Interchangeable/alternative parts in BOM (medical device)

#1
My company is developing a medical device. BOM is maintained. As part of the development, devices are manufactured and used for compassionate treatments as well as in clinical trials. There are instances in manufacturing work instructions in which several revisions of the same part are defined for the same assembly step, or more than one part for the same step. In all of these cases, the there is no change of Form Fit Function and it are real interchangeable parts. These instances are consistent with BOM and related ECO-decisions (e.g. disposition of changed component).

From a (QA) documentation control perspective I cannot have multiple revisions alive at the same time. Hence I have difficulties how to manage the configuration management of the device. Please note that this is a small company in which we cannot allow, from resources perspective, a very complicated solution. I'd love to get advice.
 
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John Predmore

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#2
Why can't you have multiple revisions alive at the same time, when there is no difference in Form/Fit/Function and they are really interchangeable? What is stopping you? Maybe someone here has an idea to overcome the prohibition.
 

chris1price

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#3
Even if the parts are interchangeable, you still need traceability of what was actually used. Can the revision details be recorded on the batch record or DHR?
 
#4
Why can't you have multiple revisions alive at the same time, when there is no difference in Form/Fit/Function and they are really interchangeable? What is stopping you? Maybe someone here has an idea to overcome the prohibition.
Multiple revisions alive in parallel are not possible due to document control considerations. At the end, an engineering drawing of a part is a document. When a new revision is released, the previous one is obsoleted by definition.
 

John Predmore

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#5
There are other companies that maintain open multiple design revisions, including in medical device industry. This is fairly common, to support warranty or multiple-customers or use-until-depleted inventory disposition decisions. One way to manage that is to have one BOM (with revision control) for development, a separate BOM for validation prototypes, a separate BOM for current manufacturing, maybe another to support aftermarket.

If you rule out what (to me) is the obvious simple choice (allow multiple open design revisions), the second idea would be assign unique part numbers to every design revision. That leads to part number proliferation with the same expanded number of design documents in your document control system, but a lot more complexity in product delivery, in my opinion. Maybe somebody else has a helpful idea.
 
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