Insights on risk management topics and tips and techniques for implementation.

Webinar - 7 essential elements of a risk management plan

iso 14971 compliance risk management plan Oct 11, 2023

Note: this article presents an excerpt of a webinar presented to subscribers of the Let's Talk Risk! knowledge-letter. Watch the full webinar here and subscribe.

Good planning is essential to the success of any project and risk management is no different. A risk management plan helps you to apply an organized and systematic approach to risk management activities. It ensures that nothing is missed, and all outputs are delivered in an efficient manner.

In this webinar, I reviewed these 7 essential elements of a risk management plan according to ISO 14971 requirements:

  1. Scope of planned activities
  2. Responsibilities and authorities
  3. Review of activities
  4. Criteria for risk acceptability
  5. Method and criteria for evaluating overall residual risk
  6. Verification activities (implementation + effectiveness)
  7. Production and post-production activities

I also shared best practices for effective implementation. As an example, we will talk about an optional 8th element to help you manage the lifecycle aspects of the risk management plan.

Here are some of the audience questions addressed during the webinar:

  1. Who do you commonly see as the owner of the RM Process, and the RM File both pre and post-production?
  2. How does one document competence when hiring an experienced person, but they do not have any access to their objective evidence (e.g. certificates) from their previous employer?
  3. Can you please provide an example for the review of risk management activities?
  4. How to define criteria where probability of harm (PoH) cannot be estimated?
  5. When a hazardous situation might have possibility to cause multiple harms like maybe 5 or 10 harms, do we need to consider each of them as individual risk and a assign a risk level for each?
  6. Can Effectiveness verification can be achieved via checking NCR’S, Complaints, Supplier NCR’s, Trending, CAPA?
  7. Do you think we should take the rate of non-conforming product or scrap rates in production to statistically assign a probability values? Or any example of how to evaluate or use production data in risk management file?
  8. How to manage the living risk management plan document? We usually update, approve or sign each time it is needed since auditor might want to make sure no any changes were made without approval of all members.
  9. Do we need to have a rationale in the plan for how to define the red and yellow regions in the risk matrix ?

Watch the full video, and download a free template here.


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