#FMEA: Quality tool

In this article I’m going to enlighten the knowledge on quality tool which is used to evaluate, prioritize and mitigate the risk associated with product, process, design and customer need. This article contains few examples which will help you to understand the risk analysis. Hope you will like this article.

What is Failure Mode Effect Analysis (FMEA):

Failure Mode Effect Analysis (FMEA): The name itself is explanatory,

“Failure modes"?mode or the way due to which something might fail.

“Effect Analysis” is the study of potential effect/consequences of failure on same as well as on different levels of the designed process, product or system.

It is the steps by step process of reviewing the procedure, process or system to find out or define the possibilities of the potential failure, their causes and effects associated with the failure.

FMEA is also well know with the name of FMECA i.e. Failure mode effect criticality analysis

History:

In late 1940’s it was discovered by US military, later it was used by the NASA and later it was first used by the Ford Motors company.

Why FMEA is required:

It helps in determining the failure and its cause before or after implementing the product, process or system. It helps in understanding the effects of failure on product, process or system and helps in eliminating potential risk associated with the failure. It is also used to control the process, procedure or system during the ongoing period i.e. It is designed at the earlier stage and remains for the life cycle of the product or process.

Types of FMEA:

There are 3 types of FMEA

Design FMEA (DFMEA): It is the process which helps in identifying the risk of failure associated with the design of the product. DFMEA is used to determine potential failures, how bad the effect could be, and how to prevent and mitigate failures.?

Process FMEA (PFMEA): It helps to identify process functions, failure modes and effects to help organizations to understand possible risks for each process step as early as possible.

System FMEA (SFMEA): The focus of SFMEAs is on system-related deficiencies

Apart from the above three FMEA other FMEAs are Software FMEA, Machine FMEA, Function FMEA???

Steps to perform FMEA??

• Create a team of members from cross function teams with abundance knowledge and experience of Design, Process, Product, Quality, System and Customer needs.
• Define the purpose of the Design, Process, Product, Quality, System and Customer needs.
• Break down each of above into its different components and analyze each component for its failure or single point of failure for its potential impact.
• Determine how serious each effect is. This is the severity rating, or S. If a failure mode has more than one effect, number it with highest severity rating for that failure mode
• For each failure mode, determine all the potential root causes. Use tools classified as?cause analysis tool, as well as the best knowledge and experience of the team. List all possible causes for each failure mode.
• For each cause, determine the occurrence rating, or O. This rating estimates the probability of failure occurring for that reason during the lifetime of your scope.
• For each cause, identify current process controls. These are tests, procedures or mechanisms that you now have in place to keep failures from reaching the customer. These controls might prevent the cause from happening, reduce the likelihood that it will happen or detect failure?after?the cause has already happened but?before?the customer is affected.
• For each control, determine the detection rating, or D. This rating estimates how well the controls can detect either the cause or its failure mode after they have happened but before the customer is affected.
• Organizations can use a risk priority number to score a system, design or process for risk potential.
• Rank or number each potential failure effect-based on criteria such as severity, likelihood of occurrence and probability of being detected.
• Go back and determine your?revised?risk levels based on completed action items to ensure you have met your risk goals

In this way failures are prioritized according to how serious their consequences are, how frequently they occur, and how easily they can be detected.

What is the risk priority number:

Risk priority number is the numerical assessment which helps in prioritizing the risk and also helps in determining the corrective or preventive actions to be taken based on assessment.

How to apply RPN:

Risk priority number is defined based on the severity, occurrence and detection.

Severity: in risk analysis it is defined as the harm or adverse effect that impacts the patient safety, efficacy and product quality

Occurrence (Probability): it is defined as the likelihood of the problem that may occur.

Detection: Control system which is capable to detect the problem/failure.

Severity (S), Occurrence (O) and Detection (D) is scaled from 1 to 3 numbering (in many organizations it is scaled from 1 to 10) where 1 is the best rating and 3 is the worst. Higher the number higher is the risk.

Each category shall be evaluated and shall be numbered on the basis of risk assessment scale, higher multiplication number indicated the higher risk and lower multiplication number indicates lower risk.

Let’s focus on the example.

