I have a classs I medical device which is an assembled product, the base used as part of the assembly was used prior to incoming inspection. The part requires material certification and dimensional inspection. The material certification was correct. The dimensional inspection was not performed. If the dimension were not correct , it would have resulted in a documented nonconformity during manufacture. If the manufacturing documents show no nonconformances can the final product be released?

I have a classs I medical device which is an assembled product, the base used as part of the assembly was used prior to incoming inspection. The part requires material certification and dimensional inspection. The material certification was correct. The dimensional inspection was not performed. If the dimension were not correct , it would have resulted in a documented nonconformity during manufacture. If the manufacturing documents show no nonconformances can the final product be released?

Hi Linda and welcome to the Cove! :bigwave:

First, what do your procedures say about this type of situation? Is it addressed in your incoming inspection procedure(s)?

Next, if it isn't addressed, my next question would be "Can the dimensional inspection be performed now, before release?" If it can, then maybe you could do a material review or deviation (from procedure, not spec) to "explain" why dimensional inspection was not done at the appropriate time.

Another option may be to open a corrective action as to why the dimensional inspection was skipped.

Hope this helps. :agree1:

I'm not a medical device guru but it would appear to me that if you've not followed the (entire) validated process, the product would not be considered shippable. If shipped at a minimum there should be an approved deviation/concession with rationale for why skipping the inspection creates zero risk.

I have a classs I medical device which is an assembled product, the base used as part of the assembly was used prior to incoming inspection. The part requires material certification and dimensional inspection. The material certification was correct. The dimensional inspection was not performed. If the dimension were not correct , it would have resulted in a documented nonconformity during manufacture. If the manufacturing documents show no nonconformances can the final product be released?

Did you do a Risk Analysis or was this point covered in PFMEAs ?

Gidget has given you very good leads and you could go in that direction. You have to weigh the risks and if the risks are not heavy, you could release with extra testing and a very solid CAPA in place to prevent it happening in future.

Hope that helps.

Here's a suggestion:

- Open a 'quality hold' (our company calls them NCMRs) and do not ship the product until you close the NCMR.

- To close the NCMR you would document what happened, what evaluation you have done (risk evaluation, FMEA review, etc) to ensure there is minimal risk, then open a CAPA.

- Ship the product assuming there is no risk.

- In your CAPA you would address how the non-conformance happened and what steps you take to address it. This might include traning or a procedure revision.

The reason for all of this is to make sure you document what you have done. If you haven't documented your actions then they never happened in the eyes of an auditor.

:2cents:

I did not hear in this conversation whether the dimension can still be measured after assembly, or if it is no longer accessible for measurement. If there is no evidence of measurement, and it cannot be measured now, then I would suggest a customer deviation in addition to the steps identified by gholland. If they are not willing to accept the risk, then there is likely a reason for that, and you may have to accept the product as non-saleable. After all, it is medical...the risks and subsequent liability can be nasty. :cool:

I have a classs I medical device which is an assembled product, the base used as part of the assembly was used prior to incoming inspection. The part requires material certification and dimensional inspection. The material certification was correct. The dimensional inspection was not performed. If the dimension were not correct , it would have resulted in a documented nonconformity during manufacture. If the manufacturing documents show no nonconformances can the final product be released?

Does the material certification purely state that material is the correct material type, or is it a certification from the supplier stating that the part was manufactured to print? Why must this part go through receiving inspection, does it have a history of nonconformance, or is it something that has always been done? Are there critical specifications if not met that can cause harm to the end user?
At this point I would open a CAPA to document the error of the system. I would then base my decision to use or not use the parts based on risk.

Phil