S
Cite one example of non-conformance without any corrective or preventive action in any field..
The company in question, Company X, had SOPs for assembling and transporting product. The SOPs were very specific about exactly what types of equipment and supplies were to be used, right down to the shipping companies and protocols. However, due to an extraordinarily unusual confluence of events, including a plant move among other things, neither of the standard shippers could pick up the product in time, and a different shipping partner had to be used.
The QA Manager reviewed the series of events, and determined that the likelihood of that particular confluence of events happening again was almost nil, so the QAM wrote an Incident Report that explained what happened, why it was unlikely to happen, and how it was essentially impossible to predict that particular series of events, let alone prevent it.
There was no corrective action needed, as the deviation did not interfere with the satisfactory delivery of the product to the buyer. There was no preventative action that could be taken, because of the inability to even predict, let alone prevent, that series of events.
The company in question, Company X, had SOPs for assembling and transporting product. The SOPs were very specific about exactly what types of equipment and supplies were to be used, right down to the shipping companies and protocols. However, due to an extraordinarily unusual confluence of events, including a plant move among other things, neither of the standard shippers could pick up the product in time, and a different shipping partner had to be used.
The QA Manager reviewed the series of events, and determined that the likelihood of that particular confluence of events happening again was almost nil, so the QAM wrote an Incident Report that explained what happened, why it was unlikely to happen, and how it was essentially impossible to predict that particular series of events, let alone prevent it.
There was no corrective action needed, as the deviation did not interfere with the satisfactory delivery of the product to the buyer. There was no preventative action that could be taken, because of the inability to even predict, let alone prevent, that series of events.