VENDOR SURVEY FORM Date prepared: NOTICE: I (We) certify that the information contained in the attached survey form is accurate and complete as of the date indicated. Where trade secret or other proprietary information is involved, the person interviewed has initialed those responses not verified by the interviewer. All information obtained will be kept confidential. A corporate officer of the company surveyed will review all responses made at the time of survey. This survey has been made with the permission of the company surveyed. Signature Title Location Signature Title Location Signature Title Location PART I - GENERAL INFORMATION Annual Sales: Years in Business: Privately Owned: Subsidiary Division: Other Plant Locations List Major Customers Type of Contract þ Not Available þ Not Available List Company Management Name Title Interviewed Product for which survey was performed (Attach Labeling): Total Number Employees Labor Ratio of Supervisors To Production Personnel Work Schedule Hours Number Shifts Days Per Week Are Training Programs for Personnel Utilized þ YES þ NO FACILITY # BUILDINGS ON SITE TYPE (SINGLE/MULTISTORY;WOOD/BRICK/BLOCK/STEEL) LOCATION IN: INDUSTRIAL PARK þ URBAN þ SUBURBAN þ RURAL þ EQUIPMENT OWNED OR LEASED SQUARE FOOTAGE IN: MANUFACTURING ADMINISTRATION STORAGE ENGINEERING, R&D LIST PROCESS CAPABILITIES AND SPECIAL MANUFACTURING EQUIPMENT ESSENTIAL TO MATERIALS BEING PROCURED. 1) 2) 3) 4) 5) IS THERE A DOCUMENT/PROCESS FLOW MANUAL OUTLINING ALL MANUFACTURING STEP, RECORDS, AND CONTROLS FROM RAW MATERIALS TO FINISHED PRODUCT (AS REQUIRED FOR SOME GOVERNMENT CONTRACTS. þ YES þ NO DOES THE MANUFACTURER HAVE LIABILITY INSURANCE þ YES þ NO INSURED BY PART II - RAW MATERIALS PURCHASING IS QUALIFICATION BASED ON WRITTEN SPECIFICATIONS AND APPROVAL OF VENDOR SOURCES þ YES þ NO ARE REJECT/ACCEPT LIMITS SHOWN þ YES þ NO IS APPROVAL BASED ON: QUALITY HISTORY SUPPLIER ON SITE OWN QC CARDS þ CERTIFICATE þ SURVEY þ TESTING þ OTHER ARE SPECIFICATION CHANGES REVIEWED AND SIGNED OFF BY QC PERSONNEL þ YES þ NO TESTING ARE WRITTEN TEST PROCEDURES IN USE þ YES þ NO TEST RESULTS ON FILE þ YES þ NO SAMPLING PLAN USED 100% þ MIL SPEC þ AQL þ RANDOM þ OTHER DO TEST RESULTS INDICATE QUANTITY SAMPLED þ METHOD OF ANALYSIS þ DATE & SIGNATURE OF ANALYST þ SAMPLE TRACEABILITY þ PART III - MANUFACTURING Master Production Records IS THERE A SINGLE CONTROLLED FILE OF MASTER RECORDS FOR EACH PRODUCT þ YES þ NO BATCH SHEETS þ LINE ENGINEERING ASSEMBLY DRAWINGS þ OTHER LIST MANUFACTURING DONE BY OUTSIDE SOURCES (SUBASSEMBLY, PACKAGING, KIT ASSEMBLY, ETC.) 1) 2) 3) 4) 5) HAS THE MANUFACTURER BEEN INSPECTED BY ANY STATE OR FEDERAL AGENCIES WITHIN THE LAST TWO YEARS þ YES þ NO NAME OF AGENCIES: WERE RECALLS INVOLVED þ YES þ NO COMMENTS IS THERE A RETENTION SAMPLE SYSTEM FOR RAW MATERIALS/COMPONENTS þ YES þ NO IN PLANT CONTROL MATERIAL ASSIGNED ALPHA-NUMERIC OR IDENTIFYING MARK FOR EACH INCOMING LOT þ YES þ NO MATERIAL VISIBLY MARKED AS SAMPLED þ APPROVED þ REJECTED þ NOT MARKED þ INVENTORY LOG OR RECORD KEPT þ YES þ NO STORAGE AREA SEPARATE