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Food processing companies around the world are implementing food safety management systems to ensure the production and distribution of safe foods and it became a result of globalization and international trade. Customers around the world are demanding safe and wholesome food products. To assist food processing companies to meet this marketplace requirement, ISO 22000 international standard that defines the requirements of a food safety management system should be applied.
It is an assurance system based on the prevention of food safety problems and is accepted by international authorities as the most effective means for controlling food-borne diseases and hazard associated with handling, processing, storage and distribution of foods.
Therefore, the aim of this study was:
a) Survey and audit for one of wheat milling mills to identify its compatibility with food safety management systems and its requirements
b) Preliminary steps for Implementation of prerequisite programs; operational PRP; and GMP.
c) Preliminary steps for implementation hazard analysis as well as food safety management system in accordance with ISO 22000 (2005)
d) Storability characteristics for wheat ; flour and its streams
e) Risk assessment to identifying CCP and OPRP’s quantitative and qualitative
f) Developing of HACCP plan for wheat milling processing line as well as ISO 22000
g) Monitoring of microbiological ; chemical and physical hazards in wheat milling industry
h) Design and implementation all documentation system
i) Monitoring and flow up after implantation to measure the effectiveness of the system
j) Design and implementation of corrective action
The obtained results could be summarized as follows:
Ι: Prerequisite Programs (PRPs):
1. Location and design of the milling processing line, walls, doors, devices and machines and disposals tanks were satisfactory constructed according to the criteria listed in ES: 3393, (2005).
2. Records of quality control for devices was not applicable ,since there was no monitoring for the temperature of the milling processing line and no monitoring control for the safety of water used in the milling processing line. The infrastructure of wheat milling processing line under investigation was evaluated and it was satisfactory according to the criteria listed in Egyptian standards (ES: 3393, 2005).
3. Environmental monitoring was unsatisfactory as there are no documents for quality control of air in the milling processing line, as well as monitoring of necessary hygienic principles in the milling processing line were applicable.
4. After the surveillance of the prerequisite programs (PRP) for the milling processing line under investigation, the unsatisfactory and not applicable criteria were reviewed with the management of establishment for taking the corrective actions necessary to be established before application of FSMS. In the same time, chemical and microbiological analysis of conditioning water was conducted.
5. All chemical and microbiological results of tested water were satisfactory complying with ES 190, (2007), which it is in concordance with WHO regulations.
6. Hand swabs from workers of processing line (packaging) were tested for total viable count, counts of coliform group, S. aureus and Moulds& Yeasts, and then tested for the presence of Salmonella spp. Total viable count of swabs from hands of plant workers was ranged from 3.00 to 1.50 log cfu/swab during the investigation period of autumn, while it was ranged from 2.00 to 1.48 log cfu/swab during spring period. In the same time, counts of Moulds were ranged from 2.13 to 1.00 and from 1.54 to < 9 log cfu/swab during the aforementioned investigation periods, respectively.
II. Preliminary steps for conducting hazard system:
A. characteristics of Wheat Flour:
7. Moisture content was 13.47.based on dry weight. Each 100 gm of dry samples contains 0.54 % ash. The chemical compositions of the Russian stream agree with the chemical composition found in the literatures. Also rheological properties, which are very critical and important for producer and consumer, provide the suitability of the flour for industrial uses.
B. Wheat flour description and its intended use:
8. Wheat flour 72 % extraction is refined meaning that the bran is removed from the rest of the grain and in the process many nutrients are removed. Flour is a dry product meaning that it has a low water activity (aw) a and moisture content between 12 and 14 %. It is packed into Plastic sacks; (50 kg) bags and should be stored in a cool dry place. Flour is prone to pest infestation if it is kept for very long periods of tim
c. Flow diagram of milling process and its steps
9. Before the preliminary hazard analysis of wheat milling processing line is conducted the process of production should be described to get the food product. The traditional wheat milling process will be discussed in four steps starting with the receiving and storage of the wheat, the cleaning house, milling and the final product. Developing processing flow diagrams was very important step for implementation of FSMS in milling processing line under investigation.
d. Storability of products:
Storage conditions should maintain the quality of the product (wheat grain or flour). The value of wheat grain and its flour streams depends not only on the market situation but also on the condition of the products. Moisture sorption isotherms describe the relationship between moisture content and equilibrium relative humidity. Sorption isotherms characteristics are important physical Properties of wheat; flour, and its streams which affects the storability of wheat and flour under different storage conditions.
10. Change in moisture content of wheat, rough bran, fine bran and flour during storage period at eight different levels of relative humidity (aw-values) took about fourty days to achieve the equilibrium levels. At water activity values from 0.11 to 0.55, the equilibrium moisture content was achieved by desorption (moisture loss) ,while at water activity values higher than 0.55 the equilibrium moisture content was achieved by adsorption (moisture gain).
