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From: Food Quality & Safety magazine, June/July 2010

The Foundation of HACCP

Prerequisite programs are key to well-defined and effective record control

by Debby Newslow

Debby Newslow

Editor’s Note: This is the second in a two-part article. The first part, “Pump Up Your Prerequisite Programs,” appeared in our April/May issue.

In a previous article, we looked at the role of prerequisite programs (PRPs) in your operation. We discussed examples and the International Organization for Standardization (ISO) 22000:2005 and Publicly Available Specification (PAS) 220:2008 standards. In this issue, we will further evaluate the necessities, including the application and integration of some effective tools into your operation.

“Well-defined” and “effective” are two adjectives used repeatedly because of the total impact they can have on your hazard analysis and critical control points (HACCP) programs and, more importantly, on the production of a safe product. A well-defined and effective program for record control is essential. Not only must a company maintain records that demonstrate compliance with the critical control points (CCPs) and direct involvement with your HACCP program, but the records must demonstrate that PRPs are being completed as defined.

If a program requires that the metal detector be checked with calibrated standards every 30 minutes, then records must be maintained to prove that this happens. If operator training is required, then records of that training must be maintained. An effective record control PRP identifies the record, the responsibility for maintaining the record, and the required retention time for keeping the record. Retention times must be realistic and provide evidence of compliance. If calibration of a retort thermometer is required annually, make certain that the records are maintained for several years to provide a comprehensive historical record that this frequency is being met.

Document Control Program

A precursor for an effective PRP is a clearly defined and effective document control program. Requirements for compliance must be written. Often, this type of document is referred to as a standard operating procedure (SOP), and SOPs must be controlled. Document control and the creation and maintenance of SOPs may be considered a PRP.

Documents must be identified and controlled to ensure that associates always have the most current document. This includes not only SOPs or other informational documents but also the forms that demonstrate compliance. A well-defined and effective document control procedure must identify both the document and responsibilities for the document, and must assure that documents are readily available to anyone who needs them in order to perform his or her area of responsibility. There must be only one version of each document: the most current version.

Training has been previously mentioned in relation to more than one program description. Actually, well-defined and effective training is a PRP that encompasses all activities within the food safety program. Required training, proof that it has been successfully completed, and evaluation of its effectiveness must be managed in a PRP. When planning your training program, keep in mind the differences between training and education. Training may be defined as a learned reaction, whereas education reflects the communication of the reason and necessity that results in an understanding of why the learned skill is important.

Other examples of PRPs may include foreign material control, water treatment, calibration, receiving inspection, storage practices, allergen control, sanitation, hazardous material control, chemical control, preventive maintenance, labeling, product identification and traceability, mock recall, cleaning, and sanitizing. The list is extensive, and actual application and severity are directly related to the nature of the product being manufactured.

Requirements for effective implementation and maintenance of prerequisite programs should be written in a usable format, involve training of personnel, and define monitoring and documentation requirements.

Review and Use PAS 220

ISO 22000:2005 combines with PAS 220:2008 to make up the requirements for Food Safety System Certification (FSSC) 22000. The Global Food Safety Initiative has approved FSSC 22000 for manufacturing companies.

PAS 220 focuses on the PRPs and specific requirements. It “specifies the exact requirements for PRPs. The specification applies to all organizations, regardless of size or complexity, as well as to all who are involved in the manufacturing step of the food chain. It should be used in conjunction with ISO 22000. Its focus is to ensure that processes are in place to minimize, mitigate, or eliminate potential food safety hazards from affecting the products, including product contamination, food safety hazard levels, and the product processing environment.”

PAS 220 is an excellent document to review and incorporate into every operation, whether or not the operation is seeking certification. It is generic and provides specific requirements; however, the extent that it applies to a given manufacturing site will depend on the product being produced.

Well-defined and effective PRPs are vitally important. The most common remarks from attendees at our HACCP plan development workshops are that the first item on the “to do list” is to review the PRPs to ensure that these are really functioning in an effective manner that is best for the operation. PRPs are unique to each operation. Requirements for effective implementation and maintenance of PRPs should be written in a usable format, involve training of personnel, and define monitoring and documentation requirements. Defined requirements must also include corrective actions where appropriate to control food safety and provide for the verification of the requirements and their effectiveness.

Verification is proof that defined requirements are being performed; however, records that confirm validation must also be identified and maintained. Validation records confirm that the correct activities are being performed and include the information that is used to define the parameters of a program. Validation for PRPs is often considered less critical than validation for a CCP; however, it is still very important to justify the parameters. It is this justification that provides the foundation for decisions and challenges to your program.

No matter how large or small your operation, producing a safe product is essential. It is imperative that your operation be built on a foundation of well-defined and effective PRPs. Communicate this importance to your associates. Stop, divide your production into individual servings, then think, “How many individuals have we touched today?” The results may surprise you. ■


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  2. Pillay V, Groenveld C. Food safety goes global. Food Quality Website. February/March 2009. Available at: Accessed May 13, 2010.
  3. 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.
  4. 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.
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  7. 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 website. Available at: www.accessdata.fda. gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=110. Accessed May 13, 2010.
  8. Newslow DL. Effective HACCP plan: not just a fairytale. Food Quality. May/June 2002: 28-37.
  9. Sansawat S, Muliyil V. Understanding the FSSC 22000 Food Safety System Certification Standard. Geneva, Switzerland: SGS SA; 2009.

Newslow is a member of the Food Quality editorial advisory board and is president of D.L. Newslow & Associates Inc. Reach her at



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