I
2012
Darden Supplier Total Quality Expectation Manual Manual Welcome Letter from Ana
Effective Date: June 1, 2012
Darden Supplier Total Quality Expectation Manual Introduction Products that are both safe safe and high quality have long been the standard of Darden. To accomplish this, it is important that everyone in our supply chain (growers, manufacturers, processors, distributors, importers importers and transporters) tr ansporters) are working hard to achieve the same goal. The purpose purpose of this manual is to facilitate meeting our standards by making Darden‟s food safety and quality requirements clear. The content of this manual reflects the requirements and general expectations for food safety and food quality systems of companies that supply Darden with food products. Three key strategic fundamentals to food safety and food quality are; Prevention, Verification and Traceability. You will find that these three vital elements are embedded throughout this manual. Where applicable, this manual references the current and anticipated requirements for the food industry from the 2011 Food Safety Modernization Modernization Act. This is done to provide guidance to our food suppliers and support your efforts to meet these regulatory requiremen requirements. ts. For the purposes of this manual, Darden is using the general term of Food Safety to include both non-intentional and intentional acts that may render the food unsafe. The requirements given in this manual are minimum requirem requirements. ents. It is your responsibility responsibili ty as a provider of food products to Darden to meet or exceed these threshold requirements, requirements, to ensure that the products produced for Darden and its subsidiaries are safe and meet or exceed thes thesee quality standards. The requirements requirements are not intended to alter or eliminate any additional requirements that may be set forth in any contract or product specifications issued by Darden. Many of the expectations in this manual are based on regulatory requirement requirementss or industry best practices. Darden reserves the right to make modificatio modifications ns to this manual at any time. You are expected to comply with all cu current rrent and applicable United States federal, state, and local regulations as well as a s contractual obligations. Not all of these requirements apply to every product; therefore, specific requirements for certain types of products are clearly defined in this manual. Together, by utilizing a risk based, process verification approach, Darden can ensure food safety and food quality standards are fully integrated into all levels of the Supply Chain. Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual Table of Contents Section 1: General Requirements and Expectations for All Suppliers
3
1.1: Compliance with Darden Expectations and Reg Regulatory ulatory Requirements
3
1.2: Darden Requirements for All Suppliers and Distributors
5
1.3: AdditionalDarden Requirements for Specific Components of the Supply Chain 1.3.1 Fresh Produce Growers and Packers 1.3.2 Foodand Fresh Produce Manufacturers and Processors, Including Seafood Packers 1.3.3 Additional Requirements for Seafood Manufactures and Packers 1.3.4 Additional Requirements for Manufacturers of Land-based Proteins 1.3.5 Additional Requirements for Manufacturers of High Risk Commodities 1.3.6 Darden Requirements Requirements for Regional Distributors 1.3.7 Darden Requirements Requirements for Food Importers of non-Seafood And non-Produce Products 1.3.8 Darden Requirements Requirements for Darden Direct Distribution Partners 1.3.9 Darden Requirements for Transporters 1.3.10 Darden Product Specification Specification Requiremen Requirements ts 1.3.11 Dry Goods and Frozen Item Shelf Life Requirements 1.3.12 Product Complaints for all Suppliers except Frozen Seafood and Fresh Produce
9 9 27 28 33 36 40 42 44 47 48 49 50
Section 2: Food Safety and Quality Management
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Section 3: Facility Standards Standards
63
Section 4: Product Control
75
Section 5: Process Control
89
Section 6: Personnel Management
92
Section 7: Best Practices
94
Glossary of Terms Appendix A Instruction on how to Demonstrate Compliance Appendix B Critical Risk Product List
97 A1-A7 B1-B2
Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual
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) Supplie Suppliers rs 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 (www.gpoaccess.gov/ .gov/cfr/index.html) c) USDA – Food Safety Inspection Service (www. fsis.usda.gov) (1) Resource: Codex Alimentarius Alimentariuswww.codexalimentarius.net www.codexalimentarius.net
2) Supplie Suppliers rs are expected to comply with aall ll Requirements given in this manual. 3) Suppliers Suppliers will ack acknowledge nowledge 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 assessme assessments nts of all data submitted. 5) Darden will conduct random verification assessme assessments nts of compliance to all applicable Regulatory Requirements. 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) Developmen Developmentt of and compliance with Product Specification Specificationss 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 determi determined ned to be in non-compliance with Darden‟s food safety and quality requirements will be placed placed on Restricted Status, meaning that no new business opportunitie opportunitiess with Darden will be allowed. 2) Corrective Actions: Suppliers will be notif notified ied of non-compliances via email and Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual will be required to submit a written plan of action within 5 business days, including root-cause analysis, corrective actions, preventative actions, timelines and responsible individuals for impleme implementing nting the corrective/preve corrective/preventative ntative action plan. 3) Critical observations must be resolved immediately. 4) No more than 90 days or agreed upon time with Darden Total Quality will be allowed for structural or equipmen equipmentt related ccorrective orrective actions to commence 5) Suppliers Suppliers will be evaluated every 30 days in order to determine progress. 6) If full implementation is not achieved by 90 days, the supplier will be subject to a full review and maybe required to resubmit all requirements for approval or the business relationship may be terminated. 7) Supplie Supplierr Reinstatement: A supplier that successf successfully ully completes all corrective actions within the 90 day timeframe will be removed from Restricted Status and will be allowed to pursue new business opportunities with Darden. (i) Repeat Non-compliance: Non-compliance: Repeated failure to comply may result in loss of business with Darden.
Date Issued: May 1, 2012
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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 a cknowledge the receipt and implemen implementation tation of Darden‟s 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 Darden‟s Critical Risk Products List List (Appendix B ) and wi will ll not use any products appearing on this list as an ingredient or final product for a Darden Restaurant under any circ*mstance. All Suppliers will acknowledge the receipt and implementation 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 compl compliance. iance. 1.2.3: Product Traceability Program: In May 2011, Darden announced to all suppliers the adoption of the GS1 GS1 US Foodservice S Standards tandards Initiative. To suppo support rt this, Darden has published milestones for suppliers to transition to bar code standards containing common data. The first Darden milestone ffor or suppliers is obtaining a company prefix prefix from the GS1 organization and then creating your location and item numbers for Darden products. In subsequent mi milestones, lestones, 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 Darden‟s adoption of GS1 standards, contact your Darden Buyer Buyer at 407-245-4000. For more informatio information n on www.gs1us.org.. GS1, please go to towww.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 w will ill 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” 2002” 3) Supplie Suppliers rs must hold their raw material and ingredient suppliers accountable for the above requiremen requirements. ts. Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual 4) Suppliers Suppliers must be able to conduct a Traceability Exercise/Mock Recall exercise must be completed within 4 hours with 100% product recovery. 5) The supplier must be able to submit Recall data to Darden in an electronic format. Demonstration of Compliance: Please reference Appendix A for instructions
on how to demonstrate compliance compliance.. 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 (Seewww.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 ba sis 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 supplier is working towards G GFSI FSI 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. http://www.mygfsi.com mygfsi.com/structure-and /structure-and-governance/g -governance/gfsifsitechnical-committee/gfsi-globa technical-committee /gfsi-global-markets-worki l-markets-working-group ng-group
Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual (4) Local Produce growers and/or packers can utilize an approved Third Party Audit based upon the Produce GAP‟s Harmonization Initiative (see www.unitedfresh.orgfor more details.) www.unitedfresh.org (5) Audit results will be reviewed by Darden Total Quality personnel with close attention being paid to the areas of, but not limited to: Raw Material Inspection Inspectionss
GAP Program GMP, SSOP and SOP Programs HACCP Risk Assessment Program Foreign Material Control Program Cold Chain Management Program Recall Program & Product Traceability, including regular mock recall exercises Pest Control Program Testing Program for Water and in-house made Ice Food Defense Program Compliance with all Country of Origin, Local, State, Federal statutory & regulatory requirements
Demonstration of Compliance: Please reference Appendix A for instructions on how to demonstrate compliance.
1.2.5: Notifications 1) Notification of Change: Suppliers Supplie rs 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 inclu include de documentation of how the supplier supplier will
address any new risks. These changes are subject to approval by Darden. 2) Notification of Contract Manufacturer/Co-Packer Use: Suppliers Supplie rs will notify Darden of any products which are produced in a plant not wholly owned and/or operated by the supplier. supplier. Darden must approve the us usee of Contract Manufacturer, Manufacturer, Co-Packer, and/or subcontractors 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 representatives.. 3) Notification of Regulatory Contacts/Actions: Suppliers Supplie rs 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. Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual
1.2.6: Illegal Use of Antimicrobials including Antibiotics
Judicious use of Antimicrobials and An Antibiotics, tibiotics, including requ required ired withdrawal periods, shall be in accordance with all FDA and USDA rregulatory egulatory requireme requirements. nts. 1.2.7: Use of Genetically Modified Organisms
Darden is opposed opposed to genetic cloning of an animal imal products. As such genetically clone cloned d animal products shall not enter Darden‟s 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 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
Date Issued: May 1, 2012
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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 Fresh Produce Growers and Packing Facilities 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. processing. These food items are su supplied pplied 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 our Food Safe Safety ty 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:
Darden‟s 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 our quality standards are delivere delivered d to our restaurants. 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 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 3 rd party or GFSI Audit for demonstration of compliance of these requirements. Additional documentation may be requested.
Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual 1.3.1.4: Expectation Good Agricultural Practices (GAP’s) and Good Manufacturing Practices (GMP’s): (GMP’s): 1.3.1.4 A
Recommended Produce Organization Guidelines
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 (GAP‟s) and FDA/ FDA/ CFR Current Good Manufacturing Practices (GMP‟s) utilizing one or more of the following organization guidelines: The United Fresh Produce GAP‟s Harmonization Initiative (www.unitedfresh.org) 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 Suppliers supplied to Darden upon request. 1) Copies of your GAP‟s, GHP‟s, and/or GMP‟s – all that apply to your operation 2) HACCP based risk analysis and program documentation for each Darden processed product including the hazard analysis and CCP‟s CCP‟s 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 organization‟s supplier food safety approval process – include all documentation you require and ask of your suppliers 10)Grower/Packer/Processor Grower/Packer/ProcessorInformation including:
Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual A. Identify and provide contact information (name, phone numbers numbers,, email, etc.) for all growers, ranches, coolers, packing sheds, and processing plants that will be utilized to source and manage Darden product B. Person in charge of food safety for your organization with phone and email contact information C. Water source for each ranch including most recent testing results D. Irrigation method for each ranch E. Traceability and Recall programs F. Accredited laboratory to be used for pre-harvest pathogen testing on high risk fresh produce, water and pesticide testing G. The most recent (not to exceed one year) 3 rd Party audit for all ranches, packing sheds, coolers, and processing plants supplying Darden product H. Results of the most recent self-inspection conducted on the fields and prior to harvest for the ranches where Darden product will be harvested harv ested I. Timely communication to Darden prior to transitions of growing fields
Demonstration of Compliance: Please reference Appendix A for instructions on how to demonstrate compl compliance. iance.
1.3.1.5:Employee Workforce Expectation:
For specifics on employee health and hygiene standards refer to the United Fresh Produce GAP‟s Harmonization Initiative (www.unitedfresh.org) 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 F DA recognized commodity specific guidance.
