Implementation and Management of Safety Systems

1. Implementation and Management of Safety Systems

2. Implementation and Management of Safety Systems 1. Prerequisites to HACCP • Prerequisite is the term used to describe systems that must be in place in order to support the HACCP (Hazard Analysis and Critical Control Point) System. • Prerequisites include, where appropriate: • cleaning and sanitation; • maintenance; • personnel hygiene and training; • pest control; • premises and structure; • plant and equipment;

3. Implementation and Management of Safety Systems 1. Prerequisites to HACCP • services (e.g. compressed air, ventilation, water, etc.); • storage, distribution and transportation; • waste management; • physical separation of activities to prevent potential food contamination.

4. Implementation and Management of Safety Systems 2. The HACCP Concept • Systematic approach of identifying and controlling hazards that could pose a danger to the preparation of safe food. • HAACP is a method of ensuring food safety by examining every step in a food operation, identifying the steps that are critical to food safety and implementing effective control and monitoring procedures at these steps. • In 1985 HACCP was first taken into consideration for general implementation in the food industry by the National Academy of Science (NAS);

5. Implementation and Management of Safety Systems 2. The HACCP Concept • In 1988, the International Commission on Microbiological Specification for Foods (ICMSF) suggested the use of systems HACCP as a base to quality control; • In the European Union, the Council Directive on the Hygiene of Foodstuffs no. 93/43/EEC, sets out the general hygiene principles and conditions for foodstuffs to apply throughout the food chain. • Among numerous requirements it states the necessity for each food business to apply the principles of HACCP.

6. Implementation and Management of Safety Systems 3. The HACCP Principles • The practical implementation of a HACCP System normally follows a methodology based on seven Principles: Principle 1 - Hazards analysis; Principle 2 - Identification of the critical control points; Principle 3 – Establishment of critical limits; Principle 4 – Establishment of a monitoring system; Principle 5 – Establishment of the corrective actions; Principle 6 – Establishment of verification, validation and review; Principle 7 – Documentation and records.

7. Implementation and Management of Safety Systems 4. The HACCP Methodology • The HACCP methodology is normally described in 12 steps: • 1. The HACCP team; • 2. Product description/characterization; • 3. Identification of the intended use f or the product; • 4. Flow diagram construction; • 5. On-site verification of the flow diagram; • 6. Identification and hazards analysis; • 7. Identification of Critical Control Points (CCPs); • 8. Establishment of Critical Limits; • 9. Establishment of a monitoring system; • 10. Establishment of corrective actions; • 11. Establishment of verification procedures, validation and review; • 12. Documentation and records.

8. Implementation and Management of Safety Systems 4. The HACCP Methodology • In this 12 steps are included the seven principles of HACCP. • When the decision is taken to use HACCP within an organization, it is important there to avoid the inclination that often occurs to charge ahead and start doing something without taking the time to consider the best approach: the use of the HACCP methodology. • HACCP system must not be carried out by one person alone but as the result of a multi-disciplinary team effort – the HACCP Team.

9. Implementation and Management of Safety Systems 4.1. The HACCP Team • It is recommended that as a minimum the core HACCP team consists of experts from the following areas: • Quality Assurance/ Technical; • Operations or Production; • Engineering; • Additional expertise. • The leader will have a key role in the success of the HACCP systems and he or she is likely to become the company HACCP expert and be regarded as such.

10. Implementation and Management of Safety Systems 4.2. Product Description/Characterization • The HACCP team skills in relation to technical issues are important here. A full understanding of the product and the process is necessary. • At this stage a product description must be constructed for two reasons: • It is essential that HACCP Team is fully familiarized with the products and process technologies to be covered by the HACCP Plan. • The product description acts as an introduction and point of historical reference to the HACCP Plan.

11. Implementation and Management of Safety Systems 4.2. Product Description/Characterization • All raw materials, substances and food contact materials shall be described to the extent necessary for the identification and assessment of hazards, including as appropriate the following: • Chemical, biological and physical characteristics; • Composition including additives and processing aids; • Origin and method of production; • Delivery method, packaging and storage conditions; • Preparation before use; • Acceptance criteria.

