Professional Documents
Culture Documents
2012
Welcome Letter from Ana
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Section 2: Food Safety and Quality Management Section 3: Facility Standards Section 4: Product Control Section 5: Process Control Section 6: Personnel Management Section 7: Best Practices Glossary of Terms Appendix A Instruction on how to Demonstrate Compliance Appendix B Critical Risk Product List
51 63 75 89 92 94 97 A1-A7 B1-B2
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Section 1: General Requirements and Expectations for All Suppliers and Distributors
1.1: Compliance with Darden Expectations and Regulatory Requirements
1.1.1: Expectation: 1) Suppliers must comply with all Country of Origin, Local, State, US FDA and USDA Federal Regulatory Requirements, including, but not limited to the following: a) Reportable Food Registry (www.fda.gov/Food/FoodSafety/FoodSafetyPrograms/RFR/default.htm) b) Code of Federal Regulations (www.gpoaccess.gov/cfr/index.html) c) USDA Food Safety Inspection Service (www.fsis.usda.gov)
(1) Resource: Codex Alimentarius www.codexalimentarius.net
2) Suppliers are expected to comply with all Requirements given in this manual. 3) Suppliers will acknowledge their intent to comply with these requirements prior to starting or continuing to do business with Darden (compliance instructions are provided in this manual). 4) Darden will conduct random verification assessments of all data submitted. 5) Darden will conduct random verification assessments of compliance to all applicable Regulatory Requirements. 1.1.2: Requirements: 1) Compliance with each element of this manual will be assessed by Darden Total Quality through a combination of components within the following framework: a) Development of and compliance with Product Specifications b) Product Specification Compliance Data c) Facility audits/certification results as required in this manual d) Periodic facility/field visits or inspections conducted by Darden personnel 1.1.3: Consequences of Non-compliance: 1) Restricted Status: All suppliers determined to be in non-compliance with Dardens food safety and quality requirements will be placed on Restricted Status, meaning that no new business opportunities with Darden will be allowed. 2) Corrective Actions: Suppliers will be notified of non-compliances via email and
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3) 4) 5) 6)
7)
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Darden Supplier Total Quality Expectation Manual 1.2: Darden Requirements for all Suppliers and Distributors
1.2.1: Acknowledge of Expectations Manual: All Suppliers to Darden will acknowledge the receipt and implementation of Dardens Supplier Total Quality Expectations Manual annually, or within 30 days of receiving a new revision. Demonstration of Compliance: Please reference Appendix A for instructions on how to demonstrate compliance.
1.2.2: Critical Risk Product List Compliance: All Suppliers to Darden will comply with Dardens Critical Risk Products List (Appendix B ) and will not use any products appearing on this list as an ingredient or final product for a Darden Restaurant under any circumstance. All Suppliers will acknowledge the receipt and implementation of Critical Risk Products List annually, or within 30 days of receiving a new revision. Demonstration of Compliance: Please reference Appendix A for instructions on how to demonstrate compliance.
1.2.3: Product Traceability Program: In May 2011, Darden announced to all suppliers the adoption of the GS1 US Foodservice Standards Initiative. To support this, Darden has published milestones for suppliers to transition to bar code standards containing common data. The first Darden milestone for suppliers is obtaining a company prefix from the GS1 organization and then creating your location and item numbers for Darden products. In subsequent milestones, you will use GS1 location and item numbers, along with lot/batch codes, on your invoices to our distribution centers; and eventually affix bar codes to our cases. For more information on Dardens adoption of GS1 standards, contact your Darden Buyer at 407-245-4000. For more information on GS1, please go to www.gs1us.org. 1) As you transition to these GS1 standards, there are minimum Traceability requirements that must be in place to be approved to provide food items to Darden. First, the Traceability Program of a supplier will include the ability to track the following product information, at a minimum: a) Number of cases produced b) Production Day Code/Lot number c) Batch Number as applicable 2) All products are traceable to their origin at least one step forward and one step back, for review and approval, ensuring compliance with the Public Health, Security and Bioterrorism Preparedness Act of 2002 3) Suppliers must hold their raw material and ingredient suppliers accountable for the above requirements.
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1.2.4: Third Party Audit Requirements: To be approved to provide food products to Darden, all Suppliers will have either a Global Food Safety Initiative (GFSI) Certification Audit (See www.mygfsi.com for a current list of recognized schemes) or a Third Party Audit, with a resolved Corrective Action Plan, within the last 6 months of application for approval, and on an annual basis thereafter. a) GSFI Certification is required for all Suppliers by June 2015. b) All Suppliers must be actively pursuing and demonstrate in writing to Darden Total Quality every 12 months, or as-requested, the progress being made toward a GFSI certification. c) Until certification to a GFSI benchmarked scheme has been achieved, all suppliers must have an annual audit of their production facilities or packing facilities performed by a third-party auditing company and submit a copy of the full audit report with corrective actions and timelines to Darden Total Quality. Approved Third Party Audits: (1) In order to become an approved Darden Supplier, we will review a third party audit from any auditing body for acceptance upon initial request to become a Darden supplier, or from the date of acknowledgement of this document. (2) During the second and third year of doing business with Darden, and while the supplier is working towards GFSI Certification, the third party audit must be conducted from one of the following auditing bodies: 1. NSF 2. Silliker 3. AIB 4. Primus 5. Steritech 6. Others as accepted by Darden
(3) Resources for Suppliers working towards GFSI Certification: i. GFSI Global Markets Capacity Building Program ii. http://www.mygfsi.com/structure-and-governance/gfsitechnical-committee/gfsi-global-markets-working-group
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1.2.5: Notifications 1) Notification of Change: Suppliers will notify Darden in the event of any change in formulas, raw materials, processes, systems, equipment, management, and/or production facility that may introduce a new risk to either the safety or the quality of the product. This notification shall include documentation of how the supplier will address any new risks. These changes are subject to approval by Darden. 2) Notification of Contract Manufacturer/Co-Packer Use: Suppliers will notify Darden of any products which are produced in a plant not wholly owned and/or operated by the supplier. Darden must approve the use of Contract Manufacturer, Co-Packer, and/or subcontractors in advance. These entities must meet the requirements of the manual, have all specifications for products, and consent to being audited by Darden representatives. 3) Notification of Regulatory Contacts/Actions: Suppliers will notify Darden of any regulatory contact, sample collection, regulatory actions or product retrievals which may relate to products, packaging materials, or ingredients produced for Darden.
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1.2.6: Illegal Use of Antimicrobials including Antibiotics Judicious use of Antimicrobials and Antibiotics, including required withdrawal periods, shall be in accordance with all FDA and USDA regulatory requirements. 1.2.7: Use of Genetically Modified Organisms Darden is opposed to genetic cloning of animal products. As such genetically cloned animal products shall not enter Dardens Supply Chain. 1.2.8: Auditor Access for Food Manufacturers & Fresh Produce Suppliers 1.2.8.1: Expectations: All members of the supply chain (growers, manufacturers, processors, distributors, importers and transporters) providing products to Darden must allow full access to both second and third party auditors at their facilities in order for those auditors to verify that good food handling practices are implemented and sustained.
1.2.8.2: Requirements: Auditor Access to a facility will include but not be limited to the following: 1) Access at any time the facility is in operation and/or in the sanitation process 2) All areas of the facility will be accessible to the auditor(s) a) Internally-both food manufacturing and storage areas as well as non-food manufacturing areas b) Externally-all surrounding areas outside of the facility anywhere on the property owned by the manufacturer or supplier
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Darden Supplier Total Quality Expectation Manual 1.3: Additional Darden Requirements for Specific Components of the Supply Chain
1.3.1: Requirements for Fresh Produce Growers and Packing Facilities
1.3.1.1: Introduction: For Darden, Fresh Produce Growers and Packing Facilities are those companies who are growing fruits, vegetables and herbs that may be to be eaten with minimal or no thermal processing. These food items are supplied to a Darden Restaurant, either through a Distributor or by direct delivery to a Darden restaurant. Fresh Produce Growers and Packing Facilities are food safety partners with Darden and are treated as an integral part of our Food Safety System. Being a food safety partner means that your company is transparent with food safety and quality processes and data, and committed to the success of Darden. 1.3.1.2: Expectation: Dardens Fresh Produce Growers and Packing Facilities are expected to have robust and effective risk-based Food Safety and Quality systems in place to ensure safe food that meets our quality standards are delivered to our restaurants. They are expected to comply with the requirements listed below and demonstrate compliance to these requirements as specified. 1.3.1.3: High Risk Product Supplier Requirements: All facilities producing High Risk Products will be required to comply with all requirements outlined in this section of the manual by product type. High Risk Produce Items include: o Leafy Greens as defined in the California Leafy Green Marketing Agreement o Green Onions o Parsley o Cilantro o Basil o Tomatoes o Strawberries Demonstration of Compliance: Darden will be using the results of your 3rd party or GFSI Audit for demonstration of compliance of these requirements. Additional documentation may be requested.
