FMEA

POKAYOKE
 FMEA

“I haven’t failed. I have found ten thousand

ways that don’t work.” – Thomas Alva
Edison
 FMEA
 FMEA: FAILURE MODE EFFECT ANALYSIS
 WHY?
 Cost of product or manufacturing / service failures very
high – Revenue loss, Customers, Legal costs, Warranty
costs etc.
 Problems could have been prevented.
 In 2010, top 20 US companies spent USD 15bn in
warranty costs.
 This does not include loss of customers, revenue loss etc.
 FMEA TYPES
 Design FMEA: For designing any new product or
service or re-designing existing product or
service.

 Process FMEA: For designing any new process

or re-designing existing process.
 FMEA - ADVANTAGES
 Potential to anticipate problems and prevent them.
 Reduce costs.
 Shorten product development time.
 Achieve highly reliable products and processes (PFMEA).

 Conditions:
 Has to be executed properly
 Right team composition
 Right preparation
 Right procedure
 FMEA – SUCCESS FACTORS
 Factor 1: Understanding the procedure and fundamentals
of FMEA – terminology and their application

 Factor 2: Cross functional team with subject matter

expertise

 Factor 3: Realistic estimation of Risk ratings

 Factor 4: Realistic estimation of revised Risk ratings

 WHAT IS FMEA?
 A method designed to:
1. Identify and fully understand the potential failure modes,
their effects and causes, for a given product or process.

2. Assess the risk associated with identified failure modes,

effects and causes, and prioritize issues for corrective
action.

3. Identify and carry out corrective actions to address serious

concerns.
 FMEA PROCESS STEPS
 Step 1: Identify potential modes of failure.
 Step 2: Identify consequences or effects for each
mode.
 Step 3: Rate the Severity (S) of each effect on a scale
of 1 to 10. 1 is Best and 10 is Worst.
 Step 4: Identify potential root causes for each failure
mode.
 Step 5: Rate the Probability of Occurrence(O) of each
root cause. Scale 1-10. 1 is least and 10 is highest.
 FMEA PROCESS STEPS
 Step 6: Identify process controls and indicators.
 Step 7: Rate Detectability (D) of each mode/root
cause. Scale 1-10. 1 is highest and 10 is lowest.
 Step 8: Calculate Risk Priority Number (RPN) and
Criticality.
RPN = Severity * Occurrence * Detectability
 Step 9: Use design to mitigate high risks or highly
critical failures and re-assess achievement of goals.
 FMEA OF CAR HEADLIGHT
 Product : Car Headlight
 For each Product or Process Step, there can be
multiple failure modes
 Potential Failure Modes
 Light doesn’t turn on
 Light doesn’t turn off
 FMEA OF CAR HEADLIGHT
 For each Failure Mode, there can be multiple
effects or consequences
 Potential Effects or Consequences
 Light doesn’t turn on
 Driver cannot see obstacles
 Car cannot be driven at night (Severity = 8)
 Light doesn’t turn off
 Battery dies
 Car won’t start (Severity = 10)
 FMEA OF CAR HEADLIGHT
 For each Failure Mode, there can be multiple
root causes
 Potential Root Causes
 Light doesn’t turn ON
 Battery dead (Occurrence = 8)
 Broken wire (Occurrence = 3)
 Broken switch (Occurrence = 3)
 Corroded switch (Occurrence = 2)
 Headlight is damaged (Occurrence = 10)
 FMEA OF CAR HEADLIGHT
 For each Failure Mode, there can be multiple
root causes
 Potential Root Causes
 Light doesn’t turn OFF
 Short circuit in switch (Occurrence = 2)
 Driver left the switch on (Occurrence = 8)
 FMEA OF CAR HEADLIGHT
 For each mode/root cause, there can be multiple
process controls or indicators
 Process Controls or Indicators
 Light doesn’t turn ON (Detectability = 6)
 Driver notices in the dark.
 Driver doesn’t notice during the day.
 Light doesn’t turn OFF (Detectability = 6)
 Driver notices in the dark.
 Driver doesn’t notice during the day.
 FMEA TABLE
Failure Mode: Light doesn’t turn on
Pot. Effect Pot. Root cause S O D RPN

Car cannot Battery dead 10 8 6 480

be driven at
night
Broken Wire 8 3 6 144

Headlight 8 10 6 480
damaged
Corroded Switch 8 2 6 96

Switch Broken 8 3 6 144

 MITIGATING RISK (CAR HEADLIGHT)
 Battery Dead
 Visual lights in console to show level of battery
charge

 Headlight damaged
 A pair of headlights at each side
 FMEA OF A CRICKET MATCH

 The manager of a cricket team wants to

identify and prioritize risk areas to
mitigate the risk of losing a match.
 FMEA EXERCISES

1. Process Step: Stock Inventory

2. Process : Quarterly Accounting Reports for a

start-up company

3. Product: Designing a premium segment ink-pen

 POKAYOKE OR MISTAKE PROOFING
 POKA – Mistake
 YOKE – To Avoid

 Pokayoke is a process improvement designed to

prevent a specific defect from occurring.

 Ideally, pokayoke ensures that proper conditions exist

before actually executing a process step, preventing
defects from occurring in the first place.
POKAYOKE EXAMPLES
POKAYOKE EXAMPLES
POKAYOKE EXAMPLES