PFMEA, Risk Reduction and Effectiveness – Advance (AIAG FMEA #4 Edition) Is your FMEA performing for you? This is advance level of PFMEA, Have basic understanding fo Core IATF Tools before refering to this presentation.

1. Why does it
always seem we
have plenty of
time to fix our
problems, but
never enough
time to prevent
the problems by
doing it right the
first time?
PFMEA, Risk Reduction and Effectiveness –
Advance (AIAG FMEA #4 Edition)
24-07-2018 Advance PFMEA By Prashant Rasekar Page # 01
Is your FMEA performing for you?

2. 1. What does the FMEA do for us?
• Reduces the likelihood of Customer complaints
• Reduces the possibility of safety failures
• Reduces the possibility of extended life or reliability failures
• Reduces the likelihood of product liability claims in legal disputes
• Improving yield and profit margins
• Reducing time to market and warranty costs
• Increasing machine and human resource availability
• Ensuring employee and customer safety
• Identifying necessary controls and developing test procedures
24-07-2018 Advance PFMEA By Prashant Rasekar Page # 02

3. Ready?
2. Today’s Goals
• Cover Page……………………………………………………………………………………………………………………………………………………………………… Page 1
• Introduction to What Does the FMEA do for us?................................................................................................................... Page 2
• Todays Goals…………………………………………………………………………………………………………………………………………………………………….Page 3
• FMEA Development process…………………………………………………………………………………………………………………………………………….Page 4
• Define Process requirements…………………………………………………………………………………………………………………………………………...Page 5
• Potential Failure Mode……………………………………………………………………………………………………………………………………………………..Page 6
• Potential effects of failure…………………………………………………………………………………………………………………………………………………Page 7
• Potential Cause of Failure and Occurrence……………………………………………………………………………………………………………………....Page 8
• Current Process controls and Detection……………………………………………………………………………………………………………………………Page 9
• Risk Reduction………………………………………………………………………………………………………………………………………………………………….Page 12
• Risk Limiting Method………………………………………………………………………………………………………………………………………………………..Page 14
• Close Gaps in system………………………………………………………………………………………………………………………………………………………..Page 17
• Maintaining the system…………………………………………………………………………………………………………………………………………………….Page 18
• Measure Effectiveness of PFMEA………………………………………………………………………………………………………………………………………Page 19
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4. PFMEAs
Input
PFD
DFMEA
Drawing & Customer
requirements
PFMEA Ranking
Guide Lines
FTQ, PPM,…
(Historical Records)
Process
Product Requirements
Failure Modes
Highest Effect of
Failure modes (Sev)
Potential Causes of
Failure mode
Occurrence Rate for
Each Cause
Output
Preventive Controls
Detection Controls
(Det)
RPN for each cause
Ready to link with PCP
3.PFMEADevelopmentProcess
24-07-2018 Advance PFMEA By Prashant Rasekar Page # 04

5. 4. Define the Process Functions / Requirements
Identify What functions in your process convert an input into an output? Process specific requirements must be specific to meet design intent or customer
requirement.
Identified Requirements must be very specific. If failure mode are multiple, it indicates the requirement is vague.
An alternate decomposition method which can be used to assign dependencies. A mapping between the functions and the structure forms a link between the
descriptions of the process and the physical entities implementing those actions.
Bring your Process Flow Diagram, Design FMEA, Drawing & Customer requirements, Bill of Process, PFMEA Ranking Guide Lines FTQ, PPM, Process capabilities
(Historical Records / lessons learned) and Decompose your process till you identify List the desired inputs and outputs .
4.1 Identify the Elements(KPI, KPC, Critical Dimensions, etc).
Elements are the physical entities and agents responsible for performing functions and achieving post-conditions.
Examples: 01
Requirements : (Part Subassembly)
• Failure Modes Captured without studying
requirements:
IMP: Lack of studying product requirement will lead to miss many failure modes that might cause quality issues
Assembly of BMC Cavity
Assembly of the
BMC cavity
Potential failure mode
Wrong Screw Used
Process Step
Wrong Screw Used
Torque Below Limit
Missing BMC Cavity
Torque above limit
Fix Metal wire in opposite
direction
* Fixing the
metal wire by
bolt (4*10)
mm.
* Assembly in
specific
Direction.
* Assembly to
specified
Torque
Assembly of the
BMC cavity
Process Step Requirements Potential failure mode

