This document provides guidelines for applying Hazard Analysis and Critical Control Point (HACCP) principles to assure food safety. It was created by the National Advisory Committee on Microbiological Criteria for Foods to advise the food industry and regulatory agencies. The document defines HACCP terms and outlines the seven HACCP principles. It also provides detailed guidance on developing and implementing an effective HACCP plan tailored to each facility.
Here are the answers to the questions:
1. Food labelling
2. Food poisoning is an acute illness caused by contaminated or poisonous food, usually lasting 1-7 days with symptoms like abdominal pain, diarrhea, vomiting and fever.
3. The 4 C principle in food hygiene are: Chilling (milk, vegetables), Cooking, Cleaning, and Clear and clean as you go. Examples of food additives are color and preservatives.
4. Food allergy is an immune system reaction while food intolerance is an non-immune reaction.
5. TACCP stands for Threat Assessment and Critical Control Points. A CCP shall be an integral step in any process flow
Our company is committed to developing and implementing Good Manufacturing Practices (GMPs) following the principles of Hazard Analysis Critical Control Point (HACCP). GMPs and HACCP programs help control food safety hazards through prerequisite programs and establishing critical control points. An effective GMP/HACCP program requires commitment from both management and employees.
This document outlines differences between food safety and food defense from a presentation given by Dr. Carol Maczka of the USDA Food Safety and Inspection Service. Food safety aims to prevent unintentional contamination, while food defense focuses on intentional contamination by biological, chemical or radiological agents. Key differences include outcomes (food safety incidents often cause illness while food defense risks death), contaminants (food defense considers heat-resistant and toxic agents), and prevention strategies (food safety uses HACCP plans while food defense uses vulnerability assessments and countermeasures). The document provides examples of both unintentional and intentional food contamination incidents.
Karthika P is an Assistant Professor in the Department of Food Science and Nutrition at Periyar University in Salem, Tamil Nadu. The document discusses Hazard Analysis Critical Control Point (HACCP), which identifies, evaluates, and controls food safety hazards. It outlines the seven principles of HACCP - hazard analysis, identifying critical control points, establishing critical limits, monitoring procedures, corrective actions, verification, and documentation. Pre-requisite programs like good manufacturing practices are also mentioned.
Validation and Verification of HACCP Plans - Webinar PresentationSAIGlobalAssurance
This document discusses validation and verification of HACCP plans. It begins with definitions of key terms like validation, verification, and objective evidence. It then covers various aspects of validating and verifying prerequisite programs that support HACCP plans, including calibration, cleaning/sanitation, good hygiene practices, pest control, training, and approved suppliers. Validation activities involve confirming that programs are effective, like challenge testing for cleaning or assessing training effectiveness. Verification ensures programs continue working as intended through ongoing checks like surface swabbing and audits. The document provides details on documentation, monitoring, corrective actions, and record keeping requirements for validating and verifying these prerequisite food safety programs.
1) The document provides an overview of food defense training covering incidents of intentional food contamination, government policy and preparedness response, and the CARVER+Shock risk assessment tool.
2) It describes incidents where food products were intentionally contaminated for economic gain or to influence elections, causing illnesses and some deaths.
3) The Food Safety Modernization Act aims to improve food protection through rules focused on mitigation strategies, foreign supplier verification, and preventative controls for human and animal food.
HACCP for the safety of Livestock ProductsDr. IRSHAD A
The document provides an overview of Hazard Analysis and Critical Control Point (HACCP) systems for ensuring food safety. It discusses the history and definitions of HACCP, the seven principles of HACCP including hazard analysis, identifying critical control points, establishing monitoring procedures, and record keeping. The document also includes an example decision tree for determining critical control points.
HACCP (Hazard Analysis and Critical Control Points) is a systematic preventative approach to food safety that identifies potential biological, chemical, and physical hazards at specific points in the food production process. It was developed in the 1960s by Pillsbury and NASA to ensure food safety for space missions. In the 1970s, the FDA adopted HACCP for low acid canned foods to reduce food poisoning. By the 1980s, HACCP use had spread throughout the US and Europe. The WHO and EU later made HACCP a legal requirement to improve global food safety standards. HACCP certification involves completing a training course on the seven HACCP principles: hazard analysis, determining critical control points, establishing critical limits
Here are the answers to the questions:
1. Food labelling
2. Food poisoning is an acute illness caused by contaminated or poisonous food, usually lasting 1-7 days with symptoms like abdominal pain, diarrhea, vomiting and fever.
3. The 4 C principle in food hygiene are: Chilling (milk, vegetables), Cooking, Cleaning, and Clear and clean as you go. Examples of food additives are color and preservatives.
4. Food allergy is an immune system reaction while food intolerance is an non-immune reaction.
5. TACCP stands for Threat Assessment and Critical Control Points. A CCP shall be an integral step in any process flow
Our company is committed to developing and implementing Good Manufacturing Practices (GMPs) following the principles of Hazard Analysis Critical Control Point (HACCP). GMPs and HACCP programs help control food safety hazards through prerequisite programs and establishing critical control points. An effective GMP/HACCP program requires commitment from both management and employees.
This document outlines differences between food safety and food defense from a presentation given by Dr. Carol Maczka of the USDA Food Safety and Inspection Service. Food safety aims to prevent unintentional contamination, while food defense focuses on intentional contamination by biological, chemical or radiological agents. Key differences include outcomes (food safety incidents often cause illness while food defense risks death), contaminants (food defense considers heat-resistant and toxic agents), and prevention strategies (food safety uses HACCP plans while food defense uses vulnerability assessments and countermeasures). The document provides examples of both unintentional and intentional food contamination incidents.
Karthika P is an Assistant Professor in the Department of Food Science and Nutrition at Periyar University in Salem, Tamil Nadu. The document discusses Hazard Analysis Critical Control Point (HACCP), which identifies, evaluates, and controls food safety hazards. It outlines the seven principles of HACCP - hazard analysis, identifying critical control points, establishing critical limits, monitoring procedures, corrective actions, verification, and documentation. Pre-requisite programs like good manufacturing practices are also mentioned.
Validation and Verification of HACCP Plans - Webinar PresentationSAIGlobalAssurance
This document discusses validation and verification of HACCP plans. It begins with definitions of key terms like validation, verification, and objective evidence. It then covers various aspects of validating and verifying prerequisite programs that support HACCP plans, including calibration, cleaning/sanitation, good hygiene practices, pest control, training, and approved suppliers. Validation activities involve confirming that programs are effective, like challenge testing for cleaning or assessing training effectiveness. Verification ensures programs continue working as intended through ongoing checks like surface swabbing and audits. The document provides details on documentation, monitoring, corrective actions, and record keeping requirements for validating and verifying these prerequisite food safety programs.
1) The document provides an overview of food defense training covering incidents of intentional food contamination, government policy and preparedness response, and the CARVER+Shock risk assessment tool.
2) It describes incidents where food products were intentionally contaminated for economic gain or to influence elections, causing illnesses and some deaths.
3) The Food Safety Modernization Act aims to improve food protection through rules focused on mitigation strategies, foreign supplier verification, and preventative controls for human and animal food.
HACCP for the safety of Livestock ProductsDr. IRSHAD A
The document provides an overview of Hazard Analysis and Critical Control Point (HACCP) systems for ensuring food safety. It discusses the history and definitions of HACCP, the seven principles of HACCP including hazard analysis, identifying critical control points, establishing monitoring procedures, and record keeping. The document also includes an example decision tree for determining critical control points.
HACCP (Hazard Analysis and Critical Control Points) is a systematic preventative approach to food safety that identifies potential biological, chemical, and physical hazards at specific points in the food production process. It was developed in the 1960s by Pillsbury and NASA to ensure food safety for space missions. In the 1970s, the FDA adopted HACCP for low acid canned foods to reduce food poisoning. By the 1980s, HACCP use had spread throughout the US and Europe. The WHO and EU later made HACCP a legal requirement to improve global food safety standards. HACCP certification involves completing a training course on the seven HACCP principles: hazard analysis, determining critical control points, establishing critical limits
FSSAI exam How to prepare, Exam Criteria, Eligibility, Pattern.krupal parmar
The document provides information about the Food Safety and Standards Authority of India (FSSAI) Food Analyst Examination. It outlines the exam dates, eligibility requirements, exam pattern, and syllabus. Candidates can apply for either the 5th Food Analyst Examination or the 2nd Junior Food Analyst Examination. The exams consist of theory papers I and II, which are compulsory, and an optional practical paper III for the Food Analyst Exam. Eligible candidates have a science background and varying levels of food analysis experience depending on the exam. Preparation involves studying the outlined syllabus which covers topics in food science, chemistry, and regulations.
HACCP (Hazard Analysis Critical Control Point) is a food safety system that identifies potential food safety hazards and puts controls in place to prevent them. It was originally developed in the 1960s for NASA space missions to ensure food safety. Since then, HACCP principles have been adopted worldwide by food standards organizations and legislation. The document provides a detailed history of the development of HACCP from 1959 to the present and describes the seven principles of HACCP and guidelines for its application, which include assembling a HACCP team, describing products, identifying intended uses, constructing flow diagrams, identifying hazards and controls, determining critical control points, and establishing monitoring, verification and documentation procedures.
FSSC 22000 V4.1, USFDA FSMA, SQF V8.0 standards now require to address the controls over food fraud & food defense through vulnerability & threat assessment. Our expert will train your team on the requirements & assist in documenting the plan for VACCP & TACCP.
This document provides an overview of best practices for ensuring readiness for food safety audits and assessments. It begins with introductions and background on the speaker, Bill McBride. The agenda then outlines topics to be covered, including an overview of food safety audits, understanding common food safety terminology, selecting the appropriate food safety standard, and what it means to be "audit ready". It also provides definitions and objectives of food safety audits. Key points made include criticisms of some auditing practices, the roles and limitations of audits, and information on standards organizations like ISO, GFSI initiatives, and the purpose of establishing the GFSI.
This document provides an overview of food safety and quality procedures for a food packaging company. It discusses Hazard Analysis and Critical Control Points (HACCP), potential food hazards at different stages of production, bacteria growth, pest control, and proper handwashing techniques. The objectives are to educate employees on food safety risks and their role in ensuring packaging does not contaminate customers' food products.
This document provides an overview of Good Manufacturing Practices (GMPs) and Hazard Analysis Critical Control Points (HACCP) programs. It discusses how GMPs and HACCP were developed to ensure food safety, the benefits of implementing these programs, and key aspects of GMPs including prerequisite programs, hazards analysis, and controlling biological, chemical and physical hazards. The summary focuses on establishing food safety programs and controlling hazards at various stages of food production.
The document discusses food safety management systems (FSMS) that are used in the global food industry. It describes several common FSMS standards and outlines their key components. The main FSMS methodology is Hazard Analysis and Critical Control Points (HACCP), which is a systematic process for identifying and controlling food safety hazards. The document also covers advantages and disadvantages of FSMS for consumers and the food industry, and proposes harmonizing standards to reduce costs and enforcing food safety regulations.
