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- Herausgeber: John Wiley & Sons
- Kategorie: Fachliteratur
- Sprache: Englisch
Guide to understand the fundamentals of HACCP and to planning and conducting food safety audits
HACCP System Auditing for Food Safety helps readers understand the fundamentals of the HACCP concept and its importance in ensuring food safety, with guidance on how to develop auditing skills including planning, executing, and reporting on HACCP audits effectively.
To aid in reader comprehension, this book incorporates many practical examples with accompanying figures and models, along with selected case studies and global practices from Europe, Canada, USA, and New Zealand to showcase international practices and standards. ISO 19011 as a standard reference is used throughout the text.
Written by a seasoned industry professional with decades of hands-on experience as an official control agent, HACCP System Auditing for Food Safety includes information on:
- Elements of the HACCP methodology, including related concepts, adapted to the specificities of the food operator
- Phases of HACCP study and application of the seven principles, respecting their internal logic and how they are interrelated
- HACCP as a management system, starting from the commitment of the management or the company’s board of directors, with tasks and responsibilities distributed among staff
- Management system auditing techniques to verify performance, whether for internal audits, supplier audits, or certification purposes
Providing the rational and scientific basis necessary to anticipate problems and to learn from the experiences and situations that arise in the food industry, HACCP System Auditing for Food Safety is an essential reference for various industry professionals, including technicians, quality managers, consultants, auditors, and official control agents.
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Table of Contents
Cover
Table of Contents
Title Page
Copyright
Dedication
Preface
Acknowledgement
1 A Necessary Evolution
References
2 The HACCP System
2.1 Characteristics of the HACCP System
2.2 The Limitations of Final Product Analyses
2.3 Reasons to Implement HACCP
2.4 Legal Basis of HACCP
2.5 HACCP Pillars
2.6 HACCP Barriers
2.7 HACCP Principles and Methodology
2.8 The Four Stages for the Implementation of HACCP
2.9 Preparation and Planning
2.10 The 12 Steps of HACCP
2.11 Assemble the HACCP Team
2.12 Describe the Product
2.13 Determining Intended Use
2.14 Construct a Flow Diagram
2.15 On-site Flow Diagram Verification
References
3 The Seven Principles of HACCP
3.1 Principle 1
3.2 Principle 2
3.3 Principle 3
3.4 Principle 4
3.5 Principle 5
3.6 Principle 6
3.7 Microbiological Analyses in the HACCP System
3.8 EU Regulation 2073/2005 and HACCP
3.9 Principle 7
References
4 The Prerequisites of the HACCP System
4.1 Type of Prerequisites
4.2 Flexibility in HACCP
4.3 Development and Implementation of Hygiene Prerequisites
4.4 Water Control
4.5 Cleaning and Disinfection Plan
4.6 Pest Control Plan
4.7 Training Plan
4.8 Supplier Control
4.9 Traceability Plan
4.10 Maintenance Plan
4.11 Good handling Practices
4.12 Good Manufacturing Practices
4.13 Waste Control Plan
References
5 HACCP as a Management System
5.1 From Words to Work
5.2 What is Required to Implement HACCP?
5.3 Building a Food Safety Culture
5.4 Management System Concept
5.5 The Concept of a Food Safety Management System
5.6 System Documentation
5.7 Food Safety Standards
References
6 Audit: Concept, Types, and Personnel
6.1 Audit Concept
6.2 Why Audit?
6.3 Persons Involved in an Audit
6.4 Types of Audit
References
7 The Food Safety Auditor
7.1 Competence of the Auditor
7.2 Achieving the Auditor’s Competence
7.3 Audit Principles
7.4 Personal Attributes of Auditors
7.5 Management Skills
References
8 Audit in Official Control
8.1 Audit vs Inspection
References
9 The Audit Process
9.1 Stages of the Audit Process
9.2 Initiating Audit
9.3 Selection of Auditors
9.4 Team Size
9.5 Establishing Contact with Auditee
9.6 Determining the Feasibility of the Audit
9.7 Preparation of Audit Activities
9.8 Opening Meeting
9.9 The Audit Tour
9.10 Document Review During the Audit
9.11 Conducting On-site Audit Activities
9.12 Sources of Information
9.13 Sampling in Auditing
9.14 Tools to Guide the Audit
9.15 Counter-auditing Techniques
9.16 Generating audit findings
9.17 Classification of Findings
9.18 Elements of a Finding
9.19 Classification of Nonconformities
9.20 Drafting of Nonconformities
9.21 Preparing Audit Conclusions
9.22 Closing Meeting
9.23 Audit Report
9.24 Completing Audit
9.25 Audit Follow-up Activities
9.26 Managing an Audit Program
References
Case Study 1: Slaughterhouse for Rabbits, with an Adjoining Cutting Plant
1 HACCP Team
2 Scope
3 Description of Product
4 Flow Diagram
5 Hazard Control Chart
6 CCP Control Chart CCP Control Chart
7 OPRP Control Chart OPRP Control Chart
Case Study 2: HACCP System of the Mass Catering Establishment Culinaria
1 HACCP Team
2 Scope and References
3 Product Description or Types
4 Identification of Intended Use
5 Flow Diagram
6 Hazard Analysis and Assessment Hazard Analysis and Assessment
7 CCP Control Chart CCP Control Chart
Index
End User License Agreement
List of Tables
Case Study 1
Table 1 Microbiological criteria at the end of the production process.
Table 2 Microbiological end-of-life criteria.
Table 3 Physicochemical criteria and other specifications for the final prod...
List of Illustrations
Chapter 1
Figure 1.1 HACCP evolution.
Figure 1.2 HACCPverse. HACCP Universe.