þ YES þ NO SEGREGATED WITHIN STORAGE AREA þ YES þ NO STOCK ROTATION (FIFO) SYSTEM USED þ YES þ NO AUTHORIZED CUSTODIAN CONTROL þ YES þ NO GENERAL HOUSEKEEPING NEAT AND ORDERLY þ YES þ NO REJECTED MATERIALS ARE: þ YES þ NO CLEARLY IDENTIFIED þ YES þ NO PHYSICALLY SEGREGATED þ YES þ NO ARE THESE MASTER RECORDS SIGNED AND DATED þ YES þ NO DOUBLE SIGNATURE þ REVISION DATES þ ARE THE PROCESS, ASSEMBLY, OR MANUFACTURING STEPS FULLY DESCRIBED: IN THE MASTER PRODUCTION RECORD: þ YES þ NO IN A SEPARATE DOCUMENT OR RECORD: þ YES þ NO IS THERE A MASTER DOCUMENT TO INDICATE: QC POINTS FOR IN-PROCESS MANUFACTURING þ YES þ NO TYPE OF TEST OR INSPECTION TO BE MADE þ YES þ NO METHOD OF MEASUREMENT þ YES þ NO WHO PERFORMS TEST OR INSPECTION þ YES þ NO LEVEL OF ACCEPT/REJECT (LIMITS) þ YES þ NO FOR MANUFACTURING, PROCESSING, SUBASSEMBLY, OR PACKAGING DONE BY OUTSIDE SOURCES, ARE THERE: MASTER PRODUCTION RECORDS þ YES þ NO QC SPECIFICATIONS AND METHODS RECORDS þ YES þ NO OUTSIDE SOURCES NOT USED þ YES þ NO PRODUCTION AREA IS THE WORK FLOW ORGANIZED þ YES þ NO DISTINCT STAGING AREA FOR RAW MATERIALS OR COMPONENTS USED IN MANUFACTURING þ YES þ NO PRODUCTION OR ASSEMBLY LINES SEGREGATED þ YES þ NO GENERAL HOUSEKEEPING AND ENVIRONMENTAL FACTORS GOOD þ YES þ NO WRITTEN PROCEDURES FOR PLANT SANITATION AVAILABLE þ YES þ NO PRODUCTION EQUIPMENT MAINTENANCE OR SERVICE RECORDS AVAILABLE þ YES þ NO CALIBRATION RECORDS KEPT ON PERIODIC BASIS þ YES þ NO MEANS OF READILY IDENTIFYING TYPE AND STAGE OF PROCESSING BEING DONE ON THE EQUIPMENT þ YES þ NO PRODUCTION RECORDS ARE PRODUCTION DOCUMENTS COLLECTED AND FILED þ YES þ NO KEPT (YEARS) COMPLETE HISTORY þ LABELING SAMPLES INCLUDED þ PARTIAL HISTORY þ TRACEABILITY BY LOT OR SERIAL# þ PACKAGING ARE FINISHED GOODS PACKAGING OPERATIONS SEGREGATED þ YES þ NO UNDER SUPERVISED CONTROL þ YES þ NO LABEL RECORDS KEPT þ YES þ NO PRE-LABEL: COUNT þ RECONCILIATION þ ARE FINISHED GOODS PROPERLY IDENTIFIED, LABELED, AND STORED þ YES þ NO PRIOR TO RELEASE þ AFTER RELEASE þ REJECTED MATERIALS ARE THERE WRITTEN PROCEDURES FOR DISPOSING OF OR REWORKING REJECTED ITEMS þ YES þ NO ARE REJECTED PRODUCTS HELD IN QUARANTINE PENDING FINAL DISPOSAL þ YES þ NO SEGREGATED AREA þ SPECIAL MARKINGS þ RETENTION SAMPLES ARE SAMPLES OF FINISHED GOODS RETAINED þ YES þ NO FROM EACH PRODUCTION RUN þ IN A SEPARATE CONTROLLED AREA þ IN THE SAME CONTAINER/CLOSURE SYSTEM IN WHICH THEY ARE SOLD þ IN CONTAINERS DIFFERENT FROM UNIT AS SOLD þ KEPT FOR A PERIOD OF (YEARS) WRITTEN LOG OR FILE þ STERILE COMPONENTS (IF APPLICABLE) ARE THERE PROCEDURES FOR ESTABLISHING AND MAINTAINING ASEPTIC CONDITIONS þ YES þ NO ARE THERE METHODS FOR ROUTINE AUDITING OF STERILE AREAS USED þ YES þ NO ARE THERE PROCEDURES FOR WORKING IN STERILE AREAS þ YES þ NO FOR CLEANING AND STERILIZATION OF EQUIPMENT þ YES þ NO FOR BULK AND FINAL PRODUCT STERILITY TESTING þ YES þ NO IS PROCESS STERILITY FOR EACH RUN DOCUMENTED IN THE PRODUCTION RECORDS þ YES þ NO STERILE PROCESS USED ETO þ RADIATION þ STEAM þ FILTRATION þ CHEMICAL þ OTHER: PART IV - QUALITY CONTROL/ASSURANCE ORGANIZATION