Barriers of HACCP team members to guideline adherence
haccp 过程关系 英语
haccp 过程关系英语HACCP (Hazard Analysis and Critical Control Point) is a systematic approach to the identification, assessment, and control of potential hazards in the food production process. It involves seven principles that are essential for ensuring food safety:1. Conduct a hazard analysis: Identify all potential hazards associated with the food production process, including biological, chemical, and physical hazards.2. Determine critical control points (CCPs): Identify steps at which control can be applied, and prevent or reduce hazards to an acceptable level.3. Establish critical limits: Set specific criteria for each CCP that must be met to ensure that the hazard is controlled.4. Monitor CCPs: Develop a system to monitor each CCP on a regular basis to ensure that critical limits are being met.5. Establish corrective actions: Develop procedures to befollowed when a deviation occurs from a critical limit.6. Verify the HACCP system: Confirm that the HACCP system is working correctly through verification activities such as testing and record review.7. Maintain records: Keep records of all HACCP activities, including hazard analysis, CCP monitoring, corrective actions, and verification.The relationship between these principles is that they work together to form a comprehensive system that ensures food safety throughout the food production process. Each principle builds upon the previous one, creating a logical sequence of steps that must be followed to effectively control potential hazards. By implementing HACCP, food producers can identify and control potential hazards before they become problems, ensuring that consumers have access to safe, high-quality food products.。
BRC Food Safety 学习笔记汇总
1.高级管理层承诺1.1.高级管理层承诺和持续改进基础要求:公司的高级管理层应能够证实其对实施本“食品安全全球标准”的要求,并推动食品安全和质量管理的持续改进过程的全面承诺。
作为基础要求,本标准高度重视“可证实的”高级管理层的承诺,并且由审核员在整个审核过程中全面关注。
可通过公司方针的策划及其内部沟通,及其在公司内部的全面实施,为本标准的实施提供足够的资源来体现。
1.1.1.公司的食品安全和质量目标的确立,应表达公司持续提供安全、合规性和符合质量要求的食品,以及对顾客负责的宗旨,体现高级管理层的承诺。
方针应由高级管理者签署,并保持最新版。
公司要定期评价方针,但不一定要更改。
1.1.2.与公司的食品安全和质量方针呼应,公司应制定相应的目标,并鼓励全体员工为实现此共同目标而工作。
可用多种途径与员工进行沟通公司的方针和目标,例如公示板,作为员工入职过程培训的内容,或者公司内部论坛等。
公司各级部门目标的达成情况,应至少每季度向高级管理汇报。
可为可公司的质量方针和目标编制适当的索引,概述公司如何履行符合产品安全、合规性和满足客户要求的质量的责任,以及公司的持续改进的目标。
1.1.3.高级管理层应对管理评审过程负责,包括主持会议,或者评审各部门会议后,提出相关会议记录或者行动计划。
高级管理层要确保管理评审提出的行动计划有专人负责,并且按时完成。
管理评审会议记录要表明有高级管理层的参与。
管理评审的目标是识别要改进的区域,并且有效、高效地持续推动食品安全和质量管理体系的改进。
管理评审会议的频率要与公司的规模、活动和操作的复杂性相关。
管理评审过程可以在某既定的时间来做,或者在一年内分阶段步骤来做,不管怎样,通常要求一年内的管理评审活动应包括如下的主题。
管理评审经常包括对管理活动的一些数据的统计评价,例如投诉率的统计,以及相应的行动计划;产品合格率的统计,等。
安装本标准要求,管理评审至少包括对如下内容的讨论: •以往管理评审行动计划和时限的回顾•内审、二方审核和三方审核的数量及实施原因,审核发现等;对必要的行动计划的回顾,包括财务或者人力资源方面的支持•关于顾客的满意统计指数、投诉以及反馈,例如是否达到目标,发展的趋势以及采取过的和/或进一步的措施,等•事故、产品不符合结果和不合格物料,及其根本原因分析•基于HACCP原理体系的回顾•对资源的要求管理评审要对以上信息进行分析,得出的结论和确定的行动计划,以推动持续改进。
加拿大农业及农业食品部
Food Safety & Quality食品安全和 质量
The Government of Canada is committed to ensuring that food produced in Canada continues to be among the safest and highestquality in the world. Canada is putting in place national, seamless food safety systems on the farm and throughout the agri-food chain - from the field to the fork. 加拿大政府承诺保证加拿大产食品继续是 最安全和最高品质的在世界范围内.加拿大正在对农场进行一个全国 的,无伤痕的食品安全系统 通过农产品链—从农田到叉子
networks to better link scientific advances to the creation of new economic opportunities与科学新技术保持更好的联络来 创造新的经济机会
International国际
The international component is designed to maximize international opportunities arising from progress on the domestic front. 国际成分被设计以 最大化进步的国际机遇在国内
加拿大正在对农场进行一个全国的无伤痕的食品安全系统通过农产品链从农田到叉子hesectoodsafetconcernswhimprovingmarketaccessopportunihesect将会改善部门能力去鉴别和回答食品安全问题和考虑通过改善市场准入和机会workingwindustryexistoodsafetmeasures同农民和工业一起工作来建造现存的食品安全措施undertakingnewmeasuresracingoodproductoodqualsharecrinformat保证新措施能保证从农场追查食品产品改善食品质量和分享重要信息sciencehecornerstonehecanadiagriculoodsectheworloodsafetenvironmentalresponsibluturesuccess科学和创新是保证加拿大农业和农产品在世界食品安全创新和对环境负责的生产的努力基础和保证其将来的成功和繁荣
食品安全体系 HACCP 基础课程 【教材】中英双语
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H.A.C.C.P Objective H.A.C.C.P的目标
To ensure a high level of consumer protection with regards to food safety systems.
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What is the role of employers? 雇主的角色?
Establish and maintain appropriate food safety culture 建立和维护适当的食品安全文化
Be committed to HACCP, implement system and provide adequate resources 致力于HACCP,确保体系的实施并提供充足的资源
Fines of up to £5000 per offence. 违反一次最高罚款5000英镑
For serious offences unlimited fines and maximum 2 years imprisonment. 严重违反的面临无限额罚款和两年以下的监禁
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HACCP plan 实施HACCP计划
Module 5 模块5
Verification
验证
Module 6 模块6
Review 评审
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Module 1
模块 1
Introduction to HACCP HACCP介绍
专业英语食品安全
VS
The background to this field is the globalization of the food industry, which has led to an increase in the need for cross cultural communication and understanding of food safety regulations
The importance of food safety
Food safety is critical for protecting consumer health and preventing the spread of foodborne illnesses
It is essential for maintaining the reputation and trustworthiness of the food industry, as well as for ensuring compliance with legal requirements
Allow additives
Different countries or regions have their own lists of allowed food additives, which may vary in terms of types, usage limits, and labeling requirements
Food safety also plays a vital role in international trade, as it is a prerequisite for the export and import of food products
食品经营安全管理制度英文
食品经营安全管理制度英文1. IntroductionFood safety is a matter of great concern for both consumers and food business operators. Consumers are becoming increasingly concerned about the safety and quality of the food they purchase, and food businesses are under immense pressure to ensure that the products they sell are safe and comply with relevant regulations and standards. To address these concerns, it is essential for food businesses to implement a robust food safety management system to manage and control the risks associated with the production, handling, and sale of food products.2. Principles of Food Safety ManagementThe management of food safety in a food business involves several key principles that must be adhered to in order to ensure the production of safe and high-quality food products. These principles include:- Hazard Analysis and Critical Control Points (HACCP): This is a systematic approach to identifying, evaluating, and controlling the hazards that may pose a risk to the safety of food products. HACCP is a preventive system that focuses on identifying critical control points in the production process and implementing measures to control the identified hazards.- Good Manufacturing Practices (GMP): GMP are a set of guidelines and procedures that govern the production, handling, and storage of food products to ensure that they are safe and of high quality. GMP cover a wide range of areas, including personnel hygiene, facility design and maintenance, equipment and utensil sanitation, and product labeling and packaging.- Traceability: Traceability is the ability to track the movement of food products through the supply chain, from production to consumption. This is essential for identifying the source of a food safety issue and implementing a recall if necessary.- Compliance with Regulations and Standards: Food businesses must comply with relevant regulations and standards governing food safety, such as the Food Safety Modernization Act (FSMA) in the United States and the European Union's General Food Law.- Continuous Improvement: Food safety management is an ongoing process that requires constant monitoring, evaluation, and improvement. Food businesses must continuously review and update their food safety management system to adapt to changes in the industry and new knowledge about food safety risks.3. Components of Food Safety Management SystemA comprehensive food safety management system should include the following components:- Food Safety Policy: The food business should have a written food safety policy that outlines its commitment to producing safe and high-quality food products. The policy should be communicated to all employees and stakeholders, and regularly reviewed and updated.- Food Safety Team: A dedicated food safety team, led by a designated food safety manager, should be responsible for implementing and managing the food safety management system. The team should be trained in food safety principles and have the authority to make decisions regarding food safety.- Hazard Analysis and Critical Control Points (HACCP) Plan: The food business should develop and implement a HACCP plan that identifies the hazards associated with its products and processes, determines critical control points, and establishes control measures to manage the identified hazards.- Good Manufacturing Practices (GMP) Procedures: The food business should have written procedures for GMP covering all aspects of production, handling, and storage of food products. These procedures should be regularly reviewed and updated to reflect changes in processes or regulations.- Product Testing and Monitoring: The food business should establish a program for testing and monitoring the safety and quality of its products. This may include regular microbiological and chemical testing, environmental monitoring, and sensory analysis.- Supplier Management: The food business should establish and implement a supplier management program to ensure that its suppliers meet the same high standards for food safety. This may include supplier audits, supplier approval processes, and regular supplier monitoring.- Training and Education: All employees involved in the production, handling, and sale of food products should receive regular training on food safety principles, procedures, and best practices. This training should be documented and regularly reviewed to ensure its effectiveness.- Incident Management and Recall Procedures: The food business should have written procedures for managing food safety incidents and implementing product recalls if necessary. These procedures should be regularly reviewed and tested to ensure their effectiveness.4. Implementation of Food Safety Management SystemThe successful implementation of a food safety management system requires the commitment and involvement of the entire organization. The following steps can help ensure the successful implementation of a robust food safety management system:- Leadership Commitment: The top management of the food business should demonstrate a strong commitment to food safety by allocating the necessary resources, setting clearobjectives, and providing visible support for the implementation of the food safety management system.- Employee Involvement: All employees should be involved in the implementation of the food safety management system through training, education, and participation in food safety activities. Employees should be encouraged to report food safety concerns and be provided with the necessary means to do so.- Communication and Training: Effective communication is essential for the successful implementation of a food safety management system. The food business should ensure that all employees are aware of the food safety policy, procedures, and their roles and responsibilities in ensuring food safety.- Documentation and Records: The food business should maintain all necessary documentation and records to demonstrate compliance with the food safety management system. This may include records of training, product testing, supplier approvals, and incident management.- Monitoring and Review: The food business should regularly monitor and review the effectiveness of its food safety management system through internal audits, management reviews, and performance indicators. Any deficiencies or opportunities for improvement should be promptly addressed.- Continuous Improvement: The food business should be committed to continuously improving its food safety management system through the identification and implementation of corrective and preventive actions, and the adoption of new best practices and technologies.5. ConclusionIn conclusion, the implementation of a robust food safety management system is essential for ensuring the safety and quality of food products. By adhering to the key principles of food safety management and implementing the necessary components, food businesses can mitigate the risks associated with food production and ensure consumer confidence in their products. The successful implementation of a food safety management system requires the commitment and involvement of the entire organization and a continuous dedication to monitoring, reviewing, and improving food safety practices.。
食品安全体系规范(HACCP)(英文版)
