Way to stream line in-process nonconformance?

[dudeistpriest]

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.

 

[Golfman25]

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.

Without specifically addressing any unique 13485 requirements, we would usually require several repeats of the same issue to do a full CAPA evaluation. What I would do is keep a pareto chart of these incidents. Then after a period of time, tackle the biggest issue and try to correct. Then move to the next issue and so on.

 

[Steve Prevette]

You said: 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.

If this is truly happening 50 times a shift, sounds to me like "Common Cause Variation" and is something that is very predictable. That doesn't make it 'Okay' but how you would handle fixing that is by examining the process and changing the process to remove the source of the problem. No amount of scrutiny of the latest defect will fix anything if this is indeed a stable and predictable result of a stable process.

What data do you have on the defects? Have you talked to the workers for their opinions?

Recommend watching Dr. Deming's Red Bead Experiment on youtube. Also, The Improvement Science Blog » History is good reading (and anything by Dr. Russ Ackoff).