The document discusses Hazard Analysis Critical Control Point (HACCP), a food safety management system. It identifies HACCP's seven principles, which include conducting hazard analysis, determining critical control points, establishing critical limits, and establishing documentation procedures. The presentation emphasizes that HACCP is important as it identifies and controls food safety hazards through its principles in order to produce food that is safe for consumption.
PRP are steps or procedures including GMP & SSOP that control conditions within a food establishment to promote safe food production. They establish basic hygienic requirements including facility location and construction, equipment cleaning, utilities like water and air, cleaning and sanitation programs, personal hygiene facilities, and more. Requirements include proper drainage, separation of raw and processed areas, smooth cleanable surfaces, pest control, and documented cleaning procedures.
The document outlines the seven principles of the Hazard Analysis Critical Control Point (HACCP) system, which is a prevention-based food safety program that identifies hazards and monitors critical control points during food production to prevent foodborne illnesses. Key aspects of HACCP include identifying biological, chemical, and physical hazards; establishing critical limits for monitoring critical control points; and maintaining records to verify the effectiveness of the system. The principles aim to anticipate and control hazards before problems occur through monitoring at critical stages of food production.
This document provides an overview of Hazard Analysis and Critical Control Points (HACCP). It defines HACCP as a system that identifies, evaluates, and controls food safety hazards. The document outlines the seven principles of HACCP, which include conducting a hazard analysis, determining critical control points, establishing critical limits, monitoring procedures, corrective actions, record keeping, and verification procedures. It provides details on each principle and how they are applied to ensure food safety is controlled at critical points in the food production process.
Food safety management system for fast food chain krunal solanki
The document outlines a food safety management system for a concept restaurant in Switzerland. It includes 7 steps for planning and designing the system, covering introduction to global food safety standards, assessment of prerequisites, management implementation, HACCP planning, training, auditing, and more. Procedures are defined for hygiene, training, facility design, pest control, and ensuring food safety in storage, preparation, service, and supplier selection. The goal is to create a comprehensive system that trains employees and monitors all aspects of food handling to prevent foodborne illness.
This document describes the HACCP plan for a meat pie produced by a bakery. It outlines the ingredients, production process, packaging, storage, and potential food safety hazards. The key steps in the process are cooking the meat filling to over 75°C to eliminate pathogens, refrigerating or freezing the pies below certain temperatures to prevent bacterial growth, and baking the pies over 200°C for 20 minutes to eliminate any remaining pathogens. Potential biological, chemical and physical hazards are identified for each step, with cooking, refrigeration/freezing, and baking steps designated as critical control points.
The document discusses food defense and the Bioterrorism Act of 2002. It outlines requirements for companies to register food facilities with the FDA, implement tracking of food from supplier to recipient, and maintain proper records. It also provides guidelines for companies to assure safe ingredients from suppliers, look for security risks, monitor employees and access, report tracking records if requested, and notify supervisors of any threats. The overall goal is to protect products, public health, and employees from potential bioterrorism risks.
in this presentation, an overview of GMPs and SSOPs was provided. In addition, HACCP seven principles and benefits of application were simply described.
The document discusses risk assessment and management strategies for food allergens in Australia. It outlines regulatory requirements for labeling major food allergens, as well as best practices for identifying allergen risks through supplier information, production processes, cleaning validation, and testing. It also describes the Voluntary Incidental Trace Allergen Labeling (VITAL) program, a risk-based system used to determine when precautionary allergen labeling is required. Mobile apps are highlighted as a way for consumers to easily access product information and make informed choices.
This document outlines the 12 steps required to develop a Hazard Analysis and Critical Control Points (HACCP) plan according to Codex principles. It discusses assembling a HACCP team with the necessary expertise, describing the product and intended use, constructing a flow diagram, confirming the flow diagram on-site, identifying and analyzing hazards, determining critical control points, establishing critical limits, monitoring procedures, corrective actions, and verifying HACCP procedures. The goal is to apply the seven HACCP principles in a structured manner to develop an effective food safety plan.
The document discusses food safety management systems and Hazard Analysis and Critical Control Point (HACCP). It explains that many food companies require suppliers to implement a food safety management system. The Global Food Safety Initiative has benchmarked several certification programs that are HACCP-based. HACCP identifies hazards and implements controls at critical points in the food production process. Implementing HACCP requires establishing prerequisite programs to control hazards, developing HACCP plans for each product, and following the seven HACCP principles of hazard analysis, critical control point identification, and establishing monitoring, corrective actions, verification and documentation procedures.
The document outlines the prerequisite programs that must be developed and implemented by companies prior to establishing their HACCP plans. There are seven prerequisite programs that address food safety from receiving to shipping: (1) Premises, (2) Transportation/Purchasing/Receiving/Storage, (3) Equipment, (4) Personnel, (5) Sanitation and Pest Control, (6) Recall, and (7) Operational Prerequisite Programs. Each program contains elements, sub-elements, and requirements to control food safety hazards in the work environment and operational practices. The prerequisite programs must be documented, updated when changes are made, and reassessed at least annually.
The document provides background information on HACCP (Hazard Analysis and Critical Control Points) and guidelines for its application. It describes how HACCP was developed in the 1960s to ensure food safety for NASA's space program. The document defines key HACCP terms and outlines the 7 principles of HACCP for identifying hazards and establishing control systems. It also discusses prerequisites, performing a hazard analysis to identify critical control points, establishing monitoring and corrective actions, and documentation requirements. The goal of HACCP is to prevent food safety hazards through implementation of control measures at critical steps.
FSSAI exam How to prepare, Exam Criteria, Eligibility, Pattern.krupal parmar
The document provides information about the Food Safety and Standards Authority of India (FSSAI) Food Analyst Examination. It outlines the exam dates, eligibility requirements, exam pattern, and syllabus. Candidates can apply for either the 5th Food Analyst Examination or the 2nd Junior Food Analyst Examination. The exams consist of theory papers I and II, which are compulsory, and an optional practical paper III for the Food Analyst Exam. Eligible candidates have a science background and varying levels of food analysis experience depending on the exam. Preparation involves studying the outlined syllabus which covers topics in food science, chemistry, and regulations.
HACCP (Hazard Analysis Critical Control Point) is a food safety system that identifies potential food safety hazards and puts controls in place to prevent them. It was originally developed in the 1960s for NASA space missions to ensure food safety. Since then, HACCP principles have been adopted worldwide by food standards organizations and legislation. The document provides a detailed history of the development of HACCP from 1959 to the present and describes the seven principles of HACCP and guidelines for its application, which include assembling a HACCP team, describing products, identifying intended uses, constructing flow diagrams, identifying hazards and controls, determining critical control points, and establishing monitoring, verification and documentation procedures.
FSSC 22000 V4.1, USFDA FSMA, SQF V8.0 standards now require to address the controls over food fraud & food defense through vulnerability & threat assessment. Our expert will train your team on the requirements & assist in documenting the plan for VACCP & TACCP.
This document provides an overview of best practices for ensuring readiness for food safety audits and assessments. It begins with introductions and background on the speaker, Bill McBride. The agenda then outlines topics to be covered, including an overview of food safety audits, understanding common food safety terminology, selecting the appropriate food safety standard, and what it means to be "audit ready". It also provides definitions and objectives of food safety audits. Key points made include criticisms of some auditing practices, the roles and limitations of audits, and information on standards organizations like ISO, GFSI initiatives, and the purpose of establishing the GFSI.
This document provides an overview of food safety and quality procedures for a food packaging company. It discusses Hazard Analysis and Critical Control Points (HACCP), potential food hazards at different stages of production, bacteria growth, pest control, and proper handwashing techniques. The objectives are to educate employees on food safety risks and their role in ensuring packaging does not contaminate customers' food products.
This document provides an overview of Good Manufacturing Practices (GMPs) and Hazard Analysis Critical Control Points (HACCP) programs. It discusses how GMPs and HACCP were developed to ensure food safety, the benefits of implementing these programs, and key aspects of GMPs including prerequisite programs, hazards analysis, and controlling biological, chemical and physical hazards. The summary focuses on establishing food safety programs and controlling hazards at various stages of food production.
The document discusses food safety management systems (FSMS) that are used in the global food industry. It describes several common FSMS standards and outlines their key components. The main FSMS methodology is Hazard Analysis and Critical Control Points (HACCP), which is a systematic process for identifying and controlling food safety hazards. The document also covers advantages and disadvantages of FSMS for consumers and the food industry, and proposes harmonizing standards to reduce costs and enforcing food safety regulations.
The document discusses Hazard Analysis Critical Control Point (HACCP), a food safety management system. It identifies HACCP's seven principles, which include conducting hazard analysis, determining critical control points, establishing critical limits, and establishing documentation procedures. The presentation emphasizes that HACCP is important as it identifies and controls food safety hazards through its principles in order to produce food that is safe for consumption.
PRP are steps or procedures including GMP & SSOP that control conditions within a food establishment to promote safe food production. They establish basic hygienic requirements including facility location and construction, equipment cleaning, utilities like water and air, cleaning and sanitation programs, personal hygiene facilities, and more. Requirements include proper drainage, separation of raw and processed areas, smooth cleanable surfaces, pest control, and documented cleaning procedures.
The document outlines the seven principles of the Hazard Analysis Critical Control Point (HACCP) system, which is a prevention-based food safety program that identifies hazards and monitors critical control points during food production to prevent foodborne illnesses. Key aspects of HACCP include identifying biological, chemical, and physical hazards; establishing critical limits for monitoring critical control points; and maintaining records to verify the effectiveness of the system. The principles aim to anticipate and control hazards before problems occur through monitoring at critical stages of food production.
This document provides an overview of Hazard Analysis and Critical Control Points (HACCP). It defines HACCP as a system that identifies, evaluates, and controls food safety hazards. The document outlines the seven principles of HACCP, which include conducting a hazard analysis, determining critical control points, establishing critical limits, monitoring procedures, corrective actions, record keeping, and verification procedures. It provides details on each principle and how they are applied to ensure food safety is controlled at critical points in the food production process.
Food safety management system for fast food chain krunal solanki
The document outlines a food safety management system for a concept restaurant in Switzerland. It includes 7 steps for planning and designing the system, covering introduction to global food safety standards, assessment of prerequisites, management implementation, HACCP planning, training, auditing, and more. Procedures are defined for hygiene, training, facility design, pest control, and ensuring food safety in storage, preparation, service, and supplier selection. The goal is to create a comprehensive system that trains employees and monitors all aspects of food handling to prevent foodborne illness.
This document describes the HACCP plan for a meat pie produced by a bakery. It outlines the ingredients, production process, packaging, storage, and potential food safety hazards. The key steps in the process are cooking the meat filling to over 75°C to eliminate pathogens, refrigerating or freezing the pies below certain temperatures to prevent bacterial growth, and baking the pies over 200°C for 20 minutes to eliminate any remaining pathogens. Potential biological, chemical and physical hazards are identified for each step, with cooking, refrigeration/freezing, and baking steps designated as critical control points.
