Can we neglect (exclude) the ISO 9001 Calibration clause?

B

blue moon

#1
Dear Friends

i have a factory

they produce metal doors for shops and crage , only cuting the metal sheet and then weld them by pressure role

they only use a metal meter for measurement the dimension of doors inprocess / finla production

they didn't make any claibration and they said that they havn't any tools to calibrate

is it ok , or they have a problem

please advice

thanks
 
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Jen Kirley

Quality and Auditing Expert
Leader
Admin
#2
Re: can we neglect calibration clause

How can you tell your welding machines are functioning at the optimal level for the sheetmetal, especially at various thicknesses?
 
B

blue moon

#3
Re: can we neglect calibration clause

no thickness needed

it have air prusser pump which make the punish on the metal , it is not clear welding

put pressing the metal

the machine have only a meter for measure the pressure , the vlaue must be in the range of 20 - 30 Kpa and this is maintain

by follow up the reading of meter every one metal welded with another
 

Randy

Super Moderator
#4
Re: can we neglect calibration clause

no thickness needed

it have air prusser pump which make the punish on the metal , it is not clear welding

put pressing the metal

the machine have only a meter for measure the pressure , the vlaue must be in the range of 20 - 30 Kpa and this is maintain

by follow up the reading of meter every one metal welded with another
You answered your own question...You have a meter and it's related to process and product so therefore you must calibrate it and maintain records no matter what your people say.
 
#5
Re: Can we neglect the calibration clause?

and presumably the overall dimensions of these door are not important? They fit any hole in a wall? So the cut off size of the blanks of steel which are then bent and welded together don't have to be accurate to obtain the finished size?

You can't neglect calibration. You need to make an inventory of all measurements which affect product conformity to specification - even if it's a sketch on a napkin - and process control, like welding current gas pressure etc.

Then you can decide what might need to be calibrated and what might simply be verified against a standard.
 
#6
Re: can we neglect calibration clause

You answered your own question...You have a meter and it's related to process and product so therefore you must calibrate it and maintain records no matter what your people say.
If I may, let me pounce (okay, maybe not pounce) on your answer a bit, Randy.

The standard says "where necessary to ensure valid results". So, you have a meter (any measuring device) that is used in a process. There is one of two possibilities. 1) the device is not used in a manner that requires valid results. Okay, then why use it? I don't know why, but there may be cases out there where folks have devices related to a process and/or product that may not be used in a manner that requires calibration or verification. The other side; 2) the measurements from the device is important. Calibration (verification) is required.

I personally do not like to see gages that are not verified (much in the same way documents that are not controlled ie "for reference only". Even if the devices do not need verification, then there is an issue. If some gages need calibration, and some don't, it is very easy to create confusion. And human nature, being what it is, employees won't take the time to find out if the gage that is closest to them is calibrated or not (or needs to be). I know, calibrating every gage can be expensive, but so can using uncalibrated gages because they were more handy than finding calibrated ones.
 

BradM

Leader
Admin
#7
Re: can we neglect calibration clause

If I may, let me pounce (okay, maybe not pounce) on your answer a bit, Randy.

The standard says "where necessary to ensure valid results". So, you have a meter (any measuring device) that is used in a process. There is one of two possibilities. 1) the device is not used in a manner that requires valid results. Okay, then why use it? I don't know why, but there may be cases out there where folks have devices related to a process and/or product that may not be used in a manner that requires calibration or verification. The other side; 2) the measurements from the device is important. Calibration (verification) is required.

I personally do not like to see gages that are not verified (much in the same way documents that are not controlled ie "for reference only". Even if the devices do not need verification, then there is an issue. If some gages need calibration, and some don't, it is very easy to create confusion. And human nature, being what it is, employees won't take the time to find out if the gage that is closest to them is calibrated or not (or needs to be). I know, calibrating every gage can be expensive, but so can using uncalibrated gages because they were more handy than finding calibrated ones.
I don't know.:) It seems to be that your very valid second paragraph answered your #1 point above.:D:agree1:

FWIW... I think the tech4arab's instruments need some level of verification. Take the 20-30kpa given, and say you have a 0-100 kpa gauge. What about if the gauge is off.... 5 kpa? Would it make a difference?

What about 10 kpa? 20? 50 kpa? Would it ever make a difference? Could anything be affected? If the answer is yes, then it's valid, and it should be checked.

If you could essentially throw an instrument away and not affect your process, then it's truly reference only. If it would affect the process in any way, or is needed to verify some process specification (must be between 20-30kpa) then it should have some level of verification done on it.
:2cents:
 
S

sixsigmais

#9
Re: Can we neglect the ISO 9001 Calibration clause?

Yes, it can be excluded. However, in your case, you mentioned that the dimension of doors inspection duing inprocess or final production, mean it can be critical dimension. I not sure about it since i dont know the customer specification. It depend to how critical the demension on this product.

If the dimension is critical, or you are using caliper to measure it, then you need go for calibration. however, as you mentioned that only metal meter are used, then what you need is verification to ensure the metal meter is in good condition, else it can be NC too.
 

Randy

Super Moderator
#10
Yes, it can be excluded. However, in your case, you mentioned that the dimension of doors inspection duing inprocess or final production, mean it can be critical dimension. I not sure about it since i dont know the customer specification. It depend to how critical the demension on this product.
The door has to be measured with something...it does have to fit in the doorframe doesn't it? Your advice isn't within 6 sigma in this case
 
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