File Notes: planned deviations or acknowledged mistakes?

E

esalsan

#1
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!
 
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M

maaquilino

#3
In my experience, failure investigations (FE) took place when a problem was found; many times it was done due to a number of customer complaints coming in for the same/similar thing. Corrective action would be taken to determine the root cause of why this happened and what the resolution was. All failure investigations and resolutions would be documented on appropriate FE forms. A failure investigation could find that the root cause of the problem was not following procedure(s), or it could find it was something completely different.

We used a form titled Deviations when something was found to not have been done according to a documented procedure. A Deviation was defined as something that was done after the fact. The form described why the procedure was not followed, what if anything was done to ensure quality was not adversely affected, and it had to be approved by appropriate management.

We used a form titled Variances when it was planned in advance to not follow a documented procedure, so this Variance form was done and approved prior to the fact of not following procedure, and included a description of, and justification for, why the procedure wasn’t being followed.

We used Deviation and Variance forms outside of FEs as well as part of them, so they were separate procedures and forms from those used in FEs. For example, if certain documentation wasn’t done according to procedure (e.g. we decided to combine two documents into one for a particular project, yet the procedure for these documents names the two of them as separate entities) we would write a Variance to state that we were combining these two procedures and why. If it was discovered the documents were done this way after they were already done, we wrote a Deviation and stated why it was done, that all required info was covered in the one document, and verbiage to show that it didn’t adversely affect anything. Neither instance would have anything to do with a failure investigation.

The non-conformance for not following procedure(s) could have been noticed in an internal/external audit; but the Deviations/Variance forms can, and did, keep an auditor from writing a non-conformance during the audit (unless maybe they didn’t agree with the justifications ;>)

Your file notes sound as though they fit the definition above of how I used Deviations, as they sound as though they’re done after the fact. Some places use the same term Deviation whether something was planned or unplanned, with a place of the form to check if the Deviation was planned or unplanned.

http://www.mddionline.com/article/documenting-failure-investigation

http://apps.who.int/prequal/trainin...ations/Day_2/Good_Documentation_Practices.pdf
 
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