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Risk Analysis for other areas
I trully appreciate all your responses and thank you. However one main question is open and that is: Is risk analysis, evaluation and control of risks associated with changes as a result of deviations, non conformances, rework and or corrective action required. How do you folk handle the above. We are still discussing this issue and some collars in manufacturing are getting "Hot". My take: risk management/ analysis is for the life of the product, including all changes that would effect form, fit, or function and be a potential safety problem for the Patient. Would appreciate any inputs. Thanks in advance.
I trully appreciate all your responses and thank you. However one main question is open and that is: Is risk analysis, evaluation and control of risks associated with changes as a result of deviations, non conformances, rework and or corrective action required. How do you folk handle the above. We are still discussing this issue and some collars in manufacturing are getting "Hot". My take: risk management/ analysis is for the life of the product, including all changes that would effect form, fit, or function and be a potential safety problem for the Patient. Would appreciate any inputs. Thanks in advance.
