I was hoping to air a few of my questions/concerns for the new issue of this standard for packaging materials. I am the quality manager for a company which produces polypropylene films for food and non-food contact.
1. 3.6 Corrective action as a fundamental clause - the verbiage here is somewhat concerning, particularly because it has been earmarked as a fundamental clause. While my company will provide root cause and corrective action for significant events (large/serious claims, major incidents of NCP, etc.), we do not have the resources to perform a 5 why exercise for every minor issue. The interpretation guide specifically states all non-conformities need subjected to RC/CA. Does anyone have similar concerns? My plan is to limit the scope in our procedure to significant events and have good records of a few instances and hope for the best. If anyone else has some thoughts or suggestion, please share!
2. 5.4.1 is a new sub-clause in process control about documenting every possible defect at each manufacturing step by the HARM team. This seems absurd at first glance as my site has 10 different processes and 70+ process steps. However, the interpretation guide example lists one defect in a process and says the auditor will be happy. I'm trying to determine whether I'm exaggerating the requirement or underselling the interpretation guide example. Any thoughts would be appreciated.
Thanks in advance everyone.