HACCP: An Effective Food Safety System Dr R C CHANDAN President, Global Technologies Inc., Minneapolis, Minnesota, USA March 7, 2019 Hazard Analysis Critical Control Points (HACCP) is a management tool that provides a structured and scientific approach to the control of identified hazards. HACCP has international recognition as an effective means of controlling food safety hazards and is endorsed as such by the Food and Agriculture Organization (FAO)/World Health Organization (WHO) Codex Alimentarius Commission. The primary quality demands of consumers, and hence quality concerns of dairy processors, are organoleptic attributes, bacteriological control and sanitation, and good nutritional value of the products, A successful food plant must manufacture safe and wholesome products. It is imperative to maximize customer satisfaction, minimize product loss and comply with sanitary codes. The quality of the food product equates survival and growth of the business. Hence process controls are necessary to produce a dairy product that is safe and acceptable to the consumer. The means by which such controls can be established is a methodology known as Hazard Analysis and Critical Control Points (HACCP). Factors such as plant conditions, manufacturing practices, housekeeping, sanitary standards, personal hygiene and work habits of employees and visitors are prerequisites to HACCP and assume critical importance in plant control of quality, product safety, personal safety and financial integrity. AN INSIGHT TO HACCP HACCP is useful in safe manufacture of a food product. Defining critical control points helps to eliminate or control hazardous microorganisms or their toxins at any point during the entire production sequence. The following information is taken from USFDA publication “Pasteurized Milk Ordinance, 2003” to illustrate the requirements for dairy plants for ensuring safety of food. For detailed description, refer to the website: http://www.cfsan.fda.gov/~ear/pmo03j-k.html#appk. HACCP is a management tool that provides a structured and scientific approach to the control of identified hazards. HACCP is a logical basis for better decision-making with respect to product safety. HACCP has international recognition as an effective means of controlling food safety hazards and is endorsed as such by the Food and Agriculture Organization (FAO)/World Health Organization (WHO) Codex Alimentarius Commission. The U.S. National Advisory Committee on Microbiological Criteria for Foods (NACMCF) has also endorsed it. The FAO/WHO Codex Alimentarius Commission was established to implement the Joint FAO/WHO Food Standards Programme. Its aim is to protect the health of consumers and to ensure fair practices in the food trade; to promote coordination of all food standards work undertaken by international governmental and non-governmental organisations; to determine priorities and initiate and guide the preparation of draft standards; to finalize standards and after acceptance by governments, publish them in a Codex Alimentarius either as regional or world-wide standards. The International Dairy Federation (IDF) has acted as technical adviser to the former FAO/WHO ‘Milk Committee’ and the present Codex Committee on Milk and Milk Products (CCMMP) for 40 years. The Code of Principles for Milk and Milk Products and 50 associated standards for milk products developed by these committees have been given renewed importance by the World Trade Organization (WTO) agreements on “Technical Barriers to Trade” (TBT) and “Sanitary and Phytosanitary” (SPS). Food legislation has four basic aims: protection of public health, protection against fraud, assurance of fair trade practices, and information to the consumer. Different regulations create many trade barriers. Regional groups attempt to harmonize provisions. The Codex Food Standards Programme has existed for over 30 years. It is unique and remarkable in international harmonisation of food standards. The HACCP concept will enable those operating under and regulating under a HACCP plan to move to a preventive approach, whereby potential hazards are identified and controlled in the manufacturing environment that is prevention of product failure. HACCP allows for a preventive, systematic approach to food safety. HACCP Principles Following are the seven HACCP principles to be included in a HACCP Plan: Conduct a hazard analysis; Determine the critical control points (CCPs); Establish critical limits (CLs); Establish monitoring procedures; Establish corrective actions; Establish verification procedures; and Establish record-keeping and documentation procedures. PRE-REQUISITES TO HACCP IMPLEMENTATION For successful implementation of HACCP system certain pre-requisites are required to be met. These are as follows: Management Commitment Real commitment and early active involvement and support of senior management from all disciplines is fundamental to effective implementation of HACCP. They should fully understand what HACCP is, what benefits it can offer and what resources would be required. Employees Involvement Implementation of the system must be carried out by the employees of the organisation. Whenever needed, help of external expertise may be taken, but it must largely be planned and implemented by the people within. Good Manufacturing Practices (GMPs) HACCP is not a stand-alone programme, but is part of a larger control system. GMPs or pre-requisite programmes (PPs) are the universal procedures used to control the conditions of the milk plant environment that contribute to the overall safety of the milk or milk product. They represent the sum of programmes, practices and procedures that must be applied to produce and distribute safe milk and milk products in a clean, sanitary environment. They differ from CCPs in that they are basic sanitation programmes that