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Ref. No. [UMCES] CBL 2017-050
ACT VS17-05
36
QUALITY ASSURANCE AND QUALITY CONTROL
All technology evaluations conducted by ACT comply with its Quality Management System
(QMS), which includes the policies, objectives, procedures, authority, and accountability needed to
ensure quality in work processes, products, and services. A QMS provides the framework for quality
assurance (QA) functions, which cover planning, implementation, and review of data collection
activities and the use of data in decision making, and quality control. The QMS also ensures that all
data collection and processing activities are carried out in a consistent manner, to produce data of
known and documented quality that can be used with a high degree of certainty by the intended user
to support specific decisions or actions regarding technology performance. ACT’s QMS meets U.S.
Environmental Protection Agency quality standards for environmental data collection, production,
and use, and the requirements of ISO/IEC 17025:2005(E),
General requirements for the competence
of testing and calibration laboratories
.
An effective assessment program is an integral part of a quality system. The ACT Quality
Assurance (QA) Manager independently conducted Technical Systems Audits (TSA) of field tests
at Maumee River field trial during May 25-28, 2016, a TSA of the Laboratory test at the Chesapeake
Biological Laboratory during July 10-18, 2016 and a data quality review of the reference data sets
from all tests conducted during the Nutrient Challenge.
Technical System Audits
A TSA is a thorough, systematic, on-site qualitative audit of sampling and measurement
processes and procedures associated with a specific technology evaluation. The objectives of the
TSAs conducted during this evaluation were to assess and document the conformance of on-site
testing procedures with the requirements of the Test Protocols, the ACT Quality Assurance Project
Plan (QAPP), and associated Standard Operating Procedures (SOPs).
The TSA was conducted in accordance with the procedures described in n EPA's
Guidance
on Technical Audits and Related Assessments for Environmental Data Operations (EPA QA/G-7)
and ISO 19011,
Guidelines for Quality and/or Environmental Management Systems Auditing
. A
TSA checklist based on the Test Protocols was prepared prior to the audits and reviewed by the ACT
Director and Senior Scientist. The TSA assessed ACT personnel, the test and analytical facilities,
equipment maintenance and calibration procedures, sample collection, analytical activities, record
keeping, and QC procedures. Reference sample handling and chain-of-custody by NASL were
observed during the laboratory test at CBL.
During the audits, the QA Manager met with ACT technical staff involved in the evaluation
and asked them to describe the procedures followed. All procedures were observed; and logbooks,
data forms, and other records were reviewed.
Key components of the audit included:
•
Assessment of Quality Assurance/Quality Control:
-
Adequacy of procedures, and
-
Adherence to procedures.
•
Assessment of Sample System:
-
Sample collection,