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3.0
ORGANIZATION AND RESPONSIBILITIES
Every organization must identify a
single individual who is ultimately responsible for the quality of the
generated data. However, all
individuals in the organization are responsible for assuring the
accountability and reliability of the data.
The following discussions assign certain tasks to various levels of
responsibility. DER recognizes that the organization structure within a
company may vary. With the
exception of the QA Officer, the duties specified below may differ from
suggested job titles and may be assigned to more than one person.
However, DER expects that all tasks outlined below are performed by an
individual or individuals within the organization.
The
role of the Quality Assurance Officer (QAO) is one of oversight.
Although the QAO usually coordinates and oversees data quality and
corrective actions, the QAO must have the ability and authority to recommend
and implement immediate
corrective
measures, without going through chains of command.
Therefore, the organizational and functional position cannot be placed
in direct lines of authority.
The Quality Assurance Officer must be
able to objectively evaluate data and perform audits without outside
influences. The responsibilities
of the QAO may be divided among several individuals (i.e. corporate QAO,
regional QA managers, etc.) and the designated QA Officer may be assigned
other duties (project management, analytical work, etc.).
However, these other responsibilities cannot bias the performance of
these tasks:
1. Reviews quality
control data to determine if test data is acceptable.
2. Updates
or supervises update of all quality control markers:
accuracy, precision and method detection limits.
3.
Periodically performs systems audits to assure compliance with all
quality assurance plans.
4.
Oversees administration of performance audits.
5.
Coordinates preparation of quality assurance reports to management,
clients and regulatory agencies.
6.
Coordinates and oversees preparation of quality assurance plans.
7. Reviews
new or proposed protocols to determine appropriate use.
Also reviews associated method validation information.
8.
Reviews, in writing, initiated corrective actions to assure
effectiveness. Recommends
additional measures if necessary.
3.2
TECHNICIAN
or ANALYST LEVEL
1.
Performs field measurement tests according to specified methodology.
2. Collects
samples using approved techniques and appropriate equipment.
3. Assures
that sample containers are properly and accurately labeled.
4. Assures
that appropriate preservatives are added and that appropriate sample
containers are used to collect required fractions.
5. Legibly
documents all activities in field logs or field data sheets.
6. Assures
that all identifying information is accurately recorded.
7.
Identifies and/or documents potential quality control problems (ex.
unacceptable calibrations, environmental conditions, etc.)
8.
Maintains equipment in working condition, and documents all
preventative maintenance and repairs.
1.
Performs required analyses according to test methods specified by rule,
permit or Quality Assurance Project Plans.
2. Assures
that all analytical equipment has been properly calibrated before beginning
tests.
3. Assures
that all identifying information (including sample ID numbers) have been
accurately transcribed into records or computer data bases.
4. Assures
that all calculations are correct.
5. Assures
that appropriate confirmatory tests or procedures have been completed.
6.
Identifies, documents and begins corrective actions on any quality
control problem which relates to the analytical test.
7.
Maintains equipment in working condition, and documents all
preventative maintenance and repairs.
3.3
SUPERVISORS
and/or SUBSECTION/SECTION MANAGEMENT
1. Assures
that all activities (either sampling or analysis) are performed according to
methods and protocols specified in the QA Plan.
2. Reviews
all analytical data by:
a.
Checking documentation for completeness and proper sample
identification.
b.
Checking raw data for calculation, interpretation or clerical errors
c.
Assuring that produced quality control data is acceptable
3.
Coordinates analytical work or field activities to assure that
completion of all tasks within established time frames.
4.
Oversees preventative maintenance activities.
5.
Evaluate and implement changes in methodology and quality control
measures.
6.
Identifies quality control problems and takes measures to correct or
eliminate the problem source.
7.
Assumes the responsibility for validating all data and assuring that
final reports are accurate before final review by management.
1. Acts
as a liaison between the client and the organization.
2.
Oversees and coordinates project activities including workplans,
quality assurance project plans and scheduling.
3. Reviews
project data prior to final report to assure that all data (field and
laboratory) are acceptable and within specified project objectives.
3.5
MANAGEMENT
1.
Responsible for overall operation of the organization including fiscal
resources and personnel.