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As HACCP has evolved, it has become apparent that HACCP programs must be supported by other facility-wide sanitation and food hygiene programs. That is, certain basic require- ments must be in place before HACCP can be effectively implemented. In the 1998

NACMCF document,40the definition of “prerequisite programs” and their relationship to HACCP was very prominent:

“Each segment of the food industry must provide conditions to pro- tect food while it is under their [sic] control. These conditions are pre- requisite to the development and implementation of HACCP. ... Prerequisite programs provide the basic environment and operating conditions that are necessary for the production of safe, wholesome food.”

Prerequisite programs, again, are not part of the formal HACCP plan and system. However, they are crucial to HACCP development, implementation, and maintenance. In contrast to HACCP, prerequisite programs typically are facility-wide in nature and not product specific; therefore, they often cross and affect many, if not all, product lines in the plant. Moreover, prerequisite programs often target objectives other than food safety, such as quality and process control. Prerequisite programs would include those programs listed in Table 9.3.

Because prerequisite programs cut across many, if not all, operations and products in the plant, it is often not possible to tie performance of a given prerequisite program to a spe- cific product lot (or even product line). Therefore, management of prerequisite programs can differ from that needed for HACCP. Most processors typically manage their prerequi- site programs within their QA/QC or other quality programs. The exception to this is when a specific prerequisite program is critical for hazard control and subsequent produc- tion of safe product. In this case, the prerequisite program or a component of the prerequi- site program would be incorporated into the plant’s formal HACCP plan, and would, therefore, be required to be managed as such.

The existence of prerequisite programs greatly influences the hazard analysis. Hazards identified at each step in the establishment’s process are assessed for likelihood of occur- rence. Adequate and reliable prerequisite programs can provide environmental and oper- ating conditions such that potential hazards would be unlikely to occur (low risk); therefore, these potential hazards would not have to be addressed in the plant’s HACCP plan. In contrast, inadequate or unreliable prerequisite programs could lead to an increased likelihood of potential hazards occurring; therefore, these hazards would have to be addressed in the plant’s HACCP plan. In terms of overall impact on the plant’s HACCP plan, the existence of adequate, well-implemented prerequisite programs leads to simpler, more manageable HACCP plans, while an absence of effective prerequisite programs will tend to increase the number of CCPs and complexity of the HACCP plan needed to pro- duce safe product.

As indicated above, facility-wide hazard control is one goal of most prerequisite pro- grams. Microorganisms can build up rapidly, and/or be transferred from one part of the plant to another if control steps are not taken. Bacteria can be introduced and spread by water, air, people, pests, and fomites (inanimate objects such as equipment, tools, utensils,

Table 9.3 Typical GMP or HACCP Prerequisite Programs in a Poultry Processing Plant

Premises and facilities Processing procedures Cleaning and sanitation (SSOPs) Personnel

Inbound materials Pest control

etc.). In addition to these biological hazards, chemical and physical hazards could be intro- duced into product if proper procedures and safeguards are not in place. The proper pro- cedures and safeguards, if not part of the plant’s formal HACCP plan, will fall into prerequisite programs.

Regardless of program, there are certain requirements for all prerequisite programs. The goal of each prerequisite program should be to thoroughly address and control items that can impact food hygiene and overall wholesomeness of the product. Ideally, each pre- requisite program should be based on written procedures (SOPs, see also discussion below), have assigned responsibilities, be subjected to measurement criteria and record keeping, and have prescribed corrective actions when criteria are not met. By having writ- ten programs, it will be easier to train responsible employees and implement the proce- dures. Moreover, the expected goals of the program will be known, which will allow for more objective assessment. Because many prerequisite programs are facility-wide, respon- sibility for implementing and maintaining programs often crosses departments within the plant; therefore, management of prerequisite programs must be a key consideration.

Premises and facilities

The processing plant should be located, constructed, and maintained in accordance with sound sanitary design and hygienic principles. Because pests can be vectors of food-borne pathogens, premises should minimize pest (i.e., rodents, insects, birds) harborages, such as areas of standing water, trees and shrubbery in close proximity to processing plant, bird nesting sites associated with the building, waste collection sites, etc. For this reason, the processing plant site should be well drained, landscaped with minimal shrubbery, and designed to facilitate waste management.