The document discusses food defense and the Bioterrorism Act of 2002. It outlines requirements for companies to register food facilities with the FDA, implement tracking of food from supplier to recipient, and maintain proper records. It also provides guidelines for companies to assure safe ingredients from suppliers, look for security risks, monitor employees and access, report tracking records if requested, and notify supervisors of any threats. The overall goal is to protect products, public health, and employees from potential bioterrorism risks.
in this presentation, an overview of GMPs and SSOPs was provided. In addition, HACCP seven principles and benefits of application were simply described.
The document discusses risk assessment and management strategies for food allergens in Australia. It outlines regulatory requirements for labeling major food allergens, as well as best practices for identifying allergen risks through supplier information, production processes, cleaning validation, and testing. It also describes the Voluntary Incidental Trace Allergen Labeling (VITAL) program, a risk-based system used to determine when precautionary allergen labeling is required. Mobile apps are highlighted as a way for consumers to easily access product information and make informed choices.
This document outlines the 12 steps required to develop a Hazard Analysis and Critical Control Points (HACCP) plan according to Codex principles. It discusses assembling a HACCP team with the necessary expertise, describing the product and intended use, constructing a flow diagram, confirming the flow diagram on-site, identifying and analyzing hazards, determining critical control points, establishing critical limits, monitoring procedures, corrective actions, and verifying HACCP procedures. The goal is to apply the seven HACCP principles in a structured manner to develop an effective food safety plan.
The document discusses food safety management systems and Hazard Analysis and Critical Control Point (HACCP). It explains that many food companies require suppliers to implement a food safety management system. The Global Food Safety Initiative has benchmarked several certification programs that are HACCP-based. HACCP identifies hazards and implements controls at critical points in the food production process. Implementing HACCP requires establishing prerequisite programs to control hazards, developing HACCP plans for each product, and following the seven HACCP principles of hazard analysis, critical control point identification, and establishing monitoring, corrective actions, verification and documentation procedures.
The document outlines the prerequisite programs that must be developed and implemented by companies prior to establishing their HACCP plans. There are seven prerequisite programs that address food safety from receiving to shipping: (1) Premises, (2) Transportation/Purchasing/Receiving/Storage, (3) Equipment, (4) Personnel, (5) Sanitation and Pest Control, (6) Recall, and (7) Operational Prerequisite Programs. Each program contains elements, sub-elements, and requirements to control food safety hazards in the work environment and operational practices. The prerequisite programs must be documented, updated when changes are made, and reassessed at least annually.
The document provides background information on HACCP (Hazard Analysis and Critical Control Points) and guidelines for its application. It describes how HACCP was developed in the 1960s to ensure food safety for NASA's space program. The document defines key HACCP terms and outlines the 7 principles of HACCP for identifying hazards and establishing control systems. It also discusses prerequisites, performing a hazard analysis to identify critical control points, establishing monitoring and corrective actions, and documentation requirements. The goal of HACCP is to prevent food safety hazards through implementation of control measures at critical steps.
This document provides an introduction and history of Hazard Analysis Critical Control Points (HACCP). It discusses how HACCP was developed in the 1960s for NASA to ensure food safety for astronauts. Since then, HACCP principles have been adopted as international food safety standards. The document outlines the chronological development of HACCP and its increased worldwide usage in food legislation over time. It describes the seven principles of HACCP and provides guidelines for applying the HACCP system to identify hazards and implement controls at critical control points to improve food safety.
History, Introduction & Scope Of MicrobiologySalman Ali
This document discusses the history and scope of microbiology. It covers key discoveries such as the first observation of microorganisms by Antonie van Leeuwenhoek and the conflict over spontaneous generation that was resolved by experiments showing that microbes were required for decay and fermentation. The "golden age of microbiology" established germ theory and Koch's postulates. This led to the development of medical, agricultural, industrial, and food microbiology.
HACCP (Hazard Analysis and Critical Control Points) is a systematic preventative approach that identifies and controls hazards in the food production process. It involves assembling a team to analyze hazards, construct a flow diagram of the process, determine critical control points and critical limits. The goal is to implement control measures that eliminate or reduce significant hazards to protect consumer safety. Key aspects include hazard analysis, identifying critical control points, establishing monitoring and verification procedures, and maintaining documentation.
Microbiology plays an important role in ensuring the quality of oral liquid pharmaceutical products. Contamination of excipients used in oral liquids can have serious health consequences. A quality control microbiology laboratory tests starting materials, manufacturing processes, and final products to ensure safety and efficacy. Acceptance criteria for non-sterile oral dosage forms specify limits for total aerobic microbial count and total yeast and mold count to minimize health risks from microbes.
As food safety continues to be a worldwide public health issue, the need for improved and more effective food safety systems has increased over the past three decades. A combination of national and international standards, industry needs, customer demands and many other factors has led to tremendous improvements of Food Safety Management Systems.
Este documento describe el sistema de Análisis de Peligros y Puntos de Control Crítico (HACCP), incluyendo su historia, objetivos, alcance y los 12 pasos requeridos para su implementación. El HACCP es un sistema preventivo para garantizar la seguridad de los alimentos y evitar riesgos a la salud, identificando y controlando los puntos críticos en el proceso de producción.
Microbiology is the study of microorganisms that are invisible to the naked eye, including viruses, bacteria, algae, fungi and protozoa. Antony van Leewenhoek first observed microorganisms in the 1600s using an early microscope. Louis Pasteur and Robert Koch established the germ theory of disease, proving that specific microbes cause specific diseases. Koch developed guidelines for proving causation that are still used today. Microbiology now impacts many fields including medicine, agriculture, food science and biotechnology.
Culture media are used to grow microorganisms outside the body for research and diagnostic purposes. There are different types of culture media classified based on physical state (solid, semi-solid, liquid) or ingredients (simple, complex, synthetic). Solid media like agar are used to isolate colonies, while liquid broths allow uniform growth. Special media can be enriched, selective, differential, or designed for transport or anaerobes. Proper preparation and sterilization of media is required to avoid contamination.
Este documento describe el sistema HACCP (Hazard Analysis and Critical Control Points), que es un sistema preventivo para garantizar la inocuidad de los alimentos. Se explica que HACCP fue desarrollado en 1960 por Pillsbury para suministrar alimentos seguros a los astronautas. El sistema HACCP se basa en 7 principios, incluyendo el análisis de peligros, identificación de puntos críticos de control, establecimiento de límites críticos y procedimientos de monitoreo y verificación.
Microbiological culture media can be classified in several ways including consistency, nutritional components, and functional use. The key types are liquid media used for broth cultures, solid media using agar plates for isolated colonies, and semi-solid media for examining motility. Media are also classified based on their nutritional components as simple, complex, synthetic or enriched. Classification by functional use includes basal media for general growth, selective media using inhibitors, enrichment media to recover pathogens, differential media using indicators, and transport media to maintain viability during shipment. Proper culture media are vital for microbiology studies and different media types are used for isolating, identifying and examining the growth of microorganisms.
This document discusses Hazard Analysis and Critical Control Points (HACCP), a food safety management system. It outlines the 7 principles of HACCP including conducting a hazards analysis, determining critical control points, establishing critical limits, monitoring systems, corrective actions, verification procedures, and documentation. The document also provides examples of food hazards and applies HACCP to a process flow map showing purchase, delivery, storage, preparation, cooking, food holding, and service.
Culture media are used to grow microorganisms under controlled conditions for identification and study. Different types of media exist depending on consistency (solid, liquid, semi-solid), ingredients (simple, complex, synthetic), and purpose (enrichment, selective, indicator). Important solid media include nutrient agar and blood agar. Key liquid media are nutrient broth and peptone water. Bacteria grown in media go through lag, exponential, stationary, and death phases. Media allow observation of microbial properties and isolation of pathogens.
A method known as 'current Good Manufacturing Practice (GMP) is used to guarantee that goods are consistently manufactured and monitored in accordance with quality standards. Good Manufacturing Practices is intended to reduce any production-related hazards associated with pharmaceuticals that cannot be avoided via evaluating the finished product.
Why is GMP crucial?
In addition to being a health risk, low-quality medications cost both governments and individual customers money.
Medicines of poor quality can harm one's health.
Unintentionally added harmful chemicals may be found in low-quality medications.
A medication won't have the desired therapeutic outcome if it contains little to no of the advertised component.
Describe GMP.
A method known as 'current Good Manufacturing Practice (GMP) is used to guarantee that goods are consistently manufactured and monitored in accordance with quality standards. It is intended to reduce any production-related hazards associated with pharmaceuticals that cannot be avoided via evaluating the finished product. The primary dangers include unanticipated product contamination, which can harm health or even result in death; inaccurate labelling on containers, which might result in patients receiving the wrong medication; and an inadequate or excessive amount of active component, which can lead to ineffective therapy or negative consequences. GMP covers every aspect of production, including raw materials, space, and tools, as well as employee training and personal hygiene. Every process that might have an impact on the final product's quality requires specific, written procedures. To be there
If there is a quality control laboratory, is GMP still required?
Yes. Quality cannot be tested into a product after it has been produced; it must be built in during the manufacturing process. GMP guards against mistakes that can't be caught by final product quality control. Without GMP, it is impossible to ensure that each individual dose of a medication is of the same calibre as the sample doses examined in a laboratory.
Can businesses afford to adopt GMP?
Yes. Making cheap items does not result in cost savings. In the long run, fixing mistakes after they have been committed is more expensive than avoiding them in the first place. GMP aims to stop mistakes from occurring. Implementing GMP is a financial investment in premium drugs. In addition to helping the pharmaceutical business and healthcare professionals, this will enhance the health of the individual patient and the community. Poor quality pharmaceutical production and distribution damage the reputation of the company, the public health system, and private health care.
WHO strives to improve GMP
WHO GMP regulations are accessible online. Please get in touch with the WHO representative in your nation, your WHO regional office, or WHO headquarters in Geneva if you need additional information.
In addition, an impartial, independent body should periodically carry out a thorough verification of the HACCP system. These authority may reside inside or outside the food operation. In addition to an on-site inspection of all flow diagrams and the pertinent data from the plan’s execution, this should include a technical evaluation of the hazard analysis and each component of the HACCP plan
To guarantee that the identified risks are avoided, handled, or reduced to tolerable levels, each CCP will comprise one or more control measures. Each control measure has one or more crucial limitations that go along with it. Temperature, time, physical dimensions, humidity, moisture content, water activity (aw), and others may all serve as critical constraints.
The preparation of beef patties is one instance (Appendix B). The procedure need to be planned to guarantee the creation of a secure product. Enteric infections, such as salmonellae and verotoxigenic E. coli O157:H7, were deemed to be the most serious biological dangers for cooked pork patties. Additionally, it is during the cooking process that control may be used to lower the intestinal pathogens to a tolerable level. It is essential to have accurate knowledge of the anticipated concentration of pathogens in the raw patties, their heat tolerance, the variables influencing how well they heat up, and the section of the patty which warms the slowest in order to guarantee that an appropriate level is routinely obtained.
Through the study and management of biological, chemical, and physical risks throughout the production, handling, and distribution of raw materials as well as the manufacture, distribution, Food safety standard and HACCP and consumption of finished goods, HACCP is a management strategy that addresses food safety.
