Finally, one of the biggest gaps in life sciences companies today is the inefficiency of the risk management programs themselves. The problem is, many people mistakenly believe that risk assessment is the same thing as risk management. In fact, risk assessment is part of a larger closed-loop process that encompasses:
• Hazard identification: Companies should have a place to centralize all risk items for proactive tracking.
• Risk assessment: Your compliance system should allow you to perform a risk assessment at any step in your process.
• Control implementation: Engineering controls, policies and audit processes can all mitigate risk, but you need to be able to link those controls to individual risk items.
• Performance evaluation: All of the above is worthless if you’re not looking at the effectiveness of your work. Quantitative risk assessment can help you calculate residual risk and determine if further action is needed.
When you get down to it, risk management is central to every step in the medical device or pharmaceutical manufacturing process. From design to implementation, supplier management to post-market feedback, filling the gaps in risk management has the ability to significantly improve results. And in the meantime, it might just help you sleep a little better at night.