reduce the potential occurrence of a milk or milk product safety hazard. Frequently, both HACCP Plan CCPs and GMPs control measures are necessary to control a food safety hazard. HACCP may be implemented only in a facility that is constructed and operated to provide a sanitary environment. Milk plant, receiving station or transfer station premises, building construction, maintenance, and housekeeping shall be maintained in a manner sufficient to provide such an environment. These factors shall be controlled by effective milk plant, receiving station or transfer station programmes or by GMPs, as the milk plant, receiving station or transfer station chooses. The exact set of GMPs will vary since their application is milk or milk product and is process specific. The existence and effectiveness of GMPs should be assessed during the design and implementation of each HACCP Plan. GMPs should be documented and regularly audited. An audit review consists of verifying that the company has a programme implemented that indicates how the company monitors and controls each of the GMPs. GMPs are established and managed separately from the HACCP Plan. The following required GMPs shall have a brief written description or checklist that the GMPs can be audited against to ensure compliance. GMPs shall include procedures that can be monitored; records that specify what is monitored; and how often it will be monitored. Each milk plant, receiving station or transfer station shall have and implement GMPs that address conditions and practices before, during, and after processing. The GMPs shall address: Factory planning and construction and plant practices (some details are provided later in a sub-section); Safety of the water that comes into contact with milk or milk products or product-contact surfaces, including steam and ice; Condition and cleanliness of equipment product-contact surface; Prevention of cross-contamination from unsanitary objects and or practices to milk or milk products or product-contact surfaces, packaging material and other food-contact surfaces, including utensils, gloves, outer garments, etc., and from raw product to processed product; Maintenance of hand washing, hand sanitizing, and toilet facilities; Protection of milk or milk product, packaging material, and product-contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate and other chemical, physical and biological contaminants; Proper labeling, storage, and use of toxic compounds; Control of employee health conditions, including employee exposure to high risk situations, that could result in the microbiological contamination of milk or milk products, packaging materials, and product-contact surfaces; and, Pest exclusion from the milk plant. In addition to the required GMPs specified above, any other GMPs that are being relied upon in the Hazard Analysis to reduce the likelihood of hazards such that they are not reasonably likely to occur, shall also be monitored, audited, and documented as required GMPs. Plant construction and practices Floors: The floors of all production areas shall be smooth, impervious, and maintained in a state of good repair. The floors of storage rooms may be constructed of concrete. The joints between the walls and floor shall be tight, impervious and shall have coved or sealed joints. Where floor drains are provided, they shall be properly trapped and floors sloped to drains. Walls and ceilings: Walls and ceilings of fabricating areas shall have a smooth, cleanable, light-coloured surface. Walls and ceilings in fabricating and storage areas shall be kept in good repair. The opening around pipes, tubes and similar items that extend through the walls and/or ceiling shall be effectively sealed. Doors and windows: All outside openings shall be effectively protected against the entry of insects, rodents, dust and airborne contamination. All outer doors shall be tight and self-closing. Lighting and ventilation: All rooms shall be adequately lighted either by natural light, artificial light, or both. A minimum of twenty (20) foot-candles (220 lux) should be maintained in fabricating areas and five (5) foot-candles (55 lux) in storage areas. Packaging, sealing, wrapping, labeling and similar procedures are considered part of the fabricating area. Ventilation shall be sufficient to prevent excessive odours and the formation of excessive water condensation. The intake of all pressure ventilation systems in fabricating areas, whether they are positive or exhaust shall be properly filtered. Separate rooms: All production areas shall be separate from non-production areas to protect against contamination. If the entire plant meets all sanitation requirements and no source of cross contamination exists, separation between areas is not required. All regrinding of plastic and the shredding, packaging or baling of paper trim shall be conducted in rooms separate from the fabricating room. They may be conducted within the fabricating room, only if such operations are kept clean and free of dust. Toilet facilities-sewage disposal: Disposal of sewage and other wastes shall be in a public sewage system or in a manner in compliance with local and state regulations. All plumbing shall comply with the local and state plumbing regulations. Toilet rooms shall have solid, tight-fitting doors that are self-closing. The toilet room and fixtures shall be maintained in a clean and sanitary condition and kept in good repair. Each toilet room shall be well lighted and adequately ventilated. Air ventilation ducts from toilet facilities shall vent to the outside. Proper hand-washing facilities with hot and cold and/or warm running water shall be provided in toilet rooms. All windows shall be effectively screened when open. Signs shall be posted in all toilet rooms reminding employees to wash their hands before returning to