Risk Assessment in Pharma: Practical FMEA & GMP Case Studies

Understanding the Event

In this session, we’re going to learn how to build an FMEA from scratch, step by step, in a way that actually makes sense -not just theory.I want you to understand not only what FMEA is, but how to really use it to prevent problems in manufacturing, cleanrooms, or anywhere in GMP.

We’ll go through the structure of the FMEA table, how to score risks, how to think about failure modes, and how to choose good mitigation actions.

By the end, you’ll feel comfortable creating a full FMEA by yourself.

This presentation explains what happened during the flooding event, why we had to change the gowning flow, and how we performed a full risk assessment to continue essential manufacturing activities safely and in compliance.

So this presentation is basically about how we evaluate risks inside each unit separately, instead of looking at the whole manufacturing site as one big thing. Every unit has its own processes, its own equipment, and its own sensitivity. So doing a single general risk assessment isn’t enough - we need to look at things unit by unit. This method helps us stay compliant with GMP, keep operations under full control, and make smart decisions when something changes. It’s a practical and structured way to make sure nothing important is missed.

Don’t let the number fool you - always think about the real-life impact.

RPN is only one piece of the puzzle.

Here I want to show you a real example: a company shipping biological products that must stay at 2–8°C. They did a formal FMEA on the whole shipment chain – from warehouse to the customer. We’ll use it as a template to understand how to think and how to write a risk assessment: define the process, list failure modes, grade S–P–D, calculate RPN and then decide what to do.

This lecture provides a clear and practical explanation of how QC laboratories perform a risk assessment for analytical reagents. You will learn why not every reagent needs lot-to-lot qualification, how analytical controls (such as SST, markers, viability, and ELISA curve parameters) can automatically detect defective reagents, and how to use a structured risk-ranking model to determine which materials are truly critical.
By the end of the lecture, you will understand the logic behind ranking reagents as high, medium, or low risk, and you will be able to apply the same decision-making approach in your own QA/QC environment.

In this session we’ll explore how to identify failure modes in gowning and material flow - two areas that are responsible for the majority of contamination-related deviations in cleanrooms. The goal is to understand where things can go wrong, why, and how to prevent it using simple, robust controls.

This session explains why we’re doing this whole process.

We want to check that the mitigation actions we implemented actually change something in real life.

Then we update the RPN to reflect the current situation.

Finally, we decide if the risk is now Acceptable, ALAP, or still too high.

This presentation is basically our roadmap for understanding how to classify risks in a cleanroom or GMP environment. Instead of drowning in numbers, we translate RPN scores into simple, practical categories. It’s meant to help us think clearly during chaotic situations - like floods, contamination events, or sudden room closures. The whole idea is to make decisions with confidence instead of guessing.

So basically, this presentation explains why we could keep manufacturing safely even though our regular gowning rooms were temporarily unavailable, and why we increased EM frequency during this period. I’ll walk you through the logic in a simple, friendly way - nothing complicated.

RPN is basically our way of understanding “how risky” something is in the process.

Instead of looking at three separate things — how bad the damage is, how often it can happen, and how easy it is to detect — we combine them into one score.

This score helps us make decisions quickly, especially in stressful situations like the flooding deviation.

It’s not meant to scare us; it just helps us decide what needs immediate attention and what can wait.

So today we’re going to connect all the pieces: what happens right after a deviation, the quick mitigations we take, and how those actions eventually grow into real CAPA and change control decisions. I want you to see the big picture: nothing stands alone. A mitigation is not a ‘band-aid’; it’s the first step in a chain that must lead to something more stable if the risk is serious. We’ll use simple examples so everything feels intuitive and not too heavy

Documentation and communication are basically the “memory” and the “voice” of the whole GMP system. If we don’t write things clearly -nobody knows what actually happened, and later we can’t prove anything. And if we don’t communicate properly - people make assumptions, misunderstand changes, or keep working based on old instructions.

During normal routine it’s important, but during events like a leak, blocked corridors, or changes to gowning rooms - it becomes critical. Good documentation protects the product. Good communication protects the people and the process.