Supplier Audit Supplier / Vendor Audit Questionnaire Step 1 of 7 - Corporate and Personnel0%Survey Completed By* First Last Position*What is your position at your company?Date Completed* Corporate and PersonnelSupplier/Manufacturer’s Name*Supplier/Manufacturer’s address/telephone number*(include all manufacturing sites, domestic and off-shore)Name, address and telephone number of parent organization, if applicable*Customer ServiceName* First Last Phone*Email* Quality Control/Quality AssuranceName* First Last Phone*Email* OperationsName* First Last Phone*Email* OtherRoleName First Last PhoneEmail List all ingredients/products currently sold to Excelsior SuperfoodsBriefly describe the type of business you are in and the general type of products or service you provide?(i.e. Raw material supplier, Contract manufacturer)Type of products manufactured at or handled by your facility Save and Continue LaterCheck OneIs your facility registered with FDA?YesNoPlease provide your FDA registration NumberCommentsHas your facility ever been inspected by FDA?YesNoNAPlease provide a copy of your last inspection reportAccepted file types: doc, docx, pdf.CommentsHas your facility been inspected by any other regulatory offices?YesNoNADate of last inspection Please provide a copy of your last inspection reportAccepted file types: doc, docx, pdf.CommentsIs there a plant-wide GMP program?YesNoNAComments Save and Continue LaterPlant, Grounds, Buildings, and FacilitiesDo written procedures exist for maintaining the facility’s grounds?YesNoNACommentsIs the facility’s design and construction such that it supports the prevention of adulteration and or contamination?YesNoNACommentsAre the facility’s floors, walls, ceilings, work surfaces and equipment constructed of materials that can be easily cleaned, sanitized and/or maintained?YesNoNACommentsIs there a pest control program in use at the facility?YesNoNACommentsIs water quality monitored for:Cleaning?YesNoNAProcessing?YesNoNAHand washing?YesNoNADrinking?YesNoNAIs there a sanitation program for the facility(s)?YesNoNAComments Save and Continue LaterEquipment and UtensilsAre scales and balances checked for accuracy and correct calibration? How often?YesNoNACommentsDo written records exist for equipment cleaning, including dates, lot numbers, material names, and type of cleaning performed?YesNoNACommentsList the types of major equipment in use at your facility Comments Save and Continue LaterQuality Control/Quality AssuranceIs there a Quality Control Department with defined responsibilities and authority?YesNoNACommentsAre your quality requirements communicated in writing to your suppliers?YesNoNACommentsDo you audit your suppliers?YesNoNAHow often?Annually2 Years5 YearsCommentsDo you have written specifications for raw materials, packaging materials, finished products and labeling?YesNoNACommentsDoes the Quality Control Unit approve/reject:Procedures?YesNoNASpecifications?YesNoNAControls?YesNoNATest Methods?YesNoNARaw materials?YesNoNAPackaging materials?YesNoNALabeling?YesNoNAProcessing records?YesNoNACommentsDoes the Quality Control Unit perform final review/release of completed batch records?YesNoNACommentsDo you use an in-house laboratory, contract laboratories or both?YesNoNACommentsDo written quality control test methods exist?YesNoNACommentsDo written records exist for all material testing?YesNoNACommentsDo you conduct identity testing on ingredients?YesNoNACommentsDo you conduct microbial content testing on ingredients?YesNoNACommentsAre finished products tested for physical characteristics?YesNoNACommentsAre finished products tested for label or potency claim?YesNoNACommentsAre finished products tested for microbial content?YesNoNACommentsDo all finished products produced at your facility have expiration dates/shelf-life statements?YesNoNACommentsDo written procedures exist defining how expiration/shelf-life dating is established?YesNoNACommentsDo written procedures exist for calibration of laboratory instruments?YesNoNACommentsDo written procedures exist for the receipt, identification, examination, handling, sampling, testing and approval/rejection of raw materials?YesNoNACommentsAre raw material containers inspected upon receipt?YesNoNACommentsIs each lot of raw material identified with a unique lot number and identified according to status?YesNoNACommentsAre raw materials inspected for filth, insects, microbial contamination or other toxins, as appropriate?YesNoNACommentsAre Certificates of Analysis used in lieu of testing?YesNoNACommentsIs a First-In, First-Out (FIFO) system used to rotate raw material stock?YesNoNACommentsDo procedures exist for handling rejected raw materials?YesNoNACommentsIs there a quarantine/release system in place?YesNoNACommentsAre raw materials, in-process materials, finished products and re-work segregated during processing and storage operations?YesNoNACommentsAre processes and procedures designed and conducted in a manner to prevent adulteration and or contamination?YesNoNACommentsDoes a written Master Production Record exist for each product produced?YesNoNACommentsAre Batch Production Records used to conduct processing of products?YesNoNACommentsDo the Batch Production Records for include sufficient information and instruction to assure that the specific batch is manufactured to meet the specifications set out in the Master Production Record?YesNoNACommentsAre tests conducted to assess purity, composition and quality of the finished product?YesNoNACommentsIs there a system in place to address batches that do not meet specifications?YesNoNACommentsAre labels and labeling control in place?YesNoNACommentsAre checks and procedures in place to ensure correct product, labeling, and packaging materials are used?YesNoNACommentsIs a finished product identified with a lot or batch number which allows the history of that batch’s processing to be determined?YesNoNACommentsIs a quarantine/release system used for finished products?YesNoNACommentsAre retained samples maintained for all raw materials and finished products?YesNoNACommentsHow long are retained samples kept?YesNoNAComments Save and Continue LaterSystems Control and Customer ServiceDo controls exist to prevent the re-shipment of previously rejected materials?YesNoNACommentsAre customers notified of a change in supply source?YesNoNACommentsAre customers notified of a change in processing in writing?YesNoNACommentsDo written procedures exist for handling customer complaints and/or concerns?YesNoNACommentsAre these records maintained or at least one year past the product’s expiration date or one year after the receipt of the complaint, whichever is longer?YesNoNACommentsDo written procedures exist for handling finished goods recall?YesNoNAComments Save and Continue LaterWarehousing and DistributionDo written procedures exist for handling and storage of finished goods in the warehouse?YesNoNACommentsDo written procedures exist for the disposition of returned finished goods?YesNoNACommentsDoes a procedure exist for discarding of non-salvageable materials?YesNoNACommentsAre material containers cleaned prior to shipment from the warehouse?YesNoNACommentsIs finished goods stock rotated on a First In, First Out (FIFO) basis?YesNoNACommentsAre any of the finished goods we receive from you subcontracted from you?If so, list them in the commentsYesNoNACommentsCertificates*Do you have any of the following certifications or registrations on facility or products? FDA Registration Organic Facility Gluten Free Kosher NON GMO Project Vegan certification NSF cGMP Registration NPA cGMP Registration None of the aboveCertificationsPlease upload any facility registrations or certificates here. Drop files here or Accepted file types: pdf, doc, docx.Allergen StatmentPlease upload: Company Allergen Statement Company Gluten Statement Drop files here or Terms and Conditions*By enterings your name below I ackwowledge on behalf of my company I have read and agree to the Excelsior Alchemy, Inc. Terms and Conditions. Link to Terms and Conditions listed here: https://www.excelsioralchemy.com/terms/Supplier ResponsibilityAfter we receive and review your self-audit responses, we will return our comments to you. Save and Continue Later This iframe contains the logic required to handle AJAX powered Gravity Forms.