Product Board Animal Feed. HACCP Manual. Appendix 15

Transcription

1 Product Board Animal Feed GP + Certification Scheme Animal Feed Sector 2006 HACCP anual Appendix 15 Productschap Diervoeder (The Hague, the Netherlands) All rights reserved. The information in this publication may be consulted on the screen, downloaded and printed as long as this is done for your own, non-commercial use. For other desired uses prior written permission should be obtained from the Product Board Animal Feed. Approved by the Animal Feed Sector Central College of Experts 20 ai 2005 Adopted by the board of the Product Board Animal Feed 7 June 2005 Applicable / published 14 December 2005 Effective date 1 January 2006 GP + Certification Scheme for the Animal Feed Sector of 2 Appendix 15 : HACCP anual (version 7 June 2005) PDV

2 1. INTRODUCTION The HACCP manual is based on the HACCP criteria, as adopted by the Central College of Experts-HACCP, version 2 September Of the HACCP criteria a new version is available. The HACCP manual wil be adapted on this. The plan is to provide this new HACCP manual in November Until then the present HACCP manual willl remain valid. At this the GP20 HACCP anual Animal Feed Sector is still operative: Following GP + Certification Scheme for the Animal Feed Sector of 2 Appendix 15 : HACCP anual (version 7 June 2005) PDV

3 Product Board Animal Feed HACCP anual Animal Feed Sector GP20 ; Productschap Diervoeder (Den Haag, Nederland) April 2003 All rights reserved. Nothing in this publication may be reproduced, stored in a database or published in any form whatsoever, whether electronic, mechanical, by photocopying or photography or by any other means, without the prior written permission of the owner/publisher. GP20; HACCP anual Animal Feed Sector Version: PDV

4 Preface In June 1999, the management of the Product Board Animal Feed determined the Plan of Approach reinforcement quality assurance animal feed sector. The immediate cause to this was the Belgian affair with dioxin-contaminated feed fats, but besides there also were the dioxin affair in Brazilian citrus pulp in 1998 and the attention for animal flour traces in feedstuffs for ruminants in 1998 and These affairs gave cause to concern on the quality of the animal feed and its guarantees in society, the government and the parties in the animal production chain. Penetrating questions were asked on the completeness and adequacy of the quality level (standardization) and the quality assurance (GP). The system of quality assurance, applied till mid 1999 for animal feedstuffs had especially been aimed at known risks in the trajectory of production, handling and processing of raw materials and basic products. The affairs mentioned before indicated that a number of possible risk factors in the raw material chain, although mostly belonging to the food branch, had insufficiently been in focus. That s why in the Plan of Approach reinforcement quality assurance animal feed sector (June 1999) it was concluded that additional, structural measures were necessary in order to prevent as much as possible this kind of risks for the food chain in the future. The main objective of the Plan of Approach is to reinforce the system of standardization, assurance and checking & monitoring in such a way that the desired quality level for animal feedstuffs, in relation to the safety of the animal products for the consumer, is sufficiently guaranteed. This improved and reinforced system should permanently have the confidence of the consumer, as well as the other chain parties in the animal production and sales and of the government. Besides, also the safety for the animal is a point of attention. One of the most important sub-objectives arising from this is the reinforcement of the GP quality system, especially with the help of the HACCP concept 1 ) in the different chains of the animal feed sector, from raw material products up to and including the users of animal feedstuffs (cattle breeders). Through this, the animal feed sector has chosen for a system of quality guarantee (both GP and HACCP) that is also applied in the food industry. This underlines that the animal feed sector (and the previous chains) forms part of the food industry. This choice has again been underlined in a quick scan that TNO Voeding performed in July-August 1999 on the GP regulation animal feed sector (quality series number 58, January 2000). An important conclusion in this report is that the present GP regulation forms a good base to build on further to use a systematic method in the identification, evaluation and control of risk factors in management. A GP system, that is also based on ISO 9002, is a condition for the functioning of an HACCP system. In an HACCP approach, a weighed and reasonable balance should be found between preventive measures, monitoring and actual inspection and analysis of raw materials on the presence of risks that may yield problems in the consecutive chains of the animal production and sales chain. This HACCP-manual animal feed sector offers a good guideline for this purpose. Besides, companies may use the different risk stock-takings and analyses of product streams that are published by the Product Board. 1 HACCP (Hazard Analysis & Critical Control Points) is a systematic method of analyzing all chains of a production process, the identification of potential hazards and judgement of risks for the product quality and safety. This should enable the companies in a chain to establish an adequate control of all possible risks. HACCP is in the European Community in the food industry a legally obliged (and accepted) method to control food safety risks.

