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MERC – DRAFT Test Plan
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the MERC staff member at each MERC partner institution. The transportation case should then
be sealed and labeled. All records should be filled out legibly in waterproof pen.
Sample Handling:
All collected physical, chemical, and biological samples will be handled in the same
manner. Each sample will be dated and coded according to the appropriate sample sequence.
The actual sample container will be labeled with a number for identification. Samples stored for
any period of time shall be routinely inspected by the MERC staff member to assure proper
preservation and label integrity. The storage containers and storage devices (e.g., freezers and
locker) must be inspected routinely for proper operation and integrity. Results of all inspections
shall be included in the sample records. All logs shall be duplicated weekly. The original shall
be retained at the MERC partner site and a copy shall be sent to the MERC Program
Coordinator.
Audits:
MERC Program Coordinator will perform a technical systems audit twice during the
evaluation. The purpose of this audit is to ensure that the tests are being performed in
accordance with the MERC Protocols, published reference methods, and any SOPs used. In this
audit, the MERC Program Coordinator may review the reference methods used, compare actual
test procedures to those specified or referenced in the Protocols, and review data acquisition and
handling procedures. A technical systems audit report will be prepared, including a statement of
findings and the actions taken to address any adverse findings.
MERC Program Coordinator will also audit approximately 10% of the evaluation data
acquired during the tests to determine if data have been collected in accordance to the Protocols
with respect to compliance, correctness, consistency, and completeness. The MERC Program
Coordinator will trace the data from initial acquisition to final reporting.
Finally, each assessment and audit will be documented, and assessment reports will
include the following:
a.
Identification of any adverse findings or potential problems,
b.
Response to adverse findings or potential problems,
c.
Possible recommendations for resolving problems,
d.
Citation of any noteworthy practices that may be of use to others, and
e.
Confirmation that solutions have been implemented and are effective.
Corrective Action:
The MERC Program Coordinator, during the course of any assessment or audit, will
identify to the MERC staff performing experimental activities any immediate corrective action
that should be taken. If serious quality problems exist, the MERC Program Coordinator will
consult with MERC Primary Investigators and is authorized to stop work. Once the assessment
report has been prepared, the MERC Program Coordinator will ensure that a response is
provided for each adverse finding or potential problem and will implement any necessary follow-
up corrective action. The MERC Program Coordinator will ensure that follow-up corrective
action has been taken.