The Less Fashionable Forms of Traceability
Much time is spent on NATA assessments discussing traceability – metrological traceability. But what about the other forms of traceability? They are just as important!
In this article we highlight the requirements for the other forms of traceability, covering traceability of records and samples. But before we get too far into things, we have a simple question…..
Why is Traceability necessary?
There are a variety of answers that could be given to this question. We’ll leave you to work out the answer(s) now, with the correct answers given at the end of this article (no peeking!).
- Because people in Ivory Towers like to think up new ways to torture us
- It helps us to minimize any costs resulting from supplier issues or recalls
- To ensure the reliability and comparability of measurements
- To improve quality control systems and reduce risk
- Because it is in the accreditation standards
What is traceability?
The Cambridge English Dictionary gives two definitions of traceability
- the ability to discover information about where and how a product was made
- the ability to find or follow something
Both definitions reflect the forms of traceability covered in the standards. The first relates to attributes of samples, while the second relates to both samples and records and the ability to track what happened through a process.
Traceability of samples basics
When it comes to sample traceability, for many labs it starts when the sample arrives at the lab, hopefully accompanied by some documentation. With little control over what has gone on with sampling and sample collection, there is a lot of trust in the provider of the sample over the accuracy of the information accompanying the sample.
Once the sample hits the lab, the chain of custody and identification process is more within the control of the lab. Labs must establish procedures for the transport, receipt, storage, handling, retention, and disposal of samples and keep records of these activities. This is important, as it ensures the movement of the sample from lab “cradle to grave” is controlled and known.
A critical aspect of sample management is the system for uniquely identifying the samples or items. This is often a component of the chain of custody process. This identifier should be recorded and maintained throughout the entire testing or calibration process.
Typically we give some sort of sample number when there are lots of samples or use a serial number for pieces of equipment. The system for sample identification does not need to be super complex with secret codes using Julian calendar dates. Keep it simple so you can easily find samples and their associated records.
Introducing tech to sample management
A common problem in labs arises from sample mix-up. Tran reported in 2020 that “Up to 75% of all medical testing errors occur during the pre-analytical phase with the majority happening before any specimen arrives at the laboratory. These include errors such as mislabeling of specimens, delayed transportation, collection into the wrong specimen container, inadequate specimen collection.” That’s a lot of errors outside of testing and calibration activities!
The area of sample management is clearly some low-hanging fruit, ripe for the picking. The good news is that a plethora of solutions are at hand!
Many people already know about bar codes and even QR codes, thanks to the COVID-19 pandemic. The decreasing costs and increasing accessibility of the equipment to produce and read these codes mean this kind of solution is attractive, provided you have some electronic system to capture and retain the embedded data.
Developments like wearable chips, blockchain, smart tags, and wifi mean that more robust systems with greater, more secure data are possible. One such approach is the RFID tag or smart label.
A smart label works by encoding, storing, and transmitting data which is read by a device. It can include technologies such as a Time Temperature Indicator (TTI), which enables critical information on perishable materials to be shown. A TTI uses colour-changing technology to indicate how long a sample has been in transit, whether it has been stored at the right temperatures and the remaining holding time since collection.
Not only can you have information on the provenance of a sample, but you can also have data on environmental and other critical considerations for the sample.
Records traceability
Your lab activities must have records that are detailed enough to replicate the exact process that produced them. Who did what, when, and how?
This means that labs need to consistently record all relevant factors and retain all the original records and any amendments. Alterations to records need to show when the alteration was made, who made the alteration, and clearly show what was altered.
This all seems simple enough, but many labs fall foul of the requirements for record keeping. People forget to record all of the details. Sometimes the forms used do not accommodate the recording of all details. Occasionally, there are issues with the integrity of information and transformation into the final result via calculations.
Going digital
The advent of electronic LIMS has helped overcome many of these challenges. However, these days we need to consider aspects such as the security of data, and access to audit trails to uncover alterations to data.
If you are transitioning from manual to electronic record systems, there are some tips for getting the most from the new system.
The first step is to identify and evaluate the risks associated with manual record-keeping practices. That will help determine the critical weaknesses you seek to address. Also, identify the opportunities for going fully digital with records. These are the things you will want to maximise.
Then, in designing the system and specifications for a LIMS, don’t design the system to make it easy for an external auditor. Do design the system so you can find records and see details efficiently
Other things to consider when introducing a digital records or sample traceability system are listed below.
- Integration with existing equipment and information management systems
- Spatial requirements
- Cybersecurity
- Validation of system
- Cost vs Benefit by considering sample throughput levels and any limitations from existing ancillary technical equipment to support the old and new systems.
The Final Word
The less fashionable types of traceability are no less important than their flashier cousin of metrological traceability. They may not hog the limelight at an assessment, but they are always in the background and can contribute significantly to a well-functioning lab.
There are great opportunities to innovate and improve these aspects of labs and improve the reliability of results. It need not mean everything goes digital. Acknowledgment and evaluation of weaknesses of existing systems and where you can get the most “bang for your buck” are essential. Remember, you don’t have to implement any digital system to meet accreditation requirements. However, a well-designed system can definitely increase productivity and reliability of outputs.
If you think there might be some things to do in the areas of sample and record traceability, we can help. It might be all you need is a quick phone call to toss around some ideas. We’re here to listen.
And the correct answer to the question? All of the above if you’re a cynic; (b)-(e) if you’re a NATA assessor; or (b)-(d) for everyone else.