ISO 13485- 8.3.1 Non-conforming material high volume

#1
Hello all,

Long time reader first time posting. Spent some time digging through archives to see if I could find the answer to my question but most inquiries ive read don’t fully answer my predicament so here goes.

Background: I recently began working in a company producing high volumes of class 1 device (only 1 product made, more than 100k units a week on average, composed of 8 parts total). Ive been tasked with working on the non-conforming materials process as the company is working towards ISO 13485:2016 certification.

As far as the standard goes, the standard states that a procedure shall be documented that allows for identification, segregations, evaluation, and disposition of non-conforming product.

The problem is that on a given day multiple non-conformances can appear that are negligible in severity (smeared ink on bag, bag on zipper wont close etc., cotton swab is damaged) ; the production team simply reports it in our system and then scraps based on a daily scrap rate allowance for low severity defects. On a side note, more serious defects are followed through correctly based on the previous paragraph.

As such, for the low impact defects that the company (via customer approval) scraps, how can I show that these defects are following the id-segregate-evaluate-disposition procedure?

My current though process is to file a NCM for each of the common cause non-conformances known that we have OKed to scrap, have the Quality director sign off on the material as “no investigation necessary unless cross X threshold scrap”, and then have future production reference back to this master NCM.

Would really appreciate any insight members could provide.
 
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somashekar

Staff member
Admin
#2
The problem is that on a given day multiple non-conformances can appear that are negligible in severity (smeared ink on bag, bag on zipper wont close etc., cotton swab is damaged) ; the production team simply reports it in our system and then scraps based on a daily scrap rate allowance for low severity defects.
Your answer is right here.
Define what constitutes your negligible in severity and by how identification is made, By whom, The segregation process, The evaluation criteria trained to who is responsible and authorised to take decision on these type of non-conformances, and what is the method of disposition of non-conforming product. I am sure the records are captured on the system as you say.
Also do mention the frequency of such NC data monitored (in your case it is the daily scrap rate allowance) to see if they are within your threashold limits that are aleady defined, who is responsible to do this monitoring and take actions to initiate a corrective action process if the rate overshoots.
smeared ink on bag, bag on zipper wont close etc., cotton swab is damaged
I hope these data is captured to analyse if there is a increase in the daily scrap rate allowance.
 

Alan_DB

Involved In Discussions
#3
Exactly as above, there can be differentiation between in process scrap and nonconforming finished goods.

If you have it documented and controlled then you should be good.

Ensure that the in process scrap is well segregated by placing in a bin or similar specifically labelled for scrap.

Is your company not the legal owner of the product? If not then ensure to get customer approval (or better, get the customer to define) your in process scrap within your procedures and that might circumvent approvals.
 

John C. Abnet

Teacher, sensei, kennari
Staff member
Super Moderator
#4
identification, segregations, evaluation, and disposition of non-conforming product.
My concern would be (for the organization's sake...regardless of ISO 13485), allowing subjectivity to be involved in such a critical industry.
My counsel would be to consider a SIMPLE visual flow diagram, with "YES"-"NO" decision points that lead the assigned individual(s) to the correct reaction.

For example...VISUAL -->no ---> tag /segregate/contain the item --> contact supervisor for disposition.
VISUAL--> yes---> can you correct the situation?--->no-->tag /segregate/contain the item--> contact supervisor for disposition
VISUAL-->yes--.> can you correct the situation?--->yes-->tag /segregate/contain the item---> log details--->correct the situation

This is a simplistic example and obviously not formatted as a decision tree/flow diagram. However, hopefully you see the intent.

Hope this helps.

Be well.
 
#5
Exactly as above, there can be differentiation between in process scrap and nonconforming finished goods.

If you have it documented and controlled then you should be good.

Ensure that the in process scrap is well segregated by placing in a bin or similar specifically labelled for scrap.

Is your company not the legal owner of the product? If not then ensure to get customer approval (or better, get the customer to define) your in process scrap within your procedures and that might circumvent approvals.
Good catch Alan_DB, reading back I glossed over that detail - we are not the legal owner of the product so the customer sets the specifications/mentioned boundaries

Your answer is right here.
Define what constitutes your negligible in severity and by how identification is made, By whom, The segregation process, The evaluation criteria trained to who is responsible and authorised to take decision on these type of non-conformances, and what is the method of disposition of non-conforming product. I am sure the records are captured on the system as you say.
Also do mention the frequency of such NC data monitored (in your case it is the daily scrap rate allowance) to see if they are within your threashold limits that are aleady defined, who is responsible to do this monitoring and take actions to initiate a corrective action process if the rate overshoots.

I hope these data is captured to analyse if there is a increase in the daily scrap rate allowance.
thank you somashekar, I think you hit the nail in the here- the documentation gap is definitely something that needs polishing.

My concern would be (for the organization's sake...regardless of ISO 13485), allowing subjectivity to be involved in such a critical industry.
My counsel would be to consider a SIMPLE visual flow diagram, with "YES"-"NO" decision points that lead the assigned individual(s) to the correct reaction.

For example...VISUAL -->no ---> tag /segregate/contain the item --> contact supervisor for disposition.
VISUAL--> yes---> can you correct the situation?--->no-->tag /segregate/contain the item--> contact supervisor for disposition
VISUAL-->yes--.> can you correct the situation?--->yes-->tag /segregate/contain the item---> log details--->correct the situation

This is a simplistic example and obviously not formatted as a decision tree/flow diagram. However, hopefully you see the intent.

Hope this helps.

Be well.
I really like this idea and will see what flow logic I can determine (especially once I consider all other sources of NC such as customer complaintsm supplier etc)
 
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