8/13/2019 PFMEA (Pankaj Nalwa)
1/21
Process Failure Mode Effect Analysis (PFMEA)
Uniparts India Limited By: Pankaj Nalwa
8/13/2019 PFMEA (Pankaj Nalwa)
2/21
Process Failure Mode Effect Analysis (PFMEA)
Uniparts India Limited By: Pankaj Nalwa
8/13/2019 PFMEA (Pankaj Nalwa)
3/21
Process Failure Mode Effect Analysis (PFMEA)
Uniparts India Limited By: Pankaj Nalwa
8/13/2019 PFMEA (Pankaj Nalwa)
4/21
Process Failure Mode Effect Analysis (PFMEA)
Uniparts India Limited By: Pankaj Nalwa
Our product or process is established, it doesnt have any failure modes.
Every product or process has modes of failure, which can arise eventhough your product or process is established and you are producing orperforming it for years.
8/13/2019 PFMEA (Pankaj Nalwa)
5/21
Process Failure Mode Effect Analysis (PFMEA)
Uniparts India Limited By: Pankaj Nalwa
FMEA takes lot of time and resources, also it does not provide any benefit. It
can be done by one person instead.
FMEA do take time and people resources as it is a team based activity.Effective FMEAs cannot be done by one person sitting alone and fillingout FMEA forms.FMEA do not require complicated statistics, still it can yield significantsavings for organization by reducing cost liabilities due to process orproduct that does not performed as required.
8/13/2019 PFMEA (Pankaj Nalwa)
6/21
Process Failure Mode Effect Analysis (PFMEA)
Uniparts India Limited By: Pankaj Nalwa
Current Paradigm
FMEA
-Taken lightly
Selective products / processes chosen.
Based on opinion.
All magically below the RPN cut-off.
-Too late
Error / Mistake proofing window long gone.
Rarely validated with field results.
Paper exercise done when pushed
8/13/2019 PFMEA (Pankaj Nalwa)
7/21
Process Failure Mode Effect Analysis (PFMEA)
Uniparts India Limited By: Pankaj Nalwa
New Paradigm
FMEA
Error / Mistake
Proofing
Process Control
Plans
Maintenance
Plans
-Taken Seriously All critical and new products / processes.
Data driven.
Roll-up RPN values.
-Early
Completed while design is still fluid.
Living document.
Ensures our products and processes are
robust
8/13/2019 PFMEA (Pankaj Nalwa)
8/21
Process Failure Mode Effect Analysis (PFMEA)
Uniparts India Limited By: Pankaj Nalwa
The objective of a FMEA is to look for all of the ways a process orproduct can fail.
A product failure occurs when the product does not function as it
should or when it malfunctions in some way.
Failures are not limited to problems with the product. Because
failures also can occur when the user makes a mistake, those types
of failures should also be included in the FMEA.
Anything that can be done to ensure the product works correctly,
regardless of how the user operates it, will move the product closerto 100% total customer satisfaction.
8/13/2019 PFMEA (Pankaj Nalwa)
9/21
Process Failure Mode Effect Analysis (PFMEA)
Uniparts India Limited By: Pankaj Nalwa
Process FMEA is an effort to prevent failures (due to process)before they happen, to assess the risk associated with those failuremodes, to rank the issues in terms of importance and to identify andcarry out corrective actions to address the serious concerns.
Process FMEAs uncover process problems related to the manufacture of
the product.
It is helpful when conducting a process FMEA to think in terms of the five
elements of a process: People, Materials, Equipment, Methods and
Environment. With these five elements in mind, ask: How can process
failure affect the product, processing efficiency or safety?
8/13/2019 PFMEA (Pankaj Nalwa)
10/21
Process Failure Mode Effect Analysis (PFMEA)
Uniparts India Limited By: Pankaj Nalwa
FMEA Core Team
It is helpful to have people in team who have different levels of familiarity
with the product or process.
Those who are most familiar with it will have valuable insights, but may
overlook some of the most obvious potential problems. Those who are lessfamiliar with the process or product will bring unbiased, objective ideas into
the FMEA process.
A point is often debated with FMEAs is what role the process expert plays
on the FMEA team. A person with expertise in the process can bring
tremendous insight to the team and can help speed the process.
8/13/2019 PFMEA (Pankaj Nalwa)
11/21
Process Failure Mode Effect Analysis (PFMEA)
Uniparts India Limited By: Pankaj Nalwa
Ten Steps for an Process FMEA
1) Review the process.