5 This HACCP manual was made by TNO Voeding in Zeist by order of the Product Board Animal Feed, assisted by a working group of experts from the compound feed industry, the sector single and the raw material trade. Prior to the determination, a consultation in a wide circle of interested people has taken place. The final version was determined by the management of the Product Board Animal Feed in arch, Panel HACCP-manual animal feed sector: TNO Voeding w. Ir. E.W. Oosterom Ir. A.W. Barendsz Dr. Ir. P. Sterrenburg w. Ir. H.J. Cnossen Ing. H.L. Heeres Ir. H. Beumer Group of experts H. Hooijer OPNV H. Kruijer OPNV Ing. H. Cazemier HISFA.A.J.H. Litjens FOO (Nevedi) B. den Hollander Comité van Graanhandelaren Ing. Y.Yntema FOO (Nevedi) Ing. F. ink KDD It is expected that during the introduction courses and implementation of the HACCP analysis, many questions will arise. These will be included in a question and answer list (Q&A list) and published on the PDV website ( At this moment it has been decided in the first place to introduce HACCP in the chains of compound feeds and single feeds (moisture-rich and fodder products), being the chain for the cattle farm, as well as in the feed fat sector. For the compound feed sector, in part 2 of the manual an example is included of an HACCP analysis for the process steps. It is the intention to extend this part during the first six months of 2000 with a example process scheme for a simple animal feed. At the beginning of 2001 the HACCP-manual will be extended with acuminated risk analysis of a (great) number of raw materials. We hope that this manual will be a practical means for the companies for the introduction of HACCP in their quality system. Besides, we expect that this approach contributes to the further improvement of the quality standard in the animal feed sector, where the starting point is: Feed for Food. On behalf of the management, J.H.. Kienhuis Chairman J. den Hartog Secretary The Hague, arch 2000

6 Code: HD.AL.01 Index HACCP-manual Animal Feed Sector Part 1 Author: TNO Voeding/PDV Page 1 of 23 Table of Contents HACCP-manual Animal Feed Sector Part 1 Code Document Page HD.AL.01 1 Introduction 2 of 23 2 Animal feed legislation and GP 2.1 Animal feed legislation 2.2 Animal feed sector GP code 3 Quality system general 3.1 anagement responsibilities 3.2 Training and education plan 3.3 Documentation, planning and other requirements 3.4 GP code measures 3.5 Definitions 4 HACCP plan 4.0 Introduction 4.1 HACCP team 4.2 End product specification 4.3 Intended use 4.4 Process diagrams Drawing up process diagrams Symbols 4.5 Confirmation of process diagrams 4.6 Identification of hazards 4.7 Determining control measures / CCP s Introduction CCP decision tree animal feed sector 4.8 Target values and critical limits for CCP s 4.9 onitoring CCP s 4.10 Corrective actions for CCP s 4.11 Verification of the HACCP system 4.12 Documentation 3 of 23 3 of 23 3 of 23 4 of 23 4 of 23 5 of 23 5 of 23 6 of 23 6 of 23 8 of 23 8 of 23 8 of 23 9 of of of of of of of of of of of of of of of 23 5 Literature 22 of 23 Enclosure 1 Summary of CCP s and PVA s 23 of 23

7 Code: HD.AL.01 Document: HACCP-manual Animal Feed Sector Part 1 Author: TNO Voeding/PDV Page 2 of 23 1 Introduction This is the HACCP-manual Animal Feed Sector. HACCP stands for Hazard Analysis & Critical Control Points. This process control system, which has been widely embraced in the foodstuffs industry as the system for controlling food safety, is introduced by way of this manual into the animal feed sector. The animal feed sector is already familiar with the taking of measures to ensure the safety of animal feed. The animal feed legislation and the animal feed sector GP code already provide for a large number of quality requirements for animal feed. Referred to here are sector-wide measures which will be drawn up if potential problems are suspected at sector level or if defects appear. Company-specific situations can not always be taken into account when drawing up these measures. The added value of HACCP compared to the more repressive mechanisms mentioned is that companies can analyse their own processes in a more pro-active manner. The risk analysis show the real risks to be expected for a specific company situation. The subsequent control measures to be taken must then be formulated. The animal feed sector will, through the implementation of HACCP, fit better into the quality structure of the foodstuff sector. With the introduction of the HACCP system within companies, quality assurance in the animal feed sector will be strengthened in a recognisable manner. The scope of this manual is assurance of the safety of food and feed for humans and animals. The manual is intended for the management and (staff)employees of companies in the animal feed sector who will be developing the company-specific HACCP system. The manual comprises a general section (Part 1; code HD.AL) and a section with examples (Part 2; code HD.VB). The general section discusses the requirements to be met before a start can be made on the implementation of HACCP (Chapters 2 and 3). Chapter 4 contains a plan for setting up a HACCP system. Account has been taken as much as possible when working out this plan with measures already drawn up in the legislation or the GP code. The symbol! is a reference to the animal feed legislation and/or the animal feed sector GP code. A number of examples have been included in the second section of the manual. The examples can be used as a guideline and support in the setting up of a company-specific HACCP system. The company, however, remains responsible for the development of its own system.