6. 5. Potential Failure Modes
Failure is defined as a manner in which a system can fail or fail to meet requirement. Assume Incoming Material are correct. Exceptions are made were historical
data indicates deficiencies of incoming part quality. If design issue is present, communicate to design team for Resolution.
Typical failure modes:
(1) premature operation,
(2) failure to operate at the prescribed time,
(3) failure to cease operation at the prescribed time,
(4) failure during operation,
(5) degraded or excessive operational capability.
• Bad Part shipped to customer .
• Root cause identified that short length part is shipped to customer .
• Part supposed to be 100% inspected with green mark Detection .
• System root cause reported : Uninspected defected part fall into OK box ( handling risks are not
analyzed in PFMEA)
Examples: 03 Handling Risks:
Suspected
parts not
mixed with
good parts
Mixed
suspected
parts into Ok
parts
* MP:
Rework
off line
*
Customer
:
Rework
off line
* End
User:
Noise
6
Green Box
close to
suspected
material
Standardize
location of
suspected
material
away from
Ok bins
5
Visual
Inspection
during LPA
7 210
Standardize areas in WI for
suspected material and ok bin
away from each other
P04
Flange
Machinin
g
Current
Process
Controls
prevention Occurrence
Current
Process
Controls
detection
Detection
Process
Step
Requirem
ents
Potential
failure mode
Potential
Effect(s)
of
Failure
s
e
v
Potential
Cause(s) of
Failure
Recommened action
RPN
IMP: Lack of studying handling risks might cause quality issues .
Examples: 02
Requirements &
Potential Failure Mode

7. 6. Potential Effects of Failure
Effect of Failure is defined as a manner in which a customer can be effected.
Be it internal Customer(Subsequent Stations) or external(Regulatory Bodies, OEM, End User/Vehicle Driver).
Best practice is to consider the effect of all (Government Regulation, OEM, End User, Subsequent Station)and consider highest ranking in the Severity.
DFEMA and PFMEA Severity ranking must be equal for a common failure mode.
Failure mode effecting KPCs, safety and compliances must be specifically identified.
Examples: 04
Effect Study: (Glass Scratch)
• Effect Study is based on End User point
of view.
• Effect is studied based on manufacturing process(MP),
customer and end user.
• Study Effect from one point of view might lead to wrong or unestimated severity ranking.
• If Sev. is underestimated, real risk will be hidden and proper controls might not be taken.
• Risk reduction priorities will not be accurate.
Scratch in
Windshield
Apperance
defect
4
Potential failure
mode
Potential
Effect(s) of
Failure
s
e
v
Scratch in
Windshield
* MP : Might
Scrap based
on size (7)
* Customer :
Rework off
line (6)
End User :
Apperance
defect (4)
7
Potential failure
mode
Potential
Effect(s) of
Failure
s
e
v
Page # 07

8. 7. Potential Cause of Failure
Potential cause indicate weakness in design and Process weakness.
Best Practice -Try to Identify more than one cause. Ambiguous phrases (e.g. Operator Mistakes, miss aligned) must not be used.
8. Occurrence
Occurrence is likely hood of failure.
If Statistical data(SPC) if available, then it can be used to determine(Lower) the Occurrence ranking.
Default Occurrence ranking 5 is consideration in absence of the historical data.
Examples: 05
Reduced Occurrence Rating by SPC

9. 9. Current Process Controls
Controls that can either Prevent the cause of failure form occurring or Detect
failure mode or Cause of failure mode.
Initial detection ranking will be bases on process control either detect cause or
failure mode. SPC may be considered as Preventive control for specific cause
whose trend is identifiable in advance of actual non-conformance being
produced, such as tool wear.
Other methods of Process Control may be.
SPC, Maintenance, Method Sheets, Work Instruction, Skill Matrix, Setup
verification, Inprocess inspection, Error Proof by Design, Lock and Key.
10. Detection
Detection may be Current Process, Subsequent Process and Best/lowest is to be considered. In order to achieve lower ranking, generally detection control is
improved.
Methods include such as Gauging, Final Test, Functional test, Visual Systems, Touch for quality, Auto Line stop, Unable to complete process, Barcode readers,
Scanners, Defect alarm systems etc.
Examples: 06
Prevention Control and Detection Control
Page # 09

10. AIAG Severity Occurrence Detection (S.O.D) Guideline Tables:
How much cause occurred at
all supported by data ?
Highest failure mode effect from end
user, customer and manufacturing
process. Best control used for cause or
whole failure mode.
Plugin the data in Process FMEA.
•PFMEA Should be available for all part numbers /processes.
•PFMEA should cover the rework , Bypass processes.
•Each Failure mode has one Severity number.
•Each cause has its RPN number.
•Each failure Mode might have more than one cause .
•S,O,D numbers should be taken based on PFMEA tables references.
•PFMEA should Cover all processes including material handling , packing & labelling .

