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ACZ Laboratories, Inc. August 10, 2007 <br />Quality Assurance Plan Version 12 <br />SOPAD018.08.07.12 Page 2 of 96 <br />TABLE OF CONTENTS <br />1 INTRODUCTION ....................................................................................................................... 3 <br />2 QUALITY SYSTEM OBJECTIVES & COMPONENTS .................................................................4 <br />3 ETHICAL AND LEGAL RESPONSIBILITY ..............................................................................16 <br />4 PERSONNEL AND RESPONSIBILITIES ..................................................................................17 <br />5 TECHNICAL TRAINING .......................................................................................................... 25 <br />6 SAMPLE COLLECTION & HOLDING TIlVIES ........................................................................ 27 <br />7 SAMPLE CUSTODY & SAMPLE HANDLING .......................................................................... 28 <br />8 PROCUREMENT, INVENTORY & TRACEABILITY OF SUPPLIES .......................................... 30 <br />9 MAINTENANCE & CALIBRATION OF INSTRUMENTATION & EQUIPMENT ......................... 33 <br />10 CONTROL & STORAGE OF RECORDS & DOCUMENTS ........................................................35 <br />11 ELEMENTS OF QUALITY CONTROL ...................................................................................... 42 <br />12 EVALUATING QUALITY CONTROL SAMPLES ...................................................................... 48 <br />13 VALIDATION & REVIEW OF ANALYTICAL DATA .............................................................. 52 <br />14 DETECTION LEVELS .............................................................................................................. 55 <br />15 SAMPLE DILUTIONS .............................................................................................................. 56 <br />16 ERROR CORRECTION PROTOCOL ....................................................................................... 56 <br />17 COMPUTER / AUTOMATED PROCESSES ............................................................................... 57 <br />18 CLIENT SERVICES ................................................................................................................. 58 <br />19 RADIOCHEMISTRY INSTRUMENTATION .............................................................................. 60 <br />2773 Downhill Drive 970-879-6590 <br />Steamboat Springs, CO 80487 www.acz.com