8 Code: HD.AL.01 Document: HACCP-manual Animal Feed Sector Part 1 Author: TNO Voeding/PDV Page 3 of 23 2 Animal feed legislation and animal feed sector GP code Companies have to operate according to legislation concerning food- en feedsafety and GP-codes or codes of conduct specified for the animal feed sector, before developing a HACCP system. Companies in the animal feed sector have to comply with animal feed legislation and the animal feed sector GP code. 2.1 Animal feed legislation Animal feed companies in the Netherlands are subject to: Dutch legislation and regulations issued by inistries including, among others, the inistry of Agriculture, Environment & Fisheries; Statutes of the Animal Feed Commodity Board (PDV). PDV is a statutory industrial organisation. This legislation and regulations have been derived from the European ( Brussels ) legislation and regulations. At European level legislation and regulations are determined by the Council of inisters and the European Commission in Brussels. Three types of legislation are distinguished: Legislation is binding in all sections for all member states and has to be adopted without modification. Directives have to be included in or modified into national legislation within a period of time as determined in the Directive by the national authority. Orders are aimed at a specific target group and are binding for those to whom the order is expressly directed. ore information on the applicable legislation and regulations can be found in the series produced by the PDV Animal feed legislation in the Netherlands.! Link to animal feed legislation 2.2 Animal feed sector GP code Companies and organisations must have implemented GP measures which are applicable to the sector into their businesses before they can set up a HACCP system. Examples of GP measures are a vermin control programme and a sanitation programme. The GP measures form the basis for the HACCP system. In the animal feed sector these GP measures are included in the animal feed sector GP code. The GP code included in the GP regulation has been written on the basis of the quality assurance standard ISO Chapter 3 deals with the relationship between ISO 9001 and HACCP.! Link to animal feed sector GP code

9 Code: HD.AL.01 Document: HACCP-manual Animal Feed Sector Part 1 Author: TNO Voeding/PDV Page 4 of 23 3 Quality system - general A company has developed a quality management system by using the ISO 9001 quality assurance standard. A number of the requirements formulated in ISO 9001 also form the management support necessary for HACCP. These general requirements, necessary for HACCP, are described in this chapter. In addition a reference is made to a summary of the measures which have already been included in the animal feed sector GP code. Finally, a list of necessary definitions is given in this chapter. 3.1 anagement responsibilities There are a number of requirements relating to animal feed safety which fall within the responsibilities of management. These include the formulation of a quality policy, the formulation of the scope of the HACCP system, the determination of tasks, responsibilities and authorities (TRA s) and the management review. 1. Formulation of a quality policy. The management lays down in a quality policy, which is a part of the total company policy, what the organisation wishes to achieve in the area of food and feed safety. It is the responsibility of management to formulate the quality policy by way of concrete objectives and to communicate this within the company. The quality policy is adjusted to the expectations of the customer and it must show that the company is aware that it is part of the food chain. The management will then ensure that the development and implementation of the HACCP system runs in accordance with the planning, that the system is maintained and adjusted in good time when necessary.! Link to animal feed sector GP code (quality policy) 2. Formulation of the scope of the HACCP system. The scope of the HACCP system must be indicated. The scope of this manual is the food and feed safety of products of animal origin. All product(group)s, process lines and production and storage locations for which the organisation is responsible must be involved in the system. The position of the business in the agricultural feed chain must also be indicated. 3. anagement review of the HACCP system When the complete HACCP system has been developed and implemented then management must ensure that the HACCP system is maintained and reviewed where and when that is necessary. Quality objectives can also be refined. This means that there is a mechanism with the effectiveness of the system can regularly be checked.! Link to animal feed sector GP code (management review) 4. Tasks, responsibilities & authorities (TRA s) When setting up the HACCP system it is also important to lay down the TRA s of employees. As an addition to the requirements formulated in the GP code, the tasks, responsibilities and authorities of employees with regard to food and feed safety should be included.

10 Code: HD.AL.01 Document: HACCP-manual Animal Feed Sector Part 1 Author: TNO Voeding/PDV Page 5 of 23 Addition of management and HACCP team member TRA s (supervision of implementation of HACCP) Addition of TRA s of production personnel and other operations employees! Link to animal feed sector GP code (Responsibilities and Authorities) 3.2 Training It is important for the setting up and implementation of the HACCP system that all personnel involved have sufficient expertise to be able to carry out their (new) tasks. anagement will ensure that the employees concerned have been adequately trained. 1. HACCP team training The management representative, the quality co-ordinator and HACCP team should be trained for HACCP. The animal feed commodity board offers sector-oriented training for this purpose. The level required can also be obtained through experience or through other courses. 2. Training of operations personnel The production and operations personnel who are responsible for the quality in the compound feed companies must be trained to stimulate awareness of food and feed safety. If one sees the importance of one s own role in this then the degree of involvement is greater. This can be brought about through courses which are specially aimed at operations personnel.! Link to animal feed sector GP code (Training)! Link to animal feed commodity board training facilities 3.3 Documentation, planning and other requirements 1. Documentation When establishing a quality system, it is important that there should be a clear, unambiguous structure in documents, instructions, forms and in the other documentation. This holds for HACCP documentation as well. The policy to be drawn up, the requirements to be laid down, the measures to be taken, etc. can be expressed in procedures, plans, instructions, other documents (like registration forms, specifications, etc.).! Link to animal feed sector GP code (quality system)! Link to animal feed sector GP code (Document and data control) 2. Planning Following implementation of a quality system it is important to plan the quality checks, sampling, analyses, registrations and inspections which should be carried out according to the quality system. Schedules and/or plans are necessary for this. The planning required for HACCP can be included in, or structured in the same way as, the quality plan specified in ISO 9001.! Link to animal feed sector GP code (quality control plan)

