One site of multi-site company closing - Quality transfer issues

[Aaria]

Hello,

In a start-up company set-up, with corporate quality in US and a component mfring/some R&D function at a site in EU - what are the points to consider for quality transfer? The site is closing and we are trying to put together all the cross-functional projects and systems to be transferred in a transition plan. What is the first thing as a quality manager I should be looking at? What is the standard industry practice for closing an mfring site?

Note: The product has a CE mark but is not on the market.

Thanks,
Aaria

 

[normzone]

Re: Site closing - quality transfer issues

You didn't mention the nature of the product line.

My experience is limited in these matters, but I did witness an FDA audit once of a very simple product. All would have been good, except that in the transfer of ownership from the origin source to the new owner, no design records were included. This made things very entertaining (for me as an observer-for-hire)

I would rather have everything I could lay my hands on, pertinent or not, than have to explain later why I could not provide something so basic.

 

[BoardGuy]

Re: Site closing - quality transfer issues

When making the transfer you should assure the following:

• Detailed task based plan with milestones for the transfer
• Transfer risks are identified, assessed and mitigation plan developed
• Last Article inspections are performed at existing source/location
• First Article inspections are performed at new source/location
• Appropriate procedures, work instructions and specifications etc. are transferred and placed under control of new source/location
• Appropriate records are transferred and place under control by new source/location
• Training of company personnel is performed at the new source/location by existing source/location.

 

[Aaria]

@normzone - thank you for your reply. The product we are dealing with is Class II medical device. Our DHR is electronic but indeed we need to make sure we have all the pertinent knowledge transfer. We are also moving lab equipment and component manufacturing from that site. What are quality systems aspect of these tasks that I should be looking at?

 

[Aaria]

@boardguy: Thank you very much for prompt response and insight into activities. I have some follow-up questions, mainly on the scope of transfer risk/mitigation plan.

@transfer risks: What kind of risks we need to be looking at mainly from Quality Systems perspective?

@questions: What about calibration activities of the lab/manufacturing equipment that we will be moving? For component manufacturing equipment, is it ok if we only do IQ/OQ and no process validation?


@Training of company personnel is performed at the new source/location by existing source/location. - Training on process and procedures? For equipment operation training, should the training be conducted on the new site or the old one?

Thanks a lot for your help.

 

[BoardGuy]

Since you have indicated this is a medical device you should be using your organizations risk assessment procedure but they would be more than just quality system and it should address customer and Regulatory requirements.

At this point the other items are based on what International Standard your quality system is based on and what are the regulatory body requirements but IQ, OQ, PQ are relevant along with whatever training is needed to produce conforming product to applicable requirements.

 

[Miner]

The biggest issues that I have encountered during product transfers have been:

• Internal drawings do not match the actual product. New location builds to drawings and product does not work.
• Undocumented knowledge of the old site manufacturing operators does not get transferred to the new location. New site cannot make it like the old even though it might meet requirements.

 

[Michael_M]

You say this is for Medical so I do not know if this applies, in the Aerospace industry, if a product changes manufacturing facilities a new formal First Article (per AS9102) is required.