Manufacturer divorced from Design process, is he justified in design process deficiencies?

LostLouie

Starting to get Involved
#1
Let me say that this site has been a wonderful source of information over many years, for a great many within the regulated industries and I'd be glad to thank those responsible for starting and maintaining it. :applause::applause:

Now for my question....:unsure:
I'm working with a medical device manufacturing site that was taken over by a much larger corporation (c. 2010). However this site has never been geared up for anything more than ISO 9001 and now, belatedly, is planning for ISO 13485:2016 accreditation. They have never been involved with product design or changes which have been imported to them from customers (other corporation sites).

My query is that they are blind to external Design development processes and have no visibility nor input to product design, will this be a justification for any non conformances in the product during an audit?

Thanks for your attention.
 
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shimonv

Trusted Information Resource
#2
Well, you can apply for ISO 13485 certificate and define the scope as a "manufacturer of XXX" with no reference to design and development.
 

LostLouie

Starting to get Involved
#3
Well, you can apply for ISO 13485 certificate and define the scope as a "manufacturer of XXX" with no reference to design and development.
OK, thanks for clarifying that point, shimonv. However would that stand up against the new MDR where I believe the manufacturer is obliged to be aware of processes upstream for product realisation?
 

shimonv

Trusted Information Resource
#4
To my knowledge, a contract manufacture is not required to be aware on development activities at the legal manufacturer. It is the responsibility of legal manufacturer to update the contract manufacturer on relevant developments / changes.
 

LostLouie

Starting to get Involved
#5
What happens if the contract manufacturer has had to change a variable to achieve the specified product dimensions? (And he has informed this to design holder) Would he then be liable to the design (and hence need to keep DHF & DMR’s)?
 

William55401

Quite Involved in Discussions
#6
What happens if the contract manufacturer has had to change a variable to achieve the specified product dimensions? (And he has informed this to design holder) Would he then be liable to the design (and hence need to keep DHF & DMR’s)?
Short answer. No.
Longer answer. As long as the change has been properly handled per a quality agreement (was prospective review and approval required? was notification only required? was V&V performed by one or both parties? was RMF maintained during change?) the CM should be OK. Different customers will have different levels of change control with their CM depending on their risk tolerance and the class of the device being manufactured. The Design Authority / Spec Developer remains responsible for the complete DHF and DMR in collaboration with the CM. Process parameters reside at the CM.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#7
For FDA suppliers are not required to adhere to the QSRs but you must evaluate them and apply risk-based controls. For EU, our NB wanted to see a valid ISO 13485 cert for our contracted manufacturer.
 

William55401

Quite Involved in Discussions
#8
For FDA suppliers are not required to adhere to the QSRs but you must evaluate them and apply risk-based controls. For EU, our NB wanted to see a valid ISO 13485 cert for our contracted manufacturer.
Ed. Careful. For US FDA compliance, CM of a finished device must be QSR compliant. There is no work around. Component suppliers? Not so much. Component suppliers are exempt from the QSR but FDA does ask Finished Device Mfrs (including CMs) about component supplier process validation. The bar keeps getting raised. HTH
 
Last edited:

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#9
Ed. Careful. For US FDA compliance, CM of a finished device must be QSR compliant. There is no work around. Component suppliers? Not so much. Component suppliers are exempt from the QSR but FDA does ask Finished Device Mfrs (including CMs) about component supplier process validation. The bar keeps getting raised. HTH
Agreed, this is correct.
 

lyobovnik

Manager QA at small Med. Device Mfr.
#10
I appreciated Ed's statement that the "suppliers are not required to adhere to the QSRs", but also William's caution regarding a "CM of a finished device"... Perhaps it will help/serve someone if I add how my small experience matches up with their words.

At my POE, we've been in both spots:
  1. We had been the CM for a bigger MDM many years and exempt from QSR compliance for the first 13 of those. We maintained our ISO9001 registration and that was enough for us in their eyes.
  2. One day they decided it would be great to source a few Finished Device lines from us. So then they needed us to register to ISO13485, and register with FDA for each affected 510k of each Finished Device. Now we host FDA as often as they want to drop in.
 
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