When inconvenient truth meets comfortable myth
Overcoming long-held beliefs about other departments in your organisation and making objective judgements about compliance is difficult for even the most experienced auditor.
You are auditing another section of your organisation. You find a few issues that aren’t quite in line with the SOPs, but you know they’ve been short-staffed for the past six months. And you’ve heard that they have a great reputation outside the organisation, so everything must be OK in here, right? So you do them a favour and leave it out of the audit report.
Are you really doing them a favour if you leave it out? Does it matter if their fume cabinet hasn’t been checked for three years or their QC has been out of spec for a week? Who suffers in the end if these things are not attended to? Yes, there definitely are little issues that can be left out of internal audit reports, but you need to think about a few things before you decide to do this:
- How significant is it? Will it affect the test results or the customer experience?
- Is this an isolated event or is it happening elsewhere as well?
- Is it a symptom of a deeper problem?
- How will it look as a newspaper headline?
Internal auditors have a responsibility to think about the good of the organisation and it’s customers even when that brings great discomfort. Issues that require system changes should go into the audit report. Isolated cases of human error need not.
The fear of offending a friend
Organisational culture is important here. This ranges from norms about the confidentiality of audit reports to clarity in defining (and backing) responsibilities and recognising the contribution that internal auditors make. Management needs to provide visible support to the internal audit program and protect auditors from repercussions.
For the auditor, it is vital to focus on the audit criteria and obtain objective evidence. Then it’s not you saying something that might offend – the evidence speaks for itself.
I thought this was how we were supposed to… ?
Seeing how the gang right next door to you have implemented the LIMS or applied the calibration requirements can come as a surprise to internal auditors. What you thought was a centralised, homogeneous system has been creatively interpreted in ways you never dreamed of. Or you might have thought that the way you do it is the way NATA says you have to.
Beware of telling another laboratory that they have to do it the way you do it. Go back to the quality system documents and the relevant standard if necessary to decide if it really is an important difference. You might even decide it’s a good idea and adopt it in your section!
Quality Managers
Internal auditing can be difficult and does have its hazards. Care for your internal auditors. Provide them with useful tools for the audit process. Reward them with extra training or interesting audit opportunities. Remind ‘assertive’ managers that the audit program is an essential part of the continual improvement process.