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Author Topic:   The Art of Auditing Calibration
Marc Smith
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Posts: 4119
From:West Chester, OH, USA
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posted 08 August 1998 07:15 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
An FYI Thread:

From: RCR9000@aol.com S
ubject: Re: Q: Cal. Lab Audit/Miller/Randall

"I have an ISO 9001 Audit coming up next week, I would like to hear some of the most common problems auditors have found with Calibration Lab's. I have both mechanical and electronic test equipment in my lab most of that equipment is traceable to NIST or ANSI specifications as possible. I use CyberMetrics GageTrak and have a good recall system, Calibration Manual just updated to current practices. I would just like to get some feed back on some common findings."

Thank You,
Jeff Miller

The most common N/Cs that I raise involving calibration are actually issued under ISO 9002, element 4.6 (Purchasing).

The most common N/C that I issue involving calibration has to do with qualification of calibration subcontractors (ISO 9001/2, element 4.6.2). Unlike suppliers providing products (that can be verified at receiving inspection) sending out a questionnaire (to be completed by the supplier) alone won't do it. There should be objective documented evidence that the calibration subcontractor complies with all of ISO 9002, element 4.11. Acceptable methods include:

- A site audit performed by your organization
- Copies of site audit(s) performed by other companies
- ISO 9002 registration of the calibration subcontractor
- ISO Guide 25 Accreditation of the calibration lab (e.g., A2LA, NVLAP)

There are actually other means of qualifying a calibration lab, but these are the most common.

The second most common N/C involves the certificates (records) provided from the calibration subcontractor. I look for these records to state that the calibration was performed in accordance with ISO 9002, element 4.11 OR equivalent (e.g., ISO 10012, MIL-STD 45662-A, ANSI/NCSL Z540-1, ISO Guide 25, NIST Handbook 44, etc.).

If these certificates (records) do not contain a statement of compliance with a quality system standard (as listed above), then I again visit purchasing to verify whether a quality system standard was invoked (as per ISO 9001/2, element 4.6.3c).

Note: There are probably some members of the group thinking - "but my ISO 9000 auditor accepts "Supplier Qualification Questionnaires / Surveys" to qualify my calibration subcontractor(s) AND doesn't look for any sort of statement of compliance on the suppliers calibration certificates (records)". In this case you have a poorly trained ISO 9000 auditor who is allowing you to circumvent requirements contained in the standard (and yes, you can tellyour auditor that I said so!).

For one to take the absurd position that a "Supplier Qualification Questionnaire / Survey" is sufficient to qualify a calibration subcontractor is to insult all of the calibration (and testing) laboratory accreditation programs being used throughout the world. I've audited over 40 calibration labs and about 20% were NOT in compliance with the standards they stated compliance with (I'm not talking about minor infractions here).


I hope that this helps,

Richard C. Randall

[This message has been edited by Marc Smith.]

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Marc Smith
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From:West Chester, OH, USA
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posted 08 August 1998 07:23 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Another:

From: "SMITH, RON D. (JSC-EM)"
Subject: RE: Cal. Lab Audit/Miller/Smith

Jeff: Here are 10 areas that we have seen or been involved in with our audits.

1.) Look at your process for verifying calibration test software, if you have it. Especially the frequency of verification, the testing verification process (documented), etc.

2.) Do you have a documented process (impact analysis) for addressing the calibration of your standards (working or reference) when their calibration measurement data has changed significantly or has been out-of-tolerance (OOT) when either you performed the calibration or they were returned from NIST or some calibration source?

3.) Is your calibration recall system documented and complete? Does the recall system notify the equipment user when the equipment dues dates are nearing expiration?, any delinquent notices? and what is the process for ensuring that the equipment is returned for calibration? Do you know the calibration status of all the equipment you perform calibrations on in you company and is it readily available?

4.) Do you know the measurement uncertainties of your standards, especially your reference standards and major working stds?

5.) Are all of your standards (working and reference) traceable to NIST or an acceptable national or defined standard? Can you show this?