Chapter 2
Figure 2.1 In audits we can distinguish the “what”, the “how” and the “what ...
Figure 2.2 Two-step audit approach.
Figure 2.3 Probability of accepting a lot P(a) as a function of the actual n...
Figure 2.4 Probability of detection in final product analysis of Salmonella ...
Figure 2.5 Effect of the quality of the lot (% of nonconforming units) on th...
Figure 2.6 Legal basis of HACCP and prerequisites in Europe.
Figure 2.7 Essential elements for HACCP.
Figure 2.8 Pillars of HACCP.
Figure 2.9 Some of the human factors involved in implementing HACCP.
Figure 2.10 Comparing Codex and NACMCF.
Figure 2.11 Elements of an FSMS. European Commission.
Figure 2.12 The four stages for HACCP implementation.
Figure 2.13 Gap analysis.
Figure 2.14 Twelve HACCP steps.
Figure 2.15 Examples of models with the phases of an FMEA study.
Figure 2.16 HACCP team position in an organization.
Figure 2.17 HACCP team members.
Figure 2.18 Flow diagram of food retail. Meals groups according to elaborati...
Figure 2.19 Different groups of meals.
Figure 2.20 Types of foods according to control factors.
Figure 2.21 Examples of pathogens and methods for their control in different...
Figure 2.22 Description of the product.
Figure 2.23 Allergens listed in Regulation 1169/2011.
Figure 2.24 Flow diagram for the production of frozen meat pies.
Figure 2.25 Flow diagram for the production of fresh unfilled pasta.
Chapter 3
Figure 3.1 Principle 1 phases.
Figure 3.2 Five causes of hazards.
Figure 3.3 Examples of hazards.
Figure 3.4 Hazard description elements.
Figure 3.5 Types of control measures according to the type and nature of the...
Figure 3.6 Risk matrix.
Figure 3.7 Example of hazard control chart.
Figure 3.8 Risk analysis components.
Figure 3.9 Comparative risk analysis and hazard analysis.
Figure 3.10 Comparison between government activities and companies.
Figure 3.11 Hazard and control measures.
Figure 3.12 Apply different controls depending on the risk assessment associ...
Figure 3.13 Decision tree application as a process.
Figure 3.14 Record model answers of decision tree.
Figure 3.15 Original Codex decision tree with 4Q.
Figure 3.16 Example I – NACMCF decision tree.
Figure 3.17 Example II – NACMCF decision tree.
Figure 3.18 Modified Campden decision tree.
Figure 3.19 Codex decision tree 2022.
Figure 3.20 ILSI decision tree.
Figure 3.21 Raw material decision tree.
Figure 3.22 PRP, OPRP, and CCP.
Figure 3.23 The 2-hour/4-hour rule.
Figure 3.24 pH monitoring corrective action.
Figure 3.25 pH monitoring trend.
Figure 3.26 Control chart model.
Figure 3.27 Six sigma.
Figure 3.28 2 Part HACCP.
Figure 3.29 Monitoring chat example.
Figure 3.30 Example of monitoring of CCP in canned vegetables.
Figure 3.31 The 5 whys technique.
Figure 3.32 Incident and corrective action log format.
Figure 3.33 Bow tie diagram.
Figure 3.34 Validation and verification work in tandem.
Figure 3.35 Validation vs. verification.
Figure 3.36 Interrelationship among validation, monitoring and verification....
Figure 3.37 The four levels of control in HACCP.
Figure 3.38 FSMS cycle.
Figure 3.39 Within- and between-batch analysis.
Figure 3.40 Interrelationship between HACCP, microbiological criteria, FSO a...
Figure 3.41 OC curve.
Figure 3.42 Diagram Two-class plans.
Figure 3.43 Diagram Three-class plans.
Figure 3.44 The 15 cases.
Figure 3.45 Interrelation between HACCP and R° 2073/2005.
Figure 3.46 Documentation recordkeeping and other principles.
Chapter 4
Figure 4.1 HACCP and other elements.
Figure 4.2 General principles of hygiene.
Figure 4.3 The House of Food Safety.
Figure 4.4 Specific and general hazards.
Figure 4.5 Flexibility options.
Figure 4.6 Diary. Source: Adapted from Food Standards Agency (2020).
Figure 4.7 Prerequisite structure.
Figure 4.8 Water parameters.
Figure 4.9 Beliefs, attitude, and behavior.
Figure 4.10 Training cycle.
Figure 4.11 Supply chain traceability scheme.
Figure 4.12 Traceability objectives.
Figure 4.13 Steam–air sterilizer.
Figure 4.14 Maintenance schedule log.
Figure 4.15 Maintenance plan of cold store room.
Chapter 5
Figure 5.1 Activity, process, procedure, documented procedure of a HACCP stu...
Figure 5.2 Management system elements.
Figure 5.3 Components of a food safety management system.
Figure 5.4 Document hierarchy of a management system.
Figure 5.5 Example of corrective and preventive action management procedure....
Figure 5.6 Horizontal and vertical standards in the food supply chain. Abbre...
Chapter 6
Figure 6.1 PDCA cycle.
Figure 6.2 The triangle of audit parties.
Figure 6.3 Types of audits depending on the parties involved.
Chapter 7
Figure 7.1 Elements of auditor competence.
Figure 7.2 Both education and professional and audit experience constitute t...
Figure 7.3 Process for gaining auditor competence.
Figure 7.4 The auditor’s proper role with the auditee.
Figure 7.5 The proper attitude of the auditor is often to avoid extremes.
Chapter 8
Figure 8.1 Differences between inspection and audit.
Figure 8.2 Auditing and inspecting have different goals, but share many comm...
Chapter 9
Figure 9.1 Four main steps of the audit process.
