Equipment Owner's Manual used for Calibration - Is it uncontrolled procedure?

C

Chance

#1
Hi,

We are audited for ISO certification and one finding that the auditor found is that we calibrate some of our equipment (internally) following the owner's manual - uncontrolled procedure.

Question: should I document (re-inventing the will) that owner's manual to make it controlled? Or should I create one generic procedure that talks about calbration and specify to calibrate X equipment, follow the X equipment owner's manual.

Thanks for all your help.
 
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D

Duke Okes

#2
Re: Owner's Manual - is it uncontrolled procedure?

I would just put the manual under some minimum level of document control, such as labeling it, having a specific location for it, and having it on controlled document list.
 

apestate

Quite Involved in Discussions
#3
Manufacturer's recommendations for calibrating equipment are usually ultra thread-bare.

I wanted to post to remind that the calibration procedure must check the instrument throughout its range. If it's a four way dial caliper, that means at least one measurement on all four surfaces, one at zero, and one at the top of the range.

However, the biggest dial caliper error is probably the dial hand indicated reading at 0, 90 degrees, 180, and 270 degrees.

Now we're starting to create a more and more valid calibration procedure.

I know, off topic.
 
D

Duke Okes

#4
Manufacturer's recommendations for calibrating equipment are usually ultra thread-bare.
I wanted to post to remind that the calibration procedure must check the instrument throughout its range. If it's a four way dial caliper, that means at least one measurement on all four surfaces, one at zero, and one at the top of the range.
However, the biggest dial caliper error is probably the dial hand indicated reading at 0, 90 degrees, 180, and 270 degrees.
Now we're starting to create a more and more valid calibration procedure.
I know, off topic.
Actually not off topic at all. This is a good recommendation ... replace the equipment manual with an internally developed calibration procedure. This allows it to be more specific to the applications for which the device is used by the company. And it would eliminate the need to control the manual.
 
#5
Manufacturer's recommendations for calibrating equipment are usually ultra thread-bare.

I wanted to post to remind that the calibration procedure must check the instrument throughout its range. If it's a four way dial caliper, that means at least one measurement on all four surfaces, one at zero, and one at the top of the range.
Now we're starting to create a more and more valid calibration procedure.
I'm not sure I agree. It's very much dependent on the manufacturer. It's OK to develop your own, but you have to start out knowing more than simply deciding to do it yourself...

Incidentally, doing a calibration of a caliper at zero and at maximum, isn't much of a calibration...and doesn't indicate if there's been any wear and therefore won't detect any linearity issues which might be present. See what I mean about developing your own procedures?

There are plenty of well established procedures for basic equipment available, particularly at GIDEP.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#6
We are audited for ISO certification and one finding that the auditor found is that we calibrate some of our equipment (internally) following the owner's manual - uncontrolled procedure.

Question: should I document (re-inventing the will) that owner's manual to make it controlled? Or should I create one generic procedure that talks about calbration and specify to calibrate X equipment, follow the X equipment owner's manual.
Neither. The manual is a document of external origin. Control it as such.
 
J
#7
Hi,

We are audited for ISO certification and one finding that the auditor found is that we calibrate some of our equipment (internally) following the owner's manual - uncontrolled procedure.

Question: should I document (re-inventing the will) that owner's manual to make it controlled? Or should I create one generic procedure that talks about calbration and specify to calibrate X equipment, follow the X equipment owner's manual.

Thanks for all your help.
It might depend too on what the equipment is that is being calibrated "per the owners manual".

Certainly in the case of fairly simple tools and equipment regular procedures should be generated that provide adequate assurance based on the usage of the tool.
Where more complicated equipment is involved, the owners manual may be the best route. In this case it would be best to "control" the manual.
It is probably easier to write something to control the manual than to write a new and complex calibration procedure.

Peace
James
 

apestate

Quite Involved in Discussions
#8
I'm not sure I agree. It's very much dependent on the manufacturer. It's OK to develop your own, but you have to start out knowing more than simply deciding to do it yourself...

Incidentally, doing a calibration of a caliper at zero and at maximum, isn't much of a calibration...
Oh, I agree. Building up a valid procedure only starts at zero and max. The next step is the 4 quadrants indicator reading of a dial caliper check. Then you might consider taking readings on a .100 gage block along the OD jaws to look for wear and tippy tips bent in.

Take a good dial caliper and see what you get at .100, .125, .150, and .175". I have never seen a calibration procedure from Mitutoyo or in GIDEP (our company recently approved as a member :D ) that tells you to check the indicator this way.

I've never heard of a cal lab checking a caliper in this way.

I was in an accredited cal lab that checks a ring gage at 2 or 3 points using a super micrometer. Out of roundness is not checked.

They check pitch diameter of thread rings the same way using two gaging spheres and a super micrometer, because they don't have every single setting plug.

Just because the calibration procedure is approved somewhere doesn't necessarily mean it is good enough. I don't really feel confidence in the calibration procedures that I've seen from ALL sources.

errr how to link this with document control... somehow...



4.2.1 d) documents needed by the organization to ensure the effective planning, operation and control of its processes,

4.2.3 a) to approve documents for adequacy prior to issue,

:>
 
J
#9
Oh, I agree. Building up a valid procedure only starts at zero and max. The next step is the 4 quadrants indicator reading of a dial caliper check. Then you might consider taking readings on a .100 gage block along the OD jaws to look for wear and tippy tips bent in.

Take a good dial caliper and see what you get at .100, .125, .150, and .175". I have never seen a calibration procedure from Mitutoyo or in GIDEP (our company recently approved as a member :D ) that tells you to check the indicator this way.

I've never heard of a cal lab checking a caliper in this way.

I was in an accredited cal lab that checks a ring gage at 2 or 3 points using a super micrometer. Out of roundness is not checked.

They check pitch diameter of thread rings the same way using two gaging spheres and a super micrometer, because they don't have every single setting plug.

Just because the calibration procedure is approved somewhere doesn't necessarily mean it is good enough. I don't really feel confidence in the calibration procedures that I've seen from ALL sources.

errr how to link this with document control... somehow...



4.2.1 d) documents needed by the organization to ensure the effective planning, operation and control of its processes,

4.2.3 a) to approve documents for adequacy prior to issue,

:>
Off topic, but I just want to say thanks for you description above. Tells me that I did a pretty good job of designing my own caliper calibration procedure. Even though I had never done calibration before. :notme:
I used the .100 block to check for any taper or bent tips, checked readings at .100, 3.000 and 6.000 (on six inch calipers) then checked the depth stem on a 1.000 inch block (for wear) and the ID tips on a 1.000 ring gage, also for wear, nicks, bent etc. These were almost exlusively digital readout calipers so I really didn't have to deal with error around the dial.
Good old common sense makes a pretty good baseline for procedure writing. :agree1:

As to some of the other things you mention, ring gages thread gages etc. I agree often times some of the most critical measures seem to be overlooked. :agree1:

Peace
James
Peace
James
 
B

Big-R

#10
Be aware of copyright laws regarding "controlling" someone else's manual. Managing revision control could be tricky in case you decide to change the cal procedure at some point.

We have a simple template in which we list the procedure. That completed template is revision controlled. This approach is helpful in the event you use the same model device for different applications (with different cal requirements).

Ryan
 
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