Other Dimensions: Quality Audit Survival
If both your system and attitude show a sincere effort to do things properly, most auditors will cut you some slack.
It starts with a phone call from the customer. In panic mode, the customer explains they have an audit coming up and they need certain calibration work done immediately. An advanced condition is terror mode when out-of-calibration gages have been discovered in the middle of an audit, but if they can be calibrated before the end of the process, all will be forgiven. Oh, and could they drop off the gages and wait while we do the calibration?
Oftentimes neither of these modes are encountered, as the auditor finds nothing of substance to create them. But, being an auditor, he has to find something, so if he comes up dry he starts asking questions no one knows the answers to except the external calibration source. This creates the hysteria mode where no one stops to think about what is being asked but passes the requests onward.
Of course, there’s no need for all of this, but humans being what they are, this means we have auditors for quality systems-and those who live in terror because of them.
Any quality auditor worthy of the name has a pretty good idea of what state your system is in within the first hour or so of an on-site audit. Similarly, he also will know if your company has been skating around the rules.
Typical of the latter is trying to save money by not getting your gages and instruments properly calibrated by credible sources. Under these conditions, the auditor will show no mercy. On the other hand, if the auditor finds a few honest mistakes but both your system and attitude show a sincere effort to do things properly, most auditors will cut you some slack. Many will help you sort out any issues they have raised.
Frustrations arise when you’ve been audited for a number of years without problems and an auditor questions something in your manual when the only thing that has changed is the auditor. It’s possible this one knows the ropes better than the previous ones, but not likely. Each has areas he specializes in when it comes to quality systems and the standards on which they are based. Assume this sort of thing happens so you won’t go into shock when it does. If the change being requesting is unreasonable, challenge it. If it’s a minor thing, you may find it easier to make the change knowing the next auditor to come along may get you to put it back the way it was.
One thing most quality standards require is that you have the appropriate documents on which your system is based. This means documents or standards from their source, not photocopies of photocopies from friends. This is extremely important if you intend to challenge an auditor. If you know and understand those documents, you can make an effective case, or alternately, have the auditor show you what part he bases his findings.
Don’t expect an auditor to talk to your calibration source about something he is questioning because the theory is that you are supposed to know all about it. The fact that you have used a properly accredited calibration source is no protection from questions that send you on a wild goose chase. Calibration labs can sympathize with you because they are now caught up in the process of an auditor grasping for something so they get silly questions being asked through you-their customer.
Recently we had a customer in hysteria mode because the auditor said they had to know what the calibration due dates were for the equipment we used. The fact we are accredited to ISO 17025 did not make any difference, neither did the fact that 17025 does not require such information to appear on reports.
We sent the dates over, which the auditor accepted without question. But they could have been lies and he would never have known and, of course, he had no way of knowing if they were appropriate for the work involved. But he found something he could hang his hat on.
Most auditors know that no system is perfect-there is always something waiting to be found. What many auditors forget is that their activities are not perfect either, but few people will call them on their decisions.
It starts with a phone call from the customer. In panic mode, the customer explains they have an audit coming up and they need certain calibration work done immediately. An advanced condition is terror mode when out-of-calibration gages have been discovered in the middle of an audit, but if they can be calibrated before the end of the process, all will be forgiven. Oh, and could they drop off the gages and wait while we do the calibration?
Oftentimes neither of these modes are encountered, as the auditor finds nothing of substance to create them. But, being an auditor, he has to find something, so if he comes up dry he starts asking questions no one knows the answers to except the external calibration source. This creates the hysteria mode where no one stops to think about what is being asked but passes the requests onward.
Of course, there’s no need for all of this, but humans being what they are, this means we have auditors for quality systems-and those who live in terror because of them.
Any quality auditor worthy of the name has a pretty good idea of what state your system is in within the first hour or so of an on-site audit. Similarly, he also will know if your company has been skating around the rules.
Typical of the latter is trying to save money by not getting your gages and instruments properly calibrated by credible sources. Under these conditions, the auditor will show no mercy. On the other hand, if the auditor finds a few honest mistakes but both your system and attitude show a sincere effort to do things properly, most auditors will cut you some slack. Many will help you sort out any issues they have raised.
Frustrations arise when you’ve been audited for a number of years without problems and an auditor questions something in your manual when the only thing that has changed is the auditor. It’s possible this one knows the ropes better than the previous ones, but not likely. Each has areas he specializes in when it comes to quality systems and the standards on which they are based. Assume this sort of thing happens so you won’t go into shock when it does. If the change being requesting is unreasonable, challenge it. If it’s a minor thing, you may find it easier to make the change knowing the next auditor to come along may get you to put it back the way it was.
One thing most quality standards require is that you have the appropriate documents on which your system is based. This means documents or standards from their source, not photocopies of photocopies from friends. This is extremely important if you intend to challenge an auditor. If you know and understand those documents, you can make an effective case, or alternately, have the auditor show you what part he bases his findings.
Don’t expect an auditor to talk to your calibration source about something he is questioning because the theory is that you are supposed to know all about it. The fact that you have used a properly accredited calibration source is no protection from questions that send you on a wild goose chase. Calibration labs can sympathize with you because they are now caught up in the process of an auditor grasping for something so they get silly questions being asked through you-their customer.
Recently we had a customer in hysteria mode because the auditor said they had to know what the calibration due dates were for the equipment we used. The fact we are accredited to ISO 17025 did not make any difference, neither did the fact that 17025 does not require such information to appear on reports.
We sent the dates over, which the auditor accepted without question. But they could have been lies and he would never have known and, of course, he had no way of knowing if they were appropriate for the work involved. But he found something he could hang his hat on.
Most auditors know that no system is perfect-there is always something waiting to be found. What many auditors forget is that their activities are not perfect either, but few people will call them on their decisions.
Looking for a reprint of this article?
From high-res PDFs to custom plaques, order your copy today!