6.) What do you do when your calibration equipment is OOT or has failed to ensure there was no adverse impact on the validity of the calibration on your customers equipment? Do you notify your customers of their equipments OOT condition? Do you recall customer equipment for re-cal, if necessary? Tho, you may not have any control over this, what do they do with that data?

7.) Do you use outside calibration sources? If so, are they audited by you and do you have documentation of your audits, any corrective actions on problems arising from any difficulties with the outside source and some manner of checking on the quality of their work?

8.) Do you provide all calibration data to your customers at each calibration? Some auditors expect this, some expect the data to be readily available from the Cal Lab, if necessary.

9.) Do you have a customer complaint action process with a corrective action process for resolving these complaints?

10.) Do you do internal quality audits on your labs operations/ documentation/processes, the quality of your technicians work, etc.?

There are a lot of other details that apply to the calibration process besides the 4.11 section.

Ron Smith
Measurement Standards and Calibration Laboratory J
ohnson Space Center
ron.d.smith1@jsc.nasa.gov

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Marc Smith
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posted 08 August 1998 11:24 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
From: RCR9000@aol.com
Subject: Re: Q: Cal. Lab Audit/Miller/Randall/Andrews/Randall

>> Richard wrote (in part)
>> "The most common N/C that I issue involving calibration has to do with
>> qualification of calibration subcontractors (ISO 9001/2, element 4.6.2).
>> Unlike suppliers providing products (that can be verified at receiving
>> inspection) sending out a questionnaire (to be completed by the supplier)
>> alone won't do it. There should be objective documented evidence that the
>> calibration subcontractor complies with all of ISO 9002, element
4.11.
>> Acceptable methods include:
>>
>> - A site audit performed by your organization
>> - Copies of site audit(s) performed by other companies
>> - ISO 9002 registration of the calibration subcontractor
>> - ISO Guide 25 Accreditation of the calibration lab (e.g., A2LA, NVLAP)"

>Andrews inquired:
> Richard - where exactly in 4.11 or 4.6 does the Standard REQUIRE that I
> exercise the controls that you mention above?

ISO 9001/2, element 4.6.2 states that:

The supplier shall:

a) evaluate and select subcontractors on the basis of their ability to meet subcontract requirements including the quality system and any specific quality-assurance requirements

Assuming we agree that in the case of a calibration subcontractor the supplier "should" be invoking ISO 9001/2 element 4.11 or equivalent (as per element 4.6.3), then it follows that the calibration subcontractor must be qualified as being able to meet the detailed requirements contained in element 4.11. This is a significant differentiating factor from all other subcontractors because the supplier is dependent upon the calibration subcontractor's compliance with an element of the standard in order to fully comply with the standard themselves (the supplier)!

> My understanding is that the type and extent of controls exercised is up
> to the individual company, taking into account various conditions and
> circumstances. "sending out a questionnaire (to be completed by the
> supplier)" may be perfectly valid in certain situations.

You are correct in that the vast majority of subcontractors can be qualified (at least initially) through the use of a questionnaire (to be completed by the supplier). This is acceptable for subcontractors providing a product whose quality can be verified at receiving inspection. However, one cannot verify that the detailed requirements of element 4.11 were met by performing a receiving inspection on calibrated equipment. For example, receiving inspection cannot verify:

- that the instrument was calibrated/checked against certified equipment having a known valid relationship to international or nationally recognized standards. (the calibration report may state that the calibration was performed using NIST traceable instruments - but how do we really know? I've found instruments being used in calibration labs that are traceable to NIST through calibrations performed "decades" ago. Is that acceptable? I've also found what is called a "calibration loop" in several calibration labs. This is where an instrument is used to calibrate another like instrument that is then used to calibrate the first instrument - the instruments are used to calibrate each other. True traceability is lost as the error of each instrument accumulates in a never-ending cycle or loop. Even though I've never found an instrument being used in a calibration lab that lacked ALL traceability to NIST, I have heard stories of instances where this was found by others.)