SPECIFICATIONREQUIREMENTSFOR AHACCP BASEDFOOD SAFETY SYSTEMCompiled by theNational Board of Experts – HACCPThe Netherlands.The Hague, the Netherlands: 3rd Version, September 2002This is the authorised English translation of the specification “Eisen voor een op HACCP gebaseerd voedselveiligheids-systeem” (3rd version, September 2002), being one of three documents which regulate the Certification Scheme for operational HACCP based food safety systems.T he two other documents; the “Certification Regulations” and the “Regulations for the National Board of Experts –HACCP” are also published by the National Board of Experts – HACCP.Certifying Bodies operating the Certification Scheme for operational HACCP based food safety systems have to comply with the “Requirements for Certification Bodies”, also established and published by the National Board of Experts – HACCP.The Certification Scheme for HACCP based Food Safety Systems is maintained by the National Board of Experts - HACCP.Certification/Registration of HACCP based Food Safety Systems on the basis of the preceding versions of this specification has been accredited by the Dutch Accreditation Council (RvA) since 1997.Copyright 2002 National Board of Experts - HACCPPrice: EURO 23,00 (excluding VAT).All rights reserved. No part of this publication may be reproduced and/or published in any form, by means of printed matters, photocopy, microfilm, recording or any other method or technology, without preceding written approval by the National Board of Experts - HACCP.National Board of Experts - HACCP,Secretariat: P.O. Box 93202, 2509 AE, The Hague, The Netherlands.Web site: email:******************************CONTENTS1 INTRODUCTION 42 SCOPE of APPLICATION 73 REFERENCE DOCUMENTS 84 TERMS and DEFINITIONS 95 HACCP SYSTEM REQUIREMENTS 125.1 Management responsibility 125.1.1 Policy5.1.2 Scope of the HACCP system5.1.3 Task, Responsibilities, Authorities5.1.4 HACCP team(s)5.1.5 Resources5.1.6 Management review5.2 Product Information 145.2.1 Product Characteristics5.2.2 Intended use5.3 Process Information 155.3.1 Flow Diagrams5.3.2 Layout5.3.3 Control and Verification of Process Information5.4 Pre-requisite program 165.5 Hazard Analysis 175.5.1 Hazard identification5.5.2 HACCP analysis (risk)5.6 Control Measures 195.6.1 Specific Control Measures5.6.2 General Control Measures5.7 Parameters and Critical Limits 205.7.1 Critical process and product parameters5.7.2 Target values, action-limit values and critical limits5.8 Monitoring and Measuring 215.9 Corrective Actions 225.10 Validation 235.11 Verification 245.12 Documentation and records 265.12.1 Documents and document control5.12.2 Records6 ANNEX I: PRE-REQUISITE PROGRAM (PRP) 277 ANNEX II: RELATIONSHIP BETWEEN THE “REQUIREMENTS” 35AND CODEX GUIDELINES FOR THE APPLICATION OF HACCP1 INTRODUCTIONReference documents; legislation; background informationFood safety is a global concern. Not only because of the continuing importance for public health, but also because of its impact on international trade. Effective Food Safety Systems shall therefore manage and ensure the safety and suitability of foodstuffs.In many countries world-wide, legislation on the safety and suitability of foodstuffs requires “HACCP” to be put in place by any food business or organisation, whether profit-making or not and whether public or private, carrying out any or all of the following activities: preparation, processing, manufacturing, packaging, storage, transportation, distribution, handling or offering for sale or supply of foodstuffs. According to EU Directive 93/43/EEC on Food Hygiene all food business operators in the European Union shall implement HACCP 1. They shall ensure that adequate safety procedures are identified, documented, maintained and reviewed on the basis of the principles used to deve lop the system of HACCP (“Hazard Analysis and Critical Control Po int”).The Joint FAO/WHO Codex Alimentarius Commission describes a series of steps, including the 7 HACCP principles giving guidance for the application of the HACCP system 2. Also, Codex advises that minimum hygiene measures should be in place before HACCP is implemented:”Prior to application of HACCP to any sector of the food chain, that sector should be operating according to the Codex General Principles of Food Hygiene, the appropriate Codex Codes of Practice, and appropriate food safety legislation.”These prerequisite programs should be well specified and documented, fully operational and verified in order to facilitate the successful application and implementation of HACCP. The General Principles of Food Hygiene 3, as recommended by Codex, form an intrinsic pa rt of this document “Requirements for a HACCP based Food Safety System”.Specific food safety requirements are detailed in legislation, hygiene codes, customer or consumer specifications. Where specific requirements do not exist, the General Principles on Food Hygiene will be applied (see Annex I). Furthermore, the 7 principles and the guidelines for the application of HACCP have been combined in this Specification with basic elements of quality management systems (ISO 9000) to establish “The Requirements for a HACCP based Food Safety System”.The reference documents used to formulate the “Requirements” have been specified in Chapter 3.The “Requirements” are primarily focused on actions and activities to ensure food safety. The assurance of food suitability is considered to be an obligatory part of a quality management system, unless deviations may lead to unsafe foodstuffs.1EU Directive 93/43/EEC on the Hygiene of Foodstuffs, dated 14 June 1993 (PbEC L175).2Codex Alimentarius Com mission, “Hazard A nalysis and Critical Control Point (HACCP) System and Guidelines for its Application”, Annex to CAC/RCP 1-1969, Rev. 3 (1997).3Codex Alimentarius Com mission, “General Principles of Food Hygiene, CAC/RCP 1-1969, Rev. 3 (1997), amended 1999.The need for a Standard or SpecificationThe specification “Requirements for a HACCP based Food Safety System” has been developed by and is placed under the authority of the National Board of Experts –HACCP in order to make a normative document/standard available. All parties involved in the food chain are represented on the National Board of Expert - HACCP. The specification can be used by Certifying Bodies to assess the continuous compliance of HACCP-based Food Safety Systems as developed and implemented by food business operators.Of course, a food business operator may also use the “Requirements” to develop its HACCP-based Food Safety System.Certification/Registration (e.g.of HACCP-based Food Safety Systems) signifies that by means of a formal statement (a certificate) and/or mark, notice is given with justified confidence that a product, process or service or system is in conformance with a pre-defined standard or (technical) specification. This includes the ability of the company to maintain conformance with the standards or specifications.In order to issue such a formal statement, the HACCP-based Food Safety System of a food business operator needs to be assessed. Certification and repetitive surveillance audits are to be effectively performed by a Certifying Body which is an independent institution (whether or not governmental) that has both the authority as well as the confidence to operate a certification system within which the interests of all involved parties are represented.For confidence the Certifying Body must use the published “Requirements” and the “Certification Regulations” in an agreed manner. The “Requirements” are documented in such a way to allow an effective assessment of the status and performance of the HACCP-based Food Safety System, as implemented by the food business operator. In the “Certification Regulations”, specific criteria are stated which have to be met by the Certifying Body when selecting a competent HACCP audit team, and rules which govern the way the certification process is designed and offered (e.g. the minimum auditor time) have to be followed.Authority is obtained when the Certifying Body is formally accredited by a recognised Body to operate the certification system for HACCP based Food Safety Systems 4 and is audited regularly by this Accreditation Body. Accreditation concerns the reliability and competence of the Certifying Body.The document “Requirements for Certification Bodies” elaborates the accreditation requirements.It must be understood that certification of a HACCP-based Food Safety System is not a guarantee of a food business operator’s continuous food safety perfor mance. The value added to a food business operator with a certified HACCP-based Food Safety System lies in the efforts made by the operating company to maintain that HACCP system and its commitment to continuously improve its food safety performance. Requirements for a HACCP based Food Safety System4The c ertification bodies must meet “General require ments for bodies operating assessment and certification / registration of quality systems”, ISO/IEC Guide 62:1996 (EN 45012) andthe Standards for auditing (ISO 10011, Part 1, 2 and 3).The requirements in this Specification provide a basis for compliance of a HACCP-based Food Safety System with (inter)national legislation and codes of practice. They include the necessary management system requirements. The structure, the sequence and interaction of the assessment process is detailed in Figure 1.In the description of every clause, the scope of the requirements is detailed. Using these clauses, the audit team assesses the documented HACCP-based Food Safety System as well as the implementation and operation of the system on the 'shop floor'. The “Requirements” lay down a generic set of requirements. An operational HACCP-based Food Safety System shall be, as a minimum, in compliance with these Requirements. In Annex II of this document each heading or paragraph of the “Requirements” refers to the corresponding text in the HACCP guidance document of Codex Alimentarius 5.Figure 1. The structure of a HACCP-based Food Safety System←↑→→→→→→→→→→In order to make the system transparent and enable assessment, the food business operator shall provide information as indicated in these “Requirements”. For each specific condition (product / product group / process / sector), specific requirements shall be detailed by the food business operator. The audit team shall assess this complete system of generic and company specific requirements.5Codex Alimentarius Com mission, “Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application”, Annex to CAC/RCP 1-1969, Rev. 3 (1997).The first version of these “Requirements” (then called “Criteria”) has been developed in co-operation with several Certification Bodies in the Netherlands in the area of food materials and processing, under the authority and responsibility of the National Board of Experts - HACCP. The 1st version was published on May 15, 1996.Due to the modification of the Codex Alimentarius (Alinorm 97/13A, Appendix II) in 1997, a revision of the Requirements became necessary. The National Board of Experts - HACCP was also able to draw on their experience in order to improve the quality of the “Requirements”. The 2nd version of the “Requirements” was published in September 1998 and translated into English in February 1999.Recent developments with respect to HACCP-based Food Safety System and developments within Codex, as well as new proposals for Food Hygiene Regulations (thereby repealing the current referenced EU Directives and Regulations), have necessitated a further revision: this 3rd version!2 SCOPE of APPLICATIONIn this document, requirements have been specified to be used during the assessment of operational HACCP systems (HACCP-based Food Safety Systems) which ensure the safety of foodstuffs during preparation, processing, manufacturing, packaging, storage, transportation, distribution, handling or offering for sale or supply in any sector of the food chain.The “Requirements” are basically applicable to all food businesses or organisations, whether profit-making or not, and whether public or private.Obviously, the food business operators shall have identified any step in their activities which is critical to ensure food safety and shall have developed, implemented, maintained and reviewed adequate safety procedures, applying the principles of HACCP, including the general principles of food hygiene, and where appropriate the relevant codes of practice and the food safety legislation.These “Requirements” are not intended for application by sup pliers and / or service companies to food businesses, like suppliers of packaging materials, food equipment, industrial cleaning services, etc..3 REFERENCE DOCUMENTSThe “Requirements for a HACCP-based Food Safety System” are based on the following reference documents:1World-wide:Joint FAO/WHO Codex Alimentarius Commission,-General Principles of Food Hygiene, CAC/RCP 1-1969, Rev. 3 (1997), amended 1999.-Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application, Annex to CAC/RCP 1-1969, Rev. 3 (1997).2International level:European Union2aGeneral Food lawRegulation (EC) no 178/2002, laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, dated 28 January 2002.2bCouncil Directive 93/43/EEC on the Hygiene of Foodstuffs, dated 14 June 1993 (PbEC L175);Specific legislation and regulations concerning food safety and hygiene have been laid down in Council Directives such as 64/433/EEC for fresh meat, 71/118/EEC for poultry meat, 89/437/EEC for egg products, 92/46/EEC for dairy products, 92/5/EEC for meat products, 91/493/EEC for fishery products, 94/65/EEC for minced meat, etc..2cDocuments under 2b will be repealed by:Proposal for a Regulation of the European Parliament and of the Council on the hygiene of foodstuffs,COM/2000/0438 final, 14 July 2000 (COD 2000/0178), and others.3National level:Netherlands, Food and Commodity Act:Warenwetregeling Hygiëne van Levensmiddelen, 12 december 1994 (DGVgz/VVP/L 942587).4Where appropriate:Numerous (International, a/o. Codex) Codes of Practice, Food Commodity Standards and (national) Hygiene Codes (generic HACCP / hygiene plans).4 TERMS and DEFINITIONSAction-limit value: A value for the product or process parameter under consideration, deduced from the critical limit value, which indicates that an intervention in the process is required.Aspect: An element of the food business operation (products, processes, PRP, services) that can interact with the food safety.Certification: Action by a third party demonstrating that adequate confidence is given that a duly identified product, process or service conforms with a specific standard or other normative document.Control (verb): To take all necessary actions to ensure and maintain compliance with criteria established in the HACCP plan.Control (noun): The state wherein correct procedures are being followed and criteria are being met.Control measure: Any action and activity that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level.Control measure, general: A measure to control a specific part of the PRP.Control measure, specific: A measure to control a CCP.Corrective action: Any action to be taken when the results of monitoring at the CCP indicate a loss of control.Critical Control Point (CCP): A step at which it is essential that a specific control measure is applied to prevent or eliminate a food safety hazard or reduce the risk to an acceptable level (see also Control measure, specific) .Critical limit: A criterion which separates acceptability from non-acceptability.Note: This criterion defines the limiting values for the product or process parameter(s) under consideration for monitoring (see action-limit values and target values).Flow diagram: A systematic representation of the sequence of steps or operations used in the preparation, processing, manufacturing, packaging, storage, transportation, distribution, handling or offering for sale of a particular food item. Food business operator: The person or persons responsible for ensuring that the requirements of thefood legislation are met within the food business under his/their control.Food handler: Any person who directly handles packaged or unpacked food, food equipment and utensils, or food contact surfaces and is therefore expected to comply with food hygiene requirements.Food hygiene: All conditions and measures necessary to ensure the safety and suitability of food at all stages of the food chain.Food safety: Assurance that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use.Food suitability: Assurance that food is acceptable for human consumption according to its intended use.General Control Measure: see: Control measure, generalHACCP (Hazard Analysis and Critical Control Point): A system which identifies, evaluates and controls hazards which are significant for food safety.HACCP audit: A systematic and independent examination to determine whether the HACCP system, including the HACCP plan and related results, comply with planned arrangements, are implemented effectively and are suitable for the achievement of its objectives.Note: Examination of the