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Warning Text %XTableStyleMedium9PivotStyleLight16`i Cover Sheet4Info & Audit Summary:Pre Audit QuestionsEFood Safety Management'MPrerequisite & Preventive Cont %WControl of Hazards - FS PlansWbGeneral Guidance   ;%fffP0@X( 3 A@@   Date:yesnon/aaDoes the milk used for cheese production meet all regulatory requirements for antibiotic testing?CRITICAL:Is an owner operated facility used to produce the product?The supplier and/or facility must assume responsibility for compliance with all requirements set forth including liability and insurance indemnification.@Does the facility have the required insurance for your products?6Does the facility participate in third party auditing?aDoes the facility have finished product testing done? (Independent lab or state obtained samples)FDoes the facility provide food safety training for all food employees?9Does the facility have a written employee illness policy?^Does the facility have a pest management program implemented to control pests in the facility?DAre labels in compliance with ingredient and nutrition requirements?~Are all allergens disclosed on the labels in accordance with Law? FALCPA (Food Allergen Labeling and Consumer Protection Act)?Does the facility use a reduced oxygen or vacuum type package for its product? Is the procedure approved by a recognized process authority?QIf providing Organic product, does the facility have the necessary certification?uDoes the product label have a clear code "Best By" date and any other recall information applied? Provide an example`We will request a copy of the endorsement with your certificate of insurance on an annual basis.The supplier must provide information on any facility being used to process, package, or store the product. All suppliers participating in third party audits should make the reports available for review by authorized ________________________ Team Members.RWhat is the water source used in the facility? Provide documentation of testing.8Do you have means of disposing of Liquid and Dry Waste? Does the facility participate in an environmental monitoring program that screens the facility for pathogenic microorganisms such as E. Coli, Listeria Sp., etc.If providing perishable Cheese (fresh, soft ripened, etc.) that requires temperature control, does the label state  Keep Refrigerated or  Keep Frozen ?RHave the facilities products ever been implicated in a foodborne illness outbreak?Supplier Name: Address: Phone Number: AUDIT SUMMARY: OPPORTUNITIES/RECOMMENDATIONS0Products Made and being considered for review: (Is the facility registered with the FDA?0Do you have a records retention policy in place?ZThe Critical Control Points/Process Controls should be validated, verified and documented.<Does the facility have a required FSMA Recall Plan in place?;Does the Facility have a Food Defense Program, if required?Does the facility have a Preventive Maintenance Program that includes a maintenance schedule of all equipment and building repairs. i.e. mixers, pasteurizers, utensils, paddles etc.. Is a sanitation step performed after any repairs?Phttps://www.fda.gov/food/guidanceregulation/foodfacilityregistration/default.htmDIs there an allergen control program (wheat, dairy, soy, egg, etc.)?hWhat organisms are you testing for and what frequency? Do you have a documented Corrective Action Plan? _Have the facilities products ever been the subject of a Recall? Class I, Class II or Class III?Owner/Manager Name: [Please provide a copy of ALL documentation including any plans to address any deficiencies.EWhere does the facility obtain the milk used to manufacture products?If the milk is obtained from their own stock, please tell us how many dairy animals are in the operation, describe the milking procedures, and how contamination is controlled or minimized.If the milk is obtained from some other farm/location, indicate how it is transported and indicate what type of systems are in place to verify the milk meets the Food Safety and Regulatory standards?Are there backflow preventers in place to protect the potable water in the facility? Provide documentation that they have been checked.Are all ingredients and sub-ingredients clearly identified in English on the label? Does it include Name and Address of Distributor or ManufacturerBSection4-ControlofFoodHazardsandFoodSafetyPlans(HACCP)LDo the