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Hazard Analysis and Critical Control Point (HACCP) is a systematic method to identify, evaluate and control food safety hazards. Since its initial development in the 1960s, HACCP has been increasingly used at every stage of the food chain. In many countries, it is a legal requirement for all food business operators to have some form of hazard analysis based on this system, and so there has been a growing interest in all aspects of HACCP.. Leatherhead Food Research has, for many years now, offered a comprehensive food safety training programme. These training courses are now going to be complemented with the first in a series of food safety publications. This guide is designed as an easy-to-use reference book to help all staff implement a thorough HACCP plan into their industry. A good understanding of HACCP is essential right across the board, from team leaders, production and engineering staff, and supervisors to those working the line including CCP monitors. The book contains detailed descriptions of all the basic information required to undertake a HACCP study. In addition to this, the book has been designed to allow photocopying of certain figures, tables and workflow diagrams. This publication has been designed as a practical user-friendly guide to HACCP, and is intended to be used as a reference back in the factory. It can be used as an introduction to the basics for those who have never received HACCP training or as a checklist for those who are already using HACCP on a daily basis.
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Founded in 1919, Leatherhead Food Research, based near London, UK, is an independent organisation delivering innovative research, scientific consultancy and regulatory guidance and interpretation. Fundamentally a membership-based organisation, Leatherhead Food International's unique portfolio of products has attracted over 1,000 companies worldwide. They represent a who's who of the global food and beverage industry, ranging from large multi-nationals to small and medium-sized companies. Leatherhead Food Research's industry-leading scientific, regulatory and market research capabilities create a unique combination of food industry acumen and scientific expertise.
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A Toolkit for Implementation
By Peter Wareing
The Royal Society of ChemistryCopyright © 2009 Leatherhead Food International Ltd
All rights reserved.
1.1 What is HACCP?
Hazard Analysis and Critical Control Point (HACCP) is a systematic method to identify, evaluate and control food safety hazards. HACCP was developed in the early 1960s to help deliver safe food for United States (US) astronauts. In space, food poisoning is not an option; Salmonella or Staphylococcus aureus are potential killers in that environment! At the same time, the US Army was also investigating systems for producing safe food for its troops, following a food poisoning incident with Staph. aureus. The National Aeronautical and Space Administration (NASA) appointed the Pillsbury Company to develop a zero tolerance food safety system, which became HACCP. An engineering principle called Failure Mode and Effects Analysis (FMEA) was used as the basis of the system of hazard analysis and control.
HACCP was first used in the meat industry in the US, before being adopted by other sectors of the food industry. Different HACCP systems began to be developed for different industries. In the late 1960s, the Codex Alimentarius Commission (CAC), a food standards body jointly funded by the World Health Organisation (WHO) and the Food and Agriculture Organisation (FAO) of the United Nations (UN), developed a standard for HACCP that is still used around the world today. This standard has been through a number of revisions, the most recent in 2003 (see Further Reading).
HACCP as a system provides a means of identifying and assessing potential hazards in food production and establishing preventive control procedures for those hazards. The emphasis on prevention of hazards reduces reliance on traditional inspection and end-product testing. A properly applied HACCP system is now internationally recognised as an effective means of ensuring food safety.
The HACCP concept can be applied to new or existing products and processes, and throughout the food chain from primary production to consumption. It is compatible with existing standards for quality management systems such as the International Organisation for Standardisation (ISO) 9000-2000 series; HACCP procedures can be fully integrated into an ISO 9000-2000 quality system. Figure 1.1 illustrates the integration of HACCP within a quality management framework, with HACCP at the centre, Pre-requisite programmes (PRPs) next, and quality management as the outer 'skin'. An explanation of PRPs is given in Chapter 2. The new ISO 22000 food safety standard formally integrates HACCP within the structure of a quality management system.
