Calibration Methods - Auditor wants federal or international calibration procedures?

Jerry Eldred

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Super Moderator
My gut instinct is that the auditor doesn't have any business telling you a specific procedure to use.

What I believe is justified in is requiring you to have adequate procedures. If they meet requirements for a properly written, documented and revision controlled procedure, I don't quite comprehend how he can require you to use federal or equivalent procedures.

What I don't know is why he didn't like you procedures. Did the auditor, without any detailed review of the content of your procedures, make a blanket requirement that you use federal or international procedures? Or was the case that you only had the manufacturer's specs, and were using those as your calibration procedure?

An internally written procedure which includes a unique document number, revision control, environmental requirements, detailed requirements of exactly what standards must be used, step by step instructions for the calibration process, documented data points including upper and lower tolerance limits (there may be other details, but I believe I have covered the majority), and a review process by person(s) documented as competent to approve the procedure, should be indisputable.

If I had a procedure in that format (refer to NCSL - National Conference of Standards Laboratories Recommended Practice RP-3, "Calibration Procedures Content & Format for Measuring & Test Equipment (M&TE), Measurement Standards (MS), and Measurement/Test Systems (M/TS)"), and it gives detailed guidance on proper procedure writing.

As for federal or international procedures, one resource is GIDEP (Government - Industry Data Exchange Program). If you are a member, they have the various Air Force, Navy, Army and other procedures, most definitely including those for calipers and micrometers, etc. Perhaps ANSI or ASTM may have some documented procedures as well.

Those are just a few thoughts. Bottom line, you do need a good procedure. If in the auditors opinion it wasn't good enough, he may have made some recommendations. I have a problem with a registrar auditor being prescriptive. I've been to ISO9000 Lead Auditor course. I do remember the instructor (who was a 30 plus year veteran in the auditing business) saying that he gets irritated on a regular basis by auditors who try to tell auditees specifics as to how to resolve an issue. He stated that the auditor can write you a nonconformance for not having an adequate procedure (spec). But he can't tell you what to do about it, as it is considered to be a conflict of interest, as he is functioning as an auditor and a consultant (in his view, a no-no).

Perhaps some others could add to my thoughts. Hope I haven't confused the issue even further.

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K

Ken K.

Calibration Methods

When our lab was first established in 1989, we wrote calibration methods for calipers, micrometers, etc. using the manufacturer's recommendations. We have been QS9000 certified since 1996 and auditors have never had a problem with this. That is until our last audit. He strongly suggested we use a federal or international calibration procedure for these instruments. I have looked high and low for these without any luck. What do you use for a calibration method for these? Shouldn't the manufacturer's recommendations suffice?
Also, since our calipers and mic's are critical we have them on a 30 day calibration schedule. Since some of the calibration dates fall on weekends and holidays, can we put a tolerance of say +\- 2 days without any repurcussions? Any help would be appreciated.
 

Marc

Fully vaccinated are you?
Leader
I agree with Jerry and I thank him for a great, detailed response!

As far as the +/- 2 days on the recall - I would not have a problem with it but I might ask how you decided this would be sufficient. All you have to show / explain is that 2 days will not be a problem. I have had clients with a 2 week and 1 month 'extension' clause in their procedures for 6 month and 1 year intervals. Sometimes you just can't get to it.

That said, I don't recommend pushing the limit. Most of you calibrations should be on time. In your case, just wanting to avoid problems of a cal due date falling on a weekend, I cannot impagine a problem with a +/- 2 day 'tolerance' on a 30 day cycle.
 
K

Ken K.

I want to thank both of you for your response.
Our current calibration methods are very detailed and do contain what Jerry recommended. Every auditor before this one never had any problems with our internal methods. We did, in fact, file a complaint with Corporate concerning his remarks. This was our 8th audit, and we've never had the same auditor twice and I think that is part of the problem.
Also, we do have a clause in our calibration procedure that states if a calibration due date falls on a Saturday, it will be performed on the Friday before and if it falls on a Sunday it will be performed on the following Monday. If it is due on a holiday and no work is scheduled, then we either calibrate on the day before the holiday or the day after depending on our workload. I just wanted to clarify if this is permissable.
Again, I thank you for your response.
 

barb butrym

Quite Involved in Discussions
I wonder why you inflict such pain on yourself. The system does not allow for "s**t" to happen as it invariably does. But if that is what you want.......
 
K

Ken K.

Barb, I really don't understand your reply. Being a Lab Manager, QS9000 is very important to me and the "pain", as you call it, comes with the territory. After 7 audits we have had no noncomformaties in our lab and I'm proud of that. To me, all the effort was worth it.
 
R

Ryan Wilde

Are your calibrations solely used for internal calibrations or do you also do calibrations for external companies? The answer to that question will decide whether your auditor was right or wrong.

If you are doing only internal calibrations, the auditor MAY be off-base. What you have to establish is: Are they effective and appropriate for the use of the tools? If the calibrations are effective and appropriate, as I would surmise that they are due to the time span that they have been in use without a problem, then they are adequate for use by your lab. (By the way, tell your auditor the "effective and appropriate" part, they love those terms!)

On the other hand, if you do external calibrations, those for other companies, then it is strongly suggested that you use "well established" procedures, otherwise known as federal standards. I see that someone pointed you to GIDEP, which is what I use as procedures. I do modify them slightly, but all in all, the actual meat and potatoes of the procedure is unchanged. Customers expect to have a standard calibration technique employed.

I'll even be so nice as to give you a handy-dandy link to GIDEP. It is a great program, and the procedures are already written! There are a few catches though:
a) you have to be in the USA or Canada;
b) you have to be a defense contractor OR subcontractor of a defense contractor (this is easy, the DOD buys cars, and you are QS certified...);
c) you have to fill out a yearly useage report, which can be a pain.

If you decide to go through with it, the addy is https://www.gidep.corona.navy.mil/

It only takes a few days to get access, and they are wonderful people that are quite helpful. The database is available online.

Hope this helps you!

Ryan Wilde
 
K

Ken K.

Thank you for the reply Ryan. All calibrations we do are internal. I will be using your link on Monday to the GIDEP. I'm just curious at this point to see how our calibration methods compare to the federal standards.
Thank all of you for your replies.
 
C

chen

i think it is better to use national calibration procedures directly or convery it to your company procedures.



[This message has been edited by chen (edited 01 June 2000).]
 
A

AJPaton

Small question - +/- 2 days is a 4 day window in a 30 day calibration schedule. That mean you could have a 34 day lapse between calibrations. If your gauges are that critical, is a 13% deviation in calibration dates appropriate?

What general guidelines are out there on varying your calibration dates?

AJP
 
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