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Process Failure Mode & Effect Analysis (PFMEA)




                 Uniparts India Limited   By: Pankaj Nalwa
Process Failure Mode & Effect Analysis (PFMEA)




                 Uniparts India Limited   By: Pankaj Nalwa
Process Failure Mode & Effect Analysis (PFMEA)




                 Uniparts India Limited   By: Pankaj Nalwa
Process Failure Mode & Effect Analysis (PFMEA)




“Our product or process is established, it doesn’t have any failure modes.”

Every product or process has modes of failure, which can arise even
though your product or process is established and you are producing or
performing it for years.




                                 Uniparts India Limited               By: Pankaj Nalwa
Process Failure Mode & Effect Analysis (PFMEA)




“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 filling
out FMEA forms.

FMEA do not require complicated statistics, still it can yield significant
savings for organization by reducing cost liabilities due to process or
product that does not performed as required.




                                 Uniparts India Limited                By: Pankaj Nalwa
Process Failure Mode & Effect Analysis (PFMEA)

                     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”
                           Uniparts India Limited     By: Pankaj Nalwa
Process Failure Mode & Effect Analysis (PFMEA)

                           New Paradigm
                                   FMEA

  Error / Mistake             Process Control           Maintenance
     Proofing                     Plans                    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”
                               Uniparts India Limited        By: Pankaj Nalwa
Process Failure Mode & Effect Analysis (PFMEA)



The objective of a FMEA is to look for all of the ways a process or
product 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 closer
to 100% total customer satisfaction.




                           Uniparts India Limited            By: Pankaj Nalwa
Process Failure Mode & Effect Analysis (PFMEA)

Process FMEA is an effort to prevent failures (due to process)
before they happen, to assess the risk associated with those failure
modes, to rank the issues in terms of importance and to identify and
carry 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?




                               Uniparts India Limited              By: Pankaj Nalwa
Process Failure Mode & Effect Analysis (PFMEA)



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 less
familiar 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.




                                Uniparts India Limited                By: Pankaj Nalwa
Process Failure Mode & Effect Analysis (PFMEA)

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.


                               Uniparts India Limited                By: Pankaj Nalwa
Process Failure Mode & Effect Analysis (PFMEA)



Ways in which a product or process can fail are called FAILURE
MODES.

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 risks
within a process or product, and then eliminating or reduce them.




                           Uniparts India Limited           By: Pankaj Nalwa
Process Failure Mode & Effect Analysis (PFMEA)



Evaluating the Risk of Failure


The relative risk of a failure and its effects is determined by three
factors:

 Severity – The consequence of the failure should it occur.

 Occurrence – The probability or frequency of the failure occurring.

 Detection – The probability of the failure being detected before the
impact of the effect is realized.




                                Uniparts India Limited            By: Pankaj Nalwa
Process Failure Mode & Effect Analysis (PFMEA)


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 Detection
rankings. 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.


                               Uniparts India Limited               By: Pankaj Nalwa
Process Failure Mode & Effect Analysis (PFMEA)




                   For High Severity 9/10




                 Uniparts India Limited   By: Pankaj Nalwa
Process Failure Mode & Effect Analysis (PFMEA)

                               Current or
 Customer        Process
                               Expected      Process             Implementation
  Design          Flow
                                 quality     Changes              and verification
Requirements     Diagram
                              performance


                                                               Recommended
                                                              Corrective actions
                  Process FMEA document                               i.e.
                                                               Error proofing


                Process                             Continuous Improvement Efforts
                Control                             And RPN reduction loop
                  Plan




                Operator             Communication of standard
                   Job
                                     of work to operators
               Instructions


                                  Uniparts India Limited               By: Pankaj Nalwa
Process Failure Mode & Effect Analysis (PFMEA)
                                       Criteria: Severity of Effect
                       These rankings results when a potential failure mode results in a final
                       customer and/or a manufacturing/assembly plant defect.
       Effect                     The final customer should always be considered first.             Ranking       Remarks
                                     If both occur, use the higher of two severities.

