/182018 WCQI W06 FMEA Gary Jing16

Which Parts of FMEA are Difficult? Is it a Cause or Effect?– Chain of Causation– Cause–effect shiftingIs Electrical Fault aCause, FM or Effect?- It depends, on whatlevel you are looking at:- At car level, it’s acause;- At sub-assembly levelis a FM;- At component level,it’s an effect.5/2/182018 WCQI W06 FMEA Gary Jing17

Which Parts of FMEA are Difficult? Types of Control– Prevention or Detection?– One of most confusing items, hard to do it right.– Prevention: Focus on preventing failure to occur,affect Occurrence (O).– Detection: Focus on preventing effect to occur,affect Detection (D).– Different sets for design and process, no overlap.5/2/182018 WCQI W06 FMEA Gary Jing18

Prevention vs. Detection ControlsDFMEA Prevention Controls typically occur prior tofinalizing the design and reduce the risk offailures during Product Validation Testing- Engineering analysis and evaluation: Antioverstress feature- Tolerance Stack-Up or Statistical Analysis,- Finite Element Analysis Detection Controls detect the failure mode,typically during Product Validation testing,prior to releasing design for customer orders- Examples include Reliability testing andPerformance testing conducted as part ofproduct validation testing5/2/18PFMEA Prevention Controls occurprior to manufacturing theproduct- Equipment setuprequirements- Poka-yoke Detection Controls occurafter manufacturing theproduct but prior toshipping product tocustomers2018 WCQI W06 FMEA Gary Jing- Product testing- Inspection19

Agenda 5/2/18Speaker’s Connection to the TopicThe Challenges and DilemmaWhich Parts being DifficultTips to Deal With the DilemmaIntegration with Related ActivitiesAn Unique PracticeTakeawaysAppendix - More Discussions on Confusing Points2018 WCQI W06 FMEA Gary Jing20

PollAre all of the FMEA columns equally important?Options: Yes / NoWhich ones are most important?Options: RPN Detection Function Failure mode Action Others5/2/182018 WCQI W06 FMEA Gary Jing21

Tips on FMEA Efficiency & EffectivenessAre all of the FMEA columns equally important?Which ones are most important?1. The most important column in FMEA ispotential failure mode (concerns)– To identify potential failures as thoroughly &completely as possible.2. The 2nd most important is thecountermeasures (actions) identified– To keep risk of FMs at acceptable level.– Be conscious on cost.5/2/182018 WCQI W06 FMEA Gary Jing22

Tips on FMEA Efficiency & Effectiveness3. The 3rd is the risk priority number (RPN)– To assess the risk, establish priorities and guideresponses.– Always highly subjective due to lack of data.– Frequently mistaken as most important in FMEA.– AIAG is moving away from using it.4. Everything else is in supporting functions– To help make better informed decisions in theprocess.5/2/182018 WCQI W06 FMEA Gary Jing23

Redirect Team’s Brain Power to Boost FMEAEfficiency & EffectivenessFocusing team resource on NUD and thetop 2 most important columns can boostefficiency & effectiveness of FMEA. The top 2 most important columns (failuremode & countermeasures) can benefit fromteam the most. An experienced lead person or a smallsubset group can handle the rest well.5/2/182018 WCQI W06 FMEA Gary Jing24

Redirect Team’s Brain Power to Boost FMEAEfficiency & Effectiveness We can let the whole group focus onbrainstorming for the top 2, and let anexperienced lead person take care of therest along with a small sub team. Focusing on NUD (new, unique, difficult),easing on ECO (easy, common, old) items,can gain efficiency.5/2/182018 WCQI W06 FMEA Gary Jing25

Agenda 5/2/18Speaker’s Connection to the TopicThe Challenges and DilemmaWhich Parts being DifficultTips to Deal With the DilemmaIntegration with Related ActivitiesAn Unique PracticeTakeawaysAppendix - More Discussions on Confusing Points2018 WCQI W06 FMEA Gary Jing26

Integration with Related Activities How is FMEA activity connected withothers that have similar intent? e.g.– Six Sigma– Product Development Process (PDP)– Dynamic Control Plan (DCP) It’ll be much more effective & efficient ifsystematically integrate FMEA withactivities with similar intent.5/2/182018 WCQI W06 FMEA Gary Jing27

Integration with Related Activities Six Sigma connection– Lean Design for Six Sigma (LDFSS), e.g.– VOC / requirement management, e.g. Failing to meet requirements is a/the primarymode of failure. How to make sure you identified hidden /latent / implied requirements?à LDFSS VOC section.5/2/182018 WCQI W06 FMEA Gary Jing28