2) Brainstorm potential failure modes.
3) List potential effects of each failure mode.
4) Assign a Severity ranking for each effect.
5) Assign an Occurrence ranking for each failure mode.
6) Assign a Detection ranking for each failure mode and /or effect.
7) Calculate the Risk Priority Number for each effect.
8) Prioritize the failure modes for action.
9) Take action to eliminate or reduce the high-risk failure modes.
10) Calculate the resulting RPN as the failure modes are reduced or
eliminated.
8/13/2019 PFMEA (Pankaj Nalwa)
12/21
Process Failure Mode Effect Analysis (PFMEA)
Uniparts India Limited By: Pankaj Nalwa
Ways in which a product or process can fail are called FAILUREMODES.
Each failure modes has a potential effect, and some effects are more
likely to occur than others. In addition, each potential effect has a
relative risk associated with it.
The FMEA process is a way to identify the failures effects and riskswithin a process or product and then eliminating or reduce them.
8/13/2019 PFMEA (Pankaj Nalwa)
13/21
Process Failure Mode Effect Analysis (PFMEA)
Uniparts India Limited By: Pankaj Nalwa
Evaluating the Risk of FailureThe relative risk of a failure and its effects is determined by three
factors:
SeverityThe consequence of the failure should it occur.
OccurrenceThe probability or frequency of the failure occurring.
DetectionThe probability of the failure being detected before the
impact of the effect is realized.
8/13/2019 PFMEA (Pankaj Nalwa)
14/21
Process Failure Mode Effect Analysis (PFMEA)
Uniparts India Limited By: Pankaj Nalwa
Using the data and knowledge of the process or product, each potential
failure mode and effect is rated in each of these three factors on a scale
ranging from 1 to 10, low to high.
By multiplying the ranking for the three factors (Severity x Occurrence x
Detection), a risk priority number (RPN) will be determined for each potential
failure mode and effect.
The risk priority number (which will range from 1 to 1,000 for each failure
mode) is used to rank the need for corrective actions to eliminate or reduce
the potential failure modes.
Once corrective action has been taken, a new RPN for the failure is
determined by reevaluating the Severity, Occurrence and Detectionrankings. This new RPN is called Resulting RPN.
Improvement and corrective action must continue until the resulting RPN is
at acceptable level for all potential failure modes.
8/13/2019 PFMEA (Pankaj Nalwa)
15/21
Process Failure Mode Effect Analysis (PFMEA)
Uniparts India Limited By: Pankaj Nalwa
For High Severity 9/10
8/13/2019 PFMEA (Pankaj Nalwa)
16/21
Process Failure Mode Effect Analysis (PFMEA)
Uniparts India Limited By: Pankaj Nalwa
Process FMEA document
Process
Control
Plan
Operator
Job
Instructions
Process
Flow
Diagram
Process
Changes
Current or
Expected
quality
performance
Customer
Design
Requirements
Implementation
and verification
RecommendedCorrective actions
i.e.
Error proofing
Continuous Improvement Efforts
And RPN reduction loop
Communication of standard
of work to operators
8/13/2019 PFMEA (Pankaj Nalwa)
17/21
Process Failure Mode Effect Analysis (PFMEA)
Uniparts India Limited By: Pankaj Nalwa
EffectCriteria: Severity of Effect
Ranking RemarksThese rankings results when a potential failure mode results in a final
customer and/or a manufacturing/assembly plant defect.The final customer should always be considered first.
If both occur, use the higher of two severities.
Customer Effect Manufacturing / Assembly Effect
Hazardous withoutwarning
Very high severity ranking when apotential failure mode affects safe
vehicle operation and/or involves
noncompliance with governmentregulation without warning.
Or may endanger operator (Machine or assembly) without
warning.
10 Criticalcharacteristic
Hazardous with
warning
Very high severity ranking when a
potential failure mode affects safevehicle operation and/or involvesnoncompliance with government
regulation with warning.
Or may endanger operator
(Machine or assembly) withwarning.
9 Criticalcharacteristic
Very High Vehicle / item inoperable (loss of
primary function)
Or 100% of product may have to be
scrapped, or vehicle / item repaired
in repair shop with repair timegreater than one hour.
8 Majorcharacteristic
High Vehicle / item operable but at a
reduced level of performance.Customer very dissatisfied.