Hazard Analysis is an essential element of the HACCP audit.HACCP plan: A document prepared in accordance with the principles of HACCP to ensure control of hazards which are significant for food safety in the segment of the food chain under consideration.HACCP based Food Safety System: (a HACCP system): The organisational structure, procedures, processes and resources needed to execute the HACCP plan(s) and meet its objectives.HACCP team: Group of individuals (multi-disciplinary) who develop, implement and maintain a HACCP system.Hazard: A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect.Hazard analysis: The process of collecting and evaluating information on hazards and conditions leading to their presence, to decide which are significant for food safety and should therefore be addressed in the HACCP plan.Monitoring: The act of conducting a planned sequence of observations or measurement of control parameters to assess whether a CCP is under control.Pre-Requisite Programme (PRP): Any specified and documented activity or facility implemented in accordance with the Codex General Principles of food hygiene, good manufacturing practice and appropriate food legislation, in order to establish basic conditions that are suitable for the production and handling of safe food at all stages of the food chain.Preventive action: Any measure or activity that will be used to prevent, to eliminate or to reduce the recurrence of causes for existing deviations, defects or any other undesired situation with respect to food safety.Primary production: Those steps in the food chain up to and including harvesting, hunting, fishing, milking and all stages of animal production prior to slaughter.Products, unprocessed: Foodstuffs which have not undergone a treatment, including products which have been, for example, divided, parted, severed, boned, minced, skinned, ground, cut, cleaned, trimmed, husked or milled, chilled, frozen or deep-frozen.Products, processed: Foodstuffs resulting from the application to unprocessed products of a treatment such as heating, smoking, curing, maturing, pickling, drying, marinating, extraction, extrusion, etc. or a combination of these processes and/or products; substances necessary for their manufacture or for giving specific characteristics to the products may be added.Risk: The probability of causing an adverse health effect caused by the occurrence and the severity of a particular hazard in food when prepared and consumed according to its intended use.Target value: The value of the product or process parameter(s) to be monitored, targeted within action-limit values (the range of acceptable variations) and certainly within critical limit values, thus securing a safe product.Step: A point, procedure, operation or stage in the food chain, including raw materials, from primary production to final consumption.Validation: Obtaining evidence (in advance) that the specific and general control measures of the HACCP plan are effective.Verification: The application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine compliance with the specifications laid down in the HACCP plan and the effectiveness of the HACCP-based Food Safety System.5 HACCP SYSTEM REQUIREMENTS5.1 Management responsibilityThe food business operator is responsible for the safety (and suitability) of the produced food.Therefor, the food business operator shall include the policy with respect to food safety in the policy of the organisation. The food business operator has ultimate responsibility for the policy of the organisation and shall document, support and communicate this policy. Periodically, the Food business operator shall verify the implementation of the policy and review the outcome.The HACCP system enables the food business operator to demonstrate his commitment and his responsibility with respect to the supply of safe products. The HACCP system ensures that all required activities are effectively defined, implemented and maintained.5.1.1 PolicyThe food business operator shall define and document (in writing) the policy of the organisation with regards to food safety. It will demonstrate the commitment of the organisation to safe food.The policy shall demonstrate that the organisation is fully aware of its position in the food chain. It will reflect the “farm-to-fork” approach, starting with the purchase and acceptance of raw materials.The policy shall be focused on the safety of foodstuffs and shall respond to the expectations and needs of its customers and consumers.The policy shall include concrete objectives 6 (proposed actions) to ensure and improve food safety for the period under consideration.The food business operator shall ensure that the policy is understood, implemented and maintained at all levels in the organisation.5.1.2 Scope of the HACCP systemThe food business operator shall define the extent (the scope) of the HACCP system. The scope shall comprise that part of the food chain and those activities of the food business for which the food operator is responsible and can be held liable: •The part of the food chain for which the food business operator is responsible begins where the responsibility of the suppliers of raw materials and ingredients ends; the responsibility of the food business operator ends where another food business in the food chain takes over the responsibility. The scope shall therefore conform with purchase and sales contracts;•All locations and process lines where food is manufactured and/or stored by the food business shall be properly indicated and be available for assessment;•All products which are supplied to the market by the food business, whether processed or handled, shall be properly specified;•All subcontracted activities (outsourced services, like packaging, storage, transport) shall be properly dealt with.For practical reasons the total product assortment may be clustered into product groups. However it is important that:6SMART objectives are Specific, Measurable, Acceptable, Realistic objectives, defined in Time.•Specific differences between individual end products have been critically evaluated;•Manufacturing and storage conditions are comparable;•Important aspects for food safety are not overlooked.A key principle is that no part of the operation of the food business can be excluded from the scope of the HACCP system; all activities must be available for assessment.5.1.3 Tasks, responsibilities and authoritiesThe food business operator shall provide appropriate documentation with respect to the tasks, responsibilities and authorities of food business operator’s employees who are in positions which involve handling food and / or controlling and ensuring the safety and suitability of the food.An organisation chart and the organisation’s reporting stru cture shall be documented.5.1.4 HACCP team(s)The food business operator shall assemble a HACCP team (or various HACCP teams if so required).The HACCP team shall develop, implement and maintain the HACCP system.The organisation shall demonstrate that the members of the HACCP team have the knowledge, expertise and different disciplines available which are required to develop, implement and maintain a HACCP system covering the total scope of the HACCP system.Minimum qualification criteria, including required expertise, shall be defined and documented for all members of the HACCP team. In addition, the assignment (including tasks, responsibilities and authorities) shall be documented for the team members.Whenever more than one HACCP team has been assembled, a co-ordinator shall be appointed to co-ordinate the development, implementation and maintenance of the HACCP system.5.1.5 ResourcesThe food business operator shall examine the requests and provide, in a timely manner, all the resources needed by the HACCP team(s) to develop, implement and maintain the HACCP system.When corrective actions, verification procedures or customers indicate that operational improvements are necessary, the food business operator shall examine the issues and provide appropriate resources to ensure food safety.5.1.6 Management ReviewThe food business operator shall review the HACCP system at planned intervals, of no more than 12 months, to ensure continuing suitability, adequacy and effectiveness. The review shall evaluate the need for changes to the HACCP system, including product safety, policy and objectives. The review shall provide evidence of the commitment to improve the HACCP system and its performance.5.2 Product Information5.2.1 Product CharacteristicsEach product (or a group of similar products: see 5.1.2) shall be fully specified and documented, including its sensitivity to and potential for safety risks.This description of the safety of the product shall encompass the food chain, ranging from raw materials used to the distribution of the finished products.The traceability of the raw materials up to and including final supply shall be described.An extensive specification of the end products is required to ensure a comprehensive assessment of the food safety procedures. This specification shall clearly define the following product characteristics:• A general product description;•Raw materials and ingredients used (composition);•General product specifications such as appearance, weight, etc.;•Specific product specifications such as chemical, microbiological and physical characteristics;•Specific requirements such as appropriate legislation, customer requirements;•General control of (chemical, microbiological and physical) safety;•Packaging, storage conditions, labelling (shelf life, product identification);•Identification of potential mishandling of the product.5.2.2 Intended useThe intended use of the product (or product group) shall be identified and documented since it has a direct influence on the required product characteristics. For instance, the product may require:•Additional preparation methods (e.g. heating) before consumption, and/or•Cooling and storage at specific temperatures, and/or•An indication of the ultimate day of use, especially after breaking the packaging, and/or•The product may be intended for use by specific (vulnerable) groups of the population, such as babies and children, pregnant women, elderly people, allergenic or sick people.The intended use of the product shall be continually reviewed; relevant legislation and regulations shall be documented. When necessary, the product characteristics and manufacturing processes may need to be adapted to conform with special legislation. Information on the label, including directions for use, may also need to be adapted. These changes shall be recorded.If mishandling or misuse of the product can result in unsafe products the products shall bear appropriate information to ensure that adequate and accessible information is available to the next persons in the food chain to enable them to handle, store, process, prepare and display the product safely and correctly. It shall be easy to identify the lot or batch when recall is required.The food business operator shall demonstrate that it has evaluated whether the intended use or misuse should include Critical Control Points such as storage conditions and preparation before consumption.。
食品质量安全控制技术的发展
Origins of HACCP 起源
Pioneered in the 1960’s for the US space program 起源于60年 代的美国太空计划
Adopted widely by many food processors and governments afterwards 随后被食品界和政府 机构采用
和储存污染 Sales related 销售污染
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Characteristic of Hazards 危害的性质
Biological Hazards生物性: Bacteria细菌 Viruses病毒 Protozoa (parasites)原生动物(寄生虫)
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Characteristic of Hazards 危害的性质continue
Establish verification procedures 建立验证程序
Establish a record keeping system 建立文件保存体系
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HACCP Control Model HACCP循环控制模式
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CCP
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How to establish HACCP
Chemical Hazards化学性: Natural - Natural toxins etc. 天然 - 天然毒素等 Intentionally added - Food additives 有意添加的 - 食品添加剂 Unintentionally added - Food contaminants 无意添加的 - 食品污染物
Identify critical control points (CCP) 确定关键控制点(步骤七)
美国FDA指导原则CPGSEC585700根腐烂的薯片英文原版
美国FDA指导原则CPGSEC585700根腐烂的薯片英文原版Guidance for Industry: Control of Salmonella in Low-Moisture Food Establishments1. Introduction2. Background3. Good Agricultural PracticesLow-moisture food establishments should work closely with their potato suppliers to ensure that proper Good Agricultural Practices (GAPs) are followed. This includes proper storage, handling, and transportation of potatoes to minimize the risk of bacterial contamination. It is also essential to maintain proper documentation and traceability to identify potential sources of contamination.4. Hygiene and Sanitation PracticesEstablishments should have robust hygiene and sanitation practices in place to prevent cross-contamination and the spread of Salmonella. This includes thorough cleaning and sanitizing of equipment, surfaces, and utensils. Employees should follow good personal hygiene practices, such as proper handwashing and wearing protective clothing, to minimize the risk of introducing bacteria into the production area.5. Environmental MonitoringRoutine environmental monitoring should be conducted in low-moisture food establishments to detect the presence of Salmonella. This can be done through swabbing of surfaces, equipment, and the production environment. Regular sampling and testing of finished products should also be conducted to ensure the absence of Salmonella.6. Employee TrainingAll employees should receive proper training on food safety practices and be aware of the potential risks associated with Salmonella contamination. Training should include information on proper hygiene practices, sanitation procedures, and the importance of following established protocols to prevent contamination.7. Hazard Analysis and Critical Control Points (HACCP)Implementing a HACCP system can help low-moisture food establishments identify potential hazards and implement preventive measures. The seven principles of HACCP should be followed, including conducting a hazard analysis, determining critical control points, establishing critical limits, monitoring procedures, corrective actions, verification, and record-keeping.8. Supplier VerificationEstablishments should have a system in place to verify the safety of their potato suppliers. This includes conducting regular audits, requesting certificates of analysis, and verifying that suppliers have adequate food safety systems in place to minimize the risk of Salmonella contamination.9. Recall PlanLow-moisture food establishments should have a recall plan in place to respond quickly and effectively in the event of a product recall. The plan should outline the steps to be taken, including notifying regulatory authorities, conducting a thorough investigation, and issuing consumer notifications to ensure the safety of the public.10. Conclusion。