12. Implementation and Management of Safety Systems 4.3. Identification of the Intended Use For the Product • The intended use of the end product shall be described. • Users and consumers shall be identified for each product/ product category and consumer groups known to be especially vulnerable to hazard shall be considered. • Children, older persons and illness people are normally considered as group of risk as their immunological system is not totally developed or is debilitated.

13. Implementation and Management of Safety Systems 4.4.Flow Diagram Construction • The flow diagrams shall be prepared for the products/product categories covered by the safety management system. • A process flow diagram is simply a diagrammatic representation of the stages involved in producing a product. Is used as the basis of the hazard analysis and must therefore contain sufficient technical detail for the study to progress. • The simplest type of flow diagram is a linear process step diagram. • Effectively, it is a description of how a product is produced chronologically, broken into logical stages.

14. Implementation and Management of Safety Systems 4.4.Flow Diagram Construction • The following types of data should be included: • Details of all raw materials and product packaging, including reception and storage conditions; • Details of all process activities, including the potential for any delay stages. • Temperature and time for all stages. This will be particular important when analyzing microbiological hazards as it is vital to assess the potential for any present pathogens to grow to hazardous levels;

15. Implementation and Management of Safety Systems 4.4.Flow Diagram Construction • Types of equipment and design features; • Details of any reworking or recycling loops; • Floor plan with details of segregated areas and personnel routing; • Distribution/ customer issues. When the process flow diagram is complete it must be verified by the HACCP team prior to the hazard assessment stage.

16. Implementation and Management of Safety Systems 4.5. On-site Verification of the Flow Diagram • The HACCP team should endeavor to ensure that the diagrammatic representation is true to the practice on the facilities floor. • This can be done by following the product through and by seeking verification from staff members involved in the particular line. • Once this is completed, only then should the diagram be verified and passed as a live document for progression to later stages. • This should be the date record on the example above. If the walk through indicates variances then these must not be ignored, but should form the basis of an updated flow diagram.

17. Implementation and Management of Safety Systems 4.6. Identification and Hazards Analysis • A hazard is something that has the potential to cause harm, it may be physical, chemical or biological. • Within the HACCP study we need to take a logical, practical approach to risk assessment. • At the end of the hazard identification step, the HACCP team will have a list of potential hazards that might occur in the raw materials or during the process. • Risk assessment involves the evaluation of the potential hazards on this list, to establish the realistic or significant hazards that the HACCP system must control.

18. Implementation and Management of Safety Systems 4.6. Identification and Hazards Analysis • Some useful definitions are: the probability or likelihood that an adverse health effect will be realized and its severity. • Following on from the identification of hazards, the process of risk assessment involves three additional steps: • exposure assessment; • hazard characterization; • risk characterization. • Hazard characterization is an evaluation of the nature of the adverse effects or severity associated with the hazard.

19. Implementation and Management of Safety Systems 4.6. Identification and Hazards Analysis • Risk characterization is the estimation of the adverse effects likely to occur in the population. • Several different approaches to risk assessment can be adopted by the HACCP team. • They include qualitative and quantitative techniques. Both the severity and the probability of the occurrence should be considered.

20. Implementation and Management of Safety Systems 4.7. Identification of Critical Control Points • A Critical Control Point is a point, step or procedure where a food safety hazard can be prevented, eliminated or reduced to acceptable levels. • To assist in finding where the correct CCPs should be, is available a tool known as the CCP Decision Tree. • A decision tree is a logical series of questions that are asked for each hazard. • The questions in the tree should be asked for each hazard at each process step. • The following decision tree is based on the one in Codex Alimentarius but with some simplifications and amendments (Fig.1).

21. Implementation and Management of Safety Systems Fig. 1 - The decision tree

22. Implementation and Management of Safety Systems 4.7. Identification of Critical Control Points Q1 – Is there a hazard at this process step? • This first question will seem obvious but it helps to focus the HACCP team’s minds on the specific process step in question. If there is no significant hazard there is nothing that needs control, and this process step is not a CCP. • If there is a hazard then you should move on to question two (Q2).