HACCP is a management method that addresses food safety by analyzing and controlling biological, chemical, and physical risks throughout the production, handling, and distribution of raw materials as well as the manufacture, distribution, and consumption of finished goods.
The document discusses Hazard Analysis Critical Control Point (HACCP), a systematic preventative approach to food safety. It defines HACCP and explains its 7 principles: 1) conduct hazard analysis, 2) determine critical control points, 3) determine critical limits, 4) establish monitoring procedures, 5) establish corrective actions, 6) establish verification procedures, and 7) establish record keeping. It also discusses applying HACCP's process approach to retail and food service establishments by categorizing foods into 3 preparation processes based on the number of times they pass through the temperature danger zone. Critical control points are identified as steps that must be done to prevent, reduce, or eliminate food safety hazards.
HACCP (Hazard Analysis and Critical Control Points) is a systematic preventative approach to food safety that involves identifying and controlling biological, chemical, and physical hazards. It includes conducting a hazard analysis, identifying critical control points, establishing critical limits, and implementing ongoing monitoring, corrective actions, and record keeping procedures. Prerequisite programs like facilities and equipment sanitation, supplier control, and employee hygiene must also be established as the foundation for an effective HACCP system. Implementing HACCP in India's food industry, especially the unorganized sector, faces challenges including lack of resources, infrastructure, and stakeholder coordination.
This document discusses the Hazard Analysis and Critical Control Point (HACCP) system for ensuring food safety. It defines HACCP and explains its seven principles for identifying and controlling food safety hazards. The document also outlines the steps to implement a HACCP program in a food processing plant, including forming a HACCP team, conducting a hazard analysis and identifying critical control points, establishing monitoring procedures, and verifying that the HACCP system is working properly. The goal of HACCP is to prevent food safety hazards through control at critical points during food production rather than relying on end product inspection.
This document provides an overview of Hazard Analysis and Critical Control Points (HACCP), a systematic preventative approach to food safety. It discusses the 12 steps and 7 principles of HACCP, including conducting a hazard analysis, identifying critical control points, establishing critical limits, monitoring procedures, corrective actions, and record keeping. The document also covers the history and benefits of HACCP, noting it originated from NASA's efforts to ensure food safety for space travel and is now widely recognized internationally as an effective food safety system.
Total Quality Management Presentation.pptxDebelaTekabe
The document discusses ISO 22000 food safety management standards and Hazard Analysis Critical Control Points (HACCP). It provides an overview of these standards and their requirements. It also discusses a case study of African Food Processing PLC, identifying problems the organization faced in complying with food safety standards and how it could address challenges. The document contains sections on ISO 22000 scope and requirements, food safety management systems, HACCP principles, differences between ISO 22000 and HACCP, and an overview of African Food Processing PLC.
In an era where food safety is of paramount importance, HACCP has emerged as a systematic and preventive approach to identifying and managing potential hazards in food production processes. This presentation aims to shed light on the fundamental principles of HACCP, its benefits, and its significance in ensuring the safety of our food supply.
Definition and Background:
We begin by defining HACCP as an internationally recognized food safety management system designed to identify, evaluate, and control hazards that may pose risks to the safety of food products. It originated in the 1960s, developed by the Pillsbury Company in collaboration with NASA, with the primary objective of ensuring safe food for astronauts. Since then, HACCP has been widely adopted and applied across various sectors of the food industry.
Principles of HACCP:
Next, we delve into the seven core principles of HACCP, providing a comprehensive understanding of its systematic approach:
a. Conducting Hazard Analysis: Identifying potential biological, chemical, and physical hazards associated with each step of the food production process.
b. Determining Critical Control Points (CCPs): Identifying critical points in the process where control measures can be applied to prevent, eliminate, or reduce hazards to an acceptable level.
c. Establishing Critical Limits: Setting measurable criteria that define the maximum or minimum values to which control measures must be maintained at CCPs to ensure food safety.
d. Monitoring CCPs: Implementing procedures to regularly observe and record the control measures applied at CCPs to ensure they remain within established critical limits.
e. Implementing Corrective Actions: Establishing protocols to take immediate action when monitoring indicates that a CCP is not within its critical limits, aiming to prevent unsafe food from reaching consumers.
f. Verifying the System: Periodically evaluating the effectiveness of the HACCP system to ensure it is functioning correctly and providing the desired level of protection.
g. Establishing Documentation and Record-Keeping: Maintaining comprehensive records of all procedures, actions, and results to demonstrate the application and effectiveness of the HACCP system.
Benefits of HACCP:
This section focuses on the numerous advantages offered by implementing HACCP within the food industry:
a. Enhanced Consumer Protection: By systematically identifying and managing hazards, HACCP significantly reduces the risk of foodborne illnesses, protecting consumer health and well-being.
b. Regulatory Compliance: HACCP is a widely recognized and mandated approach in many countries, ensuring compliance with regulatory requirements and fostering a culture of food safety.
c. Improved Product Quality: Implementing HACCP promotes consistent adherence to quality standards, leading to improved product quality and customer satisfaction.
d. Cost Reduction:
HACCP is a system to analyze food safety hazards and implement controls. It originated in the 1960s when NASA and Pillsbury developed it for space food. HACCP identifies hazards, establishes control points to prevent hazards, monitors the control points, and documents the system. The goal is to systematically prevent food safety issues rather than relying on traditional inspection and testing. HACCP considers food safety from production to consumption.
This document provides an overview of Hazard Analysis and Critical Control Points (HACCP), a systematic preventative approach to food safety. It discusses the history and development of HACCP from its origins with NASA to its current global use. The key aspects of developing and implementing an effective HACCP plan are outlined, including assembling a team, creating a flow diagram, identifying hazards and critical control points, establishing monitoring procedures, and documentation. The goal of HACCP is to analyze potential food safety hazards and identify ways to eliminate or reduce such hazards to improve food safety.
Hazard Analysis Critical Control Point (HACCP) is a management system that identifies and controls biological, chemical, and physical hazards in the food production process. The document outlines the 7 principles of developing a HACCP plan: assembling a team, describing the food and distribution, developing a flow diagram, hazard analysis to identify critical control points, establishing critical limits and procedures for monitoring, corrective actions, verification, and record keeping. The purpose is to control all steps of the food production process to prevent foodborne hazards.
Hazard analysis & critical control point by dr vikram guptaVikram Kumar Gupta
Hazard analysis and critical control point (HACCP) is a systematic preventative approach to food safety that identifies potential food safety hazards. It aims to take key actions to reduce or eliminate risks at critical control points along the food production process. HACCP involves conducting a hazard analysis to identify potential hazards, determining critical control points to monitor and control hazards, and establishing procedures to monitor the critical control points. The goal of HACCP is to enhance food safety by anticipating and preventing problems rather than relying on finished product testing.
This document discusses risk analysis and HACCP systems. It defines risk as a function of the probability and severity of adverse health effects from hazards in food. It outlines the components of risk analysis: risk assessment, risk management, and risk communication. It then details the steps of risk assessment and describes how risk assessment should consider relevant practices throughout the food chain. It also discusses risk management, risk communication, and provides a diagram of the risk analysis process. Finally, it outlines the principles and benefits of implementing a HACCP system.
Hazard Analysis and Critical Control Points (HACCP) is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production to consumption. It identifies hazards and applies controls to ensure food safety at all stages of production. The seven principles of HACCP include conducting a hazard analysis, determining critical control points, establishing critical limits, monitoring procedures, corrective actions, verification procedures, and record keeping. Implementing HACCP benefits consumers through reduced foodborne illness, and benefits industry through increased market access and reduced costs from waste and recalls.
Hazard analysis and critical control point in aquacultureharapriya behera
This document discusses Hazard Analysis and Critical Control Points (HACCP) in aquaculture. It defines key HACCP terms like hazard, hazard analysis, critical control point, critical limit, deviation, monitoring, corrective actions, verification, and record keeping. It explains the seven principles of HACCP: conduct hazard analysis, determine critical control points, establish critical limits, establish monitoring procedures, establish corrective actions, establish verification procedures, and establish record keeping procedures. For each principle, it provides details on how to implement that principle as part of a HACCP plan to ensure food safety is managed effectively in aquaculture operations.
Hazard analysis and critical control points, or HACCP (/ˈhæsʌp/), is a systematic preventive approach to food safety from biological, chemical, and physical hazards in production processes that can cause the finished product to be unsafe and designs measures to reduce these risks to a safe level. In this manner, HACCP attempts to avoid hazards rather than attempting to inspect finished products for the effects of those hazards. The HACCP system can be used at all stages of a food chain, from food production and preparation processes including packaging, distribution, etc. The Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) require mandatory HACCP programs for juice and meat as an effective approach to food safety and protecting public health. Meat HACCP systems are regulated by the USDA, while seafood and juice are regulated by the FDA. All other food companies in the United States that are required to register with the FDA under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, as well as firms outside the US that export food to the US, are transitioning to mandatory hazard analysis and risk-based preventive controls (HARPC) plans.
This is a project on Food System Management System. It is basically a PowerPoint Presentatiion which will help you to learn new things. Generally this project is given to the students of Nutrition and Dietician.
Hazard Analysis and Critical Control Point (HACCP) is a process control system designed to identify and prevent food safety hazards. It involves a systematic approach to identify hazards, assess risks, and implement controls at critical points in food production. The seven HACCP principles guide food businesses to conduct a hazard analysis, identify critical control points, establish critical limits, monitor controls, validate the system is working, and maintain records. HACCP was developed in the 1960s and its implementation has expanded globally over the past 50 years through regulations and standards to improve food safety.
This presentation is Part 5 of a training program on Food Safety Practices for the Aquaculture Industry by Michigan State University, on 22 April 2013.
