Qualification of pest control service in a "virtual manufacturer"

P

PBuckley

#1
We are a specification developer that designs a product used to take measurements of certain health statistics, (blood pressure, pulse, weight, etc.), with placement primarily in retail locations. Other than Design Control, Risk Management, & some R&D for future development, we have outsourced most other key manufacturing processes, including manufacturing, service, packaging and shipping, purchasing, complaint handling, etc., so we consider ourselves more of a virtual manufacturer. During a recent ISO 13485 surveillance audit, we received a minor non-conformance for not having our calibration lab and Pest Control service on our approved supplier's list. I can understand the Calibration Lab since we do use inspection and measurement equipment to determine product specifications and need to have a reliable lab with traceable standards, but am slightly puzzled on the observation for Pest control :confused:

If our finished product is not manufactured, assembled, or stored at our facility, and we don't maintain component inventory used for the product's manufacture, why would we have to qualify a Pest Control service? I would appreciate anyone's thoughts on this matter :thanks:
 
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Marcelo

Inactive Registered Visitor
#2
I?ve moved the thread to the ISO 13485 forum - usually better to put related questions here.

As for your question, pest control is not a specific requirement of ISO 13485 (it would be under the general environmental control or contamination control requirement), so I would argue that, unless there?s is a risk related to pest control (from your analysis), you would not need to qualify it.

ON the other hand, there?s at least one medical device regulatory requirement (ANVISA GMP) which formally require pest control...maybe the auditor was familiar with this and ended up requiring too much on ISO 13485...
 

somashekar

Staff member
Super Moderator
#3
why would we have to qualify a Pest Control service?
but am slightly puzzled on the observation for Pest control
When you do not have pest control service supplier on your approved supplier list, you may have no good control over pest, which in turn will harm you and prevent you from doing good specification development, thereby effecting your design outputs / final product ~~~ :lmao::popcorn::sarcasm:
Hii, Can you please put here the NC statement as issued to you by the CB auditor.
Approved supplier list is your QMS requirement and not from the ISO13485. What you put into this depends on your purchasing procedures that you have defined. The controls you exercise depends upon the effects of the purchased products on subsequent realizations or final product.
So the guy who supplies you your evening burgers daily need not be on this list, so is your pest control service provider if you have one.
 
P

PBuckley

#4
Hii, Can you please put here the NC statement as issued to you by the CB auditor.
The minor non-conformance stated: Two suppliers; Terminix (pest control) and Trident Calibration Laboratories (calibration) are being used, but
are not on the Approved Vendor List (AVL).

Requirements were based on the ISO 13485:2003(E) Purchasing Process clause 7.4.1. In hindsight, I think that the concern was that we were unable to show we had evaluated the supplier and classified them by risk, rather than their selection of their service "being dependent upon the effect of the purchased product on subsequent product realization or the final product."

Our easiest course of action will probably be to classify them as a low risk supplier, put a note to file that they meet our requirements for keeping bugs off the premises, put them on our ASL and call it a day.

Thanks to both you and Marcelo for your feedback. Now it's off to qualify that burger supplier . . . :lol:
 
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