QUALITY MANAGEMENT
Risk-based validation and verification in medical laboratories: an overview
The third in Stephen MacDonald’s latest series of articles focuses this month on the use of risk-based approaches and the application of methods such as FMEA, FTA, RCA and Process Mapping.
In the first two articles of this series, we introduced the principles behind risk- based approaches and explored tools like FMEA, FTA, RCA and Process Mapping. These methods help laboratories identify where things might go wrong, understand why, and put controls in place before problems impact patient care. This third article starts to apply those
tools. We’ll look at how risk-based thinking can be applied to method validation and verification and bringing new equipment into service. These are familiar processes – but by approaching them in a risk-based approach, we can make them more patient-focused. We will also tackle two broader topics. First, we’ll take a closer look at the Sigma metric. It’s a well-known tool for validation and quality control (QC) planning, but how well does it work from a risk perspective? Second, we’ll consider whether a shared, harmonised approach
Method Process Mapping
Failure Modes and Effects Analysis (FMEA)
Fault Tree Analysis (FTA)
Root Cause Analysis (RCA)
Description
Visualises each step in a method or workflow, from sample receipt to result reporting
Identifies where things are most likely to go wrong, how severe the consequences would be, and how easy it is to detect a problem
Begins with an undesirable outcome and works backwards to uncover combinations of failures
Investigates why a method failed validation,
why an instrument didn’t perform as expected, or why verification results fell outside expected ranges
Table 1. Risk assessment tools used in medical laboratories for validation and verification.
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to validation and verification could make things simpler and more consistent across different laboratories.
This article aims to show how implementing risk tools can move us beyond tick-box validation, helping laboratories focus on what really matters: reducing error, improving results, and supporting better clinical outcomes.
Risk-based thinking in validation and verification Validation and verification (V&V) are essential in ensuring that methods and equipment in the laboratory work as expected. But often, these processes are treated as a one-off technical check – something to get done and signed off. A risk-based approach shifts that mindset. Instead of simply confirming performance, it asks: where could this go wrong, and what would happen if it did? Risk-based thinking brings context to
Purpose
Spot risks like delays, handover points, manual data entry, or human judgement when the method is in clinical use
Score and prioritise risks for mitigation planning before validation starts
Design controls for high-risk tests or complex equipment and include them in the V&V to review effectiveness
Ensure fixes target the real problem, not just the symptoms
V&V. It considers not just the test system itself, but how it fits into the laboratory’s workflow, how it’s used by staff, and how results impact clinical decisions. For example, a new analyser might perform well under controlled conditions, but will it still do so during busy shifts, with different operators, or when environmental conditions vary? By using risk tools such as FMEA,
FTA, RCA, and Process Mapping, we can identify points where failure is more likely or could cause more harm. That helps focus validation efforts where they’re needed most. This approach is also in line with ISO 15189:2022 and ISO 22367:2020, which both call for laboratories to evaluate risks across pre- analytical, analytical, and post-analytical stages.
Ultimately, risk-based V&V isn’t about doing more work – it’s about doing smarter, more relevant work. It allows laboratories to plan validations that reflect real-world risks and make decisions that protect patient safety. To make this practical, laboratories can use four key tools, shown in Table 1 as a reminder, but also reviewing with a V&V focus.
Using these tools doesn’t mean more paperwork – it means smarter validation.
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