brcgs认证依据
brcgs认证依据BRCGS certification, formerly known as British Retail Consortium Global Standards, is a leading global brand and consumer protection organization. It provides certification for food safety, packaging, storage, and distribution. The BRCGS certification is recognized worldwide and is often a requirement for suppliers to major retailers. The certification is based on a set of standards that are designed to ensure the quality, safety, and legality of products. These standards cover a wide range of areas including hygiene, food safety, and quality management systems.One of the key requirements for BRCGS certification isto have a robust food safety management system in place. This includes having a documented and implemented HACCP (Hazard Analysis and Critical Control Points) plan, whichis a systematic preventive approach to food safety that addresses physical, chemical, and biological hazards as a means of prevention rather than finished product inspection.The certification also requires the implementation of good manufacturing practices (GMP) and regular internal and external audits to ensure compliance with the standards.In addition to food safety management, BRCGS certification also requires a strong focus on quality management systems. This includes having documented procedures and processes in place to ensure the consistent production of safe and quality products. It also requires a commitment to continuous improvement and the use of risk-based thinking to identify and address potential issues before they become problems.Another important aspect of BRCGS certification is the requirement for effective supplier management. This includes ensuring that all suppliers and subcontractors meet the same high standards for food safety and quality. It also requires regular monitoring and evaluation of suppliers to ensure ongoing compliance with the standards.Furthermore, BRCGS certification also emphasizes the importance of a strong and effective food safety culturewithin the organization. This includes providing training and education to all employees on food safety and quality management, as well as fostering a culture ofaccountability and continuous improvement. It also requires clear communication and transparency throughout the organization to ensure that everyone understands their role in maintaining the standards.Overall, obtaining BRCGS certification requires a comprehensive and integrated approach to food safety and quality management. It requires a commitment to continuous improvement, a strong focus on risk-based thinking, and effective supplier management. It also requires a strong food safety culture within the organization and a commitment to ongoing training and education for all employees. Ultimately, BRCGS certification is a testament to an organization's dedication to providing safe, quality products to consumers worldwide.。
【实用文档】HACCP Assessment
HACCP Audit – Compliance GuidelinesResponsible Personnel1. Is there a functional cross-departmental HACCP Team consisting of memberspossessing technical expertise from all relevant functions within theorganization?2. Has a HACCP Team Coordinator been appointed to manage activities andprovide direction for the HACCP Team?3. Do the HACCP Team members have an understanding of HACCP philosophy,either through past experience and/or participation in either an internal orexternal approved HACCP training program?4. Does local and regional management provide adequate support to ensurethat HACCP is an integral part of the organization’s operational culture?5. Does the local and regional management provide adequate support to ensurethe necessary resources (financial and personnel)are provided to ensureHACCP is an integral part of the organization’s quality systems?6. Do all personnel responsible for monitoring and reviewing established criticalcontrol points in the organization have an understanding of basic HACCPphilosophy?HACCP Systems1. Are there process maps and/or written documented procedures that detail therequirements for the HACCP system?2. Is HACCP incorporated into the initial product/package development process?3. Does the HACCP system require the entire lifecycle of the product to beassessed?4. Do effective systems exist to document the entire HACCP process, includingthe hazard identification and risk assessment?The HACCP Plan1. Does the organization have well defined and effective prerequisite programsto support the HACCP plans, including but not limited to:❑Good manufacturing practices (GMP’s)❑Policies and standard operating procedures (SOP’s)❑Employee training programs❑Pest control programs❑Environmental monitoring programs❑Sanitation SOP’s and master sanitation schedules (MSS)❑Equipment calibration and preventive maintenance programs2. Does the HACCP plan include a detailed description of each product typemanufactured that defines:❑Product description including pertinent information regarding composition and processing steps utilized during manufacturing❑Packaging formats and associated stock keeping units (SKU’s)❑Target consumer and intended use (including consumer preparation steps) ❑Storage conditions and shelf life❑Any other product attributes to support the detailed hazard identification and risk assessment required during the HACCP process3. Does the HACCP plan include a detailed process flow diagram that describesall movement, storage, processing, packaging, etc. during the manufacturing and distribution process?4. Have all potential hazards been identified for all raw and packaging materials,as well as indirect components including utilities (steam, air, water) andprocessing aids?5. Have all potential hazards been identified for each point in the manufacturingand distribution process as detailed in the process flow diagram?6. Does the hazard identification process consider all hazards relating tochemical, physical, microbiological and allergenic sources, and are thesehazards considered in the risk assessment process regardless of probability and severity?7. Has a risk assessment been performed for all hazards identified to determinethe probability of a hazard’s occurrence, as well as the severity if the hazard were to occur?8. Does the risk assessment detail the management of each hazard using thefollowing methods:❑Establishment of critical control points (CCP’s)❑Controlling the hazard through other monitoring activities or established prerequisite programs❑Dismissing the hazard as unlikely to occur based on the outcome of the9. Is there sufficient documentation supporting the outcome of the riskassessment?Definition and Management of CCP’s1. Are all established CCP’s summarized in a HACCP data table that detailscompliance with the seven principles of HACCP?❑Define the hazard❑Determine the point of control in the process (CCP)❑Establish the critical limits for the CCP❑Define the monitoring procedures for the CCP❑Define the corrective actions if critical limits are not met❑Define the verification process to ensure the CCP is controlling the hazard ❑Establish effective record keeping systems2. Does a system exist to ensure that all CCP’s are well identified throughout theprocess to increase awareness?3. Is there a process to investigate CCP deviations, including segregation anddisposition of affected products and previous production?4. Is there a process to review failures of CCP equipment, including duringroutine calibration, to determine any effect on product produced?5. Do procedures exist to ensure formal review of compliance with CCPrequirements by qualified individuals prior to release of products intodistribution?HACCP Plan Maintenance1. Is the HACCP plan reviewed by the HACCP Team on an annual basis, orfollowing significant changes to the manufacturing process?2. Does the organization’s change management process include review of theHACCP plans as a potential effect of any proposed changes?3. Does the HACCP plan include a detailed revision log to document anychanges made?4. Is there a process to perform periodic internal audits to ensure compliancewith the established HACCP plans?。
食品配送及仓储企业haccp计划
英文回答:The implementation of a HACCP (Hazard Analysis and Critical Control Points) plan is imperative forpanies involved in food delivery and storage in order to uphold the safety and quality of the products within their purview. This plan necessitates aprehensive scrutiny of potential hazards encountered at each phase of the food delivery and storage process, epassing the stages of receiving, storing, preparing, and transporting. Through this meticulous analysis, critical control points are identified, at which junctures measures can be instituted to preclude, eradicate, or diminish these hazards to levels deemed safe.执行HACCP(危险分析和关键控制点)计划是参与食品运送和储存的当务之急,以维护其职权范围内产品的安全和质量。
这项计划需要对食品运送和储存过程的每个阶段遇到的潜在危险进行综合审查,并跨越接收、储存、准备和运输阶段。
通过这种认真的分析,确定了关键的控制点,在此关头可以采取措施来排除、消除这些危险或将这些危险降低到被认为安全的程度。
The HACCP plan needs to include ways to check if the important steps are working like they should. This might meanusing temperature monitors, doing regular checks, and testing for any bad stuff. And if the checks show that something's not right, the plan should say what to do to fix it. That could be stopping production, changing how things are done, or getting rid of any products that might be affected.协调会的计划需要包括各种办法,以检查重要步骤是否象它们应该做的那样有效。
食品中微生物危害的分析和控制
第5卷 第10期 食品安全质量检测学报 Vol. 5 No. 102014年10月Journal of Food Safety and Quality Oct. , 2014基金项目: 河南省重点科技攻关计划项目(102102310027)Fund: Supported by Henan Province Key Scientific Research Project(102102310027)*通讯作者: 黄继红, 博士, 教授级高级工程师, 主要研究方向为农产品发酵工程。
E-mail: Huangjihong1216@*Corresponding author: HUANG Ji-Hong, Doctor, Senior Engineer, Henan University of Technology Institute of Biological Engineering, Zhengzhou 450001, China. E-mail: Huangjihong1216@食品中微生物危害的分析和控制张新武1, 杜小波2, 徐素玲3, 黄继红1, 2*(1. 河南省食品工业科学研究所, 郑州 450053; 2. 河南工业大学生物工程学院, 郑州 450001;3. 河南省盐产品质量检测中心, 郑州 450003)摘 要: 目前, 食源性疾病的发生和食品产品微生物指标不合格已经成为日益关注的食品问题。
本文主要针对食品中有害微生物的来源、分类、危害度、生长因子进行分析, 介绍了微生物危害识别和暴露识别, 食品微生物危害分析的原则和要素; 探讨了有害微生物的预防和控制方法, 阐述了栅栏技术和Hazard Analysis Critical Control Points (HACCP)系统在食品微生物控制上的运用, 以期对保障食品质量起到促进作用。
关键词: 食品微生物; 危害分析; 防控Analysis and control of microbiological hazards in foodZHANG Xin-Wu 1, DU Xiao-Bo 2, XU Su-Ling 3, HUANG Ji-Hong 1,2*(1. Henan Province Food Industry Research Institute , Zhengzhou 450053, China ;2. College of Biological Engineering , Henan University of Technology , Zhengzhou 450001, China ;3. Salt Product Quality Inspection Center in Henan Province, Zhengzhou 450003, China )ABSTRACT: At present, the occurrence of food-borne diseases and the over standard of microorganism indexhave become a popular concerned problem. This paper analyzed the sources, hazards and growth factors of harmful microorganisms in food, introduced the methods for microbial hazard identification and exposure iden-tification, described the principles and elements of hazards analysis about food microbiology; and discussed the prevention and control methods of harmful microorganisms. It also introduced the application of barriers and Hazard Analysis Critical Control Points (HACCP) system to control food microorganisms, in order to promote the protection of food quality.KEY WORDS: food microbiology; hazards analysis; prevention and control1 引 言食品中的微生物可以分为三大类, 可用于生产的微生物、引起食品变质腐坏的微生物和食源性病原微生物[1]。
WHO偏差处理和质量风险管理-中英文对照版-2013
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质量风险管理实例
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Training 培训
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Conclusions 结论
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Glossary 术语
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References 文献
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10. Acknowledgements 致谢
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1) Purpose 目的
The aim of this guidance document is to contribute to the understanding of a quality risk management approach in the handling of deviations from a practical perspective as per WHO expectations on the matter. This proposal does not have the intent to be prescriptive in any way.
作为全面纠正和预防措施计划的一部分一旦发现偏差就需要立即采取措施即更正必要时确定其根本原因实施系统措施即纠正措施以防止未来相同或类似的不符合项
Deviation Handling and Quality Risk Management
偏差处理和质量风险理
A note for guidance for the manufacture of prequalified vaccines for supply to United Nations agencies
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5.1.5 Purpose of Quality Risk Management 质量风险管理的目
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食品安全复习资料(英语)
英语部分1、Tell the differences between the Traditional approach and HACCP for ensuring safe food.Traditionally, industry and regulators have depended on spot-checks of manufacturing conditions and random sampling of final products to ensure safe food.HACCP: focuses on identifying and preventing hazards from contaminating food, a control approach of food quality from farm to table.2. The main factors for outbreak of foodbrone illness in US between 1970 to 1980.(1)Improper cooling(2)Lapse of 12 or more hours between preparation and eating(3)Contamination by handlers(4)Raw ingredients added without subsequent heating/cooking3. Tell main content s of HACCP principles(1)Analyze hazards.Potential hazards from farm to table , the hazards could be biological, such as a microbe; chemical, or physical items.(2)Identify critical control points.These are points in a food's process from its raw state through processing and shipping to consumption by the consumer at which the potential hazard can be controlled or eliminated. Examples are cooking, cooling, packaging, and metal detection.(3)Establish preventive measures with critical limits for each control point.The preventive measures required to ensure the elimination of any harmful microbes. For a cooked food, for example, this might include setting the minimum cooking temperature and time.(4)Establish procedures to monitor the critical control points.Such procedures might include determining how and by whom preventive measures (cooking time and temperature) should be monitored.(5)Establish corrective actionsEstablish corrective actions to be taken when monitoring shows that a critical limit has not been met--for example, reprocessing or disposing of food if the minimum cooking temperature is not met.