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9.3.
Document Control
It is critical that test personnel have access to the current, approved versions of each document required
for BWTS testing and that obsolete documents are not available for inadvertent use. MERC’s procedures
to ensure test-specific document control include the following:
•
The final, approved QAPP and Test Plan are distributed to test participants prior to testing.
•
Instrument manuals will be maintained with the instruments.
•
The QAPP, Test Plans, amendments, and deviations (must be physically available at each site
involved in testing.
•
SOPs or protocols developed for testing will be distributed to personnel who will be conducting
the procedures.
When a QAPP, Test Plan, amendment, deviation (that describes QAPP or Test Plan changes to be
implemented), manual, SOP, or protocol is revised, it will be formally distributed to each test participant.
Test participants are responsible for immediately removing previous document versions from their work
area or saving them in the project files as a historical record. The Program Coordinator is responsible for
maintaining all versions of all test documents to maintain a history of project activities.
10.
ASSESSMENT AND RESPONSE
All technology evaluation activities require a mechanism for monitoring the effectiveness and adequacy
of the QA measures integrated into the program. Assessment and response elements include assigning
appropriate, qualified persons to conduct assessments at planned, scheduled intervals; having provisions
for timely responses and implementation of corrective actions if needed; and completing the evaluation
process with written reports to technical and management staff.
MERC assessments are planned, scheduled, conducted, reported, and tracked to closure by the MERC QA
Manager. MERC utilizes assessments to determine both the suitability and effectiveness of the overall
quality system and the quality of the testing performed for each BWTS test. The standard oversight
mechanisms include: (1) quality system assessment review/audits; (2) technical assessment review/audits;
(3) data verification and validation; and (4) data assessment. Each type of review follows, as appropriate,
the planning, implementation and evaluation procedures described in the EPA documents:
•
Guidance on Technical Audits and Related Assessments for Environmental Data Operations
,
EPA QA/G-7, January, 2000;
•
Guidance on Assessing Quality Systems
EPA QA/G-3, March 2003;
•
Guidance on Environmental Data Verification and Data Validation
,
EPA QA/ G-8, January
2008;
•
Data Quality Assessment, A Reviewer’s Guide
, EPA QA/G9R, February 2006;
•
Data Quality Assessment; Statistical Methods for Practitioners
, EPA QA/ G9S, February 2006;
•
the 2003 NELAC Standard, EPA/600/R04-003.
Overall, the outcome of an assessment is expected to: (1) identify strengths and weaknesses, (2) cause
corrective actions to be taken to alleviate problems, (3) facilitate the initiation of changes to enhance the
QA program, (4) serve as a vehicle for providing technical assistance, (5) enhance awareness and
understanding of QA/QC policies and procedures; and (6) provide a measurement of the effectiveness of
QC in assuring the quality of data.