QUALITY MANAGEMENT Issue Integration issues Training gaps


Overlooked instructions for use (IFU)


Description


Errors in result formatting, barcode mismatches, sample ID inconsistencies


Knowledge doesn’t reach every team member, particularly those on other shifts


Assumption that everything is covered once analyser is installed and running


Consequences Serious delays, misreporting Skip key steps, misunderstand


warning messages, avoidable failures Gaps in safety, missed risk controls


Table 3. Issues, descriptions, consequences and solutions in risk-based validation and verification.


system integrates into existing workflows. Structured planning documents and


onboarding checklists help ensure that all key areas are considered—training completion, environmental suitability, LIS compatibility, routine maintenance plans, and more (Table 4). These documents also serve as useful records during audits or accreditation assessments, showing that verification and commissioning were approached systematically and with risk in mind.


Managing residual risk: benefit- risk analysis after validation Even with thorough V&V processes, some risks may remain – these are known as residual risks. Identifying and managing these is crucial to ensure that any potential negative impact on patient care is minimised.


Understanding residual risk Residual risk refers to the risk that persists after all mitigation strategies have been applied during the V&V process. It’s important to recognise that no method or system is entirely free from risk; the goal is to reduce it to an acceptable level. For example, despite calibrating an analyser and training staff, there might still be a small chance of erroneous results due to unforeseen factors.


Conducting benefit-risk analysis To determine whether residual risks are acceptable, a benefit-risk analysis is performed. This involves weighing the potential benefits of a test or procedure against its residual risks. Key considerations include clinical utility – does the test provide critical information that significantly aids in patient diagnosis or treatment? Also, severity of potential harm – what is the impact on patient health if the residual risk leads to an error? And finally, likelihood of occurrence –how probable is it that the residual risk will materialise? Now that we are in the third article, these terms should be coming very familiar by now!


For instance, a new diagnostic test


might offer faster results, enhancing patient care. However, if there’s a residual risk of slightly reduced accuracy, the


laboratory must decide if the benefit of speed outweighs the potential for error.


Documenting and communicating residual risks Once residual risks are identified and evaluated, they should be documented clearly. This documentation should include description of the residual risk including what the risk entails and under what circumstances it might occur. After the assessment, the findings of the benefit-risk analysis should be recorded. Finally, once all these are known, mitigation strategies including additional controls or monitoring put in place to manage the residual risk are included in the FMEA. Effective communication of these risks


to all relevant stakeholders, including laboratory personnel and clinicians, is essential. This ensures that everyone is aware of potential limitations and can make informed decisions accordingly.


Continuous monitoring and review Managing residual risk is not a one- time task. Continuous monitoring is vital to detect if the nature or level of risk changes over time. Regular reviews should be scheduled to reassess residual risks, especially when there are changes in testing methods or equipment, introduction of new technology or modification of existing systems. Important changes that are often forgotten are staffing – changes in personnel that might affect competence levels. Arguably most importantly are changes in patient population and requesting patterns including shifts in the


Concept Risk matrix Process Mapping Structured planning documents Description


Assess aspects of a method or equipment for potential harm, prioritise verification effort, determine additional safeguards


Starting point before routine use, highlight potential new risks, visualise system integration


Ensure key areas considered, useful records for audits or accreditation, systematic approach with risk in mind


Table 4. Planning documents in risk-based validation and verification. WWW.PATHOLOGYINPRACTICE.COM MAY 2025 29


demographics or conditions of the patient group being served.


Evaluating the Sigma metric approach: a risk-based perspective


The Sigma metric is a widely used tool in laboratory quality management, offering a straightforward way to assess analytical performance. By quantifying the number of standard deviations a process can accommodate within defined tolerance limits, it provides insight into the capability of a method to produce reliable results. However, while Sigma metrics are valuable, it’s essential to understand their benefits and limitations, especially when integrating them into a comprehensive, risk-based V&V framework. At its core, the Sigma metric is calculated using the following formula:


Sigma (σ) = (TEa – Bias%) / CV Where: TEa = Total Allowable Error (the maximum permissible error for a test); Bias = Systematic deviation from the true value; and CV = Coefficient of Variation, representing imprecision.


A higher Sigma value indicates a more robust method with fewer expected errors. For instance, a process with a Sigma value of 6 is considered world- class, implying only 3.4 defects per million opportunities.


Benefits of the Sigma metric in V&V


Sigma metrics provide a clear, numerical representation of method performance, facilitating objective comparisons between different assays or instruments. By understanding the Sigma level of


Solutions Test and risk-assess beforehand


Ongoing support and competency checks


Build IFUs into local procedures


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56