AND FUNCTION DOES THE QUALITY CONTROL-INSPECTION GROUP REPORT DIRECTLY TO THE TOP, INDEPENDENT OF PRODUCTION, MARKETING, OR OTHER ORGANIZATION GROUPS WITHIN THE MANUFACTURING COMPANY þ YES þ NO DOES THE QUALITY CONTROL-INSPECTION GROUP HAVE FULL AUTHORITY TO WITHHOLD SHIPMENT OR FURTHER PRODUCTION OF REJECTED ITEMS þ YES þ NO ARE THE QUALITY CONTROL PROCEDURES: REVISED ON A PERIODIC BASIS þ YES þ NO DOES THE QUALITY CONTROL/ASSURANCE-INSPECTION GROUP HAVE: ADEQUATE EDUCATION, TRAINING OR EXPERIENCE þ YES þ NO UNDERSTANDING OF THEIR FUNCTION þ YES þ NO OPERATION ARE STAMPS, TAGS, MARKERS, ETC. USED TO VERIFY INSPECTION ACTIVITY þ YES þ NO ARE THE MARKINGS USED TRACEABLE TO AN INDIVIDUAL INSPECTOR þ YES þ NO PART V - CUSTOMER COMPLAINTS/RECALL CAPABILITIES IS THERE AN ORGANIZED COMPLAINT FILE þ YES þ NO DOES EACH COMPLAINT STATE: NATURE OF COMPLAINT þ RESPONSE TO CUSTOMER (REPAIR, REFUND, REPLACE) þ FURTHER CORRECTIVE/PREVENTIVE ACTION BY MANUFACTURER þ COMPLAINT FILES KEPT FOR (YEARS) IS THERE A PERIODIC REVIEW OF COMPLAINT FILES FOR TRENDS þ YES þ NO IS THE REVIEW FILE AS A WRITTEN SUMMARY þ YES þ NO IS THERE A GROUP OR INDIVIDUAL ASSIGNED TO HANDLE CUSTOMER INQUIRIES AND FOLLOW UP ON COMPLAINTS þ YES þ NO ARE PRODUCT DEFECTS VERIFIED BY MANUFACTURER THROUGH TESTING þ YES þ NO WAS REVIEW OF COMPLAINT FILES FOR SURVEY PRODUCT MADE þ YES þ NO ARE PRODUCTION SAMPLES FOR QC TESTING: ADEQUATELY IDENTIFIED AS TO SOURCE þ YES þ NO RECORDED SOMEWHERE AT TIME OF SAMPLING þ YES þ NO ENTERED ON FILED TEST REPORT þ YES þ NO WRITTEN SAMPLING PLAN BASED ON: 100% þ MIL. SPEC þ AQL þ RANDOM þ OTHER IS THE PRODUCT USED TESTED PRIOR TO FINAL RELEASE þ YES þ NO ARE OUTSIDE SOURCES USED FOR PRODUCTION TESTING þ YES þ NO UNDER FORMAL CONTRACT þ USED TEST PROTOCOLS OR WRITTEN PROCEDURES þ COPIES IN THE MANUFACTURING FILE þ FACILITY REGISTERED OR LICENSED BY ANY FEDERAL, STATE OR PROFESSIONAL AGENCY þ OUTSIDE TEST RESULTS FILED BY THE MANUFACTURER þ IS THERE A FORMAL QUALITY ASSURANCE PROGRAM INVOLVING PERFORMANCE TESTING OF THE PRODUCT(S) AFTER RELEASE þ YES þ NO RECALL CAPABILITIES IS THERE A COMPANY RECALL PLAN þ YES þ NO SHOWS HOW DECISIONS ARE MADE AND BY WHOM þ HOW RECALL WILL BE ACCOMPLISHED þ INSTRUCTIONS FOR RECOVERY AND ACCOUNTABILITY OF RECALLED PRODUCT þ DO SHIPPING OR DISTRIBUTION RECORDS ON FILE SHOW: CUSTOMER OR DISTRIBUTOR NAME AND ADDRESS þ YES þ NO DATE OF SHIPMENTS AND QUANTITY SHIPPED þ YES þ NO LOT OR SERIAL NUMBER OF PRODUCT SHIPPED þ YES þ NO DISTRIBUTION RECORDS ARE MAINTAINED (YEARS) DISTRIBUTION RECORDS ARE STORED AS: COMPUTER LISTING þ MICROFILM/MICROFICHE þ MANUAL CARD/PAPER FILES þ PART VI - REGULATORY COMPLIANCE IS THE PLANT REGISTERED AS A DEVICE MANUFACTURER þ YES þ NO ARE THE SURVEY PRODUCT(S) LISTED WITH BUREAU OF MEDICAL DEVICES þ YES þ NO ARE ALL NECESSARY APPROVALS FOR MARKETING PRODUCTS AVAILABLE þ YES þ NO LIST OF ATTACHMENTS AND COMMENTS IS THERE A FILE WITH PAST AND CURRENT LABELING FOR EACH SURVEY PRODUCT þ YES þ NO IS THERE A FORMAL AUDITING PROGRAM OF THE QC OPERATION. IF SO, DONE BY WHOM þ YES þ NO