Visual Inspection Validation - Developing a New Medical Device

[JoseCZ]

Hi all, I am currently working in a Medical Device company which is developing a new product. We are trying to outline a procedure that will specify what we need to do to validate all critcial verification acceptance activities. I will like to know if any of you have an idea of what we can do to validate that we are 95% confident that 95% of the time the operator will do the correct material disposition. In our case which is a critical final visual inspection we are trying to focus only in in the type II error (accepting bad parts). We are using the 95/95 because is a critical output. One of the recomendation is to validate the critical visual inspection in this way:
- Have 3 inspector to inspect 3 lots of 20 part each with 3 bad parts per lot.
- Acceptance criteria: all bad parts need to be identify by all the inspectors

Any feedback on this approach or on what we should do to comply with the regulation, patient safety, risk managment and resource/work wise?

Thanks,
Jose

[Ajit Basrur]

In Reply to Parent Post by JoseCZ

Hi all, I am currently working in a Medical Device company which is developing a new product. We are trying to outline a procedure that will specify what we need to do to validate all critcial verification acceptance activities. I will like to know if any of you have an idea of what we can do to validate that we are 95% confident that 95% of the time the operator will do the correct material disposition. In our case which is a critical final visual inspection we are trying to focus only in in the type II error (accepting bad parts). We are using the 95/95 because is a critical output. One of the recomendation is to validate the critical visual inspection in this way:
- Have 3 inspector to inspect 3 lots of 20 part each with 3 bad parts per lot.
- Acceptance criteria: all bad parts need to be identify by all the inspectors

Any feedback on this approach or on what we should do to comply with the regulation, patient safety, risk managment and resource/work wise?

Thanks,
Jose

Welcome to the Cove Jose

I am not an expert in this but can refer to http://elsmar.com/Forums/showthread.php?t=23359 till we get experts next week. Usually the responses over weekend are bit slower than week days. You could also use SEARCH function to view responses on the subject.