Prism Labs

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Quality Assurance
Data Validation Data Integrity Quality Control Checks Final Project Review

 

 Company Profile

 

Introduction to Prism Laboratories, Inc.

 

 Prism Laboratories, Inc. is an integrated team of environmental and administrative professionals organized to serve the consulting and industrial communities. Prism is a small, woman-owned business located in Charlotte, NC and was originally established in 1992. The mission at Prism is to effectively assist our clients in the identification and quantification of suspected or known environmental concerns. To achieve this objective, Prism is staffed with degreed Chemists, Biologists and other Environmental Scientists. Our team is committed to providing every client with innovative and quality full service analytical and environmental solutions. As a full-service laboratory, Prism provides its clients with high quality laboratory data along with specialized services. Our goal is to serve as a valuable member of our client’s environmental problem-solving team by:

- Seeking methods and strategies that reduce excessive analysis costs;

- Providing quality and defensible test results within the required project response time, and;

- Evaluating findings with the client to assist in properly assessing their situation.

Our state-of-the-art laboratory is a 10,000 sq. ft facility equipped with the latest instrumentation and technology for environmental analyses. Prism currently holds State certifications throughout the Southeast and is NELAC accredited and US ACE certified. Prism is a privately owned, small business. The three owners, Robbi Jones, Scott Olson and Angela Overcash each take an active role in the management and operations of the laboratory. We are personally committed to providing our clients with outstanding service and quality data for a reasonable cost.

What Separates Prism from Other Labs?

Prism's combination of the personal commitment by our staff, our project control management system and the desire to produce quality data within each client’s time frame separates Prism from the competition. Our dedication to these principles are evidenced by,

- Prism's Quality Assurance/Quality Control Program, which extends from sample collection to final reporting, meets strict State and Federal Regulatory criteria. Thorough documentation and data review from the time samples are received until all analyses are complete insures the integrity of the samples and the validity of the results.

- Prism's assignment of a trained Project Manager to each special project by our Client Services Department. The Project Manager acts as a source of information requiring sample progress and questions concerning data, turn around time, sample containers and methodology.

- Prism's state-of-the-art data handling systems beginning at sample receipt with our Laboratory Management & Information System (LIMS) assures the clients that work will be completed and reported on schedule. Our chromatography data systems save time, increase sample throughput, organize data, keep permanent electronic records and generate meaningful, clear reports, which can be tailored to each clients needs.

- The owners of Prism, whose involvement in the daily operations of the laboratory and personal contact with customers, insure Prism's commitment to quality service.

-The staff at Prism includes only degreed and/or experienced professionals in key positions. This ensures our clients data supported by the knowledge and expertise necessary to assist in the identification and quantification of suspected or known environmental concerns.

Laboratory Capabilities

Prism's analytical laboratories are fully automated and designed with top-of-the line instrumentation. Our team of professionals, working together in a highly productive environment provides our clients with quality testing and evaluation services in the following areas of interest:

Soil & Groundwater Analyses under RCRA/CERCLA

TCLP and Hazardous Waste Characterization

UST Analyses under CWA

Drinking Water Analyses under SDWA

Air Sample Analyses under CAA

NPDES and Wastewater Analyses under CWA

Remedial Action Testing

 

 

 

Certifications, Accreditations & Memberships

 

NCDENR DWQ #402

NC DHHS #37735

FL DOH #E87519

SC DHEC #99012

National Environmental Laboratory Accreditation Program (NELAP)

Army Corp of Engineers (ACOE)

NC Small Woman Owned Business Enterprise

American Society for Quality Control

American Water Works Association (AWWA)

Association of Groundwater Scientists & Engineers

Carolinas Air Pollution Control Association (CAPCA)

COIL Group

Commercial Laboratories Association of NC (CLANC)

Groundwater Professionals of NC

Water Environment Federation (WEF)

Water Pollution Control Association

North Carolina Environmental Service Providers Association (NCESPA)

 

 

Quality Assurance

STATEMENT OF POLICY

It is the goal of Prism Laboratories, Inc. to meet or exceed the data quality objectives (DQOs) of our clients, state and federal environmental programs and the NELAC (National Environmental Laboratory Accreditation Committee) standard and to produce data that is legally defensible and of known quality. This quality assurance plan (QAP) is a description of the procedures that must be followed to determine the control of the accuracy and precision of the data generated in the laboratory. The management of Prism Laboratories, Inc. completely supports the policies and procedures described in this QAP.

Prism Laboratories, Inc. is committed to providing the resources, including facilities, equipment and personnel to ensure the adherence to the Quality Assurance and Quality Control protocols defined in this document.

Project managers are in charge of specific projects and customer groups. The project manager reviews new work to ensure that appropriate facilities and resources exist before accepting the work. Each project manager is responsible for the completeness of final data reports as they relate to assigned projects and customer DQOs. The vice president of analytical services is responsible for reviewing and signing of all final analytical testing reports. The quality assurance manager is responsible for the monitoring of the quality assurance program and will make recommendations for corrective actions to the president and vice president of analytical services.

Quality is the responsibility of every employee. All personnel will have access to this QAP and subsequent standard operating procedures (SOPs) and will strive to meet the specified requirements in these documents. The quality assurance manager will maintain the training program to ensure that all personnel has the knowledge necessary to meet the requirements of the QAP.

No deviations from the policies and procedures are allowed without the documented approval of the president, vice president of analytical services, and the quality assurance manager. This QAP will be reviewed and revised as necessary at least annually. Major revisions will be forwarded to appropriate copy holders.

PRISM LABORATORIES, INC.

