Thursday, March 21, 2019

Preventive Controls for Human Food


Preventive Controls in Food Safety
The preventive controls approach has been universally accepted as a proactive and systematic approach to food safety and adopted throughout the world and continue to do so. Because it helps to attempt preventing issues before they arise while focusing on the most important areas to prevent food safety issues rather than reacting to problems as they arise. Preventive control programs are not new to the world even though the nomenclature is as they are already in use in combination in different models which has been structured to work in conjunction more effectively. The most common examples are; Good Manufacturing Practices (GMPs), good agricultural practices, good transportation practices including HACCP, PRPs, OPRPs, etc. as the basis for food safety management. Successful application of preventive controls approaches usually cover every angle of intended and not intended risks within or outside which is not only helps to ensure regulatory compliance, but also minimizes the risk of producing products that can harm consumers.

As of the history of preventive controls development in food industry, that dates back to the Apollo missions, where riskbased approaches to managing food safety were pioneered during development of food for the U.S. space program in the 1960s. Initially, endproduct testing was the main focus of the quality control programs, where there were tremendous failures, as endproduct testing necessary to provide assurance that the food was safe would be so extensive that little food would be available for space flights, while there was no 100% credibility that leftover items are completely fit for use. Then focus was shifted from final product testing to preventing hazards (by the Pillsbury Company and Army laboratories as collaboration) through product formulation and process control in a riskbased approach which was named as Hazard Analysis and Critical Control Point (HACCP). The HACCP implementation was gradually expanded voluntarily in the food industry.

The general understanding is that, food safety is best assured if each producer and processor understands the significant hazards in their product and operation, and if they use scientifically sound preventive controls to significantly minimize or eliminate the hazards. As a front liner, FDA used HACCP principles in the development of low acid canned food regulations in the 1970s. The development further expanded when the U.S. National Advisory Committee on Microbiological Criteria for Foods (NACMCF) and the Codex Alimentarius Commission (Codex) published HACCP principles in the 1990s. The expansion further took turns in the world food production with various applications into several subsectors, where FDA has HACCP regulations for seafood and juice products; USDA has HACCP regulations for meat and poultry products; and HACCP is endorsed by many countries, including Australia, Canada, New Zealand and European Union.

What is a Preventive Control Program?
The preventive control programs are in a rise in the modern food industry, as US FDA and Canadian Food Inspection Agency has already introduced preventive control programs to their food safety management system requirement as food safety modernization act (FSMA) and safe food for Canadians act (SFCA). However, these programs are not very different from their predecessors as already explains, but has been modernized, improved and additional requirements are brought to justice with more rigorous and systematic approaches. In the previous models, the HACCP principles are the heart of the program while rest is come around it, which is still same but more extended support programs and more risks has been considered. Thus, understanding of these principles are useful to understand how the Preventive Controls for Human Food regulations complements the riskbased HACCP approach.

In a HACCP system, hazard analysis identifies processrelated hazards which, in the absence of control, present a food safety risk. Therefore, when such hazards are identified, Critical Control Points (CCPs) should be defined, while identifying that are essential to control the process to prevent the hazard from causing illness or injury to the human health. When these CCP process controls are identified, the critical limits should be defined for the operating conditions in the process that must be met to effectively manage the hazard. Nonetheless, monitoring of the process is carried out to provide data to demonstrate that critical limits are met, where corrective actions are predefined to enable swift action when things go wrong, thus preventing expansion of a food safety issue. All of the above activities are recorded and verified to ensure the system is operating as intended and to provide data to others (e.g., inspectors, auditors, management, new employees) to show that this is the case, recognizing that a HACCP Plan essentially addresses most of the requirements for process preventive controls.

