THE ROLE OF HACCP IN SANITATION

 THE ROLE OF HACCP IN SANITATION

The Hazard Analysis Critical Control Point (HACCP) program is a preventive approach to consistent safe food production. This program is based on two important concepts of safe food production-prevention and documentation. The major thrusts of HACCP are to determine how and where food safety hazards may exist and how to prevent their occurrence. The important documentation concept is essential to verify that potential hazards have been controlled. 

HACCP focuses on the prevention or control of food safety haz-ards that fall in the three main categories of biological, chemical, and physical hazards. The program focuses on safety and not quality and should be considered separate from or a supplement to quality assurance. 

The objective of HACCP is to ensure that effective sanitation, hygiene and other operational considerations be conducted to produce safe products and to provide proof that safety practices have been followed.

WHAT IS HACCP?

The HACCP concept was developed in the 1950s through the National Aeronautics and Space Administration (NASA) and Natick Laboratories for use in aerospace manufacturing under the name “Failure Mode Effect Analysis.” This rational approach to process control for food products was developed jointly by the Pillsbury Company, NASA, and the U.S. 

Army Natick Laboratories in 1971 as an attempt to apply a zero-defects program to the food processing industry. This technique, which assesses the flow of food through the process, provides a mecha-nism to monitor these operations frequently and to determine the points that are critical for the control of foodborne disease hazards. 

A hazard is the potential to cause harm to the consumer. A critical control point (CCP) 

is an operation or step by which preventive or control measures can be exercised that will eliminate, prevent, or minimize a hazard (haz-ards) that has (have) occurred prior to this 

point. 

The HACCP concept has become a valuable program for process control of microbial 

hazards. This approach is a har-binger of the trend toward more sophistication in food 

sanitation and inspection. It has been legitimized by governmental regulators and is being 

adopted by progressive food companies.

The HACCP concept is divided into two parts: (1) hazard analysis and (2) determina-tion 

of critical control points. Food safety and acceptability are most affected by: (1) contaminated raw food or adjuncts,improper temperature control during pro-cessing and storage (time-temperature abuse),improper cooling through failure to cool to refrigerated temperature within 2 to 4 hours, (4) improper handling after process-ing, cross-contamination (between products or between raw and processed foods), (5) inef-fective or improper cleaning of equipment, failure to separate raw and cooked prod-ucts, and (7) poor employee hygiene and sanitation practices.

Hazard analysis is a procedure for conducting risk analysis for products and ingredients by diagramming the process to reflect the manufacturing and distribution sequence, microbial contamination, survival, and proliferation capable of causing foodborne ill-ness. Critical control points are identified from a flow chart. Any deficiencies that are identified are prioritized and corrected. Monitoring steps are established to evaluate effectiveness. The HACCP program, implemented by the food industry and monitored by regulatory agencies, provides the industry with tools and monitoring points and is used to protect the consuming public effectively and efficiently. The HACCP concept provides a more rational approach to control microbial hazards in foods than does traditional inspection.

A major target of HACCP is Listeria monocytogenes. HACCP can help prevent the growth of L. monocytogenes because it requires steps to confirm the effectiveness of this concept. L. monocytogenes has been consid-ered to provide the greatest hazard through environmental contamination. Therefore, most samples are tested from environmentalsources. Environmental samples should be taken from ceilings, floors, floor drains, water hoses, equipment surfaces, and others on a random basis. Floor drains, which can carry organisms from a large area, should be tested routinely, using a rapid microbial method, such as immunoassay technology.

HACCP DEVELOPMENT

Facilities. The facilities should be located, constructed, and maintained according to sanitary 

design principles.

Supplier control. Continuing supplier guaranty and supplier HACCP system verification.Specifications. Written specifications for all ingredients, products, and packaging materials.

Production equipment. Constructed and installed according to sanitary design principles with preventive maintenance and calibration schedules that are established and documented.Cleaning and sanitation. All procedures should be written and followed.Personal hygiene. All personnel entering the manufacturing area should follow the requirements for personal hygiene.