- that an acceptable calibration method was followed. (The calibration records may list the calibration procedure that was used, but is that calibration procedure acceptable to you? Does that procedure check ALL of the functions of the instrument - particularly the functions that you use? Not every calibration lab uses the manufacturer's calibration procedure. Many internally generated calibration procedures are greatly abbreviated from the manufacturer's procedure - taking short cuts to speed the calibration process. I like to compare the "Equipment Required" section of the calibration procedure with the actual listing of equipment used in performing the calibration. There are almost always substitutions made because the calibration lab does not own the exact equipment listed. At that point I like to have the calibration lab prove to me that the equipment used really was equivalent. Sometimes it is not.)

- that the calibration subcontractor uses the same acceptance criteria that you use? (The calibration records may state that the instrument was found to be "in calibration" with the manufacturer's specifications, then again it may simply state that that the instrument was found to be "in calibration". When nothing else is stated then it is assumed that the instrument was found to meet the tolerances specified in the "calibration method" used. Some calibration labs change the tolerances of instruments in their internally generated "abbreviated" calibration procedures so they don't have to make adjustments. This may sound like business 101, but the more instruments that pass through a calibration lab - the more money they make. I've seen this situation in auditing calibration labs more than once.)

- that the calibration lab will notify the supplier if "their" instrumentation (measurement standards) are found to be out of tolerance, causing the calibration to be suspect. (Virtually all calibration quality system standards {e.g., MIL-STD 45662A, ANSI/NCSL Z540-1, ISO 10012-1} require the client to be notified if ANY instrumentation used in performing the calibration are later found to be out of tolerance. This means that every instrument used in a calibration lab must have a listing of every device it was used to calibrate since the last time it was calibrated. If ISO 9001/2, element 4.11 is invoked on a calibration lab, that means that this requirement must be met in order to satisfy 4.11.2f. How do we know that this requirement is being met without a site audit performed by someone? As you might well imagine, this requirement is costly for a calibration lab to comply with - some do not.)

- that the calibration was performed under suitable environmental conditions. (This requirement is most important for dimensional devices. The majority of calibration labs report the environmental conditions {temp/RH} on their calibration certificate or report. But is this information accurate? I was auditing a calibration lab in New York several years ago and noticed that the temperature was ALWAYS at 70 degrees F and the RH was ALWAYS at 35%. Upon touring their lab I saw no special considerations made to ensure that the environmental conditions stayed so constant. I asked a calibration technician how the environmental conditions stayed so stable and his response was that he didn't know, he had been trained to ALWAYS record the environmental conditions as being 70 degrees F and 35% RH. I asked the calibration lab manager why the calibration technicians had been instructed to always record the environmental conditions as being 70 degrees F and 35% RH. He responded that they had an environmental chart recorder in a building across the street and it almost always read 70 degrees F and 35% RH. )


After an auditor sees enough of the nonsense that "can" go on in a calibration lab, he starts to want "real" verification that the calibration subcontractor being used has been legitimately qualified.

On the topic of whether the ISO 9001/2 allows a questionnaire to be used in qualifying a calibration subcontractor, ISO 9001/2, element 4.6.2b states (in part) that the type and extent of control exercised by the supplier over subcontractors shall be dependent upon the type of product (or service) and the impact of subcontracted product (or service) on the quality of the final product.

Calibration has a significant impact on the final product (otherwise you shouldn't be going to the expense of calibrating those instruments). Therefore the supplier should make a reasonable effort to ensure that the calibration subcontractor meets the requirements contained in ISO 9001/2 element 4.11 or equivalent. Based on the discussion above, a questionnaire completed by the calibration lab is not a sufficient means of qualifying that calibration lab. The same can also be argued of a testing lab.

Upon finding a company using a questionnaire completed by the calibration lab as a means for qualifying that subcontractor, I would issue a noncompliance with ISO 9001/2, element 4.6.2 (since I am concerned with requirements of both elements 4.6.2a and 4.6.2b being met). This is clearly a judgment call with respect to the standard - and is therefore arguable. But hopefully this rather lengthy e-mail explains the reasoning for why calibration subcontractors should be viewed differently than most other subcontractors when undergoing the qualification process.