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In addition to all other applicable supplier requirements in this manual suppliers of fresh produce including growing, harvesting, packing, processing and distribution operations shall follow the most current version of Good Agricultural Practices (GAPs) and FDA/ CFR Current Good Manufacturing Practices (GMPs) utilizing one or more of the following organization guidelines: The United Fresh Produce GAPs Harmonization Initiative (www.unitedfresh.org) California Leafy Greens Marketing Agreement (LGMA) Commodity Specific Food Safety Guidelines for the Fresh Tomato Supply Chain Commodity Specific Food Safety Guidelines for the Melon Supply Chain Other FDA recognized commodity specific guidance. 1.3.1.4 B Requirements: Suppliers shall have available the following information for each product being supplied to Darden upon request. 1) Copies of your GAPs, GHPs, and/or GMPs all that apply to your operation 2) HACCP based risk analysis and program documentation for each Darden processed product including the hazard analysis and CCPs 3) A hazard analysis and/or food safety risk assessment for growers and packing facilities with control measures for those hazards identified. 4) A copy of your program documenting microbiological controls for high risk raw material. 5) Documented Environmental Monitoring Program (EMP) for mechanically cooled storage units, packing facilities and processing plants. 6) A copy of your finished product testing program. 7) Calendar of harvesting by month and location. Include transitional growing periods and all growers/ranches for entire season. 8) Product flow chart for each item from field identification to distribution including timelines where applicable 9) Your organizations supplier food safety approval process include all documentation you require and ask of your suppliers 10) Grower/Packer/Processor Information including:
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Demonstration of Compliance: Please reference Appendix A for instructions on how to demonstrate compliance.
1.3.1.5: Employee Workforce Expectation: For specifics on employee health and hygiene standards refer to the United Fresh Produce GAPs Harmonization Initiative (www.unitedfresh.org), Leafy Greens Marketing Agreement (LGMA), Commodity Specific Food Safety Guidelines for the Fresh Tomato Supply Chain, Commodity Specific Food Safety Guidelines for the Melon Supply Chain or other FDA recognized commodity specific guidance. 1.3.1.5 A: Requirements: 1) All personnel shall receive initial food safety training and supplemental training appropriate to their position 2) All personnel shall be tested to determine knowledge retention and documentation shall be on file. 1.3.1.6: Lot Definition Expectation: Lots shall be defined by the smallest practical unit of both field and finished product in order to limit the scope and scale of a recall or regulatory action. 1.3.1.6 A: Requirements:
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1.3.1.8: Agricultural Water Expectations: 1) All water sources must be clearly identified and traceable to the source. 2) All water sources shall be tested on a regular basis to ensure Darden standards are met. 3) A process shall be developed and implemented that outlines the need for management to review and approve and act upon all test results. This shall be documented to include a description of the root cause analysis of problems,
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1.3.1.8 A: Requirements: 1) Irrigation Water Standards: a) The following standards and protocol for all irrigation water sources such as canals, ditches, reservoirs and wells shall meet the following*: b) Generic E. coli and fecal coliforms 2.2 MPN/100 ml (Geometric mean of five samples). c) E.coli 0157:H7 and Salmonella species Negative/100 ml. i) Darden recognizes that currently the U.S. produce industry may not be able to attain this standard therefore Darden will work with its approved suppliers in a systematic way to assist them in attaining this goal (generic e-coli and fecal coliforms 2.2 MPN rolling geometric mean n=5). In the interim the following California Leafy Greens Marketing Agreement standard will be acceptable: Generic E. coli 126 MPN/100 ml (rolling geometric mean n=5) and 235 MPN/100 ml for any single sample. 2) Testing frequency: a. Initial Testing: Each water source and at the farthest point of distribution shall be sampled and tested prior to use if >60 days since last test of the water source a minimum of 5 consecutive samples no less than 18 hours apart is required. Generic E. coli and fecal coliforms shall be sampled for on all water sources within 14 days prior to planting. If a positive result is confirmed the current water source shall not be utilized and effective immediate corrective actions shall be implemented and documented to correct the deviation found. b. On-going Testing: Generic E. coli and fecal coliforms shall be sampled for all water sources on a monthly basis during crop production stages (growing and harvesting seasons). Deep sealed wells can be tested on a quarterly basis once 3 consecutive samples comply with the standards. i. A water sample testing positive for generic E. coli or fecal coliforms shall be re-sampled with 3 consecutive weekly samples. When 3 consecutive results are found in compliance, sampling frequency will return to monthly. ii. If a positive result of generic E. coli or fecal coliforms is detected immediate corrective actions shall be taken and documented. As a result the water source shall be sampled and tested for E. coli O157:H7 and Salmonella spp. shall be sampled immediately. iii. If a positive result on E. coli O157:H7 or Salmonella species is found in irrigation water during harvest season, then an immediate pre-harvest
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iv.
Positive pathogen test results on the effected fresh produce shall result in the crop being rejected and must not be used for human consumption. 1. All labs testing water samples shall be certified through the National
Environmental Laboratory Accreditation Conference (NELAC) (http://www.nelac-institute.org/index.php) or equivalent and use the 15
tube Most Probable Number (MPN) or other quantitative methods outlined in FDA BAM or AOAC manuals. Qualitative methods with similar detection limits may be used as well. MPN and CFU are not considered equivalent for quantitative water testing purposes. 2. Depending on risk based analysis water testing requirements may be revised by Darden Total Quality to ensure water safety and quality. Demonstration of Compliance: Please reference Appendix A for instructions on how to demonstrate compliance. 1.3.1.9: Soil Amendments Expectations: 1) No raw, incompletely composted or aged animal manure or leachate from raw manure may be used to supplement the soil 2) All animal based compost must be produced, finished product tested for pathogens and applied in compliance with the Commodity Specific Food Safety Guidelines for the Production and Harvest of Lettuce and Leafy Greens (LGMA). Compliance must be documented and retained by the grower for a minimum of 2 years.
1.3.1.9 A: Requirements: 1) Grower must maintain for a minimum of 2 years validation and verification records of microbial testing of finished compost (Certificates of Analysis or testing results from an accredited laboratory) for each lot of compost used. At a minimum the following microbes of concern and acceptance criteria shall be tested: (a) Fecal coliforms: <1000 MPN/gram (b) Salmonella spp.: Negative (c) E. coli O157H:7: Negative
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1.3.1.11: Set Back Distances for Growing Fields Expectations: 1) In order to protect growing crop and/or water supplies from potential contamination sources, minimum distances must be maintained between those fields and adjacent land, dependent on the type of risk on that land. 2) Distances may vary if a completed risk assessment takes into account variables that influence potential for contamination such as topography of land, water runoff, ground slope and physical barriers (such as fences, ditches, mounds, berms or bare soil buffers).
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Sandy soil- 100 feet Loamy or clay soil- 200 feet Slope grade > 6%- 300 feet Minimum set back distance from crop edge 100 feet 50 feet
Minimum set back distance from crop edge Municipal systems 50 feet Septic systems 100 feet Mechanical harvesting 50 feet Non-mechanical harvesting 30 feet 50 feet 10 feet 30 feet from highest water mark in the field or 2X the turning radius of the longest harvest equipment whichever is the greater.
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Note: All Darden approved growers worldwide shall participate in this program. Products and analysis in the following table may be revised. Be sure to contact Darden Total Quality to confirm you have the most recent version.
