Globally, food safety has some room for improvement. According to the World Health Organization, almost one in 10 people falls ill each year after eating contaminated food, and 420,000 die as a result. These illnesses can stem from issues around physical and chemical contaminants, additive and pesticide testing, and allergen labeling. To prevent these issues, manufacturers must ensure and prove food quality, i.e., the set of physical, chemical, biological, and sensory characteristics that make the product safe and acceptable to consumers.
To ensure process consistency and control in testing, manufacturers need food safety standards to guide their procedures. Food safety standards include measures put in place to prevent physical, chemical, and biological contaminants. The International Organization for Standardization (ISO) is an independent, non-governmental body that brings together experts from around the world to develop and share international standards.
Laboratories that conduct food safety testing often look to adhere to ISO 17025, a standard that outlines general requirements for the competence of testing and calibration laboratories. ISO 17025 helps to safeguard consumer health by ensuring that results produced by food testing laboratories are of sufficient sensitivity, reliability, and accuracy.
To better manage food safety, FDA has mandated that the testing of imported food and addressing food safety problems must be conducted by laboratories that are sufficiently compliant with ISO 17025. The new rules, which will come into effect by February 2022, will require laboratories to maintain a high level of process management and control. To achieve and maintain compliance with ISO 17025, laboratories need a system to help them manage and demonstrate adherence to requirements; many would benefit from having a laboratory information management system (LIMS) in place.
The Evolution of ISO 17025: from Prescriptive to Process Based
ISO 17025, released in 1999, became widely recognized as the international reference for testing and calibration laboratories. In 2017, an update was implemented that shifted the standard away from prescriptive requirements and toward a more process-based approach that gives laboratories more flexibility in how they operate. The updated version has a different structure and places a greater emphasis on risk assessment. There is also an increased focus on information technology, e.g., the provision of electronic test results and records.
If there were to be one single theme of ISO 17025:2017, it would be recordkeeping. The standard provides a structure to plan and measure adherence to preventive control procedures and determine their effectiveness. This “plan and measure” approach is a key ISO philosophy and can only be implemented when supported by a system that supports and enables process management and improvement. In practice, this is referred to as a “plan-do-check-act” cycle that involves planning, supporting process execution, and managing organization and performance.
ISO standards share themes and goals with other regulatory standards and systems. The implementation of ALCOA+ principles, for example, helps laboratories maintain reliable records. These principles are designed to support data integrity and look to ensure that data is attributable, legible, contemporaneous, original, and accurate, as well as complete, consistent, and enduring. By driving data integrity throughout all processes, laboratories increase confidence in the data they deliver. Hazard analysis and critical control points (HACCP) is another internationally recognized system that requires food and beverage producers to systematically look for critical points that may affect or pose a risk to product safety. By identifying these points, manufacturers can implement routine testing to monitor any critical levels and ensure corrective actions are put in place where required.
The Food Safety Modernization Act (FSMA) also provides a framework that aligns with ISO 17025:2017. Hazard analysis and preventive control are two key parts of this framework that are particularly aligned with ISO 17025:2017.
New Regulations Require a Different Approach to Quality Assurance
To be compliant with ISO 17025:2017, food testing laboratories need to implement regular testing of tools and processes to confirm suitable operation. If any issues are found, corrective processes are required, and continual monitoring would confirm the success of such adjustments. This cycle forms the basis of risk assessment and continual improvement for the organization. The updated standard has requirements that help laboratories to constantly optimize their resourcing, processes, and management systems. Overall, laboratories are encouraged to take a broader, more logical perspective in tracking the flow of how an item is tested in the laboratory.