As overall considerations, facilities should be designed to facilitate product flow and should provide for separation of operations where appropriate. Product should flow from the area of highest microbial load to the area of lowest microbial load (e.g., raw to cooked), and not “back track.” Separation of areas and of employee traffic patterns are an important consideration in preventing microorganisms from moving throughout the plant. Overall layout and design of the plant should also provide for adequate ventilation, lighting, and space for equipment and storage. Without these provisions, maintaining sanitary condi- tions in the plant will be more difficult.

Walls, doors, ceilings, and floors represent the interior surfaces in the plant, and, there- fore, need special attention. The surfaces should be easily cleaned and sanitized, impervi- ous to water, and minimize niches for collection or entry of microorganisms and pests. Walls should be solid, sealed for waterproofing, and be free of windows. In terms of the lat- ter, windows are not necessary in well-ventilated and lighted plants. If windows are pre- sent, the glass should be unbreakable, the sill should be sloped to prevent collection of debris (bacteria), and windows should not be able to be opened by employees unless required by fire regulations. Doors represent another type of opening in a wall. If doors are present, it is likely that they are there to ensure separation of different areas of the plant; therefore, they should be kept closed during plant operations. In addition to meeting the same cleaning and sanitizing requirements as walls, doors should be tight fitting and well maintained. In critical areas of the plant, doors may be supplemented with other require- ments such as air curtains, foot baths, etc. False or drop ceilings should be avoided because they allow for collection of bacteria and can become harborages for pests. In relation to ceil- ings, overhead piping, beams, etc. should be minimized. Because of their effect on heat transfer, ceiling-roof construction and insulation along with ventilation are often primary determinants (e.g., in wet processing areas) of the extent of condensation in the plant. Floors represent the interior surface most susceptible to rapid buildup of microorganisms.

Again, floors should be impervious to water, and therefore should be sealed and free of cracks. Additionally, floors should be sloped and well drained to prevent standing water. Standing water can be a breeding ground for bacteria.

In poultry and other food processing, water has always been a major premises/facility related issue. Water is used extensively in processing and cleaning operations, therefore the plant should have access to a good water source and be able to maintain water quality in the plant. Water system design and plumbing will be important in preventing water con- tamination in the plant. The water system should be designed to keep potable water pro- tected from wastewater and sewage, and plumbing/maintenance activities should not compromise this protection. In recent years, other water issues, such as availability, ade- quacy of potability standards, conservation, reuse, and wastewater treatment, have also emerged. These issues will also impact the plant’s water programs.

Cleaning and sanitation

The goal of cleaning and sanitizing is microbial control through elimination of nutrients, microbial niches, and excessive water. Microbial control is particularly important on sur- faces which come in contact with product. By USDA-FSIS regulations (9 CFR Part 417), each plant must have SSOPs to which it must adhere in its day to day operations. Beyond overall plant sanitation, SSOPs are also required for all food contact surfaces, including equipment and utensils. Beyond the specific regulatory requirements, SSOPs should spec- ify the following: item to be cleaned and sanitized, how and when the procedure is to be done (including chemical agents and other materials), and responsible personnel. A means of assessing the effectiveness of the plant’s sanitation program should also be written. The USDA inspection procedures serve as verification that the processor is complying with its SSOPs. Failure to comply can result in the inspector issuing a “noncompliance report” (NR).

Inbound materials

A poultry processor will receive a number of materials into its plant that are needed in the manufacturing process. A partial list would include raw materials, ingredients, packaging materials, cleaning and sanitizing agents, processing aids, etc. All inbound materials need to be obtained from reputable suppliers. All suppliers should have verifiable food safety programs, including HACCP where appropriate, in place. Because inbound materials can affect quality and safety of product, the processor should establish written specifications for all incoming materials, and then obtain materials from suppliers who can meet the specifications. However, specifications must be realistic. For example, a specification for Salmonella- or Campylobacter-free raw poultry would be an unrealistic specification. Documentation in the form of Letters of Guarantee and Certificates of Analysis are often used in connection with supplier specifications. Once received, materials must be stored in a sanitary manner, and this manner of storage should be a written SOP for each class of inbound material. Storage should prevent against contamination that can affect product safety. For example, cleaning agents are not to be stored with food ingredients. For perish- able ingredients, environmental control would be an important consideration.

