1、 NSF Food Safety and Quality 2002 Application of ISO 9000 and HACCP requirements to global food and beverage industries NSF Food SafetyandQuality 2002NSF International, an independent, not-for-profit, non-governmental organization, is dedicated to being the leading global pro-vider of public health
2、and safety-based risk management solutions while serving the in-terests of all stakeholders. This Guideline is subject to revision. Contact NSF to confirm this revision is current. Users of this Guideline may request clarifications and inter-pretations, or propose revisions by contacting: NSF Intern
3、ational Food Safety Systems 789 North Dixboro Road, P.O. Box 130140 Ann Arbor, Michigan 48113-0140 USA Phone: (734) 769-8010 Telex: 753215 NSF INTL FAX: (734) 769-0109 E-mail: infonsf.org Web: http:/www.nsf.org NSF Food Safety and Quality 2002 i NSF International Guideline for Food Safety and Qualit
4、y Application of ISO 9000 and HACCP requirements to global food and beverage industries Standard Developer NSF International Adopted June 20, 2002 NSF International ii Prepared by Food Safety and Quality Advisory Committee Adopted 1996 Revised June 2002 Published by NSF International PO Box 130140,
5、Ann Arbor, Michigan 48113-0140, USA For ordering copies or for making inquiries with regard to this Guideline, please reference the designation “Application of ISO 9000 and HACCP requirements to global food and beverage industries 2002.” Copyright 2002 NSF International Previous edition 1996 Unless
6、otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, elec-tronic or mechanical, including photocopying and microfilm, without permission in writing from NSF International. Printed in the United States of America. iii NSF International NSF is inc
7、orporated under the laws of Michigan as a not-for-profit organization devoted to research, educa-tion, and service. It seeks to provide risk management solutions involving public health, safety and protection of the environment. It strives to promote health and enrich quality of life. NSFs fundament
8、al principle of op-eration is to serve as a neutral medium in which business and industry, official regulatory agencies, and the public come together to develop solutions involving products, equipment, procedures, and services related to health and the environment. It is conceived and administered a
9、s a public service organization. NSF is perhaps best known for its role in facilitating the development of Standards and Criteria for equipment, products, and services that bear upon health. NSF conducts research; tests and evaluates equipment, prod-ucts, and services for compliance with Standards a
10、nd Criteria; and grants and controls the use of NSF regis-tered Marks. NSF provides food safety and quality risk management solutions. NSFs Cook satisfy customers expectations of whole-someness and value; comply with applicable standards, specifi-cations, and all other applicable regulations; comply
11、 with statutory and other require-ments of society; are available at competitive prices; and are provided at a cost which will yield a profit. 1.1 Organizational goals In order to meet its objectives, the company should organize itself in such a way that the tech-nical, administrative, and human fac
12、tors affecting the safety and quality of its products and services are controlled. All such control should be oriented toward the reduction, elimination and, most impor-tantly, prevention of safety and quality deficien-cies. A hazard analysis critical control point (HACCP) system should be developed
13、 and implemented to prevent food and beverage safety hazards and to manage food and beverage safety issues. This should include all appropriate training. A quality management system should be devel-oped and implemented for the purpose of accom-plishing the objectives set out in a companys quality po
14、licies and all appropriate training should be provided. In order to achieve maximum effectiveness and to satisfy customer expectations, it is essential that the safety and quality management systems be appropriate to the type of activity and to the prod-ucts or services being offered. 1.2 Meeting co
15、mpany/customer needs Safety and quality management systems have two inter-related aspects. 1.2.1 Company needs and interests There is a business need to attain and to maintain the desired quality and freedom from safety haz-ards and the desired quality levels at an optimal cost. The fulfillment of t
16、hese requirements is re-lated to the planned efficient utilization of the technological, human, and material resources available to the company for quality management and for the application of HACCP for identification of specific hazards and preventative measures for their control. Food Safety and
17、Quality 2002 2002 NSF International 2 1.2.2 Customer needs and expectations There is a need for consistent maintenance of confidence in the ability of the company to deliver products free from safety hazards and of the de-sired quality. This includes all labeling and other hazard awareness such as n