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2) Suppliers Responsibilities: a) The following are the suppliers responsibilities as an approved supplier/grower to Darden. (1) Contract with a certified third party testing laboratory for the purpose of sampling and testing produce (2) Schedule with the laboratory the sampling and testing of produce as outlined in this document (3) All costs associated with the sampling and testing of the produce (4) Develop as part of the suppliers food safety program a SOP that details the steps to be taken as a result of a positive pathogen test. This needs to
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3) Product Sampling and Sample Delivery: a) Every field shall be tested for pathogens. Products that have multiple harvests from the same plant (tomatoes, basil, etc.) shall be sampled prior to the first harvest. Do not sample or test for pathogens on subsequent harvests from the same field. b) Sampling shall occur no later than 7 days prior to harvest. c) The goal is to have all test results back prior to harvest. This will allow for time for sample collection, overnight shipment and presumptive positive determination. d) All sampling shall be conducted by qualified personnel with training in microbiology and sampling methodology and tested through certified 3rd party laboratories. e) Samples shall be delivered to the testing laboratory and testing initiated within 24 36 hours from sample collection. f) All samples shall be shipped refrigerated. 4) Test Results Interpretation: a) Confirmed presence of a pathogen represents a significant health risk and any sample that is positive for the pathogen tested shall be considered unacceptable and the lot not harvested for Darden. b) All tests results shall be e-mailed directly to the supplier. c) The laboratory is required to call the supplier and Darden Total Quality when any positive result is obtained. d) 60 sub samples shall be sampled over each lot following standard sampling procedures that includes a representative pattern of sampling over the entire lot. e) Sampling and testing shall follow AOAC or FDA approved methods f) Processors must be provided documentation showing that each lot of the specified commodities have tested negative for pathogens prior to receipt. Raw material lots will be rejected if documentation is not provided prior to or at time of delivery Demonstration of Compliance: Please reference Appendix A for instructions on how to demonstrate compliance.
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1.3.1.16: Produce Distributor Rework-Repack Expectations Expectation: Rework/Repack-The manual removal and replacement of defective product with acceptable quality product from the same production code/lot# of the same brand. Repacked product cannot be washed. 1.3.1.16 A: Requirements: 1) Darden must approve the facility prior to the rework/repacking of produce. 2) Notify Darden Purchasing/TQ and the supplier of the quality issue. 3) Re-work/re-packing is not acceptable if associated with a food safety related issue. 4) Document type of product, quality issue, supplier and date received and support with digital pictures (include pictures of defects, production codes and brand name on cases). 5) Document the number of cases and corresponding production codes/lot #s that require rework. 6) If you are unsure of the production codes/lot #s, contact the supplier.
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1.3.1.18: Regulatory Compliance Expectation: In addition to meeting all FDA, USDA and other U.S. food safety regulations, all fresh produce growers, packers, processors and distributors with operations outside of the U.S who supply food to Darden must meet the food safety regulations of the country in which they operate.
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Darden Supplier Total Quality Expectation Manual 1.3.2: Darden Requirements for Food and Fresh Produce Manufacturers and Processors, including Seafood Packers
1.3.2.1: Introduction: 1) For Darden, Food and Fresh Produce Manufacturers and Processors, including Seafood Packers, are those companies who are making or processing food that is supplied to a Darden Restaurant, either through a Distributor or by direct delivery to a Darden restaurant, e.g. Breadsticks and fresh fish. 2) Food and Fresh Produce Manufacturers and Processors, including Seafood Packers, are food safety partners with Darden and are treated as an integral part of our Food Safety System. Being a food safety partner means that your company is transparent with food safety and quality processes and data, and committed to the success of Darden. 1.3.2.2: Expectation: Dardens Food and Fresh Produce Manufacturers and Processors, including Seafood Packers, are expected to have robust and effective risk-based Food Safety and Quality systems in place to ensure safe food that meets our quality standards are delivered to our restaurants. They are expected to comply with the requirements listed below and demonstrate compliance to these requirements as specified. 1.3.2.3: High Risk Product Supplier Requirements: 1) All facilities producing High Risk Products will be required to comply with all requirements outlined in this manual by product type.
a) High Risk Products include:
i) Cooked/Fermented Meats ii) Desserts - containing components without full thermal step, or if classified as Potentially Hazardous Food (PHF) based on 2009 Food Code. iii) Cooked Seafood (Snow Crab Meat, Cold Water Shrimp, Cooked Lobster Meat, Crab Legs, Cooked Mussels) iv) Cheese (any cheese with moisture content above 39%) v) All Ready to Eat Processed Produce
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PARAMETER
NAME Salmonella Listeria spp E Coli S. aureus Total Coliforms Total Plate Count Chlamphenicol Nitrofurans Fluroquinolones Quinolones Malachite Green Gentian Violet Melamine Mercury
Micro
Chemical
Histamine One up and one down Aquaculture Certification Processing Plant Standards
Industry Programs
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N/A Not Applicable A1 All farmed fish produced for USA cannot be treated with Fluoroquinolones or Quinolones B1- This requirement may include other Aquaculture species depending on the source
Category Group (All Raw) Tuna, Swordfish Mahi, Snapper , Wahoo, Hamachi, Monchong, Opah, Pompano, Walu, Amberjack Pollock, Haddock, Cod, Flounder, Sole, Halibut, Grouper, Corvina, Perch, Tripletail, Whitefish Post Processing Raw product Risk Grouping A,B,C N/A A,B,C A,B,C A,B,C A,B,C N/A N/A N/A N/A N/A N/A N/A A1
PARAMETER
NAME Salmonella Listeria spp E Coli S. aureus Total Coliforms Total Plate Count Chlamphenicol Nitrofurans Fluroquinolones Quinolones Malachite Green Gentian Violet Melamine Mercury
Micro
Chemical
Products of Decomposition
A, B1 Histamine One up and one Traceability Program A,B,C down N/A Not Applicable A1 All fresh/frozen Tuna and Swordfish must conform to FDA limits of methyl mercury less than 1.0ppm. Fresh fish distributors supplying fresh Tuna or Swordfish are required to complete mercury testing quarterly each year and submit data to Darden. Any fresh Tuna or Swordfish products must not enter the supply chain for the risk of withdrawal if results exceed 1.0ppm.
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Category Group Fresh Oysters Cooked Clams, Cooked Frozen Mussels Raw Frozen Oysters, Raw Fresh Clams, Raw Fresh Mussels, Raw Calamari, Raw Sea Scallops, Raw Bay Scallops Preharvest Requirements Risk Grouping N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A A Post Processing Raw Product Risk Grouping A,C N/A A,C A,C A,C A,C N/A N/A N/A N/A N/A N/A N/A N/A N/A A,C A Post Processing Cooked Product Risk Grouping B B B B B B N/A N/A N/A N/A N/A N/A N/A N/A N/A B N/A
PARAMETER
NAME Salmonella Listeria spp E Coli S. aureus Total Coliforms Total Plate Count Chlamphenicol Nitrofurans Fluroquinolones Quinolones Malachite Green Gentian Violet Melamine Mercury
Micro
Chemical
Products of Decomposition
Histamine One up and one Traceability Program down Sourced from growing waters with temperature <50oF or Post harvest processing implemented N/A Not Applicable
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PARAMETER
NAME
Preharvest Requirements Risk Grouping N/A N/A N/A N/A N/A N/A A,B,C,D A,B,C,D N/A N/A N/A N/A N/A N/A N/A N/A
Micro
Chemical
Salmonella Listeria spp E Coli S. aureus Total Coliforms Total Plate Count Chloramphenicol Nitrofurans Fluroquinolones Quinolones Malachite Green Gentian Violet Melamine Mercury Histamine One up and one down Aquaculture Certification Processing Plant Standards
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PARAMETER
NAME Salmonella Listeria spp E Coli S. aureus Total Coliforms Total Plate Count Chlamphenicol Nitrofurans Fluroquinolones Quinolones Malachite Green Gentian Violet Melamine Mercury Histamine One up and one down Freezing, Cooling/Heating, Cooking
Micro
Chemical
Post Processing Raw Risk Grouping C N/A C C C C N/A N/A N/A N/A N/A N/A N/A N/A N/A C N/A
Post Processing Cooked Risk Grouping A,B A,B A,B A,B A,B A,B N/A N/A N/A N/A N/A N/A N/A N/A N/A A,B A,B
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Reference: DDDI Animal Welfare/Care Supplier Certification Resources for Animal Handling, Health and Welfare: Dr. Temple Grandin Animal Welfare Information Center American Veterinary Medical Association Animal Agriculture Alliance National Pork Board National Cattlemen's Beef Association Professional Animal Auditor Certification Organization, Inc. (PAACO)
1.3.4.3: Beef Expectation: 1) Beef Carcass a) All beef carcasses must be processed in USDA inspected facilities and must have a minimum of two intervention technologies in place to ensure a scientifically validated reduction of E.coli O157:H7. Both interventions must be included in the suppliers HACCP Plan or a PreRequisite program.
