BS EN ISO 16140-6:2019

Comprehensive Validation of Alternative Microbiological Methods

BS EN ISO 16140-6:2019 is an essential standard for the food and feed industries, providing a robust framework for validating alternative (proprietary) microbiological test methods against established reference methods. This standard ensures that alternative methods deliver reliable, accurate, and reproducible results, enabling businesses to make informed decisions and maintain the highest levels of food safety and quality.

Ensure Compliance and Confidence in Test Results

Compliance with BS EN ISO 16140-6:2019 is crucial for food and feed producers, laboratories, and regulatory authorities. This standard:

• Outlines a standardized validation protocol to assess the performance characteristics of alternative methods compared to reference methods
• Provides guidance on the statistical analysis and interpretation of validation data
• Helps to ensure the reliability and comparability of microbiological test results across the supply chain
• Supports regulatory compliance and builds trust in food safety management systems

Key Features and Benefits

BS EN ISO 16140-6:2019 offers a range of benefits for businesses in the food and feed sectors:

• Improved Efficiency: The use of validated alternative methods can streamline testing processes, reduce costs, and increase laboratory throughput.
• Enhanced Accuracy: The standard ensures that alternative methods deliver results that are statistically equivalent to those obtained using reference methods, providing confidence in the data.
• Regulatory Compliance: Adherence to BS EN ISO 16140-6:2019 demonstrates compliance with relevant food safety regulations and standards, such as ISO 17025 and HACCP.
• Competitive Advantage: Adopting validated alternative methods can give businesses a competitive edge by improving efficiency, reducing costs, and enhancing the reliability of their microbiological testing programs.

Comprehensive Validation Protocols

BS EN ISO 16140-6:2019 outlines a detailed validation protocol that includes the following key elements:

• Method Selection: Guidance on the selection of appropriate reference and alternative methods for validation.
• Collaborative Study: Instructions for conducting a collaborative study involving multiple laboratories to assess the performance of the alternative method.
• Statistical Analysis: Detailed procedures for the statistical analysis of validation data, including the calculation of performance parameters such as accuracy, precision, and detection limits.
• Interpretation of Results: Criteria for interpreting the validation data and determining the suitability of the alternative method for its intended use.

By following the standardized validation protocols outlined in BS EN ISO 16140-6:2019, businesses can have confidence in the reliability and comparability of their microbiological test results, ensuring the safety and quality of their food and feed products.