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• W1471109095 abstract "Recent norms of retailer organisations, chain oriented quality programmes, the new ordinance of the German government concerning the hygiene of food (Lebensmittelhygieneverordnung) and of course the EU regulation 178/2002 demand the implementation of self-control and hazard control techniques in terms of Hazard Analysis and Critical Control Point (HACCP) systems of agrofood industry. Such an analysis of course includes a risk analysis. These demands and regulations require a stronger inclusion of the production process in systems of quality assurance. The Failure Mode and Effect Analysis (FMEA) seems to be an appropriate tool to enable animal health services to support farmers to fulfil these requirements. On the level of advisory services a computer aided FMEA tool which includes elements of the HACCP concept is tested. The tool allows to document efforts made to meet the claims of quality assurance and simultaneously provides gathered knowledge in form of a knowledge data base supporting the advisory service to solve concrete problems on farm. The paper describes how to assemble such a system for the Salmonella problem in pig farms. Introduction Recent norms of retailer organisations, chain oriented quality programmes, the new ordinance of the German government concerning the hygiene of food (Lebensmittelhygieneverordnung) and of course the EU regulation 178/2002 demand the implementation of self-control and hazard control techniques in terms of the Hazard Analysis and Critical Control Point (HACCP) system of the agrofood industry. Relating to the supplier chains for meat and meat products this means to include the process of animal production in the process of quality assurance. While in the converting companies lead of experiences in quality methods have been made, there is a lack of those at the level of animal production. The establishment of those chain oriented systems may be an appropriate operational field of the Failure Mode and Effect Analysis (FMEA) in the pork production chain. The conception of this tool of preventive quality assurance is similar to the HAACP system. However the FMEA is wider composed. A combination of the two techniques FMEA and HACCP seems to be promising. To optimise the application of hazard control techniques a method manual which combines those two techniques was developed (Schmitz and Petersen, 2004). Such a “mixed” FMEAHACCP concept is provided here. FMEA method In the range of industrial production the FMEA is an established part of quality mangement as a tool of preventive quality assurance. The FMEA helps to implement a closed quality control loop by providing gathered expert knowledge. This can be used for planning as well as for executing processes (Pfeifer, 1996). The FMEA intends to detect potential sources of error and their consequences on quality characteristics as early as possible. So consecutively disturbances can be anticipated (Pfeifer, 1996). Because of this it is essential that the FMEA has to be customer oriented from the first step of production. Therefore all possible consequences of a self-inflicted failure for all succeeding chain members has to be considered. Three important contents of the FMEA are: structered failure analysis including an analysis of the causes and effects, risk assessment based on the analysis mentioned before, use of the results of risk assessment to carry out an optimisation of process or concept (Edenhofer and Koster, 1991). This aspects show that the FMEA is in fact part of a HACCP analysis. Within such an analysis the FMEA takes the parts of failure/ hazard analysis, risk assessment and it provides the actions to deal with the revealed failures and hazards. The knowledge needed to run the FMEA in an efficient way is distributed to many persons. Therefore a team with members from every step of the process of interest should be formed. The team members contribute their knowledge as experts. The discussion in the FMEA team is prepared and presented by an experienced moderator. The moderator has to encourage the other team members e.g. QM representatives and other experts to examine the process of interest very critically. And of course the moderator has to encourage the other members to be self-critical. This in addition to efficient preparation of the FMEA determines the FMEA s success. To initiate a FMEA the following steps should be taken. The first step is to fix the analysis limits. Then the process is structured and standards are assigned. In step 4 and 5 the failure analysis is done and a FMEA form established. The achieved FMEA s results are filled in a FMEA form to guarantee documentation as well as systematics and clarity. Step 6, risk assessment, is done by calculating a risk priority number (RPN). The RPN is calculated by using three variables describing the probability of the failure to occur (occurrence ,O), the severity (S) of the potential failure mode on the process and the probability to detect the failure (detection, D). Normally an assessment number ranging from 1 (no risk) to 10 (high risk) is used to describe these three variables. To facilitate assessment verbal explanations are assigned to the different values. The RPN is calculated by multiplying the values of the three variables O, S and D. The value of the RPN gives a hint whether optimisation is urgently required. Risk assessment needs a lot of supporting data to be done exactly. Optimisations (step 7) are carried out according to the following principles: Strategy amendment to exclude the cause of failure or reduce the severity. This means to restructure the system. Increase of the strategy reliability to minimise the occurrence of the failure s cause More effective detection of the failure cause. If the FMEA reveals that optimisation has to be done it has to be defined who has to do which of the recommended actions by when. This is also entered on the FMEA form. After performance of the recommended actions a risk assessment is carried out again. Risk priority numbers which had an effect on the decision are calculated again. A comparison of the two RPNs (previous and improved state) allows a final result assessment and the assessment of the relationship between achievable improvement and utilised effort. The reassessment of the risk after implementation of the recommended actions gives an estimation of the remaining risk of certain failure s occurrence. Depending on this result the team decides whether the chosen actions were successful or whether additional actions are necessary. (Stamatis, 1995) The application of FMEA software tools proved to be useful in different industrial branches. There are three main advantages: The FMEA establishment is systematised. The entered FMEA knowledge will be saved onto a knowledge database and can be used again. The effort of the establishment is reduced by the optimisation of the teamwork and by the falling back upon information already entered by means of search helps. (Schmitz and Petersen, 2001) Adaption of the FMEA concept to farm level Referring to Noordhuizen and Frankena (1999) a quality-management instrument at farm level should satisfy two basic requirements: it should provide the advisory service or the individual farmer with clear and simple procedures for elimination and control of disease risks on the farm, it should enable the farmer to prove the execution of these procedures to a third party for herd-health certification and health insurance purposes. Welz (1994) demonstrated the possibility to adapt the FMEA concept to animal production. In his study he used the FMEA to reveal interferences of product and process quality resulting from animal diseases on farm level. In the following a FMEA like approach for prevention and reduction of Salmonellosis in pig production is given. In pig production the problem of Salmonella is to be considered from two different angels. On the one hand problems in production and economical losses resulting from Salmonellosis during the production period, on the other hand the endangering of human health due to Salmonella contaminated pork-products (Waldmann and Plonait, 2001). Steinbach and Hartung (1999) assume circa 20% of human Salmonellosis in Germany to be caused by consumption of Salmonella contaminated pork-products. Referring to van Altrock and co-authors (1999) and Meyer (2004) circa 10 % of tested fattening pigs showed a positive test result. This indicates that there is a need for supporting tools to solve this problem. In literature several possible sources for the introduction of Salmonella in pig producing farms are described. The most important sources are: purchase of piglets and gilts (Lo Fo Wong et al. 2004, Berends et al. 1996), purchase of feed (Hartung 2003, Lo Fo Wong et al. 2002), biotic and abiotic vectors (Meyer 2004, Letellier et al. 1999). Each of these aspects include a lot of different subaspects. Also the transmission of Salmonella within a farm is influenced by a lot of factors. The most important are listed below: Table 1: Factors with influence on the transmission of Salmonella within a farm" @default.
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• W1471109095 title "Failure Mode and Effect Analysis (FMEA) as a decision support tool within a quality information system in pork production chains." @default.
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