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In our previous blog we have discussed about ISO 14971:2019 Risk Management for Medical Device. Please check out for the link below.

ISO 14971:2019 Risk Management for Medical Device

Risk Analysis, Risk Evaluation & Risk Control

Failure Mode Effect Analysis is a important tool for healthcare professional working in a manufacturing sector to ensure the safety of the medical device. Therefore it is important for every healthcare professional to gain knowledge about Failure Mode Effect Analysis.

Let's get into the topic.

FAILURE MODE EFFECT ANALYSIS

Failure mode effect analysis is a tool for assessing risk associated with different ways a part or system can fail, identifies the effects of these failures and provides a structure for revising the design to mitigate the risk wherever necessary. It is a bottom up approach for risk analysis.

Failure mode effect analysis provides method for quantitative analysis of risk.

Failure mode effect analysis is useful for comparing the design concepts and refining designs.

Failure mode effect analysis is a procedure for documenting the safety review in a easy to read format.

Failure mode effect analysis is a inductive process which answers the following questions.

1. What are the different ways a failure can occur?

2. If this failure occurs, then what could happen?

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WHAT ARE THE STEPS OF FMEA?

The following are the steps of FMEA.

1. Identify the modes of failure. Modes means, how many different ways a failure can occur.

2. Identify the consequences and related system effects for each mode of failure. A single failure mode may have one or more effects or consequences.

3. Identify and rate the severity (S) of each effects of different failure mode. We can classify severity as following. These criteria for severity may vary based on the subject under interest.

Negotiable (S1) – It does not have any effects.

Minor (S2) – Results in minor damage but does not cause any injury to persons involved.

Major (S3) – Results in low level injury to persons involved.

Critical (S4) – Results in minor injury to persons involved. Example: Exposure to harmful radiation or fire.

Catastrophic (S5) – Failure of device results in major injury or death of persons involved.

4. Identify the potential root cause for each failure mode.

5. Rate the probability of occurrence (O) for each of the identified root causes. We can classify the probability of occurrence as following. These criteria for probability of occurrence may vary based on the subject under interest.

Improbable (P1) – Unlikely to occur or problems may not be experienced at all.

Remote (P2) – Unlikely but possible to occur in a life span of the device under consideration.

Occasional (P3) – Occurs some times during the life time of the device under consideration.

Probable (P4) – Occurs several times during the life span of the device under consideration.

Frequent (P5) – Likely to occur often or frequently during the life span of the device under consideration.

6. Identify the availability of process controls and indicators. Example; Buzzer is used to indicate the happening of risk.

7. Rate the detectability (D) of each failure mode or root cause.

8. Calculate the Risk Priority Number (RPN). The risk priority number is the severity times the probability of occurrence and detectability (S*O*D). Based on whether risk is detectable or not, we can assign risk priority and make changes in the design.

9. Calculate the Risk Criticality. The risk criticality is the severity times the occurrence (S*O). Identify the severity and occurrence irrespective of whether we can detect it or not.

10. Use risk control measures to mitigate high risk or highly critical failures and recheck to ensure whether goals are achieved.

Now I hope you have acquired some knowledge about Failure Mode Effect Analysis. We will discuss in detail about a topic related to Biomedical Engineering in our future blogs.

NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.

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