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Pump Up Your Prerequisite Programs
The foundation of the HACCP program
by Debby Newslow
Editor’s Note: This column is the first of two parts. Part two, which will run in our June/July issue, will discuss understanding and applying effective tools to ensure that your prerequisite programs are well defined and effective.
As hazard analysis and critical control points (HACCP) has evolved in the food industry over the past 15 years, the term “prerequisite program” has also grown in popularity and understanding. Years ago, we talked about the prerequisite programs and how these were the foundation for your HACCP programs, but most of the attention was on hazard analysis and identification of critical control points.
A critical control point (CCP) is a step in the process where control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level. A prerequisite program is a program that addresses situations within the operation that ensure that possible hazards are controlled. Effective prerequisite programs are directly linked not only to the control of identified hazards but also to the effectiveness of the HACCP program overall.
In 2005, the International Organization for Standardization issued the ISO 22000 standard. This standard was the first “globally recognized food safety management systems standard that [considers] the food safety risks and impacts across the entire food supply chain.” This standard defines the operational prerequisite program (OPRP) as a plan that focuses on food safety.
IS0 22000:2005 can be defined as follows. Prerequisite program (PRP) defines the “basic conditions and activities that are necessary to maintain a hygienic environment through the food chain suitable for the production, handling, and provision of safe end products and safe food for human consumption.”
OPRP is a “PRP identified by the hazard analysis as essential in order to control the likelihood of food safety hazards and/or the contamination or proliferation of food safety hazards in the product(s) or in the processing environment.”
There is much discussion relating to the protocol for determining which factors separate a PRP from an OPRP from a CCP. It is important that we focus this article on basic prerequisite programs.
PRP Crosses Product Lines
Prerequisite programs generally cross all product lines affecting all operations, not just one specific process line or product. PRPs are usually managed system wide compared to CCPs, which are product or line specific. Examples of PRPs include good manufacturing practices (GMPs), pest control, supplier approval, and water treatment. A deviation in a prerequisite program rarely requires actions against a specific product, whereas a deviation in a CCP results in an action against the product, such as placing product on hold or performing a product recall. A deviation in an OPRP may or may not result in an action against the product, depending on the specific deviation.
Well-designed prerequisite programs provide a solid foundation for an effective HACCP program. HACCP programs do not stand alone. The National Advisory Committee on Microbiological Criteria for Foods states that the production of safe food products requires that the HACCP program be built upon a solid foundation of prerequisite programs, because “prerequisite programs provide the basic environment and operating conditions necessary for the production of safe, wholesome food.” The role of the PRP is to control or eliminate hazards wherever possible. Without well-defined, effective prerequisite programs, the HACCP program will fail.
Some PRPs are required for certain food processing segments under HACCP regulations for the U.S. Food and Drug Administration and the U.S. Department of Agriculture-Food Safety and Inspection Service. With the advent of HACCP regulations, some HACCP experts have suggested that the phrase prerequisite programs be used only for those programs required under regulation, in order to distinguish them from precursory programs, which are programs that have been deemed necessary but are not required under regulations. For the purpose of this discussion, the term prerequisite program applies to those programs that have been identified as necessary to control or eliminate a hazard in any HACCP program, whether it has been deemed regulated or not.
During the development of the HACCP program, a cross-functional team performs the hazard analysis in compliance with the requirement of the Codex Alimentarius Principle One: “Conduct a hazard analysis.” Potential hazards are identified, then evaluated to determine whether the hazard must be addressed through a CCP or OPRP, or if the hazard can actually be controlled through a prerequisite program. Control means that steps/actions/procedures are in place that ensure that the hazard does not result in a product that may cause illness or harm when consumed.
The point is that top management must ensure that resources such as time, associates, and training funds are effectively assigned to support the successful implementation and maintenance of these programs as part of management commitment.
Requirements for PRP Effectiveness
Requirements to ensure the effectiveness of the PRP, including responsibilities and required actions to be followed, must be clearly defined. These documents are most commonly referred to as standard operating procedures. Clearly defining the specific requirements, ensuring that associates are effectively trained, and evaluating results to confirm effectiveness are essential. All operations, no matter what the finished product, have some programs.
Most have written procedures and use specific forms to record the results. Are these effective? Are the requirements reflecting current activities well defined? When were the documents written? When was the last time they were reviewed to ensure that clearly defined requirements are still appropriate for current tasks? Currently, one of the most common audit findings is outdated, incomplete, and/or multiple versions of the same document.
