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  Difficulties Complying to 4.11

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Author Topic:   Difficulties Complying to 4.11
Weyli
Lurker (<10 Posts)

Posts: 5
From:Kulim, Kedah, Malaysia
Registered: Aug 1999

posted 03 August 1999 12:16 AM     Click Here to See the Profile for Weyli     Edit/Delete Message   Reply w/Quote
Hi,
We have just gone through our 1st ISO9002 surveillance audit. During which the auditor found out that we are still not fully comply with 4.11.

NCs and observations given are that we have not done the below:-

1. Calibration Report does not contain before and after calibration data.
Q: What if during the initial performance test, result shows it is within spec., therefore no adjustment is made, therefore no after calibration data is indicated in the report. Is this acceptable?
(Note: all our calibration vendors are G25 certified)

2. Calibration Report does not contain Tracebility info to National or International standards. The cal report states only the national / international agency that the calibration standard is traceable to, but the auditor was looking for the actual standard (ie, info including the serial number etc) that is used by the international agency to calibrate the calibration standard used by my calibration vendor.
Q oes the calibration report needs to be this detail?

3. Q:How to determine the calibration frequency of IMTE? The auditor told me that through time, from the differences between the before and after calibration data collected, I can determine the calibration frequency for the IMTE. How do I go about doing that? Is there any standard formula that I can use?

4. We did not specify the environmental conditions to calibrate our IMTE in.
Q o I need to give instructions to the external calibration vendor to calibrate the IMTE in the environment conditions exactly the same as the environment we use the IMTE in? Let say the multimeter is used in between 40degC 80% to -10degC 40%, does the multimeter needs to be calibrated in these conditions? Our practice is only calibrate the IMTE at room temperature because this is the most frequent condition the IMTE is used in.

5. We should separate the IMTE master list 'Calibration Required' category into 'Calibration Required' and 'Verification Needed'. Reason given is take a Block Gage for example, when I send out for calibration it is actually sent out for 'verification'. Q:Is this separate tracking list a common practice?

6. Q:For 4.11.2(f), how to determine how much data I need to refer back if a certain IMTE is out of cal?
What exactly do I need to do to fully comply with this item?

Thank you for taking time to read this long posting. Any suggestions will be appreciated.

Weyli

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Lassitude
Forum Contributor

Posts: 89
From:
Registered: Jun 99

posted 03 August 1999 11:33 AM     Click Here to See the Profile for Lassitude   Click Here to Email Lassitude     Edit/Delete Message   Reply w/Quote
quote:
1. Calibration Report does not contain before and after calibration data.
Q: What if during the initial performance test, result shows it is within spec., therefore no adjustment is made, therefore no after calibration data is indicated in the report. Is this acceptable?
(Note: all our calibration vendors are G25 certified)
Please define initial performance spec.

I will comment on each of the other questions however it sounds as if no one at your facility has a good grasp of calibration. You need before and after data to assess the instrument over time.

quote:
2. Calibration Report does not contain Tracebility info to National or International standards. The cal report states only the national / international agency that the calibration standard is traceable to, but the auditor was looking for the actual standard (ie, info including the serial number etc) that is used by the international agency to calibrate the calibration standard used by my calibration vendor.
Q Does the calibration report needs to be this detail?
At the very least you should be ready to call the lab that does your calibrations to get them to FAX you that information. I see this one go both ways - some auditors want it on the cal cert while others will give you a bit more slack. This should not be a problem for your cal lab anyway, so requesting it should not be a problem.
quote:
3. Q:How to determine the calibration frequency of IMTE? The auditor told me that through time, from the differences between the before and after calibration data collected, I can determine the calibration frequency for the IMTE. How do I go about doing that? Is there any standard formula that I can use?
There is no formula per se. This is in part why you want before and after calibration data. Calibration cycle is determined by many things: Frequency of use, calibration results (history), manufacturers recommendation, etc. Here again, the issue is having someone who understands measurement systems. Looks like you're in for an education.

