Question for you seasoned professionals.

We have a new Mfg Eng. who will not allow us to internally calibrate his equipment and does not feel that he should go outside to an approved source to have the task completed because his equipment does not measure the quality of the parts.

His equipment is only used on the equipment. Final quality checks as to whether or not the part meets specification following repair/adjustments etc. is being performed during the QC /production measures.

As such would this enable our Mfg Eng to be exempt from 7.6.2 Calibration?

Question for you seasoned professionals.

We have a new Mfg Eng. who will not allow us to internally calibrate his equipment and does not feel that he should go outside to an approved source to have the task completed because his equipment does not measure the quality of the parts.

His equipment is only used on the equipment. Final quality checks as to whether or not the part meets specification following repair/adjustments etc. is being performed during the QC /production measures.

As such would this enable our Mfg Eng to be exempt from 7.6.2 Calibration?

If this person is not making any quality related judgements about the integrity of the product, I'd agree. I would have a problem if he's making some determinations about process equipment measurements, which does have an effect on product coming off the process, since the effects may not be possible to detect. You'd have to tell us if that's the case, Cheryl.

In principle, he's correct and an exemption form should be completed and filed in your calibration management system records.

If the reading/value of the instruments is meaningless (and I do mean meaningless) then they do not need to be calibrated. On any day for any process, it would not matter if the instrument read 1, 100, or 10,000, it would have no impact.

I still say some verification/ check of some level should be made on the instrumentation. Even if acceptance is not made by the readings, it could create problems if they got off.

But to your query, if the values are never written down and no acceptance made off of them, I guess you would be "safe" to not have them calibrated. But... I still think they should be checked at some level at some interval:tg:

While 7.6.2 does not specifically include process setup verification in calibration requirements, many companies calibrate machine gages, and personal gages used to set up machines, to support

process control,
validation of processes for production, and
process monitoring.

At issue for these companies is how badly they want to avoid a set up that will produce flawed parts, which are only discovered upon inspection with calibrated equipment. Personal tool calibration is often performed to avoid that loss, not only of material but man hours and machine time to first get it wrong, then get it right.

However, it's possible he wouldn't ever produce a bad part, either because it's not possible, or because he's endowed with such skill and/or intuition that he just knows how to set up accurately.

What does the control plan say?

I'm guessing you're talking about 7.6.2 in TS 16949?

Here's my take: What's the point of measuring with equipment that you don't know is accurate? At this point it really becomes a business decision. As Jennifer mentioned above, the company has to deal with bad setups due to any problems with unknown equipment. If it's worth the risk to the company, and product verification is done downstream, it would not violate 7.6/7.6.2.

Most companies I've worked with, faced with the same stubborn attitude, end up telling the person to take the equipment home and don't allow it to be used onsite unless it's calibrated. At a minimum, if the equipment is allowed to be used onsite, it should be identified to show it is NOT calibrated (7.6c).

Question for you seasoned professionals.

We have a new Mfg Eng. who will not allow us to internally calibrate his equipment and does not feel that he should go outside to an approved source to have the task completed because his equipment does not measure the quality of the parts.

His equipment is only used on the equipment. Final quality checks as to whether or not the part meets specification following repair/adjustments etc. is being performed during the QC /production measures.

As such would this enable our Mfg Eng to be exempt from 7.6.2 Calibration?

We are talking about 17025 (since it is in this forum) aren't we? This isn't something in regards to ISO9001:2000 or AS9100, right?

We are talking about 17025 (since it is in this forum) aren't we? This isn't something in regards to ISO9001:2000 or AS9100, right?
That's what I initially thought, but there is no 7.6.2 in ISO 17025. TS 16949 however, sounds right based on the context:
7.6.2 Calibration/verification records
Records of the calibration/verification activity for all gauges, measuring and test equipment, needed to provide evidence of conformity of product to determined requirements, including employee- and customer-owned equipment...

That's what I initially thought, but there is no 7.6.2 in ISO 17025. TS 16949 however, sounds right based on the context:

There also isn't 7.6.2 in ISO9001:200x (7.6) or AS9100B (7.6). Must be TS16949. Maybe Cheryl will let us know.

Thank you so much for your speedy replies. Yes, I was referring to TS16949, 7.6.2 Calibration.

I think we are all on the same page here. I do know for certain that if our external auditor witnesses this individual taking a measurement he will indeed call for certification. His process will be the same as Jennifer's as was ours.

I have moved this post to the TS16949 Forum, since it directly relates to the requirements of TS16949.

Another Moderator may move this thread.

I guess I would want to know what kind of equipment he was working on. If one of his people is measuring a shim to make an adjustment, or measuring a hard stop, or anything of this nature. This measurement will affect the quality of the part, even if it is not measuring the actual part. I would have a problem with anyone in my organization refusing to let me calibrate a tool, If you are a calibration technician, or the quality department, it is YOUR job to determine what needs to be calibrated.:whip:. Just lke it will be your fault if an external auditor writes a nonconformity.:truce: