ML16293A187
Text
,-------------------------~---
Reference 15-GEL Quality Assurance Plan
Reference 15 - GEL Quality Assurance J>ian 09-Apr-2015 .
Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 1of109 II VERIFY THE VALIDITY OF THIS SOP EACH DAY IN USE II GEL LABORATORIES, LLC QUALITY ASSURANCE PLAN (GL-QS-B-001REVISION29)
PROPRIETARY INFORMATION This document contains proprietary information that is the exclusive property cif GEL Laboratories, LLC (GEL). No contents of this document may be reproduced or otherwise used for the benefit of others except by express written permission of GEL.
cm *.*
.GJ<iVS ...
DOCUMENT CONTROLOFFiCER CERTIFIES THIS DOCUMENT To 'BE
.. A TRUE COPY OF THE FULLY EXECUTED ORIGINAL.
Afil 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID numbe~ appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 2of109 TABLE OF CONTENTS Section 1 - Introduction ..................................................................................................................................................5 1.1 Quality Policy ....................................................................................................................................................5 1.2 Quality Goals ....................................................................................................................................................6 1.3 Key Quality Elements ...........................................................................;..........................................................6 1.4 Management Reviews ............................................:........................................................................................7 1.5 Disposition of Client Records ...........................................................................................................................7 1.6 Supporting Documents ....................................................................................................................................7
- 1. 7 Definitions ........................................................................................................................................................7 Section 2 - Organization, Management, and Personnel.. ..........................................................................:.................... 8
- 2.1 Chairman, CEO/President, Chief Financial Officer and Chief Operating Officer ............................................. 8 2.2 Technical Laboratory Cb-Directors ...................................................................................................................9 2.3 Quality Systems Director .................................................................................................................................9 2.4 Quality Systems Review ..............................................................................................,............~ .................... 10 2.5 Manager of Client and Support Services .......................................................................................................10 2.6 Production Manager and Group Leaders .......................................................................................................10 2.7 Laboratory and Technical Staff- General Requirements ............................................................................... 11 2.8 Information Systems Manager .......................................................................................................................11 2.9 Environmental Manager ...................... :...........................................................................:.............................. 11 2.10 Radiation Safety Officer .................................................................................................................................12 2.11 Director of Human Resources ....................................*....................................................................................12 2.12 Employee Training ......................................................................................................................,.................. 12 2.13 Ethics and Data Integrity ................................................................................................................................13 2.14 Confidentiality .................................................................................................................................................13 Section 3 - Quality Systems .......................... :..............................................................................................................14 3.1 Quality Systems Tearn ...................................................................................................................................14 3.2 Quality Documents ........................................................................................................................................15 3.3 Document Control ..........................................................................................................................................15 3.4 Controlled Document Review ....... :................................................................................................................16 3.5 Quality Records ................................................. :...........................................................................................16 3.6 Internal and Supplier Quality Audits ..........................................................................................................:.... 16 3.7 Managerial and Audit Review ........................................................................................................................17 3.8 Nonconformances ..........................................................................................................................................17 3.9 Corrective Action ...........................................................................................................................................17 3.10 Performance Audits .......................................................................................................................................17 3.11 Control .Charts ........................,,...................................................................................................... 18 3.12 Essential Quality Control Measures ...............................................................................................................19 Section 4- Facilities ......................................................................................................................................................20 4.1 Facility Secllrity ..............................................................................................................................................20 4.2 Utility Services ... :............................................................................................................................................20 4.3 Prevention of Contamination ................................. :.......................................................................................20 4.4 Assessment of Contamination Levels ............................................................................................................21 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when a~ original Set ID number appears on the cover page(!).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 3 of 109 Section 5 - Equipment and Reference Materials ..........................................................................................................22 5.1 General Policies .............................................................................................................................................22 5.2 Instrumentation and Support Equipment ........................................................................................................22 5.3 Procurement and Control of Purchased ltems ...............................................................................................23 Section 6 - Health and Safety ......................................................................................................................................24 6.1 Fire Safety ...................................._
.................................................................................................................24 6.2 Evacuation .....................................................................................................................................................24 6.3 Safety Equipment ...................... ,...................................................................................................................24 6.4 Radiation Safety ...................................................................................................... .- ..................................... 24 Section 7 - Traceability and Calibration .......................................................................................................................25 7.1 Calibration Criteria for Support Equipment ....................................................................................................25 7.2 Instrument Calibrations .............................................. .-...................................................................................27 7.3 Calibration Verification ...................................................................................................................................28 7.4 Bioassay Instrument Calibration and Frequency ...........................................................................................28 Section 8 -Analytical Methods and Standard Operating Procedures (SOPs) ..............................................................29 8.1 Selection of Analytical Method .......................................................................................................................29 8.2 Standard Operating Procedures (SOPs) .......................................................................................................29 8.3 Method Validation and Initial Demonstration of Capability .............................................................................30 8.4 Sample Aliquots .............................................................................................................................................31 8.5 Data Verification ..................................................................................................................................:......... 31 8.6 Standard and Reagent Documentation and Labeling ....................................................................................32 8.7 Computer and Electronic Data Related Requirements ..................................................................................33 Section 9 - Sample Handling, Acceptance, Receipt, and Internal Chain of Custody ................................................... 34 9.1 Agreement to Perform Analysis ............................. ~ .......................................................................................34 9.2 Sample Labels and Chain of Custody Forms ................................................................................................34 9.3 Sample Conditions ............... ., .........................................;................. :.................... ~ ........................................ 35 9.4 Sample Receipt ............ ,.................................................................................................................................35 9.5 Receipt of Radioactive Samples ....................................................................................................................36 9.6 Sample Tracking ............................................................................................................................................36 9.7 Internal Chain of Custody ..............................................................................................................................37 9.8 Sample Storage .............................................................................................................................................37 9.9 Sample Disposal ............................................................................................................................................38 Section 10- Records ....................................................................................................................................................39 10.1 Recordkeeping System and Design ...............................................................................................................39 10.2 Record Storage ..............................................................................................................................................41 10.3 Sample Handling Policy .................................................................................................................................41
. 10.4 Records of Laboratory Support Activities .......................................................................................................42 10.5 Analytical Records .........................................................................................................................................42 10.6 Administrative Records ................................................. :................................................................................42 Section 11 - Laboratory Report Format and Contents .................................................................................................43 11.1 Certificates of Analysis ..................................................................................................................................43 11.2 Quality Control Summary Report (QCSR) .....................................................................................................44 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only whe*n an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 4 of 109 11.3 Analytical Case Narratives .............................................................................................................................44 11.4 Electronic Data Deliverables (EDDs) ..........................................................................;.................................. 44 11.5 Types of Data Packages and Reports ...........................................................................................................45 11.6 Review of Data Reports, EDDs, and Data Packages ....................................................................................45 Section 12 - Subcontracting Analytical Samples and Outside Support Services ........................................................ .46 Section 13 - Client Satisfaction .................................. ;.................................................................................................47 APPENDIX A: REFERENCES ....................................................................................................................................48 APPENDIX B: DEFINITIONS ......................................................................................................................................49 APPENDIX C: CORPORATE ORGANIZATION CHART ............................................................................................56 APPENDIX D: CERTIFICATIONS .....................................................................................................................:........ 57 APPENDIX E: ESSENTIAL QUALITY CONTROL REQUIREMENTS ........................................................................60 APPENDIX F: .ETHICS AND DATA INTEGRITY AGREEMENT.. ...............................................................................71 APPENDIX G: EQUIPMENT LIST ..............................................................................................................................72 APPENDIX H: FACILITIES WITH EVACUATION ROUTES .......................................................................................88 APPENDIX I: STANDARD OPERATING PROCEDURES AND ANALYTICAL METHODS ........................................ 89 APPENDIX J: .SAMPLE STORAGE AND PRESERVATION REQUIREMENTS ....................................................... 101 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID numb~r appears on the cover page(!).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 5of109 SECTION 1 INTRODUCTION Section 1
- Introduction 1.1 Quality Policy GEL Laboratories, LLC (GEL) is a privately GEL's policy is "to provide high quality, personalized owned environmental laboratory dedicated to analytical services that enable our clients to meet their providing personalized client services of the highest environmental needs cost effectively."
