The Scope of "Verification of Purchased Product"

D

DaisyMae

#1
What is the scope of the section ISO 7.4.3 and the corresponding section of FDA 820.80? I understand that "Purchased Product" certainly applies to components but what about other items that may not be directly used in or as part of a finished device?

An auditor gave us a minor NC for not having receiving inspection defined for the pallets used in the warehouse or for a tool that is used to during preventative maintenance of the compressed air system to determine the various contaminant levels (i.e. oil).
Thank you in advance for the advice.
 
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H

Hodgepodge

#2
What is the scope of the section ISO 7.4.3 and the corresponding section of FDA 820.80? I understand that "Purchased Product" certainly applies to components but what about other items that may not be directly used in or as part of a finished device?

An auditor gave us a minor NC for not having receiving inspection defined for the pallets used in the warehouse or for a tool that is used to during preventative maintenance of the compressed air system to determine the various contaminant levels (i.e. oil).
Thank you in advance for the advice.
For the ISO requirement, you don't need a record of receiving inspection of pallets used in the warehouse. The tool used for maintenance doesn't need any records either.

Section 7.4.1 has a general blurb that should help you see where and when to apply receiving inspection. My emphasis in bold.
ISO 9001-2008 Section 7.4.1
The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.
 
M

MIREGMGR

#3
If you buy pallets and have a specification, I'd think you'd be obligated to verify compliance with that specification, per 7.4.3.

Is your product of such a nature that if your pallets were contaminated with a migrating substance, your product might become contaminated during shipping? Even without a specification, perhaps an auditor might recognize such a risk and discern a general duty to avoid it in some manner, such as by inspection, so as to assure safe and effective medical-device products...a core requirement of 21CFR820.

There have been a number of instances over the past two years in the US in which pharmaceutical products have become contaminated during shipping because the pallet supplier provided used pallets from general industrial exchange and the pallet wood had been treated with a migratory (and smelly, and toxic) substance. I haven't heard of such an instance with devices, but certainly it could happen.

Is your production process of such a nature that contaminants in your compressed air supply could contaminate your product? If so, perhaps the auditor wants to see evidence that you're actively preventing such contamination, per 7.5.1.1 (d).
 
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Q

QSMLauren

#4
In my opinion this goes back to 4.1 of the std "organization shall determine the processes..and application. Let's say for argument sake the pallets have no impact on product quality or product safety. That is why they do not have incoming inspection on them. I think it is up to the auditor to find evidence of the pallet actually affecting the product quality before they can write up an NCR on this one.
- Lauren
 
M

MIREGMGR

#5
Did the audit report not state what rule the non-conformance was in reference to?

Rather than our guessing as to what the auditor meant, why not ask that person, or their organization?
 
D

DaisyMae

#6
thanks everyone for the advise. To answer the question about the auditor providing reference to which part of the standard. The audit was an ISO13485 audit and the section referenced for the finding was 7.4.3
:thanx:
 
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