Why conventional end-point food testing can not effectively ensure food safety? 1.

Significant proportions of a foodstuff have to be sub-sampled for analysis to ensure representivity. 2. Food safety is only ensured with regards to tested hazards. 3. Control of hazards is reactive catching them when only it is too late!! 4. Responsibility for food safety is focused upon a relatively small component of the workforce: quality assurance and control personnel. 5. Food safety is only assured at the point of testing. The HACCP Concept Hazard Analysis and Critical Control Points A systematic food safety control approach during the food processing It is a preventative food safety system: identify the hazards that may occur at any stage in the food supply chain and put into place controls. It originated as part of the USA manned space program; the most effective way to produce safe food. It is very logical and covers all stages of food production, from primary production (farmers, growers) to the consumer. It offers increased confidence to the food industry and customers. Definitions 1. HACCP a quality management system based on an assessment of food hazards and the use of written standards and monitoring procedures to eliminate, minimize and control potential biological, chemical and physical hazards from food, insuring farm to table food safety and quality. 2. Control Point a point, step or procedure that controls food safety hazards, including those of biological, physical and chemical natures. Generally, a receiving or storage point. 3. Critical Control Point (CCP) a point, step or procedure in the producthandling process where controls can be applied and a food safety hazard can be prevented, eliminated, or reduced to safe levels. Also the point where later processing steps wont correct these safety problems. 4. Critical limit defined as a maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level, the occurrence of a food safety hazard. 5. Hazard a biological, chemical or physical agent that is reasonably likely to cause illness or injury in the absence of its control. 6. Monitoring a planned sequence of observations or measurements or critical limits designed to produce an accurate record and intended to insure that the critical limit maintains product safety. Continuous monitoring means an uninterrupted record of data. 7. Preventive Measure an action to exclude, destroy, eliminate or reduce a hazard and prevent recontamination through effective means.

8. 9.

10. 11. 12. 13. 14. 15.

16.

Risk an estimate of the likely occurrence of a hazard. Risk Assessment a scientifically based process consisting of 1) hazard identification, 2) hazard characterization, 3) exposure assessment, 4) risk characterization. Provides an evaluation of the likelihood and severity of adverse effects arising. Audit A systematic and functionally independent periodic inspection or a process to ensure compliance to requirements. Auditor A person who is qualified to carry out an audit. Acceptable level the presence of a hazard which does not pose the likelihood of causing an unacceptable health risk. Corrective Action the implementation of solutions resulting in the reduction or elimination forever of a specific cause of an identified nonconformance. Deviation failure to meet a required critical limit for a critical control point. Good Manufacturing Practices (GMPs) set of regulations requiring that quality, safety and effectiveness be built into foods, drugs, medical devices, and biological products. Goal is consumer protection, and manufacturers must comply, as they carry force of the law. Lie at the heart of quality Sanitation Standard Operating Procedures (SSOP) The documented GMP for hygiene and sanitation required to meet the regulatory requirement for food quality control

HACCP is a part of the food quality system Prerequisite Programs 1. Establishment (plant) design and facilities 2. Control of operation 3. Maintenance and Sanitation 4. Personal hygiene 5. Transportation 6. Product Information and Consumer Awareness 7. Training Programs Purpose To formalize & document operating procedures and practices Foundation for HACCP, HACCP program partially depends on the effectiveness of the prerequisite programs. weak foundation lead to failures in the HACCP program Decrease the number of Critical Control Points The relationships of GMPs, SSOP and HACCP SSOP & GMPs SSOP is based on GMPs SSOP and GMPs rely on each other GMPs and HACCP

