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3.2.3.3.
Peer Review.................................................................................... 20
4.
PERSONNEL QUALIFICATIONS AND TRAINING............................................. 20
4.1. Training Policy .................................................................................................... 20
4.2.
Processes for Ensuring Qualifications and Training ........................................... 20
4.2.1. Identification of Training Needs ............................................................... 21
4.2.2. Staff Training ............................................................................................ 21
4.2.3. Training Evaluation .................................................................................. 21
4.2.4. Training Documentation ........................................................................... 21
4.2.5. Responsibilities ......................................................................................... 22
5.
PROCUREMENT AND ACCEPTANCE OF ITEMS AND SERVICES................. 22
5.1.
Policy................................................................................................................... 22
5.2.
Procurement Documents ..................................................................................... 23
5.3.
Procurement of Items .......................................................................................... 23
5.4.
Procurement of Services...................................................................................... 23
5.5. Responses to Solicitations ................................................................................... 23
5.6. Acceptance of Purchased Items and Services ..................................................... 24
5.6.1. Testing Equipment .................................................................................... 24
5.6.2. Test Materials............................................................................................ 24
5.6.3. Services ..................................................................................................... 24
5.7. Other Agreements................................................................................................ 24
6.
DOCUMENTS AND RECORDS .............................................................................. 25
6.1. Quality Management Documents ........................................................................ 25
6.1.1. Controlled Documents .............................................................................. 25
6.1.2. Confidential Documents ........................................................................... 26
6.2. Records ................................................................................................................ 26
6.2.1. Test Project Files....................................................................................... 26
6.2.2. Test Data Records ..................................................................................... 26
6.2.3. Sample Documentation ............................................................................. 27
6.2.3.1.
Sample Identification Numbers...................................................... 27
6.2.3.2.
Sample Custody.............................................................................. 27
6.3. Maintaining Document Version Control ............................................................. 28
6.4. Compliance with Records and Documents ......................................................... 28
6.5. Documents and Records Management ................................................................ 28
6.6. Compliance.......................................................................................................... 28
6.7. Document Distribution ........................................................................................ 29
7.
COMPUTER HARDWARE AND SOFTWARE ...................................................... 30
7.1. General Procedures.............................................................................................. 30
7.2. Hardware ............................................................................................................. 30
7.3.
Software............................................................................................................... 30
7.4. Change Control.................................................................................................... 31
7.5.
Purchased Hardware and Software...................................................................... 31
7.6. Validation Policy ................................................................................................ 31
7.7. Roles and Responsibilities................................................................................... 31
8.
PLANNING................................................................................................................ 32
8.1. MERC Systematic Planning ................................................................................ 32
8.1.1. Stakeholders .............................................................................................. 32