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1.3.5.4: High Risk Finished Product Testing Program (HRFPT) 3) High Risk Finished Products must be placed on hold pending a negative pathogen test result. ALL products undergoing finished product testing for pathogens must be placed on hold pending a negative test result. Darden must be notified immediately in the event of any positive test result. Additionally, all COAs must be kept on file for a minimum of one year and shall be made available to Darden upon request. 4) High Risk Finished Products that require finished product testing are defined as follows: a) Meets FDAs definition of potentially hazardous food (PHF) according to the 2009 Food Code and applicable supplements (water activity & pH) b) Is classified as MODERATE RISK or higher in the most recent FDA/CFSAN/USDA/FSIS Quantitative Assessment of Relative Risk to Public Health from Foodborne Lm amongst RTE (2003), and FDA Risk Assessment Study for Listeria monocytogenes, and USDA/FSIS latest Regulations & Directives c) Has been the subject of a Class I, Class II, or Class III recall (as defined by FDA) in the past 5 years d) Has not had technological advances developed, mandated and implemented by regulatory agencies since the recall that reduce the occurrence of pathogens 5) If HRFPT is required, then procedures must be in-place that document sample size, sample frequency, and a list of appropriate organisms for which to test. In general, Darden TQC expects the following pathogens to be tested for in HRFPT: a) Salmonella ssp. & Listeria ssp (cheese, desserts, cooked/fermented meats) Producers of High Risk Produce please reference Produce Specific Section of this Manual
1.3.5.5: 3rd Party/External Laboratory Testing Program 1) High Risk Product Suppliers (HRPS) must use a 3rd party accredited laboratory service provider to validate their EMP and HRFPT programs.
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Darden Supplier Total Quality Expectation Manual 1.3.6: Darden Requirements for Regional Distributors
1.3.6.1: Introduction For Darden, Regional Distributors are those companies who are supplying food directly to a Darden restaurant in a geographic area or region, and not a part of Dardens custom, national distribution system (e.g. Fresh Fish, Fresh Produce, Breadsticks, etc.) Regional Distributors are food safety partners with Darden and are treated as an integral part of our Food Safety System. Being a food safety partner means that your company is transparent with food safety, quality processes and data, and committed to the success of Darden. 1.3.6.2: Expectation: Dardens Regional Distributors are expected to have robust and effective Food Safety and Quality systems in place to ensure safe food that meets our quality standards are delivered to our restaurants. This includes any I Kitchen off catalog restaurant request, which must meet the requirements below. 1.3.6.3: Requirements: 1) Supplier Verification Program: All Regional Distributors will have a documented and effectively managed Supplier Verification Program, with required elements to include: a) A Global Food Safety Initiative (GFSI) Certification Audit (See www.mygfsi.com for a current list of recognized schemes) or a Third Party Audit, with a resolved Corrective/Preventative Action Plan, of the source manufacturing facility for these types of products: i) All Fresh Produce products ii) High Risk products (a) Raw Ground Beef (b) Raw Whole Muscle Non Intact Beef (c) Cooked/Fermented Meats (d) Desserts - containing components without full thermal step, or if classified as Potentially Hazardous Food (PHF) based on 2009 Food Code. (e) Cheese (any cheese with moisture content above 39%) (f) Snow Crab Meat (g) Cold Water Shrimp (h) Cooked Lobster Meat (i) Crab Legs (j) Cooked Mussels
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1.3.6.4: Fresh Seafood Specification: All Fresh Seafood products will have a Product Specification in Dardens electronic Product Specification system. Demonstration of Compliance: Please reference Appendix A for instructions on how to demonstrate compliance.
1.3.6.5: High Risk Seafood Sourcing Verification: All sources of High Risk Seafood must be reviewed and approved by Darden Total Quality a. High Risk Seafood products are all cooked seafood products including, but not limited to: i. Snow Crab Meat ii. Cold Water Shrimp iii. Cooked Lobster Meat iv. Crab Legs v. Cooked Mussels b. Prior to food entering a Darden restaurant, Darden Total Quality personnel must review and approve this following documentation from the source facility i. Third Party Audit ii. Product and Process Control Programs iii. HACCP Program Demonstration of Compliance: Please reference Appendix A for instructions on how to demonstrate compliance.
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Darden Supplier Total Quality Expectation Manual 1.3.7: Darden Requirements for Food Importers of NonSeafood and Non-Produce items
1.3.7.1: Introduction 1) For Darden, Food Importers are those companies who are importing products manufactured or grown outside the US and selling them to our network of customized distributors for delivery to a Darden restaurant. Importers, by Darden's definition, are neither growing nor manufacturing food or food-contact items that are supplied to a Darden Restaurant.
1.3.7.2: Expectation: Food Importers are Food Safety partners with Darden and are treated as an integral part of our Food Safety System. Therefore, Dardens Food Importers are expected to have robust and effective Food Safety and Quality systems in place to ensure safe food that meets our quality standards are delivered to our restaurants. 1.3.7.3: Requirements: 1) Supplier Verification Program: All Food Importers will have a documented and effectively managed Supplier Verification Program for all manufacturing facilities from which the Importer is resourcing product for Darden, with required elements to include: a) All Food Manufacturers and Processors will have a Global Food Safety Initiative (GFSI) Certification Audit (See www.mygfsi.com for a current list of recognized schemes), or a Third Party Audit with a resolved corrective action plan within the last 6 months, and on an annual basis thereafter. b) Product Traceability in compliance with the Public Health, Security and Bioterrorism Preparedness Act of 2002, ensuring that all products are traceable to their origin at least one step forward and one step back. c) A Recall Program that is documented, managed effectively, and tested on a pre-determined and reasonable schedule. d) Randomly selected Importers will be required to submit full audit reports and supporting documentation to validate compliance to the above requirements Demonstration of Compliance: Please reference Appendix A for instructions on how to demonstrate compliance.
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3) Product Specifications: a) All Food Importers will participate in the development and approval of a Product Specification within Dardens electronic Product Specification system for every product provided to Darden. These specification documents will be actively managed and/or periodically reviewed to ensure accuracy.
Demonstration of Compliance: Please reference Appendix A for instructions on how to demonstrate compliance.
Best Practices for Importers to enable Continuous Improvement Best Practices for 2012 Implementation In preparation for upcoming Food Safety Modernization Act requirements, Importers should perform a risk-based foreign supplier verification to ensure that all imported food is not adulterated or misbranded, and has been produced in compliance with all US laws and regulations. o Verification methods may include lot inspections, annual on-site inspections, review of food safety plans and periodic product testing. Volunteer to participate in the upcoming US FDAs Voluntary Qualified Importer Program (Green Lane) to enable expedited review of food imported by your company.
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Darden Supplier Total Quality Expectation Manual 1.3.8: Darden Requirements for Darden Direct Distribution Partners (Darden Direct Distribution, Inc. and Darden Direct Logistics)
1.3.8.1: Introduction Darden Direct Distribution Partners (Darden Direct Distribution, Inc. (DDDI) and Darden Direct Logistics (DDL))are distribution centers and/or warehouses that store or supply food directly to Darden restaurants. 1.3.8.2: Expectation: Darden Direct Distribution are food safety partners with Darden and are treated as an integral part of our Food Safety System. Being a food safety partner means that your distribution center or warehouse is transparent with food safety, quality processes and committed to the success of Darden. Darden is working to ensure that all our partners are familiar with the ongoing Food Safety Modernization Act. Below are the pertinent sections of FSMA that you need to be familiar and complaint with: Sec. 103 Hazard Analysis and Risk-Based Preventive Controls: o All registered facilities will be required to conduct a hazard analysis, implement preventive controls and develop a written food safety plan to document the monitoring, correction, and verification of preventive controls. This could include documented sanitation procedures, a recall plan, a food allergen control program, supplier verification activities, and an environmental sampling program. Sec. 104 Performance Standards o At least every two years, FDA will review and evaluate relevant data to determine which foodborne contaminants pose the greatest risk. You as a registered facility will need to verify that your preventive controls are adequate and effective to mitigate the hazards identified. Sec. 111 Sanitary Transport of Food o FDA will be requiring that shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in transportation of food use sanitary practices. Specific requirements will cover sanitation; packing , isolation, and protective measures; limitation on use of vehicles; recordkeeping; information to be disclose to carrier; and list of non-food products that may be shipped if food is shipped simultaneously or subsequently.
