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work experience; experience in the application of QA/quality control (QC) requirements in technical
performance or data verification; on-the-job training in specific skill documented by qualified individuals;
and expertise in advanced technical activities based on experience and demonstrated competence.
MERC partner laboratories working on individual BWTS test operations are expected to provide the
Program Coordinator with records of educational background and work relevant to technical areas related
to the technology undergoing testing. This information will be reviewed by MERC QA Manager during
the TSA.
4.2.5.
Responsibilities
The Program Coordinator and senior research leaders are responsible for ensuring that personnel who
acquire, generate, compile or use test data are familiar with quality requirements and for verifying that
technical staff members are trained in applicable standard operating procedures and the proper use of
sampling equipment. The Principal Investigators provide staff with training materials and SOPs.
Principal Investigators are responsible for ensuring adequate resources for the professional development
and training of laboratory personnel. The MERC QA Manager is responsible for arranging for, and
assisting in, defining QA/QC training needs on a regular basis to update MERC staff with developing
QA/QC issues.
5.
PROCUREMENT AND ACCEPTANCE OF ITEMS AND SERVICES
MERC procurement activities may range from general and scientific supplies to highly sophisticated
scientific instrumentation and services which directly affect the quality of BWTS testing.
5.1.
Procurement Policy
As a unit of UMCES, MERC follows the USM Procurement Policies and Procedures (VIII-3.00) and the
University of Maryland (UMCP) Procurement Policies (VIII-3.10A, VIII-3.10B).
5.2.
Procurement Documents
Technical and quality requirements for items and services procured for a specific BWTS test are included
in the Test Plan. These requirements will typically be specified under materials and/or measurement
system equipment (QAPP Section B8, Inspection/Acceptance Requirements for Supplies and
Consumables). Procurement technical and quality requirements are generally based upon value (cost,
durability, maintainability), performance (specification compliance, operating conditions, calibration
capacity), delivery (timeliness, ease of ordering), customer support (responsiveness, technical ability),
past experience with a particular vendor, and completeness and coherence of instructions (clarity,
accuracy).
The request for items or services is initiated by the Program Coordinator. The Program Coordinator will
review purchase orders and contracts for critical supplies and equipment to ensure that they define the
level of quality needed. Purchase orders and contracted services must be complete, accurate, and clearly
describe, as appropriate:
•
the item or service needed;
•
any associated technical and quality requirements (such as purity, calibration requirements, etc.);
•
quality system elements for which the supplier is responsible, e.g., internal review of analytical
results for accuracy;