work. Eating and/or storage of food are prohibited in toilet rooms. Water supply: The water supply, if from a public system, shall be approved as safe by the local Water Control Authority responsible for water quality. There shall be no cross-connection between a safe water supply and any unsafe or questionable water supply or any source of pollution through which the safe water supply might become contaminated. Samples for bacteriological testing of individual water supplies are taken upon the initial approval of the physical structure; each twelve (12) months thereafter; and when any repair or alteration of the water supply system has been made. The examination of the sample shall be conducted in an Officially Designated Laboratory. Water baths utilizing recirculated water for cooling product-contact surfaces shall comply with the bacteriological standards of the regulatory authorities. Records of all required water tests shall be maintained at a location acceptable to the Regulatory Agency for a period of two years. Hand washing facilities: Hot and cold and/or warm running water, soap, air dryers or individual sanitary towels shall be convenient to all fabricating areas. If water is not available, solvent or soft soap dispensers, containing sanitizers, may be used. When individual sanitary towels are used, covered trash containers shall be provided. Hand washing facilities shall be kept clean. Plant cleanliness: The floors, walls, ceilings, overhead beams, fixtures, pipes and ducts of production, storage, regrind, baling and compacting rooms shall be clean. All production areas, warehouse, toilet, lunch and locker rooms shall be free of evidence of insects, rodents, and birds. Machines and appurtenances shall be kept clean. Minor accumulations of paper, plastic or metal dust and other production soils incidental to normal fabricating operations do not violate this requirement. Locker and lunchrooms: Locker and lunchrooms shall be separate from plant operations and be equipped with self-closing doors. Eating and/or storage of food are prohibited in production and storage areas. Locker and lunchrooms shall be kept in a clean and sanitary condition. Cleanable refuse containers, properly labeled, shall be provided, which are covered, impervious, leak-proof and readily accessible. Proper hand washing facilities shall be convenient to locker and lunchrooms. Signs shall be posted reminding employees to wash their hands before returning to work. Disposal of wastes: All refuse and garbage shall be stored in covered, impervious and leak-proof containers. This requirement does not pertain to production scrap. All waste containers shall be clearly labeled for their intended purpose and contents. Where possible, garbage and assorted rubbish should be stored outside the building in covered, impervious, cleanable containers. If stored inside the building, it must be contained in similar receptacles, but in an area separate from fabricating areas. Personnel-practices: Hands shall be thoroughly washed before commencing plant functions and as often as may be required to remove soil and contamination, and before returning to work after visiting the toilet room or lunchroom. All personnel shall wear clean outer garments and effective hair restraints. No person affected with any disease in a communicable form, or while a carrier of such disease, and no person with an infected cut or lesion shall work in any processing area in any capacity where there is a likelihood of such person contaminating product or product-contact surfaces with pathogenic organisms. The use of tobacco products is prohibited in production, regrind and storage areas. Insecured jewellery shall not be permitted in production areas. Monitoring and Correction of GMPs The milk plant, receiving station or transfer station shall monitor the conditions and practices of all required PPs with sufficient frequency to ensure conformance with those conditions and that are appropriate both to the milk plant, receiving station or transfer station and to the safety of the milk or milk product being processed. Each milk plant, receiving station or transfer station shall document the correction of those conditions and practices that are not in conformance. Devices, such as indicating and recording thermometers that are used to monitor PPs shall be calibrated to assure accuracy at a frequency determined by the milk plant, receiving station, or transfer station. Required Records of GMPs Each milk plant, receiving station or transfer station shall maintain records that document the monitoring and corrections. Employees Awareness-Training All staff must be made aware of the importance of quality and safety of food and their roles in achieving organisation goals. HACCP SYSTEM PLANNING AND IMPLEMENTATION Preliminary Steps Some preliminary steps are required to be followed when before preparing a HACCP Plan. A HACCP team needs to be established and suitably trained on HACCP. Necessary resources need to be ensured. Complete, up-to-date process flow diagrams are required for all milk and milk products manufactured. Flow diagrams may be combined when processes, products and hazards are similar. HACCP Plan Every milk plant, receiving station or transfer station shall have and implement a written HACCP Plan whenever a hazard analysis reveals one or more hazards that are reasonably likely to occur. The HACCP Plan shall be developed by an individual or a team suitably trained and shall be subject to record keeping requirements as detailed in sub-section ‘Records’. A HACCP Plan shall be specific to each location and milk or milk product. The plan may group similar types of milk and milk products together, or similar types of production methods together, if the hazards, CCPs, CLs, and procedures required to be identified and performed are essentially