Richard C. Randall
rcr9000@aol.com

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Marc Smith
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posted 09 August 1998 12:30 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
From: eandrews@usffiltration.com
Subject: Re: Q: Cal. Lab Audit/Miller/Randall/Andrews

Richard,

Thank you for your reply that so clearly stated your position in this matter; however, there are a few points that you raised that I wish to reply to:

First - when you stated (in part)

"Assuming we agree that in the case of a calibration subcontractor the supplier "should" be invoking ISO 9001/2 element 4.11 or equivalent (as per element 4.6.3)".

You are correct in stating that perhaps the calibration labs "should" be working to ISO 9001/2; however, "should" does not equal "must". Therefore, if the subcontracted calibration labs are not REQUIRED to follow the requirements of ISO 9001/2 (unless we invoke it) then the rest of your well thoughout and well written position does not bear up.

Secondly - you stated (in part):

"You are correct in that the vast majority of subcontractors can be qualified (at least initially) through the use of a questionnaire (to be completed by the supplier). This is acceptable for subcontractors providing a product whose quality can be verified at receiving inspection."

I did not mean to imply that questionnaires had to be utilized at all -there is no requirement for such.

Third - you stated (in part):

"that the instrument was calibrated/checked against certified equipment having a known valid relationship to international or nationally recognized standards. (the calibration report may state that the calibration was performed using NIST traceable instruments - but how do we really know?"

We could-and should-require certifications from the calibration lab certifying to that fact. And as far as "how do we really know" - I guess it is a matter of trust (and of business law) that would help us to believe.

Fourth - you stated (in part):

"Does that procedure check ALL of the functions of the instrument - particularly the functions that you use?"

Generally, the certifications will list the measurements verified. This should indicate whether or not they checked the necessary functions of the instrument.

Fifth - you stated (in part):

"that the calibration subcontractor uses the same acceptance criteria that you use?"

It is the company requesting the service's responsibility to define the acceptance criteria to the calibration lab as a part of the 4.6 requirement of defining requirements to the subcontractor.

Finally - you stated (in part):
"After an auditor sees enough of the nonsense that "can" go on in a calibration lab, he starts to want "real" verification that the calibration subcontractor being used has been legitimately qualified."

>From the content of your response I gather that you have had a number of bad experiences with the calibration labs that you have come in contact with. That is unfortunate; however, I do not feel that your experiences paint a true picture of the calibration industry as a whole (at least I hope not!). My personal experiences with calibration labs over twentysome years in the business has been the opposite. Perhaps, it is because I strive to choose labs with solid reputations (with the certifications to back them).

In the end, I think that may be the key - and a point that you have most certainly helped to emphasize - choose your calibration labs carefully and wisely. And look for objective evidence that they indeed provide the service that they claim.

Thank you Richard for taking the time from your busy schedule to help highlight this point.

Respectfully,
Ethan Andrews
eandrews@usffiltration.com

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Marc Smith
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From:West Chester, OH, USA
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posted 09 August 1998 12:52 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
From: Philip Stein
Subject: Re: Q: Cal. Lab Audit/Miller/Randall/Andrews/Randall/Stein

I have added many of my own comments, mostly contrarian, interspersed in the text.

Phil Stein, the Contrarian Metrologist

>>> Richard wrote (in part)
>>> "The most common N/C that I issue involving calibration has to do with
>>> qualification of calibration subcontractors (ISO 9001/2, element4.6.2).
>>> Unlike suppliers providing products (that can be verified at receiving
>>> inspection) sending out a questionnaire (to be completed by the supplier)
>>> alone won't do it. There should be objective documented evidence that the
>>> calibration subcontractor complies with all of ISO 9002, element 4.11.

