Quality Risk Management | RPN Ratings of FMEA Tool | Easy Example


“Quality Risk Management | RPN Ratings of FMEA Tool | Easy Example”

Many people think that risk management is very tough, tedious and time consuming job.

Today, I will clear this misconception. So guys please stay tuned & read this article till the end.

Let us first understand…

What is Quality Risk Management?

Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the drug product across the product life cycle.

We can list out all the GMP processes in our working area. With this each process all the possible or potential failure need to specified.

In front of each identified potential failure, we need to identify risk associated with each potential failure. Up to this stage, the process is called risk assessment.

After this, we need to evaluate whether the current control measures are there to mitigate or to reduce this risk or not?

If not, we need to take some action plan or mitigation plan to reduce or mitigate the risk.

As, this is a proactive approach, there will be lot of processes and with each process,

lot of potential failures will be identified and further with each potential failure lot of potential risks will also be identified.

Hence, it will be practically very difficult to take the mitigation plan for all these potential risks at a time.

So, we have to priorities our action or mitigation plan.

This prioritization can be done by calculating risk priority number also called as RPN.

During this process, we can evaluate severity of the risk , occurrence on the basis of past experience and detectability on the basis of present detection mechanism available to detect the failure related to the identified risk.

We can make quantitative numbering to all these severity, occurrence and detectability parameters.

For e.g.

                                 RPN = S X O X D


                                                 S = Severity

                                                O = Occurrence

                                                D = Detectability

We can multiply all these parameters numerical to get risk priority number value.

So that we can focus on mitigation plan for the potential risk identified which is having highest RPN value Hope now it is clear to you that, risk management is very simple.

Overall we have to identify the process or activity,

identify the possibility of failure associated with that process or activity,

further identify the risk associated with potential failure,

evaluate current controls are in place or not, find out RPN value by evaluating severity,

occurrence and detectability and finally take the mitigation plan.

This risk assessment method is calledFailure Mode Effect Analysis

Now let us take one simple practical example.

Suppose you want to perform the risk assessment of the process related to physical verification of the incoming material.

With this process, you need to identify different potential failures for example possibility of getting lower weight material,

or possibility that the material may not be from the approved source or possibility that the container may receive in damage condition or the integrity of the container seal is damaged.

For time being, Let us consider this example with only these potential failures.

Further with the help of cross functional team, you can find out maximum potential failures.

Now, in front of all these identified potential failure, you need to identify potential risk.

For example:-

If the material is underweight, the risk is associated with is commercial or productivity loss,

If the material is not from approved source, the risk associated with it is, with respect to material quality and regulatory risk also.

Similar way you can specify the potential risk for all potential failures.


In front of each potential risk, you need to specify the current controls available in your organization for example,

provision of verification 100% weight verification or evaluation of the material with respect to approved vendor or checking of the integrity of the seal as a part of incoming material receipt checklist etc.

So on.

Once current controls are specified, you can find out RPN number as explained earlier.

Let us understand quality risk management procedure with a simple example.

I will tell you that all your friends, family, neighbour, basically everyone is doing the risk management. 

Suppose, I want to go for to Kashmir for holidays. What I will do?

I have to book the flight tickets, I have to book the hotel to stay, I have to take some basic medication for my family, I have to take some warm clothes etc.

The question is why I am doing all these things?

Because at the back of my mind I am doing the risk management.


Let me explain.

First process is travel to Kashmir. I will find out potential risk by asking myself simple question ‘what might go wrong?

I can travel by bus or by train or by flight.

The risk associated with travel by train and bus is it is time consuming and I am having limited days for holiday, as mitigation plan, I will prefer to travel by flight.

Second process is stay in Kashmir. Similar way again what might go wrong?

If I am going to Kashmir, the risk associated with this process is where I will stay?

There may be possibility that, I may not get hotel or good hotel once reach there.

Hence as a mitigation plan, I will pre book the hotel from here itself Further,

If I am going with my family to Kashmir, the potential risk is, some family member may face health problem.

In such scenario, how I will search the doctor this is a risk.

Hence, as a mitigation plan, I will check with hotel whether they are having doctor on call service or not? Also,

I will take some basic medication during my travel. Same way, further I will evaluate risk associated with climate over there and as a mitigation plan, I will carry warm clothes with me.

Basically, whatever we are planning, all plannings are based on proactive identification and evaluation of the risk associated with the activity and to avoid the risk suitable plan is made means suitable mitigation plan is prepared.

I hope now you will feel risk management activity is very easy and simple.

I request you to share this “Quality Risk Management | RPN Ratings of FMEA Tool | Easy Example” to your colleagues so that they can also get benefit from this article.

For any queries, please comment in the comment section below.

Thank you so much and ensure all time compliance.

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