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Case Study (E. Coli )

Case Study (E. Coli ). Leonardo da Vinci. Summary History (1). A, 50 year old, fermented sausage facility is following the provision for weekly E. coli bacteriological analysis in final products, in compliance with Reg. 2073/2005 – 1441/2007

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Case Study (E. Coli )

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  1. Case Study(E. Coli) Leonardo da Vinci

  2. Summary History (1) • A, 50 year old, fermented sausage facility is following the provision for weekly E. coli bacteriological analysis in final products, in compliance with Reg. 2073/2005 – 1441/2007 • As it can be seen from the documented records, although for the last year it was getting weekly positive results, they were within the acceptable regulatory limits (<5/2) with a positive cfu/g range between 5000 – 50000

  3. History (2) • Final products are put in the market in two ways: --- Whole sausage --- Peeled/sliced/packaged • The products had a pH of 5.1 and a wa value of 0.88 • Bacteriological analysis concerned both products • There were no information about bacteriological analysis in swabs from benches or other working surfaces

  4. History (3) • Starter cultures were not use • Fermentation was based on naturally existing bacteria strains in the facility • Older fermented products were used, from time to time, instead of starter cultures • Final products were considered stable and were not preserved in refrigeration

  5. Summary History (4) • During the last four weeks the results for whole sausage analysis were as follows: --- Week 1  5/3, with 4.000, 15,000, 10,000, 1000, 10,000 cfu/gr --- Week 2  5/3, with 2,000, 1,000, 10,000, 6,000, 10,000 cfu/gr --- Week 3  5/4, with 10,000, 30,000, 4,000, 15,000, 20,000 cfu/gr --- Week 4 (the last one)  5/5 with 30,000, 50,000, 8,000, 20,000, 10,000 cfu/gr

  6. Summary History (5) • Same period for the packaged product the results were as follows: --- Week 1  5/3, with 10.000, 8,000, 4,000, 2,000, 6,000 cfu/gr --- Week 2  5/4, with 5,000, 10,000, 20,000, 20,000, 15,000 cfu/gr --- Week 3  5/4, with 30,000, 20,000, 50,000, 5,000, 10,000 cfu/gr --- Week 4 (the last one)  5/5, 30,000, 40,000, 60,000, 40,000, 50,000 cfu/gr

  7. Questions to be asked 1. Which could be a possible interpretation of the tabulated results? 2. What are the possible sources of results deterioration? 3. How the FSMS structure and its implementation are assessed? 4. Which actions may be taken?

  8. Comments on the Questions (1) 1. --- Excessive presence of E. coli load  fecal contamination index (Reg. 2073/2005 – 1441/2007, Annex I, point 2.1.8) --- Marginal compliance for one year  aggravation last 4 weeks exceeding acceptable regulatory upper limits 2. --- Heavily contaminated raw material --- Low general hygienic conditions during processing, including employee personal hygiene and final product contamination

  9. Comments on the Questions (2) --- Bacterial load increases during: -- meat preparation for further processing (cutting, deboning) -- batter preparation --- Low pH and Aw hurdles for E. coli growth  initial heavy load allows for significant numbers to survive --- Post processing contamination  strong possibility (elevated bacterial load in peeled/sliced/packaged products)

  10. Comments on the Questions (3) 3. --- FSMS structure cannot be assessed without documentation --- In the case, either FSMS: -- structure is inadequate -- inefficient implementation --- End result  inadequate prerequisites implementation, especially: -- sanitization programs -- personnel training and food safety culture

  11. Comments on the Questions (4) • --- Study of the FSMS documentation: -- assessment of adequacy -- review of possible deficits --- Improved implementation of proper structured FSMS

  12. Choices of possible actions • No action • Review of the HACCP system • Review of the FSMS prerequisites • Auditing the implementation of the FSMS • Training of personnel • Improve the safety level of incoming raw materials • Improve the prerequisites related to the infrastructure of the facility • Any combination of the above (specify)

  13. Comments on Choices of Possible Actions (1) • Gradual increase of E. coli load in the final products  further deterioration is expected  requirement for immediate action • Without prejudice of possible deficiencies in HACCP the main effort should point to prerequisites fulfillment • Detailed audit of the FSMS implementation, particularly the prerequisites  step by step in the chain from raw material receiving to end product delivery

  14. Comments on Choices of Possible Actions (2) • Use as a guide ISO/TS 22002-1:2009 • Particular attention suggested to be given to: --- Infrastructure conditions (buildings, machinery) and lay out --- Food safety profile of raw material --- Sanitization programs --- Food safety culture and personnel training, including personnel hygienic facilities Special effort to commit FBO to food safety culture

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