Equipment

All equipment should have sanitary design, which means that it does not directly con- tribute to product contamination, it is constructed of nonreactive, nontoxic materials, it is easily cleaned and sanitized, etc. Initially, it is very important that equipment is installed properly and by qualified personnel. When adding new equipment, there should be ade- quate space for it such that cleaning and sanitation procedures can be performed properly.

All equipment requires, to some degree, preventive maintenance and repair. While repair often cannot be predicted or scheduled, preventive maintenance can and should be sys- tematic. Therefore, preventive maintenance should follow a written SOP, and records should be kept on key pieces of equipment. Preventive maintenance helps ensure that pro- cessing steps are done as intended, and that the risk of physical and chemical hazards such as machine pieces and lubricants is minimized. Calibration of processing equipment and instruments would be a specific type of preventive maintenance program. Written preven- tive maintenance programs should include the following: specific equipment identifica- tion, exact procedures and frequency, records to be kept, and assignment of responsibility.

Processing procedures

Processing procedures must be strictly controlled primarily for quality control purposes. However, processing control is directly related to product safety in many instances. That is, how a procedure is carried out can have a direct bearing on product safety. A good exam- ple would be product formulation, in which restricted ingredients are used. Processing steps in which the ingredients are weighed, mixed, blended, added, etc. must be done properly to ensure that the ingredient’s concentration in final product is within regulatory limits. Another example would be poultry meat cutting or portioning operations, which done incorrectly could lead to physical hazards in the form of bone or metal. For this rea- son, prescribed procedures, SOPs, are needed for most if not all processing steps. These written procedures serve to communicate expectations of the process and serve as the basis for training the personnel involved in the various processing operations. Beyond specific procedures, there should be certain written expectations of how product is to handled, as well as the expected flow of product during normal plant operations. These latter issues relate to the time-temperature sequence of the product, which can be a major determinant of microbial contamination.

Personnel

All employees in the plant require training. The plant’s training program should include training the key personnel in their role and responsibility in producing safe product and complying with regulatory requirements. All personnel involved in processing operations must be trained in food hygiene principles, particularly personal hygiene. Training should target personal cleanliness and avoidance of product contamination, but should also emphasize the employee’s responsibilities in complying with hygienic practices. A formal food safety training program consists of established training material, a training schedule, and documentation of each employee’s training. An employee’s training file, the docu- mentation, should indicate education and training the employee has received related to food safety and hygiene, as well as an assessment of the employee’s proficiency in appro- priate topics. Employee turnover can be very high in poultry processing plants; therefore, processing plants must establish a solid training policy and be vigilant in ensuring that key personnel receive appropriate, effective, and documented training.

Pest control

The objective of pest control in the poultry processing plant is simply to prevent or elimi- nate pests, including insects, rodents, and birds. As stated above, these pests are vectors of pathogenic bacteria. Pest control in the processing plant is typically achieved by a multi- faceted approach referred to as integrated pest management, which aids in minimizing the need for use of chemical pesticides. Of course, the use of chemical pesticide in a food envi- ronment has food safety implications; therefore, minimizing chemical pesticide use has

food safety benefits. An integrated approach typically entails three practices: inspection, housekeeping, and physical/mechanical/chemical methods. Inspection must be con- ducted on a prescribed frequency, thus, a written SOP is needed, as are record keeping forms to document inspection results. Formal inspections should be conducted by those specifically trained in pest management, while plant personnel can conduct ongoing inspections. Housekeeping is a function of the cleaning-sanitation operations in the plant. The goal of inspection and housekeeping is to prevent pest infestation. If infestation is noted, then removal or eradication methods are needed, and there should be acceptable physical, mechanical, and chemical means available. A trained exterminator should oversee the removal or eradication procedures used in the plant. Strict records should be kept when such methods are used, particularly when chemical pesticides are involved.

Product traceability and recall

As unpleasant as it may be, recalling product once it has been produced and shipped is part of food processing. Therefore, the processor needs to develop strategies to avoid recalls in the first place, and a strategy to recall product if the need arises should be in place. Key tactics of this strategy must insure that product is effectively recovered and disposed of properly.