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Dear Covers,
My current employer has a process to document file notes and another process to execute failure investigations. Their interpretation of a file note is a document to acknowledge you have made a mistake and what you did to correct it. Their failure investigations also acknowledge that there was a non-conformance and goes a bit deeper, documenting what was the (root) cause of the failure and links to any possible corrective action.
I am happy with the notion of failure investigations, although I would recognise mistakes as non-conformances and consolidate the two under the same process but my interpretations of a file note is that they document planned deviations to process, rather than mistakes that have been made already.
Which of the two interpretations (if any) is correct? What would be the definition of a file note?
Thanks in advance!
My current employer has a process to document file notes and another process to execute failure investigations. Their interpretation of a file note is a document to acknowledge you have made a mistake and what you did to correct it. Their failure investigations also acknowledge that there was a non-conformance and goes a bit deeper, documenting what was the (root) cause of the failure and links to any possible corrective action.
I am happy with the notion of failure investigations, although I would recognise mistakes as non-conformances and consolidate the two under the same process but my interpretations of a file note is that they document planned deviations to process, rather than mistakes that have been made already.
Which of the two interpretations (if any) is correct? What would be the definition of a file note?
Thanks in advance!