Prepping for a regulator site visit: the folder they will open
An inspector’s first question is usually about last month’s dose records. How to index a folder to the site walk and survive the three cross-checks they always run.
An inspector’s first question is usually about last month’s dose records. How to index a folder to the site walk and survive the three cross-checks they always run.
Fifty one-kilo orders from five batches never match. What drifts, the four records to keep, and why mixing to density beats mixing to a fixed ratio.
Batch numbers, calibrated dose records, watering-in logs and dated hole photos: the four records that settle gel scheme warranty claims in one meeting.
An auditor reviewing a thawing operation is looking for three things: that the process was controlled, that the control was monitored, and that someone would have noticed if it went wrong. A thawing pad is part of the process, but it is not itself a control point in most HACCP plans — temperat…
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