11 Code: HD.AL.01 Document: HACCP-manual Animal Feed Sector Part 1 Author: TNO Voeding/PDV Page 6 of Other requirements A number of ISO 9001 subjects are also essential for the functioning of a HACCP system. These are:! Link to animal feed sector GP code (Calibration of equipment)! Link to animal feed sector GP code (Inspection and testing)! Link to animal feed sector GP code (Quality records)! Link to animal feed sector GP code (Tracking and tracing) 3.4 GP code measures The previous chapters have shown that a number of requirements must have already been met prior to the setting up of a HACCP system. The purpose of this section is to give a summary of the measures already incorporated in the legislation and the GP code. A large number of these measures are also essential for the setting up of a HACCP system. The sequence of the measures is based on the sequence in the animal feed sector GP code. N.B.: This summary is intended for reference purposes and is not intended to replace the GP code. 3.5 Definitions Control measures easures which control a hazard to food or feed safety to such a degree that any hazard to food is prevented, eliminated or reduced to an acceptable level. # Specific control measure (CCP) Specific control measures are specially developed and used to control the estimated risk. # General control measure (POA) General control measures are those measures (procedures or instructions) which do not specifically apply to a single process step or which are of a global nature such as the purchasing plan, maintenance plan, cleaning plan, etc. NB: For the animal feed sector these measures have often been included in the animal feed sector GP code. # Periodic measure Periodic measures are measures which are carried out once and which are periodically reviewed/ assessed Consumer Consumer (human) of products of animal origin. Target animal The animal for which the end product (compound feed or single feed) is intended. Hazard A biological, chemical or physical contaminant in food or feed with possible adverse consequences for health. Hazard-identification Identification of possible hazards in the production process using process diagrams, end product specifications, literature and other information.

12 Code: HD.AL.01 Document: HACCP-manual Animal Feed Sector Part 1 Author: TNO Voeding/PDV Page 7 of 23 GP Good anufacturing Practices. Series of agreements in a branch or sector in which the standard of conduct is laid down (often with respect to hygiene / food and feed safety). NB: For the animal feed sector these measures have been laid down in the animal feed sector GP code. HACCP (Hazard Analysis & Critical Control Points) A process control system relating to food and feed safety which identifies hazards and quantifies risks. The risks are controlled using control measures. Risk The risk of a potential hazard is the result of the severity to health and the probability of occurence. Risk analysis (within HACCP) The hazard identification and risk assessment form together the risk analysis. Risk assessment The collection and evaluation of information about a hazard in order to be able to decide whether this forms a risk for food and feed safety. Validation Obtaining evidence or confirmation that the elements of the HACCP system (such as CCP's) are effective. Verification The use of supplementary information to check whether the HACCP system is (still) effective and whether it is being used as intended. Feed safety The certainty that animal feed does not cause any negative effect on the health of the target animal when it is prepared and/or consumed in the manner intended. Humans may also not be harmed as a result of consuming products of animal origin. Food safety The certainty that food does not cause any negative effect on the consumer when it is prepared and/or consumed in the manner intended.

13 Code: HD.AL.01 Document: HACCP-manual Animal Feed Sector Part 1 Author: TNO Voeding/PDV Page 8 of 23 4 HACCP plan 4.0 Introduction Hazard Analysis & Critical Control Points, HACCP, is a process control system related to food and feed safety. HACCP can be divided up into 12 steps which are described in the Codex Alimentarius. A HACCP system can be set up and used in combination with other quality systems. The way in which HACCP is described in the Codex Alimentarius has provided the standard for this manual. The HACCP plan comprises the following twelve steps: 1. Assemble the HACCP team: The HACCP team takes care of the setting up, implementation and maintenance of the HACCP system in the company. 2. Formulate end product specifications: End product specifications and (if necessary) raw materials specifications are drawn up or obtained. 3. Identify intended use: The intended use of the product is laid down in end product specifications 4. Construct process diagrams: The production processes are shown in process steps in diagram form. 5. Confirmation of process diagrams: Process diagrams must be checked in practice after they have been formulated. 6. Identify hazards: The hazards which may be possibly expected are identified on the basis of the process diagrams and end product specifications. 7. Determine control measures / CCP s The risk is assessed for every possible hazard to be expected (risk assessment). The type of control measure which can be used to reduce the risk is then established. 8. Determine target values and critical limits for CCP s: Target values and critical limit values must be established for CCP s. 9. onitoring of CCP s: onitoring of process parameters is carried out in order to be able to determine whether the CCP is controlled. 10. Determine corrective actions: Determine which corrective actions will be taken if the critical limits are exceeded. 11. Verification of the system: The use of supplementary information to check whether the HACCP system is (still) working effectively. 12. Draw up the necessary documentation: The necessary documentation must be drawn up and/or the current documentation must be supplemented. These steps are discussed in detail in the following sections. 4.1 HACCP team The HACCP team is a multi-disciplinary company team which supervises the setting up and implementation of the HACCP system. After implementation the HACCP team plays a role in the maintenance and verification of the HACCP system. The HACCP system is specific to the company The competence of the members of the HACCP team must guarantee the proper development and implementation of the specific HACCP system. The team is free to use the completed examples which have been included as enclosures to this manual.

