SHORT REVIEWS Simple users’ guide to the hazard analysis critical control point concept for the control of food microbiological safety T. Mayes A simple guide to the application of the hazard analysis critical control point (HACCP) system for microbiological hazards is described which clearly outlines the rules to be followed for the identification and management of critical control points. The use of this guide will assist those persons or companies considering applying HACCP to understand precisely what the HACCP system is and how it should be used, as well as assisting those already applying HACCP analysis to standardize and formalize their approach. Keywords: hazard analysis critical control point; microbiological safet) The hazard analysis critical control point (HACCP) This paper outlines a simple user’s guide to the concept is a systematic approach to the identification application of the HACCP concept. The paper is not and assessment of microbiological hazards and risks intended to be a definitive guide, but rather a simple associated with the manufacture, distribution and use introduction to its basic application. For a full history of of a particular foodstuff. The concept was first pre- the development of the HACCP concept, a more sented in 1971 (APHA, 1972), initially for microbio- detailed discussion of its mechanics and illustrations of logical hazards, and has been applied extensively in the its application, the references cited herein should be food service and food manufacturing sectors (Bauman, consulted. 1974; 1990; Munce, 1984; Peterson and Gunnerson, 1974; Bryan er al., 1981; Warne et al., 1985; Snyder, 1986; Bryan, 1988). The initial development and METHODOLOGY application of the technique began in North America, but the concept has now become increasingly accepted What is the HACCP concept? by the UK foods industry and by reputable internat- ional bodies of scientists eminent in food microbiology The accepted definition of the HACCP concept is: ‘a as the most effective approach to the control of systematic approach to the identification and assess- foodborne disease. Despite this, progress in applying ment of the microbiological hazards and risks associ- the concept throughout the food industry in the UK ated with the manufacture, distribution and use of a and Europe has been relatively slow, due in part to the particular foodstuff and the definition of means for absence of a simple user’s guide to the application, of their control’ (ICMSF, 1988). the technique. It is worth noting that HACCP analysis The HACCP analysis consists of six steps (ICMSF, is specifically mentioned in the draft enforcement 1988): Codes of Practice being progressed under the UK Food 1. Identification of hazards and assessment of the Safety Act 1990 and this could stimulate increasing severity of those hazards and their risks associated European interest. with the growing, harvesting, processing or manu- facture, distribution, preparation and/or use of a raw material or final product. Unilcvcr Rcscarch Laboratory, Colworth House. Sharn- 2. Determination of critical control points (CCPs) at brook, Bedfordshirc MK44 ILQ, UK which hazards can be controlled. A CCP may be a 14 Food Control - January 1992 0956-7135/92/010014-06 0 1992 Butterworth-Hememann Ltd User’s guide to HACCP concept: T. Mayes raw material, or a location, practice, procedure or with particular micro-organisms or groups of organ- process stage. isms considered as the potential hazards to each Specification of criteria (i.e. limits and tolerances) product or group of products. For example, typical that indicate whether an operation is under control terms of reference for three different studies may be: at a CCP. (I) listeria (infectious pathogen) as a potential hazard Establishment and implementation of procedures in soft cheese; (2) Clostridium botulinum (an anaerobic to monitor that each CCP operates under con- toxin-forming spore former) as a potential hazard in trol. vacuum-packed chill-stored smoked trout; and (3) Identification of any corrective action required Staphylococcus aureus enterotoxin (an aerobic toxin when a CCP operates ‘out of control’. former) in dry pasta. Verification, i.e. the use of additional information It is preferable to select specific hazards (e.g. to ensure that the HACCP system is working. salmonella or staphylococcal enterotoxin) for each study as this will allow the definition of specific For reasons of brevity and clarity, this paper will controls. Each potential microbiological hazard must discuss the basic use of HACCP analyasis and will be chosen after taking into account the use of the therefore cover only steps l-4 of the above. product by the consumer, (e.g. in the three examples HACCP analysis is a management technique. It given, normal consumer use would not destroy the allows the systematic examination of all the many microbial hazard if it were present in the final product. processing steps involved in the preparation and use of The study team