Washington State Patrol Toxicology Laboratory Division
Quality Manual Breath Alcohol Calibration
CALIBRATION QUALITY MANUAL
TOXICOLOGY LABORATORY DIVISION
WASHINGTON STATE PATROL
TLDCalQM Printed Copies Are Uncontrolled Page 1 of 61
Revision: Original Approved by the State Toxicologist Effective Date: 9/15/08
Arch
ived /
Rep
laced
by
Revis
ion 1
on 5/
11/09
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
TLDCalQM Printed Copies Are Uncontrolled Page 2 of 61
Revision: Original Approved by the State Toxicologist Effective Date: 9/15/08
Arch
ived /
Rep
laced
by
Revis
ion 1
on 5/
11/09
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