AS9100C 7.5.1 d and calibrated equipment in the production areas

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bmartinezjbrnd

#1
We recently had an audit and were issued a CA for not having calibrated equipment in the production areas. Our current procedures state that all products will be verified at Final Inspection and all of the monitoring and measuring equipment available to Inspectors is calibrated. I am struggling to find the link from 7.5.1 d that states we need to have all measuring equipment calibrated. Please Help!
 
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R

Reg Morrison

#2
Re: AS9100C 7.5.1 d and calibration

We recently had an audit and were issued a CA for not having calibrated equipment in the production areas. Our current procedures state that all products will be verified at Final Inspection and all of the monitoring and measuring equipment available to Inspectors is calibrated.
Do you mean that you don't perform any in-process inspection? Are there any critical characteristics that don't get measured by a calibrated IMTE?
What kind of products are we talking about?
 

dgriffith

Quite Involved in Discussions
#3
We recently had an audit and were issued a CA for not having calibrated equipment in the production areas. Our current procedures state that all products will be verified at Final Inspection and all of the monitoring and measuring equipment available to Inspectors is calibrated. I am struggling to find the link from 7.5.1 d that states we need to have all measuring equipment calibrated. Please Help!
Are you saying you don't have MTE in the production area and they say you should, or that there is MTE but they say it is not calibrated and should be?
"If the measurement isn't important, why are you making one?" may apply here. If you are making in-process measurements, it should be with calibrated MTE that also meets the needs of the required measurement (e.g. you wouldn't make a millivolt measurement with a meter that only had a 1000 Volt range).

Sometimes auditors go too far when they try to "help". If a company wants to spend additional time and money fixing/reworking a product because it is only being checked at the end of production, so what. That's a 'business decision' for the company.
 

Big Jim

Trusted Information Resource
#4
We recently had an audit and were issued a CA for not having calibrated equipment in the production areas. Our current procedures state that all products will be verified at Final Inspection and all of the monitoring and measuring equipment available to Inspectors is calibrated. I am struggling to find the link from 7.5.1 d that states we need to have all measuring equipment calibrated. Please Help!
I believe your auditor is incorrect. You won't find that need anywhere in 7.5. The closest the standard comes is in 7.6 where it says "Where necessary to ensure valid results . . . measuring equipment shall be calibrated . . . " and 8.2.4 where it says "The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met . . . ".

You should read the entirety of those two elements for better understanding.

Unless you are driven by a customer requirement, your organization gets to determine when to make measurements. If those measurements are checked again as part of final inspection, you have met the requirement of "where necessary to ensure valid results" if the tool in use during production is not calibrated as long as the one used for final inspection is.

That said, I believe that it is a bad business practice not to use uncalibrated measuring tools for in process checks. Why would you permit all that value added work to take place just to scrap it at the end? Penny wise and pound foolish.
 
B

bmartinezjbrnd

#5
Thank you for the feed back.

Do you mean that you don't perform any in-process inspection? Are there any critical characteristics that don't get measured by a calibrated IMTE?
What kind of products are we talking about?

We mfg detail parts and assemblies for aircraft use. Some of the parts have in-process inspections required, using calibrated equipment. All critical characteristics are measured using calibrated equipment.

Are you saying you don't have MTE in the production area and they say you should, or that there is MTE but they say it is not calibrated and should be?

We have MTE but they say it is not calibrated and should be. Our procedures allow for technicians to use un-calibrated MTE for their own reference prior to it being turned in to Inspection department for approval.
 
R

Reg Morrison

#6
Thanks for the additional explanation of the situation, as it clarifies the original scenario. Based on what you described there would always be a risk of a technician, by using an uncalibrated gauge, to mess the job up. But, as long as the characteristic is being inspected and or tested with a calibrated device later on, you would be satisfying the requirements and intent of AS9100C. And many organizations operate that way: gages used for job setup are NOT calibrated. Some progressive-thinking organizations allow for operator self certification and, in those cases, certainly the gages used by the production technician to approve the part would most definitely need to be properly calibrated.

So the auditor is not correct.
 
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