Developing The Preventative Control Plan, Part II

March 2, 2019

The Preventive Control Plan (PCP) development process is a long and extensive process requiring expertise of personnel from different departments and commitment by senior management for its effective implementation and continued success.

The development process starts by assembling a team of Subject Matter Experts from different departments and levels in the organization who are knowledgeable in their areas of work and bring in that knowledge to table. Participation from all departments and tiers in the organization is important to ensure the robustness of the PCP, foster employee cooperation which forms the foundation for a well-rounded Preventive Control Plan.

After the team is formed, the next step is to develop SOPs for addressing elements of a PCP. This part is similar to Prerequisite program in HACCP. These elements are the foundation of a PCP and are developed to ensure controls exists for any operational hazards within a food/edibles manufacturing site. Based on CFIA guidelines there are important elements to consider for developing the PCP SOPs.

1. Process Control: Control measures to ensure consistent quality and safe product. Considerations to specifications, potential hazards from ingredients and procedures to ensure process parameters are being met and monitored are some of the important aspects of this element.
2. Commitment: This element requires a policy to be developed to show commitment by the senior management to produce food that is safe for consumption and meets all regulatory requirement. Senior Management commitment is essential for the successful implementation and effective maintenance of the Preventive Control Plan.
3. Sanitation and Pest Control: This element consists of SOPs for sanitation of the process equipment, conveyance equipment and building to ensure these are maintained in sanitary condition. Procedures to describe methods used for controlling the pest activity are also part of this.
4. Equipment and Flow: Procedures include description of the flow of employees and process and procedures for ensuring suitability of equipment for the process.
5. Maintenance: SOPs that describe how the maintenance of the equipment, conveyance and building are carried out to ensure that no hazards could potentially enter the product through these routes.
6. Handling: SOPs to describe how the ingredients, products, sanitation and maintenance chemicals are stored and how the controls (temperature, humidity) are maintained and monitored to maintain quality and safety.
7. Employee Knowledge: SOPs that describe competencies required for carrying out various tasks and how these are maintained and updated on a continuous basis to stay current with various regulations and industry best practices.
8. Employee Hygiene and Health: SOPs which describe the procedures the employees must follow to ensure hygiene. These include hand washing procedure, clothing, use of PPEs etc. Procedures related to health include steps to ensure safety of the food from cross contamination due to employee ill health.
9. Complaints and Recall: SOPs related to handling of complaints and executing a recall when required.
10. Other Regulatory Requirements: SOPS which describe procedures to ensure other regulatory requirements other than food safety like grade, weight, standard of identity, THC limit etc. are maintained.

Once this groundwork for the PCP has been completed, the team can start performing the hazard analysis similar to the HACCP Plan.

The team collectively brainstorms on the description of the product/s and the distribution chain followed by focusing on the intended use and target consumers.

Creating a flow diagram from receiving to shipping is the next important step in the process. The flow diagram is verified by the team by physically walking through the process to ensure all the steps in the process have been captured in the diagram.

As next steps the team can start its work on developing the content of the PCP. The content must be developed based on the principles below as the framework:

1. Hazards analysis to identify biological, chemical and physical hazards that could pose a risk to the finished product: Each ingredient and process step is analyzed at this stage to identify potential presence of biological, physical and chemicals hazards.
2. Description of control measures and evidence showing effectiveness: This step would involve reviewing all the SOPs to understand if the identified hazard/s are being addressed in the operational SOPs. If the hazards are being addressed, then evidence showing that the procedure is effective in controlling the identified hazard.
3. Critical Control Points (CCP) of related control measures: If there are no steps in the process addressing an identified hazard and there are no steps later in the process to reduce it to an acceptable level then additional controls must be identified at this step and it becomes the Critical Control Point.
4. Description of critical limit for each CCP: This step would involve determining what would be the upper and lower limit of the Critical control point to understand the range in which the safety of the product is not affected.
5. Monitoring procedure for CCPs: It is important to ensure the CCPs are monitored at set frequencies to ensure the controls are being consistently maintained.
6. Corrective Action Procedure in case of any noncompliance observed in the CCP monitoring.
7. Verification procedure to ensure effectiveness of the PCP.
8. Supporting documents showing evidence that all of the above requirements have been fulfilled.

A PCP development process is multi-tiered and can take anywhere from 3 months to 6 months to develop and implement dependent on the complexity of the products. A robust PCP is result of thorough risk assessment performed by a team of Subject Matter Experts who have extensive experience in understanding the food safety and regulatory risks and mitigation steps to produce safe food products. Cannabis Compliance Inc. team has this expertise and can help you with your PCP development needs. Contact us for more details.

Written by: Aparna Gulavane, Quality and Regulatory Consultant