• PQA International

Risk Assessment - What Are We Learning?

The documentaries The Bleeding Edge (2018), and The Implant Files (2019), increased awareness of the impact of insufficient risk assessment in the medical device industry. New regulations address risk, but ethics means we all must make time for necessary due diligence. We can’t let the urgent override the important.

Many small manufacturers ask “if customers are happy, and we are making money, what’s the big deal with risk - based thinking?” Risk management was already a significant part of ISO 13485 (for medical devices) and AS9100 (for aerospace) because we understand that higher risk industries should evaluate product risks. And, as a result of ISO 9001’s requirement for leadership to promote risk-based thinking, companies have implemented tools like qualitative risk grids or quantitative Process Failure Mode Effect Analysis (PFMEAs) to identify risks within the manufacturing processes and identify controls to mitigate potential negative impacts.

But 9/11, tariffs, and COVID taught us that risks are not just product related, they also come from financial pressure, public health events, supply chain constraints, and the expectations of interested parties including state and national government. Have you evaluated those too? How do you monitor and manage your risks? and more importantly, What have you learned or changed that will help prepare for or mitigate the impact of future risks?