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1. http://www.fda.gov/Food/FoodSafety/HazardAnalysisCriticalControlPointsHACCP/HACCPPrinciplesApplicationGuidelines/default.htm<br />Hazard Analysis and Critical Control Point Principles and Application Guidelines<br />Adopted August 14, 1997<br />NATIONAL ADVISORY COMMITTEE ONMICROBIOLOGICAL CRITERIA FOR FOODS<br />The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) is an advisory committee chartered under the U.S. Department of Agriculture (USDA) and comprised of participants from the USDA (Food Safety and Inspection Service), Department of Health and Human Services (U.S. Food and Drug Administration and the Centers for Disease Control and Prevention) the Department of Commerce (National Marine Fisheries Service), the Department of Defense (Office of the Army Surgeon General), academia, industry and state employees. NACMCF provides guidance and recommendations to the Secretary of Agriculture and the Secretary of Health and Human Services regarding the microbiological safety of foods.<br /> <br />TABLE OF CONTENTS <br />EXECUTIVE SUMMARY<br />DEFINITIONS<br />HACCP PRINCIPLES<br />GUIDELINES FOR APPLICATION OF HACCP PRINCIPLES<br />Introduction<br />Prerequisite Programs<br />Education and Training<br />Developing a HACCP Plan<br />Assemble the HACCP team<br />Describe the food and its distribution<br />Describe the intended use and consumers of the food<br />Develop a flow diagram which describes the process<br />Verify the flow diagram<br />Conduct a hazard analysis (Principle 1)<br />Determine critical control points (CCPs) (Principle 2)<br />Establish critical limits (Principle 3)<br />Establish monitoring procedures (Principle 4)<br />Establish corrective actions (Principle 5)<br />Establish verification procedures (Principle 6)<br />Establish record-keeping and documentation procedures (Principle 7)<br />IMPLEMENTATION AND MAINTENANCE OF THE HACCP PLAN<br />APPENDIX A - Examples of common prerequisite programs<br />APPENDIX B - Example of a flow diagram for the production of frozen cooked beef patties.<br />APPENDIX C - Examples of questions to be considered when conducting a hazard analysis<br />APPENDIX D - Examples of how the stages of hazard analysis are used to identify and evaluate hazards<br />APPENDIX E - Example I of a CCP decision tree<br />APPENDIX F - Example II of a CCP decision tree<br />APPENDIX G - Examples of verification activities<br />APPENDIX H - Examples of HACCP records<br />EXECUTIVE SUMMARY<br />The National Advisory Committee on Microbiological Criteria for Foods (Committee) reconvened a Hazard Analysis and Critical Control Point (HACCP) Working Group in 1995. The primary goal was to review the Committee's November 1992 HACCP document, comparing it to current HACCP guidance prepared by the Codex Committee on Food Hygiene. Based upon its review, the Committee made the HACCP principles more concise; revised and added definitions; included sections on prerequisite programs, education and training, and implementation and maintenance of the HACCP plan; revised and provided a more detailed explanation of the application of HACCP principles; and provided an additional decision tree for identifying critical control points (CCPs).<br />The Committee again endorses HACCP as an effective and rational means of assuring food safety from harvest to consumption. Preventing problems from occurring is the paramount goal underlying any HACCP system. Seven basic principles are employed in the development of HACCP plans that meet the stated goal. These principles include hazard analysis, CCP identification, establishing critical limits, monitoring procedures, corrective actions, verification procedures, and record-keeping and documentation. Under such systems, if a deviation occurs indicating that control has been lost, the deviation is detected and appropriate steps are taken to reestablish control in a timely manner to assure that potentially hazardous products do not reach the consumer.<br />In the application of HACCP, the use of microbiological testing is seldom an effective means of monitoring CCPs because of the time required to obtain results. In most instances, monitoring of CCPs can best be accomplished through the use of physical and chemical tests, and through visual observations. Microbiological criteria do, however, play a role in verifying that the overall HACCP system is working.<br />The Committee believes that the HACCP principles should be standardized to provide uniformity in training and applying the HACCP system by industry and government. In accordance with the National Academy of Sciences recommendation, the HACCP system must be developed by each food establishment and tailored to its individual product, processing and distribution conditions.<br />In keeping with the Committee's charge to provide recommendations to its sponsoring agencies regarding microbiological food safety issues, this document focuses on this area. The Committee recognizes that in order to assure food safety, properly designed HACCP systems must also consider chemical and physical hazards in addition to other biological hazards.<br />For a successful HACCP program to be properly implemented, management must be committed to a HACCP approach. A commitment by management will indicate an awareness of the benefits and costs of HACCP and include education and training of employees. Benefits, in addition to enhanced assurance of food safety, are better use of resources and timely response to problems.<br />The Committee designed this document to guide the food industry and advise its sponsoring agencies in the implementation of HACCP systems.<br />DEFINITIONS<br />CCP Decision Tree:<br />A sequence of questions to assist in determining whether a control point is a CCP.<br />Control:<br />(a) To manage the conditions of an operation to maintain compliance with established criteria.<br />(b) The state where correct procedures are being followed and criteria are being met.<br />Control Measure:<br />Any action or activity that can be used to prevent, eliminate or reduce a significant hazard.<br />Control Point:<br />Any step at which biological, chemical, or physical factors can be controlled.<br />Corrective Action:<br />Procedures followed when a deviation occurs.<br />Criterion:<br />A requirement on which a judgement or decision can be based.<br />Critical Control Point:<br />A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.<br />Critical Limit:<br />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.<br />Deviation:<br />Failure to meet a critical limit.<br />HACCP:<br />A systematic approach to the identification, evaluation, and control of food safety hazards.<br />HACCP Plan:<br />The written document which is based upon the principles of HACCP and which delineates the procedures to be followed.<br />HACCP System:<br />The result of the implementation of the HACCP Plan.<br />HACCP Team:<br />The group of people who are responsible for developing, implementing and maintaining the HACCP system.<br />Hazard:<br />A biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.<br />Hazard Analysis:<br />The process of collecting and evaluating information on hazards associated with the food under consideration to decide which are significant and must be addressed in the HACCP plan.<br />Monitor:<br />To conduct a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record for future use in verification.<br />Prerequisite Programs:<br />Procedures, including Good Manufacturing Practices, that address operational conditions providing the foundation for the HACCP system.<br />Severity:<br />The seriousness of the effect(s) of a hazard.<br />Step:<br />A point, procedure, operation or stage in the food system from primary production to final consumption.<br />Validation:<br />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 hazards.<br />Verification:<br />Those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan.<br />HACCP PRINCIPLES<br />HACCP is a systematic approach to the identification, evaluation, and control of food safety hazards based on the following seven principles:<br />Principle 1: Conduct a hazard analysis.<br />Principle 2: Determine the critical control points (CCPs).<br />Principle 3: Establish critical limits.<br />Principle 4: Establish monitoring procedures.<br />Principle 5: Establish corrective actions.<br />Principle 6: Establish verification procedures.<br />Principle 7: Establish record-keeping and documentation procedures.<br />GUIDELINES FOR APPLICATION OF HACCP PRINCIPLES<br />Introduction<br />HACCP is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. For successful implementation of a HACCP plan, management must be strongly committed to the HACCP concept. A firm commitment to HACCP by top management provides company employees with a sense of the importance of producing safe food.<br />HACCP is designed for use in all segments of the food industry from growing, harvesting, processing, manufacturing, distributing, and merchandising to preparing food for consumption. Prerequisite programs such as current Good Manufacturing Practices (cGMPs) are an essential foundation for the development and implementation of successful HACCP plans. Food safety systems based on the HACCP principles have been successfully applied in food processing plants, retail food stores, and food service operations. The seven principles of HACCP have been universally accepted by government agencies, trade associations and the food industry around the world.<br />The following guidelines will facilitate the development and implementation of effective HACCP plans. While the specific application of HACCP to manufacturing facilities is emphasized here, these guidelines should be applied as appropriate to each segment of the food industry under consideration.<br />Prerequisite Programs<br />The production of safe food products requires that the HACCP system be built upon a solid foundation of prerequisite programs. Examples of common prerequisite programs are listed in Appendix A. Each segment of the food industry must provide the conditions necessary to protect food while it is under their control. This has traditionally been accomplished through the application of cGMPs. These conditions and practices are now considered to be prerequisite to the development and implementation of effective HACCP plans. Prerequisite programs provide the basic environmental and operating conditions that are necessary for the production of safe, wholesome food. Many of the conditions and practices are specified in federal, state and local regulations and guidelines (e.g., cGMPs and Food Code). The Codex Alimentarius General Principles of Food Hygiene describe the basic conditions and practices expected for foods intended for international trade. In addition to the requirements specified in regulations, industry often adopts policies and procedures that are specific to their operations. Many of these are proprietary. While prerequisite programs may impact upon the safety of a food, they also are concerned with ensuring that foods are wholesome and suitable for consumption (Appendix A). HACCP plans are narrower in scope, being limited to ensuring food is safe to consume.<br />The existence and effectiveness of prerequisite programs should be assessed during the design and implementation of each HACCP plan. All prerequisite programs should be documented and regularly audited. Prerequisite programs are established and managed separately from the HACCP plan. Certain aspects, however, of a prerequisite program may be incorporated into a HACCP plan. For example, many establishments have preventive maintenance procedures for processing equipment to avoid unexpected equipment failure and loss of production. During the development of a HACCP plan, the HACCP team may decide that the routine maintenance and calibration of an oven should be included in the plan as an activity of verification. This would further ensure that all the food in the oven is cooked to the minimum internal temperature that is necessary for food safety.<br />Education and Training<br />The success of a HACCP system depends on educating and training management and employees in the importance of their role in producing safe foods. This should also include information the control of foodborne hazards related to all stages of the food chain. It is important to recognize that employees must first understand what HACCP is and then learn the skills necessary to make it function properly. Specific training activities should include working instructions and procedures that outline the tasks of employees monitoring each CCP.<br />Management must provide adequate time for thorough education and training. Personnel must be given the materials and equipment necessary to perform these tasks. Effective training is an important prerequisite to successful implementation of a HACCP plan.<br />Developing a HACCP Plan<br />The format of HACCP plans will vary. In many cases the plans will be product and process specific. However, some plans may use a unit operations approach. Generic HACCP plans can serve as useful guides in the development of process and product HACCP plans; however, it is essential that the unique conditions within each facility be considered during the development of all components of the HACCP plan.<br />In the development of a HACCP plan, five preliminary tasks need to be accomplished before the application of the HACCP principles to a specific product and process. The five preliminary tasks are given in Figure 1.<br />Figure 1. Preliminary Tasks in the Development of the HACCP Plan<br /> <br />Assemble the HACCP Team<br />↓<br />Describe the Food and its Distribution<br />↓<br />Describe the Intended Use and Consumers of the Food<br />↓<br />Develop a Flow Diagram Which Describes the Process<br />↓<br />Verify the Flow Diagram<br /> <br />Assemble the HACCP Team<br />The first task in developing a HACCP plan is to assemble a HACCP team consisting of individuals who have specific knowledge and expertise appropriate to the product and process. It is the team's responsibility to develop the HACCP plan. The team should be multi disciplinary and include individuals from areas such as engineering, production, sanitation, quality assurance, and food microbiology. The team should also include local personnel who are involved in the operation as they are more familiar with the variability and limitations of the operation. In addition, this fosters a sense of ownership among those who must implement the plan. The HACCP team may need assistance from outside experts who are knowledgeable in the potential biological, chemical and/or physical hazards associated with the product and the process. However, a plan which is developed totally by outside sources may be erroneous, incomplete, and lacking in support at the local level.