Abstract

In medical devices, Hazard Analysis and Critical Control Point (HACCP) is a quality control process that covers every production phase from raw material procurement through distribution of the finished product. HACCP is a standalone program that incorporates elements of the ISO 9000 standards and the quality system regulation. Because of its pilot status, the Office of Compliance has not issued formal guidelines on how the HACCP program will be implemented in the device industry. However, the manufacturer who creates a facility or product specific HACCP program based on the National Advisory Committee on Microbiological Criteria for Foods' seven HACCP principles may be eligible for shortened inspections by the Food and Drug Administration. The production of medical devices requires the HACCP system to be built upon a solid foundation of prerequisite programs that are established and managed separately from the HACCP plan. In developing a plan, five preliminary tasks must be accomplished before applying the HACCP principles to a specific product or process: Assemble the team, describe the device and its distribution, describe the intended use and consumer, develop a flow diagram for the process, and verify the flow diagram. When these tasks are completed, the team can apply the seven HACCP principles. Upon completion of the hazard analysis, the hazards associated with each step in the production of the device should be listed along with any measures used to control the hazards. The next step is to determine the Critical Control Points (CCPs) that will prevent, eliminate, or reduce hazards to acceptable levels. Critical limits are established to distinguish between safe and unsafe operating conditions at a CCP. Monitoring procedures assess whether a CCP is under control and provide an accurate record for future use in verification. When a deviation from established critical limits occurs, corrective actions are necessary to prevent devices that may be hazardous from reaching consumers. Finally, verification determines that the HACCP plan is valid and the system is operating according to plan. The HACCP plan should be updated and revised as needed, and all individuals involved properly trained so they understand their roles and fulfill their responsibilities. A sidebar article stresses the importance of employee participation.