DTSC relies on accurate and defensible data for regulatory decision making for the purposes of enforcement, cleanup and safer consumer products. It is essential that analytical results produced by ECL as well as commercial laboratories meet the data quality objectives of the project.
Internally, ECL implements policies and procedures to ensure the highest data quality are produced; trains staff to be technically competent and customer service oriented; and utilizes reliable and state-of-the-art equipment and instruments for analysis. These three factors working in concert, is crucial to the ECL’s ability to produce trusted and defensible data. A demonstration of the Laboratory’s competency in the field of chemical testing is its accreditation to the ISO/IEC 17025:2005 Laboratory Quality Management System where both Berkeley and Pasadena Lab received separate accreditation.
- For Berkeley’s ISO/IEC 17025:2005 accreditation, Certificate No. 5006.01
- For Pasadena’s ISO/IEC 17025:2005 accreditation, Certificate No. 5006.02
ECL’s Internal Data Review Process
Prior to the release of analytical results to the Department for regulatory decision making, ECL goes through a vigorous review process. ISO/IEC 17025 Quality Management System requires the Lab to conduct an Initial-Level Review by the scientist who performed the analytical testing and Second-Level Review by another qualified scientist and then by the Lab Supervisor.
The Initial-Level Review consists of:
- checking that the appropriate test method was used;
- checking that the appropriate equipment, reagents and supplies were used and identified on all applicable worksheet;
- checking that all manual data transfers and manual calculations have been correctly done;
- assessing that all quality control (QC) requirements met;
- assessing that all instrument check requirements are met;
- evaluating that the analytical data is accurate and complete;
- compiling a complete data package that includes reference materials, reagents and sample preparation worksheets, certificate of analysis of reference materials and quality critical equipment and reagents, instrument calibration data, raw instrument data, data reduction worksheets and final customer report;
- addressing comments and feedback made by the second-level reviewers;
- and sign off on the report once all comments and feedback have been addressed.
The Second-Level Review is performed by another scientist and then by the Lab Supervisor. The review consists of:
- verifying all the records are accurate and complete;
- verifying results are correctly calculated;
- ensuring traceability of quality critical reference materials, reagents and equipment;
- verifying quality control and instrument check requirements are met;
- providing feedback or comments on the report;
- and signing off on the report once all feedback or comments have been addressed.
This vigorous review process is essential to ensure the steps in the testing are producing trusted, accurate and defensible results for the Department to use to protect public health and the environment.
Technical Support to DTSC Core Programs
Another major area of services ECL provides is consultation to DTSC core programs on:
- Review of data packages from commercial laboratories;
- Review of quality assurance project plans (QAPP), work analysis plans (WAP), and sampling and analysis plans (SAP) to meet data quality objectives;
- Provide analytical chemistry input to DTSC guidance documents, assembly bills (AB) and senate bills (SB);
- and conduct audit of laboratories.
ECL has established a comprehensive approach that includes review of all documents and records to ensure scientifically sound, impartial and legally defensible recommendation. The recommendation may include, but not limited to, guidance on the proper scientific approach towards assessing reporting limits and limitation of method measurement associated with the testing being performed at the site. The Lab can verify if appropriate methods are used and quality control requirements are defined in the QAPP, WAP or SAP. The Lab can also review data packages to verify if commercial labs use procedures consistent with their Quality Management System and/or the data quality objectives of the project.
Regardless where the analytical results are generated, ECL applies the same high standards for data quality. The overall goal is to provide legally defensible data to support DTSC’s mandates, initiatives and projects.