quote:
4. We did not specify the environmental conditions to calibrate our IMTE in.
Q Do I need to give instructions to the external calibration vendor to calibrate the IMTE in the environment conditions exactly the same as the environment we use the IMTE in? Let say the multimeter is used in between 40degC 80% to -10degC 40%, does the multimeter needs to be calibrated in these conditions? Our practice is only calibrate the IMTE at room temperature because this is the most frequent condition the IMTE is used in.
Again, understanding of measurement systems and devices comes into play. Typically an instrument is calibrated at room ambient temp and humidity, but you have to be able to discuss what is done and why. In your example, the question becomes does is your multimeter linear and without bias from -10C to 40C? Check the manual which came with it. Use the manufacturers accuracy statement for uncertainty (+/- x volts or whatever at y degrees F). Typically there will be no significant bias between say 40F and 120F but you should be ready to state that and how you know that. State that you want it calibrated at room ambient.

quote:
5. We should separate the IMTE master list 'Calibration Required' category into 'Calibration Required' and 'Verification Needed'. Reason given is take a Block Gage for example, when I send out for calibration it is actually sent out for 'verification'. Q:Is this separate tracking list a common practice?
This horse shit and rhetoric. All you have to do is recognize what is calibratable and what is not. I personally have never seen two lists but I've never gotten into a fight over calibration vs verification. In part because most 'calibrations' are nothing more than verifications even when the equipment is calibratable. If you have a calipers you do not really send it for calibration - you send it for verification. It may not need to be calibrated - or it may. By default, you should expect the device to be in calibration when it goes in for 'verification of calibration status'.

If you are calibrating an instrument every time it is in for 'verification of calibration status', you have a problem. Shorter cal cycle may be the answer, a sturdier instrument may be the answer, but other than fixtures you should not see many actual calibrations. The expectation is you will send it for verification of calibtration status and then, if it is out of calibration, it is evaluated (Is it broken? Is it worn out? Is it used to harshly? Etc.) for a solution. Calibrate it? Repair it? Buy a more appropriate device? Shorten calibration cycle? This person is using semantics and, to be honest, you need to learn MSA fundamentals so you can 'fight'. Two lists? Bah! It's pretty basic knowing what can be calibrated and what cannot.

quote:
6. Q:For 4.11.2(f), how to determine how much data I need to refer back if a certain IMTE is out of cal? What exactly do I need to do to fully comply with this item?
You have to understand containment. Do a search here in the forums for CONTAINMENT and then come back and ask more questions after you read through a few hits.

Also see:
https://elsmar.com/ubb/Forum4/HTML/000012.html
and https://elsmar.com/ubb/Forum4/HTML/000002.html

[This message has been edited by Marc Smith (edited 03 August 1999).]

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TheOtherMe
Forum Contributor

Posts: 64
From:West Chester, OH USA
Registered: Jul 1999

posted 04 August 1999 03:46 AM     Click Here to See the Profile for TheOtherMe   Click Here to Email TheOtherMe     Edit/Delete Message   Reply w/Quote
Variations on the theme:

Subject: Re: Q: Compliance to 4.11 /Li/Stein
Date: Tue, 3 Aug 1999 11:18:26 -0600
From: ISO Standards Discussion

From: Philip Stein
Subject: Re: Q: Compliance to 4.11 /Li/Stein

>From: Neoh Wey Li
>Subject: Q: Compliance to 4.11 /Li
>
>Hi,
>We have just gone through our 1st ISO9002 surveillance audit. During
>which the auditor found out that we still do not fully comply with
>4.11.
>
> NCs and observations given are that we have not done the below:-
>1. Acceptance criteria for after calibrated IMTE is not specified. (ie,
>when the IMTE came back from calibration, based on what criteria we use
>to determine the IMTE is good). As the vendor calibrates based on the
>manufacturer's manual, what I did was to rely on the vendors
>calibration results. If the report says pass then I would assume the
>IMTE is in good condition after calibration, if it fails, then I would
>send it for repair then re-calibrate. Is this not adequate?

