Method Training – version 2

REVERSE FMEA

Knowllence © 2017 FMEA 1

Knowledge (risks and opportunities) for your excellence

Enterprise Risk
Management Heath, Safety and
Environnement

HACCP
Machinery FMEA Quality and Robustness
in design

Quality and Robustness

Medical Device in manufacturing
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 Software Modules

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Services
Training : APQP, DFMEA, PFMEA, Functional Analysis

Software development, implementation and training :

Robust Manufacturing Suite
Robust Engineering Suite
Migrate Your Existing Data (Drag and Drop, XML, …)

Moderation
Project leading
New methods
From Specifications to Control plan

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REMINDER

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Failures analysis with PFMEA

A failure is defined as the way or manner in which a

process could fail to meet process requirements.

Potential !

The PFMEA is
Preventive tool. On the project
Improve a process / a design
Helps take the right decision.
That’s not a problem solving tool! (8D, QUICK RESPONSE
QUALITY CONTROL)

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 PFMEA definition

An analytical technique for each process step that

identifies:
Ways a process may fail to meet requirements.
Consequences to the internal / external customer (Severity).
Frequency the failure will/could happen (Occurrence).
Effectiveness of current controls (prevention & Detection).
Ranking of causes and effects (Risk Priority Number).
A structured procedure for identifying and eliminating process
related failure modes.

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Reminder

Extracted from the software

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 Reminder

Requirement are the outputs of each operation / step

and relate to the requirements for the product. Provide a
description of what should be achieved at each operation
/ step.

Potential Failure Mode is defined as the manner in which

the process could potentially fail to meet the
requirement. Basic assumptions:
incoming part/material are correct (exception: historical data),
basic design of product is correct,
failure could occur but may not necessarily occur.

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Reminder

Potential Effect is described in terms of what the

customer (it can be internal customer as well) may notice
or experience.

Following questions raise:

1.Does the Potential Failure Mode physically prevent
downstream processing or cause potential harm to equipment or
operator?
2.What is the potential impact on the End User?
3.What would happen if an effect was detected prior to reaching
the End User?

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 Reminder
Potential Cause is defined as an indicator of how the
failure could occur and is described in terms of
something can be corrected or controlled. Only specific
errors or malfunctions should be listed. Ambiguous
phrases should not be use like ”operator error”.

Manpower Method Time

Skill
People Management
Procedure People

Failure
Ergonomic Paper Material Device
Environment Product Energy Tooling

Midst Material Means

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Current Process / PFMEA

Control Prevention Control Detection

Eliminate (prevent) the cause Identify (detect) the cause of
of the failure mode from failure or the failure mode,
occurring, or reduce its rate of leading to the development of
occurrence. associated corrective
action(s) or counter
The initial occurrence measures.
rankings will be affected by The initial detection rankings
the prevention controls will be based on process
provided they are integrated controls that either detect the
as part of the design intent. cause of failure, or detect
the failure mode.

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 Current Process / PFMEA

Control Prevention Control Detection

Documentation -records of
best practices, lessons
learned, etc. from similar
designs
Error-proofing in tooling
design
Example : pump pressure
indicator detect nearly all off
the events minus the
uncertainty of measurement
minus the indicator failures.
Optical detector : correct !
Visual control : according to
the situation, frequency

prevent by applying
standards and guidelines
detect by measurement and
control

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Threshold : analysis
Criteria evaluation : ranking from 1 to 10
Severity

Severity of the effects For the user

Occurrence S PFMEA shall

conform to
Probability for a defect customer
to appear, to occur requirement.
Non detection O PFMEA have
accurate
Non detection rating Severity/Occurrence
/Detection ratings.
D
Opportunity for a client to have a defect when taking
into account the existing detection device

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 Threshold : analysis

Calculation of the R.P.N

The risk priority number (RPN) is calculated by
multiplying the three rankings together
S : Severity of the effects
O : Probability for a defect to appear, to occur
D : Non detection rating

Risk priority
number = S x O x D
R.P.N

The use of an RPN threshold is

NOT a recommended practice to
determine the need for actions.

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Reminder

Recommended Actions intent is to reduce rankings in:

Severity: only a design or process revision can bring
Occurrence: process or design revision may be required. Actions
for Preventive Control brings reduction.
Detection: preferred method is the use of error proofing.

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Goals of Reverse FMEA

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PFMEA life cycle

living documents Proactive

PFMEA PFMEA PFMEA PFMEA

P- FMEA development
review review review review

Design Reactive
P-PAP
freeze
QRQC QRQC QRQC
/ 8D / 8D / 8D

Prototype
Tooling Pre serial Serial production
Design

Cross-functional teams shall review

PFMEA’s periodically.

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 Periodic PFMEA review
The frequency and/or number of PFMEA reviews shall
be determined by supplier leadership based on:
customer expectations (customer complaints, 5 whys, launch
activities, etc.),
process capability, scrap analysis.
changes to the process (Error proofing, Tier 2 changes, etc.).

Criteria to prioritize which PFMEA to review include:

Product from an acquisition, tool move or change in supplier,
PFMEA developed without adequate cross-functional
involvement,
PFMEA for part(s) with history of customer complaints, warranty,
Occurrence ratings (FTQ, scrap, etc.) have changed significantly,
PFMEA with oldest revision dates.

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PFMEA Proactive Risk Reduction Process

Establish and maintain a list of the highest (RPN) Risk
Reduction.
Opportunities based on the updated PFMEA documents.
An action plan or equivalent shall be utilized by the cross
functional.
team to track progress in reducing the RPN ratings.