A good idea, but NOT required


>>> Acceptable methods include:
>>> - A site audit performed by your organization
>>> - Copies of site audit(s) performed by other companies
>>> - ISO 9002 registration of the calibration subcontractor
>>> - ISO Guide 25 Accreditation of the calibration lab (e.g., A2LA, NVLAP)"

I think that it would be good to have one or more of these pieces of evidence. The most important issue is that none of these are required, and many of them, especially ISO Guide 25 accreditation, may be overkill. It can't hurt, but might be costly. The true weak link comes from nonconformance with 4.11.1, where it states that the measurement capability required must be known and that the measurement uncertainty must be compatible with it. If you know your required uncertainty, it's real easy to decide how hard to scrutinize your cal lab. Clarity begins at home


>>Andrews inquired:
>> Richard - where exactly in 4.11 or 4.6 does the Standard REQUIRE that I
>> exercise the controls that you mention above?
>
>ISO 9001/2, element 4.6.2 states that:
>
>The supplier shall:
>
>a) evaluate and select subcontractors on the basis of their ability to meet
>subcontract requirements including the quality system and any specific
>quality-assurance requirements
>
>Assuming we agree that in the case of a calibration subcontractor the supplier
>"should" be invoking ISO 9001/2 element 4.11 or equivalent (as per element
>4.6.3),

Not a good assumption

>then it follows that the calibration subcontractor must be qualified
>as being able to meet the detailed requirements contained in element 4.11.

Not a requirement. Some portions of 4.11 flow directly from the requirements of the cal customer and must be followed, such as traceability. Others, such as safeguarding of adjustments or control of environment are situation dependent.

>This is a significant differentiating factor from all other subcontractors
>because the supplier is dependent upon the calibration subcontractor's
>compliance with an element of the standard in order to fully comply with the
>standard themselves (the supplier)!

Maybe, maybe not. Often, other requirements such as ingredient or component traceability also flow from the prime contractor to the sub. Again, it's situational.

>> My understanding is that the type and extent of controls exercised is up
>> to the individual company, taking into account various conditions and
>> circumstances. "sending out a questionnaire (to be completed by the
>> supplier)" may be perfectly valid in certain situations.
>
>You are correct in that the vast majority of subcontractors can be qualified
>(at least initially) through the use of a questionnaire (to be completed by
>the supplier). This is acceptable for subcontractors providing a product
>whose quality can be verified at receiving inspection. However, one cannot
>verify that the detailed requirements of element 4.11 were met by performing a
>receiving inspection on calibrated equipment.

This is not strictly true. If a measurement assurance control chart is maintained on the equipment, it should show evidence of correct calibration, etc., but this is a quibble on my part. If you're doing measurement assurance, you certainly are sophisticated enough to have good controls on your cal suppliers.

> For example, receiving
>inspection cannot verify
>that the instrument was calibrated/checked against certified equipment
>having a known valid relationship to international or nationally recognized
>standards.
>(the calibration report may state that the calibration was performed using
>NIST traceable instruments - but how do we really know?

And you can't check every little thing your suppliers claim under other 9000 paragraphs either. Sure there are exceptions and improprieties, but why say 4.11 is special?

I've found
>instruments being used in calibration labs that are traceable to NIST through
>calibrations performed "decades" ago. Is that acceptable?

Depends. doesn't sound like a good idea but it's not contrary to the letter
of the definition of traceability, and at the cost of traceable calibrations these days it's not a bad idea to find other ways of maintaining your standards. I'm not advocating being sloppy or overly frugal, but rather keeping costs down by good metrology (as opposed to blindly and religiously following a tight cal schedule).

I've also found
>what is called a "calibration loop" in several calibration labs. This is
>where an instrument is used to calibrate another like instrument that is then
>used to calibrate the first instrument - the instruments are used tocalibrate
>each other. True traceability is lost as the error of each instrument
>accumulates in a never-ending cycle or loop.

If that's all you EVER do, it's risky, but if you check one or both of the instruments in a loop against other things - even the stream of unknowns coming through your regular cal load - you have some considerable insurance against systematic drift.

Even though I've never found an
>instrument being used in a calibration lab that lacked ALL traceability to
>NIST, I have heard stories of instances where this was found by others.)
>

Oh I found one, and it was the grand master for the most important measurement in the company. Its manufacturer refused to provide traceability for their calibrations. We replaced it with $75.00 worth of traceable standards and a bit of inspired measurement engineering. It's now in the front lobby in a glass case because it's so pretty.