14 Code: HD.AL.01 Document: HACCP-manual Animal Feed Sector Part 1 Author: TNO Voeding/PDV Page 9 of 23 The management of the company is responsible for the foundation of the HACCP team. They will ensure that the members of the HACCP team have time and, where necessary, money available for setting up and implementing the HACCP system. Both large and small companies must set up a HACCP team. The size of the team depends on the size of the company and the expertise of the members of the team. In a large company the HACCP team may consist of 5 or 6 people whereas in small companies it is possible to make do with 2 or 3 people. It is important that different areas of expertise are represented in the HACCP team. The more areas of expertise represented in the team, the more complete the HACCP system will be. In addition to various areas of expertise, the team members should be drawn from the various hierarchical levels within the company. This will ensure that HACCP will be accepted by the whole company. The areas of expertise which must be represented in every HACCP team are: management representative (with authority to take decisions) knowledge of methods of working on the shop floor quality co-ordinator with insight into the quality of raw materials and end products Depending on the activities of the company, and therefore if applicable, the following areas of expertise must also be represented in the HACCP team: knowledge of purchasing knowledge of the production process knowledge of storage, transport and sales technical expertise related to the machines knowledge of nutritional and agricultural matters Both the management representative and the quality co-ordinator in the HACCP team must follow a HACCP course or a comparable level must have been reached through experience. The HACCP team must, in addition to going through the 12 HACCP steps, ensure proper integration with quality systems and procedures which are already present. The general requirements mentioned in chapters 2 and 3 must therefore also be taken into consideration by the HACCP team and processed in the applicable documents. The company must record the composition of the HACCP team and the areas of expertise of the members of the team in a document or supplement any documentation which already exists. The expertise must be verifiable by, for example, diploma s or demonstrable job experience. If the required expertise is not available within the company then external specialists may be involved in the work of the team. External expertise must also be recorded in the documentation.! Link to animal feed sector GP code (Resources)! Link to animal feed sector GP code (Training) 4.2 End product specifications Information about end products is necessary to be able to estimate correctly which hazards may occur in the production process or which hazards are presented by the end products (animal feed) for animals or humans. The HACCP team maps out this information using end product specifications. End product specifications give an initial indication of possible hazards. In addition to the raw materials used (ingredients) and nutritional values of the end product, other characteristics must also be specified which have an influence on feed and food safety.

15 Code: HD.AL.01 Document: HACCP-manual Animal Feed Sector Part 1 Author: TNO Voeding/PDV Page 10 of 23 These may be chemical, physical or micro-biological characteristics (in the sense of contaminants or undesirable contents) but they may also be requirements for production, storage or transport. The characteristics mentioned in the specification must be taken into consideration by the HACCP team when setting up and implementing the company-specific HACCP system. HACCP prescribes, in theory, that every end product must be described separately in a specification. It is, for practical reasons, permissible to make product groups. The products must, however, be grouped together in such a way that differences in ingredients or processing steps will not lead to additional hazards. A division into three parts can be used in drawing up the end product specifications. Generally applicable requirements and characteristics at animal feed level can be recorded once. These characteristics apply then for all animal feed which is produced in a company. The same can then be done for the characteristics which are common to an animal species (often a product group). Characteristics which apply specifically to the product can be recorded at product level. N.B.: icro-biological requirements such as Salmonella absent in 25 grams can, for example, be recorded at animal feed or animal group level. In order to determine which amounts of contaminants are actually in the end product, it is necessary to know about the raw materials used and their production. This means that insight is necessary into raw materials by way of raw materials specifications. An example of an end product specification is included in Part 2 of this manual.! Link to animal feed sector GP code (Specifications)! Link to animal feed sector GP code (Purchasing data) 4.3 Intended use The HACCP team finds out whether the user can keep and use the product as intended without any hazard to animal or human health. This can be taken care of by, among other things, providing the right information. The end product specification must record for which target groups the product is intended. The animal species, the age of the animal and the directions for use (including storage conditions) must be laid down. In addition there must be certainty that the feed does not, if used normally, form a risk in animal products. Giving consideration to the target groups prevents hazards from being overlooked. This includes hazards to the animal and hazards which may arise for the consumer (human) of the animal products. 4.4 Process diagrams Drawing up process diagrams The HACCP team draws up a process diagram of the production process for each product (or product group) in accordance with the scope of the HACCP system. These process diagrams must indicate which process steps are used to produce a particular end product. The process diagram also indicates which raw materials and additives are used and whether any by-products are created during the process.