18、otification of aller-genic properties. 1.3 Risks, costs and benefits 1.3.1 General Risk, cost, and benefit considerations have great importance for both company and customer. These considerations are inherent aspects of most products and services. 1.3.2 Risk considerations 1.3.2.1 For the company Co
19、nsideration has to be given to the following: risks related to deficient products or ser-vices that lead to loss of image, reputation, or market; complaints; and claims, liability, or waste of human and fi-nancial resources. 1.3.2.2 For the customer Consideration has to be given to risks such as the
20、 following: those pertaining to the health and safety of people; dissatisfaction with goods and services; availability of goods and services; marketing claims; and loss of confidence. 1.3.3 Cost considerations 1.3.3.1 For the company Consideration has to be given to costs due to marketing and design
21、 deficiencies, including un-safe products, unsatisfactory materials, rework, repair, replacement, re-processing, loss of produc-tion, warranties, and field repair. 1.3.3.2 For the customer Consideration has to be given to safety, acquisi-tion, operation, maintenance, downtime, repair, and possible d
22、isposal costs. 1.3.4 Benefit considerations 1.3.4.1 For the company Consideration has to be given to increased free-dom from liability, increased profitability, and in-creased market share. 1.3.4.2 For the customer Consideration has to be given to reduced costs, improved fitness for use, confidence
23、in freedom from safety hazards, and increased satisfaction. 1.3.5 Conclusion Effective food and beverage safety and quality management systems should be designed to sat-isfy customer needs and expectations while serv-ing to protect the companys interests. The imple-mentation of a systematic HACCP ap
24、proach is an effective and rational way to assure food and bev-erage safety. An effective HACCP plan within a well-structured quality system is a valuable management resource in the optimization and control of product safety and quality in relation to risk, costs, and benefit considerations. 2 Scope
25、 and field of application 2.1 This guideline provides guidance on food and beverage safety assurance and the associated HACCP elements and guidance on food quality assurance and the associated quality management system elements. The HACCP food and beverage safety assurance elements and the quality m
26、anagement system elements are for use in the development, imple-mentation, and execution of comprehensive and inter-related food and beverage safety and quality assurance systems that provide maximum cus-tomer satisfaction and confidence. The selection of appropriate sections of this guide and the e
27、xtent of use of these sections depend on 2002 NSF International Food Safety and Quality 2002 3 factors such as markets being served, the nature of the products being manufactured, the nature of the production processes, and the needs and wants of the customers. No part of this guide is intended for
28、contractual use. It serves as a model or reference only. 2.2 Where specific methods, practices, or proce-dures are mentioned in this guide, they should be looked upon as examples only. Alternate methods, practices, and/or procedures may be used freely if they accomplish the same or similar results.
29、2.3 In all cases, this guide assumes that Good Manufacturing Practices as defined in 21 CFR and/or Good Hygiene Practices as defined in Co-dex Alimentarius, are being implemented. 3 Definitions and references 3.1 Definitions For the purposes of this Guideline, the definitions given in NACMCF, 3/20/9
30、2, HACCP; ISO 9402; Codex Alimentarius, U.S. Public Health Service Food Code of 1999 (Recommendations), and the following apply. 3.1.1 assessor/auditor: A person who has the qualifications to perform quality and food and bev-erage safety management system audits. The auditor must meet specific exper
31、ience and training requirements as enumerated in element 6 of ISO 9001:2000 in order to be qualified. 3.1.2 Codex Alimentarius: General Principles of Food Hygiene and Specific Codes of Practice as deemed necessary. 3.1.3 company: Term used primarily to refer to a business first party, the purpose of
32、 which is to supply a product or service. 3.1.4 continuous monitoring: Uninterrupted collection and recording of data such as tempera-ture on a strip chart. 3.1.5 control: (a) To manage the conditions of an operation to maintain compliance with estab-lished criteria. (b) The state wherein correct pr
33、o-cedures are being followed and established crite-ria are being met. 3.1.6 control point: Any point, step, or proce-dure at which biological, physical, or chemical fac-tors can be controlled. 3.1.7 corrective action: Procedures to be fol-lowed when a nonconformance or deviation oc-curs. 3.1.8 crite
