Need to Audit an External Calibration Laboratory? - Customer Audit Finding

A

Arnthor

#1
Dear all,

My company had engaged an external calibration lab to calibre some of the lab equipments.

I would like to ask whether is there any requirement to audit an external calibration lab? In the context of drug and device combination manufacturing.

I had a finding from a customer audit, the auditor say my company need to audit the external calibration lab. The external lab is a ISO 17025 certify lab.

Please advice how should I answer that finding.

Best regards,

Arnthor
 
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#2
Re: Audit an external calibration lab

We did audit a test house that we use, but that was as a result of them not being registered to ISO 17025.

We used our critical supplier process to guide us. Fortunately they were very helpful and I believe found the process useful, as it may be something that other customers of theirs might use.

But as your calibration lab is already ISO 17025 registered then that should cover just about everything. Perhaps a formal and documented supplier qualification would be suffice?
 

harry

Super Moderator
#3
Re: Audit an external calibration lab

I had a finding from a customer audit, the auditor say my company need to audit the external calibration lab. The external lab is a ISO 17025 certify lab.
No offense meant, but one would need to have a certain level of competency to audit a specialized set-up such as a calibration lab. Do you have such resources? If not, how?

You can fall back to the iso guidance document on outsourced processes. Under 2.3.2 - Control of out sourced processes, where it talks about the situation where the organization does not have the competency to carry out the process itself and chooses to outsourced it. A lab having an accredited quality system such as ISO 17025 and being regularly audited by their AB (specialized third party) should meet this requirement.
 
Last edited:
#4
Re: Need to Audit an external calibration lab? - Customer audit finding

I agree, one would have to be competent to check a specialist test house, which is why our Supplier Qualification process stipulates who might be able to do such a check.

In this case the specialist electronics test house was checked by an experienced electronics test engineer (with QS experience as well).

I agree that the AB audit should be sufficient when available.
 

RA Guy

Involved In Discussions
#5
I don't understand a finding that says you need to audit any supplier.
As presented in your posting, this is not a finding, but a request/directive.
You need to ensure there is adequate control of an outsourced process, but I am not aware of a QMS standard that specifically requires audits.
I am not saying you should not perform an audit, but simply that a step has been skipped in the issuance of this "finding" (i.e., giving you the opportunity to respond with an appropriate plan that may or may not include and audit). If they really want you to audit this supplier, and your company is agreeable, I'd suggest a contractual agreement that covers their expectations. Without this, next year they could issue a finding that you are not doing annual re-audits of you calibration lab or they could ask you to double your in process inspections. Your company may want to factor the cost of any additional arrangements that potentially go beyond what you consider compliant.

As far as auditing to 17025, I agree that you need specialized resources to assess technical scope(s). For the general management systems parts (doc control, records, staff training, etc.), this can be done by any competent QMS auditor. I have seen a number of 17025 audits that are broken down in this manner. Contracting a specialist just to audit the relevant technical protocols, records, equipment, staff competency, etc. could save time and money.
 
A

Arnthor

#6
Dear all,

Thank you for all the valuable information.

I think I will reply the customer in this way:

If the calibration lab have ISO 17025 certification - No audit required, to get a copy of their latest certification.

If the calibration lab does not have ISO 17025 certification, audit will based on the relevant areas of my equipments.

Hope that will satisfy that customer. :)

By the way, does anyone know where such requirements to audit a external lab come from? I am an internal auditor for ISO 13485. ISO 13485 does not have such a requirement.

Best regards,

Arnthor
 
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