>- that an acceptable calibration method was followed.
>(The calibration records may list the calibration procedure that was used, but
>is that calibration procedure acceptable to you? Does that procedure check
>ALL of the functions of the instrument - particularly the functions that you
>use? Not every calibration lab uses the manufacturer's calibration procedure.
>Many internally generated calibration procedures are greatly abbreviated from
>the manufacturer's procedure - taking short cuts to speed the calibration
>process. I like to compare the "Equipment Required" section of the
>calibration procedure with the actual listing of equipment used in performing
>the calibration. There are almost always substitutions made because the
>calibration lab does not own the exact equipment listed. At that point I like
>to have the calibration lab prove to me that the equipment used really was
>equivalent. Sometimes it is not.)
>

And sometimes you don't need a full calibration and are silly to pay for one. A metal stem thermometer used for monitoring a tank at 55 degrees was calibrated every 10 degrees from -40 to 250 at considerble cost. It's now only calibrated near the temperature required and placarded that it isn't calibrated outside of that range. Big savings by not slavishly following manufacturers recommendations. Better to use brains.

>- that the calibration subcontractor uses the same acceptance criteria that
>you use?
>(The calibration records may state that the instrument was found to be "in
>calibration" with the manufacturer's specifications, then again it may simply
>state that that the instrument was found to be "in calibration". When nothing
>else is stated then it is assumed that the instrument was found to meet the
>tolerances specified in the "calibration method" used. Some calibration labs
>change the tolerances of instruments in their internally generated
>"abbreviated" calibration procedures so they don't have to make adjustments.
>This may sound like business 101, but the more instruments that pass through a
>calibration lab - the more money they make. I've seen this situation in
>auditing calibration labs more than once.)
>

Practices such as these violate both the letter and the spirit of traceability. Every comparison in the chain must be supplied with a value that includes stated uncertainties. Just saying "in cal" can't be good enough.

>- that the calibration lab will notify the supplier if "their" instrumentation
>(measurement standards) are found to be out of tolerance, causing the
>calibration to be suspect.
>(Virtually all calibration quality system standards {e.g., MIL-STD 45662A,
>ANSI/NCSL Z540-1, ISO 10012-1} require the client to be notified if ANY
>instrumentation used in performing the calibration are later found to be out
>of tolerance. This means that every instrument used in a calibration lab must
>have a listing of every device it was used to calibrate since the last time it
>was calibrated. If ISO 9001/2, element 4.11 is invoked on a calibration lab,
>that means that this requirement must be met in order to satisfy 4.11.2f. How
>do we know that this requirement is being met without a site audit performed
>by someone? As you might well imagine, this requirement is costly for a
>calibration lab to comply with - some do not.)
>

Well this is correct except that if the cal lab is keeping control charts, all it needs to know is that its measurement process was in control when your equipment was calibrated. Then all they have to do is keep the charts - not a complete record of which instruments were used (although many do this too). The charts are a very quick indication of when things go wrong, so only a few recent customers need to be notified when there's a problem.

>- that the calibration was performed under suitable environmental conditions.
>(This requirement is most important for dimensional devices. The majority of
>calibration labs report the environmental conditions {temp/RH} on their
>calibration certificate or report. But is this information accurate? I was
>auditing a calibration lab in New York several years ago and noticed that the
>temperature was ALWAYS at 70 degrees F and the RH was ALWAYS at 35%. Upon
>touring their lab I saw no special considerations made to ensure that the
>environmental conditions stayed so constant. I asked a calibration technician
>how the environmental conditions stayed so stable and his response was that he
>didn't know, he had been trained to ALWAYS record the environmental conditions
>as being 70 degrees F and 35% RH. I asked the calibration lab manager why the
>calibration technicians had been instructed to always record the environmental
>conditions as being 70 degrees F and 35% RH. He responded that they had an
>environmental chart recorder in a building across the street and it almost
>always read 70 degrees F and 35% RH. )
>

This is the biggest joke and biggest source of confusion in all of 4.11. You don't have to maintain your environment, or even record it. All you have to do is to calculate the effect that different environmental conditions will have on your calibration and if those effects are negligible, neglect them. If you DO require environmental control, the instruments that measure the environment, such as your thermometer, had better be calibrated as well. This is a very frequent omission.