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Darden Supplier Total Quality Expectation Manual 1.3.9: Darden Requirements for Transporters
1.3.9.1: Introduction: For Darden, Transporters are those companies who are transporting products for delivery to a Darden restaurant. 1.3.9.2: Expectation: Transporters are expected to have robust and effective Food Safety and Quality systems in place to ensure safe food is delivered to our restaurants. 1.3.9.3: Requirements: 1) During all phases of food transportation, temperatures will be controlled to maintain the food at the proper temperature to maintain safety and quality. 2) Food should be handled in a manner that eliminates any possibility of crosscontamination. 3) Appropriate measures should be in place to maintain the security of the food during all phases of transport and to eliminate the possibility of intentional adulteration. 4) All Transporters shall have a documented Product Traceability Program in compliance with the Public Health, Security and Bioterrorism Preparedness Act of 2002, ensuring that all products are traceable to their origin at least one step forward and one step back. 5) All Transporters shall have a documented Recall Program that is effectively managed and tested on a pre-determined and reasonable schedule. 6) All Transporters shall use best practices to maintain the sanitation of food, including, but not limited to: a) Sanitation program b) Product Isolation in case of product non-compliance c) Strong record keeping d) Information to be disclosed to the Carrier e) List of non-food products that may be shipped simultaneously with food
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Darden Supplier Total Quality Expectation Manual 1.3.10: Darden Product Specification Requirements
1.3.10.1: Expectation: Fresh Produce Growers and Packing Shed, Food Manufacturers and Processors/Seafood Packers and Processors and Food Importers are required to have a Darden Product Specification for every product supplied to Darden prior to the product being purchased by Darden in Dardens electronic, web-based Product Specification system. 1.3.10.2: Requirement: 1. Suppliers are required to manage and acknowledge product specifications within Dardens web based product specification system. a. A product specification shall be developed and approved prior to each product being purchased by Darden. b. Suppliers are required to manage and acknowledge product specifications within Dardens web based product specification system. 2. The product specifications are managed in a web based application system. The system manages the creation, review and approval of accessibility, distribution, and revisions of all product specification documents. a. The product specification application is designed to control product specification documents. These documents pass through a review and approval routing process. 3. To access Dardens electronic Product Specification system click on this link https://supply.darden.com/SSALogin. a. If you have any questions or need assistance with accessing the iTQ system, please call 407-245-5169 M-F 8AM to 5PM EST.
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Darden Supplier Total Quality Expectation Manual 1.3.11: Dry Goods and Frozen Item Shelf life Requirements
1.3.11.1: Expectation: There shall be at least 2/3 of the shelf life remaining when the product is delivered to the distribution center.
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Darden Supplier Total Quality Expectation Manual 1.3.12: Product Complaints for all Suppliers except Frozen Seafood and Fresh Produce
1.3.12.1: Expectation: From time to time restaurants will file product complaints for product that they have received that may have a quality issues. As a supplier to Darden, it is recommended that you review the Complaint System on a frequent basis. This will allow you to see if any complaints have been filed, so that you can proactively look for any trends, perform a root cause analysis and initiate a corrective action plan, if needed. Accessing your complaints from iSupply: Log in to iSupply. Select Other Systems, and then click on Product Complaints:
This will take you into the Product Complaints application and will prompt you to log in if you have problems please contact 407-245-5169 for password help.
Viewing Your Complaints: Click on Complaints then Complaints by Product Code in the left hand navigator you will then be able to see all of your complaints.
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103
Requirement for facility, warehouse, or any facility that processes, packs, or holds food to conduct a HACCP. Facilities must implement a risk based approach to mitigate the risk of intentional adulteration of food. Requirement for the facility to have a system established to identify where it received food from and to whom the food was shipped.
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II
204
III
301
Suppliers who import food from overseas will be required to demonstrate they have completed a risk based assessment that the food is unadulterated, and produced in a manner meeting US FDA food laws.
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Darden Supplier Total Quality Expectation Manual 2.1: Preventative Controls / Hazard Analysis and Critical Control Point (HACCP)
2.1.1: Expectation: Food facilities are required to implement a written preventative controls plan meeting the requirements as set forth by the FDA/USDA. There must be a comprehensive risk-based food safety management system, designed, documented, implemented and reviewed, and supported with personnel, equipment and resources, to ensure that critical limits set to achieve the intended food safety standards are not exceeded. The attainment of this quality objective requires the design, development and implementation of a HACCP system specific to the manufacturing process and the commitment of all concerned at all stages of manufacture. The plan must have been developed as defined by the National Advisory Committee on Microbiological Criteria for Food (http:www.fda.gov/food/foodsafety/HazardAnalysisCriticalControlPointsHACCP/uc m114868.htm) or as published in the Codex Alimentarius Food Hygiene Basic Texts ISBN 92-5- 104021-4. 2.1.2: Requirements: 1) The HACCP plans must be developed following the required steps: a) Conduct a hazard analysis b) Determine the critical control points c) Establish critical limits d) Establish monitoring procedures e) Establish corrective actions. f) Establish verification procedures g) Establish recordkeeping, documentation and validation procedures h) Establish plan reassessment procedures 2) Plans must be reviewed when a change is made to the product or process or when repetitive issues occur and revised as necessary. At a minimum all plans must be reviewed annually or more frequently if required by Federal Regulations. 3) Training programs must be in place and documented to ensure that all appropriate personnel are trained to effectively execute the HACCP Plan. At a minimum, training in HACCP principles must be conducted at hiring. Refresher training must be conducted annually and documented. At least one member of the HACCP Training Team must be HACCP Certified.
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Darden Supplier Total Quality Expectation Manual 2.2: Good Manufacturing Practices
2.2.1: Expectation: All Darden Suppliers shall follow Good Manufacturing Practices (GMPs) so the products are safe and wholesome, and produced to specification. All factory personnel including visitors will comply with GMPs. All GMPs will be documented and ensure product, ingredients and packaging are managed to maintain food safety and quality. 2.2.2: Requirements: 1) In order to achieve the objectives of good manufacturing practice, it is necessary to have in place: 2) Quality Assurance i) This encompasses the design and planning to ensure raw materials; ingredient formulations; processing equipment, environment, methods and conditions; intermediates specifications; packaging and labeling specifications; quantity control specification; management and control procedures; product distribution and appropriate storage, handling which, taken all together, are capable of resulting in products complying with the product specification. 3) Effective Manufacturing Controls i) These will be designed to manage the operational production and distribution practices to ensure the processes adhere to its specified design parameters and that the resulting products actually do comply consistently with the product specification. ii) The factory will have a manufacturing process, equipment, activities, precautions, which have been fully specified in advance, and systematically reviewed. The facility will also include qualified personnel, appropriate facilities and space, suitable equipment and services, specified materials and packaging, specific policies and operating procedures and suitable transport and storage. 4) Quality Control i) Quality Control systems will be in place to provide effective monitoring systems that verify compliance with specified requirements, and define suitable corrective action in the event of out-of control occurrences. 5) Food & Allergen Control i) This is a comprehensive food production system founded on the risk assessment principles of HACCP which interlinks with quality assurance and quality control in a quality management system.