This is a mysterious requirement from your assessor. You must verify that your calibration vendor is acceptable, either because they are accredited to Guide 25, or because you audit them, or something, but there is NO requirement that you re-inspect IMTE when it is returned from service/calibration. How would you know how to do that? - you sent it out because you don't have the facilities or capability of doing it in-house.

>
>2. Calibration Report does not contain before and after calibration
>data. What if during the initial performance test, result shows it is
>within spec., therefore no adjustment is made, therefore no after
>calibration data is indicated in the report. Is this acceptable?

Yes and no. It is best to have the data. A traceable calibration has both a numerical value and a statement of its uncertainty. It would be good to have the actual number determined by the cal lab.

>
>3. Calibration Report does not contain Tracebility info to National or
>International standards. The cal report states only the national /
>international agency that the calibration standard is traceable to, but
>the auditor was looking for the actual standard (ie, info including the
>serial number etc) that is used by the international agency to calibrate
>the calibration standard used by my calibration vendor. Does the
>calibration report need to be this detailed?

The assessor is overreaching. There is no requirement beyond a statement of traceability and the aforementioned data value and uncertainty value.

>
>4. How to determine the calibration frequency of IMTE? The auditor told
>me that through time, from the differences between the before and after
>calibration data collected, I can determine the calibration frequency
>for the IMTE. How do I go about doing that? Is there any standard
>formula that I can use?

See national Conference of Standards Laboratories procedure RP-1. http://www.ncsl-hq.org

>
>5. We did not specify the environmental conditions to calibrate our IMTE
>in. Do I need to give instructions to the external calibration vendor to
>calibrate the IMTE at the environment conditions exactly the same as the
>environment we use the IMTE in? Let's say the multimeter is used in
>between 40degC 80% to 10degC 40%, does the multimeter need to be
>calibrated in these conditions? Our practice is only to calibrate the IMTE
>at room temperature because this is the most frequent condition the IMTE
>is used in.
>

You must calculate or have measured for you the performance of the instrument over all expected environmental conditions. Usually, you can refer to the manufacturer's specifications for extended ranges of environment and then calibrate at one temperature, but you must have a statement in your procedures that indicates that an evaluation of instrument performance at all expected temperatures has been done and shown to have negligible effect on your results at the required level of accuracy.


>6. We should separate the IMTE master list Calibration Required
>category into Calibration Required and Verification needed.
>Reason given is take a Block Gage for example, when I send out for calibration
>it is actually sent out for verification. Is this separate list a
>common practice?

No.

>
>7. Lastly, for 4.11.2(f), how to determine how much data I need to refer
>back if a certain IMTE is out of cal? What exactly do I need to do to
>fully comply with this item?

You must have a written procedure that says what you will do, and then you must do it. There are no requirements as to what must be done.

Philip Stein

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TheOtherMe
Forum Contributor

Posts: 64
From:West Chester, OH USA
Registered: Jul 1999

posted 04 August 1999 03:50 AM     Click Here to See the Profile for TheOtherMe   Click Here to Email TheOtherMe     Edit/Delete Message   Reply w/Quote
Subject: Re: Compliance to 4.11 /Li/Sugiarto
Date: Tue, 3 Aug 1999 12:45:18 -0600
From: ISO Standards Discussion

From: Welly Sugiarto
Subject: RE: Compliance to 4.11 /Li/Sugiarto

> NCs and observations given are that we have not done the below:-
> 1. Acceptance criteria for after calibrated IMTE is not specified. (ie,
> when the IMTE came back from calibration, based on what criteria we use
> to determine the IMTE is good). As the vendor calibrates based on the
> manufacturer's manual, what I did was to rely on the vendors
> calibration results. If the report says pass then I would assume the
> IMTE is in good condition after calibration, if it fails, then I would
> send it for repair then re-calibrate. Is this not adequate?
>

One problem on relying with calibration vendor's conclusion is that they may not use the same standard as you are. Sometime this can work against your advantage. For example, you may use a caliper to measure your product, the range of measurement is from 5cm - 10cm. With tolerance of 1 mm. Your calibration vendor may measure your caliper according to manuf. specification (which is much more stringent than what you use it for) and conclude that the caliper is out of spec, whereas in your case, the caliper is perfectly acceptable to be used.