identical, provided that any required features of the plan that are unique to a specific milk or milk product or method are clearly delineated in the plan and are observed in practice. The HACCP Plan shall, at a minimum: Include complete up-to-date process flow diagrams for all milk and milk products manufactured. Flow diagrams may be combined when processes, milk and milk products and hazards are similar. List all hazards that are reasonably likely to occur as identified in the hazard analysis specified above, and that must be controlled for each type of milk or milk product. List the CCPs for each of the identified hazards, including the appropriate: CCPs designed to control hazards that could occur or could be introduced in the milk plant, receiving station or transfer station environment; CCPs designed to control hazards introduced outside the milk plant, receiving station or transfer station environment, including hazards that occur before arriving at the milk plant, receiving station and/or transfer station; and, List the CLs that shall be met at each of the CCPs. List the procedures and the frequency with which they are to be performed that will be used to monitor each of the CCPs to ensure compliance with the CLs; Include any corrective action plans that have been developed in accordance with the corrective action requirements and that are to be followed in response to deviations from CLs at CCPs; List the verification and validation procedures, and the frequency with which they are to be performed, that the milk plant, receiving station or transfer station will use in accordance with verification and validation requirements; and, Provide a record keeping system that documents the monitoring of the CCPs in accordance with the record requirements. The records shall contain the actual values and observations obtained during monitoring. Hazard Analysis Each milk plant, receiving station or transfer station shall develop, or have developed for it, a written hazard analysis to determine whether there are milk or milk product hazards that are reasonably likely to occur for each type of milk or milk product processed or handled by the milk plant, receiving station or transfer station and to identify the control measures that the milk plant, receiving station or transfer station can apply to control those hazards. The hazard analysis shall include hazards that can be introduced both within and outside the milk plant, receiving station or transfer station environment, including hazards that can occur during handling, transportation, processing and distribution. A hazard that is reasonably likely to occur is one for which a prudent milk plant, receiving station or transfer station operator would establish controls because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that, in the absence of these controls, the hazard will occur in the particular type of milk or milk product being processed. The hazard analysis shall be developed by an individual or a team suitably trained and shall be subject to the record keeping requirements. In evaluating what milk or milk product hazards are reasonably likely to occur, at a minimum, consideration should be given to the following: Microbiological contamination; Parasites; Chemical contamination; Unlawful drug and pesticide residues; Natural toxins; Unapproved use of food or color additives; Presence of undeclared ingredients that may be allergens; and, Physical hazards. Milk plant, receiving station or transfer station operators should evaluate product ingredients, processing procedures, packaging, storage, and intended use; facility and equipment function and design; and milk plant sanitation, including employee hygiene, to determine the potential effect of each on the safety of the finished milk or milk product for the intended consumer. Corrective Actions Whenever a deviation from a CL occurs, a milk plant, receiving station or transfer station shall take corrective action by following the procedures set forth in 1 or 2 of this Section. Milk plants, receiving stations or transfer stations may develop written corrective action plans, which become a part of their HACCP Plan(s). These corrective action plans may predetermine the corrective actions that milk plants, receiving stations and transfer stations will take whenever there is a deviation from a CL. A corrective action plan that is appropriate for a particular deviation is one that describes the steps to be taken and assigns responsibility for taking those steps, to ensure that: No milk or milk product is allowed to enter commerce that is either injurious to health or is otherwise adulterated as a result of the deviation; or If such milk or milk product has entered commerce, it is expeditiously removed; and The cause of the deviation is corrected. When a deviation from a CL occurs, and the milk plant, receiving station or transfer station does not have a corrective action plan that is appropriate for that deviation, the milk plant, receiving station or transfer station should: Segregate and hold the affected milk or milk product, at least until the requirements of paragraphs 2.b and 2.c of this Section are met; Perform or obtain a review to determine the acceptability of the affected milk or milk product for distribution. The review shall be performed by an individual or individuals qualified by training or experience to perform such a review; Take corrective action, when necessary, with respect to the affected milk or milk product to ensure that no milk or milk product is allowed to enter commerce that is either injurious to health or is otherwise adulterated as a result of the deviation; Take corrective action, when necessary, to correct the cause of the deviation; and Perform or obtain timely validation by a qualified, suitably trained individual(s) to determine whether