GMPs: basic, all-round, a part of TQM system; solid (hard drive); similar in food establishments producing the same type of products HACCP: focus on CCP; flexible (software); unique in individual food establishment GMPs are a prerequisite program; essential for the development and implementation of a successful HACCP program. SSOP & HACCP SSOP supports the implementation of HACCP SSOP makes HACCP more effective GMPs & SSOP & HACCP GMPs and SSOP are prerequisite programs for HACCP. HACCP must be designed and implemented on the basis of the solid GMPs and acceptable SSOP Without GMPs, or cannot obey SSOP, HACCP will fail Hygiene and Sanitation Sanitation Procedures Main categories: Housekeeping Detailed cleaning (or deep cleaning) Periodic cleaning Verification checks Personal Hygiene Objectives: avoid contamination by the people who directly or indirectly contact the food surface by maintaining appropriate degree of personal cleanliness and operating in an appropriate manner. Codex Health Status Illness and Injuries Personal Cleanliness: hand washing, hair-nets, jewelry Personal Behavior: refrain from behavior like smoking, spitting, sneezing over unprotected food; wearing the jewelry during processing Visitors: controlled visitor policy Guidelines for the Application of the HACCP System (12 points) (HACCP implementation) 1. Assemble the HACCP team 2. Describe the product 3. Identify the intended use 4. Construct a flow diagram 5. On-site verification of the flow diagram 6. List all potential hazards, conduct a hazard analysis, determine control measures

7. Determine CCPs 8. Establish critical limits for each CCP 9. Establish a monitoring system for each CCP 10. Establish corrective action for deviations that may occur 11. Establish verification procedures 12. Establish record keeping and documentation Product Description and Intended Use Describe the product fully in terms of the key parameters that influence the safety of the product like composition, processing, the packaging system, storage and distribution conditions, and required shelf life Have a clear understanding of expected use of the product by end-users or customers. This should include the target group, which may be vulnerable. The method of distribution of the product must also be considered. Development and Verification of a Flow Diagram It should provide a clear, accurate and simple description of all the operational steps, in sequence, in the process A common problem found with flow diagrams is that product recycling or rework loops are often forgotten. A flow chart needs to be verified / confirmed against the actual processing operation, and any variations should be accounted for. It needs to be amended as the process changes over time. Major criteria in developing a process flow chart Sufficient technical data is used in developing the flow chart Supplemental information, such as site plans, equipment layouts, details of personnel routes, waste material flows also can be used. Do not forget the transfer of product from one step to the next as well as the product recycling. Needs to be amended as the process changes over time Plant Schematic: It provides detail of people movement to accompany the product movement detail of the flow diagram. (The Canadian Food Inspection Agency (CFIA) requires a plant schematic as well as a process flow diagram to detail employee traffic patterns.) Common Problems for HACCP Implementation (6 points) Differing HACCP models: Systems differ greatly depending upon country; range of models can be very confusing Differing Regulatory Requirements: Companies exporting goods to different markets with different requirements and HACCP models The Scope of HACCP Implementation: HACCP is still not 100% implemented across all food and manufacturing sectors

Resource Requirements: Underestimate the resources required in HACCP implementation in areas of upgrading prerequisite systems, setting up and maintaining documentation, and training Inadequate Prerequisite Programs: HACCP is effective only if it is based on a solid foundation of Good Manufacturing Practices (GMPs) The Seven HACCP Principles 1. Conduct a Hazard Analysis 2. CCP Identification 3. Establish Critical Limits for Each CCP 4. Establish CCP Monitoring Procedures 5. Establish Corrective Actions Procedures 6. Establish Procedures for HACCP Verification and Validation 7. Document the HACCP Program. Establishment of Record-Keeping Procedures. 2 objectives to a hazard analysis Identify all potential hazards and associated control measures. Evaluate and modify the identified hazards to insure or improve product safety providing the basis for determining the CCPs. Six Categories of Food Risk A. Food intended for consumption by at-risk populations: very young, old, immuno-compromised, or otherwise highly susceptible to potential hazards. B. Product containing sensitive ingredients: any ingredient that could be a source of a hazard or might be a good carrier of a microbiological hazard (e.g. eggs, milk). C. No process step to eliminate hazard: raw product is sold, with no processing to eliminate a potential hazard (e.g. fruits and vegetables). D. Recontamination potential before packaging: aseptic packaging is preferable because it reduces the potential for recontamination. E. Potential for product abuse: especially important if abuse is possible during distribution or consumer handling (e.g. microwaved food) F. No terminal heat process: ready-to-eat foods that do not require reheating. Consumer will not have the opportunity to eliminate remaining microbiological hazards. 3 kinds of hazards and their control measures Biological hazard: living organisms, including micro-organisms, which can put human health at risk. Include bacteria, parasites, protozoa, viruses and their toxins. Pathogenic bacteria can cause illness; vary by food; can be contaminated at all stage of the processing; need optimal condition to reach to a harmful level. Chemical Hazards: two groups. The first is natural occurring poisons, chemicals or other harmful substances. These are natural parts of foods and not from

