Keep your technical competence on track between assessments
If your lab is NATA-accredited, you’re sitting pretty – NATA has off on the findings from your last assessment, all your documents are up to date and you’ve completed a management review. So, everything is in order, right?
Not quite. All you need is to get a different lead auditor or technical assessor with a different approach, and you could see a whole raft of new issues at your next assessment.
As the person ultimately responsible for your lab’s performance, you need to ensure the fundamentals are sound, even if you’re not personally handling every operational detail. While you may rely on your team to manage day-to-day technical work, training schedules and document updates, the final responsibility for overall compliance and competence is yours.
So, should you sweat about document control and training records, or are there more important things to check on first?
Yes. You need to do both.
So how do you know where to focus your energies?
By stepping back and assessing how you are keeping up with the fundamentals of technical competence.
The 6 Pillars
There are 6 pillars of technical competence you need to maintain to keep your NATA accreditation.
They also happen to be the fundamentals that you need to focus on when managing the risks inherent in a laboratory-based business.
1. Laboratory Personnel
The right staff right now
If you’ve had staff changes since your lab originally got accreditation, you should review who is still on the team. You need at least one person who is the testing expert: the person who gets right into the technical details of the methods. It’s also important to review the other 5 pillars with the whole team to ensure everyone understands how important they are to your lab’s overall success.
Develop your team
As your business grows, it’s important to keep training other staff members to cover this role when needed. Give them experience in the demands of the role before they have to do it without backup. Don’t wait until your key technical person is about to take long-service-leave (or hospitalised!) to start expanding your staff skills.
Check processes
Are some staff more trusted than others to do particular tasks? Is it because they’re just smarter or do they know the pitfalls of undertaking certain tasks? Find out why they’re the ‘go-to’ for this task and see if you can make changes so it’s easier for everyone to get it right.
Employ the right people
When you’re hiring new staff, check NATA’s specific requirements for staff in the standard application document (ISO 15189) and specific accreditation criteria (ISO 17025) and make sure your current people meet their requirements.
Do the work
Despite what impression you may get from NATA assessments, training records do not equal actual training. Do the training, make some records of what tests and activities you covered, then you can attach those to the formal training records later on. Making records of training is a side activity to doing the actual training. Don’t be distracted from that.
2. Methods / tests
Keep your knowledge of methods up to date.
Review your test numbers and run refreshers for methods that haven’t been performed for a while. Depending on the method, staying in touch with infrequent tests could include running the QC material, reading through the method, calibrating the instrument or doing a proficiency sample.
Subscribe to services that will keep you updated on the standard methods you reference. Don’t wait until NATA comes out and tells you that you should have updated 6 months ago!
Keep an eye on relevant regulators as requirements may change over time. Stay on top of the regulations and know in advance when you will have to change methods.
Keep your test menu up to date
Get accredited for new methods that will be worth the ROI.
Find out what other methods your clients may want you to be accredited for (ask them what they want and check your competitors out on the NATA website). It’s good business sense to do more work for current, hopefully happy, clients than spend time and money trying to find new ones.
Since you are already NATA accredited, you don’t need to wait for NATA to tell you what information they want to see! You have been down this path before. Assemble it for them while you validate your methods and send it in.
Make the process easy for NATA by submitting a solid folio of information, covering (guess what?) the 6 pillars outlined in this blog.
3. Equipment
Talk to your staff about the equipment they are using. How reliable is it? How much time do they spend maintaining it? Better still, get them to show you.
It’s an uncomfortable truth that staff will find ways to work with poor or failing equipment. They may even assume you already know about it (and can’t be bothered fixing it). Make it clear to them that you’d rather fix the equipment than be horrified by the delays caused by it.
Have a plan for replacing old or out-dated equipment and be prepared to discuss what you are doing about unreliable equipment with the NATA team.
4. Facility and environment
How organised is your testing area?
How is the lab or field kit going? Is the place you do all your important testing getting a bit crowded, damaged or untidy? Does everyone know where everything goes?
Even if you don’t cross-train staff or bring new staff on board that often, you need a visual workplace where everyone can easily see where to put things away. It saves time and unnecessary decision points for everyone.
What are the conditions for testing?
Review again those points you looked at when you were going for accreditation. Consider conditions such as lighting, temperature and humidity; the use and effectiveness of alarms; and the protection of staff and equipment from samples, and vice versa.
5. Calibrations and maintenance
Review your calibration program.
Look at the results you are getting and make some decisions. If you have years of data showing that no adjustments ever needed to be made, perhaps you may not need to do the calibrations so often. Ask yourself if all the calibrated equipment is currently in use. Is your lab manager just filing reports away, assuming the calibration company will let them know if there’s a problem?
And finally, check a few calibration reports to make sure[MA6] the information in them is being actioned.
6. Proficiency testing and QC
Be diligent reviewing internal and external QC, and not just the data!
Review what internal QC you are running and if there are any new or better QC materials you can adopt. Look for new proficiency testing programs that may cover your scope of testing better than ones you’re currently enrolled in.
And of course, keep reviewing internal and external QC data to look for patterns and make sure it’s accessible so you can update your method validations from time-to-time.
Proficiency testing and quality control underpin your confidence in your test results and give valuable data for competency assessments. Give them the respect they deserve.
Finally ….
Once you’ve reviewed the 6 pillars, assess the associated risks and formulate a plan to address any issues raised. If there’s a direct impact on your test results, get on to it immediately. If not, you can spend a bit more time to address the problem.
Accreditation is not something you can simply superimpose on your lab. It takes time and commitment to build and maintain strong standards. If NATA accreditation alone isn’t enough to drive you, remember that by embedding these practices into your operations you’ll not only meet compliance requirements, you’ll also have every reason to feel proud of the quality and consistency of your laboratory’s work all year round.
If you’re not sure whether your lab is still up to scratch, a fresh set of eyes can help. Contact us today if you’d like reassurance that you are on the right track.