quality. Our mission is to be the "Analytical Firm of We define quality as "consistently meeting the needs First Choice." and exceeding the expectations of our clients." As such, GEL was established as an analytical testing we consistently strive to:
laboratory in 1981. Now a full service lab, our analytical
- meet or exceed client and regulatory requirements divisions use state of the art equipment and methods to
- be technically correct and accurate provide a comprehensive array of organic, inorganic, radiochemical, and bioassay analyses and related
- be defensible within contract specifications support services to meet the needs of our clients.
- provide services in a cost-effective, timely and efficient manner This Quality Assurance Plan provides an overview of our quality assurance program for analytical services. At GEL, quality is emphasized at every level-from the Outlined in this plan are the responsibilities, policies, and Chairman, CEO, CFO and COO to the newest of processes essential to maintaining client satisfaction and employees. Management's ongoing commitment to good our high quality of performance. The Director of Quality professional practice and to the quality of our testing Systems is responsible for revising, controlling, and services to our customers is demonstrated by their distributing the OAP. It is updated/reviewed at least dedication o.f personnel and resources to develop,
- annually. implement, assess, and improve our technical and management operations.
Everyone on our staff is expected to understand the policies, objectives, and procedures that are described in The purpose of GEL's quality assurance program is to this plan and to fully appreciate our commitment to establish policies, procedures, and processes to meet or quality and their respective roles and responsibilities with exceed the expectations of our clients. To achieve this, all regard to quality. We also expect any analytical personnel that support these services to our clients are subcontractors we employ to perform in accordance with introduced to the program and policies during their initial the quality assurance requirements delineated in this orientation, and annually thereafter during company-wide plan. All GEL employees are required to participate in training sessions.
Annual Quality Systems training. GEL's management is committed to compliance with This Quality Assurance Plan (OAP) has been and continual improvement of our quality assurance prepared according to the standards and requirements of program. The program is designed to comply with the the US Environmental Protection Agency (EPA), guidelines and specifications outlined in the following:
ANSl/ISO/IEC 17025-2005, and the National
- NELAC 2003 Environmental Laboratory Accreditation Conference
- TNI 2009 (NELAC) Quality Systems Standards June 2003 effective July 2005, and the TNI (The. NELAP Institute) Standards
- ASME/NQA-1 adopted in August, 2009.
- ANSl/ISO/IEC 17025-2005
- QAPPs, U.S. EPA QA/R5
- Department of Energy Order414.1B, 414.1C and 414.D 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page(!).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 6of109
- Current U.S. EPA CLP statements of work for
- Effective quality assurance objectives for inorganic and organic analyses measurement systems and for quality data in terms
- ANSI N42.23-1996 Measurement and Associated of accuracy, precision, completeness, and Instrument Quality Assurance for Radioassay comparability through the use of proven methods.
Laboratories
- The establishment of procedures that demonstrate
- DOE STD 1112-98 that the analytical systems are in a state of statistical control.
- Performance Criteria for Radiobioassay-ANSI N13.30-1996.
- The implementation of corrective actions and improvements to ensure the integrity of data.
- Energy Reorganization Act, 1974, Section 206, 10
- Reduction of data entry errors through CFR, Part 21 comprehensive automated data handling
- MAR LAP procedures.
- U.S. Department of Energy Quality Systems for
- The development and implementation of good Analytical Services Revision 3.0 laboratory and standard operating procedures
- U.S. Department of Defense Quality Systems (SOPs) .
Manual, Revision 4.2 and 5.0
- Ability to customize quality assurance procedures
- 10 CFR Part 21- Reporting of Defects and to meet.a client's specific requirements for data Noncompliance quality.
- 10CFR Part 50 Appendix B -Quality Assurance
- Good control of instruments, services, and Criteria for Nuclear Power Plants and Fuel chemical procurement.
Reprocessing Plants
- A continuously capable laboratory information management system (AlphaLIMS).
- 10CFR Part 61- Licensing Requirements for Land Disposal of Radioactive Waste
- Validated and documented computer hardware and software.
- NRC REG Guide 4.8 All employees who have access to the
- NRC REG Guide 4.15 AlphaLIMS system are required to participate in 1.2 Quality Goals computer security awareness training annually.
GEL's primary goals are to:
1.3 Key Quality Elements
- Ensure that all measurement data generated are A sound quality assurance program is essential to scientifically and legally defensible, of known and our ability to provide data and services that consistently acceptable quality per the data quality objectives meet our high standards of integrity. The key features of (DQOs), and thoroughly documented to provide our program are:
sound support for environmental decisions. *
- Ensure compliance with all contractual
- An independent quality assurance (QA) validation requirements, environmental standards, and and Quality Systems Department.
regulations established by local, state and federal
- A formal quality policy and OAP.
authorities.
- Management review .
Additional goals include:
- Stated data quality objectives .
- A comprehensive quality assurance program to
- A comprehensive employee training program .
ensure the timely and effective completion of each
- Ethics policy and education program .
measurement effort.
- Internal audits and self-evaluations .
- A commitment to excellence and improvement at
- A closed-loop corrective action program .
all levels of the organization.
- State-of-the-art facilities and instruments .
