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HB90.52000
CORRELATION
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COPYRIGHT
Standards Australia International All rights are reserved. No part of this work may be reproduced or copied in any form or by any means, electronic or mechanical, including photocopying, without the written permission of the publisher. Published by Standards Australia International Ltd GPO Box 5420, Sydney, NSW 2001, Australia
ISBN 0 7337 3703 X
HB 90.52000
For each Clause of ISO 9001, the HACCP Principle(s)2 having a correlation to the requirements of the ISO 9001 Clause, are listed. The layout used is shown below.
HACCP PRINCIPLES
List of relevant HACCP Principles that correlate with the above clause
CORRELATION
Discussion of correlation Comment (optional) Discussion of any related issues.
1 2
Published by CSIRO Publishing. The seven HACCP Principles are given on Page 7.
HB 90.52000
TABLE OF CONTENTS
OVERVIEW ..................................................................................................................................5 THE HACCP PRINCIPLES ............................................................................................................7 CORRELATION .............................................................................................................................9 INTRODUCTION ............................................................................................................................9 0.1 General........................................................................................................................9 0.2 Process approach .........................................................................................................9 0.3 Relationship with ISO 9004.......................................................................................10 0.4 Compatibility with other management systems .........................................................10 1 SCOPE .....................................................................................................................................12 1.1 General......................................................................................................................12 1.2 Application................................................................................................................12 2 NORMATIVE REFERENCE ........................................................................................................13 3 TERMS AND DEFINITIONS........................................................................................................14 4 QUALITY MANAGEMENT SYSTEM ...........................................................................................15 4.1 General requirements.................................................................................................15 4.2 Documentation requirements.....................................................................................17 5 MANAGEMENT RESPONSIBILITY .............................................................................................20 5.1 Management commitment .........................................................................................20 5.2 Customer focus..........................................................................................................21 5.3 Quality policy............................................................................................................22 5.4 Planning ....................................................................................................................23 5.5 Responsibility, authority and communication............................................................24 5.6 Management review ..................................................................................................27 6 RESOURCE MANAGEMENT ......................................................................................................28 6.1 Provision of resources ...............................................................................................28 6.2 Human resources .......................................................................................................29 6.3 Infrastructure .............................................................................................................30 6.4 Work environment.....................................................................................................30 7 PRODUCT REALIZATION ..........................................................................................................31 7.1 Planning of product realization..................................................................................31 7.2 Customer-related processes .......................................................................................32 7.3 Design and development ...........................................................................................33 7.4 Purchasing.................................................................................................................35 7.5 Production and service provision...............................................................................36 7.6 Control of monitoring and measuring devices ...........................................................40
HB 90.52000
8 MEASUREMENT, ANALYSIS AND IMPROVEMENT .....................................................................41 8.1 General......................................................................................................................41 8.2 Monitoring and measurement ....................................................................................42 8.3 Control of nonconforming product ............................................................................45 8.4 Analysis of data.........................................................................................................46 8.5 Improvement .............................................................................................................47 APPENDIX A MAP OF ISO 9001 CLAUSES VS HACCP PRINCIPLES .....................................49
HB 90.52000
OVERVIEW
GENERAL
Many organizations have adopted, or are familiar with, the disciplines outlined in the ISO 9000 series of quality management system Standards. Similarly many organizations have adopted a food safety system based on the HACCP Principles (Hazard Analysis Critical Control Points, see page 7). However these two approaches may be used to complement each other and, in combination, provide a very powerful tool for the control of both management and production operations. For example, the application of the ISO 9000 quality management system Standards are considered to be confined to quality and HACCP to be confined to hazard and safety issues. However the definition of what comprises quality can be very broad and often includes safety issues.
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In the food industry, one of the quality expectations of a customer is that food will not cause food poisoning or contain harmful objects. Here food safety is included in the overall aspects of food quality. Since HACCP is concerned with food safety, there is a very close alignment between quality and safety. In a hospital, HACCP principles may be applied to a range of activities and applications. For example, it may be identified that the selection of the appropriate medicines and drugs, combined with the administration of the correct dosage is an area of potential hazard and that appropriate steps are needed to avoid any possible harm coming to the patient. The patients expectation of this activity may well be that this activity is associated with the quality of care, resulting in the patient recovering from the condition which put the patient in hospital in the first place.
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HB 90.52000
ISO 9001 does not directly address legislation, regulations, codes of practice or similar decrees. However, where these play a role in the organizations activities, they need to be addressed in the appropriate procedures and thus indirectly become part of the organizations quality management system. ISO 9001s great strength, when properly implemented, is that it sets out requirements to involve the organizations top management and to make management accountable for the operation of the quality management system. It thus provides a management infrastructure to support the organizations activities. An ISO 9001 quality management system can also provide an infrastructure to support HACCP, and as such is a good guide for the practices and procedures implied but not specified in the HACCP Principles.
The seven HACCP Principles shown on page 7 are very broad statements of requirements and, to be implemented effectively, demand considerable understanding of the organizations process(es) and all the associated supporting activities. Because of their very broad and generic nature, the Principles themselves give no guidance on how to go about implementing them. Like ISO 9001, the manner in which the Principles are implemented is up to each individual organization, providing a very flexible approach to implementation. Again, like ISO 9001, the Principles do not address legislation, regulation, codes of practice or similar decrees; where these play a role in the organizations activities, they need to be addressed in the appropriate procedures and thus indirectly become part of the organizations HACCP system. Unlike ISO 9001, there is no stated requirement for support by top management for a HACCP system, although obviously this will be necessary for successful implementation. One potential use of the HACCP Principles that is not often considered is their application to aspects other than hazard. For example, by substituting palatability for hazard and conducting a similar analysis, the critical control points in a process that relate to palatability can be identified and controlled. In other words, the Critical Control Point analysis can be used for virtually any property (including quality).