1.3.1.5 A: Requirements:
1) All personnel shall receive initial food safety training and supplem supplemental ental 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: Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual 1) Field Level Lots A. Growing areas must be defined by lots established and documented to the smallest practical unit of shared risk. B. By smallest quantity of produce that is indistinguishable (equal) in its exposure to a common risk (e.g., animal, worker, irrigation)
C. By smallest quantity of produce that is distinguishable/defensible from other quantities 1) In a field this would mean defining lots by harvest block, harvest date/time and harvest crew and/or machine. 2) Finished Product Lots A. Finished product lots shall be defined at a maximum size of one calendar day‟s production. Smaller lot sizes that are defensible are desirable. desirable. B. Package coding including lot number, pack date, best by date and any other identification information information must be on each outer case and packaged inner packs. C. Lot code information must contain the following information: a) Date harvested, packed or processed b) Harvest location including grower, field and sub lots c) Common risks such as harvest crews, irrigation source, packing or processing lines, etc. D. Provide lot code interpretation to Darden Total Quality 1.3.1.7: Field Environmental Risk Assessments Expectation:
1) At a minimum, an assessment of all environmental risks shall be completed by the supplier‟s designated food safety personnel using the following timelines: timelines: a) Prior to7the first b) Within days ofseasonal harvest planting c) During harvesting operation
1.3.1.8: Agricultural Water Expectations:
1) All water sources must be clearly identified and traceable tr aceable 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 dev eloped 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, Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual corrective actions and preventative actions. If water is used to control dust on dirt roads within the growing fields it must be of acceptable quality (see water standard below) since aerosol contamination of plants and product could occur.
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 coliform coliformss ≤ 2.2 MPN/100 MPN/100 ml (Geometric mean of five samples). c) E.coli 0157:H7 and Salmonella species – Negative/100 ml.
i) 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 Marketing standard willn=5) be acceptable: Generic E. Leafy coli ≤ Greens 126 MPN/100 ml Agreement (rolling geometric mean and ≤ 235 MPN/100 ml for any single sample. 2) Testing frequency: a. Initial Testing: Each water source and at the farthe farthest st point of distri distribution bution 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. On-going Testing b. water Generic basis E. coliduring and fecal coliforms s shall be sample sampled d for all sources on a: monthly cropcoliform production stages (growing and harvesting seasons). seasons). Deep sealed we wells lls can be tested on a quarterly bas basis is once 3 consecutive samples comply with the t he 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
Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual testing of the fresh produce for E. coli O157:H7 and Salmonella species shall be conducted from each lot in production.
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. labs testing water samples shall be certified through the National 1. All 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 a nd 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 supplem supplement ent 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 m must ust be documented and re retained tained 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) fo forr each lot of compos compostt 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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Darden Supplier Total Quality Expectation Manual 1.3.1.10: Agricultural Chemicals Expectation:
Growers shall comply with label directions and all relevant local, state, and federal regulations. Fresh produce products shall meet United States requirements for agricultural chemicals usage and residues. 1.3.1.10 A: Requirements: 1) Growers shall comply with industry best practices described in Good Agricultural Practices (GAP‟s) utilizing one or more of the following organization guidelines: the United Fresh Produce GAP‟s Harmonization Initiative (www.unitedfresh.org 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
2) Pesticide testing of product must be done by the grower/supplie grower/supplierr at least seasonally to verify compliance and ensuring all Darden products have been sampled.
1.3.1.11: Set Back Distances for Growing Fields Expectations:
1) In order to protect growing crop and/or water supplies from potential 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 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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Darden Supplier Total Quality Expectation Manual 1.3.1.11 A: Requirements: Types of adjacent land use
Concentrated animal feeding operations/dairy farms (50 or more confined animals) Composting operations Non-synthetic soil amendment a mendment pile (compost teas, fish emulsions,, fish meal, blood meal, emulsions bio-fertilizers, etc.). Grazing lands and domestic animals (includes homes with hobby farms and noncommercial livestock) Types of buildings, equipment, etc. Farm housing/ranch buildings with septic tanks Farm housing and ranch buildings on municipal waste systems General Setbacks Housing developments Highways/Roads Riparian/Natural vegetation Avian wild life perches Proximity to flood waters
Date Issued: May 1, 2012
Minimum set back distance from crop edge of the field 400 feet
400 feet 400 feet
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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Darden Supplier Total Quality Expectation Manual 1.3.1.12: Animal Activity Expectation: A documented animal control program including a risk assessment must be implemented implemen ted to manage and effectively control the identified hazard. Consider checking with applicable regulatory authorities for wildlife requirements and potential barrier restrictions. 1.3.1.12 A: Requirements: 1) A thorough pre-harvest field inspection shall be performed to determine risks associated with wildlife, livestock, domestic animals and other adjacent land uses no longer than 7 days prior to harvest. 2) No animals of significant public health concern (domestic and/or wild animals to include livestock, dogs, horses, pigs, deer, etc. etc.) are permitted within the growing, packing and cooling operations. 3) If animal intrusion is evident on the growing fields or within the packing and cooling operations, management must take immediate corrective action to remove the animals and isolate and destroy any product potentially contaminated by the animals. animals. An SOP must be in place to address animal intrusion and calls for a risk assessmen assessmentt and removal of affected product
including a definition of buffer zone. 4) In fields a minimum of 3‟ radius “no harvest zone” must be implemented when evidence of animal tracks have been found. This will need to be increased to a minimum 5‟ if fecal matter is found. Animal burrows are considered as animal activity and must follow the “no harvest zone” requirements. They must be covered and re-visited in 24-48 hrs. to be checked for activity. If active, control measures such as trapping must be initiated. 5) All feces left behind require removal along with the contaminated soil. Removal shall be done after unaffected areas have been harvested and product removed in order to avoid contamination to the unaffected product. The incident shall be documented, deficiencies described and corrective actions and preventative measures taken to prevent reoccurrence. 6) If animal activity (wildlife or domestic) is likely to occur then a physical barrier such as fencing shall be required. 7) Where animal grazing is adjacent to growing fields, a barrier complying with withthe setback distance requirements shall be established between the fence and the end of the crop rows. 8) Concentrated feed lots require a barrier complying with the setback distance requirements.. Distance may vary if a comp requirements completed leted risk assessm assessment ent takes into account variables that influence potential for contamination such as topography of land, water run-off, ground slope and physical barriers (such as fences, ditches, mounds, berms or bare soil buffers). 9) Natural barriers may be acceptable provided they exclude the animals of concern. 10)Stored manure shall not be present in adjacent fields to the growing crops. Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual 11)A process shall be developed, dev eloped, implemente implemented, d, maintained and documented for monitoring all physical physical barriers to ensu ensure re continuous in integrity. tegrity. It is recommended that monitoring take place daily until control is established and then transitioned transitioned to a lesser freque frequency. ncy. Documentation sshall hall include corrective actions taken, when, by who, etc. if and when the security of the barrier is compromised. 1.3.1.13: Pre-Harvest Pathogen Testing of High Risk Produce Expectation: 1) To establish a pre-harvest microbiological testing protocol or other Darden Total Quality approved testing protocol for high risk fresh produce to verify the success of Good Agricultural Practices programs.
a) Pre-harvest testing is one of several verification tools of a successfu successfull food safety program; however however it is not a guarantee of p pathogen athogen free pro product. duct. It is a useful measure of food safety programs, establishing baselines of performance and to identify potential food safety problems with mitigating measures. 1.3.1.13 A: Requirements: 1) Sampling Frequency:
a) Frequency will be determined on a case by case basis by the Darden Total Quality Fresh Produce Team utilizing a risk based ba sed analysis that includes but is not limited to: b) History of involvement with food borne illness outbreaks, high frequency of recalls and involvement with regulatory testing programs c) Trend analysis of supplier testing data for pathogens on product d) Darden conducted risk analysis of the product and supplier that includes factors such as: (1) Geographical growing region (U.S., Mexico, Peru, etc.) (2) Animal intrusion risk (3) Water source, irrigation methods, treatments and testing results r esults (4) Personal health and hygiene programs and training (5) Soil amendments (6) GAP deviations (7) Volume of product purchased and/or number of restaurants impacted
Note: All Darden approved growers worldwide shall participate in this program. Products and analysis in the follow following ing table m may ay be revised. Be sure to contact Darden Total Quality to confirm you have the most recent version. Date Issued: May 1, 2012
Page 18
Darden Supplier Total Quality Expectation Manual Darden reserves the right to modify the testing requirements based upon a risk r isk analysis. Produce to be Sampled and Sample Analysis requirements:
Iceberg Lettuce Romaine Spring Mix Green & Red Leaf Lettuce Butter Lettuce Baby Leaf
E. coli
Salmonella
O157:H7
spp
X
X
X X X
X X X
X X
X X
Lettuce Spinach Cabbage Arugula
X X X
X X X
Green Onions Parsley Cilantro Basil Tomatoes Strawberries
X X X X X X
X X X X X X
2) Supplier’s Responsibilities: Responsibilities: a) The following are the supplier‟ supplier‟ss responsibilities as an approved supplier/growerr to Darden. supplier/growe (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 Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual include disposition of the affected product to ensure it does not enter the supplier chain. (5) No product shall be harvested or shipped prior to all microbiological tests being completed, all final results received and results negative for the pathogen(s) in question 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 test results back prior to harvest. harvest. This will allow ffor or 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 instructions on how to demonstrate compliance compliance. . Appendix A for Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual 1.3.1.14: Packing Facilities Expectation:
In addition to good manufacturing practices all fresh produce packing facilities shall comply with the following: At this time Darden does not suggest finished product testing for pathogens. 1.3.1.14 A: Requirements: 1) Water Quality
A. Water must meet the microbial standards for potable water as set forth by the U.S. Environmental Protection Agency in 40 CFR Part 141.63 (<2 MPN generic E. coli/100ml) may be used in the packing facility. If sourced outside of the U.S, the testing standard must be in compliance with the country of origin. B. For produce, such as tomatoes, that may be immersed in water and demonstrated as being susceptible to microbial infiltration from water, water temperature differenti differentials als during immersion shall be controlled in accordance with prevailing regulation or industry guidelines. C. Regular testing, annually if from a municipal water supply and quarterly if from a private well, shall be performed to verify the quality of the water, this includes water used for cooling of product, for flumes or produce spray systems and employee hand wash. D. Three consecutive analyses (fecal coliforms, generic E coli) for water utilized within the operation E. All water (including ice) used within the packing and cooling operations shall be potable. F. If water is used in any form, including ice, it shall be chlorinated or otherwise sanitized. 2) Product Wash Water Sanitation
A.Antimicrobials used in post-harvest wash water must be monitored on a frequent basis to ensure the constant effectiveness of the wash water. Testing frequency shall be continuous or at least every 60 minutes and retest within 5 minutes when adjustments are required B. A chlorine titration kit or equivalent shall be used instead of dip sticks and employees shall be trained prior to use C.An automatic monitoring system for chlorine or other sanitizers and acid used should be installed on flume systems and include automatic dispensing of chlorine and acid as needed
Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual D.Establish action levels prior to system exceeding critical limits, therefore maintaining control at all times. E. An audible and visual alarm system should be installed to assist personnel in monitoring system controls F. Documentatio Documentation n shall include all appropriate critical control parameters associated with the system in use: free chlorine, total chlorine, ORP, pH, water and product temperature, etc. G.Document any corrective actions needed along with root cause analysis H.For high risk products (ref. Darden High Risk Fresh F resh Produce Table) food contact surfaces shall be tested for total coliforms, fecal coliforms and generic E. coli I. Three consecutive analyses for 3 product contact surfaces, employee gloves (total, fecal coliforms, generic E. coli). J. Mechanically cooled product storage units utilized for high risk products and for products that do not receive a thermal cooking step shall be tested for Listeria spp. K. Listeria analysis for cold room environment, based upon growing season, no less than once per operating season L. An 18 hour minimum interval is required between samples 1.3.1.15: Processing Facilities Expectation:
The processing facility shall establish a documented food safety HACCP program (refer to section 2.1 in this manual) to address addr ess food safety concerns including trend analysis, reporting and notification to Darden when product safety parameters are found to be out of compliance.
