Nonconforming Parts found by our Service Department

[Bunny]

Background information - Medical Device manufacturer of electronic/mechanical devices. Company holds ISO 13485 registration.

I have a question about the best way to handle bad parts discovered by the Service Department. As most companies with a service department, we often receive our products in for repair and often bad components are discovered and replaced by the service team. These parts should be trended in some manner but handling them under the nonconforming process as we do Defective parts discovered in the assembly area may not be the best solution.

What is the best way to document and trend these defective parts?

 

[RoxaneB]

I have a question about the best way to handle bad parts discovered by the Service Department. As most companies with a service department, we often receive our products in for repair and often bad components are discovered and replaced by the service team. These parts should be trended in some manner but handling them under the nonconforming process as we do Defective parts discovered in the assembly area may not be the best solution.

My first thought is...Why not?

I have an idea or two as why you think this, but I'd rather hear your thoughts on the matter.

 

[silentrunning]

I would treat them exactly the same as defective line parts. Then my second project would be to find a method to detect these parts prior to being assembled and sent out to the customer. To me, that is the bigger problem.

 

[isoalchemist]

More details would help, but IMHO I'd run two processes. Line failures and infant mortality should be treated as the same, but if a part have been in the field and functioning for X time and then requires repair that is a different situation. They both require analysis and trending but combining them may well confuse the analysis.