Other Dimensions: Hints for Quality Auditors
As a provider of calibration services, I frequently take shots at some quality auditors for the silly things they demand during audits. I always offer to speak with an auditor to clear up any misunderstandings, but they always decline the invitation. I was told this is because the customer is supposed to know all this stuff and sort it out.
The following notes are for quality auditors-a peace offering if you will-but mostly so I won’t have to keep looking over my shoulder. Okay, I’ll admit it up front: I’m trying to avoid repeatedly having to answer questions that should never have been asked.
• Approved Service Providers. This is not really a technical situation; often it’s outright fraud. Your client compiles a list of people who do calibration work, complete with all the appropriate certificates of accreditation. Everything is in order, approved and impressive. Unfortunately, the work may never go to the people on the list or they send one or two simple items to one of them to keep the list valid but calibrate the rest of their stuff on their own. Tracing everything back to the source will keep you from getting fooled by this ploy.
• Traceability. Many auditors and customers insist that a calibration report must show traceability, which is not a requirement of ISO 17025. One reason for this is because a NIST report number means little if there are several companies between the auditor’s client and NIST. This is often the case and is not a problem depending on the level of precision required. The higher the accuracy required, the lower the number of people there should be between the end user of the number and NIST. Any laboratory accredited to ISO 17025 will have undergone an onsite audit with original documents evaluated by the assessor before accreditation will be granted.
• Equipment Used. Some standards require a list of the principal equipment and masters used in the calibration to be listed on the report. Such a list does not indicate if the equipment is suitable for the task, the acceptance criteria for it or whether the frequency of calibration is appropriate. ISO 17025 does not require this because only an onsite assessment of the laboratory’s equipment and processes will ensure the hardware is suitable.
• Desktop Audits. When I first encountered this term I thought I would fail completely considering my desktop’s ongoing state of disarray. When I learned what it meant I wondered why people bother with them. And then I found out: Because some auditors accept them as a valid way to evaluate a company’s quality system. Many companies insist on these forms being filled out even though a laboratory has been audited onsite by an internationally recognized accrediting agency, making them an ineffective waste of time.
• ISO 9000. Some folks still insist that their calibration source be registered to ISO 9000 and some laboratories consider that’s all they need to be in the calibration business. The main reason this is not required or acceptable is because ISO 9000 allows two parties to a contract to set their own rules. ISO 17025 clearly notes that a laboratory meeting the standard will have met the ISO 9000 rules for its quality system. ISO 9000 registration would be a waste of money.
• Copies Of Quality Manuals/Procedures. ISO 17025 lists what documentation a laboratory must provide the client and it doesn’t include copies of procedures or quality manuals. But some companies demand this material “for their files.” Considering the sources some of these folks use for calibration, I doubt they read the paperwork they are collecting or don’t understand it when they do.
I would never make a good quality auditor. I don’t have the patience to wade through the paperwork and systems they have to review. But I know where the skeletons are buried on the technical side. Fortunately for everyone, I won’t be making a career change any time soon.
The following notes are for quality auditors-a peace offering if you will-but mostly so I won’t have to keep looking over my shoulder. Okay, I’ll admit it up front: I’m trying to avoid repeatedly having to answer questions that should never have been asked.
• Approved Service Providers. This is not really a technical situation; often it’s outright fraud. Your client compiles a list of people who do calibration work, complete with all the appropriate certificates of accreditation. Everything is in order, approved and impressive. Unfortunately, the work may never go to the people on the list or they send one or two simple items to one of them to keep the list valid but calibrate the rest of their stuff on their own. Tracing everything back to the source will keep you from getting fooled by this ploy.
• Traceability. Many auditors and customers insist that a calibration report must show traceability, which is not a requirement of ISO 17025. One reason for this is because a NIST report number means little if there are several companies between the auditor’s client and NIST. This is often the case and is not a problem depending on the level of precision required. The higher the accuracy required, the lower the number of people there should be between the end user of the number and NIST. Any laboratory accredited to ISO 17025 will have undergone an onsite audit with original documents evaluated by the assessor before accreditation will be granted.
• Equipment Used. Some standards require a list of the principal equipment and masters used in the calibration to be listed on the report. Such a list does not indicate if the equipment is suitable for the task, the acceptance criteria for it or whether the frequency of calibration is appropriate. ISO 17025 does not require this because only an onsite assessment of the laboratory’s equipment and processes will ensure the hardware is suitable.
• Desktop Audits. When I first encountered this term I thought I would fail completely considering my desktop’s ongoing state of disarray. When I learned what it meant I wondered why people bother with them. And then I found out: Because some auditors accept them as a valid way to evaluate a company’s quality system. Many companies insist on these forms being filled out even though a laboratory has been audited onsite by an internationally recognized accrediting agency, making them an ineffective waste of time.
• ISO 9000. Some folks still insist that their calibration source be registered to ISO 9000 and some laboratories consider that’s all they need to be in the calibration business. The main reason this is not required or acceptable is because ISO 9000 allows two parties to a contract to set their own rules. ISO 17025 clearly notes that a laboratory meeting the standard will have met the ISO 9000 rules for its quality system. ISO 9000 registration would be a waste of money.
• Copies Of Quality Manuals/Procedures. ISO 17025 lists what documentation a laboratory must provide the client and it doesn’t include copies of procedures or quality manuals. But some companies demand this material “for their files.” Considering the sources some of these folks use for calibration, I doubt they read the paperwork they are collecting or don’t understand it when they do.
I would never make a good quality auditor. I don’t have the patience to wade through the paperwork and systems they have to review. But I know where the skeletons are buried on the technical side. Fortunately for everyone, I won’t be making a career change any time soon.
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