At this time Darden does not suggest finished product testing for pathogens.
1.3.1.15 A: Requirements:
1. An Environmental Monitoring Program (EMP) shall be established and designed to detect areas of pathogen harborage and to verify the effectivenes effectivenesss of cleaning and sanitizing programs in preventing preventing cross-contamination. The following elem elements ents must be included in a fresh produce EMP program: A. Environmental sampling on both food contact and non-food contact surfaces (e.g. drains) B. Determination of the appropriate target pathogen(s), test locations and frequency of sampling. sampling. We recommend th that at the target pathogen(s pathogen(s)) be the most resistant microorganisms of public public health significance that is likely to occur in fresh produce
Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual C. Focus environmental monitoring on an indicator organism, such as a s Listeria spp., which indicates microbial contamination but is nonpathogenic and more easily detectable than a target pathogen, such as L. monocytogenes D. Establish an action plan in the event that a microbiological test indicates the presence of a target pathogen or indicator organism E. Document and retain corrective actions and follow-up for all positive microbial test results F. Darden recommends recommends the use of a 3rd party laboratory service provider to design/develop a customized EMP that will be appropriate and effective to detect pathogens in the facility environment G. 3rd party/external laboratory testing program – refer to section 1.3.5.5 (3rd Party/External Laboratory Testing Program) for further details and requirements 2. Maintain retention samples one day beyond the declared shelf life for all Darden products and conduct ongoing quality evaluations including specification compliance 3. The processing facility shall establish a documented program to address food safety and quality concerns and complaints including trend analysis, reporting and notification to Darden when product safety or quality is found to be out of compliance.
1.3.1.16: Produce Distributor Rework-Repack Expectations Expectation:
Rework/Repack-The manual removal and replacement of defective product with Rework/Repack-The 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 unsure of the production codes/lot #‟s, contact the supplier. supplier.
Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual 1.3.1.16 B: Procedures for Reworking Whole Commodity Produce
1) QA oversight/direction is required during the rework process. 2) Good Distribution Practices (GDP) and Standard Operating Procedures (SOP) shall include but not be limited to: glove g love policy, ill employee policy, personal hygiene practices, hair restraints, and employee dress. 3) All be documented, and provided for alltotal, repacks. This willrecords includeshall but not be limited to; maintained total quantity received, repack repack yield (%), originating supplier, status of unused product, traceability data. 4) The repack area must be located away from trash and maintenance areas. 5) The surrounding walls, floors, and ceiling, must be non-absorbent, smooth and easily cleanable. 6) Equipmen Equipmentt used, such as tables, must conform to processing room standards for cleanability. 7) Standard Sanitation Operating Procedures (SSOP) for all equipme equipment nt used in the repack area must be developed and documented. 8) Adequate shielded lighting will be provided in the area. 9) Employees working in the repack area must be trained on all areas noted above as well as be tested to determine knowledge retention. retention. 10)Employee shall wash and sanitize their hands and wear gloves prior to rework of produce and as often as necessary during the process. Follow all GMP‟s throughout the process. 11)Clean and sanitize all work surfaces prior to product rework. Documentation shall include type of sanitizer and concentration levels as tested prior to use. 12)If there is more than one production code/lot # involved, each shall be reworked separately. 13)Comminglin Commingling g of production codes/lot# is unacceptable. 14)Manually remove poor quality product and replace with acceptable quality product from same brand and production code/lot #; the same boxes shall be used. 15)Document the disposition of the unusable product. Include photographs of the quality issues. 16)Re-weigh using a calibrated and validated scale all reworked cases to ensure the declared weight has been maintained. 17)Document the number of whole cases yielded for each production code/lot # following rework. 18)Forward copies of all documentation to the supplier and the Darden Total Quality Fresh Produce Team.
Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual 1.3.1.17: Social Responsibility Expectation:
Management shall develop, implement and maintain a process for hiring employees that abides by the labor laws, especially as it pertains to employment of minors for the country in which they are conducting business business.. 1.3.1.17 A: Requirements:
1) A copy of the entire labor law document will need to be on file in English and the language of the country in question for review. 2) Company policy shall include a statement stating that NO children or babies shall be allowed in the growing fields or adjacent open areas of growing fields or packing areas. 3) Management shall verify that all employees meet the current age limits as to the applicable laws for the country in question. 4) There shall be documentation on file for each employee that provides hire date, age (birth certificate and/or some other official documentation with picture) and employee training records. 5) For those employees below the recognized adult minimum age requirements for the country in question, the documentation shall include: job application with current employee picture, copy of birth certificate, government permit to work, parent‟s permission permission and copy of the parents identification to verify that all dates dates are correct. 6) No babies or underage children are allowed in the growing g rowing fields, cooling facilities or packing sheds 7) Day care facilities and schools shall be available ava ilable for all babies and school age children as applicable. 8) Day care facilities shall be well maintained, clean and properly equipped to care for children of all ages. 9) If housing units are provided to the employees, they shall be well maintained, clean and have all of the necessary facilities to ensure that acceptable hygiene standards can be achieved.
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.
Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual 1.3.1.19: Supplier Regulatory Sampling Notification Expectation:
Due to recent increases in regulatory sampling (pathogen, chemical residual, and phytosanitary) at the supplier, distributor, retail and border crossings, we are requiring re quiring that all produce suppliers alert the Darden Fresh Produce Team immediately if any samples are taken by a regulatory agency. The “Supplier Regulatory Sampling Form” will documupon document ent that suppliers w will ill use to commu communicate nicate this action. A copy of this formbe is the available request. 1.3.1.20: Darden-Primus Website Participation:
1) The Darden website within the Primus internet organization was established in order to provide our suppliers with a location to upload auditing and micro testing data as well as water and pesticide testing. Suppliers of high risk fresh produce products shall participate in this or a similar program approved by Darden Total Quality. Website access: 2) A user ID and password will need to be established by Primus for log on access. acc ess. 3) The website address is ishttp://intranet.primuslabs.com/DardenSite/ 4) To set up the information noted above and to address any issue with the site, contact the Primus Info Systems and/or Business Development representative.
Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual 1.3.2: Darden Requirements for Foodand Fresh Produce Manufacturers and Processors, including Seafood Packers 1.3.2.1: Introduction: 1) For Darden, Foodand 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 Safety System. Being a food safety partner me means ans 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: Darden‟s Foodand Fresh Produce Manufacturers and Processors, including Seafood Packers, are expected to have robust and effective risk-based risk -based Food Safety and Quality systems in place to ensure safe food that meets our quality standards are delivered to our restaurants. restaurants. They are expected to co comply mply with the requirements 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 outlined in this manual by product type. a) High Risk Products include:
i) Cooked/Fermente Cooked/Fermented d 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%) 3 9%) v) All Ready to Eat Processed Produce 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.
Date Issued: May 1, 2012
Page 27
Darden Supplier Total Quality Expectation Manual 1.3.3: Additional Darden Requirements for Seafood Manu Manufacturers facturers and Packers Seafood supplied supplied to Darden is subject to microbiological and chemical testing on finished products depending on the type of product and specification requirements. Some of the seafood products supplied supplied to Darden are subject to Raw Material testing for microbiological and chemical parameters prior to processin processing. g. The following tables identify pre- and a nd post- processing microbiological and chemical testing parameters in addition to other required programs to supply seafood to Darden. Aquaculture Fish Risk Grouping A B C
Category Group (All Raw) Chinese Catfish, Chinese Tilapia Cobia, Halibut, Catfish, Barramundi, Trout, Salmon, Tilapia, Arctic Char, Bass, Corvina, Perch, Walleye, Whitefish
PARAMETER
Micro
Chemical
Products of Decomposition Decomposition Traceability Program
Industry Programs
Date Issued: May 1, 2012
Salmonella
Preharvest Requirements Risk Grouping N/A
Post Processing – Raw Product Risk Grouping B, C
Listeria spp
N/A
N/A
E Coli
N/A
B, C
S. aureus
N/A
B, C
Total Coliforms Total Plate Count
N/A
B, C
N/A
B, C
Chlamphenicol
B
B
Nitrofurans
B
B
Fluroquinolones
A*1,B
B
Quinolones Malachite Green
A*1,B B
B B
Gentian Violet
B
B
Melamine
N/A
N/A
Mercury
N/A
N/A
Histamine
N/A
N/A
N/A
B, C
NAME
One up and one down Aquaculture Certification – Processing Plant Standards
All facilities processing aquaculture salmon, tilapia, catfish
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Darden Supplier Total Quality Expectation Manual Critical To Quality Manufacturing Data
Fresh Salmon, Fresh Trout, Fresh Tilapia, Frozen Salmon Portions. B1
To be sent to Darden using the Darden Data Collection template for each product run
N/A – Not Applicable A1– All farmed fish produced for USA cannot be treated with Fluoroquinolones or Quinolones 1
B - This requirement may include other Aquaculture species depending on the source
Wild Caught Fish Risk Grouping A
B C
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
• PARAMETER
Micro
Chemical
NAME
Salmonella Listeria spp E Coli S. aureus Total Coliforms Total Plate Count Chlamphenicol Nitrofurans Fluroquinolones Quinolones Malachite Green Gentian Violet Melamine Mercury
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
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 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.
Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual • B1– Fresh Fish distributors supplying fish associated with Scombroid/Histamine Scombroid/Hista mine poisoning are required to complete Histamine testing quarterly each year and submit data to Darden. Molluscs Risk Grouping A
B C
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
NAME
Preharvest Requirements Risk Grouping
Post Processing – Raw Product Risk Grouping
Salmonella Listeria spp E Coli
N/A N/A N/A
A,C N/A A,C
Post Processing – Cooked Product Risk Grouping B B B
S. aureus Total Coliforms Total Plate Count Chlamphenicol Nitrofurans Fluroquinolones Quinolones Malachite Green Gentian Violet Melamine
N/A N/A
A,C A,C
B B
N/A
A,C
B
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 N/A
N/A N/A
N/A N/A
Mercury Histamine One up and one Traceability Program down Sourced from growing waters with temperature <50oF or Post harvest processing implemented • N/A – Not Applicable
N/A N/A
N/A N/A
N/A N/A
N/A
A,C
B
A
A
N/A
PARAMETER
Micro
Chemical
Products of Decomposition
Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual Aquaculture Crustaceans Risk Grouping Category Group A Cooked Chinese Crawfish, Cooked Chinese Shrimp
B C D
Cooked Shrimp, Cooked Crawfish Raw Chinese Shrimp Raw Shrimp
NAME
Preharvest Requirements Risk Grouping
Salmonella Listeria spp E Coli S. aureus Total Coliforms
N/A N/A N/A N/A N/A
Pre Processing – Raw material Risk Grouping A,B,C,D N/A N/A N/A N/A
Total Plate Count Chloramphenicol Nitrofurans Fluroquinolones Quinolones Malachite Green Gentian Violet Melamine Mercury
N/A
C,D N/A C,D C,D C,D
Post Processing – Cooked Product Risk Grouping A,B A,B A,B A,B A,B
N/A
C,D
A,B
A,B,C,D A,B,C,D 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
C,D C,D C,D C,D N/A N/A N/A N/A
A,B A,B A,B A,B N/A N/A N/A N/A
Histamine
N/A
N/A
N/A
N/A
One up and one down Aquaculture Certification – Processing Plant Standards
N/A
A,B,C,D
C,D
A,B
PARAMETER
Micro
Chemical
Products of Decomposition Traceability Program Industry Programs
Post Processing – Raw Product Risk Grouping
All facilities processing aquaculture aquaculture shrimp
• N/A – Not Applicable
Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual Wild Caught Crustaceans Risk Grouping Category Group A Pasteurized Crab Meat, Cooked Stone Crab Claws, Cooked Blue Crab Claws Cooked North American Lobster Meat, Cooked Langostinos, Cooked Snow B Crab, Cooked King Crab C Raw North American Lobster, Raw Rock Lobster, Raw Deep Sea Lobster
PARAMETER
Micro
Chemical
Products of Decomposition Traceability Program
NAME
Salmonella Listeria spp E Coli S. aureus Total Coliforms Total Plate Count Chlamphenicol
Post Processing Post Processing – Raw – Cooked Risk Grouping Risk Grouping C A,B N/A A,B C A,B C A,B C A,B C A,B N/A N/A
Nitrofurans Fluroquinolones Quinolones Malachite Green Gentian Violet Melamine Mercury
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
Histamine One up and one down
N/A
N/A
C
A,B
N/A
A,B
Freezing, Post Harvest Processing Cooling/Heating, Cooking SCUBA caught Rock Lobster • N/A – Not Applicable
Harvesting Sources
Date Issued: May 1, 2012
SCUBA caught Rock Lobster will not be supplied to Darden
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Darden Supplier Total Quality Expectation Manual 1.3.4: Additional Requirements Requirements for Manufacturers of L Land and Based Proteins 1.3.4.1: Animal Handling, Health and Welfare Expectation: Processers of live animals from which the Supplier obtains any product for Darden must conduct an animal welfare audit based on the most current and appropriate guidelines for each species of animal being handled: i) Beef, Pork and Veal – American Meat Institute Guidelines http://www.animalhandling.org ii) Poultry – National Chicken Council http://www.nationalchickencouncil.com (a) http://www.nationalchickencouncil.com 1.3.4.2: Requirements: a) A 3rd Party Animal Welfare audit with resolved corrective action/preventative action plan shall be submitted to Darden at least annually. The audit detail shall in include clude the animal su survey rvey scores, audit summary and summary of findings.