23. Implementation and Management of Safety Systems 4.7. Identification of Critical Control Points Q2 – Do control measures exist for the identified hazard? • Here you need to consider the measures you already have in place along with what could be implemented. • If the answer to this question is yes, then you should move straight on to question three (Q3). • If, however, the answer is no and control measures aren’t and could not be put in place, then you must consider whether control is necessary at this point for food safety. • If control isn’t necessary here then a CCP is not required and you should move on to the next hazard and start the decision tree again.

24. Implementation and Management of Safety Systems 4.7. Identification of Critical Control Points Q3 – Is the step specifically designed to eliminate or reduce the likely occurrence of the hazard to an acceptable level? • If a process step is designed to remove a hazard or reduce it so that it is not hazardous, this is obviously a CCP. • If the step is not so designed, we have to progress to see if the hazard will be removed later in the process.

25. Implementation and Management of Safety Systems 4.7. Identification of Critical Control Points Q4 – Could contamination occur at or increase to unacceptable level (s)? • This question can require a significant level of technical expertise, and consultation with experts may be required. It has to be appreciated, may be cumulative and thus numerous process steps need to be considered to make a judgment. • The answer should be largely obvious from the hazard analysis but make sure that you have covered the following issues: • Is the immediate environment likely to include the hazard(s)? • Is cross-contamination possible via personnel? • Is cross-contamination possible from another product or raw material?

26. Implementation and Management of Safety Systems 4.7. Identification of Critical Control Points Q4 – Could contamination occur at or increase to unacceptable level(s)? • Could composite time/ temperature conditions increase the hazard? • Could product build up in deal-leg spaces and increase the hazard? • Are any other factors or conditions present which could cause contamination to increase to unacceptable levels at this step? • If the answer to question four (Q4) is yes, move on to the decision tree with the next hazard or process step.

27. Implementation and Management of Safety Systems 4.7. Identification of Critical Control Points Q5 – Will a subsequent step or action eliminate or reduce the hazard to an acceptable level? • This question is designed to allow the presence of a hazard or hazards at a particular process stage if they will be controlled either later in the process or by consumer action. • In this way it minimizes the number of process steps which are considered to be Critical Control Point (CCP) and focuses on those steps which are crucial for product safety.

28. Implementation and Management of Safety Systems 4.8. Establishment of Critical Limits • A critical limit is the monitored limit which if exceeded means the CCP will not be effective, and thus the identified hazard may occur. Critical limits must also, as far as possible, be exact and monitored. • The HACCP team must therefore fully understand the criteria governing safety at each CCP in order to set the appropriate critical limit. • In other words, you must have detailed knowledge of the potential hazards, along with a full understanding of the factors that are involved in their prevention or control. • Each CCP may have a number of different factors which need to be controlled to ensure product safety, and each of these factors will have an associated critical limit.

29. Implementation and Management of Safety Systems 4.8. Establishment of Critical Limits • In order to set the critical limits, all the factors associated with safety at the CCP must be identified. The level at which each factor becomes the boundary between safe and unsafe is then the critical limit. • It is important to note that the critical limit must be associated with a measurable factor that can be monitored routinely by test or observation. • In addition to critical limits you may find it advantageous to have another layer of control to help manage the process. • The critical limits can be used as an additional measure to indicate drift in the process, and you can then adjust the process to maintain control before the CCP actually deviates from its critical limits.

30. Implementation and Management of Safety Systems 4.9. Establishment of a Monitoring System • Monitoring is the scheduled measurement or observation at a CCP to ensure compliance with target levels and that the process is in control. • The specific monitoring procedure for each individual CCP will depend on the critical limits, and also on the capabilities of the monitoring device or method. • It is essential that the chosen monitoring procedure must be able to detect loss of control at the CCP, as it is on the basis of monitoring results that decisions are made and action is taken. • The nature and frequency of the monitoring will therefore be variable, depending on the production method and the nature of the hazard.

31. Implementation and Management of Safety Systems 4.9. Establishment of a Monitoring System • The final consideration in relation to monitoring is the means of recording. Not only is documentation a principle of HACCP, but also the monitoring serves as an essential aspect of a “due diligence” approach. • There should also be clearly indicated on any documentation or training materials the required corrective action to be taken if the monitoring exceeds the indicated critical limit; and this takes us to the next HACCP principle.