>After an auditor sees enough of the nonsense that "can" go on in a calibration
>lab, he starts to want "real" verification that the calibration subcontractor
>being used has been legitimately qualified.

This is overreaching by the auditor. It's the supplier that should be vigilant, and the auditor should validate the supplier's vigilance

>On the topic of whether the ISO 9001/2 allows a questionnaire to be used in
>qualifying a calibration subcontractor, ISO 9001/2, element 4.6.2b states (in
>part) that the type and extent of control exercised by the supplier over
>subcontractors shall be dependent upon the type of product (or service) and
>the impact of subcontracted product (or service) on the quality of the final
>product.
>
>Calibration has a significant impact on the final product

True...

>(otherwise you shouldn't be going to the expense of calibrating those instruments).

False... Most places calibrate because 9000 made them do it.

>Therefore the supplier should make a reasonable effort to ensure that the
>calibration subcontractor meets the requirements contained in ISO 9001/2
>element 4.11 or equivalent. Based on the discussion above, a questionnaire
>completed by the calibration lab is not a sufficient means of qualifying that
>calibration lab. The same can also be argued of a testing lab.
>
>Upon finding a company using a questionnaire completed by the calibration lab
>as a means for qualifying that subcontractor, I would issue a noncompliance
>with ISO 9001/2, element 4.6.2 (since I am concerned with requirements of both
>elements 4.6.2a and 4.6.2b being met). This is clearly a judgment call with
>respect to the standard - and is therefore arguable. But hopefully this
>rather lengthy e-mail explains the reasoning for why calibration
>subcontractors should be viewed differently than most other subcontractors
>when undergoing the qualification process.

And in the end, although there are many valid points here, I would disagree that calibration is anything 'special'. I think items such as segregation of nonconforming material are at least as 'special', and pretty soon we reach the conclusion that knowing your suppliers' processes more deeply than a questionnaire can do is a good idea all around.


Philip Stein Consultants in the Physical Sciences, Measurements, and Quality
National Director, American Society for Quality
Past Chair, ASQ Measurement Quality Division

Also - Check out:
http://www.ataindy.com,
http://www.metrology.org
http://www.hamvention.org

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Roger Eastin
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From:Greenville, SC
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posted 10 August 1998 08:27 AM     Click Here to See the Profile for Roger Eastin   Click Here to Email Roger Eastin     Edit/Delete Message   Reply w/Quote
Marc - this posting is good stuff. If anything points to the value of interaction, this is it! These folks obviously know their field and their critique of one another is extremely helpful for those of us with less experience. Thanks!

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Marc Smith
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posted 10 August 1998 11:34 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
This is stuff I 'steal' from the jennejohn listserve. You too can subscribe! I get a daily (actually nightly) summary. There is a QS9000 listserve but it pretty much sucks.

Yeah - I try to pick out some interesting stuff. Helps me think...

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Janie
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Posts: 11
From:Wellman, IA, USA
Registered: Aug 98

posted 26 August 1998 07:54 PM     Click Here to See the Profile for Janie   Click Here to Email Janie     Edit/Delete Message   Reply w/Quote
Help! In reply to our auditor's question of how we qualify our outside suppliers of calibration, our Mgmt Rep responded that we would either have them provide proof of ISO certification, we would do an on-site audit, or, we would accept proof of their A2LA accredidation, etc.. I feel as if we may have painted ourselves into a corner here. What other means are acceptable to qualify these folks?

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Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA
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posted 27 August 1998 07:02 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Janie,

I'm going to close this thread and start another with your name and your question. This thread is getting pretty long and I think we may get better response.

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