I have an experience in calibrating weighing instrument, the calibration body says the equipment is ok, however when we cross check to their data we found that the equipment has 4% deviation which is not acceptable.

Hence, relying on calibration vendor may not be a good idea. They can make mistake, too. After all, you are the one using the equipment, not them (calibration vendor)

> 2. Calibration Report does not contain before and after calibration
> data. What if during the initial performance test, result shows it is
> within spec., therefore no adjustment is made, therefore no after
> calibration data is indicated in the report. Is this acceptable?
>
It is always a good idea to get actual calibration data, the data can be useful for the following reasons:

1. Data can indicate whether the instrument is out of calibration or not prior to adjustment. Thus, you can then go back to your inspection record to make sure that your previous inspection (using this instrument)is valid. (4.11.2f)

2. Data can indicate if the calibration is performed accordingly. I had an experience in assiting my client to calibrate a thermometer, when we received the thermometer back we were quite surprise, because the data indicate that the calibration vendor only check the range of temperature around room temperature, whereas we also use it for our refrigerator (around freezing temperature). Our PO clearly states the range the thermometer is used for. Again, calibration vendors can make a mistake.

3. Data can indicate more precisely what range of measurement your instrument has problem. One time, we received a calibration result in which the data showed the instrument was not precise for a specific range but ok on the others, so we still use the instrument but put a warning not to use it on a certain range.

I think, you have a right to ask for calibration data, if your vendor can't give you one, I think you better look for someone else. Believe me, having the actual data is to your advantages.

> 3. Calibration Report does not contain Tracebility info to National or
> International standards. The cal report states only the national /
> international agency that the calibration standard is traceable to, but
> the auditor was looking for the actual standard (ie, info including the
> serial number etc) that is used by the international agency to calibrate
> the calibration standard used by my calibration vendor. Does the
> calibration report need to be this detailed?
>
I think asking your calibration vendor the actual standard no., to make sure the statement is not merely a "standard statement"

> 4. How to determine the calibration frequency of IMTE? The auditor told
> me that through time, from the differences between the before and after
> calibration data collected, I can determine the calibration frequency
> for the IMTE. How do I go about doing that? Is there any standard
> formula that I can use?

Refer to ISO 10012-1:1992 Annex A: Guidelines for determination of confirmation intervals for measuring equipment
>
> 5. We did not specify the environmental conditions to calibrate our IMTE
> in. Do I need to give instructions to the external calibration vendor to
> calibrate the IMTE at the environment conditions exactly the same as the
> environment we use the IMTE in? Let's say the multimeter is used in
> between 40degC 80% to 10degC 40%, does the multimeter need to be
> calibrated in these conditions? Our practice is only to calibrate the IMTE
> at room temperature because this is the most frequent condition the IMTE
> is used in.
>
The measuring equipment needs to be calibrated in environment specifies in the national/international standard for traceability purposes. For example, we have a block gage for calibrating a caliper. The gage is valid to be used in temperature of x degree centigrade (based on international standard), if you calibrate it in a room in which the temperature is siginificantly higher than x degree centigrade, the block gage can "expand" hence it is no longer valid to be used as a standard. What environmental factors need to be considered depends on the equipment itself, for block gage, temperature is a very important factor, for electronic equipment (such as multimeter), electric statics is important. Your national/international standard for calibration should specify the environmental factor to be considered.

> 6. We should separate the IMTE master list Calibration Required
> category into Calibration Required and Verification needed.
> Reason given is take a Block Gage for example, when I send out for calibration
> it is actually sent out for verification. Is this separate list a
> common practice?
>
I don't think it is necessary. You can, for example, specify in your procedure differents actions to be done if the instrument can't be adjusted (in case of verification) and actions to be done if insturment is adjustable.

