In the April/May 2002 issue of Food Safety Magazine, we explored the state of the Hazard Analysis & Critical Control Points (HACCP) system—its emergence as a routine component of the food company’s food safety program, and the limitations of the system now arising as it becomes widely implemented by non-mandated industry segments.

In Part I of this article, we considered the benefits and general limitations of the applied HACCP system, as well as the limitations of the first two HACCP principles: hazard analysis and the determination of CCPs. In this issue of Food Safety Magazine, Part II covers the application limitations of the remaining five HACCP principles, and what can be done by the food industry to address these limitations and the controversies surrounding them.

As discussed in Part I, before the HACCP concept evolved, food safety (often referred to as food hygiene, food sanitation or food protection) activities focused on sanitation inspections based on food laws and regulations, Good Manufacturing Practices (GMPs) and end-product testing.[1] Each made a unique contribution to evaluation the attributes of foods; the conditions under which foods were produced, processed, stored, marketed and prepared; and the operations and practices to which the foods were subjected. Despite these quality control and food protection activities, contaminated foods were identified, out-of-compliance code violations were commonly found, and foodborne diseases continued with increasing incidence or estimates of occurrences.

With these and other concerns about the efficacy of traditional approaches to food protection, the introduction of the HACCP concept appeared on the scene as a promising way to better ensure food safety. As the concept has matured and many food operations have implemented these systems, some limitations of the approach have come to the fore, causing loss of impact on food safety as originally planned. In Part I, we discussed the limitations and controversies surrounding HACCP Principles 1 and 2; we continue here with HACCP Principles 3 through 7.

HACCP Monitoring
Monitoring is a unique aspect of the HACCP system. The HACCP system is essentially an on-site monitoring activity of critical operations when they are occurring. Monitoring must be done at all operations that are considered CCPs, which means that monitoring done at operations other than CCPs are optional and outside food safety considerations, perhaps for quality assurance, and they should be identified as such. Monitoring results must show that the intended preventive or control measures are being carried out and are effective. Whenever feasible, foods, rather than the environment, are monitored. Monitoring focuses attention on high- risk foods and practices that, if not under control, could lead to foodborne illness. Monitoring is done to ensure that the food characteristics meet food safety specifications and that production, processing, preparation or storage approaches have been done as prescribed in the HACCP system.

Considerations for HACCP monitoring include: (a) what is monitored; (b) specific sites that are to be monitored; (c) how the monitoring is to be done and with what instruments; (d) who does the monitoring; (e) when the monitoring is done; (f) the frequency of monitoring; and (g) the record on which the results of monitoring are to be recorded. From a practical standpoint, when monitoring is done by workers and even sometimes by automatic devices, the placement of the sensor may be in a location that either fails to indicate the specified criterion, or that may not represent all parts of the product. Results may appear to be safe, but in reality, they may not be safe. For example, in product being held hot, the monitoring results may represent the highest temperature near the heat source (e.g., at the bottom of food in a steam table) rather than the lowest temperature in the food (e.g., near the top surface), which would indicate the hazard and over time suggest the risk.

Effective monitoring requires calibrated equipment that measures the attribute under consideration, its proper placement and training of operators in its use, placement in the food and interpretation of the results. Ineffective monitoring nullifies the effectiveness of the HACCP system and provides a false sense of security. Some persons who are assigned the task of monitoring a CCP want to show that the process is under control and sometimes record the specified criterion whatever monitoring results have been, or they monitor at a location in a product that gives incorrect readings—but readings that are favorable of the criterion. Others fill in monitoring forms without monitoring at all. These sorts of actions defeat the purpose of monitoring, which is to detect whether hazards exist or remain, or are introduced and must be dealt with by modifying the process or by taking additional control actions.

Actions to consider for effective monitoring procedures follow:

1. Monitoring considerations (a-g, as cited above) must be cited for each CCP in the HACCP system.

2. The criterion that is evaluated by monitoring must be specified in the HACCP system and must be the same as that listed on the monitoring form.

3. Monitoring is done at specific times, by specified persons, in a prescribed manner and with calibrated instruments.

4. Prescribed corrective actions are taken promptly by the person doing the monitoring, the person responsible for the operation, or the supervisor of the operation, whenever the criterion has not been met, and the action taken is recorded on the form.

