If the top five non-conformances were not enough reason to uplift your laboratory practices, NATA Principal Accreditation Specialist, Shelley Fox, highlights some more common pitfalls and how to dodge them.
In a recent article, we highlighted some of the top non-conformances by laboratories. Hopefully that provided a guide to where some laboratories can go wrong and ways to avoid them.
If you are keen to learn about other common non-conformances our assessors typically encounter, then read on:
5. Controlling documents
If it is anything that relates to the fulfillment of the standard, it needs to be controlled.
If a document, such as a textbook, is used as a reference when reporting results, it must be controlled. It also needs to be authorised for use and needs to be removed if it has been deemed obsolete.
Similarly, if a poster is used for reporting results, it must be controlled for the same reasons as the textbook. If staff refer to manufacturer’s instructions or a kit insert when performing a test, they must also be controlled.
4. Reviewing and updating of documents
Assessors from NATA often come across documents that are overdue for review. Laboratories need to make sure there is an effective reminder system in place to ensure documents are updated by their due date.
NOTE: NATA does not set the due dates. That is up to the laboratory to determine.
A laboratory should also be asking the question, “Are the review time frames appropriate?” For example, if there is a document that is unlikely to change or it is a low-risk document, is a one-year review timeframe suitable or can it be stretched to two years?
NOTE: NATA does not define those time frames. It is up to the laboratory to do so, but this must be based on risk.
You cannot simply stretch everything out to five years because you are not going to get to it. The laboratory must meet those review time frames.
3. Unintended use of obsolete documents
Laboratories need to have a system that will ensure that when a document is updated any obsolete versions will be removed.
For example, documents will often have a page of one of their procedures displayed on the wall for easy reference, which is fine. However, there needs to be a system in place that will make sure that if that master procedure is updated, that page is taken down and replaced with the current version.
NATA assessors can see when things have been taken down on the morning of the assessment. They can spot the telltale signs of Blu-Tack on the wall or a square spot on the wall that is a different colour to the rest of the paint.
Also beware of Post-It notes. It is not uncommon for the assessment team to see notes stuck on procedures or on the side of equipment containing instructions or additional information that is not provided in the procedure.
2. Equipment calibration
The next most common non-conformance relating to equipment is calibration. Equipment calibration is:
- Required when the measurement accuracy or measurement uncertainty affects the validity of the reported results.
- To establish the metrological traceability of the reported results.
When it has been determined that calibration is required, a calibration program must then be established. Facilities are responsible for establishing their own equipment assurance program.
1. Equipment checks
One of the most common equipment-related non-conformance relates to equipment checks. When intermediate checks are required by the Standard, these must be carried out according to a procedure.
There are two NATA documents available on our website that assist with this. The two documents should be read together.
The first is NATA General Accreditation Criteria for equipment assurance, in-house calibration, and equipment verification. Of note is appendix A, which provides some guidance as to how to create an equipment assurance program.
Secondly, there is the NATA General Accreditation Guidance document. This is more of a guide as opposed to accreditation criteria, but contains a very helpful equipment table. This document provides guidance for establishing calibration and checking intervals for equipment.
Be ready for anything
Together with what I covered in my earlier article, you should now be aware of the top areas resulting in non-conformances at laboratories. Not all of these hints and tips may apply to you or your laboratory, but hopefully they will provide an insight into what is happening in laboratories and how and why NATA assessors pick up on the non-conformances.
About the Author
Shelley Fox is a Principal Accreditation Specialist at NATA, bringing over 12 years of service. Throughout her tenure, Shelley has worked in the Human Pathology and Forensics Sectors, evolving from her initial role as a Lead Assessor to Principal Accreditation specialist, serving as a support to an Accreditation Team Leader and performing higher level duties. Most recently, she has had a lead role in NATA’s review of its Forensic Science program. Before joining NATA, Shelley worked in the field of pathology, working as a scientist, quality manager, WHS coordinator and operations manager.