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FSMA and PCQI Introduction

Working with the best available experts we can provide Food Safety Plan training, consultancy, FSMA assessment to meet 21 CFR 117, other food-related Codes of Federal Regulations, Foreign Supplier Verification Program assessment and/or FSSC 22000 assessment audits which to be tailored to meet your compliance needs.

We are food safety experts that design, write and implement HACCP Plans, FSMA Food Safety Plans and FSMA Foreign Supplier Verification Programs.

Other FSMA related consulting services include FDA inspection preparation, assistance with issues related to FDA Establishment Inspection Reports and Form 483 responses. Import issues and Import Alerts.

Global Quality Consultants can assist owners/operators of food facilities with the development of food safety plans that are specific to their facilities and meet the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). Global Quality Consultants can act as and provide the services of a highly qualified PCQI individual to oversee the implementation of FSMA at your facility.

The content of the Food Safety Plan will be consistent with the FDA’s existing guidance and regulations and will consist of the following information:

  1. Facility Information
  2. Preliminary Steps
  3. Good Manufacturing Practices (GMP) & Prerequisite Programs
  4. Hazard Analysis & Preventive Controls Determination
  5. Process Preventive Controls
  6. Food Allergen Preventive Controls
  7. Sanitation Preventive Controls
  8. Supply-Chain Preventive Controls
  9. Recall Plan
  10. Reanalysis of Food Safety Plan
  11. Food Safety Plan Report
  12. Signature
  13. Recordkeeping Procedures
  14. Important Contacts
  15. Supporting Documents

Commonly asked questions about Food Safety Plan and Preventive Controls Qualified Individuals.

The rule requires food facilities to have a written food safety plan that includes a hazard analysis and preventive controls. How often must that plan be reanalyzed?

At least once every three years. The facility must also review portions of the food safety plan under certain circumstances, such as when a preventive control is found to be ineffective.

My company has three separate food facilities. Are we required to have three distinct facility-specific food safety plans even though we produce the exact same food product at all three facilities?

The overall framework is directed to a facility. Thus, the preventive controls for human food rule establishes a requirement for every facility to have its own written food safety plan. Even if a company makes or holds similar products at separate facilities, it is unlikely that the separate facilities have the same equipment and layout. Procedural instructions must be tailored to the equipment being used, and the layout of a facility including processing lines, technologies, and raw materials utilized as they will affect the approach to applying preventive controls such as allergen controls.

What is a Preventive Controls Qualified Individual?

This is a new term in the final rule. A Preventive Controls Qualified Individual is someone who has successfully completed certain training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system. The written food safety plan required of food facilities must be prepared, or its preparation overseen, by one or more preventive controls qualified individuals. And the preventive controls qualified individual is charged with overseeing the validation that preventive controls can control identified hazards and the records review.

Do I need to employ preventive controls qualified individual (PCQI)?

The preventive controls for human food rule creates new requirements for covered domestic and foreign facilities producing human food to develop and implement a food safety plan based on hazard analysis and risk-based preventive controls. In general, the rule applies to facilities that must register under section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). However, there are a number of exemptions and modified requirements that may apply (see 21 CFR 117.5 for exemptions that may apply to your facility).

If no exemptions apply to you, then you are required to have a PCQI develop and implement your facility’s food safety plan. A PCQI is a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system. Job experience may qualify an individual to perform these functions if such experience has provided an individual with knowledge at least equivalent to that provided through the standardized curriculum.

Can I use one PCQI for all my facilities, or must I have one PCQI for each facility?

The preventive controls for human food final rule does not prohibit a company from utilizing the services of a single PCQI for multiple locations. Additionally, there are no restrictions on the proximity of the locations that are under the direction of any PCQI. Note, however, that each facility must have a PCQI prepare or oversee the preparation of a food safety plan specific to that facility in accordance with 21 CFR 117.126(a)(2).