(6)Establish procedures to verify that the system is working properlyfor example, testing time-and-temperature recording devices to verify that a cooking unit is working properly. (7)Establish effective recordkeeping to document the HACCP system.This would include records of hazards and their control methods, the monitoring of safety requirements and action taken to correct potential problems. Each of these principles must be backed by sound scientific knowledge: for example, published microbiological studies on time and temperature factors for controlling foodborne pathogens.4. Tell the two of CCP and normal measures in food processCCP1: to ensure control of a hazardHeat process stepsCCP2: to minimize a hazardFreezing and time to freezing before pathogens can multiplyEmployee hygieneThe maintenance of pH of a food product at a level that prevents growth of pathogens5. Tell the some limitations of HACCP(1)Education of nonprofessional food handlers, housewives (in the food service and in homes)(2)the accept of public (processors, inspectors, housewives, service handlers)(3)The different understanding and procedures for setting up CCPs or monitoring such stepsGiving a false assurance to consumers6. The Application of the principles of HACCP(1)Assemble HACCP team(2)Describe products(3)Identify intend use(4)Construct flow diagram: (by the HACCP team)(5)on site verification of flow diagram(6)list all hazards associated with each step and list all preventive measures to control hazards (principle 1) (7)Apply HACCP decision tree to each step (principle 2)(8)Establish target levels and tolerances for each CCP (principle 3)(9)Establish a monitoring System for each CCP (principle 4)(10)Establish Corrective Actions (principle 5)(11)Verification (principle 6)(12)Establish Record Keeping and Documents (principle 7)7. The personnel sanitary practices including(A)Disease control:medical exam., no illness, open lesion, boils, sores, infected wounds, abnormal contamination;(B) Cleanliness:(1)wearing outer garment suitable to the operation;(2)maintaining adequate personal cleanliness;(3)washing hands thoroughly;(4)removing all unsecured jewelry;(5)intact, clean, sanitary gloves with impermeable materials;(6)hairnets, headbands, caps, beard covers, hair restraints;(7)storing clothing, other personnel belonging properly;(8)properly confining the eating foods, chewing gum, drink beverage, or using tobacco;(9)precaution of microorganisms or foreign substances (perspiration, hair, cosmetics, tobacco, chemicals andskin medicines.(C) Education and training for responsible personnelEducation and training for responsible personnel for identifying sanitation failure and food contamination (background of education or experience or a both);(D) Supervision by competent supervisory personnel.8. Requirements of Good Manufacturing Practices for grounds in Food plant(A)Grounds: protecting against the contamination of foods(1)properly storing equipments, removing litter and waste, cutting weed and grass within theimmediate vicinity of the plant building or structures (not constitute attractant, breeding place, or harborage for pests);(2)maintaining the Roads, yards, and park lots cleanly; (3) adequate draining areas; (4)waste treatment and disposal;9. Requirements of Good Manufacturing Practices for Plant construction and design(1)sufficient spaces for placement of equipment and storage materials;(2)proper precaution for food safety control, operating practices, or effective design (location,time, partition, air flow, enclosed system)(3)proper precaution of outdoor bulk fermentation vessels (protective coverings, over and aroundcontrol, checking on a regular basis for pests and pest infestation);(4)construction of floors, walls, ceilings be adequate clean and kept clean and kept in goodrepair ;(5)providing adequate lighting (in hand-washing areas, dressing and locker rooms and toiletrooms and providing safe-type light bulbs, fixtures, skylights or other glass suspended;(6)providing adequate ventilation or control equipment to minimize odors and vapors;(7)provide adequate screening.10. Sanitary operations including(A) General maintenancebuildings, fixtures and other physical facilities: both in sanitary conditions and in repair sufficient,(B) Clean compounds and sanitizing agents and storage of toxic materials(1)Clean compounds and sanitizing agents properly be used and controlled;(2)properly Identifying, holding, storing toxic compounds, sanitizing agents, pesticides,chemicals;(C)Pest control(3)no pest in any area of a food plant and guard or guide dogs care;(4)proper use of insecticides and rodenticides:(D)sanitizing food-contact surface as frequently as necessary(5)sanitized and thoroughly dried holder for low-moisture food;(6)sanitized and clean for wet processing and equipment and utensils(7)cleaning non-food-contact surface as frequently as necessary;(8)single-service articles be properly stored, handled, dispensed, used and disposed;(9)adequate and safe using of sanitizing agents(E)Clean and sanitized portable equipments.Sanitary facilities and controls including11.GMP of water supply and disposal including:(A) Water supply with safe and adequate sanitary quality be sufficient from an adequate source.(B)Plumbing be of adequate size and design and adequately installed and maintained to:(1)Carry sufficient quantities of water;(2)Convey sewage and liquid disposal;(3)Avoiding constitute a sources of contamination;(4)Adequate floor drainage;(5)No backflow and cross-connection between discharge and water supply piping systems(C)Sewage disposal in to an adequate sewage system12 Hand-washing facilities and Sanitary Treatments of Toilet, Rubbish and offal disposal in GMP requirements(1) Toilet disposal be adequate and readily to accessible:(1)Sanitary condition;(2)In good repair;(3)self-closing doors;(4)the doors do not open into the area where food is exposed to airborne contamination(2) Hand-washing facilities be adequate and convenient:(a)Hand-sanitizing facilities at each location in the plant;(b)effective;(c)Sanitary towel service or suitable drying devices;(d)Devices or fixture designed for protecting recontamination of clean sanitized hands;(e)Readily understandable signs; (6) Refuse receptacles in a manner protectingcontamination of foods;(3)Rubbish and offal disposal be conveyed, stored, and disposedRubbish and offal disposal be conveyed, stored, and disposed as to minimize the develop of odor, potential for the waste becoming an attractant or breeding place for pests, and protecting contamination of foods, food contact surfaces, water supply, and ground surfaces. Good manufacture requirement for equipment and utensils13. Requirements of Equipment clean in GMP including:(A)Equipment and utensils to be adequate clean and properly maintained, preclude theadulteration of food with lubricants, fuel, metal fragments, contaminated water, or other contaminants;(B)To facility the cleaning, surface be corrosion-resistant. Seams be smoothly bonded ormaintained for minimizing accumulation of food particles, dirt, and organic matter and the opportunities for growth of microorganisms;(C)Equipments not contact food in the manufacture or food-handling area be of cleanconditions;(D)Holding, conveying, and manufacturing systems be maintained in sanitary conditions;14. Requirements of cooling and Equipment clean in GMP including:(1) Freezer and cold storage compartments be fitted with an indicating thermometer, temperaturemeasuring devices, or temperature recording devices, automatic control and alarm system. (2) Instruments and control (for measuring, regulating or recording temperature, time et.al ) beaccurate and adequately maintained, and adequate in number)(3) Compressed air or other gases be not contaminated for processing.15. Good manufacture requirement for processing and controlsAll operations in receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of foods should be strictly follow the requirements of GMP (Raw materials and other ingredients and process in each step).16、Good manufacture requirement of Raw materials and other ingredients in processingand controls(1)Raw materials be inspected, segregated, and be ascertained in clean and suitable forprocessing. Water used and containers and carriers being not contamination ordeterioration of food.(2)Both raw materials and other ingredients be at low level of microorganisms forhuman (supplier’s guarantee or certification).(3)Raw materials and other ingredients with the level of aflatoxin or other natural toxincomply with FDA regulation and action level for poisonous or deleterioussubstances (supplier’s guarantee or certification or analysis).(4)Raw materials and other ingredients and rework with contamination of pests,undesirable microorganisms, or extraneous materials comply with FDA regulation(supplier’s guarantee or certification or analysis);(5)Bulk and containers for holding raw materials and other ingredients at thetemperature and relative humidity be protecting against contamination;(6)Kept the frozen raw materials and other ingredients in frozen status and thawed in amanner that protects against contamination.(7)Liquid and dry raw materials and other ingredients be received and stored in amanner that protects against contamination.Good manufacture requirement for Manufacturing operation17. GMP requirement for food holding and treatments in Manufacturing operation.(1) Equipment and utensils and container be cleaning and sanitizing.(2) Manufacturing, packaging and storing in condition and control for minimizing the potential for growth of microorganisms or for contamination of food. Careful monitoring the physical factors (time, temperature, humidity, Aw, pH, pressure, flow rate) and manufacturing operations (freezing, dehydration, heat processing, acidification, and refrigeration) for ensuring no decomposition or contamination of food.(3)Holding food that could not support growth of undesirable microorganismsa)refrigerated food at 45 O F (7.2 O C) or below;b)frozen food in frozen state;c)hot food at 140 O F (60 O C);d)Heat treating of canned acid or acidified foods to destroy mesophilic microorganisms;(4) Adequate Measures (sterilizing, irradiating, pasteurizing, freezing, refrigerating, controllingpH or Aw) to destroy or prevent the growth of undesirable microorganisms.(5) Work-in-process protecting contamination;(6) Protecting finished food from contamination by raw materials, other ingredients, or refuse(both be not simultaneously handled);(7) Equipment, container, and utensils during in manner for protecting against contamination;(8) Effective measures (sieves, traps, magnets, electric metal detectors et. al) for inclusion ofmetal or other extraneous materials;(9) Careful disposal, reconditioning or reprocessing of adulterated foods, raw materials and otheringredients;(10) Mechanical manufacturing steps (washing, peeling, trimming, cutting, sorting, and inspecting,mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming) be performed for protecting food against contamination by dripping, draining, or draining;(11) Heating the food to the required temperature and holding time on heat blanching forminimizing thermophilic growth and contamination;18. GMP requirement for high moisture food in Manufacturing operation.(12) Batter, breading, sauces, gravies, dressing and other similar preparation(12-1) ingredients free of contamination;(12-2) adequate heat process;(12-3) adequate time and temperature control;(12-4) adequate physical protection of components by dripping, draining, or draining;(12-5) adequate cooling temperature;(12-6) disposing of batters at appropriate intervals;19. GMP requirement for post treatments (filling, assembling, packaging) in food manufacturing operation.(1) Filling, assembling, packaging, and other preparation:(2) Identified and controlled CCP for Quality control operation;(3) Clean and sanitary food-contact surface and food containers;(4) Safe and suitable materials of food containers and food packaging;(5) Physical protection from contamination (particular airborne contamination);(6) Sanitary holding procedures.20. GMP requirement for low moisture food in Manufacturing operation.(1) Control Aw of dried foods (dry mixes, nuts, intermediate moisture food, dehydrated food)(2) monitoring the Aw of food;(3) Controlling The soluble solids-water ratio in finished food;(4) avoiding moisture pickup; (a moisture barrier).21. GMP requirement for acidified food in Manufacturing operation.(1) A pH of 6.4 or below for acid or acidified food for preventing undesirable microorganisms(2) Monitoring pH;(3) Controlling amount of acid and acidified food added to low-acid food.(22) Natural and unavoidable defects:(A)FDA Maximum level of defects for recommended regulatory action;(B)necessary and feasible defect action level be changeable upon mew technology andavailability of new information;(C)no excuses of violation of the requirement for sanitary conditions and requirement for currentgood manufacturing practices.(D)no mixing of a food containing permit defect level with another lot of food. (e) upon request ofCFSAN and FDA.23. What are the primary sources of microorganisms found in foods?1.Soil and Water;2.Plants and plants products; 3.Food Utensils (食品器具、用具); 4.Intestinal Tract ofHuman and Animals (Gastrointenal Tract); 5.Food handles 食品\烹调生产者; 6. Animal feeds (动物饲料); 7. Animal Hides(动物皮); 8.Air and dust.24. Transmission tracts of bacteria in Soil and Watersoil organisms atmosphere (air) water bodieswind rainsoil organisms (rain water) water bodiesflowAquatic organisms atmosphere (air) soilCloud rainfallSome aquatic organisms (Alteromonas spp.交替单胞菌) are marine water (salinity) required and not persist in soils.25.What’s the concerns for Food handles in food processing step(1) Poor personal hygienic practicesunclean of hands, garments, hair (contamination by soils, waters, dust, other environmental sources) contamination by nasal cavities, mouth, skin, Gastrointenal Tract oh human(2) Unhealthy employee(3) Employee’s education: Employee’s understanding of food safety factors26. What’s the pollution sources of milk by Animal Hides(动物皮)Milk cow (奶牛)---raw milk---the types of organisms found in the raw milk can be a reflection of the flora of the udder---improper proceduresOrganisms in the udder and hides---contaminate the general environment, milk containers, and the hands of the handler27. Requirements for holding food that could not support growth of undesirable microorganismsa)refrigerated food at 45 O F (7.2 O C) or below;b)frozen food in frozen state;c)hot food at 140 O F (60 O C);d)Heat treating of canned acid or acidified foods to destroy mesophilic microorganisms;28. Factors for minimizing the potential for growth of microorganisms or for contamination of food in manufacturing, packaging and storing steps(24-1) Careful monitoring the physical factors (time, temperature, humidity, Aw, pH, pressure, flow rate)(24-2) Careful monitoring the manufacturing operations (freezing, dehydration, heat processing, acidification, and refrigeration) for ensuring no decomposition or contamination of food.29. How to Control Aw of dried foods(26-1) monitoring the Aw of food;(26-2) Controlling The soluble solids-water ratio in finished food;(26-3) avoiding moisture pickup; (a moisture barrier).30. Hazards Analysis should be made in food processing from:1. microbiological hazards (salmonella, S. aureus),2. chemical hazards (e.g. aflatoxin, antibiotic or pesticide residues),3. physical hazard (stone, glass, metal)4. potable water (tap water) in formulating, or handling the food5. Physical characteristics and composition (e.g., pH, type of acidulents, fermentable carbohydrate, water activity, preservatives);6: Procedures for Processing(6.a). Controlled Steps for destroy pathogenic both vegetative cells and spores (heating, pasteurization et.al)(6.b). Recontamination of the products (cross contamination, poor person’s hygienic practices et.al)31. Facility Design of GMP should be concerned about:1. Layout of the facility: separate the ready to eat (end ) products from raw materials.2.Positive air pressure for package area.3.Traffic pattern for people and moving equipments to significant resources of contamination? 