Top 5 Laboratory Assessment Non-Conformances
Achieving a perfect laboratory assessment is not an easy feat. NATA Principal Accreditation Specialist, Shelley Fox, looks back at some of the top non-conformances and how they can be avoided.
In the last year, 87% of laboratory assessments by NATA uncovered at least one non-conformance. So where did the laboratories go wrong in their assessments and what could they have done differently?
Here are the top five common examples of non-conformances and some general tips on how to avoid these danger zones.
5. Document Control
The most quoted requirements for document control are:
- Documents both internal and external that relate to the fulfillment of the requirements of the standard must be controlled.
- Documents must be periodically reviewed and updated as necessary.
- The unintended use of obsolete documents must be prevented.
So, what needs to be controlled? The answer is anything that relates to the fulfilment of the Standard. This will include (but is not limited to):
- Your internal policies, procedures and forms.
- Manufacturer’s instructions and calibration tables.
- Textbooks and posters.
Laboratories also need to make sure that there is an effective reminder system in place that will ensure that documents are reviewed by their due date. Laboratories should also consider if the review timeframes are appropriate. For example, for a document that is unlikely to change, is a 1-year review interval suitable? Or can it be extended? NATA doesn’t define the review timeframes; it is up to the laboratory to do so, but this must be based on risk.
A system must also be in place to ensure that when a document is updated, any obsolete versions are removed. For example, laboratories will often have a page from one of their procedures displayed on a wall for easy reference. There needs to be a system in place that will ensure that if the procedure is updated, that page is taken down and replaced with the new version.
Here are some examples of potential document control issues (these are inspired by real examples):
- The patient instruction handout in a collection centre was version 2 (May 2020). The current version is version 5 (July 2024).
- A laminated chart is on display in the laboratory and this is referred to when reporting results. This document was not controlled.
- Over 50 documents in the Biology department are overdue for review. These documents were due for review in October 2023.
4. Equipment
Here are at the most referenced requirements relating to equipment:
- Equipment must be verified before being placed or returned into service.
- The laboratory must establish a calibration program, which must be reviewed and adjusted as necessary to maintain confidence in the status of calibration.
- When intermediate checks are necessary to maintain confidence in the performance of the equipment, these checks must be carried out according to a procedure.
Let’s break those requirements down. Firstly, “laboratories must verify that equipment conforms to specified requirements before being placed or returned into service”. This means new equipment needs to be verified before it is used.
For example, the laboratory cannot assume that a new piece of equipment is ready to use as soon as it is unpacked. There needs to be a verification process whereby the laboratory demonstrates that it is fit for purpose in their own hands.
Similarly, equipment that has been taken out of service needs to be verified before it is placed back into service. And records need to be available to demonstrate that this took place.
Nonconformances relating to equipment calibrations and checks are also common. To find more information about the requirements, you can refer to the NATA General Accreditation Criteria for Equipment Assurance, In-House Calibration and Equipment Verification. Appendix A provides some guidance as to how to create an equipment assurance program. NATA also has a General Accreditation Guidance Document with an equipment table. This document provides guidance for establishing calibration and checking intervals for equipment.
Examples
Here are some examples of potential equipment non-conformances:
- A second automated chemistry analyser was installed in July 2024. The analyser was the same make and model as the existing analyser. The new analyser was not verified before use.
- When intermediate checks are necessary to maintain confidence in the performance of the equipment, these checks must be carried out according to a procedure. The six-monthly check for a 1 mL pipette was due in July 2024.
3. Test reports
The way in which a laboratory reports its results is crucial for customers. The standards are very detailed in the requirements for reporting of results. Results must always be reported accurately, concisely and unambiguously, and include all available information necessary for the interpretation of results. The standards are also very specific in detailing the minimum content required for reporting.
- Some of the most common examples of non-conformances that we have seen in relation to reporting are:
- Missing the minimum report requirements as detailed in the relevant standard.
- Results reported outside the scope of accreditation or carried out by external providers have not been clearly identified.
- Failure to identify amended reports.
Examples
- Test C was performed at the collection location (as opposed to within the laboratory). However, the report did not indicate this.
- The amended report sent on 1 May 2025 did not include a clear identification of the change or the reason for the change.
- The report issued on 15 April 2025 included the results of an unaccredited method. The report included the NATA endorsement, but the unaccredited method was not identified as such.
2. Training and competency
The second most common nonconformance was in the area of Training and Competency. The most quoted requirements were:
- Laboratories must document the competence requirements for each function within the laboratory.
- Personnel must be authorised to perform specific laboratory functions.
- Appropriate records and documentation must be kept.
To avoid this danger zone:
- Ensure the competency requirements for each task have been documented. This includes the skills, the knowledge, and the attributes needed for the task.
- Ensure that there are records to support that the staff member has been deemed competent.
- Consider laboratory activities such as validations and verifications, analysis of results and authorisation of results. For example, if staff are responsible for undertaking method validation, are there records to demonstrate that they have been deemed competent to do so? Similarly, if staff are responsible for analysing and authorising results, have they been deemed competent to do so?
Examples
- The competency requirements (i.e. the skills, knowledge, and attributes to undertake method B) had not been documented.
- There were no records to demonstrate that the person undertaking test C on the day of the assessment had been trained and deemed competent to do so.
- Competency assessments were overdue for five staff.
- There were no records to demonstrate that the person who undertook the validation of method D was authorised to do so.
1. Technical records
The most common non-conformance that NATA is currently seeing is in relation to technical records.
Here are the most quoted requirements:
- Records for each laboratory activity must be retained and contain sufficient information to allow for traceability and reproducibility.
- Records must include the date and identity of the personnel responsible for each relevant laboratory activity.
- Amendments to records must be traceable to previous versions.
Some of the most common issues that we are seeing include:
- Insufficient information or data recorded to establish an audit trail. For example, it is important to record the identity of the staff performing each task or the details of the equipment used, etc. There needs to be enough information to establish an audit trail.
- Original observations, data, and calculations not recorded.
- Records illegible or amendments not signed or dated.
Examples
- The worksheet used for test A did not identify the staff member performing the testing and this information was not traceable elsewhere.
- The staff member responsible for checking data transcription and authorising results was not recorded.
- Original observations must be recorded at the time they are made. Technicians do not have access to a computer for direct entry of data and the data is not recorded until a later stage when they do have access.
- Several amendments to handwritten data were noted and were made in such a way that the original data was obscured. Further, the amendments were not signed and dated.
Expertly dodge the danger zones
These were the top five areas resulting in non-conformances over the past year. There are certainly other types of non-conformances, but they do not happen as often as these.
Whether you are a new laboratory considering accreditation or an already established laboratory, by being aware of these danger zones, you can better place your facility to meet the requirements.
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.