The British Retail Consortium (BRC) published a standard for food producers for Own Brand goods being sold into the UK retail market in 1998. This has been revised and expanded with each new edition, now called the Global Standard for Food Safety, reflecting the global nature of the food supply chain. A revised version is produced every 3 years; the latest, Issue 5, was published in 2008 (see Further Reading). HACCP has played an increasing role in the standard, with the latest issue requiring a thorough review of company HACCP systems, including significant time spent in the factory inspecting the process. The BRC standard is used by companies supplying directly to retailers ('own label' products), and by other companies as a benchmark for their suppliers.
The application of HACCP at all stages of the food supply chain is being actively encouraged, and increasingly is required worldwide. For example, the CAC advises that "the application of HACCP systems can aid inspection by regulatory authorities and promote international trade by increasing confidence in food safety".
Although not intended for primary producers, many are using HACCP or a simplified version, to ensure safety of the supply chain, particularly if supplying to retailers or large companies.
There is also a strong customer demand for HACCP around the world. In many countries, there is a legal requirement for all food business operators to have some form of hazard analysis based on HACCP, as a means of ensuring food safety.
In the European Community (EC), a risk analysis approach based on HACCP has been a legal requirement for member states since 1993 for all food processing sites. More recently, new hygiene legislation, EC Regulation 852/2004 on the hygiene of foodstuffs, has been implemented throughout the EC, requiring all seven Principles of HACCP to be implemented to an appropriate level, dependent upon the complexity of the food business. This means that HACCP, in one form or another, is now required by all businesses producing food for sale to the general public. Other legislation, EC Regulation 853/2004 and EC Regulation 854/2004, lay down specific hygiene rules for food of animal origin, and specific rules for the organisation of official controls on products of animal origin intended for human consumption respectively. In the United Kingdom (UK), the EC Regulation is enforced by the Food Hygiene (England) Regulations 2006.
Other legislation upon which HACCP impinges includes EC Regulation 178/2002, the General Food Law, which prescribes safe food, traceability and recall procedures, and the rapid alert system for highlighting potentially harmful foods and ingredients entering EU trade. Also Directive 2007/68/EC amending the labelling Directive 2000/13/EC concerning allergens, since allergens have been recognised as an increasing food safety risk within the food industry. Companies should seek advice with respect to labelling, and the use of processing aids, since the regulatory position is constantly changing with respect to allergens, including which allergens are on the list of those that should be included on product labelling.
EC Regulation 2073/2005 on Microbiological Criteria is used in conjunction with the hygiene legislation to ensure the safety of processed products for consumer sale - for example, ready meals and critical ingredients - for example, meat and dairy products.
EC Regulation 2073/2005 states that in the case of microbiological monitoring indicating unacceptable results 'the Food Business Operator shall take measures to find the cause of the unsatisfactory results in order to prevent the recurrence of the unacceptable microbiological contamination. Those measures may include modifications to the HACCP-based procedures or other food hygiene control measures in place.'
Again it states 'A food management preventative approach such as employing good hygiene practices and a system based on HACCP principles must be in place. Food testing against the appropriate criteria should be undertaken, if appropriate, when validating and verifying HACCP.'
Some businesses may find it difficult to interpret the legislation for their circumstances, for example, small scale caterers. Several guidance documents are available, published under the auspices of the recommendation for 'National or Community Guides' under EC Regulation 852/2004. There are 'Safer Food Better Business' and 'CookSafe', produced by Food Standards Agency England and Wales, and Scotland, respectively (see Further Reading).
Within the UK, EC Regulation Nos. 852/2004 and 853/2004 are implemented through the Food Hygiene Regulations 2006.CHAPTER 2
PREPARATION FOR THE IMPLEMENTATION OF HACCP
2.1 Stages in the HACCP Process
Typically a HACCP study is divided into four stages, as illustrated in Figure 2.1.
Essentially, the bulk of the HACCP process is completed after stage two, with stage three concerned with running the process, and stage four, verification. We will be concerned with Stage 1 in this chapter.
2.2 Stage 1: Preparation and Planning
Good preparation is vital for an effective HACCP study. There are four stages that should be carried out before the HACCP study proper is started; these are shown in Figure 2.2.