1.)?During impurity testing out of specification result was observed for one of the unknown impurities,

Based on the investigation, root cause is identified as laboratory error i.e. extended sonication time which led to temperature excursion of sonication bath resulted into OOS result for unknown imp.

Contributing factor identified as there is no clear instruction available in the standard test procedure.

Risk evaluation was done and based on the evaluation as a part of corrective action instruction is incorporated in standard test procedure mentioning that sonication of sample for impurity test shall be done at 5*C for 10 mins.

Severity: In above case, root cause is identified as laboratory error, hence impact on the product quality, patient safety is less. Hence, severity is scaled at lower side i.e. 1

Occurrence: Based on the CAPA taken occurrence of such event is rare hence occurrence is also scaled at lower side i.e. 1

Detection: Control system is available i.e. sonication bath with inbuild chilling system is in place for the sample preparation more over chromatographic system is in place to detect any such abnormality. Hence detection is also scaled at lower side i.e. 1

Hence in above case RPN is defined as = S x D x O = 1 x 1 x 1 = 1

Based on the risk identification CAPA implementation done which reduced the risk of occurrence of such event in the future.

2.)?During impurity testing of marketed batch, out of specification results was observed for one of the unknown impurities,

Based on the investigation, root cause is identified as this unknown impurity arises due to the cross contamination of the product.

In such case,

Severity: In above case, root cause is identified cross contamination, which is having impact on quality, patient safety. Hence, severity is scaled at higher side i.e. 3.

Occurrence: Based on the investigation and review of historical data no such event has been observed for such product. However, by looking into certain factors like handling of material or environmental factors it can likely happen. Hence it is scaled at 2.

Detection: Low probability of detection before reaching the patient. Hence, scaled at 3

RPN = S x D x O = 3 x 2 x 3 = 18

Observed RPN is at higher side. Hence, immediate action is required in such case to mitigate the risk.

In above case, re-evaluate the cleaning validation procedure, implement continuous monitoring of the systems to ensure compliance with procedures. Introduce environmental monitoring to detect potential contamination sources. Use control charts and other statistical tools to track process performance and detect any deviations early.

After implementing corrective and preventive actions,?re-calculate the RPN?to ensure the risk has been adequately mitigated. Periodically review?the process and risk assessments to identify any new risks or areas for improvement.

3.) Incorrect calibration of a pH meter.

Based on the investigation laboratory error was identified i.e. instead of referring to the SOP concern analyst had performed activity on based on the memory.

Severity (S):?2 Moderate impact on product quality

Occurrence (O):? 2 Moderate likelihoods due to routine use

Detection (D):?1 Moderate chance of detection during routine checks

RPN = 2 x 2 x 1 = 4,

Risk is moderate. However, as a part of the corrective action personnel shall be trained on the procedure and calibration activity of such person shall be monitored till defined time interval. ?

Remember: In Severity, Occurrence and Detection when the severity and occurrence is numbered at higher in such case appropriate action shall be taken to mitigate the risk and evaluation of such action shall be performed continuously.

In Severity, Occurrence and Detection if Severity is placed at higher number in such case appropriate action and monitoring and evaluation of such action is required periodically. ?

Advantage of FMEA:

FMEA relies on a deep understanding of both the product and the process. It helps in breaking down the complex processes to identify the potential failure modes.

Helps in risk assessment by evaluating the risk and its potential impact by using the S, O & D concept.

It helps in prioritize risks by multiplying the severity, occurrence, and detectability scores.?This helps in identifying which risks need immediate attention.

It helps in mitigating the high-priority risks by developing the strategies eliminate, reduce, or control these risks by making changes in process, testing or enhanced monitoring.

FMEA is not a one-time activity. It is a part of continuous improvement.

FMEA helps in meeting regulatory requirements by providing a structured approach to risk management.?It guarantees the identification and mitigation of potential risks.

Limitations of FMEA:

FMEA relies on the knowledge and experience of the team members.?if the team lacks the expertise or overlook potential failure modes, the analysis might be incomplete.

It is very time-consuming. It requires thorough analysis and teamwork, which may consume significant resources.

FMEA may not identify failure modes that are outside the team’s experience or knowledge.?

Hope you must have liked this article. Stay tuned for more articles.

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