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Darden Supplier Total Quality Expectation Manual 2.3: Quality Management Systems and Quality Policy
2.3.1: Expectation: Suppliers must have policies in place that define the organizational structure, procedures and training programs that will be executed to ensure that products manufactured and supplied to Darden will be safe and meet the quality expectations of Darden. There must be a comprehensive management system, designed, documented, implemented, reviewed and continuously improved in a controlled manner to ensure that specifications set to achieve the intended product quality standards are consistently met. The attainment of this quality objective requires the involvement and commitment of all concerned at all stages of manufacture and at all levels of management. 2.3.2: Requirement: 1) Management Responsibility a) Suppliers shall have a quality policy stating their commitment to manufacturing food products that are safe, wholesome and conform to specifications. Additionally the product shall comply with all Country of Origin, Federal, State and Local Regulatory requirements. b) The quality Policy shall be communicated and understood by all levels of management and employees. c) Suppliers shall have a documented organizational program that describes the responsibility, authorities and interactions of the people who manage, perform and verify work required. This includes, but is not limited to, managers, supervisors, coordinators, auditors, lab technicians and machine operators. d) Suppliers should identify and document resources that are required in the quality plans (including training) for the management, performance of work and verification activities such as internal quality auditing. e) The plants principal executive and management team shall conduct reviews at least annually of the food safety and quality system (including all preventive control strategies such as HACCP) to ensure its continuing suitability and effectiveness in satisfying the requirements of the plants quality and safety policy and objective. Records shall be kept on file for these reviews per established record retention policy. 2) Quality Management a) The facility will have a quality assurance program covering raw material, intermediate and finished products, ingredients formulations, product and process controls, packaging and labeling, storage and handling. b) The facility will have quality control points where effective monitoring verifies compliance with specified requirements, and defines suitable corrective action in the event of out-of control occurrences.
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Darden Supplier Total Quality Expectation Manual 2.5: Product Identification and Traceability
2.5.1: Expectation: Product/food contact packaging identification and traceability systems must be able to trace all food contact packaging materials, ingredients and raw materials from immediate supplier, through finished product to immediate destinations. The system should be routinely tested to demonstrate that it is implemented and effective. Product identification and traceability procedures are a key prerequisite to ensure good manufacturing practice. 2.5.2: Product Identification Requirement: 1) The supplier must have a system in place to effectively identify and trace finished product lots and follow this through all raw materials (including primary and any other relevant food contact packaging materials and processing aids), all stages of process and the distribution of the finished product to Darden within 4 hours of a request being made. 2) In practical terms, for traceability to be effective, the responsibility of each organization is to ensure the link in the food supply chain is not broken. 3) This requires an organization to satisfy itself that its supplier of a food and food contact material has carried out checks to ensure that the documentation provided accurately describes the nature and substance of that material and its provenance (traceability/lot number). The organization should retain that documentation and, following the manufacturing process, issue documentation/labeling to the organization to which they in turn sell the food product. 2.5.3 Traceability Requirement: 1) A documented procedure must be developed and implemented to ensure that throughout all stages of companys operations raw materials, ingredients, food contact packaging, in-process and finished products are identified and traceable. Packaging should also, where practicable, be traceable to an individual delivery and/or batch. The Quality Control Manager or other specific designated person with direct responsibility for technical management is responsible for the implementation and validation of this procedure. 2) Where reworking/repacking operations are being performed traceability must be maintained through quality control documentation. 3) Traceability procedures must be tested on a pre-determined schedule to ensure traceability can be determined and documented from the supplier, through production to the first level of distribution of the finished product and backwards ensuring the material balance is equal. This needs to take into account process waste and rework.
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Darden Supplier Total Quality Expectation Manual 2.6: Food Defense (Security) and Planning
2.6.1: Expectation: Food defense involves preventing, minimizing, or responding to the deliberate contamination of food products by a variety of potential threat agents (biological, chemical, radiological or physical). These are criminal actions that involve willful intent to do harm; they cannot always be anticipated without intelligence information, however areas of greatest vulnerability can be identified. The motivation for these illegal actions includes the ability to cause illness and deaths following consumption of adulterated products and the desire to cause economic and psychological damage, including inspiring fear among the public and loss of confidence in the safety of the food supply. The supplier must develop a Food Defense Plan to identify areas of vulnerability and increase preparedness against their products being intentionally contaminated. Although the plan should be executed at all times, it may be particularly helpful during emergencies. During a crisis, when stress is high and response time is at a premium, a documented set of procedures provides facility operators the ability to more readily execute standard response actions while focusing on an appropriate course of action for the specific event. Therefore, Food Defense Plans will be particularly beneficial under elevated threat conditions, especially when there is reason to believe that the food may be targeted for attack. Development and effective implementation of prevention and response strategies at the facility will improve the defense status of their products. 2.6.2: Requirements: 1) Designing the Food Defense Plan a) Each facility must designate an individual or team responsible for the security of the establishment. The team develops an understanding of the potential vulnerabilities at each facility, based on the types of foods and processes so that effective countermeasures can be developed. No matter what type of tool is used in the assessment, the team should consider both internal and external threats. The results of the assessment should be kept confidential so that they do not provide a roadmap for future attacks. b) The facility must control access for visitors (i.e., non-plant employees) to designated areas inside the plant, including in-plant laboratories and other potentially vulnerable areas. It must address protection of vital plant systems, such as central control for airflow, water systems, and electricity. Finally, it includes screening and supervision of contract workers with authorized access to the facility. This group includes maintenance and sanitation crews, who often receive limited supervision from plant management. c) The facility must monitor equipment used in the processing facility and the flow of all raw materials, finished products, returned goods, and other items that are used in production including personnel security for employees.
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Darden Supplier Total Quality Expectation Manual 2.7: Product Non-Conformance, Crisis Management, and Recall
Definition of a Recall: Recalls are actions taken by a firm to remove a product from the
market. Recalls may be conducted on a firm's own initiative, by FDA/USDA request, or by FDA/USDA order under statutory authority.
Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. Market withdrawal: occurs when a product has a minor violation that would not be subject to FDA/USDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems would be a market withdrawal.
2.7.1: Expectation: All levels of product non-conformances will be addressed swiftly and in a pre-determined manner in order to mitigate public health risk and minimize supply chain disruptions. 2.7.2 Requirements: 1) Product Non-Conformances a) A procedure must be in place for channeling, documenting and analyzing of all complaint reports from customers or consumers. b) Action should include responding to the complainant, and must include responding to any enforcement authority involved. c) If analysis of the complaint leads to a corrective action this must be implemented through documented procedures. d) There should be a predetermined written plan to manage the recall or market withdrawal of any product known or suspected to be hazardous or otherwise unfit or sub-standard, which the manufacturer wishes to withdraw or recall. A crisis management procedure and a crisis management team must also be established. Mock recalls should be carried out on a regular basis. 2) Product Withdrawal and Recall Requirement a) All recalls and withdrawals must be managed by a designated person, with named backups, and they must initiate the recall process. b) There must be written withdrawal and product recall procedures.
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111
Facilities must implement a risk based approach to mitigate the risk of intentional adulteration of food. Requires operations engaged in the transportation of food use sanitary practices
II
202
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Darden Supplier Total Quality Expectation Manual 3.2: Cleaning and Sanitation
3.3.1: Expectation: Safe food can only be produced in clean facilities and the effective management of cleaning and sanitation is a basic requirement for the safe production of products for Darden. This will include manual and cleaning in place (CIP) procedures. 3.3.2: Requirements: 1) Sanitation Standard Operating Procedures (SSOPs) will be in place for all sanitation activities in the facility. SSOPs will be task specific and identify the cleaning chemical, its dilution and concentration, equipment to be used, and frequency of cleaning. 2) All cleaning activities will be identified on a master sanitation schedule. The master sanitation schedule will identify the entire building, and areas to be cleaned. 3) Cleaning and sanitation chemicals and equipment will be properly stored separately under controlled access. 4) All cleaning chemicals will be monitored to maintain effectiveness. 5) All chemicals used for sanitation within the facility must have MSDS sheets and labels. 6) Pre-operational sanitation a) The effectiveness of cleaning shall be monitored b) The facility must be acceptable prior to the start of production c) Results of the pre-op inspection must be documented with CAPA as needed 7) Operational Sanitation a) Operations must be conducted in a manner to ensure the facility is operated in a sanitary manner. b) Procedures to detect and address deficiencies must be in place. c) Conditions observed during operations shall be monitored and documented with corrective actions and preventative actions taken. d) Pathogen or Pathogen Indicator monitoring programs must be in place when required by either regulatory requirements or prudent food safety protection for ready-to-eat products, High Risk Commodities and High Risk Seafood products. 8) Chemical controls including lubricants a) Only chemicals acceptable for use in food processing establishments shall be used.