                             Customer Effect                 Manufacturing / Assembly Effect

Hazardous without
warning
                    Very high severity ranking when a
                    potential failure mode affects safe
                                                            Or    may  endanger  operator
                                                            (Machine or assembly) without
                                                                                                      10        Critical
                                                                                                                characteristic
                    vehicle operation and/or involves       warning.
                    noncompliance with government
                    regulation without warning.
Hazardous with
warning
                    Very high severity ranking when a
                    potential failure mode affects safe
                                                            Or    may
                                                            (Machine
                                                                       endanger
                                                                      or
                                                                                  operator
                                                                          assembly)   with
                                                                                                      9         Critical
                                                                                                                characteristic
                    vehicle operation and/or involves       warning.
                    noncompliance with government
                    regulation with warning.
Very High           Vehicle / item inoperable (loss of
                    primary function)
                                                            Or 100% of product may have to be
                                                            scrapped, or vehicle / item repaired
                                                                                                      8         Major
                                                                                                                characteristic
                                                            in repair shop with repair time
                                                            greater than one hour.
High                Vehicle / item operable but at a
                    reduced level of performance.
                                                            Or product may have to be sorted
                                                            and a portion (less than 100%)
                                                                                                      7
                    Customer very dissatisfied.             scrapped, or vehicle / item repaired
                                                            in repair department with a repair
                                                            time between ½ hr and an hour.
Moderate            Vehicle/item operable but comfort /
                    convenience item(s) inoperable.
                                                            Or a portion (less than 100%) of the
                                                            product may have to be scrapped
                                                                                                      6
                    Customer dissatisfied.                  with no sorting, or vehicle / item
                                                            repaired in repair shop with a repair
                                                            time of less than ½ hr.

                                                       Uniparts India Limited                              By: Pankaj Nalwa
Process Failure Mode & Effect Analysis (PFMEA)

                                       Criteria: Severity of Effect
                      These rankings results when a potential failure mode results in a final
                      customer and/or a manufacturing/assembly plant defect.
        Effect                   The final customer should always be considered first.              Ranking      Remarks
                                    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 a
                                                           Or 100% of product may have to be
                                                           reworked, or vehicle / item repaired
                                                                                                      5
                   reduced level of performance.           off-line but does not go to repair
                                                           department.
Very Low           Fit and Finish / Squeak and Rattle
                   item does not conform. Defect
                                                           Or the product may have to be
                                                           sorted, with no scrap, and a portion
                                                                                                      4
                   noticed by most customers (greater      (less than 100%) reworked.
                   than 75%).
Minor              Fit and Finish / Squeak and Rattle
                   item does not conform. Defect
                                                           Or a portion (less than 100%) of the
                                                           product may have to be reworked,
                                                                                                      3
                   noticed by 50% of customer.             with no scrap, on-line but out-of-
                                                           station.
Very Minor         Fit and Finish / Squeak and Rattle
                   item does not conform. Defect
                                                           Or a portion (less than 100%) of the
                                                           product may have to be reworked,
                                                                                                      2
                   noticed by discriminating customers     with no scrap, on-line but in-station.
                   (less than 25%).
None               No discernible effect.                  Or slight inconvenience to operation
                                                           or operator, or no effect.
                                                                                                      1


                                                      Uniparts India Limited                              By: Pankaj Nalwa
Process Failure Mode & Effect Analysis (PFMEA)


          Suggested P.F.M.E.A Occurrence Evaluation Criteria.
Probability                      Likely Failure Rates            Ranking    Remarks
Very High: Persistent Failures   ≥ 100 per thousand pieces           10
                                 50 per thousand pieces               9
High: Frequent Failures          20 per thousand pieces               8
                                 10 per thousand pieces               7
Moderate: Occasional
Failures
                                 05 per thousand pieces               6
                                 02 per thousand pieces               5
                                 01 per thousand pieces               4
Low: Relatively Few Failures     0.5 per thousand pieces              3
                                 0.1 per thousand pieces              2
Remote: Failure is unlikely      ≤ 0.01 per thousand pieces           1




                                                   Uniparts India Limited   By: Pankaj Nalwa
Process Failure Mode & Effect Analysis (PFMEA)
                                                 Inspectio
Detection                Criteria                 n Types          Suggested Range of Detection Methods                       Ranking
                                                 A   B   C
Almost       Absolute certainty of non-                      Cannot detect or is not checked.
Impossible   detection                                                                                                         10
Very         Control will probably not detect                Control is achieved with indirect or random checks only.
Remote                                                                                                                          9
Remote       Controls have poor chance of                    Control is achieve with visual inspection only.
             detection                                                                                                          8
Very Low     Control have poor chance of                     Control is achieve with double inspection only.
             detection                                                                                                          7
Low          Controls may detect                             Controls is achieved by charting methods, such as Statistical
                                                             Process Control.                                                   6
Moderate     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        5
                                                             after parts have left the station.
Moderately   Controls have a good chance to                  Error detection in subsequent operations, Or gauging
High         detect                                          performed on set up and first-piece check (for set up causes       4
                                                             only).
High         Controls have a good chance to                  Error detection in-station, Or error detection in subsequent
             detect                                          operations by multiple layers of acceptance: supply, select,       3
                                                             install, verify. Cannot accept discrepant part.
Very High    Controls almost certain to detect               Error detection in-station (automatic gauging with automatic
                                                             stop 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

