Hello fellow med. device makers.
I am looking for input and ideas regarding how to incorporate operators in the WIP, non-conformance process.
So as it goes right now, if our QC inspector finds a non-conformance he will write up a Non conforming Material Report (NCMR) and the case goes to MRB. If the MRB dispositions it to Rework, the part or assembly is (usually) giving to the operator to fix their work.
But for cases where it is Use As Is, (or scrap) or the guy that messed up is out of the office), the offending operator might not find out that they messed up.
Management wants to tighten this up by having every NCMR go to the perpetrator for signature. Also every error needs to be written up. (i.e forgot to inital and date an entry overwrite on a product log. This way they are made aware of their error and by signing the NCMR form, the operator feels a tad more "sting".
Our QC inspector feels this will make him out to be a "bad cop" as he will have to kind of "rub the offending operators nose" in every misdeed, making for more of an strained relationship. (folks may be less likely to communicate freely). He thinks it should be handled more informally so that minor issues can just be talked over, while significant quality lapses could be written up.
I think that some of the "bad cop" persona is part of the job of a QC inspector but also, one does not have to belittle of harass folks in order to do the QC job.
I also think that collecting data even on minor issues is important as it offers a chance to talk to folks before a big issues crops up. However, if we get too persnickety, some NCMR's will not be written up because the QC inspector will just fix the paperwork error himself to speed up the process (and save him from having to deal with a seemingly benign issue)
So, any ideas for a suitable compromise?
How do y'all deal with this?
Best regards
Rx
I am looking for input and ideas regarding how to incorporate operators in the WIP, non-conformance process.
So as it goes right now, if our QC inspector finds a non-conformance he will write up a Non conforming Material Report (NCMR) and the case goes to MRB. If the MRB dispositions it to Rework, the part or assembly is (usually) giving to the operator to fix their work.
But for cases where it is Use As Is, (or scrap) or the guy that messed up is out of the office), the offending operator might not find out that they messed up.
Management wants to tighten this up by having every NCMR go to the perpetrator for signature. Also every error needs to be written up. (i.e forgot to inital and date an entry overwrite on a product log. This way they are made aware of their error and by signing the NCMR form, the operator feels a tad more "sting".
Our QC inspector feels this will make him out to be a "bad cop" as he will have to kind of "rub the offending operators nose" in every misdeed, making for more of an strained relationship. (folks may be less likely to communicate freely). He thinks it should be handled more informally so that minor issues can just be talked over, while significant quality lapses could be written up.
I think that some of the "bad cop" persona is part of the job of a QC inspector but also, one does not have to belittle of harass folks in order to do the QC job.
I also think that collecting data even on minor issues is important as it offers a chance to talk to folks before a big issues crops up. However, if we get too persnickety, some NCMR's will not be written up because the QC inspector will just fix the paperwork error himself to speed up the process (and save him from having to deal with a seemingly benign issue)
So, any ideas for a suitable compromise?
How do y'all deal with this?
Best regards
Rx