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Darden Supplier Total Quality Expectation Manual 3.3: Water, Ice and Steam Supply
3.3.1: Expectation: a) All water used in the facility processing areas or used as ingredients must be of potable quality and a provision must be made for temperature control, storage and distribution of water. b) The FDA CFR Current Good Manufacturing Practice requires an adequate supply of potable water. This potable water must be used whenever necessary to ensure foodstuffs are not contaminated. All water must meet United States Environmental Protection Agency Drinking Water Standards http://water.epa.gov/drink/contaminants/index.cfm, or World Health Organization Guidelines for Drinking Water Quality http://www.who.int/water_sanitation_health/dwq/gdwq3rev/en/index.html. 3.3.2: Requirements: 1) Water, Ice and Steam a) All ice must be made from potable water and ice machines must be designed to protect contents from contamination. b) Any steam used directly in contact with food must not contain any substance which presents a health hazard, or is likely to contaminate the product. c) If water is recycled the purification process must achieve potable quality and the process must be monitored and documented to demonstrate its effectiveness. d) The use of both potable and recycled water systems in the manufacturing must include identification to avoid confusion on use. e) Planning must contemplate water source contamination and implementation of boil water notice vs. production shutdown. 2) Water Systems Management a) Deadlegs or blocked ends in pipework should be eliminated as much as possible or subject to a program of routine flushing. b) Water storage in tanks and cisterns must be sealed and screened to prevent pest entry and subject to regular maintenance and inspection. c) UV and Reverse Osmosis systems in the facility must have a system of maintenance to ensure UV bulbs or filters are changed in accordance with manufacturers recommendations to ensure effectiveness and must be subject to a sampling program with records available for review to demonstrate effectiveness. d) The facility must have a risk assessment completed to cover startup after any structural alterations or significant maintenance have been implemented to ensure water systems do not get contaminated by maintenance actions.
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Darden Supplier Total Quality Expectation Manual 3.4: Facilities Producing High Risk Products
3.4.1: Expectation: Facilities producing high risk products must establish procedures and processes to control risk. Be capable of removing pathogens from low care raw materials and package them to prevent cross contamination. 3.4.2: Requirement: 1) Prevention of Cross Contamination: a) There must be effective barriers between low risk and high risk areas. This must contemplate movement of ingredients/raw materials, packaging, equipment, personnel, water/drainage and airflow. b) Effective barriers means floor to ceiling barriers with breaks at designated points for incoming and outgoing ingredients, packaging and personnel. c) Cooking lines must have effective barriers for controlled delivery of cooked materials from low to high care areas, e.g. low walls under kettles to prevent low risk to high care waste water flow. d) All raw protein handling/processing/packaging must occur outside the high risk area. e) Management personnel must utilize separate changing facilities with dedicated high risk footwear and protective clothing for entry and exit from any pathogen risk area. f) Any ingredients with a risk of pathogen contamination (e.g. spice and dry goods) must undergo a thermal/biocidal process (e.g. ethylene oxide, ozone, dry sterilization) prior to entry into any high risk area. g) All ingredients, equipment, and personnel, which have entry to high risk areas, must undergo a risks assessment before entry to effectively mitigate the risk of cross contamination to cooked products. h) There must be effective intervention barriers throughout facility (e.g. Foot Baths or Foamers) 2) Facility Construction a) Contact surfaces for RTE products prior to packaging, including equipment, must be made from an impervious material which can be effectively cleaned and sanitized. b) Floors must be impervious with a gradient (e.g.1:60 -1:80) away from the high risk area to avoid the risk of waste water running back into the High Risk area. c) Permanently fixed heavy equipment must not be sited over drains limiting access for cleaning.
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d)
e) f) g) h) i) j) k)
5) Monitoring and Maintenance a) There should be separate engineering and storage facilities for both the high risk and low risk operations and maintenance staff must be trained in high risk food hygiene. b) Dedicated tools should be provided within the high risk area. Where it is necessary to remove equipment for repair, there should be a documented hygiene procedure for re-introduction to the high risk area. c) Visiting engineers should, where possible, use the factory dedicated high care risk tools. Where specialist tools are necessary they should be cleaned and disinfected prior to entry into the high risk area. 6) Product Control a) Food products must be cooled rapidly to less than 41 F (5C) within 20 minutes after cooking and chilled materials should be stored below41 F(5C). b) In process or staged product should be kept below 46 F(8oC) and used immediately or returned to chill if they exceed 46 F (8oC) or and not used until they drop below 41 F (5oC) and time temperature interaction is not more than 4 hours. c) There must be sufficient separate refrigeration capacity for the rapid chilling and separate storage of raw materials, work in progress and finished products.
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Darden Supplier Total Quality Expectation Manual 3.5: Good Control of Laboratory Practices and use of External Laboratories
3.5.1: Expectation: Any laboratory used to test food intended for sale to Darden should follow Good Laboratory Practices at all times. 3.5.2: Requirements: 1) All laboratories must have appropriate facilities, trained staff, and operate to Good Laboratory Standards such as ISO 17025 or A2LA. (www.a2la.org or
www.iso.org)
2) Chemical, biological and microbiological laboratories must be separated from each other and separate from manufacturing areas. 3) Areas within the laboratory must be so designed to avoid cross contamination within the facility and provision must be made for waste handling or accidental spills. 4) Equipment and instruments must be serviced and calibrated at suitable specified intervals by an assigned competent person, persons, or organization. 5) Approved laboratories working to traceable National Standards should in turn calibrate measuring equipment and test pieces used in the calibration process. 6) Records of the calibration procedure and results should be maintained for each instrument or item of equipment. 7) All laboratories must participate in a certified proficiency testing program.
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103
Requirement for facility, warehouse, or any facility that processes, packs, or holds food to conduct a HACCP.
104
Performance Standards
Facilities will be expected to verify that that all preventative controls are adequate and effective to mitigate all Hazards Identified.
112
Facilities are required to have effective and functioning procedures designed to ensure allergens do not become a risk to sensitive individuals.
II
202
III
301
Suppliers who import food from overseas will be required to demonstrate they have
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Darden Supplier Total Quality Expectation Manual 4.2: Foreign Object Control
4.2.1: Expectation: 1) Policies, control measures and systems must be in place for the prevention of foreign object contamination in Darden food products. 2) A risk-based system in which risks are identified and controlled through processes such as good hygiene, proper food safety auditing and HACCP must be used to identify potential foreign object hazards and the results used to direct how the foreign object is identified and removed within the facility. This analysis must be completed on incoming raw materials, applied to workforce practices, manufacturing and other equipment, and the structure and fabric of the building, to prevent and/or detect and remove foreign matter contamination. 3) Automatic inspection devices such as metal detectors, x-rays, magnets and vision systems can be used but prevention must be the priority. If foreign objects are detected, points where contamination could occur must been identified and action taken to permanently eliminate the hazards, or to put into place appropriate control systems. 4.2.2: Requirements: 1) Metal Detection a) Nuts, bolts and washers should be made of magnetic stainless steel and aluminum washers should be nickel coated, welds must be ground smooth. b) All staff that use the metal detection system must be fully trained in the metal detection procedures for checking, testing and reacting to what is required if a failure occurs. c) Control panels, override switches and sensitivity adjustments on the metal detector must be sealed and isolated with access only granted to specific supervisors/managers. d) The rejection system on the metal detector should be automatic with rejected product dropping into a lock box to be re-inspected using written documented procedures. e) The search head must be of a size appropriate for the specific food product and achievable sensitivities will relate to product size, type and packaging. f) Pipeline metal detection systems should have audible and visual indication of rejection. Reject must be to a suitable secure container. g) Free-fall "throat" detection systems should reject by double pack if automatic rejection is not possible. The system should also be fitted with an audible and/or visible alarm. It should only be possible to re-start the system using a key held by a nominated person.