- Early detection of deficiencies that might
- Adherence to standard operating procedures .
adversely affect data quality.
- Adequate document control.
- EPA/NIST traceable reference materials .
- Electronically based document control.
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 7of109
- Chain of custody and electronic sample tracking.
- Inter-laboratory comparison programs.
- Formal laboratory accreditations.
- The evaluation of subcontractor laboratories.
.* Statistical controls for analytical precision and accuracy.
- Replicate, method blank, matrix spike, tracer yield, internal standards, and surrogate measurements.
- The preventive maintenance of instrumentation and equipment.
- Independently prepared blind standard reference materials.
- Multi-level review processes.
- Focus on client satisfaction.
- Electronic tracking of client commitments, nonconformances and corrective actions.
- Trend analysis of nonconforming items.
1.4 Management Reviews The effectiveness of the Quality System is reviewed at least annually by Senior Management. These reviews address issues that impact quality, and the results of the reviews are used to develop and implement improvements to the system. Records of the review meetings are maintained as quality documents.
1.5 Disposition of Client Records In the event that the laboratory should change ownership, the responsibility for the maintenance and disposition of client records shall transfer to the new owners. In the unlikely event that the laboratory ceases to conduct business, clients shall be notified and asked to provide instructions as to how their records should be returned or disposed. If a client does not provide instructions, those records will be maintained and disposed in a manner consistent with regulations and good laboratory practices for quality records.
1.6 Supporting Documents Our laboratory operations and the quality of our analytical data comply with the specifications described in the documents listed in Appendix A.
1.7 Definitions Applicable definitions are listed in Appendix B.
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (l).
Uncontrolled documents do not bear an original Set ID number.
09~Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 8of109 SECTION 2 ORGANIZATION, MANAGEMENT, AND PERSONNEL Section 2
- Organization, Management, and Personnel position of COO. As the highest level executives, their The chart found in Appendix C depicts our philosophical approach to quality, technology and corporate organization, chain of command and flow of customer service keeps GEL unique.
responsibility. The illustration in this appendix is The Stellings, Mr. Earnst, Mr. Hodgson and Ms.
designed to ensure the overall quality and cost Bocklet comprise our Executive Committee. They are efficiency of our company's analytical products and also part of a Leadership Tearn that works to create a services. workplace environm.ent that attracts and retains highly qualified professionals.
Our structure is based on customer-focused divisions that follow a project from the point of initial As Chairman, Ms. Stelling oversees the Executive contact to the final invoicing of work. These divisions Committee and leads management in implementing total include expertise in project management, sample quality initiatives that ensure quality services that meet receipt and custody, sample preparation and analysis, stringent criteria of excellence. She has responsibility for data review, and data packaging. An independent public relations efforts and community affairs. Ms. Stelling Quality Systems Management Department monitors holds a Bachelor of Arts in Education from the University of the adherence of these divisions to the Quality South Carolina.
Assurance Program. As CEO and President, Mr. Stelling has overall The general responsibilities associated with the operational responsibility for GEL. He operates the following position levels are discussed in this section: laboratory according to corporate policies and applicable licenses and regulations.
- Chairman Mr. Stelling also has primary responsibility for the
- Chief Executive Officer (CEO) and President development and administration of our analytical testing
- Vice President and environmental consulting services. He holds a
- Chief Financial Officer (CFO) Bachelor of Science in Commerce from the University of
- Quality Systems Director Mr. Joseph M. Hodgson is GEL's Vice President.
- Laboratory Directors He is responsible for Strategic Planning, Marketing and
- Project Managers Business Development. Mr. Hodgson holds a Bachelor
- Group Leaders of Science in Business and a minor in Spanish from
- Laboratory and Technical Staff Wake Forest Univsersity.
- Information Systems Manager Douglas E. Eamst is GEL's Chief Financial Officer
- Environmental Manager ahd oversees our financial management. He is An overview of GEL's employee training protocol is responsible for contracts administration, invoicing, also provided at Section 2.12. purchasing, payroll, accounts payable and receivable, 2.1 Chairman, CEO/President, Chief Financial inventory control, property control, and financial Officer and Chief Operating Officer forecasting. Mr. Earnst holds a Bachelor of Science in Business Administration from the Citadel.
Operational responsibility rests with GEL's three owners, CFO, and COO. Kathleen H. Stelling, James The Chief Operating Officer is Carey J. Bocklet. Ms.
M. Stelling, and Joseph M. Hodgson are GEL's owners Bocklet is responsible for the daily operations of the '
and serve respectively as Chairman, CEO/President, laboratories and client services. Ms. Bocklet holds a and Vice President. Mr. Douglas G. Earnst occupies Bachelor of Science in Chemical Engineering, and a .
the position of CFO. Carey J. Bocklet occupies the 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015
- Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 9of109 ~
Master of Science in Business Administration, both from
- Establishing and implementing policies and Clemson University. procedures that support our quality standards.
Together, the Chairman, CEO/President, Vice *
- Ensuring that technical laboratory staff President, CFO and COO form GEL's Executive demonstrates initial and continuing proficiency in Committee. Their responsibilities include the following: the activities for which they are responsible.
- Ensuring that the individuals who staff our
- Documenting all analytical and operational technical and quality positions have the activities of the laboratory.
necessary education, training, and experience to
- Supervising all personnel employed in the competently perform their jobs. division.
- Ensuring that all staff members receive ancillary
- Ensuring that all sample acceptance criteria are training, as needed, to enhance performance in verified and that samples are logged into the assigned positions. sample tracking system, properly labeled, and
- Budgeting, staffing, managing, and equipping the stored.
laboratory to meet current and future analytical
- Documenting the quality of all data reported by program requirements. the division.
- Overseeing the implementation and overall
- Developing internal mechanisms and effectiveness of our Quality Assurance Plan, measurements to improve efficiency.
health and safety initiatives, and environmental
- Overseeing activities designed to ensure programs. compliance with laboratory health and safety
- Managing production and cost control activities. requirements.
- Ensuring development of capabilities in response
- Allocating the resources necessary to support an to new or revised regulations, instrumentation effective and ongoing quality assurance program.
and procedures, and quality assurance initiatives.
- Representing the company to the public and to 2.2 Technical Laboratory Co-Directors clients.
To enhance our responsiveness to clients through
- Ensuring the appropriate delegation of authorities dedicated expertise and teamwork, our laboratory is during periods of absence.
divided into two major divisions, Chemistry and
- Ensuring compliance to the ISO 17025:2005 Radiochemistry, each with its own Technical Laboratory Standard.
Director.