Figure 9.2 Overview of auditing activities.
Figure 9.3 An example audit plan.
Figure 9.4 Collecting and evaluating information.
Figure 9.5 Mind map for observing a process.
Figure 9.6 Funnel interview phases.
Figure 9.7 Dos and don’ts in interviews.
Figure 9.8 Audit triangle evidence.
Figure 9.9 FAO - WHO HACCP checklist.
Figure 9.10 Pros and cons of checklists.
Figure 9.11 Healthy diet of an auditor.
Figure 9.12 Data and objective evidence.
Figure 9.13 Evidence, criteria and findings.
Figure 9.14 Classification of findings.
Figure 9.15 Elements of a finding.
Figure 9.16 Drafting of nonconformities.
Figure 9.17 Nonconformity note (NCN).
Guide
Cover
Title Page
Table of Contents
Copyright
Dedication
Preface
Acknowledgement
Begin Reading
Case Study 1 Slaughterhouse for Rabbits, with an Adjoining Cutting Plant
Case Study 2 HACCP System of the Mass Catering Establishment Culinaria
Index
End User License Agreement
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HACCP System Auditing for Food Safety
Principles and Techniques
Luis Couto Lorenzo
Copyright © 2024 by John Wiley & Sons, Inc. All rights reserved, including rights for text and data mining and training of artificial technologies or similar technologies.
Published by John Wiley & Sons, Inc., Hoboken, New Jersey.Published simultaneously in Canada.
Originally published as Auditoría del Sistema de APPCC© Diaz de Santos, 2019
No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, scanning, or otherwise, except as permitted under Section 107 or 108 of the 1976 United States Copyright Act, without either the prior written permission of the Publisher, or authorization through payment of the appropriate per-copy fee to the Copyright Clearance Center, Inc., 222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400, fax (978) 750-4470, or on the web at www.copyright.com. Requests to the Publisher for permission should be addressed to the Permissions Department, John Wiley & Sons, Inc., 111 River Street, Hoboken, NJ 07030, (201) 748-6011, fax (201) 748-6008, or online at http://www.wiley.com/go/permission.
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Hardback ISBN: 9781394254729
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To my dear wife Lola, for her support through all these years.
Preface
Among the many subjects and disciplines covered by food safety, hazard analysis and critical control point (HACCP) is central. It provides the rational and scientific basis necessary to have the vision, the analysis, the ability to anticipate problems, and to learn from the experiences and situations that arise in the food industry. Unlike the application of general control measures, which are also essential to ensure food hygiene, HACCP provides the ability to think, rethink, and adapt resources and control strategies to achieve the desired level of food safety.
From professionals working in the food industry, who are the first and most involved in the application of the HACCP methodology in the very field for which it was created, to other practitioners such as consultants, auditors, official control agents, without forgetting the university teaching and research sector, all need to have a solid knowledge of the principles and steps to be followed to develop a consistent, feasible, and an effective HACCP system.
A great virtue of HACCP is that it is the same in all countries, so we can all speak the same language and food operators can adopt it as a system of mutual recognition to facilitate food trade.
In essence, HACCP is a simple, rational, and logical system that has remained largely unchanged since it was adopted by Codex as an indispensable tool for food safety, but at the same time it requires a thorough understanding of its concepts and the correct application of its principles to develop HACCP systems that are truly useful to the operators who have to apply them.
The comparative simplicity and also the consistency of the HACCP system have allowed it to reach our days respecting the original structure agreed in the 1990s. Thus, the modifications introduced in the latest version of the Codex document in 2022, although significant, concern nonessential aspects of the system and had already been assimilated by professionals in the previous years. Moreover, the experience gained over more than 30 years has enabled the system to mature and a general consensus has been reached in the most appropriate way to implement HACCP in the day-to-day work of the food industry.
The aim of this book is to explain in detail all the elements of the HACCP methodology, clarifying the related concepts, the phases of the HACCP study, and the application of the seven principles, respecting their internal logic and the way in which they should be interrelated to achieve a satisfactory result, adapted to the specificities of the food operator and truly effective. This is the only way to ensure that the operators will regard HACCP as an invaluable tool for the smooth running of their business and not as a burden imposed by law or customer requirements.
Once the HACCP system is operating in the food business, it needs to be periodically verified; this is not only a requirement of the HACCP system itself, in particular its principle 6, but is the way to ensure that it is working properly and is effective in achieving the food safety objectives. In practice, HACCP should be understood as a management system, in which, starting from the commitment of the management or the company’s board of directors, tasks, and responsibilities should be distributed among staff at different levels of the organization.
The best way to verify the HACCP system is to use management system auditing techniques. Auditing is a proven tool that has a wealth of experience in its use to verify the performance of management systems, whether for internal audits, supplier audits, or for certification purposes. This book follows the guidelines for auditing set out in ISO 19011:2018, the international reference standard for management system auditing.
There is a saying in the quality world that you learn to audit by auditing. But first it is necessary to have a good knowledge of the principles and techniques of auditing that must be practiced to achieve the competence required to perform this task effectively. The second part of this book is devoted to detailing the system to be followed and the skills and personal attributes that should inspire the auditor’s behavior during his or her professional practice.
Luis Couto Lorenzo Lalín, Spain June 2024
Acknowledgement
I want to thank all the wonderful staff at Wiley, especially Jonathan Rose and Shwathi Srinivasan, for welcoming my proposal and guiding me through the whole process of publishing this book. Thanks to them, a dream has come true!
I also want to thank Estefanía Cuíña and Juan Castro for their invaluable contribution to case study 1.
And finally, I want to thank Manuel Araújo and Montserrat López for their essential contribution to including case study 2.
