Tales from an auditor
remembers how two audits revealed risky calibrations
The calibration of instruments and measuring devices can be of paramount importance to ensure that an organization is able to perform at its best, which is why sub-clause 7.6 was included in ISO 9001.
While the standard does not stipulate that all instruments must be calibrated the failure to carry out such checks, or to carry them out inaccurately, might prove very costly for an organization. When calibration procedures are in place but aren’t being adhered to, an auditor can reveal risks that the auditee wasn’t aware of.
Caught out
On one particular audit I was with the managing director when I asked about the arrangements for calibrating their equipment. In response he took me to a long, narrow room with one person working in the corner.
I was introduced to the staff member and I started by asking whether there were any documents or files in connection with calibrations. He pointed to the far corner of the roombut remained seated at his computer, so I retrieved the files.
After examining them, I said: ‘I see you calibrated an instrument yesterday.’ He confirmed that he had. ‘But the results are not in these files?’ I said. ‘That’s right,’ he replied. ‘They are on the computer’. I asked to see the results and eventually they appeared on the screen. There were three reference numbers: 9.00, 7.00 and 5.00 – exactly the same as the day before!
There was no way he could have obtained those results and I knew that I had caught him out. I remained calm and courteous and suggested that we should see the instrument in question.
I asked him to redo the calibration in my presence. I let him stew for a good while and then asked whether I could have a go. I took my time in pressing home his agony, knowing full well that I could not possibly get a set of identical results as he had apparently done.
I eventually turned to him, in the presence of his managing director, and said: ‘You have lied to me. You did not calibrate this instrument yesterday.’ He had, in fact, ‘cooked’ the calibration results and, unfortunately for him, I know a lot about calibrations. He confirmed that he had lied and confessed to making up the results. I told him I would have to raise a nonconformity.
I don’t know what happened afterwards, but I imagine he received a roasting from the managing director.
New scales
If the accuracy of a measuring device is of paramount importance, an organization must not assume that it is accurate because it is new. During an audit a managing director told me how difficult it had been to get a new set of scales calibrated.
His company manufactured widgets and the simplest way to count what a customer needed was to weigh them, so the accuracy of the scales was vital. However, whenever he asked for the scales to be calibrated the sales representative said that the scales were new and didn’t need calibrating.
Eventually the salesman relented after the director explained the company needed a calibration certificate for its next audit, but said: ‘It’s going to cost you’. He returned with his primary standard calibrated weights and was embarrassed to discover that the scales were out of specification. Funnily enough no charge was ever made for the test.
In both these cases, the companies benefited from seeking ISO 9001 certification. While the auditor does not decide what needs to be calibrated, part of the auditor’s job is to see that all processes associated with calibration are carried out properly and that proper records exist. An efficient audit can reveal where these processes are not working and are leaving the organization open to risks.
About the author
Dr Dennis Green is an international consultant and principal auditor on ISO 9001 and the author of five books on quality management systems. Three of his most recent books have been published by BSI.
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