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3.2.3.2.
Informal External Review
MERC periodically may solicit reviews of documents and information products from qualified
individuals who are external to the program. External review is principally to ensure that the product is
technically sound. The MERC Director or designated senior staff person has the responsibility to
coordinate and oversee all external reviews.
3.2.3.3.
Peer Review
Peer review is a documented critical review of a specific MERC scientific and/or technical work product
and is generally considered to be the highest level of technical quality review. Peer review is conducted
to ensure that activities are technically supportable, competently performed, properly documented, and
consistent with established quality criteria. It includes an in-depth assessment of the assumptions,
calculations, extrapolations, alternate interpretations, methodology, acceptance criteria, and conclusions
pertaining to the specific major scientific and/or technical work product and of the documentation that
supports them.
The MERC Director determines which products shall undergo formal peer review as well as what type of
peer review mechanism will be utilized. The MERC Director or designated senior staff person has the
responsibility to coordinate and oversee all peer reviews. The Program Coordinator is responsible for
maintaining records sufficient to document the review process and outcomes.
4.
PERSONNEL QUALIFICATIONS AND TRAINING
4.1.
Training Policy
It is MERC policy that staff members have the knowledge, skill, and any professional certifications
needed to perform their MERC assignments and that quality management responsibilities and
requirements are understood at every stage of project implementation throughout MERC. If formal
training is available or required, such training must be documented. The MERC Director is responsible
for ensuring adequate resources to support the professional development and training of MERC
personnel.
4.2.
Processes
for Ensuring Qualifications and Training
For MERC, project personnel qualifications and training must be suitable for technical work performed in
support of testing activities. The QAPP and SOPs define the specific qualifications required for key
personnel and any specialized training. Staff qualifications are assessed as part of the test team assembly.
Training and qualification are achieved through formal education, class-time, seminars, and on-the-job
training. Training focuses on both the staff members’ specific job functions and the related QA system
requirements. Staff must have demonstrated ability in an assignment prior to working independently.
Under its quality system, MERC has established a training program that includes the following:
•
identification of training needs;
•
provision of training to satisfy these needs;
•
evaluation of effectiveness of training;
•
documentation of training and/or re-training.