Ensuring traceability in Australian and New Zealand laboratories

BOC Limited

Sunday, 01 March, 2020



Ensuring traceability in Australian and New Zealand laboratories

Traceability is now a common part of accreditation systems and business expectations.

With major audits conducted in Australian and New Zealand laboratories every two to four years, assessors are tasked with checking all necessary documentation to ensure accreditation is maintained. This process checks that the laboratory has the correct practices and quality systems in place to undertake the work they are contracted to do.

Failure to provide the right documentation and certificates can lead to corrective actions and, in some cases, loss of accreditation. This can have vast implications on the overall business. Put simply, if your accreditation is at risk, your business is at risk.

In recent years, traceability has become an increasing focus for assessors. Advancements in technology have seen an increasing number of businesses use analytical processes as part of their systems. This has led to a greater understanding of traceability, which is now a common part of accreditation systems and general business expectations.

For example, accreditation is important for laboratory managers in the food sector, with requirements around residue testing which can have significant impacts for food exporters. In the instance that a residue test fails and food has already been exported, this may result in food being dumped, which would have massive cost implications for the business.

In the defence sector, certification is of critical importance. For example, in a submarine where there is welding gas used to perform critical welds, businesses must prove that the welding gas meets a certain specification. Otherwise, if something happens to the submarine because of the weld, the liability sits with the business. For multibillion-dollar projects, the cost of using appropriately certified products becomes negligible. On these types of projects, customers need to use products that come with traceability so they can demonstrate they’ve used the right product if an accident were to happen.

What is traceability?

Traceability is how we know that a measurement is accurate. It involves linking the value that we say we have achieved to an international measure. It involves comparisons in measurements and considers how many steps are involved. A high level of traceability is something that has fewer ‘steps’ in the traceability chain. The fewer steps involved, the better, as there is less risk for error and lower uncertainty about the measurement.

Why is traceability so important?

Traceability is vital in ensuring measurements are accurate and that they meet required standards. Failing to use an accredited standard could break the traceability chain, costing time and money.

For example, if a laboratory were to use pure gas without a certificate to calibrate an instrument, they could be subject to corrective action in an audit. Pure gases are sold with a minimum purity, but they are not certified as such. Helium 99.99%, as an example, could be 99.99% pure or 99.995% pure or 99.9999% pure, but because the actual value is unknown, it can’t be used to calibrate an instrument. Therefore, it breaks the traceability chain because it is not certified. Using a certified pure gas provides the confidence that the instrument has a certified percentage of purity and the accredited certificate to back it up. If an accredited standard is not used, it could invalidate analytical results used for the period in which the unaccredited pure gas is used, wasting time and money.

By using reputable suppliers (ie, accredited ones) who meet high standards, decision-makers in laboratories can rest assured that they are operating to internationally accredited standards.

Conclusion

Traceability is an increasing focus for assessors and is of vital importance for Australian laboratories to demonstrate the quality of testing. Standards, accreditations and certificates are all important aspects for laboratory managers to consider to ensure traceability.

When preparing for an upcoming audit, laboratory managers should ensure they have all evidence together to show how they’ve used the correct reference materials made under a standard, by an accredited company with a valid certificate. If they are unsure about the traceability of their products, they should reach out to their gas supplier.

It is highly advisable to speak to a specialist and make sure you have the right level of certification and accreditation for your business.

BOC has a large team of scientific specialists who can advise on the correct gases to use, and are supported by a technical team. A simple conversation today can save a painful corrective action later. BOC also has the capability to supply documentation online for ease of doing business.

For more information please visit www.boc.com.au, or to read the full white paper go to https://www.boc-gas.com.au/en/images/BOC%20Traceability%20White%20Paper_tcm351-560079.pdf.

Related Articles

Nerves of steel: working on the frontline of COVID-19

Dr Harrison Steel has been directly involved in two significant projects that have impacted the...

GMP warehouse mapping: step-by-step guidelines for validating life science storage facilities

Good manufacturing practice (GMP) regulators have sharpened their focus on warehouse storage and...

Aus STEM workforce feels the blow of COVID‑19

Australia's research workforce will be severely impacted by the COVID-19 pandemic for an...


  • All content Copyright © 2020 Westwick-Farrow Pty Ltd