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Removing final inspector for medical device manufacturing


Starting to get Involved
Hi everyone,

I am supporting a small US medical device manufacturer (for the US market) that wishes to not have an independent final inspector for the finished device.
They would like the final inspection to be performed by the same individuals that manufactured the device (CNC, AM, so on).
Furthermore, the manufacturing facility will not have a quality representative on-site, but remote at the US HQ. Therefore, I am also concerned about NC reporting (for QMS and product), scrap, containment, and so on.

I've reviewed 21 CFR 820 and I can't really find enough defense in the regulation against the operator also being the final inspector.

Can someone give me some thoughts into this situation? Do you think these two situations are a problem? Do you think they aren't problem? Both are making me uncomfortable.

Thank you for any feedback and advice!


Starting to get Involved
I would also be concerned about independence and authority. Is it possible for a peer production operator to perform final acceptance activities? That would provide some level of independence. I have worked with a multi-site supplier with just a single Quality Manager reporting to the President-- the quality manager had no staff. Production operations, including quality assurance steps, were performed by Production. They addressed independence by having a different peer operator perform certain tasks (for example line set up verification, final acceptance). The quality culture of the organization, as well as the job descriptions & training for production employees, are key success factors.


Starting to get Involved
It may not be expressly written but there is a high degree of risk having the same individual who produced an item also perform the quality function of inspecting it. I guess, to me, the whole point is to have an extra set of eyes come in fresh and review the product prior to release because they're more likely to see something out of conformance than the person who was working on it. I recently worked with a larger company who removed many quality tasks and left it to the operators, and the results were not in their favor. There were a lot of missed things because the operators were so used to looking at what they worked on that it almost gave them blinders to what was non-conforming.

So while it's not against regulation, there's a substantial risk in it. IMO


Starting to get Involved
Thank you for your responses.
I fear that I am in a situation of having to wait until there are problems in order to defend my position - all in the name of "lean".
However, problems also put me in a bad situation. Old story, I know.


Involved In Discussions
Were you collecting inspection data/results of this final inspection being removed? If so, what does the data tell you? If you were finding issues during this independent final inspection then try to use this data to justify retaining some elements of this inspection. Otherwise, inspections without any data justifying it is just waste.

You should always be driving to reduce the cost of inspection. However to achieve this, you need to be collecting inspection results to drive down occurrences of defects and ultimately reduce inspections if the data justifies it. You could consider taking a gradual reduction in the inspection frequency by considering sampling and adopting switching rules (assuming you are doing 100% inspection right now). Also, if you were collecting inspection results then consider using this to quantify the risks with eliminating it outright.
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