modification of the HACCP Plan is required to reduce the risk of recurrence of the deviation, and modify the HACCP Plan as necessary. All corrective actions taken in accordance with this Section should be fully documented in records that are subject to verification. Verification and Validation Verification: Every milk plant, receiving station or transfer station should verify that the HACCP system is being implemented according to design. Verification activities shall include: The calibration of CCP process-monitoring instruments, i.e., pasteurisation tests, etc; At the option of the milk plant, receiving station or transfer station, the performance of periodic end-product or in-process testing; A review, including signing and dating, by an individual records that document: The Monitoring of CCPs: The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that the recorded document values are within the CLs. This review shall occur at a frequency that is appropriate to the importance of the record and as specified in the HACCP Plan; The Taking of Corrective Action: The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that appropriate corrective action(s) was taken in accordance with the corrective action requirements cited before. This review shall occur at a frequency that is appropriate to the importance of the record. A centralised deviation log is required; and, The calibrating of any process monitoring instruments used at CCPs and the performance of any periodic end-product or in-process testing that is part of the milk plant, receiving station or transfer station’s verification activities. The purpose of these reviews shall be, at a minimum, to ensure that the records are complete and that these activities occurred in accordance with the milk plant receiving station’s or transfer station’s written procedures. These reviews shall occur within a reasonable time after the records are made. The taking of corrective action procedures whenever any verification procedure establishes the need to take a corrective action. The calibration of CCP process-monitoring instruments, and the performance of any periodic end-product and in-process testing, in accordance with 1.a.(3)ii) and 1.a.(3)iii) of this Section, should be documented in records that are subject to the record keeping requirements. Validation of the HACCP Plan: Every milk plant, receiving station or transfer station should validate that the HACCP Plan is adequate to control hazards that are reasonably likely to occur. This validation should occur at least once within twelve months after implementation and at least annually thereafter or whenever any changes in the process occur that could affect the hazard analysis or alter the HACCP Plan. Such changes may include changes in the raw materials or source of raw materials; product formulation; processing methods or systems, including computers and their software; packaging; finished product distribution systems; or the intended use or intended consumers of the finished product and consumer complaints. The validation should be performed by a suitably trained qualified individual or team and should be subject to the record keeping requirements cited below. The HACCP Plan should be modified immediately whenever a validation reveals that the plan is no longer adequate to fully meet the requirements of this document. Validation of the hazard analysis: Whenever a milk plant, receiving station or transfer station does not have a HACCP Plan, because a hazard analysis has revealed no hazards that are reasonably likely to occur, the milk plant, receiving station or transfer station shall reassess the adequacy of the hazard analysis whenever there are any changes in the process that could reasonably affect whether a hazard exists. Such changes may include changes in the following: Raw materials or source of raw materials; Product formulation; Processing methods or systems, including computers and their software; Packaging; Finished product distribution systems; or The intended use or intended consumers of the finished product; and, Consumer complaints. A qualified individual or a team suitably trained should perform the validation. Records Required records: It is essential that milk plants, receiving stations and transfer stations use consistent terminology to identify each piece of equipment, record, document, or other programme throughout their written HACCP System. A milk plant, receiving station or transfer station shall maintain the following records documenting the milk plant, receiving station or transfer station’s HACCP System: Records documenting the ongoing application of the GMPs (PPs), including a brief written description, monitoring and correction records; The written hazard analysis; The written HACCP Plan; Required HACCP documents and forms specified in 1.a. through c. of this Section shall be dated or identified with a version number. Each page shall be marked with a new date or version number whenever that page is updated; A Table of Contents and centralised list of the HACCP programme records, by title, documenting the ongoing application of the HACCP System shall be maintained and provided for review; A document change log; Records documenting the ongoing application of the HACCP Plan that include: Monitoring of CCPs and their CLs, including the recording of actual times, temperatures, or other measurements, as prescribed in the milk plant’s, receiving station’s or transfer station’s HACCP Plan; Corrective actions, including all actions taken in response to a deviation; A centralised deviation log is required; and Plan validation dates. Records documenting verification and validation of the HACCP System, including the HACCP Plan, hazard analysis and GMPs (PPs). General requirements: Records required by this Section shall include: The identity and location of the