1A Necessary Evolution
Since its conception, at the end of the 1950s, until today, the hazard analysis and critical control point (HACCP) system has gone through a series of phases and circumstances that have modified it until becoming a fundamental and irreplaceable tool to ensure food safety, as recognized by numerous international bodies and institutions.
The origin of HACCP is related to the failure mode and effects analysis (FMEA) system, which we can consider its predecessor and from which it borrows part of its methodology and the systematic approach to assessing risks in a given production, for example, using flow diagrams and probability risk matrices × gravity.
Based on the FMEA, the Pillsbury Company, NASA, and US Army Laboratories in Natick developed the original formulation of HACCP for its use in flights crewed from NASA’s aerospace program. In 1971, the concept was presented publicly at the National Conference for Food Protection, co-sponsored by the Food and Drug Administration (FDA) and the American Public Health Association. At that time, the HACCP system included only three principles:
hazard identification;
determination of
critical control points
(
CCPs
); and
monitoring of CCPs.
Its application in the food industry began to take shape in 1974 with the enactment by the FDA of the regulations that applied to canned food with low acidity. And already in the 1980s, its use gradually spread to other food industry sectors.
The major milestone in the application of the HACCP system occurred in the 1990s, specifically when the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) defined the seven HACCP principles in 1992. One year later, the Codex Alimentarius Commission adopted these principles and published the Recommended International Code of Practice – General Principles of Food Hygiene, which included the annex Hazard Analysis and Critical Control Point – Guidelines for Their Application, describing the HACCP system. After several revisions, the HACCP has reached the current version: CXC 1-1969 (FAO and WHO 2022).
The importance of the publication of this General Principles of Food Hygiene is unquestionable, establishing the bases and principles of the system in a definitive way. Since then, we all have started speaking the same language and knowing what elements form the system, its methodology, and the concepts and terms that define it. This document is an essential reference for food safety auditors since it contains the requirements and criteria against which they can compare the HACCP systems designed by food operators.
With the Codex document was set up what we can call the “backbone” of HACCP: a basic structure that, since then, and with the experience acquired in the implementation of the system in the food industries, has required some modifications and the intervention of other elements that are becoming necessary to overcome the difficulties involved in its practical implementation. Some of the most significant milestones in the evolution of the HACCP system since its origin could be the following:
Publication of the Codex document.
Universal acceptance.
Need for
prerequisite programs
(
PRPs
).
The emergence of the first HACCP standards with the elements of quality management systems included.
Need for flexibility in its application to different types of operators.
Use of the audit tool to verify its operation.
Acceptance of HACCP as a food safety management system.
Application of operational prerequisites.
Need for validation of the system before its implementation.
What is not very evident in the annex Hazard Analysis and Critical Control Points – Guidelines for their Application, just mentioned in a sentence that occupies only one line, is the crucial role of the PRPs in the system’s operation, as it was recognized years later. HACCP cannot work in a vacuum; it needs to be supported on the solid basis of properly implemented prerequisites (Sperber 1998).
Over time, the practical experience gained implementing HACCP has given rise to the strong international consensus on the primary role that codes of hygiene practice should play in controlling an essential part of the hazards identified in each case. Good hygiene practices or prerequisites are the foundations of the food safety system, must be implemented first, and are valid for all food operators, including primary production; HACCP is in the second place and may not be fully applicable in some cases (Figure 1.1).
Figure 1.1 HACCP evolution.
Source: Adapted from Griffith.
Another change in HACCP is the introduction of flexibility criteria. Since in the 1990s, the HACCP system became a mandatory requirement for operators in the different sectors of the food chain – except primary production – as is the case in the European Union with Directive 93/43, the difficulties that arose in some small and medium-sized companies to be able to implement the system as a whole effectively became evident.
At that time, it became necessary to set up provisions on the flexibility necessary to adapt the application of HACCP-based procedures in some establishments. Both documents CXC 1-1969, Regulation (EC) 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs, and the guidance documents prepared by Directorate – General Health and Consumer Protection (DG SANCO) provide for the application of flexibility criteria for certain food operators. These provisions must be taken into account by food safety auditors when assessing self-control systems in these kinds of operators.
These changes and adaptations in the HACCP system have led some authors to lament the loss of its essence and original identity (Cliver 2010). There have indeed been changes, but we must also consider that HACCP was born for a very particular use and for conditions that we may describe as “in vitro” to achieve an objective of “zero defects” in the feeding of astronauts, necessary to ensure the success of the aerospace program. These conditions have little to do with the reality of the agri-food industries and with the application of the HACCP system in the different stages of the food chain, in a real food production environment, where it is not feasible to assume the zero-risk approach and in which food business operators must adjust their costs to be economically viable in a highly competitive market.
One issue that for years has been, and continues to be, the subject of debate is the possibility of extending the implementation of HACCP to all stages in the food chain, particularly primary production. Given the origin of the HACCP system, we know that its application was always more oriented to the central stages of the food chain, where there are companies that can process raw materials and carry out specific operations for the control or elimination of hazards; however, at the beginning and the end of the food chain, primary production and consumption, respectively, it is more challenging to implement.
Several HACCP experts (Sperber 2005; Cerf and Donnat 2011) recognize the difficulties in implementing the system in primary production due to the need for adequate infrastructure, technology, or even proper human resources. However, there is now a broad consensus on the need to promote good hygiene practices and good agricultural or veterinary practices as the best way to avoid or minimize the risk of hazards present at the primary production stage, which otherwise can reach the following steps in the supply chain.