cheeses produced meet all of the 21 CFR 133 "Standards of Identity"? (If so what standards do they fall under?"Section 2 - Food Safety ManagementASection3 PREREQUISITEPROGRAMS,PREVENTIVE CONTROLSandcGMPs:LEVEL 1 AUDIT VER.6 EXCELN/ARegion/Store:  YAre all ingredients and sub-ingredients compliant with Food Safety and Quality Standards?B CHow will the products be delivered to the stores: direct to the stores, through the distribution system or other?T }CRiTICALbDoes the facility have a validated FSP plan, that has been implemented for all products produced?Hours of Operation: /General Guidance for Level 1 Audit for ArtisansVWhat tests are being conducted to verify the milk does not contain antibiotic residue?{Does the facility have current Good Manufacturing Practices (cGMPs) implemented and posted for all employees and visitors? z MSection3 PREREQUISITEPROGRAMS,PREVENTIVE CONTROLSandcGMPs: Continued& .LDoes the facility produce raw milk or pasteurized cheese products? Or both?yProvide a list of products produced and production capabilities without comprimising food safety or production capacity. Company Requesting Audit: NSection4-ControlofFoodHazardsandFoodSafetyPlans(HACCP) continued& & *Section 1- Pre Audit Questions continued& & 4Approved Supplier Program - An approved supplier program is a set of procedures implemented by the facility to assure the safety and quality of incoming goods and services. It may be based on the safety risk presented by the raw material, or based on historical performance or prior history of the supplier. YAre all ingredients and sub-ingredients compliant with Food Safety and Quality Standards?iThe methods for selecting, evaluating, approving and monitoring an approved supplier must be documented. This will be risk-based and may be as simple as a good supply history, sourcing from certified suppliers (e.g. 3rd party audit), or personally auditing/inspecting the material supplier s operations, depending on risk, supplier knowledge and past history. https://dairyextension.foodscience.cornell.edu/sites/dairyextension.foodscience.cornell.edu/files/shared/Approved%20Supplier%20Program.pdfbDoes the milk used for cheese production meet all regulatory requirements for antibiotic testing? Industry shall screen all bulk milk pickup tankers and/or all raw milk supplies that have not been transported in bulk milk pickup tankers, regardless of final use, for Beta lactam drug residues. Record Requirements: Results of all testing may be recorded in any format acceptable to the Regulatory Agency that includes at least the following information: )1. Identity of the person doing the test;2. Identity of the bulk milk pickup tanker or farm bulk milk tank(s)/silo(s), milk plant raw milk tank(s) and/or silo(s), other raw milk storage container(s), etc. used for the storag< e of all raw milk supplies that have not been transported in bulk milk pickup tankers being tested*;A3. Date/time the test was performed (Time, Day, Month and Year); C4. Identity of the test performed/lot #/any and all controls (+/-);5. Results of the test;Q6. Follow-up testing if the initial test was positive/any and all controls (+/-);%7. Site where test was performed, and>http://ncims.org/wp-content/uploads/2018/06/2017-PMO-FINAL.pdfFWhere does the facility obtain the milk used to manufacture products?If the milk is obtained from their own stock, please tell us how many dairy animals are in the operation, describe and document the milking procedures, and how contamination is controlled or minimized.If the milk is obtained from some other farm/location, indicate how it is transported and indicate what type of systems are in place to verify the milk meets the Food Safety and Regulatory Standards? #SECTION 2 - FOODSAFETYMANAGEMENT:8. Prior test documentation shall be provided for a presumptive positive load using approved test methods or a verified screening positive load using test methods not evaluated by FDA and accepted by the NCIMS. *Include the BTU number(s) of the dairy farms present on the bulk milk pickup tanker and/ or all raw milk supplies that have not been transported in bulk milk pickup tankers with the above information. TWhat is the water source used in the facility? Provide documentation of testing. QReference the PMO Pg. 47, Pg. 168 (wells) App. D, Pg. 222 App. G, water testing.Water for milk plant purposes is from an adequate