In your company, who owns the Risk Management Process and why should they own that process? I've seen R&D groups owning the Risk Management Process as part of new product development, but is this a potential conflict of interest? Cross functional teams provide input/information, but the ultimate responsibility lies with R&D. Any thoughts?

We don't have a single Risk Management Process. Several departments and sub-departmental groups use procedures that incorporate risk management, and they have an ownership stake in their own procedures.

When an auditor asks to review our Risk Management, he gets multiple mini-presentations. There's no central responsibility for RM, other than Regulatory, Quality and Management providing oversight so that someone doesn't go crazy and deviate from the regulations' requirements.

What i suggest to my clients is to have a "risk manager" which is responsabile for the process...usually this is a new position and is usually phisically inside the regulatory department, but it´s responsability and authority is linked directly to top management.

Quite simple...Top Management, because it falls upon them to define responsibilities and authorities............So they choose who they believe to be to correct person regardless of job title or position as long as competency within the position can be demonstrated.

Quite simple...Top Management, because it falls upon them to define responsibilities and authorities............So they choose who they believe to be to correct person regardless of job title or position as long as competency within the position can be demonstrated.

Yes exactly so.

Yes it is a top management resposibility, but as most responsibilities it is delegated.

For product and manufacturing process risk management, our product development is the owner until the design is transfered to base business manufacturing. Then it becomes the responsibility of the manufacturing QA to monitor the risks (assess complaints, product and process non-conformities, new product standards (ISO, ASTM), etc).