What is to be documented to fulfill the requirements of ?820.65 Traceability?

What is to be documented to fulfill the requirements of §820.65 Traceability?

Hello,

I work in a company which is registered by the FDA, and produces class III implants. We are a supplier and not the distributer.

Right now we have a internal discussion, what must to be documented within the DHR, to fulfill the requirements of the §820.65 traceability. We do have a unique control number for each lot.


My questions are:

Must the employee who worked at one specific process step be documented?
Must the equipment for one specific process step be documented?
Must the measurement device for each final acceptance criteria test be documented?
Must the measurement device for each in-process acceptance criteria test be documented?

My opinion is that we have to document it all. But my problem is the derivation of requirements, because it is not clearly described in the QSR.

Thanks in advance
Philipp

Re: What is to be documented to fulfill the requirements of §820.65 Traceability?

The point of lot or unit identification and of production documentation is so that in the event of a field problem, you can limit the scope of your field action to just those units that may have the same issue, instead of every unit of that product that you've ever made.

Obviously you have an economic stake in getting that right because a very very large recall will have very very large economic impact on you. The FDA however is focused on their stakes, which are (1) the smaller a recall, the more likely it is to be practically accomplishable within the limits of FDA's finite supervisory resources, and (2) if the economic impact on you is too large, your company might go broke before the recall could be completed, and FDA wants recalls completed.

So, if particular documentation helps you to bound how units are produced in such a way that a recall could be smaller, you probably should do that documentation. If on the other hand particular documentation isn't functionally useful, i.e. it wouldn't help you to focus a needed field action on fewer units that are documented to have the same highly specific issue as a problem unit, then it's not needed for this purpose.

Of course, if documentation already exists in your DHR for other reasons, there's no reason to stop doing it.