11. Examples: 07
PFMEA Details
Page # 11

12. Input
PFMEA
FTQ , PPM
,…customer
records).
Annual Review
Plan.
Criteria for
prioritizing risk
(EX : Risk limiting
method ).
Process
Team monthly
Meeting Agenda
Shop floor reverse
PFMEA review.
Team deep dive to
reduce to risky items
as per prioritizing
criteria
Output
Reverse PFMEA
outcome ( New Failure
Modes, New Causes,
New Controls, Revised
Occ., Det Numbers).
Top risky items new
preventive, detection
controls or both.
RiskReduction
11. PFMEA Risk Reduction
24-07-2018 Advance PFMEA By Prashant Rasekar Page # 12

13. Just Say No to RPN
• Why is the RPN not and effective measure of the FMEA System?
o RPN is a derivative of Severity, Occurrence, and Detection.
o RPN is not reflect the real threat.
o RPN treats them equally
o There is not weighting factor used to evaluate the risk
Recommended Practice:
o We should assess Severity, Severity x Occurrence = Criticality, and Risk = Severity x Occurrence x Detection = RPN separately.
Example: 08
A) Prioritize based on
RPN
*Item B is selected as high priority .
* Simple to use
Not Sensitive for high severity items
.
Not Recommended
B) Prioritize based on
Severity of the risk
* Uses different methods to prioritize
risk but Sev will be taken as highest
impact .
* Sensitive to high severity items.
Recommended
Standardized Risk Prioritizing Methods
Page # 13

14. 12. Risk Limiting Method:
Priority Level
Based on Severity Zone (Severity vs. Occurrence) and Detection Level (Severity vs.
Detection)
Priority Level 1: Highest level of risk, should review for potential risk reduction
activity
Priority Level 2: Medium level of risk, next group to review for potential risk
reduction activity
Priority Level 3: Lowest level of risk, risk reduction activity not necessary.
Severity
10 3 1 1 1 1 1 1 1 1 1
9 3 1 1 1 1 1 1 1 1 1
8 3 2 1 1 1 1 1 1 1 1
7 3 2 2 2 1 1 1 1 1 1
6 3 2 2 2 1 1 1 1 1 1
5 3 3 2 2 2 2 1 1 1 1
4 3 3 3 3 2 2 1 1 1 1
3 3 3 3 3 3 3 2 2 1 1
2 3 3 3 3 3 3 3 3 2 2
1 3 3 3 3 3 3 3 3 3 3
1 2 3 4 5 6 7 8 9 10
Severity
10 3 2 1 1 1 1 1 1 1 1
9 3 2 1 1 1 1 1 1 1 1
8 3 2 2 2 2 2 1 1 1 1
7 3 3 3 3 2 2 2 2 1 1
6 3 3 3 3 3 3 2 2 1 1
5 3 3 3 3 3 3 3 3 2 2
4 3 3 3 3 3 3 3 3 2 2
3 3 3 3 3 3 3 3 3 3 3
2 3 3 3 3 3 3 3 3 3 3
1 3 3 3 3 3 3 3 3 3 3
1 2 3 4 5 6 7 8 9 10
Priority LevelDetectionZone
(SevoverDet)
3 2 2 3
2 1 2 3
1 1 1 2
1 2 3
Severity Zone
(Sev over Occ)
OccurrenceDetection
Zone
• Severity Zone: comparing the severity and occurrence numbers.
• Detection Zone: comparing the severity and detection numbers.
PFMEA Risk Reduction
Severity Zone Matrix
Detection Zone Matrix
Advance PFMEA By Prashant Rasekar Page # 14