5. The person doing the monitoring should sign the monitoring form or log upon its completion. A supervisor/manager should review the form, observe and evaluate the operation daily for verification that the monitoring was done effectively, evaluate all corrective actions taken, and then also sign the form.

6. Items not considered as CCPs should not be recorded on HACCP monitoring forms, unless it is clearly indicated that the practice or environment evaluated is not a CCP. HACCP monitoring is not self-inspection activity. It is a focused evaluation of whether the criteria at CCPs have been met.

Corrective Actions
Another attribute of the HACCP system is that prompt corrective action is taken when the results of monitoring show that the criteria have not been met or that there is a deviation of the process that may result in loss of control. These corrective actions are prescribed in the system, and operators and supervisors are given directions on specific actions to take. Therefore, the operator must stop the process or modify it to attain a product that meets the critical limits at the CCP. These actions not only result in a safe product but usually one that is of superior quality. When corrective actions are taken, the action should be documented on the monitoring record. Automatic, continuous corrective or prompt actions are unique to the HACCP system as compared with traditional food protection approaches such as inspection and end-product testing.

Verification
Verification is another unique aspect of the HACCP system. Although prompt corrective actions are the responsibility of the persons who either monitor or who are responsible for the operation that has been designated a CCP, there is a check on these responses with the HACCP approach. A supervisor, a staff member of the quality control (QC) department or a representative from a food regulatory agency evaluates CCPs, monitoring procedures and corrective actions taken. If that person does not agree with the actions taken, more appropriate actions should be initiated and specified on the monitoring record.

Some literature on the HACCP approach states or implies that the role of the person from a food regulatory agency who verifies the HACCP system is limited to reviewing records. It would be ludicrous for verification to be such a restricted and boring activity. Verification should be multi-fold and include: (a) making observations at all processes designated as CCPs as to whether the control action is effective and that monitoring is being done effectively with appropriate monitoring instruments; (b) questioning the operator or person doing the monitoring about their procedures; (c) measuring with agency instruments time- temperature exposures of operations designed to inactivate hazards or prevent proliferation or accumulation of bacteria or concentration of hazardous substances; (d) evaluating the functioning, maintenance and calibration of devices used to monitor CCPs; (e) measuring product pH, water activity or other characteristics that have food safety relationships, if applicable; (f) collecting samples at CCPs (rather than of end-products) and testing them for microorganisms of concern at that stage of the operation; and (g) doing whatever else is appropriate, depending on anticipated hazards and their prevention and control.36,38 Additionally, the process should be evaluated to determine whether previously unnoticed hazards exist or have occurred because of different ingredients, modification of the process, new equipment, or actions by untrained or new personnel.

Record Keeping
The HACCP system must be specified and on file for use by workers, supervisors and those who verify the system. Record keeping is perhaps the biggest barrier to an operating HACCP system. Many persons do not have the discipline to record or maintain such records, and they lack an understanding of the purpose for the records. They may feel, and sometimes with due cause, that it is “busy work” and that no one ever looks at the results. Some industry executives feel that their records should not be accessible to inspectors. This may be so for certain formulation records, but not for records of results of monitoring critical (disease) control points, which require periodic review as part of the verification process of HACCP systems. Because of a reluctance to do any (or very little) monitoring, prerequisites or GMPs are sometimes substituted. This nullifies the HACCP system.

Properly recorded and maintained records are invaluable in litigation. Monitoring records should be kept on file until the incubation periods for diseases of concern or the shelf-life plus this incubation period have expired, and then until they have been verified by the QC department or others.

Validation
Validation is defined in the Codex Alimentarius document as “that element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan, when properly implemented, will effectively control the hazard.”[20] It is defined in the NACMCF as “the application of methods, procedures, tests and other evaluations, in addition to monitoring to determine compliance with the HACCP plan.”[21] Presently, this activity is included under the verification principle. Validation, however, has become to mean evaluating or auditing whether HACCP systems have been designed properly and are being carried out effectively. It is a separate step conducted by others than those who design, implement and verify the HACCP systems. Therefore, the two activities—verification and validation— should be separated into different principles and steps.