supply, properly located, protected and operated. It shall be easily accessible and of a safe, sanitary quality. The water supply is approved as safe by the applicable Government Water Control Authority and, in the case of individual water systems, complies with the specification outlined in Appendix D. and the Bacteriological Standards outlined in Appendix G. uAre there backflow preventers in place to protect the potable water in the facility? Reference Item 7P of the PMO. There is no cross-connection between the safe water supply and any unsafe or questionable water supply, or any source of pollution through which the safe water supply might become contaminated. A connection between the water supply piping and a make-up tank, such as for cooling or condensing, unless protected by an air gap or effective backflow preventer, constitutes a violation of this requirement. An approved air gap is defined as the unobstructed vertical distance through the free atmosphere of at least twice the diameter of the largest incoming water supply pipe or faucet to the flood level of the vessel or receptacle. The distance of the air gap is to be measured from the bottom of the potable inlet supply pipe or faucet to the top of the effective overflow, i.e., flood level rim or internal overflow, of the vessel. In no case, may the effective air gap be less than 2.54 centimeter (1 inch).9Do you have means of disposing of Liquid and Dry Waste? q Waste disposal must meet all regulatory requirements and be conducted at a frequency to mitigate pest activity.2Do you have a records retention policy in place? A records retention policy must meet a minimum standard of 2 years and/or shelf life if longer than 2 years, with records available upon request.bDoes the facility have finished product testing done? (Independent lab or state obtained samples)Finish product testing is highly recommended for all high-risk items. These should be done on a monthly basis look for pathogenic strains of microorganisms. Ideally the facility would test and hold each batch of product, but the shelf life of the product may not allow for this in some cases. Some state agencies may pick up samples for regular testing such as in fluid milk and dairy products.ASECTION 3 - PREREQUISITE PROGRAMS, PREVENTIVE CONTROLS and cGMPs:HDoes the facility produce raw or pasteurized cheese products? Or both?.For raw cheese products, provide and verify SOPs and other documentation are in place to ensure a minimum of 60-day aging of the product before sale. The 60-day aging period STARTS when the cheese goes into an aging room at a temperature above 35F and remains above that temperature for the duration.QDoes the facility have current Good Manufacturing Practices (cGMPs) implemented? A supplier should take every precaution along the way to ensure they have a safe product in the end. cGMPs should be documented and employees and visitors should be trained to follow them. If this is a Farmstead Cheese operation, steps must be taken to prevent people/children, clothing, shoes, tools, and such from entering the cheese making room without adequate sanitation steps taken. Phttps://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm090016.htm`Does the facility have a Sanitation program? Provide documentation on your sanitation programs.https://dairyextension.foodscience.cornell.edu/sites/dairyextension.foodscience.cornell.edu/files/shared/Cleaning%20and%20Sanitizing.pdf9Does the facility have a Preventive Maintenance Program? It should include a maintenance schedule of all equipment and building repairs. i.e. mixers, pasteurizers, utensils, paddles etc. Is a documented sanitation step performed after any repairs? https://dairyextension.foodscience.cornell.edu/sites/dairyextension.foodscience.cornell.edu/files/shared/Preventative%20Maintenance%20Program.pdf}It is the responsibility of the supplier to ensure that all food employees are properly trained in the safe handling of food, Good Manufacturing Practices and HACCP where appropriate. Is it documented? Documented annual refresher training is required. Training includes internal training specific to the job being performed and external training such as Extension Service courses. https://dairyextension.foodscience.cornell.edu/sites/dairyextension.foodscience.cornell.edu/files/shared/Training%20Program.pdfTIt is the responsibility of the supplier to have a written employee illness policy. GDoes the facility provide food safety training for all food employees?