..and how to avoid them
One of our clients recently told Rachel she was the friendliest quality person she’d ever met.
She was, naturally, quite pleased to get that feedback. But it got us thinking…what does this say about all the other quality people out there?
You can’t all have resorted to nagging the laboratory staff to get things done…Or have you?
If you’ve had a NATA assessment and found yourself slipping into “just do it!” mode, take a breath. You don’t want to create feelings of resentment or annoyance from lab staff. And “just doing it” won’t necessarily lead your lab to improvements, which is meant to be the whole point of a quality management system anyway!
So, if you or your quality manager find yourself guilty of having resorted to unhelpful behaviours so your lab gets ready for NATA, it might be time to revisit your approach to the quality management system. Here are our Five Deadly Sins of quality and compliance…and how to avoid them.
#1 Fear of the assessment, AKA ‘Oh hell! NATA is coming!’
If you’re simply nervous about NATA coming, there are a few valuable things you can do to help calm your nerves.
- Get a copy of the last NATA assessment report and re-audit the issues they found. Don’t just rely on the fact that the issue is shown as “closed” in your non-conformance system.
- Remind yourself that you managed the last assessment and have improved your systems as a result.
- Do a gap analysis between where you are now and the standards you will be assessed against.
- Do you notice anything? Is there alignment with with the quality improvement cycle? Have you followed the process: Plan, Do, Check, Act?
Knowing exactly how your lab meets requirements means you can be confident going into the assessment.
#2 Staff not engaged…or worse, they complain about requirements
There’s also the possibility that some of these tasks may not be necessary. So, to keep your staff engaged as much as possible (and weed out unnecessary tasks), ask yourself these key questions:
- Do, or can, we use this data to improve our service?
- Have we set data-informed limits for acceptability?
- Are the right people seeing the data to get the most value out of it?
- What do managers need to see to know that the lab is on track?
If, after answering these questions, all the little tasks are still required, show some empathy with your staff and let them know why they need to do these tasks and how this helps the lab meet the requirements.
By reminding them how these tasks impact the lab’s assessment and overall performance, you are reinforcing how valuable they (and the work) are to the lab.
Show them you value their work…and that it’s essential to maintain quality.
Consult and set up your system with your team.
Support them to get it right. Make your quality system visible and easy to follow.
#3: The endless hamster wheel, AKA ‘I don’t understand why NATA says we should do this’
Some labs are doing tasks that make no sense to them, their manager or the quality manager. NATA may have insisted on a specific course of action, and you have not been able to get NATA to accept that it doesn’t help at all.
For example, one of our clients was told to record each time they cleaned their biohazard cabinet. We asked our client:
- Does recording each time you clean the biohazard cabinet make it more likely it will happen?
- Is there evidence of contamination in your method blanks?
- Is there a chance that someone might think someone else has done it?
As it turned out, NATA’s finding was tied to the requirement for records of equipment maintenance. Recording equipment maintenance gives you a history of the performance of the equipment so that you can plan for replacements, etc. Cleaning is not maintenance, so as our client was able to answer ‘No’ to each of the above questions, they were able to drop this requirement.
However, if they’d answered ‘Yes’ to one of these questions, recording it might have made sense and influenced their procedures.
Instead of telling your team to ‘just do it”, do some research.
Look up the accreditation requirements referenced in the NATA finding.
Check your gap analysis to understand how your lab meets this requirement.
Look for evidence that your process is working without having to implement the change NATA has suggested.
Be prepared to drop the activity in the future after the dust has settled. If a NATA assessor has specified it in detail, it could simply be their opinion of how the accreditation requirements should be met.
#4: Did they swallow a textbook? AKA not understanding accreditation requirements
Feeling like you don’t understand the ISO 17025 or ISO 15189 requirements is sure to mean you worry about all the things that NATA might find during your assessment. Even if you feel fairly sure you’re doing all the right things, it can be hard to shake the feeling that there are hidden traps in your lab processes that only NATA knows the location of!
So, the best form of defence here is to get educated. There are several courses available on how to meet NATA requirements, like this one from Maree Stuart and this other one from NATA.
Make sure you have a clear understanding of the intent behind requirements in the standard.
Consult at the Coalface – i.e. Do a GAP analysis with your team, so you understand their issues and bring them on board with any necessary changes.
Speak to a consultant. They can do all this work for you, educate you and your team, and give you ideas on meeting requirements more effectively.
#5 Guilt, fear, frustration, AKA ‘It’s my fault that the lab doesn’t comply with the ISO requirements’
While it is your job to provide workable systems for staff to use, it’s not your job to do it all. So, create a process that ensures everyone does their part and seek help when you need it. Your process doesn’t need to be onerous. Simply follow these key steps to ensure compliance:
Study the current process to see how it might already meet that requirement.
Build onto your existing systems, rather than design a whole new process.
When you implement new processes make sure you include initial training and a plan for how you will share updates and other information with your team.
Check in with your people from time to time. Revisit the findings and be prepared to accept feedback from NATA, consultants and your team.
Create procedures that can be audited in the future.
Hounding your team or stressing out when a NATA assessment is due isn’t necessary. If you follow our tips above, you’ll find that you’re prepared, open to suggestions and confident you can implement any relevant suggestions.
You may also find that people are starting to call you a ‘friendly’ quality person…now wouldn’t that be something?
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