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TABLE OF CONTENTS
Page
APPROVAL PAGE ............................................................................................................ 2
TABLE OF CONTENTS.................................................................................................... 3
1.
INTRODUCTION ........................................................................................................ 7
1.1.
Purpose .................................................................................................................. 7
1.1.1. MERC Purpose ........................................................................................... 7
1.1.2. Quality System Purpose .............................................................................. 7
1.2.
Scope ..................................................................................................................... 7
1.3. Background ........................................................................................................... 8
2.
MERC QUALITY SYSTEM MANAGEMENT AND ORGANIZATION .............. 10
2.1. Quality Assurance Policy .................................................................................... 10
2.2. Allocation of Appropriate Resources to Support the Quality System................. 10
2.3. Organization and Quality System Roles, Responsibilities, and Authorities ....... 11
2.3.1. MERC Director and Principal Investigator............................................... 11
2.3.2. MERC Co-Investigator ............................................................................. 11
2.3.3. MERC Program Coordinator .................................................................... 11
2.3.4. MERC Facility Manager ........................................................................... 11
2.3.5. MERC Quality Assurance Manager ......................................................... 11
2.3.6. MERC Data Manager ............................................................................... 11
2.3.7. MERC Advisory Board............................................................................. 12
2.3.8. Vendors ..................................................................................................... 12
2.4. Technical Activities Supported by the MERC Quality System .......................... 12
2.5. Management Assurances of Implementation ...................................................... 12
2.6.
Independence of the QA Manager....................................................................... 12
2.7. Dispute Resolution .............................................................................................. 13
3.
MERC QUALITY SYSTEM COMPONENTS ......................................................... 13
3.1. Quality System Description................................................................................. 13
3.2. Quality System Tools .......................................................................................... 13
3.2.1. Program Quality System Tools ................................................................. 13
3.2.1.1. Quality Management Plan ............................................................... 16
3.2.1.2. Quality System Annual Report and Work Plan............................... 16
3.2.1.3. Quality System Process Assessments.............................................. 16
3.2.1.4. Quality System Training ................................................................. 16
3.2.2. Project-Specific Quality System Tools ..................................................... 17
3.2.2.1.
Systematic Planning and Data Quality Objectives Process............ 17
3.2.2.2.
Program Quality Assurance Project Plan ....................................... 17
3.2.2.3.
Test Plan ......................................................................................... 18
3.2.2.4.
Standard Operating Procedures ...................................................... 18
3.2.2.5.
Field and Laboratory Notebooks, Forms, and Records.................. 18
3.2.2.6.
Technical Systems Audits .............................................................. 18
3.2.2.7.
Data Quality Assessments .............................................................. 19
3.2.2.8.
Data Verification and Validation ................................................... 19
3.2.3. Information Quality Tools ........................................................................ 19
3.2.3.1.
Internal Review .............................................................................. 19
3.2.3.2.
Informal External Review .............................................................. 20