2.3 HACCP Awareness and Basic Training
There may need to be a basic HACCP awareness session to explain what it is, why it is needed and how it works, before the study can start.
Basic training needs must be addressed before the study can start. Management commitment is essential to ensure that the team has enough time to carry out the HACCP study, and that additional monitoring, calibration or control equipment is provided if required. Management commitment means that there is an understanding of the benefits of HACCP, both financial and operational, and the degree of continuing commitment required. HACCP does not end with the completion of a study and production of a HACCP manual, which sits on the shelf gathering dust. HACCP is a continuing, living system, which must be appraised on a regular and scheduled basis.
An effective HACCP plan is best carried out as a multidisciplinary team exercise to ensure that the appropriate product-specific expertise is available. The team should include members familiar with all aspects of the production process as well as specialists with expertise in particular areas such as microbiology or engineering. If expert advice is not available onsite, it may be obtained from external sources.
Well-designed teams comprise between four and six experienced personnel; any more and the team becomes too large and unwieldy. The leader must understand HACCP and its implementation. Core disciplines include production or operations, quality assurance or technical, engineering, and microbiology, with one person acting as the team leader.
Often some parts of the study will require additional specialist knowledge, for example, supplier assurance, purchasing, research and development, distribution, hygiene or cleaning. An essential requirement is the ability to evaluate risk and make safe judgements.
2.5 Resource Assessment - Baseline Audit
A gap analysis should be carried out before the HACCP analysis is performed, asking some of the questions below:
Have staff been adequately trained, both in general food hygiene practices, and more specifically in HACCP?
Has the HACCP team leader received HACCP training?
Has the HACCP team received training at the right level?
Is there management commitment to HACCP?
Is there a requirement for a form of quality manual or other procedure control, which will make the implementation of HACCP easier?
How is the HACCP study going to be structured; in stages, or looking at the whole process at once?
The HACCP team should be trained to Level 2 (Foundation) as a basic requirement, with the Team Leader trained to Level 3 (Intermediate). Preferably the whole team should be trained to Level 3.
2.6 Pre-requisite Programmes (PRPs)
Before a HACCP system is set up it is essential that another set of basic procedures is in place to ensure that good workplace practices are in operation. Codex says "Prior to the application of HACCP to any sector of the food chain, that sector should have in place PRPs such as Good Hygienic Practices (GHPs) according to the Codex General Principles of Food Hygiene, the appropriate Codex Codes of Practice, and appropriate food safety requirements".
The term PRPs was first described by the WHO, and refers to all those hygienic practices and operational controls, including staff training, which help to ensure that food is produced in the most hygienic manner possible. PRPs include much of what is often referred to as Good Manufacturing Practice (GMP).
PRPs include factors for control of raw materials, operational control, personal hygiene and training, sanitation and maintenance practices, control of food, packaging and sanitary waste, design of buildings and equipment, control of pests, traceability and recall procedures. Companies that do not take PRPs into account before they set up HACCP systems will find that they have too many Critical Control Points (CCPs) and, because of the dilution of effort, poor control of their HACCP. PRPs control risks that cannot have effective real time monitoring procedures, or those repetitive hazards that occur at different locations in the factory. PRPs can be considered as those routines and policies that continue even when the food process stops. Figure 2.3 shows typical PRPs for HACCP. Figure 1.1 illustrated this in a slightly different way.
It is important to make sure that the location of the factory does not compromise food safety or spoilage considerations. The design, layout and general construction should minimise build up of dirt and waste debris, and should be adequately proofed against the ingress and settling of pests. There should be adequate toilets and hand washing facilities for the size of the operation. Equipment must be easy to clean, and it should be maintained and calibrated regularly, to ensure hygienic and accurate operations. Food factories need an adequate supply of clean water for washing, and for direct heating or cooling, if used. It is critical to make sure that waste water flow across the factory does not compromise food safety. Control and maintenance of facilities is very important, for example, control of air temperature, chill stores, freezers, adequate lighting and ventilation.