In the history of HACCP, the appearance of the first standards or HACCP certification schemes was relatively early; Australia, the Netherlands, and Denmark were the most innovative and those who first saw the need for or usefulness of these standards in implementing HACCP. In 1994, the first food safety standard, the Safe Quality Food (SQF), appeared in Australia, and shortly after HACCP became mandatory in Europe, the second standard, the Dutch HACCP code “Requirements for a HACCP-Based Food Safety System” appeared in 1996, followed somewhat later by the Danish standard DS 3027:1997.
The change introduced by these standards is fundamental to understanding the subsequent HACCP evolution. Although what they do is add some aspects of quality systems, such as ISO 9000, to facilitate the management of the HACCP system, the important aspect is the qualitative leap that occurs when moving from the idea of the plan or HACCP study done on paper to a food safety management system, understood as a set of procedures to be applied by the staff of a specific organization in their daily activity – something that has ended up being entirely accepted and assumed by the bodies and institutions involved in HACCP management.
The assignment of roles and responsibilities both at management levels and between operators and supervisors, document control, implementation of documented procedures, notification and withdrawal of nonconforming products, and calibration of equipment, among others, are elements of quality systems that, over time, have demonstrated their compatibility with the HACCP system and synergy with its functioning and efficiency within the framework of a food safety management system.
In the first versions of the Danish and Dutch standards, there was little mention of PRPs, which has been corrected in their subsequent editions in conformity with the broad consensus achieved later regarding the role of prerequisites within the self-control system. Currently, safety standards or certification schemes typically include three components: the HACCP plan, PRPs, and elements of quality management; however, they may differ in the relative importance given to each of these components within the structure of the standard.
With the experience acquired in its implementation by food operators, HACCP goes from being understood as a mere document – a theoretical exercise on paper carried out by a team of people more or less competent, which ended with the delivery of the HACCP study – to become conceived as a set of provisions and procedures to implement in the different levels of business management, i.e. a food safety management system. Having a HACCP system is not having the HACCP study; the HACCP study alone does nothing for food safety. Food operators need to implement HACCP in their daily activity to see its results. As we will see later, one of the objectives of the audits is precisely to check the degree to which they comply with the provisions established in the documented system.
Despite the time that has passed, there are still people with difficulties in understanding what HACCP consists in, and this will continue as long as they approach this system without the appropriate training and guidance. HACCP is not a magic wand that alone solves the problems in a system, nor a fairy tale; it is a set of ideal arrangements, impeccable on paper but unfeasible in practice because of their cost or difficulty in implementation in a real food production environment. The basis for its effectiveness undoubtedly resides in a good study, adapted to the circumstances of each production in a specific organization. However, it will obtain the expected results only with constant work in its implementation and efforts to keep it operational and updated.
Other types of reactions to HACCP may come from skeptics, who think that HACCP contributes nothing since it is unnecessary and only a bureaucratic burden imposed from the official control –in countries where HACCP is mandatory – or a requirement to conclude a supply contract. Indeed, among those who nurture this group, there are many operators who, by the type of product or by the less exposed position they occupy in the food chain, are not aware of having lived or generated any food incident and also those who think that end-product testing is enough to ensure the safety of their food products, therefore they do not have to be worried. That is a misconception that can turn out very expensive, but it is possible to avoid this with appropriate training and awareness or, unfortunately, after experiencing an incident in their production. That is when many food operators begin to understand the false sense of safety caused by final product analyses and only then realize that the right way to ensure food safety is with the proper implementation of PRPs of hygiene – and HACCP when needed – as the most effective tools to achieve the required level of food hygiene.
For years, I have seen many times how managers or food safety technicians finally realized the real importance of the implementation of prerequisites only after overcoming a severe setback or how they started to recognize, for example, the irreplaceable value of a traceability program not only in achieving the food safety required but for the consistent performance of the business. In any case, to the most reluctant to adopt the HACCP system, we should ask: Do you know another better alternative?
Once HACCP was understood as a safety management system, it was easier to accept that the audit was the most appropriate way to check the functioning of the HACCP system in practice; a tool that, at that time, had already been tested enough in quality and environmental management systems, which facilitated the transfer of all that experience to its application in food safety. Therefore, we can assume that the guidance provided by ISO 19011, “Guidelines for auditing management systems,” perfectly applies to the HACCP system.
Compared with food safety standards audits, the HACCP system audit entails an added degree of difficulty as it does not specify the requirements as explicitly or as detailed as they are in those certification schemes. This difficulty requires the HACCP auditor to have a solid knowledge of the system’s principles and methodology and sufficient experience to determine whether the HACCP team applied the principles correctly and efficiently.
The International Organization for Standardization (ISO) published its standard for food safety management systems, ISO 22000, in September 2005, a standard that was born with the vocation of becoming the reference standard for all operators in the food chain at a time when there were already too many food standards in place. Although this objective has not been achieved since it remained with other certification schemes with great global implementation, such as the International Featured Standard (IFS) and Brand Reputation Compliance Global Standards (BRCGS), ISO 22000 became a reference model of the structure and elements a food safety management system should contain. ISO 22000 is based on the structure of ISO 9000 and integrates HACCP principles and Codex implementation, setting up auditable requirements for the HACCP plan in combination with PRPs and other aspects of management systems.
One of the concepts introduced by ISO 22000:2005 was that of operational PRPs, a novelty that caused some debate in the field of food hygiene on whether it was really necessary to add new concepts and whether it brought some advantages against the elements already defined. We will discuss these aspects later, but we may anticipate that their rationale can be justified by the need to control some hazards identified in the production process that does not fit with the characteristics required for CCPs. However, they require enhanced monitoring than prerequisites related to the control of the production environment, so they are a better choice for improving control in specific food processes.