16 Code: HD.AL.01 Document: HACCP-manual Animal Feed Sector Part 1 Author: TNO Voeding/PDV Page 11 of 23 Each process, production or processing step must be shown separately in the process diagrams. Hazards can be identified using these company-specific process diagrams (see section 4.6 ff.). The following items are important when drawing up process diagrams: Choose an end product or product group Define the limits of the description of the process (start-end) ake simple, clear diagrams Limit the number of symbols to make things clearer and simpler Use unambiguous terminology for products and/or processes Work as much as possible from top to bottom and from left to right Describe the main process for the end product or product group Detail the main process into sub-processes Show the relationship among the sub-processes with a connector symbol Show raw materials and additives, semi-manufactured products, by-products and end products. A process diagram can be divided up into a main process and sub-processes. The drawing up of a main process can be useful if the process is complicated because of many process steps and/or if there are many input and output flows. The major process steps in the production process are included in the main process diagram. Each main process step is then worked out in a more detailed process diagram where all the process steps are shown separately. A map of the floor plan of the production areas can be useful when systematically mapping and verifying the production processes Symbols Four symbols are used when drawing up the process diagrams. ain process step This symbol shows the major activities or operations for a part of the process in the main process diagram. The main process steps are worked out in more detail in sub-process diagrams. Process step This symbol indicates an activity or operation (a process step). Hazards are identified based on the process steps (see 4.6).

17 Code: HD.AL.01 Document: HACCP-manual Animal Feed Sector Part 1 Author: TNO Voeding/PDV Page 12 of 23 Product This symbol indicates a tangible product (for example a raw material) or other tangible materials (for example steam or air) which enters or leaves a process. Connector symbol This symbol indicates the beginning or end of the process diagram. When it is used as a begin symbol then the name of the process in question can be given in it. When it is used as an end symbol then the name of the next sub-process can be given in it. This shows the cohesion of the various subprocesses. Please refer for a completed example to Part 2 of this manual. 4.5 Confirmation of process diagrams After the process diagrams have been drawn up they must be checked in practice by the HACCP team. In this test the HACCP team checks the processes once again on site (verification of the process diagram). When the same operation is carried out by different persons and/or shifts it is important that the process diagrams are checked against the working methods of all these persons and/or shifts. If it is shown in practice that process steps have been missed then the process diagrams must be changed. The test is intended to make certain that the right process diagrams are used. If the process diagrams and what is done in practice agree with one another then the next step may be taken. 4.6 Hazard identification Using the end product specification and the expertise of the HACCP team, the process diagrams are used to systematically determine for every step in the process which hazards may actually be expected. This activity is called hazard identification and is part of the risk analysis. The HACCP team meets a number of times to identify these hazards per process step and to identify them as completely as possible. It is recommended that, where necessary, external advisors are used in these brainstorming sessions to avoid incompleteness due to company blindness. When defining the hazard the source and/or origin of the hazard can be indicated briefly. This makes the subsequent establishment of control measures simpler (see section 4.7).

18 Code: HD.AL.01 Document: HACCP-manual Animal Feed Sector Part 1 Author: TNO Voeding/PDV Page 13 of 23 A hazard can be described as a contaminant in feed which can have adverse consequences for the health of humans and animals. In addition to the hazards (risk factors) which are included in the animal feed sector GP code, three types of hazard are distinguished: 1. Chemical hazards are undesirable chemical elements which may make the product unsafe for consumption. They may be present in the raw materials or may contaminate the product during the production process through, for example, contact. Examples are residues of pesticides, hormones, antibiotics, heavy metals, environmental pollution, mycotoxins, PCB s, dioxins, cleansing agents, lubricants, mineral oils, etc. Too high a concentration of desirable elements can also be a hazard and may make the product unsafe for consumption. Animal feed sector GP code: Chemical hazards: Undesired substances and products Residues of additives and animal drugs Production additives Biological decomposition products Criteria for the fat ratio inerals and acid remains 2. icrobiological hazards relate to the presence of undesirable micro-organisms. The microorganisms can, as a result of their (natural) presence, contamination or development, result in a product being unsafe for consumption. Consumption of the product can then cause food infections or food poisoning. A distinction is made among vegetative micro-organisms, toxigenic (toxin forming) micro-organisms and spore forming micro-organisms. Examples are Salmonella, Enterobacteriaceae and oulds and Yeasts (the latter group as indicator organisms). Animal feed sector GP code: (icro-)biological Veterinary risks (animal diseases) hazards Hygiene (Salmonella control) 3. Physical hazards Physical hazards are foreign bodies such as glass, plastic, metal components, stones, bones, etc., which may be present in the raw materials or contaminate the product. This makes the product unsafe for consumption. Animal feed sector GP code: Physical hazards Remains of packaging materials In the example in Part 2 a number of hazards are identified per process step. Every company must, however, evaluatet its own situation to determine with which (additional) hazards the company is confronted. It is recommended that a list is drawn up of concrete hazards from the point of view of product specifications and (business) expertise which is specific to the company. This list is the basis for going through the decision tree.! Link to animal feed sector GP code (Production)! Link to animal feed sector GP code (Chapter 3; Risk factors)

