Case Studies

From 2002 to the present, Truesdail provides courier and laboratory analytical services on a Quarterly basis for PG&E in support of the Hinkley and Topock Environmental Compliance programs.  The sample analyses includes Hexavalent Chromium with low level reporting limits (0.200 ppb), carbonate, oil and grease, cations and other various metals, and volatile organic compounds.  The project follows the same scope of work, quality assurance protocols, analyses methods, Level IV reporting, and EDD generation as Case Study #1.  In addition, the project also includes the generation and submittal of EDFs (Geotracker) files to PG&E

The table below provides analyses methods and designated analysts for the work to be performed.  Truesdail’s analytical testing SOPS are provided in Attachment

Table 1.  Method and Analyst Information

The equipment and instrumentation that will be used for the work is provided below:

Table 2 – List of Analytical Services Laboratory Equipment

Truesdail has developed a system for tracking, documenting, and complaints made by both clients and employees.  Using SugarCRM, all client correspondence is entered and within the program, we have developed a module that when checked, will alert the Quality Assurance Manager that a complaint has been made.  Truesdail defines a complaint as being a grievance against the company or second requests for action.  All complaints are brought to the Executive Management’s attention.  Should the complaint warrant, a Corrective Action Report/Preventative Action Report (CAR/PAR) is generated.  A CAR/PAR is only considered closed when it has been agreed by the Executive Management and the Quality Assurance Manager that the actions taken and proposed will prevent a repeated complaint.

Due to the thirteen years of experience, Truesdail is very familiar with the site locations as well as the high level of quality control necessary for this highly sensitive project.  There are no logistical concerns.  Prior to the commencement of work, the PG&E Quality Assurance Project Plan (QAPP) and the Hinkley and Topock Addendums will be distributed and re-reviewed to ensure the proper execution of the work.

Recently, Truesdail completed analyses of hexavalent chromium for a project with the same low-level reporting limits and sample containers that this project requires.  Truesdail only needs to be notified of award status in order to schedule couriers and procure fresh ammonium sulfate buffer.

Truesdail’s Quality Control (QC) Plan will cover the three major parts of the program:  (1) overall quality activities, (2) activities specific to the collection of samples, and (3) the preservation of and quality activities specific to sample analysis and reporting.  The Quality Assurance and Quality Control Manager is to establish and maintain the quality systems and all related forms and procedures.  It is the responsibility of each laboratory manager to monitor his or her lab to insure compliance with the instruction and procedures outlined by the QA/QC Manual.  The QA Manager audits each department annually to ensure compliance and that updates for performed methods have been implemented.  A copy of Truesdail’s Quality Assurance Manuals are provided in Attachment 3.

The department managers are to routinely meet with the QA/QC Manager and with the group leaders to determine if the policies and procedures are in place and ensure the instruments are calibrated properly based on the method or manufacture’s specifications.

Truesdail’s General QA Manual covers activities common to all our laboratories that are needed for a well-documented program and produce good-quality information.

Our General QA Manual covers Company quality policy, quality standards met, and responsibilities.  It also covers how to perform the following QA/QC tasks:

• Establishing reporting limits and calibration ranges.
• Measuring the degree of completeness.
• Checking internal and external Q/C
• Using system blanks, method / reagent blanks and calibration blanks
• Using calibration standards, instrument check standards, and QC check standards
• Using spiked duplicates and interference check samples
• Using surrogate compounds
• Recording and reading control charts.
• Material and Equipment Specifications: Company policies and procedures defining the requirements for equipment, chemicals, and supplies are established. Also, requirements for maintenance, repair, calibration and record keeping are established.
• Operational Procedures: This portion of the QA Manual establishes the requirements for Standard Operating Procedures (SOP’s), QA/QC procedures, and methods for tracking QA/QC requirements unique to specific projects or contracts. Also covered is the use of reference procedures, reference standards, data acquisition and validation, reporting requirements, and record retention.
• Equipment and Calibration: This section covers calibration systems for specific general use lab systems such as balances, thermometers, meters, weight sets, gauges, pipettes, etc. Requirements for traceability, frequency of calibration, and traceability of standard reference materials are documented.  Methods for dealing with records, out of tolerance procedures, reporting of problems, and other types of documentation are covered.
• Document Control: Our QA Manual provides specific requirements for control of key documentation this includes SOP’s, QA Manuals, forms, training documents, data forms, etc.
• Corrective Actions: We have set up specific actions and forms to be completed whenever corrective actions are needed as determined by problems defined by staff during testing, problems established by internal or external audits, problems or complaints from customers or regulatory bodies.
• Facilities and Equipment: We document the types of equipment required, specifications, and preventive maintenance. We document requirements for facilities such as hoods, temperature control, security etc.  Requirements for specific supplies and chemicals are documented.  Also included are requirements for supplies such as sample containers, shipping containers, and expendables