Assessment Process

Assessing is mechanism by which we measure compliance. Assessing is the only way to check that the procedures, protocols, and policies are being followed. Assessing provides documentation for regulators and inspectors that show how your operation is meeting current standards.

Risk cannot be eliminated but risk can be reduced. PFC reduces risk to operators by reviewing all documentation, policies, and SOPs required under botanical safety and handling guidelines. Record keeping and documentation are a cornerstone of maintaining the standards, and ensuring ongoing compliance.

Preliminary Assessment

In many cases, the company seeking certification may request an optional preliminary assessment of their operations which is offered through PFC’s Advisory Services. This gives PFC the opportunity to identify in advance any weaknesses that may exist in the company’s management systems.

A preliminary assessment gives the company sufficient lead- time to correct deficiencies before assessments are conducted and assists PFC in planning for the certification. The scope of the preliminary assessment is determined by the company and may range from a review of documents to a full assessment, including on-site operational observation and assessment. While the preliminary assessment is optional, it is recommended. Ultimately, it may save time and expense by revealing deficiencies that, if corrected before the required assessments, can save the expense of follow-up assessments before certification can be granted.

Documentation Assessment

A PFC Independent Assessor assigned to the company will retrieve all local and state licensing documents, as well as management system documents and manuals. The assigned PFC assessor will review the documentation to determine whether it meets all requirements of local and state regulations, and the AHPA and AHP standards.

Documentation should include, at a minimum:

1. Standards manual(s) – outlining systems utilized to ensure compliance with state and local law and regulations as well as the AHPA and AHP guidelines
2. Operating procedures – including detailed descriptions on how to perform system functions;
3. Work instructions – defining specific job activities affecting the safety and quality of products and processes; and
4. Quality documentation – documents that demonstrate how quality is managed including records, charts, files, inspection and testing records, assessment results, implementable product recall procedures, adverse event reporting, and any other records of objective evidence.

If the documentation fails to meet standards, the deficiencies will be identified in an assessment report, and the licensee is required to take corrective action before certification can be awarded. Once PFC has determined that the documented management systems are satisfactory, a facility assessment will be scheduled.

Training Assessment

A PFC assessor assigned to the company will verify that all paid and volunteer staff has successfully completed the required PFC trainings. Successful completion of PFC required courses is documented by passing the corresponding on-line tests with a score of no less than 80%. All company staff must successfully complete the required trainings prior to receiving certification and all new hires are required to successfully complete the required trainings within 30 days of hire date in order for the company to maintain PFC approved company status.

Facility Assessment

The assigned PFC assessor(s) will complete a thorough on-site assessment of the facility and its operations. An assessment agenda will be prepared for the licensee prior to the arrival of the PFC assessor(s) including a daily schedule and any accommodation requests. It is the assessor(s) responsibility to verify whether the management systems of the company meet all of the requirements of applicable standards.

Upon arrival at the facility, the PFC assessor(s) will conduct an introductory meeting followed by a full facility walk-through to observe activities and confirm that the operating procedures outlines in the document assessment have been successfully implemented. All PFC assessors reserve the right to obtain samples for the purpose of laboratory testing, conduct private interviews with employees, inspect documents and records, observe work processes, and examine equipment. The objective of the facility assessment is to verify technical competency including statements, documented procedures, records, and written policies.

If deficiencies are found during the course of the assessment, the PFC assessor(s) will bring the deficiencies to the licensee’s attention and record them in the assessment report as required or suggested corrective actions, depending on the severity of the deficiency. The assessment report will specifically describe, in detail, what deficiency was observed, the related standard or policy to which it relates, and the necessary corrective actions required to remedy the deficiency. PFC assessment reports also include a recommended timeline for the company to receive certification. This timeline varies depending on potential corrective actions.

Product Testing

PFC provides a wide range of comprehensive medical cannabis product safety testing, where available (services may be limited in some states). PFC’s independent laboratory testing services assist certified companies with the establishment of product stewardship by confirming content and purity, identifying problems with contamination, and determining potential for human and environmental exposure risk to ingredients and by-products including potential allergens, residuals, and microbiological adulterants.

The PFC program specializes in examining product composition, proper packaging, labeling, and storage protocols that ensure public and patient safety. PFC laboratory testing conducted for certification verification is provided by PFC independent certified labs conforming to AHPA and AHP guidelines, as well as all applicable local and state laws and regulations. Laboratory testing for the purposes of certification verification is limited to necessary testing to meet standards. Where allowed by state law, our independent certified laboratory testing facilities can also provide patients, caregivers, and licensees cannabis analytical services as requested.

Exit Meeting

Upon completion of the on-site assessment, the assigned PFC assessor(s) will conduct an exit meeting. A summary review of the facility assessment will be discussed with management or the primary contact person, and regulators as applicable. If deficiencies were recorded, they will be described at this time and included in the final facility assessment report. All PFC applicants will be given a reasonable time period to implement any required corrective action(s).

Corrective Action

All companies with identified deficiencies will be given a reasonable timeframe to implement the mandated corrective action. PFC requires that all corrective actions be implemented and approved by the assigned assessor before certification can be granted. The corrective action response must include objective evidence, which shows the necessary corrective actions have been completed. PFC may require a follow-up on-site facility assessment, limited to the area of concern, depending on the nature of the deficiency. Certification cannot be awarded until any and all deficiencies have been adequately corrected.

Within 10 business days of the facility assessment (if no deficiencies are found) or upon confirmation of completed corrective actions, PFC will issue a confidential report and certification decision (report will be provided to regulators if necessary). All documentation will be forwarded to PFC’s Peer Review Board, and the Executive Committee will review the assessment report and checklist prior to issuing a decision on the certification.  If the Peer Review Board grants a company certification, they are notified immediately and the appropriate certification materials will be issued.

In the event that an application for PFC certification is denied, an appeal may be submitted within 10 business days of the issuance of the decision. PFC provides an independent Dispute Board that includes  at least three members from the PFC Peer Review Board. Each Dispute Board member must have sufficient knowledge and expertise in the discipline to perform a review of materials and reports and issue an impartial decision.

The assigned PFC assessor and PFC staff will continually monitor certified operations throughout the annual certification period. PFC is committed to working with companies engaged in the PFC Program to achieve excellence by providing ongoing support and monitoring of corrective actions.

In the event of a law or regulation change, or when AHPA or AHP releases updated standards, a review assessment may need to be completed. PFC staff will notify certified companies of any updates to rules, regulations, and/or standards and provide an explanation of actions required by the company to comply with said update, including a required timeframe for compliance.