Demonstration of Compliance: Please reference Appendix A for instructions on how to demonstrate compliance.
Reference: DDDI Animal Welfare/Care Supplier Certification
Resourcesfor 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 Profession al 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 supplier‟s HACCP Plan or a PreRequisite program. Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual 2) Raw Beef Whole Muscle – Intact a) Supplier of whole muscle beef shall have validated intervention technologies to effectively reduce or eliminate E. coli 0157:H7in place and be included in the HACCP Plan or a Pre-Requisite program. 3) Raw Beef Whole Muscle – Non-Intact a) All fresh/frozen steak suppliers that process mechanically tenderized or needle injected steaks must have at least one validated intervention technology to effectively reduce or eliminate E. coli 0157:H7in place and be included in the HACCP Plan or a Pre-Requisite program. 4) Raw Ground Beef a) All source raw materials for grinding or finished product E. coli 0157:H7sample tests shall be performed utilizing test methods in Section 5.5 of USDA‟s Laboratory Guidebook. Guidebook. b) All source material or finished product shall be sampled based on “robust testing” for E. coli 0157:H7as defined by FSIS and/or have a statistically and scientifically justified equivalent or better sampling plan. c) Grinding facilities shall have demonstrated procedures to prevent grinding any un-tested source materials or must have a documented finished product testing program that meets USDA/FSIS definition of “robust testing”. d) A supplier of ground beef may not test positive for Salmonella at a rate exceeding the applicable National Pathogen Reduction Performance Standard without corrective action to Darden. 5) Event Day Program a) Suppliers shall establish an “unusual event” program where unusually high levels of presumptive positive beef trim and/or source material positive tests for E. coli O157:H7 have occurred occurred.. An “unusual event” program shall be predetermined in each suppliers program and shall have decision making documents to support criteria and actions to include product disposition upon an occurrence of an “unusual event.” event.”
Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual 1.3.4.4 Third Party Audit –E. E. coli 0157:H7Addendum requirements by product type Requirements: 1) Whole Muscle a) Suppliers of whole muscle beef shall have a Third Party – E. coli O157:H7 control addendum to their Third Party Independent Food
Safety Audit at least annually, with the addendum submitted to Darden. 2) Raw Ground Beef a) Suppliers of Raw Ground Beef shall have a Third Party – E. coli O157:H7 control addendum to their Third Party Independent Food Safety Audit at least annually, with the addendum submitted to Darden. 3) Raw Whole Muscle Non-Intact a) Each supplier of raw whole-mu whole-muscle scle non-intact beef product shall require a Third Party – E. coli O157:H7 control addendum from all raw
beef suppliers suppliers used for raw whole muscle non intact be beef. ef. The addendum shall be completed at least annually, and made available to Darden upon request. Demonstration of Compliance: Please reference Appendix A for instructions on how to demonstrate complianc compliance. e.
1.3.4.5: Poultry Expectation: 1) Suppliers shall have appropriate intervention technologies in place and be included in their HACCP Plans to reduce or limit the amount of Salmonella and Campylobacter in poultry products. (See: USDA FSIS Compliance Guideline for Controlling Salmonella and Campylobacter in rd
3 must Edition Maythat 2010) 2) Poultry Suppliers ensure they have appropriate programs in place to prevent and control avian influenza and other diseases in poultry. Demonstration of Compliance:Test results shall be available upon request.
Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual 1.3.5: Additional Requirements Requirements for Hi High gh Risk Co Commodities mmodities Certain products are considered High Risk by Darden because they may potentially support the growth of bacterial pathogens and will not receive any further cooking, or they may be served partially cooked, cooked, at our restaurants. High Risk Comm Commodity odity Items include: Cooked/Fermen Cooked/Fermented ted Meats Desserts - containing components without full thermal step, or if classified as Potentially Hazardous Food (PHF) based on 2009 Food Code. Cheese (with moisture content greater than 39%)
Producers of High Risk Produce please reference Produce Specific Section of this Manual
o
The goal of the High Risk requirements are to provide guest safety and brand protection by ensuring all High Risk Product suppliers maintain adequate and appropriate pathogen prevention systems, systems, which include verification of the microbiological safety of: Raw materials Environmental non-food and food contact surfaces Finished product
1.3.5.1: Expectation: High Risk product suppliers must maintain 4 program requirements: 1. High Risk Raw Material Mat erial Testing/Certification 2. Environmental Monitoring Monitoring Program for Non-food and Food Contact Surfaces 3. High Risk Finished Product Testing 4. 3rd Party/External Laboratory Testing Program
Annually, all High Risk suppliers will complete a Darden Supplier Conducted High Risk Self Audit to demonstrate compliance to the above four programs. 1.3.5.2: Requirements: 1. High Risk Raw Material (HRRM) Testing/Certification a. It is required that all High Risk Raw Materi Materials als (HRRM) be tested and found negative for pathogens before they are used in finished finished product for Darden Restaurants. b. HRRM are defined as any ingredient that may naturally harbor pathogens (e.g. non-pasteurized eggs, cream, cheese, milk, beef, or
seafood), or that may support the growth of pathogens and will not be Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual subjected to a controlled & documented thermal kill step during product processing. c. Testing status can be in the form of: i. Certificate of Analysis (CoA) from the supplier of a particular HRRM or ii. HRRM can be tested prior to use 1) If the Darden supplier chooses to test product before use, then a controlled and documented “HOLD/TEST/RELEASE” protocol must be in-place in -place to ensure HRRM is not used before test results are received. Each step of the “HOLD/TEST/RELEASE” “HOLD/TEST/RELEAS E” process must be well documented and all CoAs or test results must be reviewed, approved, and released by a Quality Officer before product can be used. 2) All COA‟s must be kept on file for a minimum of one year and shall be made available to Darden upon request. 1.3.5.3: Environmental Monitoring Program (EMP) 1) An EMP is intended to monitor for bacterial contamination of working surfaces within the facility of a High Risk Product Supplier. 2) An effective EMP must be developed based on facility size, product line, and production volume. All EMPs‟ must contain a protocol for swabbing & testing surfaces, the frequency and rotation of testing, the time during a production day for testing (while testing during production for indicator organisms can be an effective indication of process control, testing during production for any pathogen carries risks and must be accompanied by an adequate product hold procedure to include any product affected by an EMP test), and a map or list of specified surfaces to be tested. It is required that a variety of surfaces be tested on rotating basis that represents: a) Non-food contact surfaces (e.g. door knobs, employee break areas, processing room drains, etc.) b) Food contact surfaces (e.g. slicing blades, cutting boards, grinding g rinding augers) 3) The EMP of non-food and food contact surfaces must call for pathogen or indicator organism testing that is appropriate to product type. Darden TQC considers consi ders the testing regiments listed below “appropriate”; however other indicator organisms may be substituted as appropriate and with approval by Darden TQC: a) Listeria species (cheese, desserts, cooked/fermented meats) 4) Darden TQC recommends use of a 3rd party laboratory service provider to design/develop a customized EMP that will be appropriate and effective to detect pathogens in the manufacturing environment. 5) Composite testing of environmental samples is acceptable, as long as corrective actions for positive results are aimed at ALL sites sampled within a
single composite sample. Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual 6) It is crucial for the EMP to have an effective system of Corrective and Preventative Action (CAPA) documentation. Thorough documentation of all CAPAs is mandatory any time a positive environmental test result occurs. All CAPAs must be immediate and thorough. The effectiveness of CAPAs must be verified by repeat testing. If follow-up tests do not yield negative results, then the CAPA was not effective.
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 must be placed on hold pe pending nding a negative test result. Darden must be notified immediately in the event of any positive test result. Additionally, all COA‟s must be kept on file for f or 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 FDA‟s definition of potentially hazardous food (PHF) according to the 2009 Food Code and applicable supplem supplements ents (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 rd 1) service High Risk Product Suppliers (HRPS) use a 3programs. party accredited laboratory provider to validate their EMP must and HRFPT Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual rd
2) All 3 party laboratories used for this validation should meet these criteria: a. Certified by ISO 17025, NELAC, or A2LA rd
b. Participate in a 3 party check sampling program rd
3) All testing procedures used by 3 party or corporate-sponsored laboratories must follow FDA-BAM and ICMFS ICMF S guidelines. 4) All HRPS are encouraged to use their 3rd party accredited laboratory to conduct microbiological testing; however if a corporate-sponsored laboratory is used for testing, then that laboratory must meet the criteria listed above. 5) A 3rd Party/External Accredited Laboratory partner should be used to design/certify all microbiological testing programs for High Risk Raw Materials (HRRM), Environmental Monitoring Program (EMP), and High Risk Finished Product Testing (HRFPT). A 3rd Party/External Accredited Laboratory must certify that sampling frequencies are appropriate for production volumes, and that sample sizes are adequate to detect the presence of pathogens.
Date Issued: May 1, 2012
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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 ar e supplying food directly to a Darden restaurant in a geographic area or region, and not a part of Darden‟s 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 Food Safety System. Being a food safety partner mean meanss that your company is transparent with food safety, quality processes and data, and committed to the success of Darden. 1.3.6.2: Expectation: Darden‟s Regional Distributors are expected to have robust r obust 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 requiremen requirements ts below. 1.3.6.3: Requirements: 1) Supplier Verification Program: All Regional Distributors will have a documented and effectively effectively managed Sup Supplier plier Verification Program Program,, with required elements to include: a) A Global Food Safety Initiative (GFSI) Certification Audit (See www.mygfsi.com www.mygfsi.comfor 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 Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual 2) Aquaculture products not under contract with Darden:
i) Product Traceability in compliance with the “Public Health, Security and Bioterrorism Preparedness Preparedness Act of 2002”, ensuring that all products are traceable to their origin at least one step forward and one step back. ii) A Recall Program that is documented, managed effectively, and tested on a pre-determined and reasonable schedule. iii)Randomly selected Distributors 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 compliance..