In recent years, it has been noted that operators have difficulty understanding the concept of validation of the system. Although this concept has been clarified and consolidated, thanks to the work of some authors and the publication of guides explaining the differences between validation and verification (Ilsi 1999; FAO and WHO 2008), in practice, there continues to be some confusion and lack of experience among HACCP practitioners on how to validate control measures and the HACCP system as a whole.
This may be because, during this time, the validation has remained somewhat hidden among the verification activities within the HACCP Principle 6, as evidenced by the fact that, in practice, many manuals barely include validation activities documented. Another reason that may explain this lack of understanding is the need for sound scientific knowledge by HACCP team members to conduct HACCP validation properly. Some authors (Wallace et al. 2011) suggested the convenience of considering validation as an independent HACCP principle to make it more visible to HACCP professionals.
Thus, validation and maintenance of the system, also claimed as an independent principle for similar reasons, would be the two new principles of the HACCP system to add to the seven established since the 1990s, according to some authors. Without going into assessing the benefits arising from this proposal, the truth is that these requirements are already part of the system, included in the “macro principle” 6, and in that sense, they must be applied with the same rigor as the rest, even if the operators are not aware of this in many cases.
Figure 1.2 HACCPverse. HACCP Universe.
Sometimes, a greater specificity in the system description may be missing, for example, in Codex documents, so that HACCP principles can be interpreted and applied in the same way by all interested parties: operators, technicians, consultants, official control agents, and auditors. Thus, some authors (Wallace et al. 2011) state the lack of guidance or guidelines available to HACCP team members on how to carry out the practical application of HACCP principles, such as conducting the hazard analysis, making informed decisions, and determining which hazards must be considered significant.
The fact that we refer to principles rather than more detailed requirements of food safety, at first glance, can be considered a deficiency or a limitation; however, it may be the key to maintaining the HACCP structure stable and recognizable by all for the past 30 years – a period characterized precisely by significant transformations in the food industry. What is certain is that this basic structure – the backbone of HACCP, described so concisely in the Codex document – has not stopped adding concepts, disciplines, techniques, and applications to constitute a whole set of subjects related to the implementation and management of self-control systems: this is the universe HACCP, or – imitating the concept “Twitterverse” coined for the former name of the well-known social network X – the HACCPverse (Figure 1.2).
References
Cerf, O. and Donnat, E. (2011).
Application of hazard analysis – critical control point (HACCP) principles to primary production: what is feasible and desirable?
Food Control
22: 1839–1843.
Cliver, D.O. (2010).
HACCP is dead
.
Food Technology
64 (3): 104.
Danish Standards (2002). DS 3027:2002: Management of Food Safety based on HACCP (Hazard Analysis and Critical Control Points) – Requirements for a Management System for Food Producing Organizations and Their Suppliers. Danish Standards. Copenhaguen.
Europe, European Parliament and Council (2004). Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs.
Official Journal of the European Union
139 (1): 1–54.
FAO and WHO (2022).
General Principles of Food Hygiene. Codex Alimentarius Code of Practice, No. CXC 1-1969
. Rome: Codex Alimentarius Commission.
FAO and WHO (2008).
Guidelines for the Validation of Food Safety Control Measures. Codex Alimentarius Guideline, No. CXG 69-2008
. Rome: Codex Alimentarius Commission.
International Life Science Institute (ILSI) Europe (1999). Validation and Verification of HACCP.
http://www.ilsi.eu/publication/
National Advisory Committee on Microbiological Criteria for Food (NACMCF) (1997).
Hazards analysis and critical control point principles and application guidelines
.
https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines/
(accessed 25 November).
Sperber, W.H. (1998).
Auditing and verification of food safety and HACCP
.
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9 (2–3): 157–162.
Sperber, W.H. (2005).
HACCP does not work from farm to table
.
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16: 511–514.
Wallace, C.A., Sperber, W.H., and Mortimore, S.E. (2011).
Food Safety for the 21st Century
. Oxford, UK: Wiley-Blackwells.
2The HACCP System
In the hazard analysis and critical control point (HACCP) audit, we may distinguish two parts: the object of the audit, i.e. “what” is audited; and the audit system, i.e. “how” we do this task. The versatility of this management tool allows us to check management systems based on different disciplines: quality, environment, safety, hygiene at work, etc. In the field of food safety, it is the HACCP system that determines the object and scope of audit methods and techniques.
Other questions that may arise are “what for,” regarding the purpose and type of audit, and “against what,” i.e. what are the criteria, requirements, or reference standards to use as elements “against” which compliance with the system is compared (Figure 2.1).
In the audit process of a HACCP system, we may distinguish two phases:
Assess whether the HACCP plan is under the HACCP methodology and principles.
Check whether the provisions of the HACCP plan are implemented as described; i.e. verify whether “they do what they say they do.”
Most of the activities carried out by the audit team focus on verifying these two objectives. But we still have to add another, not the least important: to check the system’s effectiveness and assess if the expected results are being achieved. Because if, after all the effort made for the design and implementation of the system, the results obtained are far from those expected, then there is something wrong with the whole system, which involves analyzing the cause of this ineffectiveness and adopting the appropriate solution (Figure 2.2).
To determine the system’s effectiveness, we must use objective data related to production and business development or indicators such as the number of noncompliant products, incidents, reprocesses, customer returns, customer complaints. In addition, this is how the food operator can perceive the real added value of food safety management systems (FSMSs). In the first stage, the task of the auditor is to review the documentation of the HACCP system and, based on the information available of the company, such as food sector, size, organization, production lines, evaluate if the food operator correctly applied the HACCP principles and if they completed the HACCP study for each of the activities included. To carry out this assessment, the primary reference available to the auditor is the HACCP methodology and principles, as described in the document Guidelines for the Application of the Hazard Analysis and Critical Control Point System, approved in 1993 by the Food and Agriculture Organization (FAO) Codex Alimentarius Commission, or in the NACMCF HACCP Implementation Guide, adopted in 1997.
