MRB (Material Review Board) Investigations

[sweet1]

I work for a Manufacturer of Class I Medical Devices. ISO13485:2016 (as of a week ago by the skin of our teeth). The products are very low risk, non sterile. Due to our somewhat antiquated machines and unstable processes, we tend to have a lot of cosmetic failures. We follow our NC process and all NCs are reviewed by the MRB group during a brief daily meeting as well as a more formal weekly meeting. I lead these meetings and assign investigation to the appropriate department managers.

Most of our internal NCs are due to production operators not paying attention or being unclear as to what constitutes as a failed product, even though we have documentation and training that they must sign off on. These failures are identified during a final release inspection. Many of our corrective actions refer to "retraining" on the production side, but the failures continue to occur so clearly it is not effective.

Our operations manager is assigned these NCs for investigation, but does NOTHING. We cannot close these out until an investigation, CA and verification are done. I have a large number of NCs where the goods have been dispositioned and I am only awaiting the corrective action. Is there any way around this or is it acceptable to not perform an investigation? I will be rewriting our NC process and can incorporate anything, but I need to make sure we are still compliant.

Any advise?

Thanks in advance. This is my first post, but I have been a lurker for about a year

 

[yodon]

Congrats on your first post! An interesting one.

I guess the cost of the daily meetings plus ostensibly scrap doesn't outweigh the desire for improvement? It sounds clear that management is not interested in resolving the issue.

 

[Sidney Vianna]

Any advise?

Welcome to The Cove. I moved this thread to the ISO 13485 forum because it is important for people to realize the context of the question is under a medical device manufacturing context.

Can you share what has been the disposition of the rejected products, in general? Are they scrapped? Accepted as is? Reworked? That has an impact on the answers.

 

[sweet1]

Welcome to The Cove. I moved this thread to the ISO 13485 forum because it is important for people to realize the context of the question is under a medical device manufacturing context.

Can you share what has been the disposition of the rejected products, in general? Are they scrapped? Accepted as is? Reworked? That has an impact on the answers.

Thank you for moving this. Still learning how to navigate here.


Generally our dispositions are either to scrap or "rework" (which is generally sorting out the N/C parts and then approving the conforming, no reprocessing).

 

[Sidney Vianna]

Generally our dispositions are either to scrap or "rework" (which is generally sorting out the N/C parts and then approving the conforming, no reprocessing).

That being the case, it might behoove you to quantify monetarily how much is being wasted in nonconforming products and bring that to the attention of upper management, so they apply the pressure for the interested parties to investigate the actual root cause and apply true corrective action, but, remember, it might be more "cost effective" to maintain this seemingly poor quality arrangement and end up sorting bad product than to invest in new equipment.

Good luck.

 

[Woody]

Sidney Vianna provides good insight: translate all the activities associated into dollars. The Operations Manager doing nothing is the likely reason the problems do not go away. While I am not at all familiar with ISO 13485, I am certain there must be a Management Review activity. This is the great equalizer. Where a process metric does not meet the goal, action is to be taken. Find a way to bring these issues before Management Review to get past the do-nothing ops manager.