The next part of our discussion on Risk Management is in regards to the Risk Management Report. ISO 14971 states that “prior to release for commercial distribution of the medical device, the manufacturer shall carry out a review of the risk management process. This review shall at least ensure that: the risk management plan has been appropriately implemented; the overall residual risk is acceptable; appropriate methods are in place to obtain relevant production and post-production information.”
Your company will need to establish a risk management report that will summarize all of the risk management activities that have taken place, as well as the risk/benefit analyses and explanation of the overall risk acceptability. Included in this report should also be your plan for evaluating risks during production and post-production periods.
The risk management report tends to be an area that isn’t documented sufficiently. In many cases, companies will end their risk assessment documentation with the FMEA. Or, if there is a report, it tends to simply state that “risk analyses were conducted in accordance with the risk management plan and the overall residual risks were found to be acceptable.” This does not provide sufficient understanding as to why the company feels the risk is acceptable or how they plan to manage any residual risks.
The risk management report should summarize the results of all risk management activities to summarize several items: the risk management plan has been implemented appropriately, the residual risk is (or is not) acceptable, and that appropriate methods have been put in place to obtain information throughout the product’s life. The primary sections that should be included in the report include:
- Reference to the risk management plan
- A list of all risk management activities that have been completed
- Identification of any significant residual risks
- What the plans are to monitor the residual risks
- A final statement on the acceptability of the residual risks and why they are acceptable
- It is also beneficial to include mention of any benefits of the device.