>The facility should be conducting environmental sampling/testing verification on a monthly basis. Sampling areas should include a minimum of food contact equipment, aging rooms walls, condensate drains, floor drains, wheels on equipment etc. The program should include documented corrective actions and investigations.FDA or the State conducts sampling and screening for pathogens on a routine basis. It is best for the facility operator to have a good method of surveillance to detect and mitigate any organisms of concern. Review records of all findings. If done by a service company, please ask for reports, insurance certification, and license. If done by owner/operator, please review records and logs for license (if using pesticides), pest monitoring and measures taken to control pest. All pesticides must be controlled and monitored. {https://dairyextension.foodscience.cornell.edu/sites/dairyextension.foodscience.cornell.edu/files/shared/Pest%20Control.pdfHow will the products be delivered to the stores: direct to the stores, through the ________________________ distribution system or other? bDoes the Distribution System follow the FDA Sanitary Transport Regulations, if required? Please explain how the product will be delivered to the store. If delivering cold product, it must be delivered under temperature control through refrigeration or other effective method. Please explain how traceability and cold chain integrity will be maintained. >https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm383763.htmIf nutritional information is being disclosed, the facility must have an accredited lab or use other industry standards to generate the information. If any health claims ( low fat ,  fat free etc.) are made, they must fol< low the NLEA standards. Ehttps://www.fda.gov/iceci/inspections/inspectionguides/ucm074948.htm Are all allergens disclosed on the labels in accordance with Law? FALCPA (Food Allergen Labeling and Consumer Protection Act)? The Food Allergen Labeling and Consumer Protection Act require that ALL major food allergens (the Big 8) be clearly identified on the label. Milk, wheat, tree nuts, peanuts, shell fish, fish, eggs, and soy.Are all ingredients and sub-ingredients clearly identified in English on the label? Does it include Name and Address of Distributor or Manufacturer?IIt is important to have clear instructions for the retailer and consumer.\Does the facility have a validated FSP implemented for all Milk and Dairy products produced?FSection 4 - Control of Food Hazards and Food Safety Plans (FSP/HACCP):9Ensure that the facility has a strong FSP plan and verification documents for cooking temperatures, Pasteurization temperatures, cooling temperatures, holding temperatures and transportation. Ask for copies of calibration logs as well as all other PCs. The plan must be reviewed annually. What was the last review date? Facility should have a FSP team in place with a Preventive Control Qualified Individual. The PCQI should have proper and adequate training. The FSP should reference regulatory pasteurization requirements if applicable. FSP should reference Prerequisite programs such as GMP's, Cleaning and Sanitizing schedules, SOPs & other procedures. !$If your facility qualifies for the exemption as a  very small business as defined in 21 CFR 117.3 because, during the preceding three calendar years, the business (including any subsidiaries and affiliates) averaged less than $1,000,000, adjusted for inflation, per year, in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale; or - Your facility meets the definition of  qualified facility in 21 CFR117.3 because: a. During the preceding three calendar years, the average annual monetary value of the food manufactured, processed, packed, or held at your facility that was sold directly to qualified end-users (as defined in 21 CFR 117.3) exceeded the average annual monetary value of the food sold by your facility to all other purchasers; and b. The average annual monetary value of all food sold during the preceding three calendar years was less than $500,000, adjusted for inflation. ~Second, you must attest that: 1. You have identified potential hazards associated with the food being produced, are implementing preventive controls to address the hazards, and