Incoming Inspection Plans under Design Control (part of DMR)?

[JoePap01]

Hi Folks.

There is a debate (of which I am a part) as to whether Incoming Inspection plans should be a part of the DMR. I was wondering how others are handling this and under what rationale? I have my opinion on the matter but in the spirit of objectivity I'd like to hear all sides.

Thanks in advance for any and all responses!

Joe

 

[Ronen E]

Hi,

IMO incoming inspection is an integral part of the manufacturing process ("recipe" for making the device) and therefore it should be at least referenced (could be indirectly) from the DMR. If a component is used in multiple devices it may be more efficient to have its incoming inspection process spelled out in a stand-alone document which could be referenced from multiple DMRs.

Cheers,
Ronen.

 

[Ajit Basrur]

In addition to my friend Ronen earlier, the very requirement in 21 CFR Part 820.181 states the below - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.181

Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;

Thus inspection plans are necessary.

 

[JoePap01]

Thanks for the responses. The "argument" against believes the CFR is referencing INSTRUMENT ("final") QA and not necessarily that of the materials/components used to manufacture said instrument. Specs and user needs are not defined by the incoming inspection, nor is instrument release based on it. In fact, many would say the ideal is that there is no incoming inspection performed in-house and the suppliers be made responsible. If Suppliers have control of inspection then it is out of scope.

There are interesting arguments each way...

Thanks again! Any additional input is welcomed.

Joe

 

[Ronen E]

Thanks for the responses. The "argument" against believes the CFR is referencing INSTRUMENT ("final") QA and not necessarily that of the materials/components used to manufacture said instrument. Specs and user needs are not defined by the incoming inspection, nor is instrument release based on it. In fact, many would say the ideal is that there is no incoming inspection performed in-house and the suppliers be made responsible. If Suppliers have control of inspection then it is out of scope.

There are interesting arguments each way...

Thanks again! Any additional input is welcomed.

Joe

Hi,

QA stands for Quality Assurance. IMO "assuring the quality of the final device ("instrument") only" is meaningless; to assure the quality it is usually essential to cover all the steps, including the quality of the inputs (among them raw materials etc.). It is a holistic approach.

Regarding elimination of incoming inspection and making the supplier accountable - it's usually done based on significant good performance history, and even then there are usually matching inspections at the supplier's side. It's not that there is no inspection; it's just that the location is different. Either way, if in the current situation you in fact have an incoming inspection, such an alternative arrangement ("ship to stock") is irrelevant. The existing incoming inspection has to be a part of your DMR because it's happening and is under your company's / site's responsibility. Once it's actually eliminated it could (and should) be removed from the DMR.

Cheers,
Ronen.