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Darden Supplier Total Quality Expectation Manual 4.3: Food Allergens and Sensitizers
4.3.1: Expectation: All food products produced for Darden shall be labeled so that all Regulatory requirements for food allergens and sensitizers are met. Food formulations must accurately identify allergens. Also production scheduling, ingredient management, and prerequisite programs must assess the risk of allergen cross contamination. e.g. Milk, Eggs, Peanuts, Tree nuts, Fish, Shellfish, Soy, Wheat, Gluten, Sesame, Sulphites, Mollusks,
4.3.2: Requirements: 1) Allergen and Sensitizer Control a) If allergens and/or sensitizers cannot be eliminated from the formulation the allergen must be identified on the label and per Regulatory Requirements. b) Accidental allergen inclusion must be prevented by proper attention to process control or physical separation in different production areas. c) If equipment is shared, the product containing the allergen must be produced at the end of the allergen free production runs and then equipment adequately cleaned prior to the next run. d) Ingredients containing allergens and/or sensitizers must be stored separately and appropriately labeled. e) Allergen and/or sensitizer free ingredients must be stored in a way to avoid contamination with allergens. f) Allergen and/or sensitizer labeling must be separate and clearly identifiable. g) In shared production applications labeling must identify production on a line used to produce food with that allergen. Labeling must take into consideration shared buildings used to produce food with allergens/sensitizers.
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Darden Supplier Total Quality Expectation Manual 4.5: Heat Preserved Food
4.5.1: Expectation: 1) Thermal processing is a preservation method designed to make the product microbiologically safe and prevent intrinsic spoilage due to enzyme activity. Methods of heat treatment include pasteurization, ultra-heat treatment and sterilization. 2) Commercial sterility is the condition achieved by application of heat, sufficient alone or in combination with other ingredients and/or treatments, to render the product free of microorganism capable of growing in the product at non-refrigerated condition (over 50F or 10C) at which the product is intended to be held during distribution and storage. 4.5.2: Requirements: 1) Commercial Sterility a) All commercially sterile food supplied to Darden will have been subject to a heat treatment destroying all vegetative pathogens and organisms capable causing spoilage in the food under non-refrigerated(but below 110F) storage conditions. b) Low acid foods with a pH value of 4.6 or above and intended for storage under non-refrigerated (but below 110F or 43C) conditions must be subjected to a thermal process designed to achieve a 12 log reduction of botulinum or equivalent, if the formulation does not prevent botulinum growth. c) Any supplier producing low-acid foods packaged in hermetically sealed containers must adhere to the requirements outlined in CFR: Part 113 http://ecfr.gpoaccess.gov/cgi/t/text/textidx?c=ecfr&sid=f7cd1d3ff180ae237d453e96096dd330&rgn=div5&view=text& node=21:2.0.1.1.12&idno=21 d) The physical, chemical and microbiological characteristics of each specific product must be considered in determining the conditions to achieve commercial sterility. This must be applied to new products or changes to existing ones. e) Water used in manufacturing or in direct contact with the food must be of potable quality and free from substances that cause harm to health, substances that may corrode packaging and harmful organisms in cooling waters. f) Water must be treated to maintain microbiological integrity i.e. chlorination. g) Mechanical unloading and handling systems must be designed to handle dry packages quickly, avoid damage to container closures and keep conveyers clean to avoid contamination of products through pinholes in closures.
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Darden Supplier Total Quality Expectation Manual 4.6: Cooked and Chilled Foods
4.6.1: Expectation: Cooked and chilled foods are perishable and must be kept below 5C/41oF. Risks associated with cooked and chilled foods have to be assessed and controlled (e.g. Assessments for raw material perishability, the effectiveness of processing on pasteurization, risk of pathogen growth and cold chain management). The HACCP process must be employed in the production of chilled foods. 4.6.2 Requirements: 1) Ingredients a) Specifications for ingredients/raw materials should include microbiological standards based on risk. b) Perishable ingredients/raw materials should be purchased only from the vendors own approved suppliers who should furnish regular test results and agree to warn the purchaser of any problems in maintaining standards. c) The temperature of highly perishable raw materials must be tested at the time of delivery and not be accepted if their temperatures fall outside agreed specified ranges. 2) Product Formulation a) Product formulation must take a multiple hurdle approach where the finished formulation is assessed for pH, water activity, and use of preservatives. 3) Processing Parameters a) Cooked and chilled foods must undergo one of the thermal processes shown below or its equivalent. b) Heated to 70C/ for not less than 2 minutes (or equivalent). c) Heated to 90C/194oF for not less than 10 minutes (or equivalent). (1) Milk 63C/145oF for not less than 30 min or 72C/162oF for not less than 16 seconds (or equivalent) (2) Milk based products with 10% milk fat or added sugar for not less than 66oC/151oF for 30 minutes (or equivalent). d) Frozen dairy dessert mix 69C/157oF for not less than 30 min (or equivalent). e) Heated product should be cooled as quickly as possible through the temperature range 63C/145oF to 5C/41oF or less to minimize risk of spore germination and outgrowth. f) Temperature and time control are the principal controlling factors for the safety of chilled foods. Effective temperature and time control throughout the cold chain is particularly important to slow or inhibit the growth of pathogenic bacteria. Cold foods, for reasons of safety or quality, are designed
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Darden Supplier Total Quality Expectation Manual 4.8: Finished Product Control, Testing, and Inspection
4.8.1: Expectation: To ensure the safety and quality of products, Suppliers shall implement testing and inspection procedures to monitor the relevant parameters and launch corrective actions if results fall outside specified limits. 4.8.2: Product Control Expectation: 1) The factory must ensure that quality control is based on minimum quantity as per the requirements identified in the specifications for Darden products. 2) These requirements must be documented in manufacturing specifications and Quality Control staff must be aware of the specified control limits. 3) Quality Control personnel must have the authority to hold product considered to be outside specified control limits with a defined procedure for resolution. 4) All verification checks must be distributed through the production period and records maintained for review. 5) Quality Control procedures should be developed by the Quality Control Manager considering the following: i) Product characteristics which need to be checked ii) Equipment required and the appropriate measurements to be taken iii) Level of accuracy required iv) Acceptable limits of variability v) Skills and qualifications required by quality control personnel vi) Points in the process where the measurements will be undertaken vii)Product characteristics to be assessed and the acceptance criteria viii) Documentation to be completed ix) Requirements for verification of the results of product testing 6) Any product failing to meet specifications at any stage in the process must be placed on hold, be suitably marked and/or held in a quarantine area awaiting a decision on its disposition. 7) In the event of non-conforming product being placed on hold status, a decision must be made on appropriate disposition. 8) Nonconformance must be documented, investigated and resolved with a corrective action. All corrective actions must be monitored for effectiveness. 4.8.3: Pack Quantity Control Expectation: 1) Quality Control and Production personnel must be aware of the minimum gross/net pack, pieces or volumes and this must be documented 2) Packed product may also be sold to a specific count. Where bulk product is not subject to legislative requirements it must conform to the relevant specification.
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Enhanced tracking and tracing of food and recordkeeping Foreign Supplier Verification Program
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Requirement for facility, warehouse, or any facility that processes, packs, or holds food to conduct a HACCP. Facilities will be expected to verify that that all preventative controls are adequate and effective to mitigate all Hazards Identified. Facilities are required to have effective and functioning procedures designed to ensure allergens do not become a risk to sensitive individuals. Requirement for the facility to have a system established to identify where it received food from and to whom the food was shipped. Suppliers who import food from overseas will be required to demonstrate they have completed a risk based assessment show the food is unadulterated, and produced in a manner meeting US FDA food laws.
The facility will have documented procedures in place to handle specific materials containing know allergens to ensure that cross contamination is mitigated and all products containing allergens are correctly labeled.
Facilities must be capable of demonstrating transparent traceability for all ingredients and packaging sourced and finished product sold. These must be clear, complete, account for all materials and subject to a robust validation process. Suppliers will be required to conduct their own evaluation of the food safety plans of the facilities from which they source food. This will also include the supply chain, and may require testing to validate the process.
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Facilities must implement a risk based approach to mitigate the risk of intentional adulteration of food.
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Control of Birds Steps must be taken to prevent birds being attracted to, roosting on, or entering facility buildings. Good hygiene standards around the facility perimeter (e.g. keeping all waste containers covered) must be maintained. All external doors must be kept closed when not in use and holes in the external structure proofed against bird entry. Netting of canopies should also be considered where there is a local problem with birds.
Date Issued: May 1, 2012 Page 95
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Glossary of Terms
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Appendixes
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