TS 16949 and Form, Fit or Function? What about Calibration of Oven Controllers?

First time post and pretty much a quality newbie, so be gentle.
My company recently went through a surveillance audit with a finding for uncontrolled measurement equipment being used on the floor. Now I'm part of a teaam reviewing the calibration system for the entire plant. I'm struggling with the definition of what needs to be controlled and at what level.
Meters, calipers I get. What about oven controllers? Do they need to be cal'd? If our process will catch any defect created by a bad controller, does it need to be cal'd? or just verified? or just identified as no-cal required?
Sorry for the 101 question, but I'm just getting my feet wet on TS-16949 and standards in general.

Re: Form, Fit or Function?

Hello new quality person,
In quality, you can not control what you do not know. Calibrating as much as possible is a course. The requirements are set by standard(s) and your company’s QMS. Ovens, or specifically their controllers are generally calibrated or at least the system is monitored, which is a removable/temporary monitoring method. You have the option to tag items NCR,(no cal required), reference only, and functional checked in some cases. With the door opened on calibration problem(s). There might be more which needs help. A review of your QMS documents in this area is likely needed. Checking against 16949 requirements. Sometimes an auditor is just pointing out the tip of the problem(s).The process of controlling will mean identifying devices and their purposes. Marking "standards" with ID numbers and having them labeled with calibration tags. This indicates their calibrated dates, and due calibration dates. A team would likely be carrying a role of little dots, and marking everything touched and reviewed. Also a roll of NCR stickers and reference stickers to make a first line of control. Items not calibrated would get RED OUT OF CAL tags, and in some places these items would be collected to stop them from being used. The list of what should be checked or reviewed is long. If it measures, or does something to the product being made, then it is a likely a calibration needed device. Sometimes a machine is monitored or checked by a hand held device. The device is calibrated. The production machine maybe. Maintenance for sure.
Having a list of likely items helps. [Heat guns, soldering irons, hand held meters, solder re-flow ovens, Ovens, refrigerators, scales, tape measures, calipers, micrometers, many electrical devices.]
Making/developing one as you go. Discussing the problem, and what you are doing to the people/areas involved. You are fixing a company problem. Letting people know that they are not at fault, will keep them from hiding items, and actually bringing them to you.
This is a first response here at the cove. More to follow for sure.
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I recommend the [Search] button, near the top of the page, for locating similar topic discussions. There is a lot already posted about this standard and similar issues. A Elsmar Cove search, not google.

Re: Form, Fit or Function?

This has been tossed around many time here...
The standard says in 7.6 that "monitoring and measurement equipment needed to provide evidence of confomity of product" needs to be controlled.

This is a pretty narrow scope and chances are that there is other equipment that your organization may want to control in order maintain consistent processes.

At the bare minimum you need to control tools that are used to approve product.

The first time I went through ISO9002 in 1995 we went nuts with calibrating stuff, right down to a calibrated stop watch I used for time and motion studies.

Why don't you throw out some examples of gauges that are giving you and your team problems?

Your example of an overn controller... If you are checking the product characteristics at the end and the oven controller is not used to approve anything and is not monitoring the product itself, then 'no' according to the standard. But it might still be a good idea to keep it on a calibration cycle to make sure your process is consistent...keep in mind it's also up to you to set the calibration cycle. If you have oven controllers that historically rarely go out of whack but are important in keeping the process consistent, then put them on a long calibration interval.

Re: Form, Fit or Function?

oops - I realized I wrote the above from the ISO9001 perspective and then saw this is in the 16949 forum.

So disregard if it adds no value.
If it does, great.

I need more vacation....

Re: Form, Fit or Function?

thanks for the thoughts and the catch. I'm hearing that monitoring and measuring is one of the few areas that 16949 exceeds 9001. but I have no idea

Re: Form, Fit or Function?

Your comment about ISO 9001 and TS 16949 is common. I sure hope there is an available hard copy, or e-copy at your company available to you. Looking at your QM is a good plan, but being in QA, you should have access, and do a read. Flying in the dark w/o lights only works most of the time. Googling will get you help, and here also. Get a copy of the Standard to view.
The are always gray area in control of the equipment. One person would check an oven, while another would not. There is a judgement to be made for most of the equipment in your facility. A key point is: If there are items floating about, so to speak, without any marking(s), then they are auditor targets. So: remove the targets, and likely exceed requirements to the level your process areas need to. Involving people in the areas helps. A course of action could be. Minimal to clear specific auditor finding, or a chance to review methods, and with agreement of fellow QA people a lifted review of equipment. As just mentioned overkill is possible. A plan of atack might be servey and identify. discuss depth of increased calibrations. Tag equipment, and determin best seriving method(s), being 1) in house checks, verifications, or calibrations. 2)additional commercial calibration support.
Just a quick review of TS 16949 over ISO 9001 comes up with @
http://elsmar.com/Forums/fileslist.php?mode=allfiles&sortby=filename&pageamt=1&criteria=TS+16949
The first item in this Elsmar Cove search. The ISO 17025 standard is listed as a process requirement for services. If you are calibrating items to ISO 17025, this becomes very expensive quickly. This one factor means you have to seriously evaluate you calibration plan to not over-calibrate and spend a bunch of money wastefully. Owning a copy of ISO 17025 become important also. Knowing this now is a good QA policy tool for you to discuss with others. Knowing ISO 17025 completely is important, but knowing the need is a BIG first step.