The importance of this Codex document for the application of the HACCP system is crucial, as it defines what the HACCP system is and the essential elements that make it up. In this way, from the very moment of its publication, it was possible to have a standard reference for all countries, achieving that all the parties involved both in the implementation of HACCP and in its verification used the same concepts, spoke the same language, and referred to the same system unequivocally.
Figure 2.1 In audits we can distinguish the “what”, the “how” and the “what for”.
Figure 2.2 Two-step audit approach.
If we did not have this reference document, the HACCP system would have as many different contents as each user and take multiple forms, and the task of the auditors would be very complicated because they did not have the elements or criteria with which to compare the HACCP plans of food operators and thus determine their compliance.
Auditing against the principles of the HACCP system rather than against the requirements defined in the clauses and points of a standard or certification scheme can pose an added difficulty for food safety auditors. This lack of specificity of HACCP principles requires the auditor to have a deep knowledge of the methodology and principles of the system and to know how general principles apply to the particular situation of each food operator. That lack of specificity also requires auditors to have a margin of flexibility to assess the adaptation of HACCP requirements to the characteristics of each food operator, such as size and production orientation, provided that the result must be a consistent and effective system to ensure the safety of the food produced.
Because of the above, it is worth asking if, to facilitate the HACCP evaluation, it would be desirable for the HACCP system to have more development and specificity in its requirements, as is the case in HACCP standards. It may be an issue to debate; however, we should note that, presumably, the fact that the system is defined only from the steps and principles is what has given it the robustness and stability necessary to remain during all these years as the international reference and the basis of FSMSs for all operators in the food chain.
2.1 Characteristics of the HACCP System
Schematically, we may state that the HACCP system has the following characteristics:
structured;
logical;
preventive;
based on science;
risk management;
practical;
common sense;
cost-effective; and
realist.
Like the failure mode and effects analysis (FMEA), its methodological antecedent, the HACCP study is structured through the sequential application of a series of steps. The HACCP team, in a reasoned and logical way, based on the process data and the available scientific information, must identify the hazards that may arise from each stage of a given production. The next step is to establish the likelihood that the hazards identified as potential will cause harm to consumers. Having determined the risk for each significant hazard, the HACCP team must establish what preventive measures can avoid them or reduce their presence to an acceptable level.
One concept that should be clear from the outset is that HACCP does not aim to control and manage all potential hazards as if achieving a zero-risk level were possible. This approach is neither realistic nor economically feasible; such control measures would entail an unbearable cost for food operators and make their productive activity practically impossible.
The generalization of the implementation of the HACCP system among food operators meant a paradigm shift in food safety, which we can describe as follows:
The responsibility for providing safe food to consumers lies with food companies through their self-monitoring systems.
Official control now has the role of supervision and verification of the self-control systems of food operators.
Food safety assurance is no longer based on inspection and end-product testing but on the application of preventive measures.
Food legislation no longer specifies most of the particular requirements, but food operators decide based on HACCP principles and procedures.
Both official control and
food business operators
(
FBOs
) adopt audit techniques to check the functioning and effectiveness of self-control systems.
2.2 The Limitations of Final Product Analyses
The traditional food control system was based on inspection and analysis of the final product; despite the widespread implementation of HACCP, there is still some predisposition, both in food operators and in official control agents and other stakeholders, to overestimate the usefulness of food safety inspection and analysis for food safety control.
Therefore, we must remember that the final product analysis has certain limitations that we should not overlook:
They are corrective, not preventive
: they detect problems after they have occurred; this means having to act on the noncompliant product: reprocess or dispose of it while it is still in the possession of the manufacturer; or, in some cases, recover it from the market when it has already been distributed, with the higher costs that this entails, as well as the loss of image and consumer confidence.
Slow
: Some tests may take several days to obtain results; this means a longer time until the problem is detected and implies keeping the merchandise retained or, worse, the risk of having to withdraw it from the market when it has already left the food operator’s premises.
Expensive
: although it depends on the number of samples analyzed, in general, laboratory analysis has a high cost for the operator, to which must be added the units of product that are lost when the analyses are destructive.
The probability of detecting defective products is often low. Undoubtedly, the most crucial limitation from the point of view of food safety, since, despite the false sense of security that sampling plans can provide to the operator, the calculation of probabilities explains how often it can be to consider acceptable batches of product with a certain number of defective units that end up reaching the consumer.
Setting the goal of inspecting 100% of production units is not always realistic or feasible under the conditions in which people typically work in the food industry. Even in cases where the operators can have a system that allows them to inspect all the units, human errors will eventually occur, mainly if we refer to monotonous tasks, in which it is normal for the attention to decline over time or by the distractions that occur during the working day.
In addition, not all defects are equally obvious or easy to detect on visual inspection, and then there are all those that are not noticeable to the naked eye. Therefore, inspecting the final product is not a method to ensure the absence of defects and food safety.
The same goes for final product analyses; it is not possible to analyze 100% of the production, first because, in the case of destructive analyses, we would leave nothing to sell and second because that would mean an unaffordable cost for FBOs. The only solution is to take a sample of the set of units produced and infer the state of the whole production from the result of that sample. The problem, which many people need to realize, is that sampling is always associated with the probability of detection of defective or contaminated units. The number, size, and nature of the collected samples greatly influence the results’ representativeness. However, even in the most comprehensive sampling plans, increasing the number and size of the samples, it must always be borne in mind that there is a probability of detecting defective units and that there are going to be cases where the result of the analysis of the batch sample is acceptable when the batch is not acceptable.