32. Implementation and Management of Safety Systems 4.10. Establishment of Corrective Actions • HACCP principle 5 requires that a corrective action must be taken when the monitoring results show a deviation from the critical limit(s) at a CCP. • Ideally any corrective action should be planned to correct any deviation from the specified tolerances before they are exceeded and control is lost. • Practically this cannot always be achieved while the process is out of control, and which therefore may represent a safety hazard. • HACCP plan is therefore likely to have two levels of corrective action, i.e., actions to prevent deviation and actions to correct following deviation.

33. Implementation and Management of Safety Systems 4.10. Establishment of Corrective Actions • Corrective action procedures should be developed by the HACCP team and should be specified on the HACCP control chart. • This will minimize any confusion or disagreements which might otherwise have occurred when the action needs to be taken. It is also important to assign responsibility for corrective action both to prevent and correct deviations. • It is important that detailed records are kept of all stages. It is essential that you investigate the cause of the deviation, and take appropriate steps to ensure that it does not happen again.

34. Implementation and Management of Safety Systems 4.10. Establishment of Corrective Actions • The defined corrective action procedures are added to the HACCP Control Chart which should detail: • What is to happen to the suspect product; • How the process /equipment is to be adjusted; • Who is to do what; • Who is to be informed.

35. Implementation and Management of Safety Systems 4.11. Establishment of Verification Procedures, Validation and Review • In order to confirm that the an HACCP procedure is working correctly, a system of verification should be set up. • This may involve internal audit, additional microbiological or other testing of finished or intermediate product, or more detailed testing around specific CCPs. • Its aims are to verify that the original HACCP procedure is still appropriate, and that specific monitoring procedures and corrective actions are still being properly applied. • There are three key things to consider here: verification, validation, and review.

36. Implementation and Management of Safety Systems 4.11. Establishment of Verification Procedures, Validation and Review Verification • In relation to HACCP, therefore, this is the step that we take to make sure that what is laid down in the HACCP documentation accurately reflects what is occurring in reality. • Verification shall be planned. The planning shall include: • purpose, method, frequency, • responsibility, • records. • Verification results shall be recorded and shall be communicated to the food safety team (HACCP team).

37. Implementation and Management of Safety Systems 4.11. Establishment of Verification Procedures, Validation and Review Validation • Is the means of establishing the effectiveness of the HACCP system and is technically a part of verification. This would normally be the use of routine testing or sampling to confirm that the control the HACCP provides is effective. • Alternatively it might involve auditing the HACCP system to provide a measure of its effectiveness. • Validation activities shall include actions to confirm that: • The established critical limits for CCPs are capable of achieving the defined levels; • The efficacy of the control measure constituting the control system; • The combination of control measure to assure adequate control of the identified hazards to obtain end products that meet the defined acceptable levels.

38. Implementation and Management of Safety Systems 4.11. Establishment of Verification Procedures, Validation and Review Validation • Food safety management system validation is an assessment carried out at planned intervals to confirm that the overall performance of the systems ensures food safety. • The food safety management systems validation shall include: • Results of verifications to assess whether identified hazards are in control; • Results of internal audits to show that the planned activities are taking place; • Evaluation of potential unsafe products and of corrections; • Complaints related to food safety. • The output of the validation shall outline the necessity of reviewing the hazards analysis and the configuration of the control measure system.

39. Implementation and Management of Safety Systems 4.11. Establishment of Verification Procedures, Validation and Review Review • Is usually taken to mean the setting of dates and a formal procedure to verify and validate the HACCP system, for example, every six months. • There are also numerous situations under which review should be triggered prior to a review date. • Review programs should be formalized as the HACCP program is completed; with most premises an absolute maximum period of six months is required, although it is usual that the HACCP team regularly conduct reviewing of the HACCP.

40. Implementation and Management of Safety Systems 4.11. Establishment of Verification Procedures, Validation and Review Review • The HACCP team shall periodically assess complaints related to food safety, audit reports, and results of verification analyses. • The necessity of reviewing the hazard analysis and the configuration of the control measure system shall then be considered. • The input for the updating activities shall be: • Communication with the HACCP team; • Other information concerning efficiency of the food management system; • Output from the food safety management system validation; • Output from management review.