15. Example: 09 - Risk Limiting Method PFMEA Risk Evaluation
In above example: S=7, O=3, D=7. RPN Value 147
By referring to Severity VS Occurrence Matrix , Severity zone = 2
By referring to Severity VS Detection matrix, Detection zone = 2
By referring Severity zone VS Detection zone in Priority Matrix = 2 Priority
Although the PRN value is High, The Priority is in 2nd level. Here there are further scope of improvements which can be initated Depending upon the
Occurrence data.
PFMEA Risk Reduction
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16. PFMEA Risk Reduction
Example : 10
Risk Reduction
Criteria
Risk
Risk Reduced
ProactiveApproach
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17. 13. Close the Gaps in the System
• Gap 1 – ineffective evaluation of RPN leading to wasted time and effort
• Gap 2 - lack of process improvements not effectively implemented because of ignorance of assessing the critical factors with high risks
• Gap 3 – failure to address ALL high risk failure modes: High Severity, High Criticality, RPN with a value under the “threshold” assigned by the process that could lower Customer
satisfaction (internal and external Customers)
• Gap 4 – neglect to include systemic interfaces as part of the FMEA
• Gap 5 – the dangerous “we don’t know what we don’t know” – not addressing the unknown because we are only as good as the team working on the FMEA – we may not effectively
choose the correct resources within the organization to be part of the FMEA team
• Gap 6 – not including critical voices in the process – Customer, Operator, Quality, Testing or Analysis
• Gap 7 – not implementing effective quality tools to perform the FMEA assessment with in the team environment.
• Gap 8 – missing links to internal and external quality data
• Gap 9 – failure to identify critical characteristics
• Gap 10 – failure to effectively train people on the basics of completing a FMEA process
• Gap 11 – lack of resources assigned to the process – time, people, research, and follow-up
• Gap 12 – not linking Mistake Proofing with failure modes.
• Gap 13 – assuming Detection controls are better than they really are or are implemented when they are not.
• Gap 14 – neglecting to capture all the details
• Gap 15 – Failure to maintain the system
• Gap 16 - Primary detection method relies heavily on visual inspection.
• Gap 17 - Internal/external PPM are not used for Occurrence.
• Gap 18 - High risk item identified but not controlled by SQ tools.
Note:
~We are very quick to celebrate small wins.
~We must ensure the loop is closed.
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18. 14. Maintaining the System
• Ensure you update process flow charts, control plans, and FMEA data with the following:
• internal non-conformance data – impacts occurrence and detection
• Gather warranty data – RMA (Authorized returned material) data – impacts severity and detection
• Customer Complaints - impacts severity and detection – could impact occurrence
• Process changes - impacts severity and occurrence
• Internal Process Audit results – impacts occurrence - could impact detection
• Product changes - impacts severity and detection – could impact occurrence
• Personnel changes – impacts occurrence and could impact detection (if missing poke-yoke)
• Statistical Analysis trends – impacts occurrence and could impact detection
• Systemic changes – could impact severity, occurrence, and detection
• Customer Audit results – impacts the systemic interfaces identified in the FMEA
• Changes in customer identification of critical characteristics – impacts the risks identified during the initial FMEA
assessment – could impact severity and detection
• Changes in approved suppliers – could impact occurrence
• Assessment of changes in calibration – could impact occurrence and detection
• Changes in measurement techniques – could impact detection
• Changes in inspection – could impact occurrence and detection
• Changes in equipment - could impact severity, occurrence, and detection
• Changes in field application - could impact severity, occurrence, and detection
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19. B- Warranty / field failure data to assess FMEA effectiveness
• Warranty / Field failures impact the Customer’s perception.
• The same basic principles apply as with internal NCR methodology
• Look at the number of warranty / field failures failure modes reported versus the number of FMEA identified failure
modes
• Management team should establish a goal for this KPI – the metric would report against that goal
• Number if identified failure modes for the product / number of warranty failure modes = capability
15. Measure FMEA Effectiveness
C- Internal nonconformance data
Internal Nonconformances could impact the occurrence and/or detection ratings
• How do we do this?
• Simply be reviewing the identified failure modes listed in the FMEA as compared to the failure mode identified on the NCR
• How does one use internal nonconformances to assess FMEA effectiveness
• Internal Nonconformances could impact the occurrence and/or detection ratings
• Simply be reviewing the identified failure modes listed in the FMEA as compared to the failure mode identified on the NCR
• It is a good thing to contain your defects but did you capture the failure mode in the FMEA?
• Simple math can be used to evaluate this measure.
• Number of NCR identified that were not contained in the FMEA.
• Management team should establish a goal for this KPI – the metric would report against that goal
• Example: 18 NCRs issued this month – review of identified indicated 5 failure modes were not listed on the FMEA.
A- process control capability index
Compare performance to a target.
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20. Any Queries: Email
Rasekar.Prashant@gmail.com
Future presentation may be for Deviation/Bypass Management. IATF Requirement 8.7.1.1 Customer Authorization for Concession