                                                     Uniparts India Limited                                     By: Pankaj Nalwa
Process Failure Mode & Effect Analysis (PFMEA)



      10
                   Confirmed Critical Characteristic
      9
  S   8
  e   7                          Confirmed Significant
  v
                             Characteristic; Action Required
  e   6
  r   5
  i
      4                               Annoyance
  t
  y   3                                       Zone
      2
      1
           1   2    3    4      5    6    7     8      9   10
                              Occurrence



                        Uniparts India Limited                  By: Pankaj Nalwa

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Process F.M.E.A

  • 1. Process Failure Mode & Effect Analysis (PFMEA) Uniparts India Limited By: Pankaj Nalwa
  • 2. Process Failure Mode & Effect Analysis (PFMEA) Uniparts India Limited By: Pankaj Nalwa
  • 3. Process Failure Mode & Effect Analysis (PFMEA) Uniparts India Limited By: Pankaj Nalwa
  • 4. Process Failure Mode & Effect Analysis (PFMEA) “Our product or process is established, it doesn’t have any failure modes.” Every product or process has modes of failure, which can arise even though your product or process is established and you are producing or performing it for years. Uniparts India Limited By: Pankaj Nalwa
  • 5. Process Failure Mode & Effect Analysis (PFMEA) “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 filling out FMEA forms. FMEA do not require complicated statistics, still it can yield significant savings for organization by reducing cost liabilities due to process or product that does not performed as required. Uniparts India Limited By: Pankaj Nalwa
  • 6. Process Failure Mode & Effect Analysis (PFMEA) 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” Uniparts India Limited By: Pankaj Nalwa
  • 7. Process Failure Mode & Effect Analysis (PFMEA) New Paradigm FMEA Error / Mistake Process Control Maintenance Proofing Plans 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” Uniparts India Limited By: Pankaj Nalwa
  • 8. Process Failure Mode & Effect Analysis (PFMEA) The objective of a FMEA is to look for all of the ways a process or product 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 closer to 100% total customer satisfaction. Uniparts India Limited By: Pankaj Nalwa
  • 9. Process Failure Mode & Effect Analysis (PFMEA) Process FMEA is an effort to prevent failures (due to process) before they happen, to assess the risk associated with those failure modes, to rank the issues in terms of importance and to identify and carry 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? Uniparts India Limited By: Pankaj Nalwa
  • 10. Process Failure Mode & Effect Analysis (PFMEA) 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 less familiar 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. Uniparts India Limited By: Pankaj Nalwa
  • 11. Process Failure Mode & Effect Analysis (PFMEA) 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. Uniparts India Limited By: Pankaj Nalwa
  • 12. Process Failure Mode & Effect Analysis (PFMEA) Ways in which a product or process can fail are called FAILURE MODES. 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 risks within a process or product, and then eliminating or reduce them. Uniparts India Limited By: Pankaj Nalwa
  • 13. Process Failure Mode & Effect Analysis (PFMEA) Evaluating the Risk of Failure The relative risk of a failure and its effects is determined by three factors:  Severity – The consequence of the failure should it occur.  Occurrence – The probability or frequency of the failure occurring.  Detection – The probability of the failure being detected before the impact of the effect is realized. Uniparts India Limited By: Pankaj Nalwa
  • 14. Process Failure Mode & Effect Analysis (PFMEA) 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 Detection rankings. 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. Uniparts India Limited By: Pankaj Nalwa
  • 15. Process Failure Mode & Effect Analysis (PFMEA) For High Severity 9/10 Uniparts India Limited By: Pankaj Nalwa
  • 16. Process Failure Mode & Effect Analysis (PFMEA) Current or Customer Process Expected Process Implementation Design Flow quality Changes and verification Requirements Diagram performance Recommended Corrective actions Process FMEA document i.e. Error proofing Process Continuous Improvement Efforts Control And RPN reduction loop Plan Operator Communication of standard Job of work to operators Instructions Uniparts India Limited By: Pankaj Nalwa