> 7. Lastly, for 4.11.2(f), how to determine how much data I need to refer
> back if a certain IMTE is out of cal? What exactly do I need to do to
> fully comply with this item?
>
The thing is, most of the time, you never know when your equipment is out of spec. You only know that your equipment was "ok" last time you calibrated it. The equipment can fall out of spec any time in between. The longer the calibration interval, the longer the period you need to re-inspect your product. (You only need to inspect it based on sampling , no need 100%, make sure to check it from the most recent.. if you can be assured that the most recent inspection using that equipment is "ok", you probably don't need to check all previous inspection data). The important thing to consider is RISK, since your measuring equipment is out of spec, what are the risks? Is there any other inspection further down the process that can still "catch" NC product? what effect is a non-accurate measurement to your overall product performance? The more severe the effect (for example: impact to health and safety), the more stringent your re-inspection method should be.

> Thank you for taking time to read this long posting. Any suggestions are
> appreciated.

Welly

If you need more information, please do not hestitate to contact me directly at: well@u.washington.edu I used to work as an ISO 9000 consultant for several years before coming back to school pursuing my MBA/MSE degree

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TheOtherMe
Forum Contributor

Posts: 64
From:West Chester, OH USA
Registered: Jul 1999

posted 07 August 1999 09:15 AM     Click Here to See the Profile for TheOtherMe   Click Here to Email TheOtherMe     Edit/Delete Message   Reply w/Quote
The voice of 1 more expert:

Subject: Re: Q: Compliance to 4.11 /Li/Andrews
Date: Wed, 4 Aug 1999 12:41:35 -0600
From: ISO Standards Discussion

From: eandrews@usffiltration.com
Subject: Re: Q: Compliance to 4.11 /Li/Andrews

>WL Neoh's inquiry and my responses;
>"We have just gone through our 1st ISO9002 surveillance audit. During
>which the auditor found out that we still do not fully comply with 4.11.

>NCs and observations given are that we have not done the below:-
>1. Acceptance criteria for after calibrated IMTE is not specified. (ie,
>when the IMTE came back from calibration, based on what criteria we use
>to determine the IMTE is good). As the vendor calibrates based on the
>manufacturer's manual, what I did was to rely on the vendors
>calibration results. If the report says pass then I would assume the
>IMTE is in good condition after calibration, if it fails, then I would
>send it for repair then re-calibrate. Is this not adequate?"

Response #1 - Acceptance criteria needs to be stated; however, it may be stated exactly as you did above. That is acceptable - provided that is what you do and what works for you.

>"2. Calibration Report does not contain before and after calibration
>data. What if during the initial performance test, result shows it is
>within spec., therefore no adjustment is made, therefore no after
>calibration data is indicated in the report. Is this acceptable?"

Response #2 - The calibration reports need to show the before and after conditions. If no adjustments were made it should indicate such.

>"3. Calibration Report does not contain Tracebility info to National or
>International standards. The cal report states only the national /
>international agency that the calibration standard is traceable to, but
>the auditor was looking for the actual standard (ie, info including the
>serial number etc) that is used by the international agency to calibrate
>the calibration standard used by my calibration vendor. Does the
>calibration report need to be this detailed?"

Response #3 - No it does not. If the auditor wishes that information they may contact your calibration lab. The lab should have that information (you may wish to verify that they indeed do).

>"4. How to determine the calibration frequency of IMTE? The auditor told
>me that through time, from the differences between the before and after
>calibration data collected, I can determine the calibration frequency
>for the IMTE. How do I go about doing that? Is there any standard
>formula that I can use?"

Response #4 - This is not required by ISO 9001 or ISO 9002. It is only required that you calibrate the equipment at regular intervals - how you arrive at those intervals is up to you.

