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Are you wasting time & money on NATA requirements?

The assessment is over, you have ushered the audit team out the door and you already know how you’re going to fix most of those niggly things they brought up.  The assessment team were really helpful and you know it’s going to feel great to get all of these NATA requirements ticked off.

You’re not sure why these issues are important enough to be in the assessment report, but you need to get the response under control so the “Just Do It” approach wins.  You get the assessment report and hold a meeting to decide who will do what, including all the observations and recommendations.  Great work – you’ll have everything fixed and your reply to NATA post haste.

Can I just say whoa?!

When we behave like this we are focussing on one risk: the risk of NATA being annoyed with us for not having a response in time.  What about the other risks?  The real risk to your business presented by the issues the audit team identified?  The risk of wasting time and money on interventions for trivial problems?  The possibility of the same issue coming up in future assessments, which can threaten your accreditation and your reputation.

This is the time to slow down and take a quality improvement approach to each of the issues raised by the auditors. Here’s my step-by-step process to address these findings so that hopefully they never come back to haunt you again.
Understand the problem
Study the finding closely.  Make sure you have understood exactly what the auditors found that is wrong & why it is wrong.  Go and check what they were looking at if you haven’t seen it.  Look up the clause of the standard that they refer to […]

By |June 26th, 2017|ISO 15189 Accreditation, ISO 17025 Accreditation, NATA Accreditation|Comments Off on Are you wasting time & money on NATA requirements?

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

10 Tips to Avoid NATA Paper Warfare

Some lab / quality managers enjoy corresponding with NATA and arguing the point with them.  But most of us don’t.  Other labs inadvertently get caught up in three, four or even more rounds of correspondence with NATA following an assessment.  It can be frustrating and time consuming.  You seem to be talking at cross purposes at times and you may even start to wonder if the NATA staff were actually at the same assessment as you were!

After an assessment you need to get the follow-up over and done with as quickly as possible so you can turn your attention to more significant issues.  It’s not that NATA is not significant, but that many of the issues they find are compliance issues with no immediate impact on your output or business security. In the normal run of business they would be prioritised much further down the list.  So we need to minimise the amount of time spent dealing with these issues, whilst managing the risk of having a poor NATA assessment in the future.

Here are my key steps to stay out of the mire:
Be a good host
Before the assessment, make sure everyone knows who is who on the assessment team: who the technical assessor is, who are the NATA staff members and what the difference is.  If you don’t know much about the technical assessor you can google them to find out a bit more about their background. This gives you an opportunity to establish rapport right from the start and have good open lines of communication. This is small task that can make things run a lot smoother.
Stick like glue
Do not leave any assessor or NATA staff member alone to interview junior staff members.  […]

By |April 1st, 2017|ISO 15189 Accreditation, ISO 17025 Accreditation, NATA Accreditation|Comments Off on 10 Tips to Avoid NATA Paper Warfare

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?

Supervision or Teamwork?

NPAAC has produced four revisions of the Requirements for the Supervision of Pathology Laboratories document in the past 6 years.  Each of these drafts has been met with dismay by any pathology laboratory wanting to determine their most effective organisation structure and to foster a culture of teamwork, continual improvement and learning amongst all of their staff.

What follows is my quick review of the draft that was circulated in October 2016.
Supervision Requirements
S3.2 Requires full time on-site supervision to direct the operations of a pathology laboratory. The person can only supervise one category G laboratory.

S3.3 Every test must be covered by an APP with the relevant scope of practice.

The effect of these two provisions together is that there will be a lot of very bored pathologists and/or Clinical Scientists working in pathology laboratories trying to find something useful to do while they meet the full-time supervision requirements. Oh no, wait –we already know that there are not enough pathologists or Clinical Scientists to fill these roles anyway.  Where are these highly qualified, but somehow lacking in ambition staff going to come from?  Who has tried to find a full-time Immunologist lately?

How will NATA staff, encountering non-compliant organisations, insist on them meeting a requirement that they know is impossible for pathology laboratories to meet?
Risk management and handling clinical incidents
S1.6 This is repetition of what is in ISO 15189. I cannot understand why NPAAC insists on repeating things that are already in an international standard for medical laboratories.

S1.7 Again, this is repetition of one of the most fundamental requirements in any quality system.  There is nothing in this that is not already covered in ISO 15189.
Supervision Requirements for Category B Laboratories
S3.6 Specifies how many days of supervision […]

By |January 4th, 2017|ISO 15189 Accreditation, NATA Accreditation|Comments Off on Supervision or Teamwork?

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