Validation consists of a review of process flow diagrams, the HACCP system and plan, and on-site observations and measurements to determine (a) whether it includes all actual and potential hazards and that when in effect, risks of foodborne illness resulting from eating the product are low; (b) whether additional hazards have been introduced or that operations have been modified and if so, CCPs selected, critical limits set, and monitoring and verifications procedures specified; (c) that it covers all applicable CCPs; (d) that monitoring is to be done precisely with calibrated instruments that can evaluate the process effectively; and (e) that the HACCP system has been carried out effectively. Periodic audits are necessary to evaluate this.

What Can Be Done About HACCP Limitations?
A HACCP system, sometimes referred to as “the worksheet,” consists of a cross-comparison of each step-by-step operation in the left column by row of a table with sequential columns on the right describing each associated component of the HACCP system.[11] These components are “Hazards,” their “Severity,” the estimated “Risks,” whether the operational step is a “CCP,” and the “Type of CCP.” Continuing for all operations identified as CCPs are columns containing instructions on the “Critical Limits” or “Criteria for Prevention or Control,” “Monitoring Procedures,” “Monitoring Record,” “Corrective Actions to Take,” and “Verification Procedures.” Entries in each block should be as detailed as necessary to describe fully the situation or action; not just a word or short phrase as is commonly seen in generic HACCP system guidelines, short articles on the HACCP approach, or in company-generated HACCP plans, as is sometimes the case. After systems are designed, they should be reviewed by supervisors of production, QC and others, and modified, if applicable, for practicality, but not at the sacrifice of food safety.

Highlights of the HACCP system using non-scientific language ought to be prepared from the complete HACCP plan for use in operational manuals and training to address the limitations described. These would cover “summary of the hazards,” “control criteria,” “monitoring procedures,” and “corrective actions” for each CCP, but not other operations. Although information in the HACCP system and the highlight table is essentially the same, presentations differ. For example, in the “Hazards” column, there may be a statement for a slicing operation that includes the following information: contamination by Staphylococcus aureus, Shigella, Salmonella typhi, hepatitis A and E viruses, Norwalk-like viruses during slicing from bare hands of workers; contamination by S. aureus, Clostridium pefringens, Bacillus cereus from improperly cleaned slicer; bacterial growth while on slicer or after slicing before refrigeration; bacterial growth associated with scraps on slicer; and spread of contaminants from contaminated pieces to previously uncontaminated slices. In the highlight table, then, there may be a statement such as: “Contamination and spread of contaminants and possible bacterial growth during slicing.” The same sort of simplifying the key features of other CCPs should be presented for each highlighted element.

It is crucial to understand the effectiveness of the HACCP system and its limitations. Such a review, which ordinarily fits on a single page, briefly summarizes the system, points out any remaining hazards and assesses their risks of occurrence. Implemented HACCP systems, such as those for raw meat and poultry processes, may only minimize or reduce hazards; there are no kill steps. During a heating process, vegetative bacteria may be killed, but not spores. After these operations and perhaps the complete process, remaining hazards and the risk of their occurrences need to be stressed in the summary, so that those responsible for food processing and preparation frilly understand limitations, if any, of their operations. With this information, they can decide whether to take the risks of starting or continuing the process; to modify the process and make it safer; or to advise their customers of risks associated with the products and of appropriate actions to take to eliminate or reduce the remaining hazards. Also, with this information, the purchaser can be aware of both subsequent preparation steps that must be taken to render the product safe and to take precautions so as not to spread contaminants. Food regulatory agencies can become aware of where to focus their verification or validation activities and inspections, as well as what areas in training and health education should be stressed. Therefore, a summary of HACCP systems pointing out such limitations, if any, and stating remaining risks should be elevated to HACCP principle status.

