Deciding if Calibration is needed for Production Instruments

M

Marcus CLF

#1
Dear all,

I have joined my new company for 7 months and adopted a new job as a Quality System Engineer. Part of my job is to carry out auditing to different department in my company.
When I auditing the calibration system of 1 of my production departments, the department head requested to exempt the calibration system of the department from ISO scope. I was confused whether the department or company itself have the authority to exempt the calibration of production measuring instrument from quality system (we are ISO9001:2000 certified manufacturing company). The reason given was that the department head does not want to face any complication during ISO audit because they have too many process measuring instruments need to be calibrated/verified.

Beside, they also explained that their process measuring instruments do not directly affect the quality of finished product (which I believe is a lie). Another question here, How to know what instrument need to be calibrated/verified?

The calibration system for product measuring tool (maintained by Quality Department) are well complied. But process/production measuring tools calibration (maintained by production process owner) have not been practiced accordingly. Do I need to enforce the establishment of a calibration system which is well documented and no hiding? Any strong fact I can apply on this issue? :thanx:
 
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Stijloor

Staff member
Super Moderator
#2
Hello Marcus,

The "strong fact" as you call it, is the Standard itself.

From ISO 9001:2000:

7.6 Control of monitoring and measuring devices

The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 7.2.1).

The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.

Where necessary to ensure valid results, measuring equipment shall
a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded;
b) be adjusted or re-adjusted as necessary;
c) be identified to enable the calibration status to be determined;
d) be safeguarded from adjustments that would invalidate the measurement result;
e) be protected from damage and deterioration during handling, maintenance and storage.

In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained (see 4.2.4).

When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.


You can use the ISO 9001 requirement as a "strong fact." However, I sense that you have a Top Management problem. Those are harder to solve. Because, why was this particular department allowed to claim "exceptions" and "exclusions" from the calibration requirements?

You may want to speak with your boss, and find out what can be done. And by the way, don't fall in the trap of categorizing measuring devices "for reference only." That's a sorry excuse for NOT taking responsibility for the integrity and the quality of the measurement/testing system.

Hope this helps to start the process. Please keep us posted.

Stijloor.
 
#3
The simple answer is that if anyone is making decisions about product or process 'acceptability' (does it meet a specification), then the equipment used should be calibrated or at least verified as operating correctly.

It really doesn't matter (to your management) what the ISO standard says, since most management have never read it or know why it exists, however, they might see the benefit of either having problems of processing or production/productivity because the operators didn't get the correct data they needed to control the thing.

If they are concerned about the cost of calibration or the disruption of removing the equipment to perform the calibration, there are many ways to over come that resistance.

Do you have anyone in the organization who is experienced in running an effective calibration management system? If not, it could be useful to find one.
 

BradM

Staff member
Admin
#5
Hello Marcus!

This is a little bit of my opinion, as maybe some of our auditing pros would need to weigh in. I could not imagine an ISO 9001 audit in a production/mfg. environment going well without having any calibration program.

Instruments are calibrated for good reason, not just because "it's the law". For the most part, even when "it's the law" there is a very good reason for it also. I cannot conceive that someone would spend that kind of money for certification and not want to invest a little more for a decent calibration program.

Do you have any industry/regulatory/ or customer requirements that would mandate calibration of instruments?

Do you have drawings/specifications that you produce product against? If you have no confidence in your measuring instruments, how do you know you are doing what you say you are doing?

Short answer- I guess you could mark every instrument off as reference only. But that just seems like a colossal waste of time and money. Eventually, there are going to be some problems with failures, complaints, differences among processes, etc.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#6
In my opinion, a department exempting itself from calibration needs is a department very likely to receive a nonconformance during registrar's audit unless they can show the instruments do not verify or impact product quality.

That means calibration needs can extend beyond inspection instruments. If that department is bothered by the number of instruments needing inspection, I wonder if the managers are making the issue too complicated or disruptive.

It's often enough to do in-house verifications (which can be considered calibration) on hand held tools. A skilled inspector with controlled conditions can calibrate many types of dimensional tools, and keep track using software, which is soon paid for with savings from in-house calibration.

I'd urge your management to consider viable options before they get the idea they can just decide they can pick and choose which elements of the standard they need to follow.
 

harry

Super Moderator
#7
It would do posters a lot of good when they come to inquire about calibration problems by providing us with relevant information in order to get relevant and good answer.

Information such as:
1. what are you manufacturing
2. what are your measurement tolerance/allowance
3. what kind of production measuring devices are you talking about
4. how are your processes set up
5. do you have Quality check and where are the check-points along the process

In particular, I am referring to this post where many good ideas and answers were provided so far. Unfortunately, things could be different because of the nature of the industry the OP is in.

The OP mentioned previously that he is in the Aluminum Extrusion industry. In Malaysia, they extrude sections for our door/window frames, interior decoration & partition and facade purpose. This is not a high-tech industry, where the extrusion die plays a great part in terms of quality of finishing and dimensional properties. Such being the case, it is possible to set-up your processes and controls such that the production people may perform some in-process checking only whereas the dimensional approval, monitoring and control comes from the Quality department whom the OP mentioned had calibrated instruments.

The traditional production department (hot and stuffy) in this industry are filled with foreign workers and helmed by supervisors who are usually not that conversant with quality matters or handling of instruments. If I were to set up the quality plan, I would rather let the quality department (with engineers - OP) handle it. It is just a matter of deploying the right people for the right job.

The answer to the OP’s query is: it is possible not to calibrate the instruments of the production department. They could be verified (compare with your calibrated instruments or measuring blocks, etc) for confidence purpose. All these are dependent on how you set up your quality control/check system.

As Andy put it: if anyone is making decisions about product or process 'acceptability' (does it meet a specification), then the equipment used should be calibrated or at least verified as operating correctly.
 
#8
When working with folks and trying to determine the need for calibration, I often use the car dashboard and the display instrumentation as an analogy:-

Firstly, you (management) only need a few measurements to guide the process, but they'd better be accurate - like speed (it's the law), gas (you'll run out or keep stopping too many times to fill up and miles (how do you know when to turn, finish your journey or calculate your mpg?)

There are others (revs, trip etc.) but these don't tell you much more. On my Chevrolet, GM have designed a 'hidden' display which shows a wide range of other measurements being made but not fully required to drive effectively.

So, when driving you can make legally important decisions about the process - that's why the car manufacturer has to calibrate the speedometer (+/- 5%), and the gas gauge should be studied for linearity, stability etc, so you know when to stop at the gas station. You might verify it against the calibrated gas pump (that's a law too) to know how much you put in.

NOTE: Rarely is a gas gauge linear in it's displaying the tank contents. Mine stays at full for some time, then rapidly drops to the low end, followed by the warning light!

If you know the gas gauge is accurate you can maximize travel time, minimize trip tops (efficiency) and calculate fuel consumption costs accurately.

This normally works for people to decide what's in or out of the calibration system.
 
T

TIMMYS - 2010

#9
I read the post and find the department head's comments disturbing. The feeling that I get is that the department head is only concerned with production issues and not concerned with the quality of product. I would not purchase any product from an organization with this leadership.

Regarding the calibration of gages. The standard is quite clear but is not well defined in some areas such as personal tools. If this is a support shop where tooling fixtures are made to manufacture products then you could allow the measurement equipment to be excluded from calibration recall. Any Measurement and Test equipment used for production or inspection should always be calibrated and certified periodically regardless of how a department head feels about the requirement. I would write a non-conformance on this if I were the auditor. But that's just me.

Regards,
TIMMYS
 
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