Operational controls are also important, for example, control of cross contamination for physical, microbiological and chemical hazards; time and temperature within processes; control of raw materials; hygienic control of packaging and document control.
Good storage facilities are required, both for raw materials and finished products. If finished products are chilled, then control of the chill chain from processing, through storage, transportation and delivery to the customer is critical.
2.6.1 Control of PRPs
PRPs are controlled by a rigorous internal audit procedure; the BRC has noted the importance of auditing of PRPs by raising internal audits to a 'Fundamental Requirement'; i.e. one that must be in place and followed correctly to ensure adherence to good practices. Further details on auditing procedures are contained within Section 3 of this book, Running the HACCP system.
Table 2.I provides a summary of PRPs, their areas of control and examples of some typical procedures; this list is not exhaustive. It may not be necessary to prepare a list especially for the HACCP study; it may already exist in the contents page or introductory section of the Quality manual. A blank copy of this table has been included in Appendix 1 and online at www.leatherheadfood.com/haccpbook-support-documents to be photocopied and completed as required.
2.7 Scope of Study
The scope should be determined before the HACCP study is started. First, the starting point of the study must be considered as to whether it begins at raw material intake, or before or after that point in the process. It needs to be decided which hazards are to be examined – all hazards, or just biological, chemical and/or physical. Alternatively, the study can just examine one particular hazard, as a result of new evidence, for example, Escherichia coli O157:H7.
Table 2.II provides a summary of what a typical document summarising the scope of the HACCP study and its team members could list; a blank copy of this form is included in Appendix 1.
Once the start point and hazards have been determined, the HACCP system needs to be structured in one of three basic ways; as a linear, modular or generic based plan.
A linear approach is where HACCP is applied to each individual product that the company produces. Unless the company only produces a few products, this will lead to a large number of HACCP plans that will become difficult to manage. The plan starts with raw materials, and works through to the finished product. This approach is suited to small businesses or those producing relatively few products. This was common in many food businesses starting out in HACCP; they have usually evolved into the systems described below, or combinations of these, with linear elements.
Excerpted from HACCP by Peter Wareing. Copyright © 2009 Leatherhead Food International Ltd. Excerpted by permission of The Royal Society of Chemistry.
All rights reserved. No part of this excerpt may be reproduced or reprinted without permission in writing from the publisher.
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Table of Contents
1.1 What is HACCP?
2 Preparation for the Implementation of HACCP
2.1 Pre-requisite Programmes (PRPs)
2.2 Resource Assessment
2.4 Scope of Study
3 HACCP Principles
3.2 Codex Logic Sequence
4 Principle 1 - Conduct A Hazard Analysis
4.2 Information Gathering
4.3 Building the HACCP Plan
5 Principle 2 - Determine CCPs
5.2 Critical Control Points
5.3 Prevention, Elimination or Reduction?
5.4 The Decision Tree
6 Principle 3 - Establish Critical Limits for Each CCP
6.2 Critical Limits
6.3 Target Values
7 Principle 4 - Establish A Monitoring System for Each CCP
7.2 Establish a Monitoring System for Each CCP
8 Principle 5 - Establish Corrective Actions
8.2 Establish Corrective Actions
8.3 Corrective Action Plans
8.4 General Principles
8.5 Example of Corrective Action
9 Principle 6 - Establish Verification Procedures
9.2 Validation - When and How?
10 Principle 7 - Establish Documentation and Record Keeping
10.2 The HACCP Manual
11.2 Approach to Implementation
11.3 Requirements for Implementation
12 Maintenance of the HACCP System
12.1 And Finally...
13 Case Study
13.1 UK Regional Cheese Production Case Study
Appendix 1 HACCP Toolkit
Appendix 2 Food Pathogens
Appendix 3 Frequently Asked Questions
Appendix 4 HACCP Glossary
Appendix 5 Further Reading