QUALITY MANAGEMENT
is flawed – but they show why local verification must take into account the reality of your working environment.
Implementing risk tools can help laboratories focus on what really matters: reducing error, improving results, and supporting better clinical outcomes.
Instead of blindly repeating manufacturer claims, laboratories can tailor their V&V plans to focus on what matters: how the method will be used, where it might fail, and how to reduce the risk of harm. In the process, V&V becomes more meaningful, more defensible, and more aligned with the laboratory’s broader responsibility to manage risk and ensure safe, reliable results.
Verification of standard methods and equipment commissioning Verification often gets less attention than full method validation, but it’s just as important, especially when risks aren’t immediately obvious. Verifying a standard method or introducing new equipment isn’t just about checking numbers against instructions for use (IFU), it’s about confirming that everything works in your laboratory, with your staff, under your conditions.
Risks unique to verification Even when using a well-established IVDR/CE-marked analytical system, there are important risks that can influence performance in ways that wouldn’t be captured in manufacturer validation studies. Setting up new equipment brings its own category of risk. Even when installed by the manufacturer, there’s no guarantee it will operate flawlessly in your
Local factors for consideration Environmental conditions Matrix effects
Operator variability Details
Room temperature, humidity, power supply stability High lipid content, haemolysis, icterus
Staff loading samples, interpreting interface messages, responding to flags
Table 2. Local factors for consideration in risk-based validation and verification. 28
specific setting. Table 2 summarises some effects specific to the local laboratory that should be considered in a risk-based context. Environmental conditions can subtly but significantly affect method performance. A method that performs perfectly in a temperature-controlled manufacturer facility may behave differently in a busy, fluctuating clinical laboratory. Factors like room temperature, humidity, or even power supply stability can introduce variability that’s easy to overlook unless it’s considered during verification. Matrix effects are another common issue. Manufacturers may verify methods using clean, pooled or artificial sample matrices, but real patient samples can behave very differently. For example, high lipid content, haemolysis, or icterus may interfere with certain assays and are tested by manufacturers to give operating limits. However, this interference may be more common in your patient population than anticipated, and therefore may carry a different risk than that which was validated by the manufacturer. Operator variability also matters. Even semi-automated methods still rely on staff to load samples, interpret interface messages, or respond to flags. A method verified by a specialist during a manufacturer’s site visit might perform differently when used by the full team. These risks don’t mean the method
Risks during equipment implementation Integration issues are common when connecting analysers to laboratory information systems (LIS) or middleware. Errors in results formatting, barcode mismatches, or sample ID inconsistencies can all lead to serious delays or misreporting. These problems might not emerge until routine use unless they’re tested and risk-assessed beforehand. Training gaps often emerge after the initial rollout. While manufacturers typically offer training at installation, the knowledge doesn’t always reach every team member – particularly those on other shifts. Without ongoing support and competence checks, users may skip key steps or misunderstand warning messages, leading to avoidable failures. Overlooked instructions for use (IFU) can also create gaps in safety. It’s easy to assume that once the analyser is installed and running, everything is covered. But manufacturer IFUs often contain important risk controls – like warm-up periods, reagent storage conditions, or recalibration triggers – that must be built into local procedures to ensure ongoing safe operation. Table 3 shows just a few of the hidden vulnerabilities that can emerge if risk isn’t actively managed during implementation.
Using risk tools to support verification and onboarding This is where structured risk assessment becomes really valuable. Rather than relying on intuition or checklist habits, tools like risk matrices, process maps, and structured planning templates can make onboarding and verification more robust. A risk matrix allows laboratories to assess which aspects of a method or piece of equipment pose the greatest potential for harm. For example, a test that directly influences emergency treatment decisions – like potassium, glucose or troponin – should maybe prompt a higher level of scrutiny than a low-risk screening assay. The matrix helps prioritise verification effort and determine when additional safeguards (like confirmatory testing or higher QC frequency) are needed. Process mapping is an ideal starting point before bringing equipment into routine use. Mapping out every step – from sample receipt to result reporting – can highlight areas where new risks might be introduced, such as changes in data flow, reagent handling, or user interfaces. It also helps staff visualise how the new
MAY 2025
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