Risk Management Process and ISO 14971

Product Management

The person ultimately responsible for the device should always be involved. The reason is that they have the legal if not moral obligation of ensuring that the product they place on the market is safe. This person usually has the ultimate say in what resources to make available. This includes any additional resources that will have to be made available as a result of a newly recognized risk.

The product manager is also usually the best person to know the product’s use with regards to the questions: Who, Where, When, What and How. These questions will surely come up in a proper hazard evaluation. The product manager will ensure that the proper answers are given in such cases.

Regulatory Affairs and Quality Management

Having a Regulatory Affairs manager or Quality manager is a way of ensuring that products that have unmitigated risks do not make it to the market. Hopefully, your organization has placed their authority way up in the organization chart to giving them the capacity to enact on their decisions. A true member of the RA/QA organization should not have any reporting structure to management responsible for getting out the product (or providing service).

Other members of the RA/QA team that should participate include the ones responsible for the CAPA system. This includes nonconformances, deviations and customer complaint handling. Their previous experience dealing with non-compliances makes them an ideal participant to ensure that previous corrected problems are not inadvertently “undone” by new mitigations.

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