Finished product visual status - Each box must have a QC status identifier?

[Denis]

Hi,can any offer some advice on a thorny issue regarding final inspection and booking product into Finished Goods warehouse?

We produce various cleanroom contamination products ( liquid based in this instance) in cleanroom conditions. Once our product has been made it is packed into boxes ( typically 8 bottles to a box. These boxes are then put onto pallets, possibly as many as 80 on one pallet.

The pallets are then sent for irradiation, where the pallets remain intact and are not broken down at all.

Product arrives back at our factory, where we perform a sampling plan to determine that the detex label has changed colour to positively confirm that irradaition has occured.

Paperwork is then completed and product should be booked into finished goods, however..............

Various auditors have made the point that each box should have a QC status identifier. In this case a stamped message "QC Approved".

This causes us a real bottle neck in booking product in due to the shear volume of product returning from irradiation. Not only that, but I see it as a totally none added value task.

Any comments / help

Denis;

Your instincts are correct. At times auditors would like belts, suspenders, garters, etc. and ignore that at some point, systems either function or they don't. Additional "things" at that point only confound the issue further.

There is no requirement regarding the need to identify each box/case individually after sterilization. However, your Q system / procedures should clearly state how someone can ascertain the status of cases at all times regarding their sterility. For example, use of quarantine areas, some sort of pallet label with the number of cases & lot numbers, or only full pallet "rule-of-thumb" are some examples that should be captured in the SOP. Also used are release-to-stock reconciliation reports /audits.

The integrity of the system is ultimately in the hands of the employees. To remove an auditors doubts, demonstrate training & follow-up with periodic mini-audits that demonstrate functionality of the system. These mini-audits should only be conducted at a frequency dictated by issues (or lack of them) found.