Training. All employees should receive training in personal hygiene, GMPs, cleaning and sanitation procedures, personal safety, and their role in the HACCP program.Chemical control. Documented procedures must be adopted to assure the segregation and proper use of non-food chemicals (i.e., cleaning com-pounds, fumigants, pesticides, and rodenticides) in the plant.Receiving, storage, and shipping. Raw materials and products should be stored under sanitary conditions.

Traceability and recall. Raw materials and products should be lot-coded and a recall system developed so that rapid and complete traces and recalls may be accomplished when necessary.

Pest control. An effective past control system should be implemented.

Essential steps to the development of a HACCP plan are:Conduct of a hazard analysis.

Identify steps in the process where the hazards of potential significance occur.List all identified hazards associated with each step.

List preventive measures to control hazards.

Identification and documentation of the CCPs in the process.Establishment of critical limits for preventive measures associated with each identified CCP.Establishment of CCP-monitoring requirements, including monitoring frequency and person(s) responsible for the specific monitoring activities.

A food and its raw materials may be classified into categories as follows:

Category 1. Risk assessment as accomplished through examination of the food for possible hazards.

Category 2. Assignment of hazard categories through identification of general food hazard characteristics.

Determination of CCPs is also part of the development process. Not all steps in a process should be considered critical, and it is important to separate critical from non-critical points. Critical control points must be monitored to ensure that the steps are under control. Monitoring may include observation, physical measurements (temperature, pH, Aw), or microbial analysis and most often includes visual and physiochemical measurements because microbial testing is often too time-consuming. Monitoring must be verified by laboratory analysis to ensure that the process is working. The HACCP concept has been effective because:

Sanitation Standard Operating Procedures— The Cornerstones of HACCP Although SSOPs are interrelated with CGMPs, they detail a specific sequence of eventsnecessary to perform a task to ensure sanitary conditions. Standard operating procedures (SOPs) are either SSOPs or manufacturing SOPs. CGMPs should guide the development of SSOPs. SSOPs contain a description of the procedures that an establishment will follow to address the elements of preoperational and operational sanitation relating to the prevention of direct product contamination.In meat and poultry plants, SSOPs cover daily preoperational and operational sanita-tion procedures that establishments implement to prevent direct product contamination or adulteration. Deviations and corrective actions taken must be documented and maintained for a minimum of 6 months and must be made available for verification and monitoring. 

Corrective actions: (1) include procedures to ensure appropriate disposition of contaminated products, (2) restore sanitary conditions, and (3) prevent the recurrence of direct contamination or product adulteration, including the appropriate reevaluation and modification of the SSOPs and the procedures specified therein.

HACCP PRINCIPLES

HACCP is a systematic approach to be incorporated in food production as a means to ensure food safety. The basic principles that underlie the HACCP concept include an assessment of the inherent risks that may be present from harvest through ultimate con-sumption. It is necessary to establish critical limits that must be met at each CCP, appro-priate monitoring procedures, corrective action to be taken if a deviation is encountered, record keeping, and verification activities. The following discussion indicates the seven basic principles of HACCP and gives a brief description of each.

Conduct a hazard analysis through the identification of hazards and assessment of their severity and risks by listing the steps in the process where significant hazards occur and describing preventive measures. This step provides for a systematic evaluation of a specific food and its ingredients or components to deter-mine the risk from hazardous microorganisms or their toxins. Hazard analysis can guide the safe design of a food product and identify the CCPs that eliminate or control hazardous microorganisms or their toxins at any point during production. Hazard assessment is a two-part process, consisting of charac-terization of a food according to six hazards followed by the assignment of a risk category based upon the characterization.Ranking according to hazard characteris-tics is based on assessing a food in terms of whether: (1) microbially sensitive ingredients are contained in the product, (2) the process contains a controlled processing step that effectively destroys harmful microorganisms,a significant risk of postprocessing contamination with harmful microorganisms or their toxins exists, (4) a substantial potential exists for abusive handling in distribution, in consumer handling, or in preparation that could render the product harmful when consumed, or (5) a terminal heat process after packaging or cooking in the home exists.Hazard Analysis and Assignment of Risk Categories

Food should be ranked according to hazard characteristics A through F, using a plus symbol ( ) to indicate a potential hazard. The number of pluses determines the risk category. If a product falls under hazard class A, it should automatically be considered as risk category 

VI. Hazards can also be stated for chemical or physical hazards, particularly if a food is subjected to them. A description of the six hazards follows:

Hazard A: This hazard applies to a special class of nonsterile products desig-nated and intended for consumption by at-risk populations, e.g., infants or older, infirm, or 

immunocompromised individuals.