Due to high volume and variety of analytical tests The Technical Directors report to the Executive performed in the Chemistry Laboratory, the Technical Committee and are ultimately responsible for the Director for the Chemistry Laboratory has the daily technical content and quality of work performed within assistance of a Production Manager and Group each division. They are also responsible for strategic Leaders.
planning, profitability and growth, personnel management and business development. Other 2.3 Quality Systems Director responsibilities include: Our Quality Systems Director (QSD) reports directly
- Monitoring and meeting profitability and growth to the CEO. The QSD manages the design, objectives of the division. implementation and maintenance of our quality systems in a timely, accurate, and consistent manner.
- Establishing and implementing short and long range objectives and policies that support GEL's In addition to having responsibility for the initiation goals. and recommendation of corrective and preventive
- Defining the minimum level of qualification, actions, the QSD is responsible for:
experience, and skills necessary for positions in
- Establishing, documenting, and maintaining their divisions. comprehensive and effective quality systems.
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (I).
Uncontrolled documents do not bear an original Set ID number.
og.:.Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 10of109
- Developing and evaluating quality assurance
- Designating quality systems authorities in times policies and procedures pertinent to our of absence to one or more appropriately laboratory functions, and communicating these knowledgeable individuals.
with the division directors and managers.
- Overseeing notification if required for compliance
- Ensuring that the operations of the lab are in with Energy Reorganization Act, 1974, 10 CFR, conformance with the Quality Assurance Plan Part 21, should data recall be necessary.
and meet the quality requirements specific to 2.4 Quality Systems Review each analytical method.
The effectiveness of the Quality System is reviewed
- Ensuring that laboratory aGtivities are in on a regular basis during meetings of the Leadership compliance with local, state, and federal Team, which may be as often as weekly, but not less than environmental laws and regulations. quarterly. These meetings address issues that impact
- Reviewing project-specific quality assurance quality, and the subsequent discussions are used to design plans. and implement improvements to the system. At least
- Ensuring that quality control limits are annually, a management assessment of GEL's Quality established and followed for critical points in all System is conducted and reported. The QSD maintains measurement processes. records of these assessments.
- Initiating internal performance evaluation studies. 2.5 Manager of Client and Support Services using commercially purchased certified, high- Project Managers (PMs) serve as primary liaisons purity standard reference materials. to our clients. PMs, under the guidance of the Manager
- Performing independent quality reviews of of Client and Support Services, manage the company's randomly selected data reports. interaction with clients. They are the client's first point
- Conducting periodic audits to ensure method of contact and have responsibility for client satisfaction compliance. and for communicating project specifications and changes to the appropriate laboratory areas.
- Conducting or arranging periodic technical system evaluations of facilities, instruments and Additional responsibilities include:
operations.
- Retaining clients and soliciting new work.
- Overseeing and monitoring the progress of
- Managing multiple sample delivery orders and nonconformances and corrective actions. preparing quotes.
- Communicating system deficiencies,
- Working with clients to define analytical recommending corrective action to improve the methodologies, quality assurance requirements, system, and defining the validity of data generated reports, deliverables, and pricing.
during out of control situations.
- Overseeing sample management and informing
- Preparing and updating quality assurance laboratory staff of the anticipated arrival of documents and reports to management. samples for analysis.
- Coordinating inter-laboratory reviews and
- Conducting a review of client documents (i.e.
comparison studies. quotes, invoices, routine and specialized
- Overseeing Stop Work Orders in out-of-control reports).
situations.
- Working with the accounting team on invoicing
- Administering accreditation and licensing. and collection issues.
- Administerin'g our document control system. *
- Working with the Laboratory Directors, Production
- Providing guidance and training to laboratory Manager, and Group Leaders to project workloads staff as requested.
- and determine schedules.
- Evaluating subcontractors and vendors that 2.6 Production Manager and Group Leaders provide analytical and calibration services. Group Leaders are a critical link between project management, lab personnel, and support staff. They 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (I).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 11 of 109 report to the Technical Directors and have the following
- Identifying potential sources of error and responsibilities: reporting any observed substandard conditions
- Planning and coordinating the operations of their or practices.
groups to meet client expectations.
- Identifying and correcting any problems affecting
- Scheduling sample preparation and analyses the quality of analytical data.
according to holding times, quality criteria, and
- Identifying and performing all client specific client due dates. requirements outlined in the special requirements
- Ensuring a multi-level review of 100% of data on the pull sheet of every batch.
generated by their groups. 2.8 Information Systems Manager
- Coordinating nonconformances and corrective, The Information Systems Manager reports directly to actions in conjunction with the Quality Systems the COO. The responsibilities of this position include Management team. management of the Computer Services Team and
- Serving as technical resources to their groups, AlphaLIMS, our laboratory information management including data review. system.
- Managing special projects, reviewing new work The combined responsibilities of the Information proposals, and overseeing the successful Systems Team, performing under the leadership of the implementation of new methods. Information Systems Manager, include the:
- Monitoring and controlling expenses incurred
- Development and maintenance of all software within their groups such as overtime and and hardware.
consumables.
- Translation and interpretation of routines for
- Providing performance and career development special projects.
feedback to their group members.
- Interpretation of general data and quality control 2.7 Laboratory and Technical Staff* General routines .
.Requirements
- Optimization of processes through better At GEL, every effort is made to ensure that the software and hardware utilization.
laboratory is sufficiently staffed with personnel who
- Customization, testing and modification of data have the training, education, and skills to perform their base applications .
. assigned jobs competently.
- Maintenance and modification of our computer Depending upon the specific position, laboratory modeling, bar coding, CAD, statistical process personnel are responsible for: control, project management, and data
- Complying with quality assurance and quality packaging systems.
control requirements that pertain to their group
- Development and maintenance of client and and/or technical function. internal electronic data deliverables.
- Demonstrating a specific knowledge of their
- Validation and documentation of software used in particular function and a general knowledge of processing analytical data.
laboratory operations.
2.9 Environmental Manager
- Understanding analytical test methods and standard operating procedures that are The Environmental Manager oversees our physical applicable to their job function. facility, laboratory and radiation safety programs, and instrumentation. This position reports to the COO, and
- Documenting their activities and sample manages and supervises the functions and staff interactions in accordance with analytical assigned to these areas.
methods and standard operating procedures.
Responsibilities of the Environmental Manager
- Implementing the quality assurance program as it include:
pertains to their respective job functions.
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (I).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 12 of 109
- Planning, evaluating, and making 2.11 Director of Human Resources recommendations for facility maintenance, The Director of Human Resources reports directly additions and renovations. to the CEO. The OHR manages the design,
- Overseeing building renovations and new implementation, and ongoing development of our construction activities. Human Resources. Responsibilities of the OHR
- Implementation of the Chemical Hygiene and include:
Radiation Safety programs.
