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Validation of outsourced processes - Calibration - How do we validate that?

R

Ron Durham

#1
Our company had a recert audit this month by Orion.
Our auditor stated that outside calibration is an outsourced process and how do we validate that process. That never has been an issue in our previous audits. One of our calbration companies is ISO 9001:2000 certified and 2 of them are ISO 9001:2000 compliant. Is this necessary.

Thanks, Ron
 
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RoxaneB

Super Moderator
Super Moderator
#2
Ron Durham said:
Our company had a recert audit this month by Orion.
Our auditor stated that outside calibration is an outsourced process and how do we validate that process. That never has been an issue in our previous audits. One of our calbration companies is ISO 9001:2000 certified and 2 of them are ISO 9001:2000 compliant. Is this necessary.

Thanks, Ron
That's never been an issue for us, either. We do, however, have our outside calibration/validation companies on our Approved Vendor List and they subject the rules we've established for that process. How does your company address them?
 
R

ralphsulser

#3
Are any A2LA certified? We considered the outside calibration services as suppliers and they are A2LA certified. We listed them on our Approved Suppliers list. We have passed 2 TS16949 audits and this was never mentioned as anything other than how we document the service.
 
K

Kevin H

#4
Ron, why would you choose an outside calibration service cerified or compliant to ISO 9001, rather than accredited to ISO 17025? The 17025 standard would seem to be a better choice when selecting calibration services. (Note - I "live" in an /ISO/TS system, so we do not really have much choice.)

I'm a bit surprised that your auditor wrote the finding against outsourced processes, rather than 7.6: Control of monitoring & measuring devices. They may have felt that you inadequately defined the requirements for your calibration process, or have seen something that raised an issue. N.B. that is just a WAG. The best bet, would be to discuss with the auditor and try to understand his underlying reasoning.
 
R

Ron Durham

#5
Outsourced processes

Roxane:

We don't list our calibration houses on our approved vendors list. We have been using them for over 10 years and have not ever had an issue with them. What are the rules you established for that process?

Ralph:
None of the calibration companies are certified to A2LA. The only thing we have done outside is our cmm's, electronic height gages, ring gages and thread gages. 95% of our measuring tools are calibrated in house.

One more question on outsourced processes. We send out a lot of parts for anodizing. This is for cosmetic purposes only. We use companies that have been surveyed and recommended by our customers. I stated in our manual that I validate the process by using certs and customers recommended by our customers. That was ok by the auditor but our Purchasing Manager said that if we have a customer that doesn't care who we use then we use someone who has been approved by one of our other customers(Boeing, Storage Tek).
Our auditor said we needed to validate that process by use of a mail in survey or onsite audit. This seems like a lot of work for cosmetic parts. After all we know what our customers require and they have never had an issue with any anodized parts that we send them.
Thanks, Ron
 

Al Rosen

Staff member
Super Moderator
#6
Ron Durham said:
Roxane:

We don't list our calibration houses on our approved vendors list. We have been using them for over 10 years and have not ever had an issue with them. What are the rules you established for that process?

Ralph:
None of the calibration companies are certified to A2LA. The only thing we have done outside is our cmm's, electronic height gages, ring gages and thread gages. 95% of our measuring tools are calibrated in house.

One more question on outsourced processes. We send out a lot of parts for anodizing. This is for cosmetic purposes only. We use companies that have been surveyed and recommended by our customers. I stated in our manual that I validate the process by using certs and customers recommended by our customers. That was ok by the auditor but our Purchasing Manager said that if we have a customer that doesn't care who we use then we use someone who has been approved by one of our other customers(Boeing, Storage Tek).
Our auditor said we needed to validate that process by use of a mail in survey or onsite audit. This seems like a lot of work for cosmetic parts. After all we know what our customers require and they have never had an issue with any anodized parts that we send them.
Thanks, Ron
I'm confused. What you have described, I would not consider validation but control of suppliers. Is that what your auditor was concerned about? What clause did the auditor cite?
 
V

vanputten

#7
Confused by thread

Hello All:

I think the answer to Ron's question may have nothing to do with ISO 17025, 9001, or accredditation.

You asked another organization to perform a process for you. You outsoruced the process. Did you compare what you asked them to do with what they did? Compare the inputs you gave the service provider with the output they gave back to you.

The controls you place over an outsourced process may include a requirement for registration or accreditation. But I am not so sure it has to.

Regards,

Dirk
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#8
Ron Durham said:
None of the calibration companies are certified to A2LA.
No laboratory can be certified to A2LA.....a laboratory CAN e accredited BY A2LA.....

Remember A2LA is one, but only one, of several recognized accrediting bodies operating in North America. The others which are also internationally recognized and EQUALLY acceptable include IAS, NVLAP, SCC/CLAS (Canada), and EMA (Mexico). Nationally recognized bodies include IAS, NVLAP, L-A-B, and ACLASS. Within the U.S., either of these bodies is acceptable.

If you cal provider(s) become accredited by either IAS, A2LA, NVLAP, L-A-B, ACLASS, SCC/CLAS, or EMA, you should have no problem.

Hershal
 
R

ralphsulser

#9
Hershal said:
No laboratory can be certified to A2LA.....a laboratory CAN e accredited BY A2LA.....
Hershal
But they can have a Certificate to show they are Accredited to A2LA and we have those on file.:D
 
C

Craig H.

#10
Ron,

An auditor recommended a mail-in survey? I have a pet peeve about those things. The folks who will take the time to fill one out honestly are the ones you should worry about the least, generally speaking. Fly-by-nighters will send you smoke. How to tell the difference?

We once used mail-in surveys, I hate to admit. The highest self-scorer started having problems, so I/we did a site audit. What a joke that was.

I'd say that you can make the criteria for your system. Why not decide which materials and outsourced work are critical, and put them on a list?

We then decided that an ISO 9001 certificate or a site audit were necessary UNLESS we had a good track record with the supplier. Its in our purchasing procedure.
 
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