milk plant, receiving station or transfer station; The date and time of the activity that the record reflects; The signature or initials of the person(s) performing the operation or creating the record; and, Where appropriate, the identity of the milk or milk product and the production code, if any. Processing and other information shall be entered on records at the time that it is observed. The records shall contain the actual values and observations obtained during monitoring. Documentation: Will include The records in paragraphs 1.a. through c. of this Section shall be signed and dated by the most responsible individual onsite at the milk plant, receiving station or transfer station. This signature shall signify that these records have been accepted by the firm. The records in paragraphs 1.a. through c. of this Section shall be signed and dated: Upon initial acceptance; Upon any modification; and, Upon verification and validation in accordance with the requirements cited above. Record retention: Following should be considered. All records, required by this Section, shall be retained at the milk plant, receiving station or transfer station for perishable or refrigerated products, for at least one year after the date that such products were prepared, and in the case of frozen, preserved, or shelf-stable products, for two years after the date that the products were prepared or the shelf-life of the product, whichever is greater, unless longer retention time is required by other regulations. Records that relate to the adequacy of equipment or processes used, such as commissioning or process validation records, including the results of scientific studies and evaluations, shall be retained at the milk plant, receiving station or transfer station facility for at least two years after the date that the milk plant, receiving station or transfer station last used such equipment or process. Off-site storage of processing records is permitted after six months following the date that the monitoring occurred, if such records can be retrieved and provided on-site within twenty-four hours of a request for official review. Electronic records are considered to be on-site if they are accessible from an on-site location. If the processing facility is closed for a prolonged period, the records may be transferred to some other reasonably accessible location(s) but shall be immediately returned to the processing facility for official review upon request. Official review: All records required by this Section shall be available for official review at reasonable times. Records maintained on computers: The maintenance of records on computers, in accordance with the requirements cited above, is acceptable. TRAINING AND STANDARDISATION HACCP training for industry and regulatory personnel will be based on the current “Hazard Analysis and Critical Control Point Principles and Application Guidelines”. Regulatory Agency personnel responsible for the evaluation, licensing and regulatory audits of facilities using the HACCP Programme will have specialised training in conducting HACCP System audits. Industry, State and Federal regulatory and other related personnel should ideally be trained together. This may not be practical always. They should however have close interaction among themselves to the extent possible to ensure that they understand the HACCP plan similarly. HACCP AUDITS AND FOLLOW-UP ACTIONS State Regulatory Audits, Enforcement Audits, Actions and Follow-up Audits shall be conducted of the milk plant, receiving station, or transfer station facility, and HACCP Programme to ensure compliance with the HACCP System. The audit may be announced at the discretion of the auditor under certain circumstances, i.e., initial audit, follow-up audit, new construction, pasteurizer checks, etc. When unannounced audits are conducted, the audits shall not be completed until appropriate milk plant personnel have had an opportunity to make all pertinent records available for review by the auditor. A usual time frame for various audits is presented in Table 2. Table 2. Audit time frames Audits Frequency Minimums First Year after Initial Regulatory Audit Initial audit; Next audit in thirty (30) to forty-five (45) days; and four (4) month intervals thereafter, unless the Regulatory Agency determines that a greater frequency is warranted. Subsequent Audits Every six (6) months unless the Regulatory Agency determines that a greater frequency is warranted. Compliance Follow-Ups Compliance follow-ups shall be made as frequently as necessary to assure that problems observed by the Regulatory Agency have been resolved. Auditing Procedures Pre-Audit Management Interview: Review and discuss the milk plant HACCP System including: Changes in the management structure; The Hazard Analysis – Ensure that all milk or milk product hazards are addressed; Changes in the HACCP Plan; Changes in the GMPs (PPs); Changes in the flow diagram; and, Changes in milk or milk products or processes. Review past Audit Reports (AR) and corrections of deficiencies and non-conformities, if any; In-milk plant review of the implementation and verification of the HACCP System; Review records of the HACCP System; Review compliance with other applicable regulatory requirements*; Discuss findings and observations; Prepare and issue an AR based on findings of deficiencies and non-conformities. The AR shall include timelines for the correction of all identified deficiencies and non-conformities; and, Conduct the exit interview. Note: Examples of other applicable requirements: Raw milk supply source; Labelling compliance; Adulteration; Licensing requirements; Drug residue testing and trace back requirements; Regulatory samples in compliance; Approved laboratory utilised for the required regulatory tests; and, Pasteurisation equipment design and installation.