ISO 13485 Clause 7.3.8 ---- on Business Transfer

[mpfizer]

The company I work for recently had a business transfer agreement with a 30 plus year old medical device company.

We recently were audited for ISO 13485 and the auditor said

NONCONFORMITY:

Design Transfer was not evident in the design history File for......... Product
The organization shall document procedures for transfer of design and development outputs to manufacturing. These procedures shall ensure that design and development outputs are verified as suitable for manufacturing before becoming final production specifications and that production capability can meet product requirements. Results and conclusions of the transfer shall be recorded . The ISO 13485 clause they referred to is 7.3.8. & 4.2.5

As we were not the original company to design and validate the products ( which are 30 years in the market ) and all the documents have name of old company and signatures of people who may have left , what is the procedure we should follow to close this NC --- the corrective action taken ?

Any help would be highly appreciated.

Thanks
Michelle

 

[Bruce Wade]

I will be interested in this discussion. We are in a similar position and the company from which we acquired our medical device left the records in a bit of disarray...

 

[Tidge]

I am imagining that there wasn't a formal assessment of the adequacy of the new (to you) production processes and methods before you agreed to start making the (legacy) product.

For 30+ year-old devices, this could be difficult, as there is a very real possibility that whatever originally passed as a "Design History File" might predate regulatory-required Design Controls (at least in the USA)!

Here is my attempt at practical advice that is offered with the assumption that your company got a DHF, but that it is thin. I would first look at every element of production and answer this question: Where did that come from? As you do this, I would simultaneously try to assess how the thing (feature, process step, etc.) impacts the overall risk profile for the device. Some examples:

• specification, and inspection of characteristics (at incoming, in-process, final)
• process parameters used in manufacturing, including validation of assembly/test methods

This retrospective review will cover what you do, but it won't specifically answer this question: Are you missing doing anything that you should be doing? This may have been addressed when you took over manufacturing, if not you will need some sort of analysis to cover that portion as well.