Our Approach Quality Assurance (QA) support for chemical, biological, radiological, nuclear, and explosives (CBRNE) measurement programs is a core competency of Signature Science and our longest standing business area. Our approach to QA support draws upon our corporate expertise in measurement quality assurance and applied statistics, coupled with many years of experience in the application of this theory and practice to CBRNE sampling and analytical programs. We specialize in development and implementation of QA programs tailored to the specific mission and needs of our clients. Recognizing that measurement data support decisions, we focus on reducing the incidence of false-positive and false-negative decision errors by measuring, monitoring, and controlling error in the data upon which decisions are based. The objective of our QA support services is to help ensure that measurement data are technically defensible and appropriate for their intended use. Because our QA support efforts are tailored to the specific needs and missions of individual programs, they range from developing and implementing comprehensive QA programs to providing discrete support efforts in particular areas. These include functions such as proficiency testing, experimental design and statistical data analysis, auditing analytical laboratories and field sampling efforts, tracking and trending analytical data and Quality Control (QC) results, and providing accreditation support.
Our Staff Signature Science has a cadre of Quality Assurance professionals with extensive experience that include certified QA specialists - American Society for Quality (ASQ) Certified Quality Engineers and ASQ Certified Quality Auditors - as well as staff members who have completed formal training as ISO/IEC 17025 assessors by the American Association of Laboratory Accreditation (A2LA). All of our certified QA staff also have degrees in relevant scientific disciplines, including chemistry, biology, and statistical science. Most of our QA staff members have direct laboratory and/or sampling experience, including both organic and inorganic analytical chemistry experience, molecular and microbiology experience, and experience with sample preparation and analysis. Several staff members have direct experience in organic synthesis, analytical methods development, explosives sampling and analysis, and assay development for molecular bio-assay techniques.
Specialized Equipment/Facilities Signature Science has specialized equipment and facilities that contribute appreciably to our capabilities to provide cutting edge services in the QA of CBRNE progams. These include fully equipped chemical and biological laboratories for preparation and characterization of proficiency testing samples; powerful, industry-standard statistical analysis software packages for data analysis; and world-class information management hardware and software.
On the laboratory side, Signature Science maintains dedicated laboratory facilities for preparation of proficiency test samples for CBRNE programs. In addition, we have access to state-of-the-art chemical and biological laboratories for characterization and analysis of proficiency test samples and materials. Our chemistry laboratories contain all of the required facilities for organic and materials synthesis, along with a wide variety of gas and liquid chromatography, mass spectrometry and optical spectroscopy instrumentation. Our biological laboratories provide both microbiology and molecular biology capabilities. The microbiology laboratory operates at a Biosafety Level-2 (BSL-2), and has a full complement of equipment needed to culture and identify bacteria aerobic and anaerobic) and other microorganisms. The molecular biology laboratory includes an ABI PRISM® 7000 Sequence Detection System and a Ruggedized Advanced Pathogen Detection (R.A.P.I.D.) System, including Joint Biological Agent Identification and Diagnostic System (JBAIDS) updated software.
Statisticians at Signature Science use the powerful computational and graphical capabilities of SAS® and S-Plus statistical software capabilities to perform detailed statistical analysis of data sets of any size or complexity. The graphical capability of these industry standard software packages, coupled with the flexibility of their proprietary programming languages, allows for complex data visualization and exploration. Data management staff at Signature Science have experience developing, maintaining, upgrading, and querying data in various types of databases and knowledge management systems including Microsoft Access®, Oracle®, and SQL®.
Applications Our QA support comprises a range of individual services which may be combined in a variety of ways, depending upon the specific program need. These include:
QA program development, implementation, and oversight
Quality program documentation, including preparing, reviewing, and controlling Quality Manuals, QA Program Plans, Standard Operating Procedures (SOPs), and other quality program documents
Measurement data assessment
Estimation of false-positive and false-negative error rates
Estimation of quantitation errors
Proficiency testing, including designing, preparing, and evaluating proficiency test samples and web-based results, collection, and reporting
Laboratory accreditation support
Data tracking, trending, and interpretation
Tracking and trending of QA and QC data
Tracking and trending of program measurement data
Interpretation of measurement data in the context of historical results and relevant QA/QC data
Method validation support, including designing, implementing, and evaluating method development and method validation efforts
Experimental design and statistical data analysis for focused studies
Current and Past Experience Customer Listing Signature Science staff began providing QA/QC support for the DoD and related agencies in the early 1990s. Since then, we have provided support for the Department of Homeland Security, the National Guard Bureau Weapons of Mass Destruction Civil Support Teams, the Joint Program Executive Office for Chemical and Biological Defense, the Critical Reagents Program, the Pentagon Force Protection Agency, Edgewood Chemical and Biological Center, the Dahlgren Naval Surface Warfare Center, and a number of other related organizations. For 15 years prior to that, our staff supported a diverse assortment of environmental sampling and analysis programs. During that time period, Signature Science staff earned a national reputation for QA expertise by providing an extensive range of QA and QC services supporting programs for the Air Force Center for Environmental Excellence, the U.S. Army Corps of Engineers, the U.S. Environmental Protection Agency and other government organizations, as well as numerous programs for private and commercial clients.