1.3.6.4: Fresh Seafood Specification: All Fresh Seafood products will have a Product Specification in Darden‟s 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. Lobster Meat iv. Cooked 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.
Date Issued: May 1, 2012
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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) manufactured For Darden, Food Importers are those aretoimporting products or grown outside the UScompanies and sellingwho them 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, Darden‟s Food Food Importers are expected to have robust and effective Food Safety and Quality systems sy stems 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 (Seewww.mygfsi.com www.mygfsi.comfor 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 Preparedness Act of 2002”, ensuring th that at 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.
Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual 2) 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 products products entering a Darden restauran restaurant, t, Darden Total Quality personnel must review and approve the 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.
3) Product Specifications: a) All Food Importers will participate in the development and approval of a Product Specification within Darden‟s electronic Product Specification system for every every product provided to D Darden. arden. These sp specification ecification 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 FDA‟s “Voluntary Qualified Importer Program (Green Lane)” to enable expedited review r eview of food imported by your company.
Date Issued: May 1, 2012
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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 our Food Safety System. Being a food safety partner mean meanss 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 Modernization Act. Below are the pe pertinent rtinent sections o off 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 inclu include de documented sanitation p procedures, rocedures, a recall plan, a food allergen control program, supplie supplierr verification activities, and an environmental sampling sampling program. Sec. 104 Performance Standards o Atdetermine least everywhich two years, FDA will review andpose evaluate relevant data to foodborne contaminants 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 requi requirements rements will cover ssanitation; anitation; 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 simultaneou sly or subsequently. subsequently.
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Darden Supplier Total Quality Expectation Manual Sections 103 and 111 will go into effect effect as of July 2012. Section 104 is an ongoing initiative.
1.3.8.3: Requirements:
Darden Direct Distribution Partners will have either a Global Food Safety Initiative (GFSI) Certification Audit (See (Seewww.mygfsi.com for a current list of recognized schemes) or a Third Party Audit, with a resolved Corrective Action Plan. a) All Darden Direct Distribution Partners must have an annual audit of their Distribution Center or Warehouse Warehouse by a third-party auditing company and submit a copy of the full audit report r eport with corrective actions and timelines to Darden Total Quality. b) GSFI Certification shall be required for Darden Direct Distribution Partners twelve months after a GFSI benchmarked scheme for Distribution Centers and Warehouses is implemented. c) In the interim, Darden recommends that either the BRC Storage and Distribution audit or IFS Logistics audit is performed. d) If another third party audit scheme is selected by the t he Darden Direct Distribution Partner, then the audit must include the following components: i) Preventative Control or HACCP Program (1) Pest Control (2) Allergen Control (3) Temperature Control (4) Product Segregation ii) Good Warehousing Practices iii)Sanitation iv)Food Defense and Security v) Traceability and Recall 1.3.4 Darden Specific Requirements for Darden Direct Distribution Partners: Temperature Probing Process
1. Temperatures of inbound product are properly evaluated to meet Darden standards. a. A procedure is fully developed and implemented and temperatures are documented on the receiving paperwork. b. The procedure involves non-invasive product probing to avoid potential cross contamination. c. Master cases temperatures of product areinselected from specified areas determining different areas of the trailer. tra iler.of the trailer for Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual Temperature Control Process
1. All frozen and refrigerated areas are maintained at target temperatures and have acceptable operating ranges established and documented. 2. Maximum allowable temperature limits are: Frozen Items: 10°F or belowItems: (Reject if above 10°F) Refrigerated a). Sauces - 35°F to 40°F (Reject if outside range) b). All others - 28°F to 40°F (Reject if outside the range.) The temperatures in these areas are monitored several times throughout a 24hour period and documented. 3. Critical limits are established and corrective actions occur as needed and are documented. 4. Acceptable operating temperatures, critical limits and corrective actions are listed on log forms. 5. Temperature logs of all of the above are complete. complete. Documents ref referencing erencing refrigerated facilities are retained for 1 year and 2 years for aall ll frozen facilities. Hot Loads In the event that a delivery is being made that has product temperatures that do not meet the above requirements, Darden Total Quality at 407-245-5330 must be immediately notified for final disposition of the product. Damages / On-Hold Execution Process In the event product is put on-hold, the urgency surrounding that situation must be high. The critical nature of cor correctly rectly accounting for and disp dispensing ensing of the product is essential to minimizing the amount of product that gets to our restaurants. Typically the timing around these situations is short and therefore demands a strong
discipline and process process to be in place. The better the pro process cess and documentation around controlling on-hold product execution, the less risk to our restaurants receiving unsafe product or product that does not meet specification. On-Hold Execution Standard Operating Procedure shall include the following:
1. A procedure for Product on Hold activities is documented and maintained. 2. Product disposition is provided within 24 hours to Darden, in writing as a s part of the facilities' "On-Hold" procedures. 3. A procedure is in place for follow-up to ensure that disposition is requested, received and action is taken in a timely manner per Darden‟s instructions. instructions. 4. When disposition instructions are received, this information is included in the disposition section of the "On-Hold" log. Date Issued: May 1, 2012
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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 t hose 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, temperature temperaturess 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) during Appropriate measu measures should and be intoplace to maintain the ility security of the food all phases ofres transport eliminate the possibility possib 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
Date Issued: May 1, 2012
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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/Se Processors/Seafood afood Packers and andsupplied Food Importers are prior required to product have a Darden Product Specification for Processors every product to Darden to the being purchased by Darden in Darden‟s electronic, web-based web-based Product Specification system. 1.3.10.2: Requirement:
1. Suppliers Suppliers are required to manage and acknowledge product specifications within Darden‟s web based product 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 a nd acknowledge product specifications within Darden‟s web based product specification ssystem. ystem. 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 documents pass through a review and approval routing process. 3. To access Darden‟s electronic Product Specification system click on this link https://supply.darden.com/SSALogin. 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.
Date Issued: May 1, 2012
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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.
Date Issued: May 1, 2012
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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 i n – if you have problems please contact 407-245-5169 for password help.
Viewing Your Complaints: Clickbeon Complaints then Complaints by Product Code in the left hand navigator – you will then able to see all of your complaints.
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Darden Supplier Total Quality Expectation Manual
Section 2: Food Safety and Quality Management Darden expects that all facilities producing and storing sto ring food designed for Darden restaurants meet all the following requirements relating to Food Safety and Quality Management. It is expected that facilities will have documented procedures designed to meet the criteria detailed in this section. Suppliers that meet these standards will also be required to ensure that they conform to the United States FDA 2011 Food Safety Modernization Act (FSMA). Pertinent sections of the 2011 FSMA F SMA which relate to Food Safety and Quality Management Title I
Section 101
Area Inspection of records
Regulation Facilities must provide access to the FDA to see all food related records.
Supplier Impact Facilities are required to maintain records about food safety plans, testing, operating procedures, corrective actions and have them in such a form that they demonstrate food safety and quality have been underwritten
I
103
Hazard analysis and risk based preventive controls
Requirement for facility, Requirement warehouse, or any facility that processes, packs, or holds food to conduct a HACCP.
I
106
Protection Against Intentional Adulteration
II
204
Enhanced tracking and tracing of food
Facilities must implement a risk based approach to mitigate the risk of intentional adulteration of food. Requirementt for the facility Requiremen to have a system established to identify
Facilities are required to take a preventative approach to mitigating risks using the HACCP system. This will mean that Darden suppliers must develop food safety plans. Facilities must develop effective food defense plans to avoid the food they produce/transport being intentionally intentionall y contaminated.
III
301
and recordkeeping
where received food was from and to it whom the food shipped.
Foreign Supplier Verification Program
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.
Date Issued: May 1, 2012
Facilities must be capable of demonstrating transparent traceability for all ingredients and packaging sourced finished product sold. Theseand 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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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 implemen implementt a written preventative controls plan meeting the requirements as set forth by the FDA/USDA.
There must be a comprehensi comprehensive ve 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/HazardAnalysis (http:www.fda.gov/foo d/foodsafety/HazardAnalysisCriticalControlPoints CriticalControlPointsHACCP/uc HACCP/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 personnel are trained to effectively execute the HACCP Plan. At a minimum, training training in HACCP principles must be conducted conducted at hiring. Refresher training must be conducted annually and documented. At least one member of the HACCP Training Team must be HACCP Certified.
Date Issued: May 1, 2012
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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 (GMP‟s) so the products are safe and wholesome, and produced to specification. All factory personnel including visitors will comply with GMP‟s. All GMP‟s 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 formulations;; processing equipme equipment, nt, environment, metho methods ds and conditions; intermediates specifications; specifications; packaging and labeling specifications; quantity control specification; management and control procedures; product and appropriate storage, handling which, taken all together, aredistribution 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, equip equipment, ment, activities, precautions, which have been fully specified in advance, and systematically reviewed. The facility will also a lso include qualified personnel, appropriate facilities and space, suitable equipmen equipmentt 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 d efine suitable corrective action in the event of “out“out-of control” occurrences. occurrences. 5) Food & Allergen Control i) This is a comprehensi comprehensive ve food production system founded on the risk assessment principles principles of HACCP which interlinks with quality assurance and quality control in a quality management system. Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual 6) Quality Management System i) There will be a food safety and quality management system designed by the factory demonstrating how the factory will meet its production to specification obligations.
Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual 2.3: Quality Management Systems and Quality Policy 2.3.1: Expectation: Suppliers m must ust have policies in place that define the o organizational rganizational 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 comprehensi comprehensive ve management system, designed, documented, implemented, implemente d, reviewed and continuously 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) Supplie Suppliers rs shall have a quality policy stating their commitment to manufacturing
food productsthe that are safe, wholesome and all conform to specifications. Additionally product shall comply with 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) Supplie Suppliers rs shall have a documented organizational program that describes the responsibility, responsibi lity, 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) Supplie Suppliers rs 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 effectivenesss in satisfying the requirements of the plant‟s quality and safety effectivenes 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“out-of control” occurrences. occurrences. Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual c) The facility will have an effective manufacturing operation where the manufacturing process, equipment, activities, precautions are fully specified in advance, and systematically reviewed in light of information from the quality management system. d) The manufacturing operating system will address the requirement for appropriately qualified personnel, personnel, adequate facilities and space, suitable equipment equipme nt and services, specified materials including packaging, specified policies and procedures, and suitable storage and a nd transport.
Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual 2.4: Documentation 2.4.1 Expectation: Document management is essential in Good Manufacturing Practice and HACCP systems. It defines the product, process ingredients; it communicates information and is the basis of an audit. 2.4.2 Requirements: The documentation will include, but not limited to, the following: Manuals/Policies
Quality Manuals Quality Policy HACCP Manual MSDS Documents Food Safety Policy Environmental Program
Procedures
Date Issued: May 1, 2012
Production Training Audits Pest Control Maintenance Procurement Supplier Approval Incidents and Recalls Quality Control Hygiene Traceability Calibration Personnel Documents
SOP’s
Specifications Purchasing Machinery Operation Sanitation
Records
Quality CCP Monitoring Material Receipt Approval Records Ingredient Testing Process Control Product Control Complaints Audits Sanitation
Additional
Site Plans COP‟s COP‟s Legislation Equipment Manuals
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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 implemente d 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 t o 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 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 implemen implemented ted to ensure that throughout all stages of company‟s operations raw r aw 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 impleme ntation 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 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 consumptio n 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 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 assessmen assessmentt 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, syst ems, 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. Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual d) The plan must include controlled access to ingredient and product storage areas and the maintenance of appropriate records. Ensuring storage security will protect against the intentional contamination or misuse of ingredients or non-food items used in the plant as food adulterants. Storage areas should be adequately secured and monitored, with access limited to authorized personnel only. e) The plan must consider access to the establishment by unauthorized intruders. Potential security measures include perimeter control through the use of fencing, gates, guard stations, and key card access. All entry ways, windows, vents, and delivery docks should be secured. Exterior lighting and closed circuit camera systems may also be used. f) The plan must ensure the integrity of the raw materials received and the finished products shipped from the facility. Potential security measures include purchasing raw materials only from recognized and approved vendors, establishing controls on incoming deliveries, limiting driver access a ccess to the facility during deliveries, careful inspection and inventory accounting of delivered materials, use of tamper-evident packaging for finished products, and the use of tamper-evident seals on incoming and outgoing shipments. g) Once the Food Defense Plan is developed, it must be tested and implemented. Key elements of implemen implementation tation include assigning responsibili responsibilities, ties, training staff, conducting drills, developing contact lists, and creating a recall plan. h) The Food Defense Plan should be reviewed regularly (at least annually) and updated as necessary to address changes in process or newly identified threats.