11. The rates of vapor sorption (K-values) could be divided into 3 main parts. The lowest values of sorption rats were observed for aw <0.44, while the sorption rates increases for aw-values between 0.44 to 0.75 and the kinetics is the fastest at aw > 0.75. For rough Bran, fine bran and flour the desorption behavior lasted until aw values of 0.55 and 0.65 and k-value turned positive thereafter.
a. Equilibrium Moisture Content
12. Wheat grains showed the lowest values for equilibrium moisture content at all tested aw- levels (0.1637g H20/g D.M at aw=0.85). On other side, fine bran showed higher values of equilibrium moisture content (0.2294 (g H20/g D.M) at aw=0.85). The equilibrium moisture content of wheat Flour was 0.2g H20/g D.M at aw = 0.85.
B. Mathematical description of sorption isotherms curves:
13. The GAB equation showed the lowest values of sum of squares due to regression (SSR) and due to the experimental error (SSE) .Furthermore, the percentage of deviation between experimental and predicted values of moisture content (E %), were lower than 10% and ranged between 2.8 to 5.17 % indicating the suitability of GAB equation to represent the sorption isotherms data of wheat grain and their streams.
14. Henderson equation gave high values of the statistical parameters (SSR, SSE, S2R and S2E). The E % of Henderson equation gave a good relationship between the tested and experimental values where the E % values ranged between 3.71 to 8.32 %.
15. The value for monolayer moisture content (Mo values), heat of sorption for monolayer moisture content (C-values), heat of sorption for multilayer moisture content (K-values), surface area of sorption sites (A-values) as well as safe water activity values for storage of wheat and its streams were calculated in the present work .The reported M0 and C values for wheat grains were 0.093 (g H2O /g DM) and 13.82 (KJ /mol), respectively at 25 OC, which are in line with the values reported in the present work. On other side, the M0 and C values reported for wheat flour were in the range of 0.876(g H2O /g DM) and 12 to 45.6 (KJ /mol), respectively.
III. Hazard analysis:
a. Hazard identification and description of accepted levels
16. Critical limits for storage in silos are identified. Samples were free from salmonella as well as from remnants of mice, moulds and yeast count not exceeded 1x 104 cfu/g and <2 live insects /kg of the lot samples were found. The limits for heavy metals and impurities in this stage should be less than 1 ppm and 5 % /lot sample, respectively.
17. Preparation of milling is considered as CCP1 and its critical limits are as follows; Insects should be absent as well as foreign matter. Also heavy metals should be <1 ppm and impurities should not exceed 0.2 % from the sample.
18. Critical limits for hydration step were also established, concerning microbiological analysis, which it should be <1 cfu/ml for coliforms group and E. coli and <50 Cfu/ml for total viable count at 37 oC. Water samples should be odorless and colorless and the water total hardness should be <500 ppm, while iron and manganese concentration should be lower than 0.5 ppm
19. Packaging and labeling critical limits were given as follows: packaging material should free from pathogen microorganisms like salmonella as well as insects and contains <100 cfu /swab for quantification of yeast and moulds and <0.5 ppm for lead which will represent the printing ink.
20. Flour storage and releasing product and transportation. Critical limits includes were: absence of biological hazards and the total aftatoxin (B1, B2, G1, G2)concentration form represented sample should be lower than 10 ppm and for aftatoxin B1 it should be <5 ppm. Besides, sample should be absence from any insects or foreign matter.
b. Hazard assessment and its tools:
• Failure Mode and Effects Analysis (FMEA)
21. Risk Priority Number (RPN) is used as risk assessment tools to measuring hazards and identifying its severity; wheat in truck and receiving on site was registered as 225 RPN before corrective action is undertaken and it was decreased to become 72 after the corrective action was taken.
22. Hazard Problem raised from storing in silos are the cause of fungal infection and insect and the PRN ratio was 160 and improved to be 96 when corrective action are undertaken which was represented in re-aeration, fumigation and activation of pest-control program.
23. Wettability step for wheat is identified as a hazard step by using water, which not comply with the standards concerning chemical and microbiological contamination. The PRN ratio was 160 and it was improved to be 72, when corrective actions are undertaken.
24. Hazard in packaging and storage of end products (flour and its streams); The RPN ratio for this was identified as 160 and 200 for packaging and storage respectively, and it decreases to 64 and 48 respectively after corrective actions were undertaken.
