interlaboratory comparison

An interlaboratory comparison (ILC) is a process, defined by the international standard ISO/IEC 17043, for organizing, performing, and evaluating measurements or tests on the same or similar items by two or more laboratories. It is a primary form of Proficiency Testing (PT). Within a risk management framework, ILC serves as a critical verification and validation tool to assess the technical competence of laboratories and the reliability of their results. The standard ISO/IEC 17025, which outlines general requirements for laboratory competence, mandates participation in PT to ensure data quality. This activity effectively identifies systematic biases between labs or performance issues within a single lab, thereby mitigating operational risks such as product recalls, regulatory penalties, or reputational damage arising from inaccurate test data. It differs from 'calibration,' which compares an instrument to a higher-level standard; ILC evaluates the performance of the entire testing system, including personnel, methods, and equipment.

In enterprise risk management, interlaboratory comparison (ILC) is a proactive measure to ensure quality control and regulatory compliance. A typical implementation involves three steps: 1. **Planning and Selection:** The risk management team identifies test items linked to Critical Quality Attributes and selects a suitable ILC scheme from an accredited Proficiency Testing (PT) Provider as per ISO/IEC 17043. 2. **Execution and Review:** The laboratory performs the test and submits results. Upon receiving the performance report, the quality assurance unit analyzes key metrics like z-scores to identify any unsatisfactory results and investigates the root cause. 3. **Corrective and Preventive Action (CAPA):** Based on the findings, a CAPA process is initiated to address issues such as inadequate training, method misinterpretation, or equipment drift. For instance, a semiconductor company in Hsinchu Science Park participates in an ILC for silicon wafer contamination analysis. This validates their in-house lab's precision against global peers, ensuring their data meets client requirements and reducing the risk of shipping non-conforming products by an estimated 20%, thereby enhancing audit readiness for standards like IATF 16949.

Taiwanese enterprises face several key challenges when implementing ILCs. First, the **high cost** of participating in international proficiency testing (PT) schemes, including fees and logistics, can be a significant barrier for small and medium-sized enterprises. Second, there is a **limited availability** of local PT providers for specialized, niche industries, such as advanced biotechnology or specific electronics components, making it difficult to find relevant schemes. Third, a **gap in expertise** often exists in interpreting complex standards like ISO/IEC 17043 and aligning them with local Taiwanese regulations (e.g., from the Taiwan Food and Drug Administration, TFDA). To overcome these challenges, enterprises can: 1) **Collaborate** with industry associations to co-develop or commission customized, cost-effective local PT schemes. 2) **Engage** expert consultants for gap analysis and to identify the most appropriate ILCs. 3) **Prioritize** participation based on a risk assessment, focusing resources on tests most critical to product safety and regulatory compliance.

Winners Consulting specializes in interlaboratory comparison for Taiwan enterprises, delivering compliant management systems within 90 days. Free consultation: https://winners.com.tw/contact