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Darden Supplier Total Quality Expectation Manual 2.7: Product Non-Conformance, Crisis Management, 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 without evidence of manufacturing manufacturing or distribution problems would be a market withdrawal.
2.7.1: Expectation: All levels of product non-conforman non-conformances ces 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 implemen ted 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 ou outt 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. Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual c) Procedures must be clear, practical and capable of being implemented effectively in a timely fashion. The recall system must be exercised at least annually and test traceability from the finished product to raw materials and food contact packaging materials used and from a batch of raw material to the individual batches of finished products that it was used to manufacturer goods. d) The length of time for a product withdrawal/recall test between initiation and completion should also be recorded to ensure a potential withdrawal/recall would be carried out in an appropriate timescale. e) There must be a written procedure for verifying effectiveness of a recall or withdrawal Product Recall Guidelines – please reference Best Practices Section 7.2
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Section 3: Facility Standards It is expected that facilities will have documented procedures and a facility designed and maintained to meet the criteria detailed in this section. Suppliers that meet these standards will also be required to ensure that they conform c onform to the United States FDA 2011 Food Safety Modernization Act (FSMA). Pertinent sections of the 2011 FSMA which relate to Facility Standards Title I
Section 101
Area Inspection of records
Regulation Facilities must provide access to the FDA to see all food related records.
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
I
106
Protection Against Intentional Adulteration
I
111
Sanitary Transportation of Food
II
202
Laboratory Accreditation for Analysis of Foods
Date Issued: May 1, 2012
Food analysis results will only be accepted from accredited laboratories.
Supplier Impact Facilities are required to maintain records about food safety plans, testing, operating procedures, corrective actions and have them in such a form that they demonstrate food safety and quality have been underwritten Facilities must be secure with documented procedures to prevent unauthorized entry as part of their food defense plan.
Suppliers must ensure that the transport systems used to move and to store food operate according to defined procedures with written records demonstrating the safe and sanitary transportation of food products. Facilities must only use laboratories that conform to Good Laboratory Practice, with external verification by a suitably qualified authority.
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Darden Supplier Total Quality Expectation Manual 3.1: Pest Control 3.3.1: Expectation: Pest prevention and control will be implemented effectively in all facilities producing or handling Darden food products with the objective of maintaining a pest free facility. If
the facility finds pests it must react quickly to eliminate the activity. The facility general manager must ensure that a senior manager/technician employed by the facility has responsibility for pest control and prevention. Only competent personnel with suitable training, knowledge and experience will manage pest prevention.
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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 (SSOP‟s) will be in place for all sanitation activities in the facility. SSOP‟s will be task specific and identify the cleaning chemical, its dilution and concentration, equipment 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
under controlled access. 4) separately 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 r equirements or prudent food safety protection for ready-to-eat 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 foodstuffs are not n ot contaminated. All water must meet United States Environmental Protection Protection Agency Drinking Water Standards http://water.epa.gov/drink/contaminants/index.cfm,, or World Health http://water.epa.gov/drink/contaminants/index.cfm Organization Guidelines for Drinking Water Quality http://www.who.int/water_sanitation_health .int/water_sanitation_health/dwq/gdwq3rev/en/inde /dwq/gdwq3rev/en/index.html x.html.. http://www.who 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 mus mustt 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 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 manufacturer‟s recommendations 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 assessme assessment nt 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. Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual e) The facility must maintain a schematic of all water pipework on site to show layout, directional flows and location of all tanks, valves and other appliances of the system. f) Monitoring programs must must be in place aand nd records kept for a minimum of 2 years or longer if required by company policy or national regulation to demonstrate effectiveness effectiveness of water treatment.
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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 removin removing g 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. a reas. This must contemplate movement movement of ingredients/raw materials, packaging, equipm equipment, ent, 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/process handling/processing/packaging ing/packaging must occur outside the high risk area. e) Management personnel 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. a rea. g) All ingredients, equipment, 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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Darden Supplier Total Quality Expectation Manual d) Drainage in high risk and low risk areas should not be connected or if this is not possible effective back-flow systems must be installed. e) Adequate and suitable hand washing facilities must be provided at the entrance and, where necessary, within working areas of the facility. facility . f) There must be effective air handling systems in place with filtration, positive pressure, and separate maintenance access according to the risk. 3) Transfer of Ingredients and Equipment into High Risk Area a) Equipmen Equipment, t, ingredients and personnel must undergo a risk assessmen assessmentt as to how they will enter the high risk area. b) This must include pumping of bulk liquids e.g. oil, into the high risk area. ar ea. c) Cooking equipment must discharge cooked product directly into the high risk area with provision for prevention of cross contamination. d) Any blanching operation must occur separately to the high risk area are a since blanched product is not cooked product and is classed as raw. e) Control panels/equipment panels/equipment must be duplicated if access is required from high and low risk areas. They must not be accessible to both sides. f) Terminal sanitizer sprays located on entry conveyers must be automated to activate when the conveyer is working. g) All conveyers must break at the barrier between low and high risk areas. h) Sanitizing sprays must have a minimum contact time prior to entry to the high risk area. i) Double bagging of packaging materials or bags in box tipping should be used if spraying is not manageable. j) All equipment must must be subjected to sanitizing as it enters the high risk area. If chilling is required there must be separate refrigeration/ice equipme equipment nt in the high risk and low risk areas. 4) Personnel Requirements
a) There must be a written implemented policy on health requirements covering all on-site and visiting personnel. All food handling ha ndling staff, temporary and permanent must receive training on all relevant aspects of high care food production and procedures. b) There must be separate high risk changing areas and high risk uniforms provided. All high risk uniforms must be laundered by the facility or via commercial services. c) All personnel personnel wishing to access High R Risk isk areas should use h high igh care changing rooms and follow changing disciplines e.g. i) Outdoor or low risk clothing and footwear removed. ii) Facility headwear on (if not already being worn). iii)Cross High Care barrier. iv) High Care footwear on. v) Thoroughly wash and dry hands. Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual vi) High Care coat on. vii)Thoroughly Thoroughly wash and dry hands, and disinfect before or upon entering the production area. viii) On leaving the high care area, protective clothing (with the exception of hair covering) should be removed in the reverse order. d) The facility must provide boot/footwear washing stations located outside production areas and these must be dosed with the appropriate cleaning solutions. e) The effective cleaning of footwear should be subject to visual evaluation. f) High risk areas with dry operations shoul should d avoid the use of boot washers and footbaths to avoid spreading contamination. g) In wet environments the amount of water in the facility environment should be minimized to avoid spread of contamination h) Head covering should be disposable hair net or full head cover and changed daily. Once removed headgear should be replaced. i) Adequate hand washing facilities, knee or photocell operated, must be provided at the entrance to and, where necessary, within working areas of the plant. j) The hand washing facilities must be positioned prevent entry to production areas without hand washing, dryingtoand application ofthe a sanitizer. k) Procedures for replacing and changing into protective clothing and footwear prior to reentering the high care area following emergency evacuations need to be drawn up and a nd available for immediate impleme implementation. ntation. 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 speciali specialist st tools are necess necessary ary 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 (5°C) within 20 minutes after cooking and chilled materials should be stored below41° F(5°C). b) In process or staged product should be kept below 46 4 6 ° F(8oC) and used immediately or returned returned to chill if th they ey 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 refrigeration capacity for the rapid chilling chil ling and separate storage of raw materials, work in progress and finished products. Date Issued: May 1, 2012
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Darden Supplier Total Quality Expectation Manual d) Sufficient ambient storage capacity must also be provided for the separate storage of dry raw materials and packaging.
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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 t o 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 www.a2la.orgor or Good Laboratory Standards such as ISO 17025 or A2LA. (www.a2la.org www.iso.org) 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) Equipmen Equipmentt 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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Darden Supplier Total Quality Expectation Manual 3.6 Warehouse Storage 3.6.1: Expectation: 1) Ensuring the safety and quality of food in storage requires the development development of procedures to ensure the preservation of food and to minimize the risk of contamination.
2) Darden Suppliers shall store all packaging materials, ingredients and finished product in a manner as to prevent contamination (direct or environmental) and/or degradation. 3.6.2: Requirements:
Suppliers must have all the appropriate controls in place to address the following: 1) Temperature and humidity controls 2) In,storage First Out or best by walls dates 3) First Proper of (FIFO) productper offmanufacturing of floors and away from 4) Segregation of food, non-food, raw and cooked products 5) Vertical storage of food with like allergens 6) Fire control program 7) Segregation of hazardous materials from food 8) Regulatory inspection, if required. 9) The facility shall only be used for food storage and logistic related services. 10)The facility should utilize pallet racking systems, when possible, to avoid pallet stacking and pallets on the floor. 11)Forklift and other trucks used within the warehouse should be battery driven or otherwise equipped equipped to prevent fume or fuel contamination. 12)Procedures should be in place to undertake regular inspections of forklift trucks to minimize the potential for product contamination and records should be retained of the inspections undertaken. 13)All vehicles, containers, etc., should be free from rodents, birds and insects or contamination from them; free from odors, nails, splinters, oil and grease, accumulations of dirt and debris; and should be in good repair, without holes, cracks or crevices that could provide entrances or harborages for pests. 14)Vehicles bringing product to a warehouse should be inspected before loading/off-loading loading/off-loadin g for evidence of product damage, pest infestation, and objectionable odors. 15)If damaged product is received on a vehicle it must be kept separate from other product and handled in a manner in which to prevent exposure to other foods on the vehicle, or other warehouse inventory, to prevent contamination or infestation.
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Darden Supplier Total Quality Expectation Manual 16)A procedure must be set up to deal with consequenc consequences es of accidents and damage occurring when goods are in storage or distribution, e.g. spillage procedures, salvage or condemnation following damage to goods in a road traffic accident. 17)Security precautions should include means of preventing and deterring any tampering with goods in storage and distribution such as the use of tamper evident seals.
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Section 4: Product Control Darden expects that all facilities producing food designed for Darden restaurants meet all the following requirements relating to Product Control. It is expected that facilities will have documented procedures designed to meet the criteria detailed in this section. Suppliers that meet these standards will also be required to ensure that they conform to the United States FDA 2011 Food Safety Modernization Act (FSMA). Pertinent sections of the 2011 FSMA which relate to Product Control Title I
I
Section 101
103
Area Inspection of records
Regulation Facilities must provide access to the FDA to see all food related records.
Hazard
Requirement for facility,
analysis and risk based preventive controls
warehouse, or anyorfacility that processes, packs, holds food to conduct a HACCP.
I
104
Performance Standards
Facilities will be expected to verify that that all preventative controls are adequate and effective to mitigate all Hazards Identified.