contamination. The second is the added poison chemicals or harmful substances, they may intentionally or unintentionally add to foods at some point during any stages of processing. The best method of control is prerequisite programs Physical Hazards: any physical material not normally found in food, which causes illness or injury to an individual using the product, or if found naturally in the product, is normally removed. Objects which do not cause illness or injury are not considered hazards. Control Measures Biological: temperature extremes; chemical preservatives; sterilization; pH, water activity; prevention of contamination; personal hygiene; packaging; raw materials control; process sanitation; process design; modified atmospheres Chemical: use approved chemicals only, have detailed product specifications for all chemicals that enter the plant, maintain letters of guarantee from suppliers, inspect trucks used to ship finished product, properly label and store all chemicals, properly train employees who handle chemicals Physical: insure that plant specifications for building design and operation are accurate and updated regularly, insure that letters of guarantee for ingredients and product supplies are accurate and updated regularly, perform random visual exams on incoming product and materials, use magnets and metal detectors to help find metal fragments, use stone traps and bone separators, keep equipment well maintained, train employees to identify potential problems. Questions to Consider When Conducting a Hazard Analysis Ingredients Sensitive ingredient; supply sources Intrinsic Factors Hazards might result if composition is not controlled; permit pathogen survival or multiplication and toxin formation or not; similar products and safety record for them Procedures Used for Processing Process include a controllable step or not; what hazard if the product is subject to recontamination between processing and packaging Microbial Content of Food Normal microbial count; population change during storage or not, alter the safety or not Facility Design Equipment Design and Use Packaging Sanitation Employee Health, Hygiene and Education Conditions of Storage between Packaging and the End User Intended Use Intended Customer

A CCP differs from a control point (CP) The CP is any step in the process at which a hazard can be controlled. It is usually related to quality and production issues, and not to safety. Information gathered during the hazard analysis is essential to identifying which steps in the process are CCPs. Decision trees are often used to facilitate the identification of each CCP. Decision trees Q1: Do control measures exist? Q1a: Is control at this step necessary for safety? Q2: Is the step specifically designed to eliminate or reduce the likely occurrence of a hazard to an acceptable level? Q3: Could contamination with identified hazard occur in excess of acceptable level or could these increase to unacceptable levels? Q4: Will a subsequent step eliminate identified hazards or reduce the likely occurrence of a hazard to acceptable level? Y Q1 N Q1a
Modified

N Q2 Y N CCP Q4 Q3 Y

Not CCP Y

How to use decision tree for CCP determination The content above Important considerations when using decision tree Use it after completing the hazard analysis. Use at the step where hazards present in identified HACCP program. If a subsequent step can better control the hazard, it may be the preferred CCP. More than one step may be involved in controlling a hazard. More than one hazard may be controlled by a single specific control measure. Key points of critical limits. (Critical limit and operational limit) CLs are the criteria that differentiate between safe and potentially unsafe CLs are defined by regulations, safety standards and scientifically proven values They are measurable parameters can be determined and monitored via testing & observation Operational limits are set at more stringent levels to provide a action zone for process management Operational limits established after critical limits have been set. These are designed to prevent deviation from the critical limits. They must be tighter than the critical limits, to provide a safety factor for the process. Operational limits must provide the processor with the ability to adjust the process

