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We have a situation where we are working on a FMEA for the completion of a documentation work pack, in the process map there is a clear process step where the company Review and approve the documentation pack before sending to the customer. The requirement is "work pack approved by all parties in the allocated time frame" the question we are asking ourselves in this situation is this an FMEA requirement/function or is it a current control, would welcome comments on this as we have a difference of opinion in the team