Page 12 - Protocols for In-Situ pH Sensors

ACT pH Sensor Verification Protocols, PV12-01
12
Calibration and maintenance procedures, schedules, and standards (certified reference
materials) for all equipment used in the test.
8.2
Assessment, Response and Corrective Action
Every effort will be made throughout the Verification to anticipate and resolve potential
problems before the quality of performance is compromised. One of the major objectives of
these Verification Protocols is to establish mechanisms necessary to ensure that data quality
objectives will be met. Internal quality control measures described in the protocols, which is peer
reviewed by external experts, implemented by the technical staff and monitored by the ACT
Chief Scientist, will give information on data quality on a day-to-day basis. The responsibility
for interpreting the results of these checks and resolving any potential problems resides with the
Chief Scientist. Technical staff has the responsibility to identify problems that could affect data
quality or the ability to use the data. Any problems that are identified will be reported to the ACT
Chief Scientist, who will work with the ACT Quality Assurance (QA) Manager and Technical
Advisory Committee to resolve any issues. Action will be taken to control the problem, identify
a solution to the problem, and minimize losses and correct data, where possible.
Fundamental principles of the ACT assessment and response process include:
Assessments shall be performed by a QA Manager, who shall be independent of direct
responsibility for performance of the Verification.
Each assessment must be fully documented.
Each assessment must be responded to by the appropriate level of the ACT team. ACT
quality assessment reports require a written response by the person performing the
inspected activity, and acknowledgment of the assessment by the ACT Director.
Corrective action must be documented and approved on the original assessment report,
with detailed narrative in response to the assessor’s finding. Initials and date are required
for each corrective action response. Acknowledgment of the response will be provided by
the ACT Director.
Implementation of corrective actions must be verified by the ACT QA Manager to ensure
that corrective actions are adequate and have been completed. This will be done in real-time if
corrective actions can be immediately performed and signed off on the assessment report.
8.2.1
Assessments
The standard oversight mechanisms for a Verification Test include: (1) performance
evaluation audits (PEAs); (2) technical system audits (TSAs); audits of data quality (ADQs); and
data quality assessments (DQAs). The ACT Chief Scientist will be responsible for ensuring that
the following audits are conducted as part of this verification.
Performance Evaluation Audits
Performance evaluation (PE) audits are quantitative evaluations used to assess the ability
of the ACT measurement system to provide reliable data. The evaluation consists of providing a
known reference standard with defined purity and stability to the ACT analytical team for
analysis. A PE sample contains known pH. The analytical results obtained by the ACT team