>5. We did not specify the environmental conditions to calibrate our IMTE
>in. Do I need to give instructions to the external calibration vendor to
>calibrate the IMTE at the environment conditions exactly the same as the
>environment we use the IMTE in? Let's say the multimeter is used in
>between 40degC 80% to 10degC 40%, does the multimeter need to be
>calibrated in these conditions? Our practice is only to calibrate the IMTE
>at room temperature because this is the most frequent condition the IMTE
>is used in.

Response #5 - Calibration houses usually calibrate equipment at set environmental conditions (eg; 68 deg. F at 40-60% rel. h). Unless you are doing very close tolerance work this method of calibration is adequate. If all of your calibration work is outsourced, a sentence stating that the calibration environment utilized by your calibration house is an acceptable environment is sufficient. If you do some in-house calibration work another statement about acceptable room temperature and humidity ranges is sufficient (just make sure that you have a (calibrated) instrument to verify the conditions).

>6. We should separate the IMTE master list Calibration Required
>category into Calibration Required and Verification needed.
>Reason given is take a Block Gage for example, when I send out for calibration
>it is actually sent out for verification. Is this separate list a
>common practice?

Response #6 - He/She is off on this one. Ask for where that is required by 4.11 of ISO 9002. Calibration/Verification - the debate between the usage of the two words can be quite protracted (see list archives ); however, there is no requirement for a separation of the two groupings. As for your gage blocks - you indeed send them out for calibration and you probably receive a 'Calibration Certificate' in return - I doubt that you receive a "Verification Certificate".

>7. Lastly, for 4.11.2(f), how to determine how much data I need to refer
>back if a certain IMTE is out of cal? What exactly do I need to do to
>fully comply with this item?"

Response #7 - This is a tough one. Unless you have a system that allows for part/tool traceability you are going to have a tough time figuring out EXACTLY what parts were inspected with what instrument. You do need to have defined some system for verifying the previous inspection results - to the "greatest practical extent". This one will require some thought on your end.

WL - from the overall tone of the above items it seems that the auditor brought up some valid points; however, there are also a number of items where he/she was off the mark and perhaps was interjecting their own bias into the audit.

Hope my responses are somewhat useful. I'm sure you will receive others from the list members and perhaps all together will provide some useful insights.

Good Luck,

Ethan Andrews
eandrews@usffiltration.com

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Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA
Registered:

posted 14 August 1999 06:58 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
Subject: Re: Q: Compliance to 4.11 /Li/Randall
Date: Mon, 9 Aug 1999 11:49:41 -0600
From: ISO Standards Discussion

From: RCR9000@aol.com
Subject: Re: Q: Compliance to 4.11 /Li/Randall

> From: Neoh Wey Li
> Subject: Q: Compliance to 4.11 /Li
>
> Hi,
> We have just gone through our 1st ISO9002 surveillance audit. During
> which the auditor found out that we still do not fully comply with
> 4.11.
>
> NCs and observations given are that we have not done the below:-
> 1. Acceptance criteria for after calibrated IMTE is not specified. (ie,
> when the IMTE came back from calibration, based on what criteria we use
> to determine the IMTE is good). As the vendor calibrates based on the
> manufacturer's manual, what I did was to rely on the vendors
> calibration results. If the report says pass then I would assume the
> IMTE is in good condition after calibration, if it fails, then I would
> send it for repair then re-calibrate. Is this not adequate?

Did you document the above explanation in your procedure(s)? If not, then your auditor may have a valid point.

While there is no specific requirement for you to inspect your IM&TE upon return, you must still examine the calibration report to determine whether the IM&TE was found in or out of tolerance.

> 2. Calibration Report does not contain before and after calibration
> data. What if during the initial performance test, result shows it is
> within spec., therefore no adjustment is made, therefore no after
> calibration data is indicated in the report. Is this acceptable?

The calibration report must include the calibration "results" (not necessarily before and after "point" data). If the initial performance test found the instrument within spec., then it should say so (this is required by most calibration quality system standards).