To illustrate this concept of probability associated with sampling plans, we can start with a simple case. Imagine that we take a single sample (n = 1) to determine the acceptability of a batch in which the presence of a contaminated unit would lead to the rejection of the batch (c = 0). In this case, the probability of detecting the contaminated units coincides precisely with the percentage of contaminated units in that batch. For example, if 50% of the units are contaminated, with a single sample half the time, we can detect these contaminated units. The bad news is that batches with 50% of their units contaminated would be distributed to the market an equal number of times. If the percentage of contaminated units drops to 10%, then only one in ten times would we be able to detect contaminated batches, which means that 90% of batches with 10% of their units contaminated would come to market. As we can see, this approach is unacceptable from the point of view of food safety. Suppose we want to improve the detection capacity. In that case, we can increase the number of samples, so if we take two samples (n = 2), the probability of accepting a batch with 10% of the contaminated units would be 0.9 × 0.9 = 0.81 (the probability of two independent facts is the product of their probabilities); as we can see, this probability decreases. However, we still have only a 19% chance of detecting the defective batch.
To understand better the effect of increasing the number of samples, in the following graph, we can compare the probabilities of acceptance between two sampling plans n = 1 and n = 5 for different percentages of defective units (Figure 2.3).
When we look at the column of 5% defective units, with the one-sample plan, the probability of accepting the lot is 0.95, and with the five-sample plan, the probability drops to 0.77, although it is still too high.
In addition to the number of samples, the sample’s representativeness depends on the nature of the food and the homogeneity of the distribution of contamination among the units of the lot, more homogeneous in the case of liquids.
In the following table, we can see the joint effect of the number of samples, the concentration of contamination, and the homogeneous or heterogeneous distribution of contamination among all the lot units on the probabilities of detection of the contaminated units (Figure 2.4).
Sampling plans are used to decide whether a batch of product is acceptable; for this, it is necessary to have a criterion to compare the results of the units of samples analyzed. A sampling plan, therefore, consists of a sampling procedure and a decision criterion.
Each sampling plan is defined by n and c; n is the number of sample units collected independently and separately, and c is the maximum number of sample units to obtain positive results to accept the batch. For example, in a plan n = 10 and c = 2, we take ten sample units, and we can accept the lot when two of ten, or less, test positive. In other cases, the sampling plan includes the term defined by the letter m (in a two-class attribute plan), which refers to the maximum concentration of a microorganism for the result of the unit analyzed to be acceptable. Thus, the plan n = 10, c = 2, and limit m means that the lot is acceptable even if two samples of the ten collected exceed the concentration m. The attribute plans of three classes still define one more term: M, a concentration greater than m, which cannot be exceeded in any case.
Figure 2.3 Probability of accepting a lot P(a) as a function of the actual number of defective units for two sampling plans n = 1 and n = 5 (ICMSF 2011).
Figure 2.4 Probability of detection in final product analysis of Salmonella contaminated milk powder (1) assumes 100% detection capability of the test (most are 90%).
Predictably, the higher the term n and the smaller the c, i.e. c = 0, the plan’s ability to discriminate defective batches increases. However, unless the entire batch is analyzed, which we have already seen as an unfeasible approach, there is no way to avoid some degree of risk in each acceptance and rejection of a lot.
Therefore, in practice, we are looking for a compromise or balance solution between the number of samples to be analyzed and the risk we can assume. The most severe plans are used for the most serious risks to the population.
In all sampling plans, it is possible to determine what is known as the consumer risk, i.e. the probability of accepting a batch whose microbial load exceeds the limit specified or with a proportion of defective units higher than established. Reciprocally, there is also the producer’s risk, i.e. the probability of rejecting an acceptable lot. No matter how much we try to increase sampling plans’ rigor or discrimination capacity, these two types of risk will always be present.
The following table shows how different sampling plans influence the probability of accepting a batch with a known percentage of defective units. This table again clearly shows how final product analysis is not an effective way to ensure the safety of food produced when the percentages of defective units are low. It would be necessary to analyze more than 3000 or 5000 sample units to detect batches with 1% of their units defective with 95% or 99% probability. It should also be borne in mind that a defect rate of 1% is intolerable for most food operators; if we consider the average batch sizes produced in the food industry, this would mean sending hundreds of defective products to the market every day. No company could work in such conditions, and it is not acceptable from the point of view of food safety (Figure 2.5).
After looking at these examples, it is easy to conclude that food safety cannot be based solely on the analysis of the final product; food operators must focus their resources on establishing control systems that prevent or minimize the occurrence of problems in a given production or activity. This is, therefore, one of the most straightforward reasons for justifying the need for HACCP.
What we say does not mean that final product analyses are unnecessary, but that we must recognize their limitations, determine the most appropriate uses, and see at which points in the food chain the information they provide is most helpful. For example, in the case of imported products, where there is no information on the conditions of the preparation of the consignment received, the only way to decide on its destination is by analyzing an appropriate number of samples, depending on the characteristics of the lot and the associated risks.
Figure 2.5 Effect of the quality of the lot (% of nonconforming units) on the probability of acceptance for different sampling plans.
2.3 Reasons to Implement HACCP
Many executives and managers of the food industry are unaware of the usefulness of the HACCP system to guarantee the safety of the food they market, nor of the benefits that its implementation can bring to the proper functioning of their business as a food company. The lack of knowledge of the system, the lack of experience, the biased perception of food risks, and preconceived ideas about what they can get from HACCP or how to manage it usually mean that the reasons why a company should implement the HACCP system are often not well understood. Among the reasons that we can expose to justify the implementation of HACCP are the following:
Problems can be avoided before they occur
