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9.
IMPLEMENTATION OF WORK PROCESSES
9.1.
Compliance with Approved Planning and Technical Documents
MERC BWTS performance evaluations are implemented according to the Test/QA Plans and technical
documents (e.g., Standard Operating Procedures) prepared during planning. A kick-off meeting will be
held prior to the start of each test to review procedures for the test with all testing staff. Test personnel
have access to the approved planning documents, approved changes to planning documents, and all
referenced documents. When a prescribed sequence for the work is defined during the planning stages,
work performed shall follow that sequence. Changes to that sequence need to be documented by either
amendment (planned changes) or deviation (unplanned changes). All staff will be notified of the change,
and appropriate action will be taken to ensure that obsolete or superseded procedures are identified and
removed from use. All implementation activities are documented. Suitable documents are bound
notebooks (e.g. laboratory record books, or LRBs), field and laboratory data sheets, spreadsheets,
computer records, and output from instruments (both electronic and hardcopy). All documentation is
implemented as described in the planning documents. All implementation activities are traceable to the
planning documents and traceable to test personnel.
9.2.
Special Procedures
The QAPP, Test Plan, and referenced technical documents must define the procedures for BWTS testing.
The level of detail must be adequate for a qualified individual to perform the procedure independently. In
some cases, the level of detail needed to adequately describe a procedure is best documented in a
specialized, detailed SOP or protocol.
An SOP is developed if the procedure is routine. SOPs are controlled documents and formally approved
and tracked. If the procedure is test-specific then a protocol is adequate. Protocols are test-specific
documents prepared by the senior research personnel, the Program Coordinator, or the QA Manager.
Protocols must be version-controlled in some manner.
A special procedure requiring a detailed SOP or protocol is required if the procedure:
•
is complex, involves many steps, and must be completed follow a regime of timing and sequences
(e.g., analytical methods);
•
is lengthy and is best captured in a separate document;
•
involves the quantitative preparation of chemical solutions that impact data quality (e.g.,
calibration solutions);
•
involves the setup, use, and operation of complex equipment or instruments that will impact data
quality and that are not easily operated by following simple manufacturer instructions (analytical
instruments).
The Program Coordinator is responsible for operations that need written procedures/SOPs, and for
preparing, updating, approving, withdrawing, and archiving procedures. The QA Manager is responsible
for ensuring that all technical procedures described in the QAPP and/or Test Plan are adequately
described in a written procedure.