- Administration, orientation, and indoctrination of
- Installing, maintaining, repairing, and modifying all new employees.
analytical instrumentation.
- Administration and compliance with Federal,
- Providing technical expertise and training in State, and Local employment regulations.
instrumentation operation, calibration, and
- Sourcing candidates for all functional positions to maintenance.
maintain and strengthen the technical services
- Monitoring and ensuring regulatory compliance provided by GEL.
for waste management operations and off-site disposal.
- Management of occupational health and safety as it relates to Federal, State, and OSHA regulations.
2.10 Radiation Safety Officer The Radiation Safety Officer (RSO) reports to the 2.12 Employee Training Environmental Manager. The RSO is responsible for the administration and execution of GEL's To ensure that our clients receive the highest Radiation Protection Program. This person provides quality services possible, we train our employees in the technical guidance and leadership for all issues general policies and practices of the company, as well concerning radiation health and safety as well as direct as the specific operating procedures relative to their operations to ensure compliance with South Carolina positions. We conduct and document this training Department of Health and Environmental Control according to GL-HR-E-002 for Employee Training and (SCOH EC) regulations for radioactive materials. GL-QS-E-017 for Maintaining Technical Training Records.
Responsibilities of the RSO include: New employees participate in a company
- Establishing and enforcing policies consistent orientation shortly after they are hired. During with the principles and practices designated to orientation they receive information on quality systems, maintain all exposure to ionizing radiation "As ethics/data integrity, laboratory safety, and employment Low As Reasonably* Achievable" (ALARA). practices. Each new employee is also provided a
- Supervising Radiation Protection Specialists in manual that reiterates our policies on equal opportunity, the execution of radiological surveys and benefits, leave, conflicts of interest, employee maintenance of the Radioactive Material performance, and disciplinary action. Employees can License inventory. access standard operating procedures, the Quality
- Executing the Personal Dosimetry, Air Effluent Assurance Plan, Safety, Health, and Chemical Hygiene Monitoring, and Sealed Radioactive Source Plan, and the Laboratory Waste Management Plan on Leak Test Programs. GEL's Intranet.
- Developing procedures and protocols to establish Other training provided on an ongoing basis may and maintain compliance. include:
- Providing training for staff in proper radiation
- Demonstration of initial proficiency in analytical protection practices. methods and training to SOPs conducted by a trainer who has been documented as qualified and proficient in the process for which training is being provided.
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (l).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 13 of 109
- Demonstration of continued analyst proficiency is A confider)tiality statement accompanies the updated annually, usually during the first quarter electronic transfer of data from GEL via telefacsimile of each year. Proficiency is demonstrated using (fax) or electronic mail systems (email). Government the same processes as those used for initial affiliated auditing agencies have access to pertinent Demonstration of Capability. (Refer to Section laboratory records. However, contrad, third party, and 8.3.1.) client auditors have access only to those records that may be applicable to their inspection and shall not be
- Company-wide, onsite training.
granted access to client records that may be considered
- Courses or workshops on specific equipment and in conflict with their interests, unless prior authorization analytical techniques. has been given by the submitting client. Confidential
- University courses. information may be purged of references to client
- Professional and trade association conferences, identity, project and/or sample identity by the laboratory seminars, and courses. so that records may be provided to other entities (e.g.
auditors) for review.
Documentation of employee training is the joint responsibility of the employee and the applicable Group Leader. If an SOP is revised during the course of the year, training to the revised SOP must be documented.
2.13 Ethics and Data Integrity As our corporate vision statement explains, "We are a company that values: Excellence as a way of life, Quality Service, a Can-Do attitude, and a fundamental commitment to Ethical Standards." Employees attend ethics education programs that focus on the high standards of data integrity and ethical behavior mandated by our company and expected by our clients.
The annual ethics training includes:
- Specific examples of unethical behaviors for the industry and for the laboratory.
- Explanation of Internal Auditing for unethical behaviors and practices.
- GEL use of electronic audit functions using instrument and AlphaLIMS software. *
- Explanation of GEL's Ombudsman policy for reporting inappropriate activities.
- Examples of consequences of inappropriate or unethical behaviors/practices.
All employees sign an Ethics and Data Integrity Agreement that reflects their commitment to always perform their duties*with these high standards. (Refer to Appendix F.)
2.14 Confidentiality The laboratory maintains the confidentiality and proprietary rights of information including the type of work performed and results of analysis. Laboratory personnel and staff are informed of this policy and sign a confidentiality agreement.
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 14 of 109 SECTION 3 QUALITY SYSTEMS Section 3
- Quality Systems
- Reports to the Quality Systems Director
'c Our Quality Systems include all quality assurance
- Demonstrates strict adherence to and support (QA) policies and quality control (QC) procedures of the company ethics policy.
necessary to plan, implement, and assess the work we
- Demonstrates knowledge of the Quality System perform. GEL's QA Program establishes a quality defined under NELAC, TNI, DOECAP, management system (QMS) that _governs all of the DOELAP and other quality standards such as activities of our organization. ANSl/ISO/IEC 17025-2005.
GEL's quality management system is designed to
- Plans, schedules and participates in GEL's conform to the requirements specified in the standards client audits, internal audits, and subcontractor referenced in Appendix A. Essential elements of our audits quality management system are described in this
- Conducts conformance audits as necessary to section. verify implementation and closure of audit 3.1 Quality Systems Team action items The quality systems team is responsible for
- Serves as liaison to client and third party managing GEL's QA Program. This team functions auditors independently of the systems it monitors and is
- Coordinates laboratory responses to audit comprised of the Quality Systems Director, Lead Auditor, reports and prepares final response QA Officers, and/or Specialists.
- Monitors progress of corrective actions Following is a summary of the responsibilities of
- Prepares and monitors progress of internal and each position. subcontractor audit reports .
3.1.1 Quality Systems Director 3.1.3 Quality Assurance Officers
- Reports to the CEO
- Report to the Quality Systems Director
- Demonstrates strict adherence to and support of the
- Demonstrate strict adherence to and support of the company ethics policy company ethics policy.
- Serves as management's representative for quality
- Demonstrate the ability to evaluate data objectively
- Responsible for the implementation and without outside influence maintenance of the QMS
- Have documented training and/or experience in
- Supervises the Quality Systems Team and their QA/QC procedures and knowledge of the Quality functions system as defined under NELAC, TNI and ISO
- Initiates and recommends preventive action and 17025 solutions to quality problems
- Have knowledge of analytical methods
- Implements appropriate action to control quality
- Assist in the conduct of internal and supplier audits problems until solutions are implemented and and requests for pricing reviews verified to be effective
- Administer corrective actions and nonconformances
- Verifies that effective solutions are implemented
- Monitor and respond to client -identified
- Demonstrates knowledge of the Quality System as nonconformances and technical inquiries defined by NELAC, TNI, ANSl/ISO/IEC 17025,
- Implement and maintain statistical process control DOECAP, and DOELAP. (SPC) system 3.1.2 Quality Systems Lead Auditor 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 15 of 109
- Ensure the monitoring of balances and weights, and Finally, our Standard Operating Procedures (SOPs) temperature regulation of ovens, water baths, and are used to describe in detail those activities that affect refrigerators quality. SOPs are prepared, authorized, changed, revised
- Coordinate the monitoring of DI water system and released, and retired in accordance with GL-ADM-E-001.