32. Equipment Design of GMP should be concerned about:1.Time and temperature control, necessary ?2.Proper size?3.Sufficient for controlling tolerance in various performances?4.Reliable(可靠的)or prone to frequent breakdowns (倾向经常出毛病) ?5.Easy for clean and sanitized ?6.Possible for producing contamination with hazard substances (e.g. glass) ?7.Safety devices: metal detector, magnet, filters, screen, thermometer, deboners, dud (破布) detectors33. Package of GMP should be concerned about:1. Method of package: multiply of microbial pathogens/formation of toxins ?2. Labeled: “keep refrigerated” if is necessary ?3. Instruction for safe handling/preparation4. Package materials for resistance of the entrance of microbial contamination?5. Tamper evident package feature (所装料特性标志:防雨、防钩、防潮等)6. Legible and accurate code7. Proper label34. Intended Consumer for food safety1.General public?2.Population with increased susceptibility (敏感性) to illness (e.g. infants, the aged, the infirmed, immunocompromised individuals)35.Environmental Needs of BacteriaTemperature and TimepH (AcidityWaterAir36. Intrinsic parameters of foods that affect microbial growth1.pH2.Moisture contents3.Oxidation---reduction potential (Eh)4.Nutrient content5.Antimicrobial constituents6.Biological structures37. Extrinsic parameters1.Temperature of storage2.Relative humidity of environment3.Presence and concentration of gases in the environment.38.Drying methods:Sun drying: fruit such as grapes, prunes(李子), apricots(杏仁), figs(无花果)===needs a large of space for a large of quanties of products.Commercial methods: spray, drum, evaporation, freeze-drying.39.Water Activity (aw) in the environment:Aw =p/p0p: vapor pressure of pure solutionp0 :vapor pressure of pure solvent (usually water)R.H. (relative humidity)=100 x awa w指相同温度下,食品的水蒸汽压P和纯水的蒸汽压P0之比。
Barriers 020123c-贩
Team Name:
NO. 障碍(Barriers) 预测计划需要改进 A Forcast - 1 plan needs to be improved 需要一个经过更新的供应商评估流程 B Need - 2 an updated supplier evaluation process 需建立一份经过更新的合格供应商名单 C Need - 2.1 an updated Qualified Supplier List 针对新的供应商的加入,需要一个经过更新的供应商评估流程 Need an updated evaluation process to allow new Suppiers to be D approved - 2.2 需建立一个评估流程,进而强化同供应商的关联 Need to develop an evaluation process in order to enforce the association E -with 2.3 our suppliers 采购周期时间太长 F The - 3 Purchasing Cycle Time is too long / Supplier Lead Time 制定计划周期时间太长 G The - 4Cycle Time for making plan is too long Date: 影响 力 难度 Impa Di.30 #### 4.90
#### 5.00
#### 4.00
#### 4.30 #### 5.30
#### 5.50
原材料和成品库需清洁且有条理化 Raw Material and Finished Goods Warehouse needs to be cleaned and to H be - well 5 organized 5.1 需培训仓库职员并有明确的工作职责 Warehouse staff need training and know their working responsibility 5.1 clearly. 5.2 库存不准确 The - 5.2 inventory is not accurate (raw material) 部分国外采购原材料的供应商来源单一 Overseas supplier for supplying some materials - single source. - 6 产成品质量需要提高 Quality - 7 for Finished Goods needs to be improved 用于生产的原材料需改进 The Raw Materials needed for production needs to be improved. - 7.1 需回顾并更新各项标准 -Each 7.2 standard needs to be reviewed and updated. 沟通与职责 -Communicaton 8 and Responsibility 确立恒安与供应商之间的战略 Establish - 8.1 a strategy between HengAn and our Suppliers 确立恒安与顾客之间的战略 Establish - 8.2 a strategy between HengAn and our Suppliers
洁净词汇中英文对照
GMP英语PIC/S的全称为:Pharmaceutical InspectionConvention/Pharmaceutical Inspection Cooperation Scheme, PIC/S(制药检查草案), 药品检查协会(PIC/S) ,也有人称PIC/S为医药审查会议/合作计划(PIC/S)PIC的权威翻译:药品生产检查相互承认公约API(Active Pharmaceutical Ingredient) 原料药又称:活性药物组分Air Lock 气闸Authorized Person 授权人Batch/Lot 批次Batch Number/Lot-Number 批号;Batch Numbering System 批次编码系统;Batch Records 批记录;Bulk Product 待包装品;Calibration 校正;Clean area洁净区;Consignment(Delivery)托销药品。
FDA(FOOD AND DRUG ADMINISTRATION):(美国)食品药品管理局IND(INVESTIGATIONAL NEW DRUG):临床研究申请(指申报阶段,相对于NDA而言);研究中的新药(指新药开发阶段,相对于新药而言,即临床前研究结束)NDA(NEW DRUG APPLICATION):新药申请ANDA(ABBREVIATED NEW DRUG APPLICATION):简化新药申请TREATMENT IND:研究中的新药用于治疗ABBREVIATED(NEW)DRUG:简化申请的新药DMF(DRUG MASTER FILE):药物主文件(持有者为谨慎起见而准备的保密资料,可以包括一个或多个人用药物在制备、加工、包装和贮存过程中所涉及的设备、生产过程或物品。
只有在DMF持有者或授权代表以授权书的形式授权给FDA,FDA在审查IND、NDA、ANDA时才能参考其内容)HOLDER:DMF持有者CFR(CODE OF FEDERAL REGULATION):(美国)联邦法规PANEL:专家小组BATCH PRODUCTION:批量生产;分批生产BATCH PRODUCTION RECORDS:生产批号记录POST-OR PRE- MARKET SURVEILLANCE:销售前或销售后监督INFORMED CONSENT:知情同意(患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验)PREscriptION DRUG:处方药OTC DRUG(OVER—THE—COUNTER DRUG):非处方药GMP文件常见缩写ABPI Association of the British Pharmaceutical Industry ADR Adverse Drug Reaction AE Adverse EventAIM Active Ingredient ManufacturerANDA Abbreviated New Drug ApplicationANOVA Analysis of VarianceASM: Active Substance ManufacturerATC Anatomical Therapeutic ChemicalATX Animal Test Exemption CertificateBAN British Approved NameBIRA British Institute of Regulatory AffairsBNF British National FormularyBP British PharmacopoeiaC of A Certificate of AnalysisC of S Certificate of SuitabilityCENTRE FOR DRUG EVALUATION (CDE)Centre for Pharmaceutical Administration (CPA)CMS Concerned Member State CMS每个成员国COS Certificate of SuitabilityCPMP Committee for Proprietary Medicinal Products CRA Clinical Research AssociateCRF Case Report FormCRO Contract Research OrganizationCTA Clinical Trial ApplicationCTC Clinical Trial CertificateCTD Common Technical documentCTX Clinical Trials ExemptionDDD Defined Daily DoseDGC Daily Global ComparisonDIA Drug Information AssociationDMF Drug Master FileDrug Registration Branch (DR, Product Evaluation & Registration Division, CPAEDQM (European Directorate for the Quality of Medicines) 欧洲联盟药品质量指导委员会EEA 欧洲经济地区EGMA European Generics Medicine AssociationELA Established License ApplicationEMEA European Medicines Evaluation AgencyEMEA (European Agency for the Evaluation of Medicinal Products)欧洲联盟药品评价机构EP European PharmacopoeiaEPAR European Public Assessment ReportsESRA European Society of Regulatory AffairsEuropean Pharmacopoeia Commission 欧洲药典委员会FDAFDA Food and Drug AdministrationFinal Evaluation Report (FER)Free Sale Certificates (FSCs)GCP Good Clinical Practice GCP药品临床研究管理规范GLP Good Laboratory PracticeGLP 药品临床前安全性研究质量管理规范GMP Good Manufacturing PracticeGMP 药品生产质量管理规范GSP药品销售管理规范Health Sciences Authority (HSA)HSA’s Medicines Advisory Committee (MAC)IB Investigators BrochureICH International Conference for Harmonization IDMC Independent Data-Monitoring CommitteeIEC Independent Ethics CommitteeIND Investigational New DrugINN International Non-proprietary Name International Conference on Harmonization (ICH) IPC In Process ControlIRB Institutional Review BoardLICENCE HOLDERMA Marketing AuthorizationMAA Marketing Authorization ApplicationMAA上市申请MAH Marketing Authorization HolderMAH 销售许可持有者MCA Medicines Control AgencyMHW Ministry of Health and Welfare (Japan)MR Mutual RecognitionMRA 美国与欧盟的互认协议MRAs (Mutual Recognition Agreements) 互相認證同意MRFG Mutual Recognition Facilitation GroupMRP Mutual Recognition ProcedureNAS New Active SubstanceNCE New Chemical EntityNDA New Drug ApplicationNew Chemical Entities (NCEs)New Drug Applications (NDAs)NSAID Non Steroidal Anti Inflammatory DrugNTA Notice To ApplicantsOOS Out of SpecificationOTC Over the CounterPAGB Proprietary Association of Great BritainPh Eur European PharmacopoeiaPIL Patient Information LeafletPL Product License POM Prescription Only MedicinePRODUCT OWNERPSU Periodic Safety UpdatesQA Quality AssuranceQC Quality ControlRAJ Regulatory Affairs JournalRMS Reference Member StateRMS相互认可另一成员国RSD Relative Standard DeviationRx Prescription OnlySAE Serious Adverse EventSMF Site Master FileSOP Standard Operating ProcedureSOP (STANDARD OPERATION PROCEDURE)标准运作程序SPC Summary of Product CharacteristicsTherapeutic Goods Administration (TGA)USP US PharmacopoeiaVMF Veterinary Master FileVPC Veterinary Products CommitteeA.A.A Addition and Amendments 增补和修订AC Air Conditioner 空调器ADR Adverse Drug Reaction 药物不良反应AFDO Association of Food and Drug Officials食品与药品官员协会(美国)ACC Accept 接受AQL Acceptable Quality Level 合格质量标准ADNA Abbreviated New Drug Application 简化的新药申请BOM Bill of Material 物料清单BPC Bulk pharmaceutical Chemicals 原料药CBER Center for Biologics Evaluation Research生物制品评价与研究中心CFU Colony Forming Unit 菌落形成单位DMF Drug Master File 药品管理档案CDER Center for Drug Evaluation and Research药物评价与研究中心CI Corporate Identity (Image) 企业识别(形象)CIP Cleaning in Place 在线清洗CSI Consumer Safety Inspector 消费者安全调查员CLP Cleaning Line Procedure 在线清洗程序DAL Defect Action Level 缺陷作用水平DEA Drug Enforcement Administration 管制药品管理DS documentation System 文件系统FDA Food and Drug Administration食品与药品管理局(美国)GATT General Agreement on Tariffs and Trade关贸总协会GMP Good Manufacturing Practice 药品生质量管理规范GCP Good Clinical Practice 药品临床实验管理规范GLP Good Laboratory Practice 实验室管理规范GSP Good Supply Practice 药品商业质量规范GRP Good Retail Practice 药品零售业质量管理规范GAP Good Agriculture Practice 药材生产管理规范GVP Good Validation Practice 验证管理规范GUP Good Use Practice 药品使用规范HVAC Heating Ventilation Air Conditioning空调净化系统ISO International Organization for Standardization 国际标准化组织MOU Memorandum of Understanding 谅解备忘录PF Production File 生产记录用表格OTC Over the Counter (Drug) 非处方药品PLA Product License Application 产品许可申请QA Quality Assurance 质量保证QC Quality Control 质量控制QMP Quality Management Procedure 质量管理程序SDA State Drug Administration 国家药品监督管理局SMP Standard Management Procedure 标准管理程序SOP Standard Operating Procedure 标准操作程序TQC Total Quality Control 全面质量管理USA United States Pharmacopoeia 美国药典质检专业术语1. 认可的实验室 accredited laboratory2. 提前装运通知 advanced shipment notification (ASN)3. 基准确定 benchmarking4. 经营计划 business plan5. 计算机辅助设计 computer aided design (CAD)6. 计算机辅助工程 computer aided engineering (CAE)7. 校准 calibration8. 应急计划 contingency plan9. 持续改进计划/方案continuous improvement plan/program10. 合同 contract11. 控制计划 control plan12. 纠正措施计划 corrective action plan13. 不良质量成本 cost of poor quality14. 横向职能方法 cross-functional approach15. 装配性设计 design for assembly (DFA)16. 实验设计 design of experiment (DOE)17. 设计纪录 design record18. 设计责任供方 design-responsible suppliers 19. 文件document ation20. 安全关注 due care21. 设备 equipment22. 工程批准的授权engineering approved authorization23. 执行职责 executive responsibility24. 有限元分析 finite element analysis (FEA)25. 可行性 feasibility26. 先进先出 first in first out (FIFO)27. 失效模式及后果分析failure mode and effects analysis (FMEA)28. 功能验证 functional verification29. 几何尺寸与公差geometric dimensioning & tolerancing (GD&T)30. 作业指导书 job instruction31. 实验室 laboratory32. 实验室范围 laboratory scope33. 末件比较 last off part comparison34. 全尺寸检验 layout inspection35. 防错 mistake proofing36. 多方论证方法 multi-disciplinary approach37. 运行业绩 operational performance38. 预见性维护 predictive maintenance39. 超额运费 premium freight40. 预防性维护 preventive maintenance41. 解决问题 problem solving42. 程序 procedures43. 过程审核 process audit44. 过程流程图 process flow diagram flow chart45. 产品 product46. 产品实现 product realization47. 产品审核 product audit48. 项目管理 project management49. 质量功能展开 quality function deployment (QFD)50. 质量手册 quality manual51. 反应计划 reaction plan52. 外部场所 remote location53. 重复性和再现性研究repeatability and reproducibility studies54. 现场 site55. 特殊特性 special characteristics56. 分承包方 subcontractor57. 分承包方的开发 subcontractor development58. 供方 supplier59. 投标 tender60. 工具/工装 tool/tooling更衣室 Changing Room一更 First Changing Room手消室 Hands Disinfection Room气闸室 Airlock Room洁具室 Cleaning Tools Room清洗室 Cleaning Room模具室 Dies Room内包装室 Immediate Package Room安全门 Emergency Door外包清室Outer Package Removing Room存料间Storage Room of Raw Materials粉碎室 Pulverizing Room备料室 Materials Preparing Room硬胶室 Hard Capsules Filling Room软胶室 Soft Capsules Room制粒干燥室Granulating and Drying Room总混间 Blending Room中间站 Intermediate Station压片室Tablets Room Compression Room包衣室 Coating Room配浆间 Coating Mixture Preparing Room铝塑包装间Packing Room传递窗 Transferring Window外包装室 Outer Packing Room蒸馏水室 Water Purifying Room质检室 Quality Control Room浓配室 Concentrated Solution Room稀配室 Diluted Solution Room灌封室Filling and Sealing Room存瓶室 Ampul Storage Room洗瓶室 Ampul Cleaning Room灭菌间 Sterilizing Room灯检室 Light Inspection Room粉针室 Lyophilized Sterile Powder Room冷冻干燥机 LyophilizerUrine Analyzer 尿液分析仪blood sugar(glucose ) analyzer血糖分析仪test strip 测试条reagent 试剂Semi-automatic Biochemical Analyzer半自动生化分析仪Automatic Blood Cell Analyzer全自动血细胞分析仪Urine sediments analyzer尿沉渣Bio-safety Cabinet 生物安全柜Incubator培养箱High Frequency Electrotome 高频电刀shadowless lamp无影灯High speed refrigerated centrifuge高速冷冻离心机hot air sterilizer热空气消毒箱microbiological incubator微生物培养箱Halogen light 卤素灯disposable sterile injector 一次性无菌注射针injection set注射器disposable venous infusion needle一次性静脉输液针disposable infusion set 一次性使用输液器blood transfusion set输血器infusion bag液袋urine drainage bag集尿袋blood bag血袋medical catheter医用导管stainless steel needle不锈钢医用针管blood taking needle采血针needle destroyer针头销毁器automatic packer自动纸塑包装机scalp vein set头皮针uniprocessor version单机版network version网络版macromolecule-solvent 高分子溶解的macromolecule cold accumulation 高分子蓄冷cold treatment冷疗法ice pack冰袋eyeshade 眼罩Medical injection pump医用灌注泵lithotrite 碎石机extracorporeal shock wave lithotrite体外冲击碎石机Ballistic intracroporeal lithotrite气压冲击体内碎石机Laparoscope 腹腔镜Urology 泌尿外科kidney stones 肾结石Multi-parameter monitor, 多参数监护仪maternal monitor/fetal monitor母亲/胎儿监护仪ICU monitor 重症监护仪anesthetic equipment 麻醉机respirator呼吸机electronic colposcope 电子阴道镜smog absorber烟雾吸收器digital film room 数字胶片室Permanent Magnet Open Magnetic Resonance system 永磁开放式磁共振系统Ultrasonic Color Doppler Diagnostic system彩色超声多普勒诊断系统Mobile CT system 移动CT系统X-ray Mammary Machine 乳腺X线机Mammography乳腺high precision Stereotaxic 高精度脑立体定向仪portable Type-B ultrasonic 便携式B超Sterilization and Disinfection Equipment消毒灭菌设备Radiotherapeutic equipment.放射疗法设备pharmaceutical equipments.制药设备horizontal pressurized steam sterilizer普通卧式压力蒸汽灭菌器medical electronic linear accelerator医用电子直线加速器high frequency X-rays diagnostic machine高频X射线诊断机simulated positioner模拟定位机high frequency mobile X-rays machine高频移动X射线机暖通专业词汇中英文对照(一)ahu air hundling unit 空调箱air conditioning load空调负荷air distribution气流组织air handling unit 空气处理单元air shower 风淋室air wide pre.drop空气侧压降aluninum accessaries in clean room 洁净室安装铝材as-completed drawing 修改竣工图ayout 设计图blass stop valve 铜闸阀canvas connecting termingal 帆布接头centigrade scale 摄氏温度chiller accessaries 水冷柜机排水及配料chiller asembly 水冷柜机安装工费chiller unit 水冷柜机基础clean bench 净化工作台clean class 洁净度clean room 洁净室无尘室correction factor修正系数dcc dry coll units 干盘管district cooling 区域供冷direct return system异程式系统displacement ventilation置换通风drawn No.