Dear all,
It was discovered in the secondary packaging line that, the label attaching machine was run in a different set of parameters against what was written in the Batch packaging record (BPR). The parameters involves are those that do not impact product quality, such as packaging speed, etc.
Unfortunately, BPR only state a specific speed to run instead of providing a range. I read that anything against the written procedure / document is a deviation. But in this case, the operator run the packaging at a lower speed to reduce the defect rate.
May I know should this consider as deviation or incidence?
The event is a deviation or an incidence depending on your SOP on Deviation.
However, the BPR does not have any provision to run the packaging machine at different speeds (low/medium/high) this should be treated as a deviation as per my understanding.
Secondly, please review your packaging process validation / performance qualification (PQ) results and data obtained during the validation. And try to correlate the machine speed and defect rate. This aspect should have been considered during the packaging process validation or PQ of the packaging machine. Accordingly, you can revise the BPR to include a range of speeds of packaging machine which can reduce the defect rate.