19 Code: HD.AL.01 Document: HACCP-manual Animal Feed Sector Part 1 Author: TNO Voeding/PDV Page 14 of Determining control measures / CCP s Introduction When the hazards have been identified, it must be established in which process step(s) there will be a critical control point (CCP) and/or which other control measures are necessary. In order to do this, the identified hazards are subjected to the CCP decision tree for the animal feed sector.! Link to animal feed sector GP code (Process control) The identified hazards must be identified for each process step. A risk analysis table can be used for this. An example of such a table is included in Part 2 of this manual CCP decision tree animal feed sector Each identified hazard must be assessed by the HACCP team using the CCP decision tree. The CCP decision tree is used to determine whether a hazard must be controlled using a specific control measure (CCP), a general measure (POA) or another periodic measure. The CCP decision tree for the animal feed sector is shown in this section. Part of the CCP decision tree is the risk assessment. This determines which type of control measure is necessary to eliminate hazards and/or to reduce risks and to control them at an acceptable level. Control measures can vary from technical/technological solutions to organisational and/or procedural measures. Where possible the control measures can be integrated with the measures in the animal feed sector GP code. There are, therefore, various possibilities for controlling risks.

20 Code: HD.AL.01 Document: HACCP-manual Animal Feed Sector Part 1 Author: TNO Voeding/PDV Page 15 of 23 CCP decision tree animal feed sector Question 1: Are there identified hazards present which have a harmful effect on the safety of the product and/or can the hazard exist or be increased to unacceptable levels? Yes No stop and continue 1 Question 2: Which types of control measure(s) are necessary according to the risk assessment? specific general periodic none 1 measures 4 measures 3 measure 2 stop and continue 1 include in verification procedures include measures as POA s and in verification procedures Question 3: Are the specific control measures referred to present? Yes No modify the process or product and start again at question 1 Question 4: Has this process step been specifically developed to eliminate the risk or to reduce it to an acceptable level? No Yes Question 5: Will the risk be eliminated in a subsequent process step or will it be reduced to an acceptable level? Yes No CCP stop and continue 1 1 Stop and continue with the next hazard Risk assessment Severity Probability of occurrence (in end product; at consumption) Great edium Small Small edium Great

21 Code: HD.AL.01 Document: HACCP-manual Animal Feed Sector Part 1 Author: TNO Voeding/PDV Page 16 of 23 Risk assessment Risk assessment is a method by which classes of risk can be defined. Risk is determined by two elements, severity and probability of a potential hazard. The assurance for each risk class is characterised by (a combination of) control measures. Severity is the consequence for the consumer and/or the target animal when exposed to the hazard. Severity is divided into three levels: great: fatal consequences, serious illness, irrecoverable injuries both immediately or in the longer term medium: substantial injuries and/or illness, occurring both immediately or in the longer term small: minor injuries and/or illness, not or hardly occurring or only in extremely high doses for a long period of time The probability is the frequency that the hazard will occur in the end product at the moment of consumption by humans and/or the target animal. The probability is based on measurements, observations or expectations in a company-specific situation and it is divided into three levels: small: practically impossible or not probable medium: might occur, it has been known to occur great: occurs repeatedly Risk class Control measures 1 No measures necessary. 2 Periodic measures are measures which often cover a one-time activity. These measures must be reviewed periodically which means they must be checked against the insights available at that moment. 3 General control measures, such as proper hygiene facilities, procedures for cleaning and desinfection personal hygiene instructions and maintenance, vermin control, maintenance and calibration, purchasing procedures and raw materials specifications, complaint handling and recall procedures, etc. These general control measures are often called POA s (Points of Attention) or GP measures. For the animal feed sector these measures have mostly been included in the animal feed sector GP code. 4 Specific control measures are specially developed and used to control the risk. In part two there is a summary of existing GP-measures (enclosure 1) and supplementary measures are mentioned (enclosure 2).

22 Code: HD.AL.01 Document: HACCP-manual Animal Feed Sector Part 1 Author: TNO Voeding/PDV Page 17 of 23 Completing the risk analysis table (see examples in Part 2) During identification of the hazards at each process step and working through the CCP decision tree, the risk analysis table can be filled in line for line. This shows, demonstrable on paper, that the HACCP analysis has been carried out. 1. The hazards are identified per process step in the process diagram (section 4.6) and they are entered in the risk analysis table. In the table the columns No., Process step and Hazard description are filled in per line. 2. An indication is given per hazard of which of the three categories apply (: micro-biological, C: chemical, F: Physical). Fill in column Cat. 3. The CCP decision tree is gone through for each hazard and consists of a number of questions. The risk assessment is mentioned in question 2 of the decision tree. The probability, the severity and the risk class are completed in the appropriate columns in the table (columns Probability, Severity and Risk). 4. In the Explanation column there must always be a short explanation of the results per hazard. This explanation is intended to explain the choice made by the HACCP team. In addition, this information can be used in later verifications and it can also be used by HACCP teams which have changed their composition. In this way the considerations remain accessible and clear. 5. When the decision tree has been gone through, the (control) measures must be summed up in the column Types of measures. These can also be measures which are mentioned in the animal feed sector GP code. Completed examples have been included in Part 2 of this manual. A number of hazards have been identified in these risk analysis tables. The results per hazard (using the CCP decision tree) are, however, not filled in. Because this is a general example, not a company-specific situation, it is difficult to estimate the severity and probability of potential hazards. Probability, in particular, is very company-specific. The HACCP team of a company is also responsible for identifying other hazards (additional, company-specific hazards). A list is made of all the measures in the risk analysis table in the examples which have already been mentioned in the animal feed sector GP code. A great number of hazards are, therefore, already partly controlled by one or more measures in the GP code. In addition to this and depending on the results of the risk assessment, these measures must be supplemented with company-specific measures. N.B.: If the risk assessment for the hazard results in a 4", then there is a CCP. Even if a number of measures are mentioned in the GP, additional specific control measures (CCP) must be formulated in that case. If the risk assessment for a hazard results in a 2" or a 3", then the measures already recognised in the GP may be effective enough to sufficiently reduce the hazard. See also the summaries of measures (part 2; enclosure 1 and 2).