must have a clear view on the types and a food product, and allows the identification of the levels of hazard (e.g. salmonella, C. botulinum, S. processes or operations that are critical to the safety of aureus) that are regarded as dangerous to the consumer. the product. Many commercial food processes involve over 50 different stages from raw material production Analysis or acquisition to final product use. HACCP analysis allows management to identify the stages (typically The first step is to audit the entire process under study between five and ten) that are critical to the safety of to produce a flow diagram of the process that can be the product and therefore allows managers to concen- used as the basis for the study. trate technical resources to ensure that the critical Audits must be carried out by closely following operations are adequately controlled. actual processing operations. Effective auditing tech- A proper HACCP study will produce a list of niques which structure data collection have already potential hazards and corresponding CCPs, together been described (Mayes and Kilsby, 1989), but whatever with operating limits and monitoring procedures for auditing technique is used, the flow diagram arising each CCP. The HACCP technique is equally applicable from the audit data should contain as a minimum, to the identification and control of microbiological, details of all raw materials used, all processing and chemical, or foreign body hazards. packaging stages and a complete time-temperature A HACCP study should ideally be carried out as part history throughout the process and distribution, of a product and process development brief so that together with data on pHIA, conditions and other potential hazards can be identified and ‘designed out’ at parameters affecting growth, survival, death, or pos- the beginning of the project and should be repeated sible contamination. Additional data such as the before any significant changes are made to product or hygienic design characteristics of equipment and hold- process conditions. up volumes should also be collected. Data must also be This paper describes the basic application of HACCP collected on the instructions for the use of the product analysis. Once people are familiar with the application by consumers. Once such a flow diagram is available it of the basic philosophy, a more detailed analysis may be used by the study team to identify where involving the quantification of risk, concern ranking of hazards can be introduced into the product and the hazards, CCPl/CCP2 ranking, product abuse situations associated CCPs that will minimize the risk or prevent and HAZOP hazard analysis can be considered the hazard from occurring. (ICMSF, 1988; Mayes and Kilsby, 1989). This is best carried out as a team activity. The nominated study team leader should proceed through The hazard analysis study team and its terms of the entire process, using the audit data as a guide, and reference ask a series of questions at each stage to determine: (1) if the hazard under study (e.g. salmonella) can be A HACCP study will require the acquisition and introduced into the product either via raw materials or evaluation of technical data and, as a minimum, the processing or can be allowed to grow to dangerous study should be carried out by a microbiologist or other levels; (2) if the formulation or composition of the raw appropriate specialist who is an expert in the particular materials or product is essential to the safety of the operation. However, it is much more preferable to product; and (3) if the processes are specifically establish a hazard analysis study team consisting of a rendering the raw materials, intermediate product, or process manager or supervisor responsible for the final product safe by removing, inhibiting, or prevent- process in question, an engineer, a quality assurance ing contamination and/or growth of the hazard under manager and the microbiologist. The use of such a discussion to dangerous levels. multidisciplinary study team will greatly improve the A consideration of the hazards should take into decisions made by the group. account realistic potential process deviations e.g. high- The terms of reference for the study must be defined er or lower product times and temperatues, pH and A, clearly at the outset and the detail must be confirmed values, and the amount and distribution of any preser- by the study team. Each study should be carried out vative. Consideration should also be given to the Food Control - January 1992 15 User’s guide to HACCP concept: T. Mayes For each raw material used: Question 1 (and if necessary Question 2) for each raw 01. Could the raw material material used. realisticallycontain Question 1. Could the raw material realistically the hazard under study YES - kg. salmonella) at - NO contain the hazard under study at levels dangerous to levek dangeroustq the consumer? the consumer? The study team should use whatever data is available REPEAT FOR REMAINING RAW to them, e.g.