are monitoring the performance of the preventive controls to ensure that such controls are effective; or 2. Your facility follows State, local, county, tribal, or other applicable non-Federal food safety law, including relevant laws and regulation of foreign countries, based on licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency (such as a State department of agriculture), or other evidence of oversight. XDo the cheeses produced if required meet all of the 21 CFR 133 "Standards of Identity"? Rhttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=133https://dairyextension.foodscience.cornell.edu/sites/dairyextension.foodscience.cornell.edu/files/shared/Allergen%20Program.pdf;The facility must have an allergen control plan that meets the FSMA requirements. Allergen Preventive Controls should be identified and documented including labeling. The facility should also validate its cleaning program via testing. The employees must have been well trained on allergen control in their facility.Reduced Oxygen packaging has been implicated in many foodborne illness outbreaks including some caused by Clostridium botulinum and Listeria monocytogenes. Facility must have a HACCP/FSP plan to control the hazards associated with this type of packaging. PACKAGED form. (2) "Reduced oxygen packaging" includes: (a) Vacuum PACKAGING, in which air is removed from a PACKAGE of FOOD and the PACKAGE is HERMETICALLY SEALED so that a vacuum remains inside the PACKAGE; (b) Modified atmosphere PACKAGING, in which the atmosphere of a PACKAGE of FOOD is modified so that its composition is different from air but the atmosphere may change over time due to the permeability of the PACKAGING material or the respiration of the FOOD. Modified atmosphere PACKAGING includes reduction in the proportion of oxygen, total replacement of oxygen, or an increase in the proportion of other gases such as carbon dioxide or nitrogen; (c) Controlled atmosphere PACKAGING, in which the atmosphere of a PACKAGE of FOOD is modified so that until the PACKAGE is opened, its composition is different from air, and continuous control of that atmosphere is maintained, such as by using oxygen scavengers or a combination of total replacement of oxygen, nonrespiring FOOD, and impermeable PACKAGING material; (d) Cook chill PACKAGING, in which cooked FOOD is hot filled into impermeable bags which have the air expelled and are then sealed or crimped closed. The bagged FOOD is rapidly chilled and refrigerated at temperatures that inhibit the growth of psychrotrophic pathogens; or (e) Sous vide PACKAGING, in which raw or partially cooked FOOD is vacuum packaged in an impermeable bag, cooked in the bag, rapidly chilled, and refrigerated at temperatures that inhibit the growth of psychrotrophic pathogen. 9SHave the facilities products ever been implicated in a foodborne illness outbreak? A history of foodborne illness outbreak could be caused by a poor food safety management structure. Ensure that all corrective actions have been made and no pending investigations are in operation. Have facility share results of any product testing done after incident. xHave the facilities products ever been the subject of a Recall? Class I, Class II or Class III? Recall Classifications  Class I: Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve. nThese guidelines categorize all recalls into one of three classes, according to the level of hazard involved:Class II: Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.Class III: Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.Any supplier producing items for sale must be able to recall any item that may have been adulterated, mislabeled, misbranded or otherwise negatively affected. !http://bit.ly/RecallPlanChecklist}https://dairyextension.foodscience.cornell.edu/sites/dairyextension.foodscience.cornell.edu/files/shared/Recall%20Program.pdf$ https://www.usda.gov/topics/organic[All items must have easily identifiab<;le information on each individual retail package or bulk container to ensure that if a recall is initiated, the product can be identified and pulled. The identification system used on the package must be permanent in nature and have the required information to trace back the item to a production lot or batch.Khttps://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM503566.pdf 