Were the responsible associates trained on these documents, and do records prove the training took place? Another common finding is a lack of any training record(s) to confirm that the associates were trained on the requirements. The point is that top management must ensure that resources such as time, associates, and training funds are effectively assigned to support the successful implementation and maintenance of these programs as part of management commitment.
Many times, management is surprised to hear the term management commitment emphasized during HACCP training and subsequent HACCP program development activities. Although management commitment is not one of the seven principles of HACCP, Codex Alimentarius states that “management commitment is necessary for the implementation of an effective HACCP system.” It also emphasizes that “the successful application of HACCP requires the full commitment and involvement of management and the work force.”
Management must convey a positive message of commitment through all levels of the operation in both words and actions. It is recommended that management formally monitor all food safety activities on an ongoing basis through hands-on discussions with the HACCP coordinator, to ensure the continued suitability and effectiveness of its operation.
Examples of PRPs common to most operations include:
GMPs as defined in 21 CFR 110 for cGMPs. GMPs are probably one of the most well-known programs. Potential hazards could be foreign materials such as jewelry, hair, or gum. An effective GMP program defines requirements for wearing jewelry, hairnets, and beard snoods, as well as for eating and/or drinking (including chewing gum) in the process areas. If this is effective, the hazard is controlled and does not have to be addressed in the HACCP program.
Pest Control: Pest control is part of basic GMP compliance. Having an effective pest control program goes beyond hiring an external company for pest control. Your pest control program must be clearly defined. A company associate must be in charge of the program, responsible for working with the external supplier to ensure the program’s total effectiveness, making sure that certain activities are performed as defined, required records such as rodent bait activity are kept, and recommendations or other concerns are addressed in a manner both timely and effective. Results from the external service company must be monitored and confirmed to be effective. An external pest control company must be approved and evaluated as an approved critical supplier. Supplier approval programs are another essential prerequisite program.
Supplier Approval: A supplier approval program must be defined and implemented to ensure that suppliers who are critical to your food safety program are identified and monitored effectively. Many potential hazards related to materials and raw ingredients used in the processes may be controlled through a well-defined and effective supplier-assurance program. Think about recent food safety recalls. How many have resulted from a hazard caused by the supplier?
Internal Audits: An effective and well-defined internal audit program that monitors and records the effectiveness of defined program requirements is a must. Findings (both nonconformances and potential nonconformances) must be documented and addressed in a timely manner based on potential seriousness. Audit team members must be trained not only in the process and requirements being audited, but also on the basics of auditor techniques and audit protocol.
Clearly, it is important to focus on your prerequisite programs. In the next installment of this article, I will discuss understanding and applying effective tools to ensure that your programs are well defined and effective based on the needs of your operation. I will also provide examples of more programs and discuss the integration of the requirements of ISO 22000:2005 and PAS 220:2008 into your system. ■
- Stevenson KE, Bernard DT. HACCP: A Systematic Approach to Food Safety. 3rd ed. Washington, D.C.: The Food Processors Institute; 1999.
- Pillay V, Groenveld C. Food safety goes global. Food Quality Web site. February/March 2009. Available at: www.foodquality.com/mag/ 02012009.03012009/fq_03012009_FE3.htm. Accessed March 21, 2010.
- International Organization for Standardization (ISO). ISO 22000:2005. Food Safety Management systems—requirements for any organization in the food chain. Section 3.8. Geneva, Switzerland; 2005.
- International Organization for Standardization (ISO). ISO 22000:2005. Food Safety Management systems – requirements for any organization in the food chain. Section 3.9. Geneva, Switzerland; 2005.
- National Advisory Committee on Microbiological Criteria for Foods (NACMCF). FDA Web site. August 14, 1997. Hazard analysis and critical control point principles and application guidelines. Available at: www.fda.gov/Food/FoodSafety/HazardAnalysisCriticalControlPointsHACCP/ucm114868.htm. Accessed March 21, 2010.
- Schmidt RH, Newslow DL. Hazard analysis critical control points (HACCP)—prerequisite programs. FSHN 07-02. University of Florida IFAS Extension Web site. 2007. Available at: http://edis.ifas.ufl.edu/fs138. Accessed March 21, 2010.
- U.S. Food and Drug Administration. Title 21 Code of Federal Regulations (21 CFR 110). Current good manufacturing practice in manufacturing, packing, or holding human food. FDA Web site. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=110. Accessed March 21, 2010.
- Newslow DL. Effective HACCP plan: not just a fairytale. Food Quality. May/June 2002: 28-37.