- volatile organics storage coolers SOPs are accessible electronically via GEL's Intranet.
- Maintain Method Detection Limit studies 3.3 Document Control
- Write or review quality documents and standard The control of quality documents is critical to the operating procedures under the direction of the QS effective implementation of our Quality Program. We Director define and control this process in accordance with GL-
- Provide training in quality systems and good DC-E-001 for Document Control. Responsibilities for laboratory practices. document control are divided between the Group Leaders and the Document Contro1 *officer (DCO).
- Manage laboratory certification processes Group Leaders are responsible for:
- Coordinate the receipt and disposition of external and internal performance evaluation samples.
- Supporting the development and maintenance of NOTE: Once PE samples have been prepared in controlled documents that apply to their respective accordance with the instructions provided by the PE departments.
vendor, they are managed and analyzed in the same
- Reviewing all quality documents annually for manner as environmental samples from clients. The continued validity.
analytical and reporting processes for PE samples are
- Ensuring documentation that the affected not specially handled. employees are aware of revisions to documents or 3.1.4 Quality Systems Specialists manuals.
- Reports to the Quality Systems Director The Computer Services Team is responsible for:
- Electronic maintenance of all records required for
- Demonstrates strict adherence to and support of the control, re-creation, and maintenance of analytical company ethics policy.
documentation.
- Assist the team as directed with respect to Records
- Maintenance of electronic copies of archived data Management, Document Control, Laboratory and the electronic log of how they were determined.
Certification, temperature and weight calibrations, logbook review, training documentation, and The DCO is responsible for:
nonconformances, etc.
- Demonstrating strict adherence to and support of 3.2 Quality Documents the company ethics policy.
- Managing the system for the preparation, Our Quality Systems policies and procedures are authorization, change, revision, release, and documented in the QA Plan (GL-QS-B-001) and other retirement of the Quality Manual, QAP, project supporting documents. GEL's management approves all plans, and standard operating procedures.
company quality documents. Pre-approval is secured for any departures from such documents that may affect
- Ensuring that current controlled documents are quality. accessible via GEL's Intranet.
In addition, to the QA Plan, Quality Systems allows
- Managing a system to document current revision for QA Project Plans (QAPjP) and includes standard numbers and revision dates for all distributed operating procedures and any other quality assurance documents and manuals.
program requirements defined by individual contracts.
- Managing a system to identify the nature of The QA Plan describes the quality standards that we document revisions.
apply to our laboratory operations. We use Quality
- Maintaining hard or electronic copies of obsolete Assurance Project Plans to specify individual project documents.
requirements. The QA Plan and supporting documents
- Maintaining electronic or hard copy originals of all are verified to be understood and are implemented controlled documents.
throughout the laboratory fractions to which they apply.
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 16 of 109 Revisions to controlled quality documents are
- Stored in a manner that protects them from loss, made by replacing individual sections or the entire damage, and unauthorized alterations.
document, as determined by the DCO.
- Accessible to the client for whom the record was 3.4 Controlled Document Review generated.
Internally generated controlled documents undergo
- Retained and disposed in the identified time period.
a multi-level review and approval process before they The generation, validation, indexing, storage, are issued. These levels include a procedural review, retrieval, and disposition of our quality records are technical and/or quality review and the final authorization detailed in GL-QS-E-008 for Quality Records of the appropriate manager or director. To ensure that Management and Disposition. The quality records of new or revised standard operating procedures are not subcontracted services are also required to meet the implemented prematurely, SOPs are effective upon the conditions established in this SOP.
date of the final approval signature.
3.6 Internal and Supplier Quality Audits 3.5 Quality Records We conduct internal audits annually to verify that our Quality records provide evidence that specified operations comply with the requirements of our QA quality requirements have been met and documented. program and those of our clients. We perform supplier We generate them in accordance with applicable audits as necessary to ensure that they too meet the procedures, programs, and contracts. Quality records requirements of these programs. Both internal and include but are not limited to: supplier audits are conducted in accordance with GL-
- Observations QS-E-001 for the Conduct of Quality Audits.
- Calculations 3. 6.1 Audit Frequency
- Calibration data Internal audits are conducted at least annually in
- Certificates of analysis accordance with a schedule approved by the Quality
- Certification records Systems Director. Supplier audits are contingent upon
- Chains of custody the categorization of the supplier, and may or may not be conducted prior to the use of a supplier or subcontractor
- Audit records (Refer to GL-QS-E-001.) Type I suppliers and
- Run logs, instrument data, and analytical logbooks subcontractors, regardless of how they were initially
- Instrument, equipment, and building maintenance qualified, are re-evaluated at least once every three logs years.
- Material requisition forms Additional internal and supplier audits may be
- Monitoring logs scheduled if deemed necessary.
- Nonconformance reports and corrective actions 3.6.2 Audit Team Responsibilities
- Method developmer:it and start-up procedures including method detection limit studies Internal and supplier audits are conducted by qualified staff under the direction of the Lead Auditor or
- Technical training records Quality Systems Director. A qualified audit team
- Waste management records member shall have the technical expertise to examine
- Standard logs the assigned activities .
- Software validation documentation We do not allow staff to audit activities for which they
- Standard Operating Procedures (SOPs) are responsible or in which they are directly involved. It is
- Sample collection and field data the responsibility of the Lead Auditor to ensure that such Our quality records are: confticts of interest are avoided when the audit team is assembled.
- Documented in a legible manner.
The Leadership Team has a significant role in the
- Indexed and flied in a manner conducive to ready internal audit process, including:
retrieval.
- Provision of audit personnel 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 17 of 109
- Empowerment of the audit team with authority to Reporting and Dispositioning and Control of make the audit effective Nonconforming Items. We regularly review SOPs, client
- Development and implementation of timely complaints, and quality records, including completed corrective action plans NCRs, to promptly identify conditions that might result in situations or services that do not conform to specified
- 3. 6. 3 Identification and verification of OF/s quality requirements.