• Pareto diagram for risk hazard Classification
The main advantages of the Pareto diagram and estimated RPN’s ratio is that, it presents the stages that can cause problem in a way that can be easily understood and focuses on the very root of this problem so as to identify a suitable solution
III. Hazard analysis:
IV. Identifying of Operational Prerequisite Programs
25. Wheat grain should be purchased as closer as possible to the production specifications. Otherwise other ingredients like packaging material; disinfection and sanitizers should be supplemented with its Material Safety Data Sheets (MSDS) during study together with their resulting RPN values. These operations need operational pre-requisite program and are registered as OPRP1
26. Storage in Silos is the second step after receiving and it monitored with monitoring program to be able to follow up respiration ratio; pest control program; microbiological detection and quantification for fungal and pathogenic microorganisms during study. As described in storability section and RPN results, these operations need operational pre-requisite program and are registered as OPRP2
27. During investigation the food safety team performed monitoring program for examination of hydration of water used in wettability step. However, during investigation and RPN evaluation, these operations need operational pre-requisite program and are registered as OPRP3
28. Concerning packaging and flour storing and its declaration to clients, it was found during study and RPN evaluation, that those steps need operational requisite program and are considered as OPRP 4 and OPRP 5 respectively .O
V. Establishing HACCP plan:
A. Identification and determination of critical control points
29. CCP1 represent the sifting process and metal detector step for the hydrated grains transported through conveyers from storage silos to the mill. The hazards in CCP1 are the presence of insects, insect’s eggs as well as physical hazard. Based on RPN values, steps are specifically designed to eliminate or reduce the occurrence of the hazard to an acceptable level. Any living forms of insects that might have escaped the other methods of detection will be removed by the sifter.
30. CCP 2 represent the flour sieving, during study; food safety team become responsible for visual inspection of metal detector and it should be in place before packaging to avoid final product being returned due to physical contamination. If mill decides to mix back (recycle) product, it is advised that the product should be tested before it mixed back into the system.
VI. Monitoring system for critical control points and OPRP’S:
A. Microbiological analysis of wheat grains:
31. Wheat grains contained microbiological load with little variations according to the season of investigation. Therefore, wheat grains tested during autumn contained 4.85, 2.72, 2.10, 1.89 and 4.69 log cfu/g for total plate count and counts of moulds, aerobic and anaerobic spore forming bacteria and coliform group, respectively.
B. Chemical and pesticide residual analysis of wheat grains
32. Tested wheat grains contained 12.3 % protein on dry base. The level of total aftatoxin (G1, G2, B1, and B2) was lower than 0.17 ppm. For heavy metal analysis [(lead (Pb), arsenic (As), mercury (Hg) and cadmium (Cd)], all results were < 0.01 ppm.
33. Pesticide residual found in wheat grain. Were examined by gas chromatography and the results were : chlorapyrifose 0.15 ppm; Diazinon 0.01 ppm; Malaathione 0.044 ppm and trizophorase 0.015 .
C.Monitoring of microbiological and pesticide residual analysis of wheat flour:
34. Wheat flour, after different milling steps had a microbiological load of 4.30, 3.63, 2.10, 1.58 and 2.53 log cfu/g for total plat count and counts of moulds, aerobic & anaerobic spore forming bacteria and coliform group, respectively during autumn seasons. On the same time, Salmonella sp. were not detected at any period of investigation.
35. All pesticide residual in wheat flour results were lower than the MRL so that flour at the end of milling process indicates that it is free from pesticide residual.
D.Monitoring of wheat bran; Microbiological analysis:
36. The microbiological load of tested wheat bran during the spring seasons for the aforementioned microbiological criteria were 5.25, 3.09, 2.04, and <1 Log cfu/g, respectively. With respect to coliform group, wheat bran had a higher load in comparison to wheat flour since it recorded 4.06 and 4.16 log cfu/g during investigation periods of autumn and spring seasons, respectively.
III. Monitoring system for critical control points and OPRP’S:
VII .Corrective action:
37. The Corrective action plans for the CCPs as well as OPRP’S represent the action which should be taken to bring the process back under control before the deviation lead up to hazard. The procedures should correct the non-conformity and should deal with the products (flour and its streams) that were produced while the process was out of control.
VIII Establishment of verification plans:
38. Typical verification activities should include final product testing, where the final product should be tested three times per year and it should conform to the client requirements. During study, food safety team established verification plans to confirm that allover processes of food safety management system are implemented effectively and updated.
IX .Documentation and record-keeping procedures
39. Records and documentation kept in documentation library for all processes including production, processing and distribution. These records kept for at least the shelf life of the product
X. Handling of potentially unsafe products:
40. Handling of nonconforming products, which could be has a negative effect in food chain with recall or withdrawal these products it should be released as safe after approval from food safety team and it should undergo a package of procedures like microbiological testing of recharged packages and reworked flour and coded with special code to facilitate the process tracing pack.
XI .Food safety management system verification (Internal audit)
In this study, internal audit was conducted and used as a systematic and independent examination to determine whether activities and results comply with the documented procedures. Also whether these procedures are implemented effectively and are suitable to achieve the objectives.