  • 17. Process Failure Mode & Effect Analysis (PFMEA) Criteria: Severity of Effect These rankings results when a potential failure mode results in a final customer and/or a manufacturing/assembly plant defect. Effect The final customer should always be considered first. Ranking Remarks If both occur, use the higher of two severities. Customer Effect Manufacturing / Assembly Effect Hazardous without warning Very high severity ranking when a potential failure mode affects safe Or may endanger operator (Machine or assembly) without 10 Critical characteristic vehicle operation and/or involves warning. noncompliance with government regulation without warning. Hazardous with warning Very high severity ranking when a potential failure mode affects safe Or may (Machine endanger or operator assembly) with 9 Critical characteristic vehicle operation and/or involves warning. noncompliance with government regulation with warning. Very High Vehicle / item inoperable (loss of primary function) Or 100% of product may have to be scrapped, or vehicle / item repaired 8 Major characteristic in repair shop with repair time greater than one hour. High Vehicle / item operable but at a reduced level of performance. Or product may have to be sorted and a portion (less than 100%) 7 Customer very dissatisfied. scrapped, or vehicle / item repaired in repair department with a repair time between ½ hr and an hour. Moderate Vehicle/item operable but comfort / convenience item(s) inoperable. Or a portion (less than 100%) of the product may have to be scrapped 6 Customer dissatisfied. with no sorting, or vehicle / item repaired in repair shop with a repair time of less than ½ hr. Uniparts India Limited By: Pankaj Nalwa
  • 18. Process Failure Mode & Effect Analysis (PFMEA) Criteria: Severity of Effect These rankings results when a potential failure mode results in a final customer and/or a manufacturing/assembly plant defect. Effect The final customer should always be considered first. Ranking Remarks 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 a Or 100% of product may have to be reworked, or vehicle / item repaired 5 reduced level of performance. off-line but does not go to repair department. Very Low Fit and Finish / Squeak and Rattle item does not conform. Defect Or the product may have to be sorted, with no scrap, and a portion 4 noticed by most customers (greater (less than 100%) reworked. than 75%). Minor Fit and Finish / Squeak and Rattle item does not conform. Defect Or a portion (less than 100%) of the product may have to be reworked, 3 noticed by 50% of customer. with no scrap, on-line but out-of- station. Very Minor Fit and Finish / Squeak and Rattle item does not conform. Defect Or a portion (less than 100%) of the product may have to be reworked, 2 noticed by discriminating customers with no scrap, on-line but in-station. (less than 25%). None No discernible effect. Or slight inconvenience to operation or operator, or no effect. 1 Uniparts India Limited By: Pankaj Nalwa
  • 19. Process Failure Mode & Effect Analysis (PFMEA) Suggested P.F.M.E.A Occurrence Evaluation Criteria. Probability Likely Failure Rates Ranking Remarks Very High: Persistent Failures ≥ 100 per thousand pieces 10 50 per thousand pieces 9 High: Frequent Failures 20 per thousand pieces 8 10 per thousand pieces 7 Moderate: Occasional Failures 05 per thousand pieces 6 02 per thousand pieces 5 01 per thousand pieces 4 Low: Relatively Few Failures 0.5 per thousand pieces 3 0.1 per thousand pieces 2 Remote: Failure is unlikely ≤ 0.01 per thousand pieces 1 Uniparts India Limited By: Pankaj Nalwa
  • 20. Process Failure Mode & Effect Analysis (PFMEA) Inspectio Detection Criteria n Types Suggested Range of Detection Methods Ranking A B C Almost Absolute certainty of non- Cannot detect or is not checked. Impossible detection 10 Very Control will probably not detect Control is achieved with indirect or random checks only. Remote 9 Remote Controls have poor chance of Control is achieve with visual inspection only. detection 8 Very Low Control have poor chance of Control is achieve with double inspection only. detection 7 Low Controls may detect Controls is achieved by charting methods, such as Statistical Process Control. 6 Moderate 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 5 after parts have left the station. Moderately Controls have a good chance to Error detection in subsequent operations, Or gauging High detect performed on set up and first-piece check (for set up causes 4 only). High Controls have a good chance to Error detection in-station, Or error detection in subsequent detect operations by multiple layers of acceptance: supply, select, 3 install, verify. Cannot accept discrepant part. Very High Controls almost certain to detect Error detection in-station (automatic gauging with automatic stop 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 Uniparts India Limited By: Pankaj Nalwa
  • 21. Process Failure Mode & Effect Analysis (PFMEA) 10 Confirmed Critical Characteristic 9 S 8 e 7 Confirmed Significant v Characteristic; Action Required e 6 r 5 i 4 Annoyance t y 3 Zone 2 1 1 2 3 4 5 6 7 8 9 10 Occurrence Uniparts India Limited By: Pankaj Nalwa