Opportunities for Improvement are identified Our Quality Group processes, categorizes and conditions that may adversely affect the quality of trends nonconformances. Trending information may be products or services. Several examples of objective provided to the Leadership Team and Group Leaders of evidence are used to support an OFI, which might be the affected areas.
classified as a finding, concern, observation, and/or recommendation. 3.9
- Corrective Action The Lead Auditor may initiate a Nonconformance There are two categories of corrective action at GEL.
Report (NCR) or Corrective Action Request and Report One is corrective action implemented at the analytical and (CARR) referencing the OFI. The NCR or CARR is then data review level in accordance with the analytical SOP.
entered into the NCR system per GL-QS-E-012 for NCR The other is formal corrective action documented by the Database Operation. Quality Systems Team in accordance with GL-QS-E-002.
Formal corrective action is initiated when a Implementation of a corrective action is later verified nonconformance reoccurs or is so significant that by a re-audit of the deficient area, review of new or permanent elimination or prevention of the problem is revised documents, or, if the OFI does not warrant required.
immediate action, the corrective action may be verified during the next scheduled audit. We include quality requirements in most analytical SOPs to ensure that data are reported only if the quality 3.7 Managerial and Audit Review control criteria are met or the quality control measures Our Leadership Team reviews the audit process at that did not meet the acceptance criteria are least annually. This ensures the effectiveness of the documented.
corrective action plan and provides the opportunity to Formal corrective action is implemented according introduce changes and improvements. to GL-QS-E-002 for Conducting Corrective/Preventive We document all review findings and corrective Action and Identifying Opportunities for Improvement actions. Implementation plans and schedules are and documented according to GL-QS-E-012 for NCR monitored by the Quality Systems Team. Database Operation.
3.8 Nonconformances Any employee at GEL can identify and report a Processes, materials, and services that do not meet nonconformance and request that corrective action be specifications or requirements are defined as taken. Any GEL employee can participate on a corrective nonconforming. Such nonconformances can include action team as requested by the OS team or Group items developed in-house or purchased from vendors, Leaders. The steps for conducting corrective action are samples received from clients, work in progress, and detailed in GL-QS-E-002.
client reports. In the event that correctness or validity of the At GEL, we have a nonconformance reporting laboratory's test results is doubted, the laboratory will system (NCR) that helps us prevent the entry of take corrective action. If investigations show that the defective goods and services into our processes and the results have been impacted, affected clients will be release of nonconforming goods and services to our informed of the issue in writing within 5 calendar days of clients. Our NCR system provides a means for the discovery.
documenting the disposition of nonconforming items and 3.10 Performance Audits for communicating these to the persons involved in the In addition to internal and client audits, our process affected by the adverse condition(s). laboratory participates in annual performance evaluation .
Nonconformances are documented according to studies conducted by independent providers. We GL-QS-E-004 for the Documentation of Nonconformance 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 18 of 109 routinely participate in the following types of performance certification for radionuclide analysis in drinking water audits: also use the study. This program is conducted in
- Proficiency testing and other inter-laboratory strict compliance with the USEPA National Standards comparisons. for Water Proficiency Testing Studies.
- Performance requirements necessary to retain
- Water Pollution (WP). Biannual program for waste certifications (Appendix D). methodologies. Parameters include both organic and inorganic analytes.
- Evaluation of recoveries of certified reference and in-house secondary reference materials using
- Water Supply (WS): Biannual program for drinking statistical process control data. water methodologies. Both organic and inorganic
- Evaluation of relative percent difference between parameters are included.
measurements through SPC data. At GEL, we also evaluate our analytical performance We also participate in a number of proficiency on a regular basis through statistical process control testing programs for federal and state agencies and as acceptance criteria. Where feasible, this criterion is required by contracts. It is our policy that no proficiency applied to both measures of precision and accuracy and evaluation samples be analyzed in any special manner. is specific to sample matrix.
Our annual performance evaluation participation We establish environmental process control limits at generally includes a combination of studies that support least annually. In Radiochemistry, quality control the following: evaluation is based on static limits rather than those that are statistically derived. Our current process control
- US Environmental Protection Agency Discharge limits are maintained in AlphaLIMS.
Monitoring Report, Quality Assurance Program (DMR-QA). Annual national program sponsored by We also measure precision through the use of matrix EPA for laboratories engaged in the analysis of duplicates and/or matrix spike duplicates. The upper and samples associated with the NPDES monitoring lower control limits (UCL and LCL respectively) for program. Participation is mandatory for all holders precision are plus or minus three times the standard of NPDES permits. The permit holder must analyze . deviation from the mean of a series of relative percent for all of the parameters listed on the discharge differences. The static precision criteria for radiochemical permit. Parameters include general chemistry, analyses are O- 20% for activity levels exceeding the metals, BOD/COD, oil and grease, ammonia, contract required detection limit (CRDL).
nitrates, etc.
- Accuracy is measured through laboratory control
- Department of Energy Mixed Analyte Performance samples and/or matrix spikes, as well as surrogates and Evaluation Program (MAPEP). A semiannual internal standards. The UCLs and LCLs for accuracy program developed by DOE in support of DOE are plus or minus three times the standard deviation contractors performing waste analyses. from the mean of a series of recoveries. The static limit Participation is required for all laboratories that for radiochemical analyses is 75 - 125%. Specific perform environmental analytical measurements in Instructions for out-of-control situations are provided in support of environmental management activities. the applicable analytical SOP.
- ERA's MRAD-Multimedia Radiochemistry . 3.11 Control Charts Proficiency test program. This program is for labs seeking certification for radionuclides in wastewater Per the U.S. Department of Energy, Quality and solid waste. The program is conducted in strict Systems for Analytical Services (DOE QSAS): Control compliance with USEPA National Standards for charts are a graphical representation of data taken from Water Proficiency study. a repetitive measurement or process. Control charts may be developed for various characteristics, (e.g.
- ERA's lnterLaB RadCheM Proficiency Testing mean, standard deviation, range, etc.) of the data. Per Program for radiological analyses. This program MARLAP "A control chart has two basic uses:
completes the process of replacing the USEPA
- As a tool to judge if a process was in EMSL-LV Nuclear Radiation Assessment Division control.
program discontinued in 1998. Laboratories seeking 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 19 of 109
- As an aid in achieving and maintaining available for review. Data points may be determined as statistical control. outliers based on the process knowledge of the For applications related to radiation detection procedure being evaluated and the professional opinion instrumentation or radiochemical processes, the mean of the data reviewer.
(center line) value of a historical characteristic (e.g. During their annual system review, management will mean detector response), subsequent data values and evaluate the need to consolidate any redundant control limits placed symmetrically above and below the procedures and/or policies to help eliminate any center line are displayed on a control chart." confusion for work processes.
