Integrated Agency Inspection Model – Consultation Draft (December 4, 2013)
3.0 Preventive control plans
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A preventive control plan describes a systems-based approach that focusses on prevention as a way to achieve regulatory compliance. Preventive control plans are recognized internationally as an effective way to mitigate risks and minimize hazards.
A preventive control plan, suitable to the operations, must be developed, documented, implemented, and maintained, as a condition of a licence. Licence holders and other regulated parties are responsible for monitoring and controlling their operations, correcting any deviations as they occur, and maintaining ongoing compliance. This includes receiving, storage and transportation of incoming and outgoing commodities, and the principles related to biosecurity and biocontainment. The requirement for the preventive control plan will be set out and/or referenced in regulation. Preventive control plans must be made available to the CFIA upon request.
The process of managing a preventive control plan will continually generate new information that could be used to actively improve operations in ways that foster regulatory compliance. Management commitment is essential to the implementation and ongoing maintenance of an effective preventive control plan. Consistent communication is key to meeting human, animal or plant health or other regulatory requirements. In addition, management must ensure that employees and service providers:
- are trained;
- are capable of performing the duties; and,
- are able to demonstrate an understanding of compliance.
The preventive control plan approach provides the regulated party with the flexibility to consider a number of process control or quality management type systems (for example, third-party assurance systems such as the Global Food Safety Initiative (GFSI), the International Organization for Standardization (ISO), the Canadian Seed Institute (CSI)) and the mandatory Hazard Analysis and Critical Control Points (HACCP) approach presently employed in some hatcheries. The approach would accommodate most systems currently in use by industry. The proposed preventive control plan requirements are similar to HACCP systems, but differ in that the proposed plans must also address other regulatory requirements (for example, animal health, plant health, labelling, product quality, composition). Regulated parties, including those currently operating under a systems approach such as mandatory HACCP, would be able to transition to the new model with little or no adjustment.
Preventive control plan approach provides flexibility for consideration of a number of management systems.
The CFIA is considering the development of model systems and tools to assist small businesses in meeting this requirement. The CFIA's Compliance Promotion Strategy is currently under development and will outline how regulated parties can seek guidance.
Regulated parties who strive to adopt the best practices and innovative, commercial or technological strategies would be recognized by the CFIA through adjustments to oversight, as appropriate.
3.1 Elements of a preventive control plan
Depending on the nature of the operation, preventive control plans would include some or all of the following elements:
- process and product controls
- sanitation, biosecurity, biocontainment, pest control and chemicals
- hygiene, biosecurity and employee training
- equipment design and maintenance
- physical structure, surroundings and maintenance
- receiving, transportation and storage
- traceability, recall and complaints
Each element listed above must address the following criteria:
a. Hazards and controls
The plan would have to:
- identify potential hazards at any stage in an operation or in the commodity, and specify control measures for these hazards (for example, drug residues, pests and/or diseases, allergens)
- identify regulatory requirements and specify control measures to achieve compliance (for example, product composition, net quantity, quality [grade], label declarations, pest/pathogen exclusion).
- identify the control measures that are to be validated, including any critical limits or tolerances;
- describe how the regulated party would validate that the control measures will achieve the critical limits and the outcomes before implementation; and
- describe how the control measures would be re-validated whenever there is a change that may impact the process parameters.
b. Monitoring procedures
Monitoring confirms that all control measures are followed, and would include:
- identifying an appropriately-trained responsible person
- identifying appropriate monitoring procedures
- establishing and following the monitoring frequency
- recording the monitoring results
- establishing procedures to follow when deviations occur, including isolation of potentially-affected commodities or production lots
c. Verification procedures
Verification procedures confirm that monitoring and quality control procedures are followed and that control measures are capable of consistently achieving the outcome, and would include
- identifying an appropriately-trained responsible person to conduct the verification, other than the person who conducts the monitoring
- establishing the verification frequency
- recording the results of verification
- establishing procedures to follow when deviations occur
- where sampling and testing are used (of the environment or a commodity), the procedures would be described
- using accepted sampling and test methodologies that provide accurate and meaningful results (e.g. accredited laboratories and authorized seed samplers)
d. Corrective actions
The preventive control plan would outline steps that would be taken following a deviation, and would include
- determining the root cause of the deviation, and preventing recurrence;
- controlling the commodity by
- determining if the commodity is in compliance with regulations and
- bringing an affected commodity into compliance or disposing of it as appropriate; and
- recording corrective actions taken.
e. Management review (review by the regulated party)
The regulated party would review the preventive control plan and its associated records to assess its ongoing effectiveness. The review would include:
- identifying team members who will conduct the review
- establishing the review frequency (at least annual)
- determining whether the preventive control plan has achieved the outcomes (including review of deviations and corrective actions)
- identifying and implementing necessary changes for continuous improvement
- recording the results of the review
Records are evidence that the regulated party has implemented the preventive controls as designed and that it is effective. Regulated parties would generate a number of different types of records, suitable to their operations. These must be available for review by the CFIA.
The preventive control plan would need to identify all records associated with each element of the preventive control plan. It would also indicate where and for how long the records would be retained, including, but not limited to:
- validation of control measures (for example, critical limits or tolerances)
- monitoring (demonstrating control of a hazard or regulatory requirement; for example, shipping, purchase orders, training, equipment calibration and maintenance, pest/disease management records)
- verification procedures
- complaints and how they were resolved
- deviations and corrective actions taken
- management review by regulated party
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