Robbi A. Jones

President

DATA VALIDATION

Data validation is the process of reviewing analytical results to assure that they are of a verifiable and acceptable quality. This process relies on the use and success of quality control samples, as well as the experience of the laboratory personnel in determining the integrity of the data generated. The ultimate responsibility for the data lies with the vice president of analytical services, who performs the last validation of sample results; however, several other individuals are responsible for their parts of the validation process. These roles and the data validation process are defined in this section.

DATA INTEGRITY

Each level of data validation requires that an individual check the integrity of various activities and systems which directly affect the validity of the analytical measurement.

These individuals and their responsibilities are outlined below:

Raw Data and Calculations - All analysts are responsible for raw data and calculations.

Department supervisors are responsible for assuring that members of their staff are trained in data reduction and reporting. All raw data, calculations, and final results are reviewed by department supervisors, who are responsible for all activities and data generated within their respective departments.

Sample Prep Logs - Sample Preparation personnel are responsible for maintaining a current log of all activities conducted within their area. The department supervisor is responsible for reviewing prep logs on a routine basis.

Instrument and Analytical Logs - Any analyst involved in the operation of an instrument is responsible for maintaining a current log of all activities associated with an instrument.

It is the responsibility of the appropriate department supervisor to review this log on a regular basis.

Calibration and QC Criteria - Each analyst is responsible for meeting the calibration and QC criteria for their methods. Supervisors review these data before data are released.

Legal Chain-of-Custody - In the event that legal, internal chain-of-custody procedures are required, the laboratory director is responsible for implementing and monitoring the sample custody process, including the procurement of analyst signatures at points of transfer.

Systems Review - The Quality Assurance Manager is responsible for monitoring all of the above systems for completeness and effectiveness.

VALIDATION OF DATA - RESPONSIBILITIES

Laboratory Analyst – The Laboratory Analyst is responsible for the analysis of samples and generation of results. Analysts are trained in raw data reduction, linear regression, and initial data review steps. Analysts check data for accuracy and completeness.

Department Supervisors – Department Supervisors are responsible for reviewing analyst data, QC results, logbooks, and login records.

Project Manager - Several individuals in the laboratory act as a client project manager.

The Project Manager is responsible for reviewing the chain-of –custody information against the LIMS login information. This individual is also responsible for the tracking and timeliness of a particular project through the laboratory. In the event that a client request "verbal results", the project manager may advise the client on the applicability and acceptability of such results. In most cases, the project manager is the primary individual responsible for helping a client interpret minor questions concerning the laboratory report and the validity of the reported data.

Quality Assurance Manager – The Quality Assurance Manager is responsible for conducting audits of logbooks, raw data, holding time violations, calibration records, etc.

This person reviews a percentage of laboratory reports prior to reporting. May issue quality assurance notices, data qualifiers, or quality assurance narratives if necessary.

The Quality Assurance Manager is responsible for the overall implementation and review of the laboratory's quality systems.

Login Personnel and Department Supervisors - Responsible for reviewing the chain of custody information submitted by the client against the samples received.

Laboratory Director - Ultimately responsible for all activities and data within the laboratory.

VALIDATION OF DATA – LABORATORY QUALITY CONTROL CHECKS

Method Reagent Blanks - Any contamination present in the method reagent blanks warrants reanalysis of any samples which contain that analyte found in the blank. Some notable exceptions include common laboratory artifacts, such as methylene chloride and phthalates - in such cases, internal guidances have been established to monitor and reduce their presence; however, data will be qualified in the event that laboratory contamination is suspected.

Matrix Spikes - Matrix spike recoveries which fall outside of the established control limits warrant that all samples analyzed within that batch of samples be reanalyzed and qualified, in the event that sample matrix interferences are suspected.

Blank Spikes - Blank spikes, or laboratory control samples, must fall within the guidelines established in each method or within QC limits established by the laboratory,whichever is more stringent.

Quality Control Check Samples - QC Check Samples are analyzed as blind samples at least semiannually. In the event that unacceptable performance is indicated, the analytical method is audited and corrective actions are implemented.

Duplicate Samples - If duplicate samples results fall outside of the allowable range, they shall be reanalyzed to determine if matrix problems are present. No additional data will be reported until the problems have been corrected.

Continuing Calibration Standards - Continuing calibration standards which fall outside of the allowable range shall be reanalyzed. If the acceptance criteria are exceeded again, a new calibration verification standard shall be prepared and analyzed, or a new curve will be run.

Surrogate and Internal Recoveries/Responses - Surrogates and internal standards are checked against method requirements or internally generated control limits, whichever are more stringent or appropriate.

FINAL PROJECT REVIEW

The project manager is responsible for final project review prior to issuance of the final

report. The quality assurance manager reviews a portion of all the reports. The key areas that are reviewed prior to submission to the client are:

Field and laboratory raw data

Transcription errors

Calculation errors

Calibration data

Mass spectral interpretation

Times and dates of analysis

Chain-of-Custody

Holding Times

Anomalies concerning interdepartmental data

DATA REPORTING

Data can be reported in several forms depending on the request of the client. In order to protect confidentiality of the data, results or reports will not be sent to someone other than the person originally requesting the data, unless written consent has been given for the release of the data to someone else. Copies of data sheets which may be included in QC data packages are prepared in such a manner that the receiver is not able to review data from other clients on the same data sheet.

DATA STORAGE

All vital data generated within the laboratory are placed on hardcopy. Raw instrument data is archived to offsite servers for protection from hardware failures. All archived information is maintained for a minimum of five years within the laboratory, unless a longer period is required. Archived data are generally stored chronologically; however, final reports are stored by client name, then chronologically (as well as by sample ID), to aid in data retrieval.

Examples of paper records archived include: final reports, sample log-in worksheets, field data sheets and notebooks, chain-of-custody records, and laboratory logbooks.

All such data are protected from environmental degradation and stored in a secure area.