
To determine whether traceability methods are effective during the operation process, examine how the organization identifies and tracks each product or service at various stages of production. Effective traceability systems typically involve unique identifiers or batch numbers, which should be applied consistently and visibly on all outputs. These identifiers ensure that products can be tracked from raw materials through to delivery, enabling quick and accurate recall or quality checks if necessary. Verification of this compliance involves reviewing both the organization’s procedures for applying these identifiers and the records kept at each stage to confirm they meet quality and operational standards.
An assessment should also consider the organization’s methods for identifying the status of outputs in relation to monitoring and measurement criteria. This ensures that all products and services are evaluated at appropriate intervals, with the status of each recorded to show if they meet the established quality requirements. Records of each inspection or test point should be readily available, as these provide a clear picture of the product’s journey through the production or service process. Such records indicate whether traceability is maintained throughout, helping confirm that the organization has strong oversight at each critical stage.
Lastly, evaluate the organization’s documentation and retention of traceability information. Effective traceability requires thorough documentation practices that retain necessary information throughout the lifecycle of each product or service. This documentation should capture not only product identifiers but also relevant details from inspection, testing, and approval processes. Verification of compliance involves reviewing these documents to ensure they are accurate, complete, and accessible as needed, providing a traceable history that aligns with ISO 9001 requirements.