Internal Audit

The easiest internal audit program ever

I recently discovered there’s a way to do internal audits that takes (almost) no time at all.  I got an invitation to a webinar Freshening Up Your Internal Audit Program featuring a dude who has been around the ISO 9001 certification scene for many decades.  (Aha! I thought.  I’m finally going to learn the secret from a real veteran of internal auditing).

When we got to the secret, I was amazed by the completely different approach to auditing.  This was more than a freshen up, it was radical surgery.  There are no horizontal, vertical, process, observational, or outcome audits: they have all been excised.

This quality manager produces a detailed Compliance Matrix (it’s like a gap analysis with much more detail) and updates it every year (you can get a copy if you make it to the end of the webinar).  And the Compliance Matrix is it.  There is usually quite a vigorous discussion with the ISO auditor when they come, but he manages to get it across the line.

Now I wasn’t quite ready to adopt this approach whole-heartedly, but there were some great lessons in the webinar that I’d like to share with you:
There is no right way to do internal audits
The ”tell me, show me” or process method used by certification and accreditation bodies is not mandatory.  Many of us are married to the belief that observational process audits are the only “proper” kind of audit (you know, the ones we learn about in the NATA/SAI/Lloyds internal audits courses). I know I was for many years and I love auditing that way because it suits my curious nature and visual learning style.

However, if you follow the requirements trail for internal audits, it leads you back to […]

By |June 15th, 2017|Internal Audit, ISO 15189 Accreditation, ISO 17025 Accreditation, NATA Accreditation, Quality improvement|Comments Off on The easiest internal audit program ever

Are internal auditors better than managers?

Internal auditors can be better at identifying process improvements than most managers – let me tell you why.
What a manager may never see
There are things that internal auditors see that a manager would never have known about if not for the audit program. These can include: tests failing and needing to be repeated; risky work-arounds to compensate for poorly designed processes; retesting QCs until a result falls within spec; using calibration factors incorrectly; biased sampling; poor labeling practices; unsafe work methods; some staff having their own special way of doing a task; continuing to perform tasks made redundant by process changes.

Most of these you will never know about unless you directly observe them.  So why does an internal auditor see them when the manager walks through the laboratory every day and does not see it?  I can think of a couple of reasons.

When a manager strolls through the lab their mind is filling in the picture with all sorts of details that they believe happen in that lab. This is not a fault of the manager, this is being human.  Unless they go into the lab with the intention of studying a particular process, they will likely see very little of interest.

When a manager arrives in the lab, they are thinking “I am the expert on this process” whereas the auditor is thinking “I don’t know much about this process”.  Neither of these is wrong, but they have a big effect on what types of questions are asked, and how the answers are listened to.  A good internal auditor approaches the audit with a child’s mind – curiosity and wonder.

When an internal audit has been arranged, everyone is primed and ready to demonstrate and […]

By |March 25th, 2017|Internal Audit, NATA Accreditation|Comments Off on Are internal auditors better than managers?

The Perils of Internal Auditing

When inconvenient truth meets comfortable myth
Overcoming long-held beliefs about other departments in your own 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 confidentiality
of audit reports to clarity in defining (and backing) responsibilities and recognising the contribution that internal auditors make. […]

By |December 1st, 2016|Internal Audit|Comments Off on The Perils of Internal Auditing

3 Secrets for a successful audit program

At this time of year many of us are surveying the wreckage of our laboratory internal audit programs, wondering if we can fit in a couple more before the end of the year and reign in the backlog.  Rest assured that you are not alone!

This is a good time to review your approach to the audit program and see how you can shake it up a bit.  Think about what determines the success of your audit program. Is it whether every single audit that was on the schedule was completed on time? Or is it whether your senior management are happy with the outcomes and control of risks?
Don’t confuse purpose with objectives
The purpose of an audit program is to do audits.  If you only focus on the purpose, you will just keep on doing audits, producing reports and piling up a lot of minor non-conformances.  This is when we can get demotivated and disenchanted.

Take a look at your laboratory’s objectives and think about how the audit program could support them.   If your organisation wants to become more efficient, then your audit program should be aiming to identify process improvements that can save time or resources in producing test results.  This will inform what approach you take to audits – you may move away from looking for compliance to adopt a process approach.

If your organisation is new to accreditation and just wants to meet NATA’s (or ISO) requirements, then auditing for compliance with the criteria documents can be a priority.  This is also a great way for staff to learn about the requirements. But avoid getting stuck in this type of auditing for too long, as it rarely leads to any real improvements.

When the customer […]

By |November 17th, 2016|Internal Audit, ISO 15189 Accreditation, ISO 17025 Accreditation, NATA Accreditation|Comments Off on 3 Secrets for a successful audit program