<br />Due to the technical nature of the information required for hazard analysis, it is recommended that experts who are knowledgeable in the food process should either participate in or verify the completeness of the hazard analysis and the HACCP plan. Such individuals should have the knowledge and experience to correctly: (a) conduct a hazard analysis; (b) identify potential hazards; (c) identify hazards which must be controlled; (d) recommend controls, critical limits, and procedures for monitoring and verification; (e) recommend appropriate corrective actions when a deviation occurs; (f) recommend research related to the HACCP plan if important information is not known; and (g) validate the HACCP plan.<br />Describe the food and its distribution<br />The HACCP team first describes the food. This consists of a general description of the food, ingredients, and processing methods. The method of distribution should be described along with information on whether the food is to be distributed frozen, refrigerated, or at ambient temperature.<br />Describe the intended use and consumers of the food<br />Describe the normal expected use of the food. The intended consumers may be the general public or a particular segment of the population (e.g., infants, immunocompromised individuals, the elderly, etc.).<br />Develop a flow diagram which describes the process<br />The purpose of a flow diagram is to provide a clear, simple outline of the steps involved in the process. The scope of the flow diagram must cover all the steps in the process which are directly under the control of the establishment. In addition, the flow diagram can include steps in the food chain which are before and after the processing that occurs in the establishment. The flow diagram need not be as complex as engineering drawings. A block type flow diagram is sufficiently descriptive (see Appendix B). Also, a simple schematic of the facility is often useful in understanding and evaluating product and process flow.<br />Verify the flow diagram<br />The HACCP team should perform an on-site review of the operation to verify the accuracy and completeness of the flow diagram. Modifications should be made to the flow diagram as necessary and documented.<br />After these five preliminary tasks have been completed, the seven principles of HACCP are applied.<br />Conduct a hazard analysis (Principle 1)<br />After addressing the preliminary tasks discussed above, the HACCP team conducts a hazard analysis and identifies appropriate control measures. The purpose of the hazard analysis is to develop a list of hazards which are of such significance that they are reasonably likely to cause injury or illness if not effectively controlled. Hazards that are not reasonably likely to occur would not require further consideration within a HACCP plan. It is important to consider in the hazard analysis the ingredients and raw materials, each step in the process, product storage and distribution, and final preparation and use by the consumer. When conducting a hazard analysis, safety concerns must be differentiated from quality concerns. A hazard is defined as a biological, chemical or physical agent that is reasonably likely to cause illness or injury in the absence of its control. Thus, the word hazard as used in this document is limited to safety.<br />A thorough hazard analysis is the key to preparing an effective HACCP plan. If the hazard analysis is not done correctly and the hazards warranting control within the HACCP system are not identified, the plan will not be effective regardless of how well it is followed.<br />The hazard analysis and identification of associated control measures accomplish three objectives: Those hazards and associated control measures are identified. The analysis may identify needed modifications to a process or product so that product safety is further assured or improved. The analysis provides a basis for determining CCPs in Principle 2.<br />The process of conducting a hazard analysis involves two stages. The first, hazard identification, can be regarded as a brain storming session. During this stage, the HACCP team reviews the ingredients used in the product, the activities conducted at each step in the process and the equipment used, the final product and its method of storage and distribution, and the intended use and consumers of the product. Based on this review, the team develops a list of potential biological, chemical or physical hazards which may be introduced, increased, or controlled at each step in the production process. Appendix C lists examples of questions that may be helpful to consider when identifying potential hazards. Hazard identification focuses on developing a list of potential hazards associated with each process step under direct control of the food operation. A knowledge of any adverse health-related events historically associated with the product will be of value in this exercise.<br />After the list of potential hazards is assembled, stage two, the hazard evaluation, is conducted. In stage two of the hazard analysis, the HACCP team decides which potential hazards must be addressed in the HACCP plan. During this stage, each potential hazard is evaluated based on the severity of the potential hazard and its likely occurrence. Severity is the seriousness of the consequences of exposure to the hazard. Considerations of severity (e.g., impact of sequelae, and magnitude and duration of illness or injury) can be helpful in understanding the public health impact of the hazard. Consideration of the likely occurrence is usually based upon a combination of experience, epidemiological data, and information in the technical literature. When conducting the hazard evaluation, it is helpful to consider the likelihood of exposure and severity of the potential consequences if the hazard is not properly controlled. In addition, consideration should be given to the effects of short term as well as long term exposure to the potential hazard. Such considerations do not include common dietary choices which lie outside of HACCP. During the evaluation of each potential hazard, the food, its method of preparation, transportation, storage and persons likely to consume the product should be considered to determine how each of these factors may influence the likely occurrence and severity of the hazard being controlled. The team must consider the influence of likely procedures for food preparation and storage and whether the intended consumers are susceptible to a potential hazard. However, there may be differences of opinion, even among experts, as to the likely occurrence and severity of a hazard. The HACCP team may have to rely upon the opinion of experts who assist in the development of the HACCP plan.<br />Hazards identified in one operation or facility may not be significant in another operation producing the same or a similar product. For example, due to differences in equipment and/or an effective maintenance program, the probability of metal contamination may be significant in one facility but not in another. A summary of the HACCP team deliberations and the rationale developed during the hazard analysis should be kept for future reference. This information will be useful during future reviews and updates of the hazard analysis and the HACCP plan.<br />Appendix D gives three examples of using a logic sequence in conducting a hazard analysis. While these examples relate to biological hazards, chemical and physical hazards are equally important to consider. Appendix D is for illustration purposes to further explain the stages of hazard analysis for identifying hazards. Hazard identification and evaluation as outlined in Appendix D may eventually be assisted by biological risk assessments as they become available. While the process and output of a risk assessment (NACMCF, 1997) HYPERLINK quot;
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(1) is significantly different from a hazard analysis, the identification of hazards of concern and the hazard evaluation may be facilitated by information from risk assessments. Thus, as risk assessments addressing specific hazards or control factors become available, the HACCP team should take these into consideration.<br />Upon completion of the hazard analysis, the hazards associated with each step in the production of the food should be listed along with any measure(s) that are used to control the hazard(s). The term control measure is used because not all hazards can be prevented, but virtually all can be controlled. More than one control measure may be required for a specific hazard. On the other hand, more than one hazard may be addressed by a specific control measure (e.g. pasteurization of milk).<br />For example, if a HACCP team were to conduct a hazard analysis for the production of frozen cooked beef patties (Appendices B and D), enteric pathogens (e.g., Salmonella and verotoxin-producing Escherichia coli) in the raw meat would be identified as hazards. Cooking is a control measure which can be used to eliminate these hazards. The following is an excerpt from a hazard analysis summary table for this product.<br />StepPotential Hazard(s)JustificationHazard to be addressed in plan?Y/NControlMeasure(s)5. CookingEnteric pathogens:e.g., Salmonella,verotoxigenic-E. colienteric pathogens have been associated with outbreaks of foodborne illness from undercooked ground beefYCooking<br />The hazard analysis summary could be presented in several different ways. One format is a table such as the one given above. Another could be a narrative summary of the HACCP team's hazard analysis considerations and a summary table listing only the hazards and associated control measures.<br />Determine critical control points (CCPs) (Principle 2)<br />A critical control point is defined as a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level. The potential hazards that are reasonably likely to cause illness or injury in the absence of their control must be addressed in determining CCPs.<br />Complete and accurate identification of CCPs is fundamental to controlling food safety hazards. The information developed during the hazard analysis is essential for the HACCP team in identifying which steps in the process are CCPs. One strategy to facilitate the identification of each CCP is the use of a CCP decision tree (Examples of decision trees are given in Appendices E and F). Although application of the CCP decision tree can be useful in determining if a particular step is a CCP for a previously identified hazard, it is merely a tool and not a mandatory element of HACCP. A CCP decision tree is not a substitute for expert knowledge.<br />Critical control points are located at any step where hazards can be either prevented, eliminated, or reduced to acceptable levels. Examples of CCPs may include: thermal processing, chilling, testing ingredients for chemical residues, product formulation control, and testing product for metal contaminants. CCPs must be carefully developed and documented. In addition, they must be used only for purposes of product safety. For example, a specified heat process, at a given time and temperature designed to destroy a specific microbiological pathogen, could be a CCP. Likewise, refrigeration of a precooked food to prevent hazardous microorganisms from multiplying, or the adjustment of a food to a pH necessary to prevent toxin formation could also be CCPs. Different facilities preparing similar food items can differ in the hazards identified and the steps which are CCPs. This can be due to differences in each facility's layout, equipment, selection of ingredients, processes employed, etc.<br />Establish critical limits (Principle 3)<br />A critical limit is 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. A critical limit is used to distinguish between safe and unsafe operating conditions at a CCP. Critical limits should not be confused with operational limits which are established for reasons other than food safety.<br />Each CCP will have one or more control measures to assure that the identified hazards are prevented, eliminated or reduced to acceptable levels. Each control measure has one or more associated critical limits. Critical limits may be based upon factors such as: temperature, time, physical dimensions, humidity, moisture level, water activity (aw), pH, titratable acidity, salt concentration, available chlorine, viscosity, preservatives, or sensory information such as aroma and visual appearance. Critical limits must be scientifically based. For each CCP, there is at least one criterion for food safety that is to be met. An example of a criterion is a specific lethality of a cooking process such as a 5D reduction in Salmonella. The critical limits and criteria for food safety may be derived from sources such as regulatory standards and guidelines, literature surveys, experimental results, and experts.<br />An example is the cooking of beef patties (Appendix B). The process should be designed to ensure the production of a safe product. The hazard analysis for cooked meat patties identified enteric pathogens (e.g., verotoxigenic E. coli such as E. coli O157:H7, and salmonellae) as significant biological hazards. Furthermore, cooking is the step in the process at which control can be applied to reduce the enteric pathogens to an acceptable level. To ensure that an acceptable level is consistently achieved, accurate information is needed on the probable number of the pathogens in the raw patties, their heat resistance, the factors that influence the heating of the patties, and the area of the patty which heats the slowest. Collectively, this information forms the scientific basis for the critical limits that are established. Some of the factors that may affect the thermal destruction of enteric pathogens are listed in the following table. In this example, the HACCP team concluded that a thermal process equivalent to 155° F for 16 seconds would be necessary to assure the safety of this product. To ensure that this time and temperature are attained, the HACCP team for one facility determined that it would be necessary to establish critical limits for the oven temperature and humidity, belt speed (time in oven), patty thickness and composition (e.g., all beef, beef and other ingredients). Control of these factors enables the facility to produce a wide variety of cooked patties, all of which will be processed to a minimum internal temperature of 155° F for 16 seconds. In another facility, the HACCP team may conclude that the best approach is to use the internal patty temperature of 155° F and hold for 16 seconds as critical limits. In this second facility the internal temperature and hold time of the patties are monitored at a frequency to ensure that the critical limits are constantly met as they exit the oven. The example given below applies to the first facility.