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HB 90.52000
Principle No. 1
Identify the potential hazard(s) associated with food production at all stages, from growth, processing, manufacture and distribution, until the point of consumption. Assess the likelihood of occurrence of the hazard(s) and identify the preventive measures for their control.
Principle No. 2
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Determine the points/procedures/operational steps that can be controlled to eliminate the hazard(s) or minimize its likelihood of occurrence.
Principle No. 3
Establish critical limit(s) which must be met to ensure that the Critical Control Point is under control.
Principle No. 4
Establish a system to monitor control of the Critical Control Point by scheduled testing or observations.
Principle No. 5
Establish the corrective action to be taken when monitoring indicates that a particular Critical Control Point is not under control.
Principle No. 6
Establish procedures for verification which include supplementary tests and procedures to confirm that the HACCP system is working effectively.
Principle No. 7
Establish documentation concerning all procedures and records appropriate to these principles and their application. Codex Alimentarius ALINORM 95/13 Annex to Appendix III also includes a logic diagram on the application of HACCP Principles, and this is reproduced as a flowsheet on page 8. This flowsheet shows that, before the principles can be applied, a significant amount of preparatory work has to be done. It should be noted that HACCP Principle 2 is basically a decision process. As such it does not actually correlate well with any of the ISO 9001 Clauses. However, it is of major significance since the application of the remaining HACCP Principles is dependent on the decisions made.
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HB 90.52000
Assemble the HACCP team Describe the product Identify the intended use
Construct the flow diagram
List all identified hazards associated with each step and consider preventive measures to control hazards Identified hazard Biological Chemical Physical Step Preventive measure
Apply HACCP decision tree to each step with identified hazard(s) (answer each question in sequence) Q1 Do preventive measures exist? Yes No Is control at this step for safety? No Q2 Not a CCP Yes Stop* Yes Modify step, process or product
Is the step specifically designed to eliminate or reduce the likely occurrence of a hazard to an acceptable level? No
Q3
Could contamination with identified hazard(s) occur in excess of acceptable level(s) or could these increase to unacceptable level(s)? Yes No Not a CCP Stop* No Critical Control Point
Q4
Will a subsequent step eliminate identified hazard(s) or reduce likely occurrence to an acceptable level? No Yes Not a CCP Stop*
Establish a monitoring system for each CCP Establish corrective action for deviations that may occur
FLOWSHEET LOGIC SEQUENCE FOR APPLICATION OF HACCP (Ref. Codex Alimentarius ALINORM 95/13 Annex to Appendix III)
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HB 90.52000
CORRELATION
INTRODUCTION
0.1 General
The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organizations quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organization. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation. The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked NOTE is for guidance in understanding or clarifying the associated requirement. This International Standard can be used by internal and external parties, including certification bodies, to assess the organizations ability to meet customer, regulatory and the organizations own requirements. The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.
In addition, the methodology known as Plan-Do-Check-Act (PDCA) can be applied to all processes. PDCA can be briefly described as follows. establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organizations policies. implement the processes. monitor and measure processes and product against policies, objectives and requirements for the product and report the results. take actions to continually improve process performance.
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HB 90.52000
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HB 90.52000
HACCP PRINCIPLES
CORRELATION
There are no HACCP Principles that correlate with Clause 0 Introduction Comment Clause 0.2 Process approach of the Introduction provides the basis on which the Standard has been developed. Figure 1 presents the overview of the Standard in pictorial form as a process approach which involves a number of Plan-Do-Check-Act (PCDA) cycles. In a sense the HACCP Principles follow a similar PCDA pattern in that
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Principles 1 and 2 cover the planning activities (plan); Principle 3 sets out the control parameters (do); Principle 4 provides for the measurement (check); and Principle 5 provides the feedback loop for action (act). Principles 6 and 7 cover the necessary documentation of the system and the provision of the necessary records. The Standard provides a comprehensive quality management system, with involvement of all levels of the organization and covering the all the activities within the organization. The HACCP Principles apply at a lower level in that they directly address the organizations processes on a process by process basis without considering the organizational structure and management processes necessary to support them. If they are considered at a somewhat higher level they can be interpreted as covering planning, and process control on an overall basis. Thus the HACCP Principles can be applied within the quality management system which can be used to deliver the system support needed for the activities not addressed by the HACCP Principles but necessary for their successful implementation.
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HB 90.52000
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CLAUSE 1 SCOPE
1.1 General
This International Standard specifies requirements for a quality management system where an organization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.
NOTE In this International Standard, the term product applies only to the product intended for, or required by, a customer.
1.2 Application
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All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion. Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organizations ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.
HACCP PRINCIPLES
CORRELATION
There are no HACCP Principles that correlate with Clause 1 Scope
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HB 90.5-2000, Correlation between ISO 9001:2000 and the HACCP Principles Correlation between ISO 9001:2000 and the HACCP Principles
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