I
112
Food Allergy
Facilities are required to have
and Anaphylaxis Management
effective anddesigned functioning procedures to ensure allergens do not become a risk to sensitive individuals.
II
202
Laboratory Accreditation for Analysis of Foods
Food analysis results will only be accepted from accredited laboratories.
III
301
Foreign Supplier Verification
Suppliers who import food from overseas will be required to demonstrate they have
Supplier Impact Facilities are required to maintain records about food safety plans, testing, operating procedures, corrective actions and have them in such a form that they demonstrate food safety and quality have been underwritten Facilities are required to take a
preventative approach to mitigating risks using the HACCP system. This will mean that Darden suppliers must develop food safety plans. Facilities will ensure that all product control procedures mitigate identified risks through documented protocols which are subject to continuous verification and routine review. The facility will have documented procedures place to handle specific in materials containing know allergens to ensure that cross contamination is mitigated and all products containing allergens are correctly labeled. Facilities must only use laboratories for food and ingredient testing that conforms to Good Laboratory Practice, with external verification by a suitably qualified authority. Suppliers will be required to conduct their own evaluation of the food safety plans of the
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Darden Supplier Total Quality Expectation Manual Program
completed a risk based assessment show the food is unadulterated, and produced in a manner meeting US FDA food laws.
facilities from which they source food. This will also include the supply chain, and may require testing to validate the process.
4.1: Raw Materials Control
Please reference commodity specific section for requirements for raw material control. Produce – page 9 - 27 Seafood – page 27- 32 Land based proteins - page 33-35
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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 process processes es 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, equipment, and the structure and fabric of the building, to prevent and/or detect and remove r emove foreign matter contamination. 3) Automatic inspection devices such as metal detectors, x-rays, magnets and vision systems can be used but prevention 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 v isual indication of rejection. Reject mus mustt be to a suitable secure con container. tainer. g) Free-fall "throat" detection systems should should reject by double pack if automatic rejection is not possible. The system should also be fitted with an audible and/or
visible alarm.person. It should only be possible to re-start the system using a key held by a nominated
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Darden Supplier Total Quality Expectation Manual h) Testing frequencies must contemplate contemplate shift starting and finishing, product changes, and line breaks with verifications at least at hourly intervals. Metal detectors must be recalibrated following adjustment. All test results must be timed, dated and signed by the person conducting the test and verified by a supervisor/manager supervisor/m anager with specific responsibility for that activity. i) The system must have written procedures to correctly identify and quarantine product which failed metal detection. These procedures must document that a manager will supervise the retesting of the product. j) Product that is rejected must be inspected at a separate time using documented procedures designed to allow the facility to recover the metal contamination and identify the source. This must occur in a separate area to production to avoid cross contamination with product that was not implicated with the rejection. 2) Magnets a) Magnets can be used at appropriate locations in the production process process with location based on assessment. When used they should be subject to regular, documented inspection inspection and daily cleanin cleaning. g. Systems sho should uld be in place for
reporting any abnormal well asand traceability relevant materials. A documented record offindings all sieve as integrity magnet to checks and raw retained foreign matter should be kept for future reference. 3) X-Ray Detection a) For many different types of products, X-ray technology offers the possibili possibility ty of being able to scan the finished packed product for all types of metals as well as any other dense foreign body contaminants e.g. glass, mineral stone, bone and may also have other product quality monitoring benefits e.g. missing components/under-fill. 4) Glass and Hard Clear Plastic Management
a) The term „glass„glass-like materials‟ applies to hard plastic, polycarbonate, and other similar materials. A policy must be written to stress the importance of preventing product contamination and this policy should be incorporated into the factory operation. b) The facility must complete a risk assessment of all glass and glass like lik e materials. The risk assessment must be signed off by the senior manager responsible. c) The risk assessment must then be used to form the basis for determining subsequentt action such as replacement, protection and monitoring the condition subsequen of the material. d) Glass in the facility including changing areas, production and access corridors, packaging and ingredient stores should be minimized or covered to contain breakage.
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Darden Supplier Total Quality Expectation Manual e) New equipment introduction or changes to existing equipment must be fully reviewed to ensure that glass is, if possible, totally eliminated and that any hard plastic used is appropriate to reducing breakage hazards. 5) Monitoring of Glass and Hard Clear Plastic a) Glass and hard clear plastic materials must be identified by location and subject to a condition audit. b) If situated in close proximity to a production line or ingredients, glass and hard clear plastic should be inspected daily. c) For all other areas there must be a regular audit of the condition of the glass, or clear hard plastic, at a frequency determined by the risk assessment. 6) Glass and Hard Clear Plastic Breakage a) Any breakage of glass or hard clear plastic should be reported immediately to senior site management and the incident managed by a written procedure. b) At a minimum minimum,, the procedure for production and associated storage areas should include production stoppage, isolation of product, checking for glass fragments
on uniforms andshape/weight boots, cleanup of glass fragments dedicated glass cleanup equipment equipme nt and evaluation of glass towith determine percentage glass unaccounted. c) Once cleanup has occurred senior factory management must verify that the area affected is clear of glass fragments. d) Product gathered from the affected area is not acceptable for supplying Darden. 7) Wood a) All non-essential wood that is not covered must be removed from all production areas. Wooden pallets must be replaced with plastic pallets in these areas. b) If wood cannot be removed from production areas a risk analysis must be completed to identify the risk of product contamination with wood.
c) The risk management plan to reduce the risk of product contamination must then be documented and a nd implemented.
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Darden Supplier Total Quality Expectation Manual 4.3: Food Allergens 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, 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 Requirem Requirements. ents.
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 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 4.4: Manufacturing Specifications 4.4.1: Expectation: Darden suppliers shall ensure that specifications exist for raw materials including packaging, work-in-progress, and finished products, including any product or service
that could affect the integrity of the product. 4.4.2: Requirements: 1) Specifications will be based on a risk assessment and be adequate and accurate to ensure they meet legal requirements and other requirements identified identified in any Darden Expectation. 2) All manufacturing instructions will comply with recipes as documented in Darden specifications. 3) The supplier will have a documented procedure for formal agreement and amendment of specifications including the regular review process. 4) Specifications and their contents will be made available to relevant production personnel.
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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 50°F or 10°C) at which the product is intended to be held during distribution and storage. 4.5.2: Requirements: 1) Commercial Sterility a) All sterile food supplied topathogens Darden will been subject to a heatcommercially treatment destroying all vegetative andhave organisms capable causing spoilage in the food under non-refrigerated(but below 110°F) storage conditions. b) Low acid foods with a pH value of 4.6 or above and intended for storage under non-refrigerated (but below 110°F or 43°C) 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 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 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 microbiolo microbiological gical 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 h) Packaging structure, seals and closures must be free of defects that would affect their effectiveness in closure. 2) In Container a) The Scheduled Process must be developed by a trained profession professional al with experience in this area. Once developed, the scheduled process must be documented, approved and registered by Regulatory Authority and retained on file at the facility and a nd appropriate processing records kept. b) Process control steps must be established to demonstrate steps in the scheduled process are monitored and functioning correctly. This may include, but are not limited to, loading, headspace in filling, temperature monitoring, monitoring, venting, etc. c) Cooling water must be of potable quality and chlorinated leaving a residual chlorine level. d) All containers must be dried before handling to avoid transition of post processing contaminated surface water to closures. 3) Heat Treatment followed by Aseptic Packaging a) If aseptic packaging is used, staff must be thoroughly trained in its application. b) The temperature of all food contact surfaces must achieve commercial sterility before operation using validated and monitored procedures, while nonfood contact surface must be subjected to chemical sterilization. c) Fillers must be cleaned and sterilized and separated from the external environment. Fillers must be designed for the packaging and volumes must be controlled for the application. d) Automatic continuous flow sterilization and batch sterilization must have temperature logging system documenting correct product temperatures,
pressures and holding times. e) In continuous-flow sterilization the control system should ensure that the correct product sterilization temperature and holding time are a re achieved, monitored and records kept. This type of system must reroute rejected product from the filling operation. f) Any plate or tubular plate heat exchangers must be checked for pinholes and cooling water pressure must be low enough to avoid entry through pinholes. g) There must be a system to protect all packaging materials from contamination.
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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 5ºC/41 5ºC/4 1oF. Risks associated with cooked and chilled foods have to be assessed and controlled (e.g.
Assessmen Assessments ts forrisk rawofmaterial perishability, effectiveness of processing pasteurization, pathogen growth andthe cold chain management). The on 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 a ccepted 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 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 70°C/ for not less than 2 minutes (or equivalent).
c) Heated to 90°C/194oF for not less than 10 minutes (or equivalent). (1) Milk 63°C/145oF for not less than 30 min or 72°C/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 69°C/157 oF for not less than 30 min (or equivalent). e) Heated product should be cooled as quickly as possible through the temperature range 63°C/145oF to 5°C/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 to be stored at refrigeration r efrigeration temperatu temperatures res (at or below 5°C/40 oF) throughout their entire life.
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Darden Supplier Total Quality Expectation Manual 4.7: Dry Goods 4.7.1: Expectation: Dry goods operations are prone to contamination from dust, and these operations must
be designed to contain dust dust or manage its rem removal oval via extraction systems systems.. Suppliers should undertake a risk assessment to determine risks with regard to dry goods including allergens. 4.7.2: Requirements: 1) Factory environment must be free of dust buildup on facility support structures. Any extraction systems must be installed with filtration to minimize product contamination. 2) Any mixing, fluidized bed or processing operation should be enclosed to minimize dust spreading. If this is not possible dust extraction equipment must be installed. 3) Any formulations that use hygroscopic materials which become sticky must devote special attention with regard to cleaning as they are ar e not always removed by dry cleaning. 4) Wet cleaning methods must be available with appropriate precautions regarding the risks of humidity supporting microbial growth. 5) All dry goods used in food formulations mus mustt meet documented levels for vegetative organisms to avoid proliferation proliferation/generation /generation of spores. 6) Particular care should be taken to prevent air-borne dust from causing microbiological contamination of raw materials, finished product and plant.
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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 a nd 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 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 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 measuremen measurements ts will be undertaken vii)P Product roduct characteristics to be assessed and the acceptance criteria viii) Documentation to be completed ix) Requiremen Requirements ts 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 dispositio disposition. n. 8) Nonconforman Nonconformance ce 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 a ware 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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Darden Supplier Total Quality Expectation Manual 4.8.4: Equipment Control Expectation: 1) All balances must be tested daily against ag ainst standard test weights, which are traceable to national standards. 2) All results must be documented and reviewed by Quality Control personnel before commencement of production. 3) In the event that equipment is broken the Quality Control personne personnell must be informed and written procedures followed for replacement and/or repair. Any product produced after the last successful verification must be identified and place under quarantine. 4.8.5: Labeling Control During Production Expectation: 1) Product labels must be controlled, secured and removed from labeling areas after production is complete. 2) Labels must be approved by Quality Control with written verification for review. 3) The quality checks should include as applicable to the label and relevant product specification: i) Label format ii) Product code iii)Product, variety and country of origin iv) Volume, weight, size or count v) Darden Bar code vi) Processing plant/supplier identification number/code vii)Durability Durability date either use by, display until and/or best before date) viii) Print clarity and size of print. ix) Accuracy of nutrition facts panel/ingredients/allergens 4) The first and the last label of both product, pack and tray end label should be checked, signed off and affixed to the Quality Control record and labels checked during production at a defined frequency.
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Section 5: Process Control Darden expects that all facilities producing food designed for Darden restaurants meet all the following requirements relating to Process Control. It is expected that facilities will have documented procedures designed to meet the criteria detailed in this section. Suppliers that meet these standards will also be required to ensure that they conform to the United States FDA 2011 Food Safety Modernization Act (FSMA). Pertinent sections of the 2011 FSMA which relate to Process Control Title I
Section 101
Area Inspection of records
Regulation Facilities must provide access to the FDA to see all food related records.
