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.
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.