Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food

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When the hazard analysis identifies hazards requiring a preventive control, the FSP also includes the following written documents:

  • Preventive controls (see 21 CFR 117.135), as appropriate to the facility and the food, to ensure safe food is produced, including:
    • Process controls.
    • Food allergen controls
    • Sanitation controls
    • Supply-chain controls.
    • Recall plan.
    • Other controls
  • Procedures for monitoring the implementation of the preventive controls, as appropriate to the nature of the preventive control and its role in the facility’s food safety system.
  • Corrective action procedures, as appropriate to the nature of the hazard and the nature of the preventive control
  • Verification procedures, as appropriate to the nature of the preventive control and its role in the facility’s food safety system

The preventive controls approach to controlling hazards used in an FSP incorporates the use of risk-based HACCP principles in its development. (See the HACCP principles and their application as described by the National Advisory Committee on Microbiological Criteria for Foods.) Although an FSP and a HACCP plan are similar, they are not identical.

  • Supply-chain controls
  • Food allergen controls
  • Sanitation controls
  • Process controls

Sanitation controls may be important to prevent contamination with microbial pathogens, especially for RTE foods that are exposed to the environment. Process controls are applied at specific processing steps, where critical parameters such as time and temperature may be identified to control the hazard of concern.

  • The effect of the control on identified potential food safety hazards (e.g., Does the preventive control significantly minimize or prevent the potential food safety hazards identified? Is the preventive control hazard-specific or does it control more than one hazard? Does the control effectiveness depend upon other controls? Can the preventive control be validated and verified?)
  • The feasibility of monitoring those controls (e.g., Are the critical limits (minimum or maximum values) and, if appropriate, operating limits, for the preventive control measurable and practical? Can you obtain the results of monitoring quickly (i.e., real-time) to determine if the process is in control? Are you monitoring a batch or continuous process? Are you monitoring continuously or doing spot checks? Can the parameters be monitored in-line or must the product be sampled? Will the monitored parameters be indirectly linked to the critical limit (i.e., belt speed or pump flow rate for time of process)? Who will perform the monitoring or checks and what are the required qualifications? How is the monitoring to be verified?)
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