Hazard B: Products that fit this hazard contain “sensitive ingredients” in terms of microbial hazards.

Hazard C: Foods in this hazard group are manufactured through a process that does not contain a controlled pro-cessing step to effectively destroy harmful microorganisms.

Hazard D: Foods that fit this hazard are subject to recontamination after pro-cessing and before packaging.

Hazard E: With this hazard, there is substantial potential for abusive han-dling in distribution or in consumer handling that could render the product harmful when consumed.

Hazard F: Foods in this group have not been subjected to a terminal heat process after packaging or when cooked in the home.Information developed during the hazard analysis serves as a guideline to identify the steps in the process that are CCPs. CCPs are located at any point where hazards require prevention, elimination, or reduction to acceptable levels. Examples of CCPs may include but are not limited to specific sanita-tion procedures, cooking, chilling, product formulation, and cross-contamination pre-vention.

Establish critical limits for preventive measures associated with each identified CCP. A critical limit is one or more pre-scribed tolerance limit that must be met to ensure that a CCP effectively controls a microbial health hazard to an acceptable level. Information about critical limits is essential for safe control of a CCP. Each preventive measure has associated with it critical limits that serve as boundaries of safety for each CCP. The critical limits for preventive measures may be specified for time,temperature, physical dimensions, pH, Aw, etc. Establish procedures to monitor CCPs.Scheduled testing or observation of a CCP and its limits is accomplished through monitoring. Results obtained from monitoring must be documented. From a monitoring standpoint, failure to control a CCP is a critical defect. A critical defect may result in hazardous or unsafe conditions for those who use or depend on the product. Monitoring procedures must be very effective because of the potentially serious con-sequences of a critical defect.

Monitoring is a planned sequence of observations or measurements to assess whether a CCP is under control and to pro-duce an accurate record for future use in verification. Establish corrective measures to be taken when there is a deviation from an established critical limit. Specific corrective actions must demonstrate that the CCPs have been brought under control. Deviation procedures should be written in the HACCP plan and agreed to by the appropriate regulatory agency prior to approval of the plan. If a deviation occurs, the production facility should place the product on hold until appropriate corrective actions and analyses are completed.Establish procedures for verification that the HACCP plan is working correctly.Verification is accomplished through methods, procedures, and tests to deter-mine that the HACCP system is in compliance with the HACCP plan. Verification confirms that all hazards were identified in the HACCP plan when it was developed. It may be accomplished through chemical and sensory methods and testing for con-formance with microbial criteria when established. 

Establish effective record-keeping proce-dures that document the HACCP plan.

The HACCP plan must be on file at the food establishment to provide docu-mentation 

relating to CCPs and to any action on critical deviations and pro-duction disposition. It 

should clearly designate records that are available for government inspection.

The HACCP plan should contain the fol-lowing documentation:

Listing of the HACCP team and assigned responsibilities.

Product description and its intended use.

Flow diagrams of the entire manufacturing process with the CCPs identified.

Descriptions of hazards and preventive measures for each hazard.

Details of critical limits.

Descriptions of monitoring to be con-ducted.

Description of corrective action plans for deviations from critical limits.

Description of procedures for verifica-tion of the HACCP plan.Listing of record-keeping procedures.

HACCP Auditing and Validation

After an HACCP plan has been developed and implemented, it should be audited within the first year to determine its effectiveness. Verification should have been accomplished to review those activities, other than monitoring, that determine the adequacy of and compliance with the plan. Verification confirms adherence to requirements and procedures. Auditing may be conducted through the HACCP team, management, or a consultant and/or food scientist. Auditing should include a comprehensive review of the entire plan with evaluation and documented observations, conclusions, and recommendations. Auditing serves as a report card for the plan and provides future direction.