Risk assessment tool FMEA FMECA, Failure mode effect analysis (FMEA ) Failure mode effect criticality analysis (FMECA ): How to do risk assessment?

What is Risk Assessment tool FMEA FMECA, the Failure Mode Effect Analysis? Failure mode effect analysis (FMEA) as the word suggests this tool used for assessing the risk associated with the pharmaceutical process, new product inclusion and so on, is exhaustive and it lists down all the processes, and all the failures.

Risk assessment with FMEA

While doing risk assessment by FMEA FMECA one thing is to be noted even if there is very less likelihood of the occurrence of the failure, the mode of failure is listed and their effects on the pharmaceutical product which might go wrong is recorded.

Then after the preparation of an exhaustive list of modes of failure the likeliness of failure or the probability of the failure is written.

Each failure mode is given rating for

1) Probability: High probable to lowest probable rating is given. (P) Rating 1 to 5 , 1 for lowest probability and 5 for highest probability.

2) Severity: how severe the failure will be if it occurs, rating is given based on the severity of failure; a high server is considered as high risk. (S) Rating 1 to 5 , 1 for lowest severity and 5 for highest severity.

3) Detectability of failure: More the detectible less is the rating (D)

4) Dormancy: For how long the failure will remain undetected, if auto detected within seconds? The lesser the dormancy time risk is low and vice versa.

Risk priority number RPN number:

Is a simple multiplication of ratings of probability X Severity X Detectability

Higher the number is the risk.

For example, let’s consider 3 as the raking for probability, severity, and detectability,

3X3X3 = 27 is the number which is considered as high risk.


Probability=3 severity=3 detectability= 2

18 is also considered as high risk.

Probability=2 severity=3 detectability= 3

18 is also considered as high risk.

Probability=3 severity=2 detectability= 3

18 is can be considered as moderate risk.

Any value beyond 27 should be considered high risk, and mitigation strategy should be formulated for risks even classified as, low risk to high risk.

What to do after a risk mitigation strategy is formulated?

After risk evaluation analysis, rating and making a mitigation strategy, the same is required to be communicated to all stakeholders.

Many times risk assessment with FMEA is not sufficient to justify the risk analysis in pharmaceutical manufacturing, therefore it can be combined with one or the other tool.

Risk assessment with Failure mode effect criticality analysis FMECA.

In FMEA the effect of failure mode is evaluated and a mitigation strategy is formulated.

In FMECA the failure effect on each part of the system ( facility or a department or an equipment system) is subjected to failure mode effect criticality analysis.

FMECA is originated out of FMEA the main difference is that the FMECA looks at an entity as one and explodes it in to various parts like steps or department or activities and preforms evaluation of risk on each one of them.

FMECA is explained better way in following schematic diagram of FMECA.

Failure mode effect criticality analysis FMECA
Failure mode effect criticality analysis FMECA

Example of a system could be explained with exploded diagram of a electric motor where each part will be subjected to failure mode criticality analysis. will an example of  FMECA.

Below diagram is example of typical risk analysis process in pharma industry.

Risk assessment with fmea fmeca
Overview of typical Risk Management work flow

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