图号elevation立面图entering air temp进风温度entering water temp进水温度fahrenheit scale 华氏温度fan coil unit 风机盘管ffu fan filter units 风扇过滤网组final 施工图flow velocity 流速fresh air supply 新风供给fresh air unit 新风处理单元ground source heat pump地源热泵gross weight 毛重heating ventilating and air conditioning供热通风与空气调节hepa high efficiency pariculate air 高效过滤网high efficiency particulate air filters高效空气过滤器horizontal series type水平串联式hot water supply system生活热水系统humidity 湿度hydraulic calculation水力计算isometric drawing轴测图leaving air temp 出风温度leaving water temp出水温度lood vacuum pump中央集尘泵mau make up air hundling unit schedule 外气空调箱natural smoke exhausting自然排烟net weight 净重noise reduction消声nominal diameter 公称直径oil-burning boiler燃油锅炉one way stop peturn valve 单向止回阀operation energy consumption运行能耗pass box 传递箱particle sizing and counting method 计径计数法Piping accessaries 水系统辅材piping asembly 配管工费plan 平面图rac recirculation air cabinet unit schedule循环组合空调单元ratio controller 比例调节器ratio flow control 流量比例控制ratio gear 变速轮 ratio meter 比率计rational 合理性的,合法的;有理解能力的rationale (基本)原理;原理的阐述rationality 有理性,合理性rationalization proposal 合理化建义ratio of compression 压缩比ratio of expansion 膨胀比ratio of run-off 径流系数ratio of slope 坡度ratio of specific heat 比热比raw 生的,原状的,粗的;未加工的raw coal 原煤 raw cotton 原棉raw crude producer gas 未净化的发生炉煤气raw data 原始数据raw fuel stock 粗燃料油raw gas 未净化的气体real gas 实际气体realignment 重新排列,改组;重新定线realm 区域,范围,领域real work 实际工作ream 铰孔,扩孔rear 后部,背面,后部的rear arch 后拱rear axle 后轴rear-fired boiler 后燃烧锅炉rear pass 后烟道rearrange 调整;重新安排[布置]rearrangement 调整,整顿;重新排列[布置] reason 理由,原因;推理reasonable 合理的,适当的reassembly 重新装配reaumur 列氏温度计reblading 重装叶片,修复叶片recalibration 重新校准[刻度]recapture 重新利用,恢复recarbonation 再碳化作用recast 另算;重作;重铸receiving basin 蓄水池receiving tank 贮槽recentralizing 恢复到中心位置;重定中心;再集中receptacle 插座[孔];容器reception of heat 吸热recessed radiator 壁龛内散热器,暗装散热器recharge well 回灌井reciprocal 倒数;相互的,相反的,住复的reciprocal action 反复作用reciprocal compressor 往复式压缩机reciprocal feed pump 往复式蒸汽机reciprocal grate 往复炉排reciprocal motion 住复式动作reciprocal proportion 反比例reciprocal steam engine 往复式蒸汽机reciprocate 往复(运动),互换reciprocating 往复的,来回的,互相的,交替的reciprocating ( grate ) bar 往复式炉排片reciprocating compressor 往复式压缩机reciprocating condensing unit 往复式冷冻机reciprocating packaged liquid chiller往复式整体型冷水机组reciprocating piston pump 往复式活塞泵reciprocating pump 往复泵,活塞泵reciprocating refrigerator 往复式制冷机recirculate 再循环recirculated 再循环的recirculated air 再循环空气[由空调场所抽出,然后通过空调装置,再送回该场所的回流空气]recirculated air by pass 循环空气旁路recircilated air intake 循环空气入口recirculated cooling system 再循环冷却系统recirculating 再循环的,回路的recirculating air duct 再循环风道recirculating fan 再循环风机recirculating line 再循环管路recirculating pump 再循环泵recirculation 再循环recirculation cooling water 再循环冷却水recirculation ratio 再循环比recirculation water 再循环水reclaim 再生,回收;翻造,修复reclaimer 回收装置;再生装置reclamation 回收,再生,再利用reclamation of condensate water蒸汽冷凝水回收recombination 再化[结]合,复合,恢复recommended level of illumination 推荐的照度标准reconnaissance 勘察,调查研究record drawing 详图、大样图、接点图recording apparatus 记录仪器recording barometer 自记气压计recording card 记录卡片recording facility 记录装置recording liquid level gauge 自动液面计recording paper of sound level 噪声级测定纸recording pressure gauge 自记压力计recording water-gauge 自记水位计recoverable 可回收的,可恢复的recoverable heat 可回收的热量recoverable oil 可回收的油recoverable waster heat 可回收的废热recovery plant 回收装置recovery rate 回收率relief damper 泄压风门return air flame plate回风百叶。
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Barriers of HACCP team members to guideline adherenceMa.Patricia V.Azanza *,Myrna Benita V.Zamora-LunaDepartment of Food Science and Nutrition,College of Home Economics,University of the Philippines,Diliman,Quezon City 1101,PhilippinesReceived 29September 2003;received in revised form 9October 2003;accepted 9October 2003AbstractA cognitive-behavior model to evaluate barriers to HACCP guideline adherence by HACCP team members was developed.It was based on the theory of experiential learning where knowledge,attitude and behavior must be sequentially overcome.Twenty-seven HACCP team members from four food processors participated to assess barriers to guideline adherence.Non-awareness to HACCP guideline was a major barrier.The national government was recognized as key source of HACCP -mitment to adopt HACCP guideline was established.Also,the need for food processor management to understand that teams must be multidisciplinary to ensure guideline adherence has been established.Ó2004Elsevier Ltd.All rights reserved.Keywords:HACCP guideline;Barrier model;Adherence1.IntroductionHazard analysis critical control point (HACCP)is a food safety tool that is more recently advocated by international and national regulatory institutions as either voluntary or mandatory prescription to food processing (Gilling,Taylor,Kane,&Taylor,2001;Suwanrangsi,2000;Taylor,2001;Torres,2000;Wallace &Williams,2001).These recent advocacy efforts to propel HACCP implementation are now in fact over-whelmingly evident in most food safety government programs.Despite the orchestrated efforts of inter-national institutions like Codex Alimentarius Commis-sion (CAC)to drum up HACCP awareness and compliance,only food industries in more developed countries are currently apt to immediately implement this food safety tool.The Philippine government,as signatory of the General Agreement on Tariffs and Trade Uruguay Round Final Act,and now as member nation of World Trade Organization,abides by the provisions of the Treaty including the Agreement on the Application of Sanitary and Phytosanitary Measures (SCRA,1997).Under this Agreement,the Philippine government isencouraged to harmonize its national food safety mea-sures with international standards,guidelines and rec-ommendations developed by international regulatory agencies,primarily the CAC.The HACCP guideline has been recommended by CAC as part of its revised guidelines on the General Principles of Food Hygiene as early as 1993(Fogden,2000).In a memorandum from the Office of the President of the Philippines,Mal-aca ~nang,Philippines to the secretaries of various con-cerned food regulatory agencies and its affiliates,a directive was issued pertaining to the accreditation program for food processors that stipulates that Good Manufacturing Practices (GMP)and HACCP be the underlying systems for processing of safe foods for ex-port (Ramos,1997).Although large-scale food processing establishments have been identified as key players in Philippine econ-omy,micro-to small-scale establishments still have a significant contribution to the viability of the food economy sector.The smaller food industries in this country are numerous as a result of chronic national economic problems,which is further aggravated by the more recent political turmoils (Marfil &Pablo,2002;Pablo,Javellana,&Marfil,2002).Prompting the underdeveloped food industry sectors towards HACCP guideline awareness,implementation and adherence tends to be more difficult because these industries are reported to be ill-equipped with the required industry intrinsic support system to attain it (Taylor,2001).*Corresponding author.Tel.:+632-920-5301;fax:+632-926-1449/926-2813/920-5473/920-2091.E-mail address:ma_patricia.azanza@.ph (Ma.P.V.Azanza).0956-7135/$-see front matter Ó2004Elsevier Ltd.All rights reserved.doi:10.1016/j.foodcont.2003.10.009Food Control 16(2005)15–22/locate/foodcontLikewise,these less developed industries are less likely to invest in HACCP knowledge acquisition.Problems in guideline adherence by underdeveloped food industries have been reported to be partly miti-gated by understanding in-depth of the specific barriers to compliance(Cabana et al.,1999;Gilling et al.,2001). Utilizing the behavioral adherence model for technical barrier assessment for specific food industry has been reported previously to facilitate identification of appropriate intervention strategies for HACCP adher-ence(Gilling et al.,2001).The HACCP plan implementation is generally vested upon the efforts of a team in an establishment rather than on the commitment of a single individual.This study for thefirst time,evaluated HACCP guideline adherence barriers specific to HACCP team members of micro-to small-scale beverage and meat processors. Baseline information established in this study could facilitate HACCP implementation in the local micro-to small-scale food processing industries thru the under-standing of barriers to guideline adherence.2.Materials and methods2.1.Cognitive-behavior barrier model to HACCP guide-line adherenceThe study developed a cognitive-behavior barrier model to HACCP guideline adherence for individuals comprising the HACCP team(Fig.1).The model was established by consolidating various concepts from similar models used in assessing physician adherence to medical guideline(Cabana et al.,1999;Pathman,Kon-rad,Freed,Freeman,&Koch,1996)and food industry adherence to HACCP guideline(Gilling et al.,2001).16Ma.P.V.Azanza,M.B.V.Zamora-Luna/Food Control16(2005)15–22Briefly,the consolidated model divided the major bar-rier categories into knowledge,attitude and behavior. Subcategories of these general barriers included aware-ness,familiarity and comprehension for knowledge while the subcategories for attitude major barrier com-prised of agreement and commitment.Adoption and adherence were the subcategories for the last major barrier,behavior.The study further classified each subcategory into themes of barriers as industry intrinsic or extrinsic factors.The research proponents formulated working definitions included in the consolidated model through a series of brainstorming sessions.2.2.Survey of respondentsThe survey to assess the barriers to HACCP guideline adherence specific to HACCP team members of micro-and small-scale food processors was conducted as part of2research projects aimed to develop HACCP plans for these industries.Participating small-scale food pro-cessing industries were defined based on the amended Philippine Magna Carta for Small Scale Enterprises (Republic Act8289).Micro-scale industries were busi-ness establishments having a capital outlay of6US $30,000(PhP1.5M),excluding the cost of land where the plant and equipment are located,whereas small-scale industries have>US$30,0006$300,000(6PhP15 M).The respondents of the survey were recruited from HACCP team members of participating industries in the two earlier mentioned studies.Communications were made to HACCP team mem-bers from small-scale meat processors from Pampanga (n¼16)and micro-to small-scale beverage processors of the National Capital Region and Region4(n¼48), Philippines to recruit survey respondents.The names of government-registered beverage and meat processors were obtained from the Department of Trade and Industry,Bureau of Food and Drug,and Local Gov-ernment Units.Additional names of food processors were also obtained from professional organizations including Pampanga Association of Meat Processors and Foundation of Food Science and Technology,Inc. The names of unregistered processors,referred by other processors and vendors encountered in the test areas were also included in the lists.The modes of commu-nication used to recruit participants were through the following,used either singly or in combination:elec-tronic and ordinary mails,field visits,or telephone calls. Amongst those who responded positively to the recruitment phase of the survey were two HACCP team members of processors per test industry.2.3.The HACCP technical barrier surveyA questionnaire was designed based on the developed cognitive-behavior barrier model to HACCP principle adherence(Fig.1)for members of the HACCP teams. Briefly,it included questions on demographics and, levels of knowledge,attitude and behavior barriers of respondents to HACCP guideline.The survey tool in-cluded some questions with multiple choices for the answers and other open-ended queries(Table1).For awareness and familiarity of HACCP guideline under the knowledge major barrier,the interrogative pro-nouns:when,from whom and where were used to query about pertinent HACCP knowledge information. Questions on accessibility and adequacy of HACCP information were likewise included under the knowl-edge barrier category.The role of external sources of HACCP information including government,media, consumer,market and technical consultants in the adoption of the guideline were likewise asked.The capability of individual members to sustain guideline implementation was placed under the adherence major barrier.Follow-up questions were used to fully elucidate details of some unclear responses.The HACCP team members were individually asked to respond to the questionnaire using the face-to-face narrative interview technique.The interview was con-ducted by the research proponents who read each of the questions aloud during the interview.Respondents were given adequate time to answer each query in writing. Questions were translated to the appropriate regional dialects to which survey respondents were more familiar with when necessary.Results of the study were tabu-lated.Frequency and percentage distributions were calculated(Gatchalian,1989).3.Results and discussion3.1.Cognitive-behavior barrier model to HACCP guide-line adherenceThe developed cognitive-behavior barrier model to HACCP guideline adherence in the study(Fig.1)was modified from similar guideline adherence models gen-erated by Pathman et al.(1996)and Cabana et al.(1999) for medical guidelines,and Gilling et al.(2001)for HACCP guideline.The ladderized barrier concept for evaluation of knowledge,attitude and behavior in guideline adherence as presented by both Cabana et al. (1999)and Gilling et al.(2001)was adopted in this new developed model as general barrier categories.The generated working definitions for the general barrier categories included:knowledge as a body of acquired facts;attitude as mental reaction to knowledge;and behavior as the action taken as a result of knowledge acquisition and attitude development.It was hypothesized in the developed barrier model for HACCP guidance adherence that the HACCP team member designate mustfirst become aware,and beMa.P.V.Azanza,M.B.V.Zamora-Luna/Food Control16(2005)15–2217exposed to the guideline at least more than once before comprehension is attained.Having full understanding of the principles,the team member was assumed to develop the proper attitude which may subsequently lead to agreement and commitment.Such attitude was expected to cause a change in behavior through adoption and finally adherence to the guideline.However,it was ex-pected that HACCP knowledge acquisition alone could not ensure HACCP guideline compliance.Gilling et al. (2001)reported that right attitude should be supported by the appropriate industry intrinsic and extrinsic environmental factors to facilitate HACCP compliance (Fig.1).3.2.Profile of HACCP team members respondentsThe HACCP team member respondents of the study belonged to micro-to small-scale industries(Table2).It has been previously reported that micro-to small-scale food industries are generally not in the position to implement the HACCP guideline due to their small company size,lack of technical expertise and training, rapid turnover of trained personnel,and lack of appropriate resources support prerequisites to HACCP guideline adherence(Panisello&Quantick,2001;Tay-lor,2001;Torres,2000).The CAC and World Health Organization(WHO)fortunately,in its effort to address the unique needs of the small and less developed food processing industries,sponsored the development of fundamental strategies for implementing HACCP in these level of industries(WHO,1999).However,the formal schemes to facilitate the actual implementation of the strategies for underdeveloped food businesses are yet to be fully realized.The survey respondents belonged to HACCP teams comprising of4–10members representing various work divisions in their companies(Table2).Ideally,HACCP team members should be multidisciplinary consisting of individuals who have the appropriate technical skills and expertise about the product and its processes(NAC-Table1Details of survey tool used to determine technical barriers of HACCP team members to HACCP guideline adherenceBarrier Subcategories Survey itemsKnowledge AwarenessA body of acquired facts First heard or read about the guideline When have youfirst heard or read about theHACCP guideline?