5https://www.accessdata.fda.gov/scripts/fdplanbuilder/https://dairyextension.foodscience.cornell.edu/sites/dairyextension.foodscience.cornell.edu/files/shared/Food%20Defense%20Program.pdf 'Required by July 2019 if > $10,000,000.Is there a documented Approved Supplier Program: i.e. COA's, allergen statements, antibiotic free claims, ingredient specifications, 3rd party audits etc.?j IDoes the Approved Supplier Program meet or exceed the FSMA requirements? *the six months would be for grade A products which by nature have a short shelf life. Some cheese may fall into this category, however, there are some where cheese can age 2 or more years. Records of all sample test results shall be maintained for a minimum of *six (6) months by the industry at the location where the test methods were run, and/or another location as directed by the Regulatory Agency and as agreed to by industry. For the laboratory survey, two (2) years of records shall be available at the facility at the time of the survey. For further information see page 359 of PMO: =W?these guidelines are for Grade A PMO which is every 3 years. uDoes the facility have all required regulatory permits? (State/Local Health/Ag permit, Milk and Dairy, tax id, etc.) Whttps://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/ucm122814.htmsSection 1- Pre Audit Questions - Please complete this questionnaire and attach or provide all supporting documents.!_21 cfr 117 - Current GMP, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. Does the owner use an off-site facility, shared kitchen or Co-Packer to produce, store or hold product? If yes, provide more information (See 2.01)https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM499509.pdf https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm"Annual verification is recommendedRecords required. NCorrective action plan required if temperature is not met, how is it handled? Does the facility have a Sanitation program? Provide documentation on your sanitation programs and should include all areas of the facility interior and exterior.Sanitation methods should include the responsibility for the cleaning of the food handling and processing equipment. Are Sanitation Preventive Controls identified and documented in the FSP? Are the Sanitation Preventive Controls adequate? A Master Sanitation Program should include a cleaning schedule of processing areas, and routine common area cleaning i.e. break rooms, bathrooms, storage areas, doors (overhead and man doors), exterior etc. Verification of cleaning should be documented. IYou need to be licensed to handle exterior bait stations in most States. kthis form contains information "if certified to SQFI" Can we remove those two lines? (Under Notification)A mock recall should be performed annually and documented, 100% of the product should be accounted for. Have the supplier or operator demonstrate compliance with traceability requirements. All product (100% is the goal) from a lot or production date must be accounted for in a two-hour period to be considered a successful trace. A mock recall should include, finished product, an ingrediant and food grade packaging. KDoes the facility have a required FSMA Recall Plan in place? A mock recall should include finished product, ingredient and food grade packaging. =v xmz~t J IjޘE#gTfQc zhp^ ccB ZO {  dMbP?_*+%&?'?(?)?"dXX333333?333333?&<3U}  ?$?(  $? Q>+a $C *Group 46"v+] `4 4 B $  V:?))))B|CE.FQ.RUVW&||@`~~|Freeform: Shape 47" Ð PK![Content_Types].xmlJ0*miG]`Hm6 Xwt?. g#Wi3E).+7 >ON ޑ1ˋz "+R RhB.} /<^ITխ%rHK4uK~I0xM e`|X}đ I`߽N4aG2$RKIZ)4(M9`ctB{m:f@`3n|O,ܗr޾jxR0T ,0@}WBLǬ5vPK!Q_&drs/shapexml.xmlY[r6Lpmlb;W'qZMLOE ,+{*.+<($Y@_2k^:2Tحɯ9K<`;tkbVgm!6!/Y,jSʔV V?tMŖɱ0֝0̠Upȹ6"0G3<"BqjwujQL4 Ҫ>3@W y Tht&ҺS17 Lq#krL< ,:[^=gž6Zs0ؖaj) Záe¹"n1b9{OȘ]]M ָAc|".yp0)fF@G%"v8aR:fcq9DžK[D'GqFщ3:g9]0K 4\$u$:r襈.>X 9QtF;&$vra'‚1d0 9y A4gǧ/, ƸF +( L$H9vd2 45H/ĒHiID.ReWI_Tc Ո7?i: #]5sYKa;-F;O5&#Y12Zotve}vS y',|SҸ<ɳJv>/Kfι 5R[ܽ?ſh/o\p/Sn ajBKFWU#9&V{4ut|KCfOn3|&k]Zb9xΛ)i" Ҙ ցk}Mݾ4‹TA?E$\1eڤGYw ^۳Ƣ 'Spxup/PK!|drs/downrev.xmlDAK1aMԲiBt3Mn&K71o7+bYHBAxݲQZ<@3)8Sb'^ӱN*)0|Oo{:)]',Ö==[jS;kRȱy*KyE(u}5,&P$~4﫷_J+.z1QPnV1PK-![Content_Types].xmlPK-!1_a ._rels/.relsPK-!Q_&)drs/shapexml.xmlPK-!|}drs/downrev.xmlPK Q>.]` "0@<aLevel 1 Audit - Artisan and Farmstead Cheesemakers The Level 1 Audit was created to help local artisan cheese makers fill the needs of retailers. 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