Or product may have to be sorted
and a portion (less than 100%)scrapped, or vehicle / item repairedin repair department with a repair
time between hr and an hour.
7Moderate Vehicle/item operable but comfort /
convenience item(s) inoperable.Customer dissatisfied.
Or a portion (less than 100%) of the
product may have to be scrappedwith no sorting, or vehicle / item
repaired in repair shop with a repair
time of less than hr.
6
8/13/2019 PFMEA (Pankaj Nalwa)
18/21
Process Failure Mode Effect Analysis (PFMEA)
Uniparts India Limited By: Pankaj Nalwa
Effect
Criteria: Severity of Effect
Ranking RemarksThese rankings results when a potential failure mode results in a final
customer and/or a manufacturing/assembly plant defect.The final customer should always be considered first.
If both occur, use the higher of two severities.
Customer Effect Manufacturing / Assembly Effect
Low Vehicle / item operable but comfort /
convenience item(s) operable at areduced level of performance.
Or 100% of product may have to be
reworked, or vehicle / item repairedoff-line but does not go to repair
department.
5Very Low Fit and Finish / Squeak and Rattle
item does not conform. Defectnoticed by most customers (greater
than 75%).
Or the product may have to be
sorted, with no scrap, and a portion(less than 100%) reworked.
4Minor Fit and Finish / Squeak and Rattle
item does not conform. Defectnoticed by 50% of customer.
Or a portion (less than 100%) of the
product may have to be reworked,with no scrap, on-line but out-of-
station.
3Very Minor Fit and Finish / Squeak and Rattle
item does not conform. Defectnoticed by discriminating customers
(less than 25%).
Or a portion (less than 100%) of the
product may have to be reworked,with no scrap, on-line but in-station.
2None No discernible effect. Or slight inconvenience to operation
or operator, or no effect.1
8/13/2019 PFMEA (Pankaj Nalwa)
19/21
Process Failure Mode Effect Analysis (PFMEA)
Uniparts India Limited By: Pankaj Nalwa
Probability Likely Failure Rates Ranking RemarksVery High: Persistent Failures
100 per thousand pieces 1050 per thousand pieces 9
High: Frequent Failures 20 per thousand pieces 810 per thousand pieces 7
Moderate: Occasional
Failures
05 per thousand pieces 602 per thousand pieces 501 per thousand pieces 4
Low: Relatively Few Failures 0.5 per thousand pieces 30.1 per thousand pieces 2
Remote: Failure is unlikely 0.01 per thousand pieces 1
Suggested P.F.M.E.A Occurrence Evaluation Criteria.
8/13/2019 PFMEA (Pankaj Nalwa)
20/21
Process Failure Mode Effect Analysis (PFMEA)
Uniparts India Limited By: Pankaj Nalwa
Detection Criteria
Inspectio
n Types Suggested Range of Detection Methods Ranking
A B C
AlmostImpossible Absolute certainty of non-detection Cannot detect or is not checked. 10Very
Remote
Control will probably not detect Control is achieved with indirect or random checks only. 9Remote Controls have poor chance of
detectionControl is achieve with visual inspection only. 8
Very Low Control have poor chance of
detection
Control is achieve with double inspection only. 7Low Controls may detect Controls is achieved by charting methods, such as Statistical
Process Control. 6Moderate Controls may detect Control is based on variable gauging after parts have left the
station, or GO/NO-GO gauging performed on 100% of the parts
after parts have left the station.5
Moderately
High
Controls have a good chance to
detect
Error detection in subsequent operations, Or gauging
performed on set up and first-piece check (for set up causes
only).4
High Controls have a good chance to
detect
Error detection in-station, Or error detection in subsequent
operations by multiple layers of acceptance: supply, select,
install, verify. Cannot accept discrepant part.3
Very High Controls almost certain to detect Error detection in-station (automatic gauging with automaticstop feature). Cannot pass discrepant part. 2
Certain Controls certain to detect Discrepant parts cannot be made because item has been error-
proofed by process/product design. 1
8/13/2019 PFMEA (Pankaj Nalwa)
21/21
Process Failure Mode Effect Analysis (PFMEA)
Uniparts India Limited By: Pankaj Nalwa
Severity
10 Confirmed Critical Characteristic9
8
Confirmed Significant
Characteristic; Action Required
7
6
5
4 Annoyance
3 Zone
2
1
1 2 3 4 5 6 7 8 9 10
Occurrence