23 Code: HD.AL.01 Document: HACCP-manual Animal Feed Sector Part 1 Author: TNO Voeding/PDV Page 18 of Target values and critical limits for CCP s The HACCP analysis determines where specific control measures are necessary to control CCP s in order to be able to guarantee the safety of the product. These are the measures which are divided into risk class 4 during the risk analysis. Specific control measures relate to (process) parameters which can be so controlled that hazards related to the safety of food and feed are avoided, eliminated or reduced to an acceptable level. If there were to be no control then there would be a great risk. When describing the specific control measures, target values and critical limits must be set and recorded. A target value is set for the measured value of the parameter. This value obviously lies within the critical limit values. Critical limits are values within which the measured value of the (process)parameter may vary in order to be sure that a safe product is obtained. If the limits are exceeded then there is an unacceptable situation. N.B.: It is permitted to make use of a so-called action limit before the critical limit is reached and the process is, therefore, no longer controllable. When the action limit is attained direct action can then be taken without the critical limit actually being reached. An action limit is a value between a target value and a critical limit value. When determining the target values and critical limits for CCP s it is obligatory to comply with the requirements set by the relevant legislation and regulations for food and feed safety. If there are no legal requirements with respect to target values and critical limits, then the target values set with respect to CCP s must be validated through one s own research and described in a validation report. Such a validation report should, therefore, be available. See enclosure 1 for an example of a summary of CCP s and POA s. 4.9 onitoring CCP s onitoring is the planned measurement, analysis and/or observation (visual testing) of the process parameters in order to be able to establish where a CCP is under control. The monitoring of CCP s can be a continuous, semi-continuous or charge-driven measurement depending on the process step and the nature of the (process) parameter to be measured. If there is no continuous monitoring then the batch in question must be blocked from the previous measurement moment if the critical limit values are exceeded. The way in which the measurements and/or observations are carried out and recorded, the frequency of measurement and the employee responsible for monitoring must be recorded in a (job)instruction. The results of the monitoring are recorded on registration forms.! Link to animal feed sector GP code (Documentation) See enclosure 1 for an example of a summary of CCP s and PVA s.

24 Code: HD.AL.01 Document: HACCP-manual Animal Feed Sector Part 1 Author: TNO Voeding/PDV Page 19 of Corrective actions for CCP s After the setting of target values and critical limits and the setting up of a monitoring programme, a decision must be made on corrective actions to be carried out if a critical limit is exceeded. In that case the safety of the end product can, after all, no longer be controlled. Examples of corrective actions taken when critical limit values are axceeded are: Example Corrective actions: identification of the non-conforming products and temporary block on the product or batch adjustment of the process; recovery of production conditions unblocking the product or the batch through actions varying from : - recovery of the product or the batch - destruction of the product or the batch - recall from the market The way in which the measurements and/or observations are carried out and recorded, the employee responsible for monitoring, the corrective action and the employee responsible must be recorded in an (job)instruction. The results of the monitoring and the results of the action to be taken in the event of deviation must be recorded on registration forms. N.B.: Corrective actions (HACCP term) should not be confused with corective measures (ISO/GP animal feed term). See appendix 1 for an example of a summary of CCP s and POA s Verification of the HACCP system After the HACCP system has been developed and implemented periodic verification of (elements of) the system must take place. The HACCP team has a major task in this. Verification is the use of supplementary information to verify whether the system is still effective and whether it functions as intended. The verification results must be recorded in writing. Verification of (elements of) a HACCP system must consist of: 1. Verification of CCP s Trend analysis of measurement data for the parameters associated with the CCP s, any deviations in the process and the corrective actions taken. The measuring equipment used for CCP s must also be calibrated.! Link to animal feed sector GP code (Control of inspection, measurement and testing equipment) 2. Verification of the HACCP system by sampling and analysis of products. Periodic examination of end products for micro-biological and chemical characteristics is a method of finding out whether the HACCP system is still working as intended. The end product specifications are used for this. When analysis results do not conform to the end product specifications then corrective measures must be taken.