Risk Management Process and ISO 14971

CLINICAL EXPERTS

Knowing how a change will impact a product is best suited to a clinical expert; someone who preferably uses the device or has extensive knowledge of the product’s actual use in the field.

Clinical experts can often make a determination if the change will have an impact on the product’s workflow. Let’s consider a simple change to the device’s packaging color. The hospital procedure says – “Get the red colored catheter package”. Hopefully, there is additional identification requirements, but for the sake of argument the manufacturer doesn’t have an idea on how the hospital procedure is impacted by the change. The clinical expert can identify the risk and can also suggest mitigation by ensuring that adequate notice is provided to the hospital to allow them to change their procedure.

A more important contribution of the clinical expert is that they can give essential input into whether the change will have an impact on the product’s safety and efficacy and whether addition clinical testing/validation is required before releasing the product.

RISK ASSESSMENT PROCESS

The process of conducting an actual Risk Assessment begins by bringing together the team members. The best way to do this is in person (all together). It’s been widely known that ‘brainstorming’ sessions are effective in addressing a wide comprehensive lists. The reason for this is that while one person thinks linearly – the rest of the team as a whole is working in three dimensions.

THE STEPS

The first step in conducting a Risk Assessment is to identify the product’s Intended Use. You should list all the functions associated with the product.

The next step is to identify all the known (actual as well as potential) hazards associated with the product. This can be done in several ways and should include input from:

Nonconformances
Customer complaints
MDRs

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