Risk Management

Thank you for your interest in risk management process improvement.

The risk management process is the sum total of the activities to decrease risk, within areas regulated by the FDA or necessary to maintain ISO13485 registration, performed by a company. These activities are typically directed in general by a risk management SOP in the quality system, and in particular by a risk management plan for a product development project.

Smaller companies often have very minimal SOPs in general, including for risk management. The SOP that smaller companies typically do have is not much more than a barebones statement of very high level policies with little guidance on how to conduct a risk management program. There are usually no implementing SOP procedures that define how the risk management process is to be carried out.

Barebones risk SOPs can be acceptable, as long as company personnel are familiar enough with proper risk management techniques and documentation that they can produce risk activity documentation adequate in content and consistent in format. This is often not the case in small entrepreneurial companies. As a company grows, or if the company outsources it's engineering, manufacturing, or both, having an improved risk management process becomes prudent. The key is improving risk management without overburdening a small organization.

A good start would be to improve the risk management SOP by first adding to it the most important procedural elements needed for risk management, making it a combined policy/procedure SOP. Second, rather than describing in the SOP everything needed in a risk management plan (the most important of the risk management documents), provide a risk management plan template as part of the quality system. A template not only documents what should be in the risk management plan, but also how it should be formatted. A template gives risk management plan authors a good start, as it can contain "boilerplate" entries that only have to be revised when necessary. A template approach lends consistency to risk management plans and assures that necessary elements are not forgotten.

AlvaMed has had considerable experience in developing quality system and risk management SOPs and templates for companies of various sizes, tailored to their unique needs. Let us assist you in improving your risk management process.

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