When You Deal With Risk, Don’t Be a Firefighter!

In this episode of the Qualitalks Podcast, Alex Hall and Yan Kugel discussed Risk Management in the pharmaceutical industry.

Risk Management is a critical topic that is, unfortunately, misunderstood by many pharmaceutical companies. Many take the reactive approach instead of the proactive one, and that can cause them a lot of money and risk customer lives. Any decision–making process about risks to product quality involves risk management to a greater or lesser extent.

Here are some of the things that we can learn in the pharma industry about Risk Management:

1. What is the definition of Risk?

2. How does it affect the pharma industry?

3. How to avoid these Risks in the pharma industry?

4. What is the Role of Upper Management?

5. What are the strategies for Risk Management?

What is the definition of Risk?

Risk – It is the combination of the probability that some harmful event happens and its severity in the basics.

How does it affect the pharma industry?

Alex believes that when we think about harm, we always think about the harm to the patient, and what can go wrong for our patients. In line with this topic, we also need to think about harm in terms of compliance status. Like the compliance in the regulatory dossier, manufacturing practice, and business activities. It has a lot of effects in the business industry in terms of profits and business reputations. It should be applied in other industries like the CRA’s crisis management readiness.

How to avoid these Risks in the pharma industry?

• Have an excellent business continuity plan/management.
• Have a system in place for the availability of the staff.
• Have a fire drill in order to get ready for an alternative site transfer and IT solutions.
• Documentations should always be available off-site that can be used anytime.
• Make plans for worst-case scenarios (like a global pandemic) and test those plans to ensure that they actually work.
• Make sure that true risk management should always be a proactive activity.

What is the Role of Upper Management?

A lot of senior management is unaware that we MUST do Risk Management, and also have the benefits from a money perspective if we do it correctly. We can actually save ourselves an awful lot of money.

Roles:

• Look at different things in the quality arena and set priorities.
• ICH Q9 – this should be a regulatory guideline on what we need to be doing for quality risk management that can be applied to different aspects of the pharmaceutical industry and should be implemented by the upper management.
• Implementing the tools that it recommends and put the process in place.
• Senior Management has the power to govern this process.
• Senior Management should be implementing the needs of the risk management committee and governance process that is led at the very highest levels.
• There should be at least one senior board member on that committee, who is the overarching.
• Get involved with the quality department and do risk mitigation.
• Senior management should have full visibility and accountability.

What are the strategies for Risk Management?

The Risk Management Strategy defines the approach, responsibilities, and activities that should be done to effectively manage the risks and issues. The Risk and Issue Management Strategy contains a brief explanation of the manner in which risks and issues will be handled by a responsible individual(s) and how risks and issues will be raised, analyzed, reviewed, communicated, and escalated.

In doing risk analysis, whether it is proactive or reactive we should have a very good documentation process and escalation process that we can learn a lot from.

Being Prepared

All products and all processes have an inherent element of risk.

The important questions include:

• What risks are involved? 

• What impacts do the risks have? 

• How do we manage the risks to keep them within acceptable levels? 

A Risk Management Plan helps to answer these questions above.

Enjoy this episode of the Qualitalks Podcast and don’t forget to subscribe so you don’t miss new episodes.

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