and bring it back into control before the production of out-of-specification product P.S. CCPs should be controlled below the critical limits. Four types of monitoring 1. Visual Observations watch worker practices, inspect raw materials. It is the process being checked and not the product itself. 2. Sensory evaluations check for off-odours, off-colours, off-flavours, and product texture. 3. Physicochemical evaluations pH or acidity, viscosity, solids content, salt content, water activity, time, temperature, pressure. Adaptable to continuous monitoring. 4. Microbiological analysis. Test the microbiological quality of raw materials, time consuming The Four General Steps to Corrective Action Identifying Causes of Deviation Determining Product Disposition: determine the proper method for nonconforming product disposal Recording the Corrective Action: assist in the identification of problems; help to determine if the HACCP plan needs to be modified Re-evaluating the HACCP plan: an important step involved in the corrective action process Validation and Verification Validation ( )- obtaining evidence that the elements of the HACCP plan are effective; Make sure we are doing the correct things Verification( )- the application of methods, procedures, tests, and other evaluations, in addition to monitoring to determine compliance with the HACCP plan; Make sure the things we are doing are correct Events that may require verification inspection of the HACCP plan New information on product or process safety, or the manner in which the consumer uses a product When foods have been implicated in food-borne disease When established criteria have not been met To verify that changes have been made correctly, following a modification in the HACCP program Following significant modification to process points that are critical What is the process approach? Dividing the many food flows in an establishment into broad categories based on activities or stages in the flow of food through the establishment, then analyzing the hazards, and placing managerial controls on each grouping.

Danger zone 5-57 The Scope of HACCP The scope of HACCP programs based on the particular hazard can be expanded or limited at the discretion of management. HACCP programs should be reserved exclusively for safety issues. Although microbiological issues are often the primary focus of safety concerns, HACCP programs should focus on more than just these issues. Quality Control programs deal with other quality issues which were implemented years ago. These should not be part of a true HACCP program. Give at least three ways to establish critical limits Limits should be established through experimentation, or from regulatory sources, expert opinions, industry standards, research studies, equipment manufacturers recommendations or literature surveys Critical limits can be based on: temperature, time, physical dimensions, humidity, moisture level, Aw, pH, salt concentration, etc. They must be established on a technological and scientific basis. HACCP myth A common misconception is that HACCP by itself will ensure that the end product will be of good quality and will meet all legal requirements. Another misconception is that HACCP is sometimes mistakenly confused with employee health and safety. HACCP is purely a management system controlling the safety of a product that will be consumed and is not concerned with the safe working environment of the people involved in its production. 1. A misunderstanding that you need to reconstruct your facilities because they are old. 2. A misunderstanding that you cant carry out HACCP without approval 3. Misunderstandings that you have to collect a lot of data and that your factory has to be large. 4. Bad manufacturing efficiency is equal to increase in cost. 5. A misunderstanding that you cant carry out HACCP without an expert or a qualified person. 6. A misunderstanding that you cant carry out HACCP because you have no heat processing. 7. A misunderstanding that you cant carry out HACCP because you have no testing equipment. 8. A misunderstanding that you need a perfect inspection system. 9. A misunderstanding that you need perfect preparations from the beginning. 10. A misunderstanding that the same types of factories have the same types of HACCP systems

 There are many myths on understanding HACCP Characters of retail and food service industries Wide range of employee resources (from executives to front line employees). Difficult to conduct in-house training because employees may speak different languages, and there may be high employee turnover. Many are new, small businesses. Low profit margin, less money to work with than other segments of the food industry. Endless number of production techniques, products, menu items, and ingredients used. Suppliers, ingredients, menu items and specifications can change frequently. Company personnel should have been needed on the HACCP team.
the majority HACCP team member should be its own (company/factory) staff

Assemble the HACCP Team: The team should be multi-disciplinary. It should include relevant technical and scientific expertise, and knowledge of the operation. The team should include a production specialist, an engineer, a quality assurance or quality control technical specialist, someone from hygiene management, and a microbiologist, if one is warranted. Staff with practical knowledge should be included, as well as management. Usually, 4-6 people on the team is best. The team leader should be a production specialist (manages the study and team meetings). The leader is usually a person with specific training and expertise in HACCP principles and implementation. One member of the HACCP team needs to take notes at meetings and to draft the HACCP plan as it emerges from discussions with the team. All members of the team should receive basic training in HACCP principles. If appropriate expertise is not available on site, expert advice should be obtained from other sources. Lack of the content of three generic models (Chinese Style Dried Sausage, Poultry Slaughter, Cold Storage/Freezer Facilities) and one practical example (Refrigerated Stick and Sliced Celery)