Ed, The relevant section of ISO 9001:2000 is clause 7.6 "Control of Monitoring and Measuring Devices". If you read this clause (it's only half a page) you will see that calibration of equipment is not an end in itself, but only a means to 'ensure valid results'. If you can do this without the need to calibrate your 'support and stimulus' equipment, then you have no problem with ISO 9001. As you do not use the measurements on the gauges of this equipment for the production of any results, then they cannot have any detrimental effect on 'ensuring valid results'. Most companies prefer to find ways to minimise the number of devices they need to calibrate, in order to keep costs down. (Not that I'm suggesting that your metrology gurus are 'empire-building' ;-). May I suggest that you play the ISO 9001 game by submitting a Corrective Action proposal to amend your current calibration procedures in order to reduce calibration costs, without in any way compromising quality or ISO 9001 compliance. This should bring the problem to the attention of Quality Assurance and bypass the interests of the your Metrology department. Regards, Jon Griver http://www.601help.com The Medical Device Designer's Guide to IEC 60601-1
In some ways, I have the luxury of having a Metrology Department that maintains the periodic calibration on all of my test equipment. OTOH, as a "customer" of this Metrology Department's "product", I would like to have some control over my overhead costs. And my latest bright idea has me getting stomped by the gurus of the status quo. I need to get smarter about how a calibration system works, and how flexible it can be. My lab has about 500 pieces of capital equipment, and the way I see it, all my equipment falls into one of two categories. The first category consists of those instruments which are used to measure the parameters of our company's products, and determine if the performance of those products falls within a range of acceptable tolerance. Data from these measurements is often contractually reported to our customers. Every equipment within this category needs to be maintained on a program of periodic, traceable calibration. But then there's the second category; which consists of support and stimulus equipment. Items here are old analog signal generators, function generators, amplifiers, pulse generators, sweepers and power supplies. To me, none of this equipment needs ANY periodic calibration. I base this on practical usage. Who can accurately read a power supply mechanical 80-amp ammeter that has a 1.5" long scale? Who can set a function generator frequency control that covers 2 decades, logarithmically, in 270 degrees of rotation? If I need to apply a 100 kHz signal in bursts of 2 milliseconds at a 1 Hz rate, I'll use a calibrated, traceable oscilloscope to set the uncalibrated generator to exactly what I need. The same for that power supply; if I need to know the current to 2% or better, I'll use a calibrated resistor and a calibrated DMM. And I couldn't care less about the gain of an RF power amplifier, as long as it pumps out enough power to create the field I need. Now, I'm not trying to justify the use of distorted, unstable or junky equipment. I'm just trying to spend my calibration dollars the most efficient way. And the way I see it, about 1/4 of my equipment fits my definition of not needing periodic calibration because I can monitor the results with calibrated equipment. So I proposed that these items be tagged with some kind of "uncalibrated" or "user verified" or "no calibration required" label. The gurus of Metrology say this can't be done, our ISO9000 Quality System will not allow this. I can't understand how a customer-oriented quality system can't be crafted to meet the needs of all of the customers of that system. And I suppose I'm felling a bit squeezed, what with my customers expecting me to use COTS equipment to function in military environments. I have to get more out of what I have, and the old military concept of everything in sight is on periodic calibration has to yield to current reality. So, am I getting shoveled upon regarding the impossibility of having a category of officially non-calibrated equipment alongside my calibrated equipment? How have you dealt with calibration program costs? Regards, Ed Ed Price [email protected] WB6WSN NARTE Certified EMC Engineer & Technician Electromagnetic Compatibility Lab Cubic Defense Applications San Diego, CA USA 858-505-2780 (Voice) 858-505-1583 (Fax) Military & Avionics EMC Is Our Specialty