> 3. Calibration Report does not contain Traceability info to National or
> International standards. The cal report states only the national /
> international agency that the calibration standard is traceable to, but
> the auditor was looking for the actual standard (ie, info including the
> serial number , etc.) that is used by the international agency to calibrate
> the calibration standard used by my calibration vendor. Does the
> calibration report need to be this detailed?

The calibration report is not required to contain any more than a statement of traceability. Your calibration subcontractor should maintain a "record of use" for each instrument calibrated (provided that a calibration quality system standard was invoked). The "record of use" will provide detailed evidence of traceability (one assumes that you verified this when you qualified the calibration subcontractor).


> 4. How to determine the calibration frequency of IMTE? The auditor told
> me that through time, from the differences between the before and after
> calibration data collected, I can determine the calibration frequency
> for the IMTE. How do I go about doing that? Is there any standard
> formula that I can use?

If you have a large enough sample size you can statistically monitor the number (or percentage) of instruments of a given type that are found in tolerance (2 sigma is typical depending upon the critical nature of the measurements made).

The calibration industry will refer to this a K factor.

As does Mr. Stein, I also would refer you to NCSL RP-1.

> 5. We did not specify the environmental conditions to calibrate our IMTE
> in. Do I need to give instructions to the external calibration vendor to
> calibrate the IMTE at the environment conditions exactly the same as the
> environment we use the IMTE in? Let's say the multimeter is used in
> between 40degC 80% to 10degC 40%, does the multimeter need to be
> calibrated in these conditions? Our practice is only to calibrate the IMTE
> at room temperature because this is the most frequent condition the IMTE
> is used in.

Most calibration reports include the environmental conditions at the time of calibration -- however, most electronic instrumentation is not significantly affected by typical factory floor temperature variations. Dimensional tools on the other hand can is affected by temperature which can be compensated for through "correction factors" (as Mr. Sugiarto points out).

> 6. We should separate the IMTE master list Calibration Required
> category into Calibration Required and Verification needed.
> Reason given is take a Block Gage for example, when I send out for
> calibration it is actually sent out for verification. Is this separate
> list a common practice?

In my experience it is not a common practice to separate these devices into separate lists.

> 7. Lastly, for 4.11.2(f), how to determine how much data I need to refer
> back if a certain IMTE is out of cal? What exactly do I need to do to
> fully comply with this item?

The standard does not dictate "how" you must comply with this element.

What is the worse thing that can happen if defective product leaves your facility? If a safety related issue could arise, then I would say that you should have complete traceability OR take additional measures to mitigate this possibility (e.g., maintaining a 4:1 or greater test accuracy ratio between you IM&TE and product being measured). One would assume that in this situation there would be requirements for traceability and recall of defective product should the need arise.

However, if you're manufacturing small electronics or film for commercial use (and no one is going to die or be injured) then I would perform an impact analysis only (since no traceability is required). In other words, the impact analysis would tell the auditor that defective product "may" have left the facility, but you're not going to do anything about it -- other than perhaps adjust the calibration interval of the instrument (but even this is not required).

Where traceability is not utilized, this requirement (4.11.2f) often becomes little more than a paperwork exercise.

Overall, the best suggestion that I can make is for you to (1) make sure that your calibration subcontractor knows what they're doing (a lot of them don't). Really qualify the calibration lab -- invoke ISO 25 or ANSI/NCSL Z540-1. If possible, try to use a calibration lab that is either accredited to ISO 25 (by NVLAP, A2LA or NQA-USA) or at least ISO 9000 registered. (2) After you're satisfied with the qualifications of your cal lab, call your calibration subcontractor and talk about your calibration program. Most will be willing to help you develop your in-house program because they know that you will come to rely on them for all of your calibration needs. Allow them to work with your people to setup your calibration recall system. If they know their business, they should certainly know how to address calibration recall!

BTW, I noticed that a couple of respondents mentioned ISO 10012-1. It is my understanding that this standard is scheduled to be canceled when ISO 17025 replaces ISO Guide 25 (later this year).