<br />Process StepCCPCritical Limits5. CookingYESOven temperature:___° FTime; rate of heating and cooling (belt speed in ft/min): ____ft/minPatty thickness: ____in.Patty composition: e.g. all beefOven humidity: ____% RH<br />Establish monitoring procedures (Principle 4)<br />Monitoring is a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record for future use in verification. Monitoring serves three main purposes. First, monitoring is essential to food safety management in that it facilitates tracking of the operation. If monitoring indicates that there is a trend towards loss of control, then action can be taken to bring the process back into control before a deviation from a critical limit occurs. Second, monitoring is used to determine when there is loss of control and a deviation occurs at a CCP, i.e., exceeding or not meeting a critical limit. When a deviation occurs, an appropriate corrective action must be taken. Third, it provides written documentation for use in verification.<br />An unsafe food may result if a process is not properly controlled and a deviation occurs. Because of the potentially serious consequences of a critical limit deviation, monitoring procedures must be effective. Ideally, monitoring should be continuous, which is possible with many types of physical and chemical methods. For example, the temperature and time for the scheduled thermal process of low-acid canned foods is recorded continuously on temperature recording charts. If the temperature falls below the scheduled temperature or the time is insufficient, as recorded on the chart, the product from the retort is retained and the disposition determined as in Principle 5. Likewise, pH measurement may be performed continually in fluids or by testing each batch before processing. There are many ways to monitor critical limits on a continuous or batch basis and record the data on charts. Continuous monitoring is always preferred when feasible. Monitoring equipment must be carefully calibrated for accuracy.<br />Assignment of the responsibility for monitoring is an important consideration for each CCP. Specific assignments will depend on the number of CCPs and control measures and the complexity of monitoring. Personnel who monitor CCPs are often associated with production (e.g., line supervisors, selected line workers and maintenance personnel) and, as required, quality control personnel. Those individuals must be trained in the monitoring technique for which they are responsible, fully understand the purpose and importance of monitoring, be unbiased in monitoring and reporting, and accurately report the results of monitoring. In addition, employees should be trained in procedures to follow when there is a trend towards loss of control so that adjustments can be made in a timely manner to assure that the process remains under control. The person responsible for monitoring must also immediately report a process or product that does not meet critical limits.<br />All records and documents associated with CCP monitoring should be dated and signed or initialed by the person doing the monitoring.<br />When it is not possible to monitor a CCP on a continuous basis, it is necessary to establish a monitoring frequency and procedure that will be reliable enough to indicate that the CCP is under control. Statistically designed data collection or sampling systems lend themselves to this purpose.<br />Most monitoring procedures need to be rapid because they relate to on-line, quot;
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processes and there will not be time for lengthy analytical testing. Examples of monitoring activities include: visual observations and measurement of temperature, time, pH, and moisture level.<br />Microbiological tests are seldom effective for monitoring due to their time-consuming nature and problems with assuring detection of contaminants. Physical and chemical measurements are often preferred because they are rapid and usually more effective for assuring control of microbiological hazards. For example, the safety of pasteurized milk is based upon measurements of time and temperature of heating rather than testing the heated milk to assure the absence of surviving pathogens.<br />With certain foods, processes, ingredients, or imports, there may be no alternative to microbiological testing. However, it is important to recognize that a sampling protocol that is adequate to reliably detect low levels of pathogens is seldom possible because of the large number of samples needed. This sampling limitation could result in a false sense of security by those who use an inadequate sampling protocol. In addition, there are technical limitations in many laboratory procedures for detecting and quantitating pathogens and/or their toxins.<br />Establish corrective actions (Principle 5)<br />The HACCP system for food safety management is designed to identify health hazards and to establish strategies to prevent, eliminate, or reduce their occurrence. However, ideal circumstances do not always prevail and deviations from established processes may occur. An important purpose of corrective actions is to prevent foods which may be hazardous from reaching consumers. Where there is a deviation from established critical limits, corrective actions are necessary. Therefore, corrective actions should include the following elements: (a) determine and correct the cause of non-compliance; (b) determine the disposition of non-compliant product and (c) record the corrective actions that have been taken. Specific corrective actions should be developed in advance for each CCP and included in the HACCP plan. As a minimum, the HACCP plan should specify what is done when a deviation occurs, who is responsible for implementing the corrective actions, and that a record will be developed and maintained of the actions taken. Individuals who have a thorough understanding of the process, product and HACCP plan should be assigned the responsibility for oversight of corrective actions. As appropriate, experts may be consulted to review the information available and to assist in determining disposition of non-compliant product.<br />Establish verification procedures (Principle 6) <br />Verification is defined as those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan. The NAS (1985) (2) pointed out that the major infusion of science in a HACCP system centers on proper identification of the hazards, critical control points, critical limits, and instituting proper verification procedures. These processes should take place during the development and implementation of the HACCP plans and maintenance of the HACCP system. An example of a verification schedule is given in Figure 2.<br />One aspect of verification is evaluating whether the facility's HACCP system is functioning according to the HACCP plan. An effective HACCP system requires little end-product testing, since sufficient validated safeguards are built in early in the process. Therefore, rather than relying on end-product testing, firms should rely on frequent reviews of their HACCP plan, verification that the HACCP plan is being correctly followed, and review of CCP monitoring and corrective action records.<br />Another important aspect of verification is the initial validation of the HACCP plan to determine that the plan is scientifically and technically sound, that all hazards have been identified and that if the HACCP plan is properly implemented these hazards will be effectively controlled. Information needed to validate the HACCP plan often include (1) expert advice and scientific studies and (2) in-plant observations, measurements, and evaluations. For example, validation of the cooking process for beef patties should include the scientific justification of the heating times and temperatures needed to obtain an appropriate destruction of pathogenic microorganisms (i.e., enteric pathogens) and studies to confirm that the conditions of cooking will deliver the required time and temperature to each beef patty.<br />Subsequent validations are performed and documented by a HACCP team or an independent expert as needed. For example, validations are conducted when there is an unexplained system failure; a significant product, process or packaging change occurs; or new hazards are recognized.<br />In addition, a periodic comprehensive verification of the HACCP system should be conducted by an unbiased, independent authority. Such authorities can be internal or external to the food operation. This should include a technical evaluation of the hazard analysis and each element of the HACCP plan as well as on-site review of all flow diagrams and appropriate records from operation of the plan. A comprehensive verification is independent of other verification procedures and must be performed to ensure that the HACCP plan is resulting in the control of the hazards. If the results of the comprehensive verification identifies deficiencies, the HACCP team modifies the HACCP plan as necessary.<br />Verification activities are carried out by individuals within a company, third party experts, and regulatory agencies. It is important that individuals doing verification have appropriate technical expertise to perform this function. The role of regulatory and industry in HACCP was further described by the NACMCF (1994) (3).<br />Examples of verification activities are included as Appendix G.<br />Figure 2. Example of a Company Established HACCP Verification Schedule<br /> <br />ActivityFrequencyResponsibilityReviewerVerification Activities SchedulingYearly or Upon HACCP System ChangeHACCP CoordinatorPlant ManagerInitial Validation of HACCP PlanPrior to and During Initial Implementation of PlanIndependent Expert(s)(a)HACCP TeamSubsequent validation of HACCP PlanWhen Critical Limits Changed, Significant Changes in Process, Equipment Changed, After System Failure, etc.Independent Expert(s)(a)HACCP TeamVerification of CCP Monitoring as Described in the Plan (e.g., monitoring of patty cooking temperature)According to HACCP Plan (e.g., once per shift)According to HACCP Plan (e.g., Line Supervisor)According to HACCP Plan (e.g., Quality Control)Review of Monitoring, Corrective Action Records to Show Compliance with the PlanMonthlyQuality AssuranceHACCP TeamComprehensive HACCP System VerificationYearlyIndependent Expert(s)(a)Plant Manager(a) Done by others than the team writing and implementing the plan. May require additional technical expertise as well as laboratory and plant test studies.<br />Establish record-keeping and documentation procedures (Principle 7)<br />Generally, the records maintained for the HACCP System should include the following:<br />A summary of the hazard analysis, including the rationale for determining hazards and control measures.<br /> <br />The HACCP Plan<br />Listing of the HACCP team and assigned responsibilities.<br />Description of the food, its distribution, intended use, and consumer.<br />Verified flow diagram.<br />HACCP Plan Summary Table that includes information for:<br />Steps in the process that are CCPs<br />The hazard(s) of concern.<br />Critical limits<br />Monitoring*<br />Corrective actions*<br />Verification procedures and schedule*<br />Record-keeping procedures*<br />* A brief summary of position responsible for performing the activity and the procedures and frequency should be provided<br />The following is an example of a HACCP plan summary table:<br />CCPHazardsCritical limit(s)MonitoringCorrective ActionsVerificationRecords <br />Support documentation such as validation records.<br /> <br />Records that are generated during the operation of the plan.<br />Examples of HACCP records are given in Appendix H.<br />IMPLEMENTATION AND MAINTENANCE OF THE HACCP PLAN<br />The successful implementation of a HACCP plan is facilitated by commitment from top management. The next step is to establish a plan that describes the individuals responsible for developing, implementing and maintaining the HACCP system. Initially, the HACCP coordinator and team are selected and trained as necessary. The team is then responsible for developing the initial plan and coordinating its implementation. Product teams can be appointed to develop HACCP plans for specific products. An important aspect in developing these teams is to assure that they have appropriate training. The workers who will be responsible for monitoring need to be adequately trained. Upon completion of the HACCP plan, operator procedures, forms and procedures for monitoring and corrective action are developed. Often it is a good idea to develop a timeline for the activities involved in the initial implementation of the HACCP plan. Implementation of the HACCP system involves the continual application of the monitoring, record-keeping, corrective action procedures and other activities as described in the HACCP plan.<br />Maintaining an effective HACCP system depends largely on regularly scheduled verification activities. The HACCP plan should be updated and revised as needed. An important aspect of maintaining the HACCP system is to assure that all individuals involved are properly trained so they understand their role and can effectively fulfill their responsibilities.<br />(1) National Advisory Committee on Microbiological Criteria for Foods. 1997. The principles of risk assessment for illness caused by foodborne biological agents. Adopted April 4, 1997.<br />(2) An Evaluation of the Role of Microbiological Criteria for Foods and Food Ingredients. 1985. National Academy of Sciences, National Academy Press, Washington, DC.<br /> <br />(3) National Advisory Committee on Microbiological Criteria for Foods. 1994. The role of regulatory agencies and industry in HACCP. Int. J. Food Microbiol. 21:187-195.<br />APPENDIX A<br />Examples of Common Prerequisite Programs<br />The production of safe food products requires that the HACCP system be built upon a solid foundation of prerequisite programs. Each segment of the food industry must provide the conditions necessary to protect food while it is under their control. This has traditionally been accomplished through the application of cGMPs. These conditions and practices are now considered to be prerequisite to the development and implementation of effective HACCP plans. Prerequisite programs provide the basic environmental and operating conditions that are necessary for the production of safe, wholesome food. Common prerequisite programs may include, but are not limited to:<br /> <br />Facilities.