•Now•Last6months•Last year•Last2years•Last3years or moreFamiliarityDenotes fuller knowledge based on continues awareness but still without complete under-standing of the essence of the guideline as they were originally designed Are you able to use the term HACCP and its related concepts in casual discussions?If yes, cite specific situations.ComprehensionDenotes familiarity with the guideline with full understanding,proximate to the essence of the concept as it was originally designed What is the impact of the HACCP guideline implementable to the operations of your company?Attitude AgreementMental reaction to knowledge Belief in the HACCP guideline,in general orsome parts of it To what extent do you agree with the HACCP guideline?•Full/in general•Partial•Not at allCommitmentPledge to adopt the guideline Are you willing to pledge to adopt theHACCP guideline in your line of work? Behavior AdoptionAction taken as a result of knowledge acquisition and attitude developmentPutting the guideline into action,change inpracticeAre you willing to put the HACCP guidelineinto action?•Yes•NoAdherenceSustained adoption Do you think as a member of your company,you can sustain the implementation of theHACCP guideline in your line of work?Briefly explain your answer18Ma.P.V.Azanza,M.B.V.Zamora-Luna/Food Control16(2005)15–22MCF,1999).Unfortunately,majority of the members of the HACCP teams from the two participating meat processors essentially came from similar work sectors. The HACCP team member respondents from1meat processor were all quality control officers,while the team from the other meat processor was constituted with mostly line workers.The apparent inappropriate con-stitution of the meat HACCP teams may have been mainly based on the decision of their respective man-agements.The organizational set-up of the micro-and small-scale processing industries are not complex and major decisions are traditionally the unilateral respon-sibility of the management rather than any other sector of the company.The sectoral skewdness of the group composition for the HACCP teams for meat processors lends itself to a limited perspective and lack of technical expertise to all significant aspects of the product and its processes that might be pertinent to the HACCP plans.The memberships of the beverage HACCP teams were more appropriately assembled as multidisciplinary groups.The respondents from HACCP teams of the beverage industries were from various disciplines including personnel from:the research and develop-ment,production,quality control and,sales and mar-keting.The multidisciplinary membership of the beverage HACCP teams might not be again based on the critical view of the responsible management on the appropriate constitution of the teams but rather more as a consequence of the diminutive nature of the company. Choice of the HACCP team members was quite limited in the participating beverage processors considering the very small employment numbers which were composed of5–18workers only(Table2).The educational background of HACCP team mem-bers was quite diverse.There were those who completed tertiary education.Others,however,were only able to have vocational training and some primary education. For those teams consisting of mostly undereducated members,technical difficulties in acquiring knowledge and transposing these into implementable activities might be encountered.The apparent educational inad-equacy of some of the members of the teams might beTable2Profile of HACCP team member survey respondents coming from meat and beverage industriesFood industry profile Teammember(n)Category distribution(%)aGender Position in theestablishmentHighest educational levelMeat industry1.Meat processor small scale,30y operational,100workers,2shifts/d(8h/shift),2tnitrite-cured meat production/dFemale90Research andDevelopmentOfficer10Tertiary level8010Male10Quality controlofficer80Food Technology andNutritionManagementEducationComputer Science andEngineeringDraftsman10Secondary level10Vocational(i.e.Secretarial)102.Meat processor small scale,operational for30yrs,employed100workers,2shifts/d(8h/shift),2production/d t nitrite-cured meatFemale50Supervisor12Secondary level80 8Male50Line Worker88VocationalComputer TechnologySecretarial20Beverage industry1.Beverage processor micro-scale,12y operational,18workers,2200cup production/d(300ml cup),500bottle production/d(500ml bottle) young coconut juiceFemale50Owner25Masters level(i.e.Child Psychology)254Male50Supervisor75Tertiary levelBusiness AdministrationHotel and RestaurantManagement752.Beverage processor b micro-scale,10y operational,5workers,300 cup production/d young coconut juice(300ml cup)5Female60Supervisor20Primary level60 Male40Line Worker80Secondary level40n,number of HACCP team members per establishment.a Percent values relative to number of HACCP team members per establishment.b Cooperative-base.Ma.P.V.Azanza,M.B.V.Zamora-Luna/Food Control16(2005)15–2219further aggravated by the fact that small companies may have limited access to HACCP information and provide less resources for skill development for them(Taylor, 2001).The gender profile of the HACCP team member designates indicated inclusion of50–90%female.In a matriarchal society such as the Philippines,females tend to dominate food management concerns(Fernandez& Alegre,1988).The female-skewdness of the HACCP team composition is,therefore,expected since assurance of food safety is usually associated with women in the country.3.3.Knowledge levelThe knowledge-,attitude-and behavior-related bar-riers of HACCP team members of micro-to small-scale meat and beverage processors are shown in Table3. Results showed that most of the respondents were not aware of HACCP principles and tasks.Familiarity was the highest knowledge level achieved among the respondents.This current HACCP knowledge level of the respondents may be due in part to the inadequate and inappropriate information dissemination systems available within the country.Based on a more general industry perspective,Gilling et al.(2001)similarly identified lack of awareness of the HACCP guideline as one of the technical barriers restricting HACCP guideline adherence in U.K.food processing establishments.However,this was true only for a small proportion of food businesses in the UK. There may be a disparity in HACCP awareness levels of food processors in the Philippines and UK.which could be attributed to the more widespread and comprehen-sive HACCP information dissemination efforts exerted by the better developed country(Gilling et al.,2001; Taylor,2001).Details of HACCP knowledge-based barriers identi-fied by HACCP team member survey respondents are presented in Table4.Since majority of the respondents did not go beyond the familiarity level,they were unable to identify intrinsic and extrinsic factors influencing knowledge barriers(Fig.1).For the few who were aware and already familiar with the HACCP guideline,time and accessibility of HACCP information were of prime importance to attain full comprehension that could eventually lead to a change in behavior.Fortunately,the Philippine national government was the main external source of information although lim-ited through the conduct of seminars/workshops by concerned agencies.The National Meat and Inspection Commission,Philippines and University of the Philip-pines Diliman were the government agencies specified by respondents to provide HACCP information.According to the respondents who graduated from tertiary education in food technology and food science relatedfields,academic institutions offering undergrad-uate degree in food technology programs now covered HACCP in their curricula.Majority of the respondents who had some level of HACCP knowledge still per-ceived that HACCP information from available sources were limited.Even if the information were made avail-able HACCP team members still felt that they were not generally given adequate time to fully comprehend it.In the Philippines,HACCP information dissemination systems usually comprised of seminars/workshops thatTable3Barriers to HACCP principle adherence by HACCP team members from micro-to small-scale meat and beverage processing industries Barrier Subcategories Percentage distribution(%)Meat industry Beverage industryTeam1 (n¼10)Team2(n¼8)Team1(n¼4)Team2(n¼5)Knowledge Non-awareness401002580 No previous exposure to HACCP principlesAwareness400500Once heard or readFamiliarity2002520>1exposure but without full understandingAttitude Agreement3002520 Full-belief in HACCP principlesCommitment4002520Pledge to adoptNo response301005060Lack of knowledge of HACCP principlesBehavior No responseLack of knowledge of HACCP principles100100100100 n,number of team members per establishment.20Ma.P.V.Azanza,M.B.V.Zamora-Luna/Food Control16(2005)15–22are characteristically providing copious amount of information for short periods of time.Evaluations of the efficacy of such HACCP seminar/workshops,however, are rarely done.3.4.Attitude and behavior levelsIn terms of attitude and behavior-related barriers, this study considers non-awareness to be translated to the inability of the team members to develop the proper attitude toward the HACCP guideline.In fact,inade-quate knowledge level is the reason for non-adoption of the guideline.To the survey respondents who only reached knowledge levels of awareness and familiarity, agreement and commitment were fortunately already expressed.Ideally,HACCP team members should have attained full comprehension to develop the proper atti-tude towards the guideline.Theoretically,the cognitive-behavior model devel-oped in this study should require that each member must have full knowledge of what the HACCP guideline is all about,develop an action concept of what appro-priate behavior would lead to the efficient functioning of the HACCP plan,develop positive attitudes towards HACCP procedures and a belief that the team is capable of implementing plans(Johnson&Johnson,1987).This model follows the basic concept of experiential learning where awareness is a requisite for expansion of skill performance(Bandura,1986;Johnson&Johnson,1987; Stage&Associates,1993).The HACCP learner there-fore,must comprehend the guideline to be able to de-velop positive attitude and behavior towards it.The application of the cognitive-behavior barrier model for HACCP guideline adherence could still be further studied particularly for HACCP team mem-bers who belong to establishments,which are already HACCP parison of results generated in this study which,is based on responses of HACCP team members from teams which are still in its early stage of HACCP plan implementation,must be compared with the results obtained from responses of those who be-longed to HACCP compliant processors.Only at this point could the model be fully evaluated and appreciated.4.Summary and recommendationsThe cognitive-behavior barrier model to HACCP guideline adherence designed in the study presents the sequence of barriers that must be overcome by HACCP team member designates tofinally reach a point con-ducive to HACCP adherence.The model starts withTable4Knowledge-based barriers to HACCP principle adherence identified by HACCP team members from micro-small-scale meat and beverage processing industriesKnowledge acquisition barriers Percentage distribution(%)Meat industry Beverage industryTeam1 (n¼10)Team2(n¼8)Team1(n¼4)Team2(n¼5)Sources of HACCP information are obtained from......Industry intrinsic sources...Co-worker600500...No response4010050100 ...Industry extrinsic sources like...Seminar/workshop conducted by...ernment4005020...Academe100100...No response501005080 Accessibility of HACCP information from identified source is......Easy00020...Not easy900750...No response101002580 Adequacy of HACCP information from identified source is......Satisfactory100250...Not satisfactory8007520...No response10100080 Adequacy of time to comprehend HACCP information from identifiedsources is......Satisfactory100020...Not satisfactory800750...No response101002580n,number of team members per establishment;total…100%due to multiple answers.Ma.P.V.Azanza,M.B.V.Zamora-Luna/Food Control16(2005)15–2221knowledge acquisition followed by proper attitude development leading to eventual behavioral change targeting adherence.The model tries to provide niches for possible identifiable barriers within the major cate-gories cited.The study was conducted to analyze barriers that impede HACCP guideline adherence of27HACCP team members from four micro-to small-scale Philip-pine food processors.The study established that non-awareness of respondents of the HACCP guidelines was the major barrier to adherence.Currently the major external source of HACCP information for the team members is the national government mainly through seminars/workshops.Respondents showed an optimistic attitude toward HACCP guideline implementation de-spite their low HACCP knowledge competence level.It is evident that the management responsible for the HACCP team membership needs to fully appreciate the fundamental concept of the group to be multidisciplin-ary.The respondents from HACCP teams were found to be multidisciplinary have been formed only accidentally since the processors involved had limited employees and had to include everyone to the team.More intensive knowledge-based intervention strate-gies specifically designed for HACCP team members must be formulated and implemented as an initial step to achieve HACCP guideline adherence.Furthermore,gov-ernment and other sources of HACCP information must continue to advocate HACCP adherence in Philippine food industries.Additional efforts on a national scale must be exerted to make HACCP information more accessible. 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