QUALITY MANAGEMENT Benefits of Harmonisation


Consistency in Patient Care: Standardised V&V practices mean that patients receive the same quality of testing and interpretation, irrespective of the laboratory they attend.


Enhanced Quality Assurance: Uniform procedures facilitate the implementation of


harmonised approach can simplify adherence to international standards such as ISO 15189.


Challenges to Achieving Harmonisation Variability in Resources: Laboratories


differ in terms of equipment, personnel expertise, and financial resources.


Implementing Harmonised Practices


Develop Standard Operating Procedures (SOPs): Collaborate with professional bodies and other laboratories to create SOPs that outline standard V&V processes.


Adaptation to Local Needs: It’s essential to retain Participate in External Quality Assessment Schemes flexibility to address specific local or regional


comprehensive quality assurance programmes. health concerns and patient demographics. Regulatory Compliance: Adopting a


Change Management: Transitioning to harmonised practices requires effective


change management strategies, including staff training and updates to existing protocols.


Table 5. Harmonisation practices for a common approach to risk-based validation and verification.


a method, laboratories can tailor their QC strategies. Higher Sigma processes may require less frequent QC checks, while lower Sigma processes might necessitate more stringent monitoring. Laboratories can prioritise resources and attention towards methods with lower Sigma values, identifying areas that need improvement to enhance overall quality. All of this has risk at its core, so applying a method such as this where higher risk assays are focused on for improvement aligns with our desire for risk-based V&V.


Limitations from a risk-based perspective


While the Sigma metric offers valuable insights, relying solely on it can be limiting due to its focus on only analytical performance. Sigma primarily addresses analytical errors, potentially overlooking pre-analytical and post- analytical factors that can significantly impact test outcomes. Also, the choice of performance specification, if it is restricted to biological variation, as is common, is not clinical risk based, when compared to clinical outcome studies or simulations that link performance to risk of patient misdiagnosis. Sigma assumes stable processes, in particular with choice of bias value for determination of the process Sigma metric. This may not account for variations due to environmental factors, operator differences, or equipment wear over time, particularly once a method is in use. In doing so it may oversimplify the complexities of real-world laboratory operations that might not be fully captured by a single metric, leading to an incomplete risk assessment. That being said, the Sigma approach is still considered a very useful approach to V&V and setting up processes in the initial phase.


Integrating Sigma metrics into a risk-based framework To harness the strengths of the Sigma metric while mitigating its limitations, laboratories should combine Sigma with risk assessment tools like FME and FTA


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to gain an holistic view of potential risks across all phases of testing. Central to achieving this is to evaluate how analytical performance, as indicated by Sigma, aligns with the clinical purpose of the test. Some assays may require higher precision due to their critical role in patient management.


By thoughtfully integrating Sigma metrics into a broader, risk-based quality management strategy, laboratories can enhance their V&V processes. Of course, if this approach is applied across all disciplines it also helps with harmonising approaches for V&V.


Harmonising validation and verification practices across laboratories A harmonised approach aims to ensure consistency, reliability and quality of test results, regardless of where they are performed. There are many factors to consider, as shown in Table 5. By systematically addressing these


areas, laboratories can work towards a more harmonised approach to V&V, ultimately enhancing the quality and reliability of laboratory services across the board.


Designing a common validation approach Creating a comprehensive validation package helps ensure laboratory methods and equipment perform reliably and safely. By adopting a risk-based approach, laboratories can focus their validation efforts on areas with the highest potential impact on patient care, aligning with standards such as ISO 15189:2022. In Table 6, we can see that the same tools will help support these efforts.


Implementing a common validation approach Customise each component of the validation package to reflect the unique aspects of the laboratory’s environment, patient population, and regulatory requirements. It’s a good idea to get


stakeholder involvement early by engaging with laboratory personnel, quality assurance teams, and clinicians, throughout the validation process to ensure comprehensive risk identification and mitigation. And of course the process should be completed, and monitored prospectively by recognising that validation is an ongoing process. Regularly review and update the validation package to incorporate new information, address emerging risks, and adapt to changes in clinical practice or technology.


Continuous monitoring and the validation lifecycle Validation is not a one-time event but an ongoing process that ensures laboratory methods and equipment consistently perform as intended. Continuous monitoring throughout the validation lifecycle is crucial for maintaining quality and mitigating risks in laboratory operations. To integrate continuous monitoring post V& effectively V, laboratories should use Key Performance Indicators (KPIs) by defining measurable metrics that reflect the performance and stability of methods or systems. Such data require regular review through scheduled assessments of monitoring data to identify trends and implement corrective actions as needed. Findings should be documented and maintained using comprehensive records of observations, and interventions, to support transparency and accountability.


Conclusions


In this article, we’ve explored the application of risk-based thinking in laboratory V&V processes. By integrating tools such as Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA), Root Cause Analysis (RCA), and Process Mapping, laboratories can proactively identify and mitigate potential risks. These tools are then used to supplement the traditional method comparison, linearity, imprecision etc studies with which we are


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(EQAS): Engage in EQAS to benchmark performance against other laboratories.


Utilise Standardised Validation Tools: Implement validation and verification toolkits that provide templates and guidelines for consistent method evaluation.


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