Washington State Patrol Toxicology Laboratory Division

Quality Manual Breath Alcohol Calibration

CALIBRATION QUALITY MANUAL

TOXICOLOGY LABORATORY DIVISION

WASHINGTON STATE PATROL

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Revision: Original Approved by the State Toxicologist Effective Date: 9/15/08

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Washington State Patrol Toxicology Laboratory Division

Quality Manual Breath Alcohol Calibration

TABLE OF CONTENTS

TABLE OF CONTENTS ......................................................................................................................................2

INTRODUCTION..................................................................................................................................................4

1.0 QUALITY MANAGEMENT SYSTEM ............................................................................................................5

1.0.1 POLICY ...................................................................................................................................................5

1.0.2 DEFINITIONS ...........................................................................................................................................5

1.0.3 QUALITY POLICY STATEMENT ..................................................................................................................6

1.0.4 QUALITY ASSURANCE OBJECTIVES ..........................................................................................................7

1.0.5 QUALITY ASSURANCE PROGRAM .............................................................................................................8

1.0.6 QUALITY SYSTEM RECORDS: ACCESS, FILING, STORAGE, RETENTION AND DISPOSAL .............................10

2.0 DOCUMENT CONTROL POLICY AND PROCEDURES............................................................................12

2.0.1 POLICY .................................................................................................................................................12

2.0.2 DEFINITIONS .........................................................................................................................................12

2.0.3 PROCEDURE .........................................................................................................................................13

2.0.4 REVISIONS TO PROCEDURES, TRAINING AND TECHNICAL DOCUMENTS....................................................15

2.0.5 SUBMISSION OF REQUESTS FOR SIMS SOFTWARE REVISIONS ................................................................16

2.0.6 APPROVED DATAMASTER INSTRUMENT SOFTWARE.................................................................................16

3.0 CONTROL OF NONCONFORMING WORK...............................................................................................17

3.0.1 POLICY .................................................................................................................................................17

3.0.2 DEFINITIONS .........................................................................................................................................17

3.0.3 PROCEDURE .........................................................................................................................................18

3.0.4 NOTIFICATION OF CLIENTS ....................................................................................................................21

3.0.5 RESPONSIBILITY FOR AUTHORIZING RESUMPTION OF WORK ..................................................................21

3.0.6 CORRECTIVE ACTION ASSESSMENT .......................................................................................................21

4.0 INTERNAL AUDITS AND MANAGEMENT REVIEWS...............................................................................23

4.0.1 POLICY .................................................................................................................................................23

4.0.2 DEFINITIONS .........................................................................................................................................23

4.0.3 PROCEDURES .......................................................................................................................................24

5.0 PURCHASING SERVICES AND SUPPLIES..............................................................................................26

5.0.1 POLICY .................................................................................................................................................26

5.0.2 PROCEDURE .........................................................................................................................................26

6.0 TRACEABILITY AND QUALITY CONTROL ..............................................................................................29

6.0.1 TRACEABILITY AND QUALITY CONTROL OF REAGENTS............................................................................29

6.0.2 VALIDATION OF EQUIPMENT AND INSTRUMENTATION ..............................................................................29

6.0.3 TRACEABILITY OF MEASUREMENT STANDARDS ......................................................................................33

6.0.4 OTHER DIVISION REFERENCE DATABASES .............................................................................................34

6.0.5 UNCERTAINTY OF MEASUREMENT..........................................................................................................35

7.0 PERSONNEL QUALIFICATIONS AND TRAINING....................................................................................37

7.0.1 SCOPE .................................................................................................................................................37

7.0.2 DEFINITIONS .........................................................................................................................................37

7.0.3 QUALIFICATIONS OF PERSONNEL...........................................................................................................38

7.0.4 TRAINING..............................................................................................................................................38

7.0.5 JOB PERFORMANCE ..............................................................................................................................41

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Revision: Original Approved by the State Toxicologist Effective Date: 9/15/08

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Washington State Patrol Toxicology Laboratory Division

Quality Manual Breath Alcohol Calibration

7.0.6 PROFESSIONAL DEVELOPMENT PROGRAM..............................................................................................42

8.0 ASSURING THE QUALITY OF CALIBRATION RESULTS .......................................................................44

8.0.1 POLICY .................................................................................................................................................44

8.0.2 PROFICIENCY TESTING ..........................................................................................................................44

8.0.3 TECHNICAL PROCEDURES AND METHODS...............................................................................................47

8.0.4 DEVIATION FROM POLICY OR PROCEDURE..............................................................................................52

8.0.5 RESOLUTION OF ISSUES CONCERNING TECHNICAL PROCEDURES............................................................52

9.0 CALIBRATION RECORDS, REVIEWS, AND REPORTS ..........................................................................53

9.0.1 POLICY .................................................................................................................................................53

9.0.2 DEFINITIONS .........................................................................................................................................53

9.0.3 REVIEW OF REQUESTS .........................................................................................................................54

9.0.4 CALIBRATION DOCUMENTATION .............................................................................................................54

9.0.5 CALIBRATION REVIEW ...........................................................................................................................55

9.0.6 TECHNICAL PEER REVIEW IN SPECIAL SITUATIONS .................................................................................58

9.0.7 RESOLUTION OF TECHNICAL DIFFERENCES OF OPINION.........................................................................58

9.0.8 FOCUSED CALIBRATION WORK REVIEW .................................................................................................58

10.0 RESEARCH PROJECTS, PUBLICATIONS AND PRESENTATIONS.....................................................60

10.0.1 POLICY FOR RESEARCH PROJECTS......................................................................................................60

10.0.2 PROCEDURE FOR RES