I think the confusion here is the mis-use of the operational definitions of common cause and assignable/special cause. We must remember that these are operatational definitions, limited in scope and useful for a very special situation: responding to process fluctuations with actions that are looking for something that changed or did not. The definition does not apply to "inside" or "outside" the process. It refers to normal levels of all input factors. A factor that suddenly changes levels is still part of the process, it's just that the factor ahs gone to a level not normally seen. All processes can improved regardless of common or special causes of variation. or whether or not the 'defect' is a result of variation or error as in this case.
we really don't have that situation going on and the standard doesn't overtly recognize the applicablility of "SPC thinking" when identifying and requiring action on nonconformities. This particular event is not a NC to the standard but to internal procedures. it is relatively trivial. can corrective action to prevent re occurence be taken. Absolutely. from changing the process to eliminate teh need for dual records to automating the process so that a single entry can be reported multiple ways: by operation, operator or department etc.
It is interesting that the standard requires correction as to cause for internal audits but not for registration or other second or third party audits.
we really don't have that situation going on and the standard doesn't overtly recognize the applicablility of "SPC thinking" when identifying and requiring action on nonconformities. This particular event is not a NC to the standard but to internal procedures. it is relatively trivial. can corrective action to prevent re occurence be taken. Absolutely. from changing the process to eliminate teh need for dual records to automating the process so that a single entry can be reported multiple ways: by operation, operator or department etc.
It is interesting that the standard requires correction as to cause for internal audits but not for registration or other second or third party audits.