34、rion: A requirement on which a judgment or decision can be based. 3.1.9 Critical Control Point (CCP): A point or procedure in a specific food system where loss of control may result in an unacceptable health risk. 3.1.10 Critical Control Point (CCP) decision tree: A sequence of questions to facilita
35、te and determine whether a control point is a Critical Control Point. 3.1.11 critical defect: A deviation at a CCP that may result in a hazard. 3.1.12 critical limit: A criterion that must be met for each preventative measure associated with a critical control point. 3.1.13 customer: Ultimate consum
36、er, user, cli-ent, beneficiary, or second party. 3.1.14 deviation: Failure to meet a critical limit. 3.1.15 fault tree analysis: Top-down method of analyzing system design and performance. It is a method to analyze all components of a process that could cause a failure to occur, i.e., environ-mental
37、 conditions, training, materials, procedures equipment. 3.1.16 FDA: United States Food and Drug Ad-ministration. 3.1.17 food and beverage quality: Those char-acteristics of food, other than safety, which affect customer acceptance. 3.1.18 food and beverage safety: The sum total of all activities to
38、preclude foodborne disease or injury. 3.1.19 good hygiene practices (GHPs): Good manufacturing practices. 3.1.20 good manufacturing practices (GMPs): Good hygiene practices. Food Safety and Quality 2002 2002 NSF International 4 3.1.21 HACCP: Hazard analysis critical control points a systematic appro
39、ach to assure food or beverage safety. 3.1.22 HACCP food and beverage safety co-ordinator: Person who coordinates the plan and its implementation. 3.1.23 HACCP food and beverage safety plan: The written document that is based upon the prin-ciples of HACCP and delineates the procedures to be followed
40、 to assure the control of a specific process or procedure. 3.1.24 HACCP food and beverage safety sys-tem: The result of the implementation of the HACCP plan. 3.1.25 HACCP team: The group of people who are responsible for developing a HACCP plan. 3.1.26 HACCP plan revalidation: One aspect of verifica
41、tion in which a documented periodic review of the HACCP plan is done by the HACCP team with the purpose of modifying the HACCP plan as necessary. 3.1.27 HACCP plan validation: The initial re-view by the HACCP team to ensure that all ele-ments of the HACCP plan are accurate. 3.1.28 hazard: A biologic
42、al, chemical, or physical property that may cause a food to be unsafe for consumption. 3.1.29 monitor: To conduct a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record for future use in verification. 3.1.30 organization: A compa
43、ny, corporation, firm, or enterprise, whether incorporated or not, or public or private. 3.1.31 preventative measure: An action to ex-clude, destroy, eliminate, or reduce a hazard to acceptable levels and prevent recontamination through effective means. 3.1.32 regulatory: Official in nature, usually
44、 re-ferring to a government or legal requirement. 3.1.33 requirements of society: Requirements including laws, statutes, rules and regulations, codes, environmental considerations, health and safety factors, and conservation of energy and materials. 3.1.34 risk: An estimate of the likelihood of oc-c
45、urrence of a hazard. 3.1.35 sanitation standard operating proce-dures (SSOPs): Written procedures, methods, and processes that assure compliance with appli-cable regulatory sanitation requirements. 3.1.36 severity: The seriousness of a hazard. 3.1.37 verification: Methods, procedures, and tests used
46、 to determine if the HACCP system in use is in compliance with the published HACCP plan. 3.2 References Code of Federal Regulations, Title 21 (21 CFR), Part 110: U.S. FDA, Current Good Manufacturing Practices in Manufacturing, Packing or Holding Human Food, 20021Codex Alimentarius, Draft HACCP Princ
47、iples, 6/14/912FDA/CFSAN FDA Food Code, 19993ISO 9000-2000 12/15/2000, Quality Management Systems - Fundamentals and Vocabulary4ISO 9001:2000 12/15/2000, Quality Management Systems Requirements4ISO 9004:2000 (12/15/2000), Quality manage-ment system Guidelines performance improve-ments4NACMCF (HACCP)
48、; 3/20/92, “Executive Summary National Advisory Committee on Microbiological Criteria for Foods, Hazard Analysis and Critical 1U.S. Government Printing Office, Washington, DC 20402 2International Standards Organization, Case postale 56, CH 1211 Geneva 20, Switzerland 3U.S. Public Health Service, Foo
49、d and Drug Administra-tion, U.S. Department of Health and Human Services, 5285 Port Royal Road, Springfield, VA 4International Standards Organization, Case postale 56, CH 1211 Geneva 20, Switzerland 2002 NSF International Food Safety and Quality 2002 5 Control Point System,“ 3/20/199254 System guidelines 4.1 Documentation requirements 4.1.1 Operational procedures The food and beverage safety and quality systems should be organized in such a way that adequate and continuous control is exercised over all activi-ties affect
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