I hope that this helps,

Richard C. Randall

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Marc Smith
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posted 14 August 1999 07:00 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
From: Carlos Pereira da Cruz
Subject: Re: Q: Compliance to 4.11 /Li/Randall/Cruz


>BTW, I noticed that a couple of respondents mentioned ISO 10012-1. It is my
>understanding that this standard is scheduled to be canceled when ISO 17025
>replaces ISO Guide 25 (later this year).
>

ISO 10012-1 will stand, ISO 17025 wil replace EN 45001

Carlos

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Weyli
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posted 17 September 1999 03:10 AM     Click Here to See the Profile for Weyli     Edit/Delete Message   Reply w/Quote
Hi all,

Thank you for providing me with very helpful information.

I got to know from one of our calibration vendors that according to ISO/IEC G25, Accuracy is not required to be included in a calibration report. In ISO10012 -1, 4.8 also does not state Accuracy as one of the items required in cal reports.
Only uncertainty is required.

Does this mean I can set my own acceptance criteria for after cal IMTE (4.11.2(C)) and not neccessary to include Accuracy as acceptance criteria as long as Uncertainty is stated(4.11.1)?

And ISO10012-1 4.8(f) "the designated limits of permissible error". How do I interpret this?

Thank you very much.
Wey Li

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Marc Smith
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posted 21 September 1999 11:43 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
quote:
In ISO10012 -1, 4.8 also does not state Accuracy as one of the items required in cal reports. Only uncertainty is required.

Does this mean I can set my own acceptance criteria for after cal IMTE (4.11.2(C)) and not neccessary to include Accuracy as acceptance criteria as long as Uncertainty is stated(4.11.1)?


Sounds like it to me.

quote:
And ISO10012-1 4.8(f) "the designated limits of permissible error". How do I interpret this?
I don't have 10012-1 here and I hate to comment out of context. If I can dig up a copy in the next day or two I'll get back on this. Or if you want to post more of 4.8 so I can see the context.

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Weyli
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posted 22 September 1999 06:37 PM     Click Here to See the Profile for Weyli     Edit/Delete Message   Reply w/Quote
Hi Marc,
Thank for the reply.

ISO10012-1
4.8 Records
The supplier shall maintain records of the make, type and serial no. of all relevant measuring equipment (including measurement standards). This records shall demonstrate the measurement capability of each item of measuring capability of each item of measuring equipment. Any calibration certificates and other relevant information concerning its functioning shall be available.

Calibration results shall be recorded in sufficient detail so that that the traceability of all the measurement can be reproduced under conditions close to the original conditions, thereby facilitating the resolution of any anomalies.

The recorded information shall include:
a) (IMTE ID)
b) (calibration date)
c) ( before and after cal data)
d) (cal interval)
e) (cal procedure)
f) the designated limits of permissible error
g) (traceability)
h) (environment condition, corrections)
i) (uncertainty)
j) (detais of maintanence done)
k) Any limititions in use
l) (person calibrate the IMTE)
m) (person ensuring correctness of cert info)
n) (cal cert ID number)

Thanks.
Weyli


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Marc Smith
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posted 23 September 1999 08:18 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
You've got me there. Do you have a calibration cert you can look at?

f) the designated limits of permissible error
i) (uncertainty)

These are the 2 issues. Sorry I can't help further. We need an expert here.

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Weyli
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posted 23 September 1999 09:58 PM     Click Here to See the Profile for Weyli     Edit/Delete Message   Reply w/Quote
I have a cal cert of 25.000mm ring gage.

The cert states,
Instrument Error:
Nominal value = 25mm
Measured value = 25.0002mm
Correction = -0.0002mm

(I wonder this is the permissible error that the guide is refering to? Or is this the accuracy of the gage?)

And the uncertainty is +/- 0.0001mm at 95% confidence level.

Weyli

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Marc Smith
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posted 24 September 1999 02:57 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
I believe that's it.

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