dudeistpriest
Registered
For 13485 on nonconformance, my understand is that every nonconformance requires to be documented and investigated. We are a device that is bottle filled consumer product, so we have very high quality standards that we hold ourselves to (300% inspection). For instance if a small spec is on the shrink wrap or it's slightly misaligned it gets pulled and removed then put through the oven again, would something like that actually require a whole investigation? We have this happen maybe 50+ times a shift and we are small company.
In another instance, for even the smallest scuffs or cosmetic imperfections we pull those for customer samples or R&D, even though that isn't a "Design Requirement" would this still require and nonconformance report? How do other companies handle these situations, can we define these as nonconformance or does every single thing shrink wrap or cosmetic defect need a report? It seems crazy to me to be generating 5+ reports every day so looking for a better way to handle the realities of manufacturing.
In another instance, for even the smallest scuffs or cosmetic imperfections we pull those for customer samples or R&D, even though that isn't a "Design Requirement" would this still require and nonconformance report? How do other companies handle these situations, can we define these as nonconformance or does every single thing shrink wrap or cosmetic defect need a report? It seems crazy to me to be generating 5+ reports every day so looking for a better way to handle the realities of manufacturing.