41. Implementation and Management of Safety Systems 4.12. Documentation and Records • The key purposes of HACCP documentation are to ensure product safety and to illustrate that all seven principles have been followed. • Documentation serves to illustrate legal compliance to the other principles, it makes review easier, it provides a marketing advantage and it serves to contribute to “due diligence”, either in court or to an enforcement officer. • HACCP principle seven requires that effective record-keeping procedures are established to document the HACCP system. • Records may be kept of all areas which are critical to product safety, as written evidence that the HACCP plan is in compliance, i.e., verification that the system has been working correctly.

42. Implementation and Management of Safety Systems 4.12. Documentation and Records • The types of HACCP records which might be retained are as follows: The HACCP plan - as the critical document in the HACCP system the current HACCP plan should be kept. This will mean the process flow diagram and HACCP control chart, details of the HACCP team, any CCP deviations and corrective action details; Critical control points (CCP) monitoring records – this should clearly detail the CCP number, critical limits, indicate any deviations and corrective actions taken and persons involved; Training records – should include HACCP training, auditor training, food hygiene training and so on;

43. Implementation and Management of Safety Systems 4.12. Documentation and Records Audit records; Meeting records; The HACCP system procedures – may wish to consider producing an HACCP procedural document for your company as a way of drawing together all activities associated with the HACCP programme.

44. Implementation and Management of Safety Systems 5. Operation of the HACCP System

45. Implementation and Management of Safety Systems 5.1. Manage and Review Complaints • The first thing to appreciate about customer complains is that if all complains are investigated a significant number will either never be understood or be due to events that are outside the control of the producer. • It is therefore impossible to achieve zero complaints, and impractical to suggest all complaints should trigger HACCP review. • Therefore, the company needs to establish what customer complaints mean; what is unusual and what level or type of complaint requires action.

46. Implementation and Management of Safety Systems 5.2. Control of Non-Conforming Product • The organization shall establish documented procedures, which ensure that no potentially unsafe products are supplied to the customer. • A documented procedure shall be established and maintained to define how it is ensured that the handling and control or disposal of products manufactured while a critical control point (CCP) deviated from the critical limits, preventing the non-conformity from presenting a hazard to food safety. • Each product batch affected should be evaluated for possible clearance as safe for distribution. Clearance of the product may occur, where any of the conditions apply (ISO 22000). • Linked to traceability is the issue of what happens to products that do not meet specifications or other critical limits and are thus deemed to be non-conforming.

47. Implementation and Management of Safety Systems 5.2. Control of Non-Conforming Product • Obviously such products need to be controlled to ensure they are not confused with conforming products. When non-conformance is identified the non-conforming product should be specified and the fault and extent of the fault recorded. • The product should then be clearly identified. • Assuming the product is not safety reworkable or cannot otherwise be used, then disposal should be recorded and supervised.

48. Implementation and Management of Safety Systems 5.3. Maintaining HACCP System • HACCP should at this juncture be integral to the way food safety is controlled. • HACCP should be seen as a way of life throughout the entire company from the moment that the initial studies are completed and the implementation is under way. • These include: • the HACCP audit, • microbiological and chemical testing, • analysis of data, • awareness of new emerging hazards, and keeping the HACCP plan up to date. This is the final key stage of HACCP.

49. Implementation and Management of Safety Systems 5.3. Maintaining HACCP System • The HACCP system must include verification procedures to provide assurance that the HACCP plan has been implemented effectively and that it is complied with on a day-to-day basis. • Maintaining the HACCP system involved various stages: • Defined standards and regular audit; • On-going maintenance; • Data analysis; • Corrective and preventative action; • HACCP plan re-validation; • Documentation – controlled update.

50. Implementation and Management of Safety Systems 5.3. Maintaining HACCP System • The HACCP plan will need to be updated and amended periodically to ensure that it remains current. This is only really common sense – an HACCP plan which was drawn up a year ago is unlikely to reflect current activities accurately. • The HACCP audit may also provide reasons for change but remember that the audit is only a sampling exercise, an indicator of whether the HACCP plan is being complied with and is correct.