Process Failure Mode Effects Analysis (PFMEA) by Mayukh Ghosh Page 1 of 5

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Process Failure Mode Effects Analysis (PFMEA)

Contributor: Mayukh Ghosh
Posted: 09/30/2010 12:00:00 AM EDT | 4

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Tags: failure mode effects analysis | FMEA | process failure mode effects analysis | PFMEA | risk priority number | failure
mode | field failure | Mayukh Ghosh | Methodologies, Statistical Analysis, and Tools | Process Management

A Process Failure Mode Effects Analysis (PFMEA) is a structured

analytical tool used by an organization, business unit, or cross-
functional team to identify and evaluate the potential failures of a
process. PFMEA helps to establish the impact of the failure, and
identify and prioritize the action items with the goal of alleviating Enter email address here.

risk. It is a living document that should be initiated prior to process

of production and maintained through the life cycle of the product.

PFMEA evaluates each process step and assigns a score on a

scale of 1 to 10 for the following variables:

1. Severity — Assesses the impact of the failure mode (the error in the process), with 1 representing the least
safety concern and 10 representing the most dangerous safety concern. In most cases, processes with
severity scores exceeding 8 may require a fault tree analysis, which estimates the probability of the failure
mode by breaking it down into further sub-elements.
2. Occurrence — Assesses the chance of a failure happening, with 1 representing the lowest occurrence and
10 representing the highest occurrence. For example, a score of 1 may be assigned to a failure that
happens once in every 5 years, while a score of 10 may be assigned to a failure that occurs once per hour,
once per minute, etc.
3. Detection — Assesses the chance of a failure being detected, with 1 representing the highest chance of
detection and 10 representing the lowest chance of detection.
4. RPN — Risk priority number = severity X occurrence X detection. By rule of thumb, any RPN value
exceeding 80 requires a corrective action. The corrective action ideally leads to a lower RPN number.

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Process Failure Mode Effects Analysis (PFMEA) by Mayukh Ghosh Page 2 of 5

How to Complete a Process FMEA

A simple explanation of how to complete a process FMEA follows below:

• Form a cross-functional team of process owners and operations support personnel with a team leader.
• Have the team leader define the scope, goals and timeline of completing the FMEA.
• As a group, complete a detailed process map.
• Transfer the process map for the steps of the FMEA process.
• Assign severity, occurrence and detection scores to each process step as a team.
• Based on the RPN value, identify required corrective actions for each process step.
• Complete a Responsible, Accountable, Consulted, and Informed (RACI) chart for the corrective actions.
• Have the team leader on a periodic basis track the corrective action and update the FMEA.
• Have the team leader also track process changes, design changes, and other critical discoveries that would
qualify and update the FMEA.
• Ensure that the team leader schedules periodic meetings to review the FMEA (based on process performance, a
quarterly review may be an option).

Some Caveats

1. FMEAs should never be filled out by only one person; it needs to be filled out by the team that owns the
process. Buy-in from every team member is required to prevent the FMEA from becoming an afterthought.
2. It is a good idea to spend the time to identify which process really needs an FMEA. Conducting too many
FMEAs on non-critical processes will consume resources without returns.
3. Once the decision is made to pursue an FMEA, it is critical to include people in the team who have
extensive experience with the process and who can share historical data that will prove invaluable while
assigning severity, occurrence, and detection scores. This step will help to provide a more accurate
representation of the immediate to-dos and wish list items the team needs to complete from a risk
standpoint to quality and the customer.
4. It is extremely critical to spend time at the “gemba” or the actual spot where the process takes place, as it is
useful to understand in detail each and every process and sub-process that will be part of the FMEA.
5. As pre-work for the FMEA, it is wise to have the data for the field failures (failures of the product at a
customer location) available with some preliminary analysis completed. Some items, like a Pareto chart
highlighting what have been the failure modes for the field failures, can be powerful pieces of information
that can add to the validity of the FMEA.
6. A no brainer, any time there is a change to the process, spec, design, material, etc., the FMEA will need to
be updated, and a new RPN value will need to be calculated.
7. In my opinion, a fixed time interval for reviewing the FMEA of the process must be assigned, with the
flexibility to revisit upon a change. This must be a mandatory part of the organization's engineering change
management system.

I welcome all comments on this article.

Contributor: Mayukh Ghosh |

Like 6 people like this.

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4 Comments
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hamid@mataha.se 10/06/2010 6:43:58 AM EDT Report Abuse

Hi! I would like to ask you about RPN-assessment (Severity, Occurrence and Detection). In point
number one “Severity” You have mentioned that score of 1 is representing the least safety that could
be concerned and score of 10 is representing the most dangerous safety concern. I do agree with you
because I understand the logic behind it. But I could not understand the logic in point number two.
Additionally, in point number two you have mentioned that score of1 represents the highest occurrence
and score of 10 represents the lowest occurrence. However your example exhibits something else.
There is a contradiction between the statement and the example. How come failure that occurs once in
every 5 years assigned as most high compare it with failure that occurs once per hour or once per
minute etc? Best regards
Replies (1)

leansigmaghosh 10/04/2010 7:52:07 PM EDT Report Abuse

Thank you for your comments Stanley and Dhruvdar ..appreciate it

Replies (0)

dhruvdar 10/02/2010 12:08:27 AM EDT Report Abuse

Fixing the upper limit for RPN is a common practice with a lot of companies, the most common one
being 100. However, this is generally incorrect, as it has been frequently observed that teams
preparing the FMEA then "manage" to get all their RPNs below that number, so that they do not have

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to take any actions (as in "Recommended Actions"). That is why some of the big 3 companies and tier
1s later changed this requirement for suppliers, to say that there was no threshold limit for RPN.
Instead the supplier should take the top few high risk items and work on reducing the risk, irrespective
of the RPN number. This ensures continuous improvement, rather than stopping at an arbitarary
number. Another requirement added was that if the Severity is greater than a certain number, then the
Occurrence and / or Detection must be reduced to certain defined levels (irrespective of the original
RPN value). The objective here is that as the impact of the failure is high, one should try to ensure that
it never occurs, or is detected if it occurs.
Replies (0)

stanley.taylor@tds.net 10/01/2010 3:13:58 PM EDT Report Abuse

I like the Article, but about the RPN change above 80 is false. This is for Automotive (GM) flaw.
Remember if your severity, is between (5-8) then your occurance will be between (5-7) This is a
Automotive flaw to. Always work back when you have a High RPN, and what the actual RISK, is. What
I mean by Flaws, is it is a good system but not actual. It Lies. Always review the items below and
incorperate them in, and (95%) of the time will be low to actual RPN's. Please goe to Section three 4th
edition pages 103 - 107 chapter 4. You need to include (DRBFMEA) Error Proofing, Evaluating
Criteria, FMECA, and how it relates analysis, and FTA, Fault Tree Analysis. I agree and as stated here
in the 4th edition, PFMEAs should be audited at least once a year, and when ever there is a change
and if it is systemically it should be changed on all systems across the board at the same time.
Replies (0)

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