I
103
Hazard analysis and risk based preventive
Requirement for facility, Requirement warehouse, or any facility that processes, packs, or holds food to conduct a
I
104
controls Performance Standards
I
112
Food Allergy and Anaphylaxis Management
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.
II
204
Enhanced tracking and tracing of food and recordkeeping
III
301
Foreign Supplier Verification Program
Requiremen Requirement t 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.
Supplier Impact Facilities are required to maintain records about food safety plans, testing, operating procedures, corrective actions and have them in such a form that they demonstrate food safety and quality have been underwritten Facilities are required to take a preventative approach to mitigating risks using the HACCP system. This will mean that Darden suppliers must develop food safety plans.
Facilities will ensure that all product control procedures mitigate identified risks through documented protocols which are subject to continuous verification and routine review.
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 demonstrating transparent traceability forofall 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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Darden Supplier Total Quality Expectation Manual 5.1: Manufacturing Controls 5.1.1: Expectation: The manufacturing process must consistently produce finished products which meet the specification and are protected against contamination or spoilage. 5.1.2: Requirements: 1) All product production processes must be established through production trials before written procedures are documented. 2) Written procedures must be clear and available in all languages spoken in the facility. 3) Procedures must include production stoppages through breakdowns and emergencies. 4) All raw materials must be stored separately until positively released by Quality Control. 5) Materials requiring pretreatment and work in progress or staged product must be identifiable.
6) Raw materials must be inspected regularly throughout their shelf life period and evaluated against defined requirements.
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Darden Supplier Total Quality Expectation Manual 5.2: Labeling 5.2.1: Expectation: All products which are manufactured exclusively for Darden must be labeled with the
product specific labeling requirements (e.g. production date, Darden specific bar code) and all labels must correctly correspond to the product concerned, and must comply with the legislative requirements of the country in which the product is to be sold. 5.2.2: Requirements: 1) All products which are manufactured exclusively for Darden must be labeled with product specific labeling requirements as defined in the specification. 2) The accuracy of the label must be verified by the production supervisor and Quality Control before a production run. 3) There must be controls in place to ensure that only correct packaging is available for use during the production run. 4) Obsolete packaging and labeling must be used up per agreement with Darden or
destroyed. 5) There must be specific procedures for product packed in temporary packaging. This must include product date and traceability information. 6) Packaging labels must comply with current FDA and any other pertinent legal requirements.
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Section 6: Personnel Management Darden expects that all facilities producing and storing food designated for Darden restaurants meet all the following requirements relating to Personnel. It is expected that facilities will have documented procedures designed to meet the criteria detailed in this section. Suppliers that meet these standards will also be required to ensure that they conform to the United States FDA 2011 Food Safety Modernization Act (FSMA). Pertinent sections of the 2011 FSMA which relate to Personnel Title I
I
Section 101
106
Area Inspection of records
Regulation Facilities must provide access to the FDA to see all food related records.
Protection
Facilities must implement a
Against Intentional Adulteration
risk based approach to mitigate the risk of intentional adulteration of food.
Supplier Impact Facilities are required to maintain records about food safety plans, testing, operating procedures, corrective actions and have them in such a form that they demonstrate food safety and quality have been underwritten Facilities must develop
effective food defense plans to avoid the food they produce/transport produce/transpo rt being intentionally contaminated.
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Darden Supplier Total Quality Expectation Manual 6.1: Employee Training 6.1.1: Expectation: There will be a planned and documented training program for all personnel inclu including ding full time, part-time, temporary employees and contractors. 6.1.2: Requirements: 1) The training program shall include but not be limited to the following topics: 2) HACCP/Food Safety 3) Good Manufacturing Practices (GMP‟s) (GMP‟s) 4) Chemical control 5) Allergen control 6) Sanitation 7) Food Hygiene 8) Laboratory practices, testing and calibration 9) Internal auditing 10)Regulatory requirements 11)Maintenance 12)Food Defense 13)Personal requirements requirements (e.g. hand washing, attire, when/what to report in relation to illness)
All training will be documented, maintained and with records identifying participants with signatures of completion date, training contents and effectiveness evaluations. There will be a program of refresher training at yearly intervals.
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Section 7: Best Practices 7.1 Pest Control Contracted Pest Control Services The facility must maintain a contract which defines the services provided in addition to valid licenses demonstrating the pest control company is a current licensed pest management company. The facility must maintain certificates of technicians demonstrating their training in pest management. The facility will have a procedure in place to either accompany the Pest Control Services technician during visits or routinely verify that the Pest Control Services are meeting the requirements of the contract. Routine visits must not be less than 12 times/year at 1 month intervals planned in advance with factory management. Additional visits to treat infestations, correct pest activity, or respond to facility needs must be part of the contract. Responsibility Respons ibility for removing evidence of pests (e.g. droppings) should be formally agreed between theold facility and the contractor. Original copies of inspection reports should should be left at the facility at the time of the visit and should be signed by both the contractor and a facility representative.
In House Pest Control Systems If the facility operates its own internal pest control system it must be managed by an appropriately qualified senior manager/technician and any facility personnel applying pesticides be certified to apply pesticides. This certificate must be up to date and maintained on file.
Pest Control Plan The pest control system must cover the entire site and include inspections for all pests, likely to infest food or packaging materials. Pest control points such as but not limited to bait traps, glue traps, Electronic Fly Killers, mechanical traps must be clearly identified on an up to date site plan and at the physical location. Each location must be visited and pest activity assessed at least 6 times each year or more frequently if environmental conditions make pest presence more common. All monitoring stations must be dated, inspected and replenished as necessary. Pest activity must be recorded and used to define corrective actions. All Corrective and Preventative Actions (CAPA) must be signed off by the individual completing the CAPA, and verified by the responsible senior manager/technician.
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Darden Supplier Total Quality Expectation Manual Bait boxes must be robust, tamper resistant, locked in place with keys on site and designed to prevent any accidental poisoning or injury to non-target species. All pesticides must be approved by the relevant regulatory authority and their use must comply with current local and national legislation. Material Sheets for all bait and a nd pest control measures must be kept on site asData part Safety of the facility records. All bait and pest control measures must be kept in a secure location away from food processing, food storage or packaging storage areas. Pesticides must be used in such a way as to ensure there is no risk of contamination of foodstuffs, foodstuffs, food packaging materials, food contact surfaces or personnel. Treatments must be planned and not routine and where pesticide is applied, records of its use including type, location, and quantities used must be kept. There must be no use of toxic bait in food preparation, production or packing areas unless an active infestation is being treated and all bait preparations must be retained within bait boxes. Loose grain bait must not be used in internal or
external locations. Insecticides must not be used in any way that puts food products or raw materials at risk of contamination. Insecticidal fogging should not be routine and should not take place in any food production, packaging or storage areas to avoid dead insects falling into and contaminating food or packaging. Proofing and building maintenance programs must consider the risk of flying insect entry and there must be no unscreened openings from the exterior in preparation, production, or packaging areas. Electronic fly killing units (EFKs) should be positioned in all production and storage areas in locations that do not cause ca use food or packaging contamination. Tubes in the EFKs should be replaced at least annually but the date of the last tube change must be clearly marked on each tube or Corrective Action/Preventative Action report. Pest activity at each monitoring station must be recorded and trended to actively assist in any action taken to maintain pest prevention prevention..
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.
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Darden Supplier Total Quality Expectation Manual 7.2 Product Recall Best Practices Protocol: The supplier must identify a Crisis Management Team to deal with any serious incident affecting its products. This team must have the authority to make all the necessary decisions in connection with a particular incident, including ordering a
public recall of anstatements entire product or particular production batch, and allbe necessary media and relevant authorities as necessary. Theauthorizing team should comprised of the following: Marketing director Sales/comme Sales/commercial rcial director Production/techni Production/technical/distribution cal/distribution director Corporate affairs/public relations manager Food Safety & Quality Assurance director/manager Identification of the Problem: The indications of a serious problem are most likely to arise from: Internal control systems
A complaint from consumer, sales customer, or enforcement authority authority An inquiry from the media Evidence of accidental or malicious contamination An exhortation threat A telephone call from the regulatory authorities The actions of a pressure group
Immediate Action and Procedures: At the first indication of a possible problem, the Crisis team should be convened to decide appropriate action.
Actions: Assemble the Crisis Team Identify the product(s) to be recalled. Confirm location of product(s) in own storage and that have been sent out and draw up the distribution list. Withdraw and isolate all suspect product(s) from primary (Own Storage). Advise Darden of received product identified under the recall notice and distribute the code/codes to be recalled. Complete an accountability exercise to verify that all suspect products have been withdrawn. Investigate cause of the problem and rectify. Communicate Corrective actions to Darden.
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Glossary of Terms
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Darden Supplier Total Quality Expectation Manual Anaphylaxis: Anaphylaxis is a severe, potentially life-threatenin life-threatening g allergic reaction. It can occur within seconds or minutes of exposure to something you're allergic to, such as the venom from a bee sting or a peanut. AOAC: Association of Analytical Communities," AOAC INTERNATIONAL is committed to be a proactive, worldwide provider and facilitator in the t he development,
use, and harmonization validated analytical methods and laboratory quality assurance programs andof services. CFU: Colony-formi Colony-forming ng unit (CFU or cfu) is a measure of viable bacterial or fungal numbers Cistern: A waterproof receptacle for holding liquids, usually water. FDA: Food and Drug Administration Free fall throat detection systems: designed specifically for the inspection of free falling products in vertical packaging applications. FSIS: The Food Safety and Inspection Service is the public health agency in the t he U.S. Department of Agriculture responsible for ensuring that the nation's commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged. FSMA: The FDA Food Safety Modernization Act (FSMA) was signed into law by President Obama on January 4th, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. GFSI: The Global Food Safety Initiative (GFSI) is a collaboration between some of the world's leading food safety experts from retailer, manufacturer and food service companies, as well as service providers associated with the food supply chain. GHP: Good Harvest Practices. HACCP: Hazard Analysis & Critical Control Points is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. Headspace: The volume left at the top of an almost filled jar, tin, or other container before sealing. Hermetically: Completely sealed, especially against the escape or entry of air High Care Area: An area designed to a high standard where practices relating to personnel, ingredients, equipment, equipment, packaging and environment aim to minimize product contamination by pathogenic micro-organisms. High Risk Area: A physically segregated area, designed to a high standard of hygiene, where practices relating to personnel personnel,, ingredients, equipment, packaging and environment aim to prevent product contamination by pathogenic micro-organisms Hygroscopic:readily taking up and retaining moisture Loamy: Soil composed of a mixture of sand, clay, silt, and a nd organic matter. MPN: Most Probable Number Multiple hurdle: several types of interventions throughout the processing operation to achieve pathogen reduction
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Darden Supplier Total Quality Expectation Manual ORP: Oxidation-Reduction Potential PAACO: Professional Animal Animal Auditor Certification Organizati Organization. on. The miss mission ion of this organization is to promote the humane treatment of animals through education and certification of animal auditors, as well as the review r eview and certification of animal audit instruments, assessments and programs. Photocell: Photocells are sensors that allow you tobydetect light of a national Phytosanitary Inspections -- A certificate issued the agency government indicating that an export shipment has been inspected and is free from harmful pests and plant diseases. Pipeline metal detection systems: are designed for installation in food production environments where there is a need to inspect liquid, paste and slurry products as they travel through process pipelines. Proliferation: The process by which an organism produces others of its kind. USDA: United States Department of Agriculture
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Appendixes