<br />The establishment should be located, constructed and maintained according to sanitary design principles. There should be linear product flow and traffic control to minimize cross-contamination from raw to cooked materials. <br /> <br />Supplier Control.<br />Each facility should assure that its suppliers have in place effective GMP and food safety programs. These may be the subject of continuing supplier guarantee and supplier HACCP system verification. <br /> <br />Specifications.<br />There should be written specifications for all ingredients, products, and packaging materials. <br /> <br />Production Equipment.<br />All equipment should be constructed and installed according to sanitary design principles. Preventive maintenance and calibration schedules should be established and documented. <br /> <br />Cleaning and Sanitation.<br />All procedures for cleaning and sanitation of the equipment and the facility should be written and followed. A master sanitation schedule should be in place. <br /> <br />Personal Hygiene.<br />All employees and other persons who enter the manufacturing plant should follow the requirements for personal hygiene. <br /> <br />Training.<br />All employees should receive documented training in personal hygiene, GMP, cleaning and sanitation procedures, personal safety, and their role in the HACCP program. <br /> <br />Chemical Control.<br />Documented procedures must be in place to assure the segregation and proper use of non-food chemicals in the plant. These include cleaning chemicals, fumigants, and pesticides or baits used in or around the plant. <br /> <br />Receiving, Storage and Shipping.<br />All raw materials and products should be stored under sanitary conditions and the proper environmental conditions such as temperature and humidity to assure their safety and wholesomeness. <br /> <br />Traceability and Recall.<br />All raw materials and products should be lot-coded and a recall system in place so that rapid and complete traces and recalls can be done when a product retrieval is necessary. <br /> <br />Pest Control.<br />Effective pest control programs should be in place.<br />Other examples of prerequisite programs might include quality assurance procedures; standard operating procedures for sanitation, processes, product formulations and recipes; glass control; procedures for receiving, storage and shipping; labeling; and employee food and ingredient handling practices.<br />APPENDIX B<br />Example of a Flow Diagram for the Production of Frozen Cooked Beef Patties<br /> <br />1. Receiving (Beef)<br />↓<br />2. Grinding<br />↓<br />3. Mixing<br />↓<br />4. Forming<br />↓<br />5. Cooking<br />↓<br />6. Freezing<br />↓<br />7. Boxing<br />↓<br />8. Distributing<br />↓<br />9. Reheating<br />↓<br />10. Serving<br /> <br />APPENDIX C<br />Examples of Questions to be Considered When Conducting a Hazard Analysis<br />The hazard analysis consists of asking a series of questions which are appropriate to the process under consideration. The purpose of the questions is to assist in identifying potential hazards.<br />Ingredients <br />Does the food contain any sensitive ingredients that may present microbiological hazards (e.g., Salmonella, Staphylococcus aureus); chemical hazards (e.g., aflatoxin, antibiotic or pesticide residues); or physical hazards (stones, glass, metal)?<br />Are potable water, ice and steam used in formulating or in handling the food?<br />What are the sources (e.g., geographical region, specific supplier)<br />Intrinsic Factors - Physical characteristics and composition (e.g., pH, type of acidulants, fermentable carbohydrate, water activity, preservatives) of the food during and after processing. <br />What hazards may result if the food composition is not controlled?<br />Does the food permit survival or multiplication of pathogens and/or toxin formation in the food during processing?<br />Will the food permit survival or multiplication of pathogens and/or toxin formation during subsequent steps in the food chain?<br />Are there other similar products in the market place? What has been the safety record for these products? What hazards have been associated with the products?<br />Procedures used for processing <br />Does the process include a controllable processing step that destroys pathogens? If so, which pathogens? Consider both vegetative cells and spores.<br />If the product is subject to recontamination between processing (e.g., cooking, pasteurizing) and packaging which biological, chemical or physical hazards are likely to occur?<br />Microbial content of the food <br />What is the normal microbial content of the food?<br />Does the microbial population change during the normal time the food is stored prior to consumption?<br />Does the subsequent change in microbial population alter the safety of the food?<br />Do the answers to the above questions indicate a high likelihood of certain biological hazards?<br />Facility design <br />Does the layout of the facility provide an adequate separation of raw materials from ready-to-eat (RTE) foods if this is important to food safety? If not, what hazards should be considered as possible contaminants of the RTE products?<br />Is positive air pressure maintained in product packaging areas? Is this essential for product safety?<br />Is the traffic pattern for people and moving equipment a significant source of contamination?<br />Equipment design and use <br />Will the equipment provide the time-temperature control that is necessary for safe food?<br />Is the equipment properly sized for the volume of food that will be processed?<br />Can the equipment be sufficiently controlled so that the variation in performance will be within the tolerances required to produce a safe food?<br />Is the equipment reliable or is it prone to frequent breakdowns?<br />Is the equipment designed so that it can be easily cleaned and sanitized?<br />Is there a chance for product contamination with hazardous substances; e.g., glass?<br />What product safety devices are used to enhance consumer safety? <br />metal detectors<br />magnets<br />sifters<br />filters<br />screens<br />thermometers<br />bone removal devices<br />dud detectors<br />To what degree will normal equipment wear affect the likely occurrence of a physical hazard (e.g., metal) in the product?<br />Are allergen protocols needed in using equipment for different products?<br />Packaging <br />Does the method of packaging affect the multiplication of microbial pathogens and/or the formation of toxins?<br />Is the package clearly labeled quot;
Keep Refrigeratedquot;
if this is required for safety?<br />Does the package include instructions for the safe handling and preparation of the food by the end user?<br />Is the packaging material resistant to damage thereby preventing the entrance of microbial contamination?<br />Are tamper-evident packaging features used?<br />Is each package and case legibly and accurately coded?<br />Does each package contain the proper label?<br />Are potential allergens in the ingredients included in the list of ingredients on the label?<br />Sanitation <br />Can sanitation have an impact upon the safety of the food that is being processed?<br />Can the facility and equipment be easily cleaned and sanitized to permit the safe handling of food?<br />Is it possible to provide sanitary conditions consistently and adequately to assure safe foods?<br />Employee health, hygiene and education <br />Can employee health or personal hygiene practices impact upon the safety of the food being processed?<br />Do the employees understand the process and the factors they must control to assure the preparation of safe foods?<br />Will the employees inform management of a problem which could impact upon safety of food?<br />Conditions of storage between packaging and the end user <br />What is the likelihood that the food will be improperly stored at the wrong temperature?<br />Would an error in improper storage lead to a microbiologically unsafe food?<br />Intended use <br />Will the food be heated by the consumer?<br />Will there likely be leftovers?<br />Intended consumer <br />Is the food intended for the general public?<br />Is the food intended for consumption by a population with increased susceptibility to illness (e.g., infants, the aged, the infirmed, immunocompromised individuals)?<br />Is the food to be used for institutional feeding or the home?<br /> <br /> <br />APPENDIX D<br />Examples of How the Stages of Hazard Analysis are used to Identify and Evaluate Hazards* Hazard Analysis StageFrozen cooked beef patties produced in a manufacturing plantProduct containing eggs prepared for foodserviceCommercial frozen pre-cooked, boned chicken for further processingStage 1 Determine potential Hazard hazards associatedIdentification with productEnteric pathogens (i.e., E. coli O157:H7 and Salmonella)Salmonella in finished product.Staphylococcus aureus in finished product.Stage 2 Hazard EvaluationAssess severity of health consequences if potential hazard is not properly controlled.Epidemiological evidence indicates that these pathogens cause severe health effects including death among children and elderly. Undercooked beef patties have been linked to disease from these pathogens.Salmonellosis is a food borne infection causing a moderate to severe illness that can be caused by ingestion of only a few cells of Salmonella.Certain strains of S. aureus produce an enterotoxin which can cause a moderate foodborne illness.Determine likelihood of occurrence of potential hazard if not properly controlled.E. coli O157:H7 is of very low probability and salmonellae is of moderate probability in raw meat.Product is made with liquid eggs which have been associated with past outbreaks of salmonellosis. Recent problems with Salmonella serotype Enteritidis in eggs cause increased concern. Probability of Salmonella in raw eggs cannot be ruled out.If not effectively controlled, some consumers are likely to be exposed to Salmonella from this food.Product may be contaminated with S. aureus due to human handling during boning of cooked chicken. Enterotoxin capable of causing illness will only occur as S. aureus multiplies to about 1,000,000/g. Operating procedures during boning and subsequent freezing prevent growth of S. aureus, thus the potential for enterotoxin formation is very low.Using information above, determine if this potential hazard is to be addressed in the HACCP plan.The HACCP team decides that enteric pathogens are hazards for this product.Hazards must be addressed in the plan.HACCP team determines that if the potential hazard is not properly controlled, consumption of product is likely to result in an unacceptable health risk.Hazard must be addressed in the plan.The HACCP team determines that the potential for enterotoxin formation is very low. However, it is still desirable to keep the initial number of S. aureus organisms low. Employee practices that minimize contamination, rapid carbon dioxide freezing and handling instructions have been adequate to control this potential hazard.Potential hazard does not need to be addressed in plan.* For illustrative purposes only. The potential hazards identified may not be the only hazards associated with the products listed. The responses may be different for different establishments.<br /> <br /> <br />APPENDIX E<br />Example I of a CCP Decision Tree<br />Important considerations when using the decision tree:<br />The decision tree is used after the hazard analysis.<br />The decision tree then is used at the steps where a hazard that must be addressed in the HACCP plan has been identified.<br />A subsequent step in the process may be more effective for controlling a hazard and may be the preferred CCP.<br />More than one step in a process may be involved in controlling a hazard.<br />More than one hazard may be controlled by a specific control measure.<br />* Proceed to next step in the process.<br /> <br /> <br />APPENDIX F<br />Example II of a CCP Decision Tree<br />*Proceed to next step in the described process<br /> <br /> <br />APPENDIX G<br />Examples of Verification Activities<br />Verification procedures may include: <br />Establishment of appropriate verification schedules.<br />Review of the HACCP plan for completeness.<br />Confirmation of the accuracy of the flow diagram.<br />Review of the HACCP system to determine if the facility is operating according to the HACCP plan.<br />Review of CCP monitoring records.<br />Review of records for deviations and corrective actions.<br />Validation of critical limits to confirm that they are adequate to control significant hazards.<br />Validation of HACCP plan, including on-site review.<br />Review of modifications of the HACCP plan.<br />Sampling and testing to verify CCPs.<br />Verification should be conducted: <br />Routinely, or on an unannounced basis, to assure CCPs are under control.<br />When there are emerging concerns about the safety of the product.<br />When foods have been implicated as a vehicle of foodborne disease.<br />To confirm that changes have been implemented correctly after a HACCP plan has been modified.<br />To assess whether a HACCP plan should be modified due to a change in the process, equipment, ingredients, etc.<br />Verification reports may include information on the presence and adequacy of. <br />The HACCP plan and the person(s) responsible for administering and updating the HACCP plan.<br />The records associated with CCP monitoring.<br />Direct recording of monitoring data of the CCP while in operation.<br />Certification that monitoring equipment is properly calibrated and in working order.<br />Corrective actions for deviations.<br />Sampling and testing methods used to verify that CCPs are under control.<br />Modifications to the HACCP plan.<br />Training and knowledge of individuals responsible for monitoring CCPs.<br />Validation activities.<br /> <br />APPENDIX H<br />Examples of HACCP Records<br />Ingredients for which critical limits have been established. <br />Supplier certification records documenting compliance of an ingredient with a critical limit.<br />Processor audit records verifying supplier compliance.<br />Storage records (e.g., time, temperature) for when ingredient storage is a CCP.<br />Processing, storage and distribution records <br />Information that establishes the efficacy of a CCP to maintain product safety.<br />Data establishing the safe shelf life of the product; if age of product can affect safety.<br />Records indicating compliance with critical limits when packaging materials, labeling or sealing specifications are necessary for food safety.<br />Monitoring records.<br />Verification records.<br />Deviation and corrective action records.<br />Employee training records that are pertinent to CCPs and the HACCP plan.<br />Documentation of the adequacy of the HACCP plan from a knowledgeable HACCP expert.<br />