For successful implementation of HACCP systems, several groups of persons need to be trained and educated about HACCP principles and techniques. These include: persons who design HACCP systems; those responsible for operations designated as CCPs; persons who monitor CCPs; those who verify or validate HACCP systems; executive staff of processing and foodservice establishments, companies and chains; administrators of public health and food regulatory agencies; and legislators and policy makers who promulgate laws or formulate regulations related to food safety and special interest lobbyists who influence the passage of laws or regulations. Suggestions for approaches for these groups are available in the literature.[11,13,39]

Without an understanding of hazards associated with food production, processing and preparation, rational approaches for prevention and control will not be realized. Hence, HACCP-focused training of those involved in food production, processing and preparation, and food safety is essential and must be considered as an integrated part of the HACCP concept. This is quite different from information that is typically given in food handler training classes or GMP training for processors.

Conclusion
Some of these issues have become controversial. Documents by certain groups often are considered guidelines or standard operating procedures, yet they miss or complicate certain phases of the HACCP concept. Despite these often accepted documents, common microbiological sense must prevail. It must be based on epidemiological information and scientific investigations.

The HACCP system employs on-site monitoring of preventive or control measures and prompts corrective actions at operations where hazards are likely to occur and where risks of these are high. Or, at least that was what it was meant to do. HACCP was meant to be a direct and simple approach for food safety. But with its utilization, many other aspects of regulations and records have made this concept quite complex. And, it appears that this is going to continue, as indicated by some of the recommendations of the Food Hygiene Committee of Codex Alimentarius, the NACMCF, and other groups. The name has come to mean “total food protection” and everything to do toward this end, rather than its initial meaning of determining and monitoring a few operations where control can be accomplished. Perhaps we need to return to the original three components of the HACCP concept as set down by the ICMSF.6 These are hazard analysis, CCP identification and monitoring of operations where contamination is likely, survival may occur or growth is likely. The approach was to evaluate foods and their processing and to identify hazards and assess their risks. It continues to determine one operation or a few operations that are critical. Criteria to ensure food safety at that or these operations are established, and the operations are monitored to ensure that the criteria are met and promptly corrected if they are not. If this system is properly designed, carried out and maintained, there ought to be high assurance of food safety, despite possible aesthetically undesirable situations.

For HACCP systems to be effective, there must be management commitment of the concept and insistence that the systems are properly designed, implemented and maintained and that monitoring is done with state-of-the-art instruments. To accomplish this, food workers must be trained and disciplined to follow the plan, monitor effectively, truthfully record monitoring results and take appropriate corrective actions. Supervisors must verify that this is being done.

Frank L. Bryan, Ph.D., M.PH., is president of Food Safety Consultation and Training, in Lithonia, GA, which specializes in HACCP system development, including conducting HACCP system evaluations in food processing plants, foodservice establishments and food markets. Internationally known for his work in food safety, Bryan served as a scientist director at the Centers for Disease Control and Prevention, Public Health Service from 1956-1985, and was an active member of the International Commission on Microbiological Specifications for Foods from 1974-1996.

References
1. Bauman, H.E. The HACCP concept and microbiology hazard categories. Food Technol (28), p.30. 1974.
6. ICMSF. Microorganisms in Foods 4, Application of the Hazard Analysis Critical Control Point (HACCP) System to Ensure Microbiological Safety and Quality Blackwell Scientific Publications, Ltd., Oxford. 1988.
11. Bryan, F.L. Teaching HACCP techniques to food  processors and regulatory officials. Dairy Food Environ. Sanitat. (11), p. 562. 1991.
13. Moy, G., et al. Application of HACCP to food manufacturing: Some considerations on harmonization through training. Food Control (5), p.131.1994.
20. Codex Alimentarius Commission. Report of the Twenty-Ninth Session of the Codex Committee on Food Hygiene. Washington, DC, October 1996.
FAO/United Nations, Rome. pp.21-40. 1997.
21. NACMCF. Hazard Analysis and Critical Control Point Principles and Application Guidelines. (source unlisted). p.35. 1997.
36. Bryan, FL., et al. Procedures to Implement the Hazard Analysis Critical Control Point System. IAMFES, Ames, IA. p.72. 1991.
38. Bryan, FL., et al. Procedures to Investigate Foodborne Illness, 5th Ed. IAMFES, Ames, IA. p. 142. 1987.
39. Mayes, T. HACCP training. Food Control (5), p. 190. 1994.