Extracted
from the software

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 Tracking matrix

Extracted from the software

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Limits of PFMEA review ?

PFMEA is a „one man show”.
Scoring is not according to customer guidelines.
Scoring is not consistent.
Primary detection method relies heavily on visual inspection.
Failure modes are missing, not revised at work station.
Internal/external PPM are not used for Occurrence.
Scoring driven by low RPN or set by action limit.
New scoring is not revised after recommended action
implementation.
High risk item identified but not controlled by SQ tools.
Management is not involved & does not allocate resources for
regular reviews.
PFMEAs not used for continuous improvement - only updated
when problems occur.

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 Reverse PFMEA purpose

Reverse PFMEA is intended as a tool to assist in PFMEA

reviews and RPN reduction efforts based on actual data
from in-station audits of all the failure modes.

This review is an attempt to discover or create new

Potential Failure Modes not considered during PFMEA
development as well as validate Occurrence and
Detection ratings based on real data.

Assist in PFMEA In-station

review audit
Based on
actual data

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Reverse PFMEA definition

Reverse PFMEA is an on-station review of all failure

modes included in PFMEA conducted by cross-functional
team, focused to verify that all failure modes have proper
controls (prevention/detection) and they are working
properly.

"Go and See"

PFMEA
Gemba is the Japanese
term for "the place"

“If the problem exists on the shopfloor

then it needs to be understood
and solved at the shopfloor.
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 History

Reverse FMEA was developed :

In Quality Systems Basics 2009.
By General Motors Corporation Global Purchasing Supply
Chain.

It was included in the PSA quality requirements in the

“risk reduction process” in 2013.

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Continuous FMEA improvement

Check your
PFMEA !

Living
documents

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DEPLOY REVERSE FMEA

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Reverse FMEA team

A team should be defined.

It should be cross-functional (similar like PFMEA core

team) with :
one external auditor as "fresh eyes" for the audit.
maintenance engineer to supervise the verification and avoid
any damage to the station.

In order to standardize the audit concept, the teams

should work together on a Reverse PFMEA. This will
ensure that the same criteria is used to avoid affecting
the result of the audit.

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 Overview – Reverse FMEA Flow diagram
According the audit schedule, review every failure
modes according the existing PFMEA

The failure modes

have proper controls
Audit
(prevention / No
detection) schedule
Yes

Are the controls

working properly? No
Yes
Are the D and O
value accurate and
consistent? No
Yes
Verify next failure mode in FMEA
List of
No
findings
All failure modes in
PFMEA controlled? and tasks
Yes
Once all failure modes are verified , next step is try to
create new failure modes not included in the PFMEA

Yes
New potential
failure modes
Check
found?
list
No

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Audit schedule
To take into account :
Work station accessibility.
Work station availabilities

R FMEA schedule
Work station Week 10 Week 11 Week 12 Week 13 Week 14 Week 15 Week 16 Week 17 Week 18
WS 10 done
WS 20 done
WS 30 delayed planed
WS 40 planed
WS 50 planed
WS 60 planed
WS 70 planed
WS 80 planed
Line A WS 90 planed
Work station
WS 1010 done
WS1020 done
WS 1030 done
WS 1040 planed
WS 1050 planed
WS 1060 planed
WS 1070 planed
WS 1080 planed
Line B WS 1090 planed

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 Inputs for Reverse FMEA

Existing PFMEA.
Control plan.
Reverse FMEA check list.
List of claims.
Scraps analysis
Past quality issues
Error proofing verification results.
Work station audit.

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Existing failure modes

Confirm the current failures modes have the identified
methods and controls in place.

Failures
modes

Controls
Causes Extracted from the software

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 Controls analysis
Are the controls ‘prevention and detection” working
properly?

Error proofing verification :

Error Proofing Device – (CAN NOT MAKE) - Devices which
prevent the manufacture or assembly of nonconforming product.
Error Detection Device – (CAN NOT PASS or CAN NOT
ACCEPT) - Devices which prevent the transfer of nonconforming
product (e.g. 100% in-line inspection equipment).
Error proofing devices shall be verified at least once per day.
Verification results shall be recorded.
Have reaction plans to device failures ( e.g. Control of
nonconforming)

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Factual Occurrence and Detection

Occurrence and Detection ratings are accurate to real data

Capabilities analysis.
Scraps analysis and statistics.
Customer claims.

Customer claims Scraps analysis

Past quality issues

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 New potential failure modes

Use the check list to identify new failure modes.

Involve the operator in the audit.

Experiment with the station in order to try to find new

failure modes :
example: using similar components that could be mixed, or try to
assemble parts inverted to see what happened, etc.)
NOTE: This verification will be under the supervision of the
maintenance engineer to avoid any damage to the station.

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Check list : GM example 1/2

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 Check list : GM example 2/2

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Findings and list of tasks

Once they finished the audit, all the findings should be

documented in an action plan with champion and dates
to complete and increase the prevention of defects at the
production line.
Update the PFMEA with new modes, causes.
Extra analysis have to be listed in list of tasks.

Take some pictures.

List of
tasks
living documents

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CONCLUSION

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Conclusion

Leadership shall support RPN reduction activities and

provide necessary resources for periodic cross-
functional team reviews.

A Reverse PFMEA process should be implemented.

Cross-functional teams shall completely review PFMEA’s

for:
Occurrence and Detection ratings are accurate to real data
Updates are made for each reactive & proactive event.

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