Posted by William Mullane | August 31, 2015
A key component of the new preventive controls rule is the requirement for a written “food safety plan”. The FDA mandates that “the plan must be designed to identify and significantly minimize or prevent hazards in order to prevent illness or injury”.
The food safety plan must contain the following components:
- Hazard analysis: identify known or reasonably foreseeable hazards for each food product; determine if hazards are “reasonably likely to occur”. Must evaluate biological, chemical, physical, and radiological hazards. Only consider hazards that occur naturally or unintentionally (FDA will be proposing a separate, new food defense rule related to intentionally added hazards)
- Preventive controls: These include process controls, food allergen controls, supplier controls, sanitation controls, and a written recall plan. There may include critical control points (CCP’s), which are a form of process controls.
- Parameters: These are values or tolerances associated with some, but not all, preventive controls. They may provide maximum, minimum, or a combination of numerical values.
- Monitoring procedures: Must specify frequency of monitoring and how monitoring will be performed.
- Corrective Action procedures: Procedures must specify how a problem is identified and corrected, must include disposition of affected product for safety, and ensure contaminated product is not introduced into commerce.
- Verification procedures: Can include calibration of preventive controls and instruments or equipment used to perform preventive controls, review of records by a QI, validation of certain preventive controls by a QI to demonstrate controls are effective and science-based, and reanalysis of the plan by QI at least every 3 years or for significant changes.
- Record keeping: Must be specified for each of the requirements,, including records showing the training of the QI.
- Recall Plan: In part 117.137(b), FDA specifies the plan must describe the following steps:
- Directly notify recipients of product, and how product is to be returned or disposed of
- Notification of the public about hazards in product when protection of public health is necessary
- Conduct effectiveness checks of the recall
- Disposal or reworking procedures of recalled food
The food safety plan must be developed by, or the process of development overseen by, one or more “preventive controls qualified individuals”. Every facility must develop it’s own plan, rather than use a non-specific template developed by a corporate entity that is distributed to multiple facilities.
- Federal Register: Volume 78, No. 11, January 16, 2013, narrative with explanation: page 3730; straight text of regulation: page 3802
- 21CFR 117.126
- Section 103 FSMA
- Supplemental notice of proposed rule making for September 19, 2014