Ok, here's the scenario...
We received a minor nonconformance in our re-cert audit in Dec. 08 because risk management was not begun before design input phase of a new product, since results of risk management have to be included in design input.
Ok, this new product has since gone through 510K approval and we are currently trying to get the CE mark testing completed. Product is being produced for inventory, though.
My question is this: Since the product design and development phase is essentially complete, is it acceptable to go back and do risk management activities for this product retrospectively and include the results in the design input portion of the Design History File? Or, do we write an explanation of what happened and why results of risk management are absent from this particular Design History File? With the understanding, of course, that going forward this won't happen again.
Thoughts, ideas, or suggestions are welcome...
Thanks...
We received a minor nonconformance in our re-cert audit in Dec. 08 because risk management was not begun before design input phase of a new product, since results of risk management have to be included in design input.
Ok, this new product has since gone through 510K approval and we are currently trying to get the CE mark testing completed. Product is being produced for inventory, though.
My question is this: Since the product design and development phase is essentially complete, is it acceptable to go back and do risk management activities for this product retrospectively and include the results in the design input portion of the Design History File? Or, do we write an explanation of what happened and why results of risk management are absent from this particular Design History File? With the understanding, of course, that going forward this won't happen again.
Thoughts, ideas, or suggestions are welcome...
Thanks...
