Even the best companies might face the situation that an old unclosed event fall out of the closet. It can be a two-year old CAPA, a five-year old change, an ancient deviation left alone.
What can you as QA do when you find a rogue record like this?
Of course, first you need to evaluate if you have any chance to gather some information to follow-up with the record.
However, if the record is really old, that means that no PQR, no QMR could catch it in time, and it fell of the grid.
All you can do is evaluate the process/product related to the record - checking PQRs, validation reports, SOPs. If you ensure that everything is OK around the topic (you know: validated, qualified, etc.) after this micro-inspection, be brave and close the record, with adding the comment that closing this record has no impact on the validated/qualified state.
In this way, you can achieve to have a bright clean Quality management system.
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