However, the preventive controls process incorporates controls beyond those managed as processrelated CCPs in the HACCP framework. Therefore, such preventive controls address not only CCPs, but also controls for hazards related to food allergens, sanitation, suppliers and others requiring a preventive control. The preventive controls approach also recognizes that critical limits, defined by NACMCF as: “A maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level the occurrence of a food safety hazard may not be required for some preventive controls. The broader term, parameters and values, supports identification of a frequency or other metric to assess compliance, rather than setting a precise minimum or maximum value to which a parameter must be controlled. i.e., immediate corrections (like recleaning a line before start up) may be more appropriate than formal corrective action involving product risk evaluations for some preventive controls. Finally, the extent of validation activities (or demonstrating the controls actually work) may be less rigorous for some preventive controls than others.

Food Safety Plans
The Food Safety Plan is the primary document that guides the preventive controls for food safety system. The Food Safety Plan is developed using a systematic approach to identify those hazards that require preventive controls to prevent foodborne illness or injury. Nonetheless, it is a dynamic document, which must be kept current if changes are made to the system or to equipment when new products are added, or new hazards are identified. Food Safety Plan includes a number of elements such as hazard analysis, which is used to identify required preventive controls for the process, for sanitation, for food allergens and supplychain programs, where production process necessary to address the hazards requiring a preventive control. These given elements, along with a recall plan make up the Food Safety Plan. Many GMPs and other prerequisite programs are managed outside of the Food Safety Plan. While these are separate programs and may not require the same level of documentation as the elements of the Food Safety Plan, which are important. They are generally managed using standard operating procedures with documents and records kept as appropriate. Keep in mind that elements of GMPs that are not covered in the Food Safety Plan are still required by regulations, since most of the food production facilities required to build based on physical GMP requirements as primary requirement. Preventionbased food safety management can be integrated into any operation; however, the process can seem complicated until the basic concepts are understood.

Developing a Food Safety Plan, including determining where preventive controls are required; involves a systematic process based on science to help ensure the safety of the product. The basic is hazard analysis, which is intended to identify hazards requiring a preventive control. When these hazards are known, preventive controls that are essential to prevent the hazard from causing illness or injury are to be identified. Thus, preventive controls may include process preventive controls, allergen preventive controls, sanitation preventive controls, supplychain preventive controls or other preventive controls that are essential for the product. Once preventive controls are identified, determination of relevant parameters that define the conditions which must be met to effectively manage the hazard. Monitoring, corrective action and verification procedures for each of the preventive controls identified must also be included in your plan as appropriate to ensure the effectiveness of the controls.

Monitoring provides documentation that demonstrates these conditions are met, where corrective actions or corrections are predefined to enable swift action when things go wrong, thus preventing expansion of a food safety issue. Once, things go wrong or out of control, it is necessary to clarify, if it was because a hazard was overlooked (in which case you must adjust the hazard analysis), or if a preventive control was not properly identified or implemented. All of the above is recorded and verified to ensure the system is operating as intended and to provide a record for others (e.g., inspectors, auditors, management) to show that this is the case. Some elements of a preventive controls system which are critical to the process also require validation to demonstrate that the controls actually work. This activity may be less rigorous for some preventive controls than others.

A recall plan is also a mandatory element of a Food Safety Plan when a hazard requiring a preventive control is identified. Nonetheless, system should have procedures to maintain implementation records to document that organization has implemented the given Food Safety Plan. Because your Food Safety Plan will be used or reviewed by regulators, employees, auditors, customers and potentially consultants, which may also be useful to include a brief description of the facility or company along with a list of Food Safety Team members, product descriptions, a process flow diagram and a process description to help people understand the structure of the plan.

Reference:
https://www.uvm.edu/extension/necafs/clearinghouse/resources/fspca-preventive-controls-human-food-participant-manual
https://en.wikipedia.org/wiki/Hazard_analysis_and_risk-based_preventive_controls
https://www.fda.gov/downloads/food/guidanceregulation/fsma/ucm584807.pdf
https://www.uvm.edu/extension/necafs/clearinghouse/resources/food-safety-plan-builder-preventive-controls


No comments:

Post a Comment