For GEL's Chemistry, Radiochemistry, and 3.12 Essential Quality Control Measures Bioassay laboratories, the Computer Services Team Some quality control measures are method-specific.
(CST) developed a program where Group Leaders are There are, however, general quality control measures sent email notifications that provide LCS failures by that are essential to our quality system. These quality compound/analyte name. This assists the Group Leader measures include:
with monitoring out of control situations due to laboratory contamination or analyst error. This program sends
- Monitoring of negative and positive controls notifications once a week.
- Defining variability and reproducibility through Each Group Leader may utilize programs in LIMS duplicates where they can review trending data as control charts by
- Ensuring the accuracy of test data including work order or by the SPC program. calibration and/or continuing calibrations, use of GEL's QA Officer or designee shall review control certified reference materials, proficiency test charts during the period when the LIMS SPC program samples, etc.
queries data points for analyses that require dynamic
- Evaluating test performance using method detection SPC limits for quality control parameters. This is limits and quantitation limits or range of applicability performed on a biannual basis. At this time, any out of such as linearity control conditions will be identified and a corrective
- Selecting the appropriate method of data reduction action initiated. The QA Officer shall be able to stop unsatisfactory wor~ or prevent the reporting of results
- A copy of GEL's Ethics and Integrity Agreement is generated from this program. provided in Appendix F. *
- Dynamic SPC limits for control parameters are generally developed when more than 20 data points are 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 20 of 109 SECTION 4 FACILITIES Section 4
- Facilities 4. 2. 1 Deionized Water Our laboratory is designed with a full-service We have two independent deionized water (DI) approach to handling environmental needs. The layout systems. One serves radiochemistry while the other provides dedicated space for radiochemical analyses, serves the remaining laboratories. DI water is made bioassay analysis, organic extractions, semi-volatile from city water flowing through a reverse osmosis organic analyses, volatile organic analyses, metals system and a deionization system capable of producing analyses, general chemistry analyses, and air analyses. 5 gallons per minute of Type I laboratory water.
The laboratory and support offices occupy We monitor compliance according to GL-LB-E-approximately 85,000 square feet engineered to meet 016 for The Collection and Monitoring of the DI Water the stringent quality control and utility requirements of Systems. Our monitoring activities and frequencies can the modern environmental laboratory. Records are be found in Table 1 of the SOP.
- temporarily stored on-site then warehoused in a climate- 4.3 Prevention of Contamination controlled building off-site. The diagram in Appendix H depicts the layout of the laboratories. Work areas that are free of sample contaminants, constituents and measurement interferences are Discussed in this section are: important to the generation of quality data. With this in
- Facility security mind, we designed our laboratories to prevent
- Utility services and deionized water contamination and reinforce this design with good
- Prevention of contamination laboratory practices.
- Assessment of contamination In addition to keeping our work areas free of dust 4.1 Facility Security and dirt accumulations, policies and features that prevent or minimize contamination include:
Our facility features secured laboratory and storage areas. Restricted entry assures sample integrity and *
- An air conditioning system that controls the client confidentiality, which satisfies clients and potential environment of individual laboratories for optimum national security interests. performance of sensitive instruments and to eliminate potential cross contamination.
Visitors cannot gain entry without being escorted through the laboratory by authorized personnel. A
- Segregation of volatile and semi-volatile laboratories designated sample custodian and a bar-coded chain-of- to minimize potential contamination associated with custody provide a second level of security. the use of commonly required solvents.
4.2 Utility Services
- Negative and positive pressure air locks to isolate selected laboratories to prevent the entry of airborne Each defined laboratory area is equipped with the contaminants.
following utilities:
- Fume hoods to remove fumes and reduce* the risk of
- Cold water aerosol and airborne contaminants and personal
- Hot water safety hazards are* monitored in accordance with
- Deionized water GL-FC-E-003 for Fume Hood Face Velocity
- Compressed air Performance Checks.
- Natural gas
- Restricted access to the volatiles laboratory
- Vacuum (authorized personnel only) .
- 110 Volt AC
- Designated area for glassware preparation wherein
- 208 Volt AC (at selected stations) all glassware used in sample prep and analysis is
- Specialty gas~s (as required) cleaned according to GL-LB-E-003 for Glassware Preparation.
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 21of109
- Segregated storage areas for volatiles and
- Chemical and physical interference radioactive samples.
- Constituent carryover during analysis
- Production, use, and monitoring ofType I DI water. Contamination in each of the volatile storage coolers
- Tracking and trending of any significant sample is monitored by the weekly analysis of water blanks.
and/or reagent spills using the AlphaLIMS NCR Two DI water blanks are placed in each monitored cooler system, allowing efficient analysis of any potential at the beginning of each month with one being analyzed contamination. each week. If the concentration of any target analyte 4.4 Assessment of Contamination Levels exceeds the PQL, this is verified (with the second blank for that week) and corrective action is implemented to We evaluate contamination resulting from the eliminate the source of contamination, evaluate the .
following sources on the basis of quality assurance and effect of samples stored in the cooler, and to notify quality control data derived from the analytical method clients. SOP GL-OA-E-058 discusses these practices in and method blanks.
detail.
- Sample containers
- Reagent water
- Reagents and solvents
- Sample storage 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page(!).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effectiv~ March 2015 Page 22 of 109 SECTION 5 EQUIPMENT AND REFERENCE MATERIALS Section 5
- Equipment and Reference Materials identified to indicate its calibration status. We maintain GEL's ability to efficiently generate data that are records for each major item of equipment, reproducible, accurate, and legally defensible is instrumentation, and all reference materials significant to attributable to our use of high-quality instruments, quality performance. These records are often in the form equipment, and reference materials. of maintenance logs, which are kept in accordance with GL-LB-E-008 for Basic Requirements for the Use and Provided in this section are: Maintenance of Laboratory Notebooks, Logbooks,
- GEL's policies governing instruments, equipment, Forms, and Other Recordkeeping Devices.
and reference materials Documentation included in these records includes
- Identification of instrumentation and support but is not limited to:
equipment *
- Equipment name
- Procurement protocol
- Manufacturer's name 5.1 General Policies
- Type identification .
It is our policy to purchase instrumentation,
- Serial number or other unique identification equipment and high-quality reference materials that
- Date received and date placed in service (if meet or exceed the method and regulatory requirements available) for the analyses for which we are accredited. If we need
- Current location to use instruments or equipment not under our
- Condition when received (if known) permanent control, we ensure that it also meets these
- Manufacturer's instruction, where available standards.
- Dates and results of calibrations and or verifications Instrumentation and equipment are placed into
- Date of next calibration and/or verification, where service on the basis of ability to meet method or written procedures do not specify frequency regulatory specified operating conditions such as range
- Details of maintenance carried out to date and and accuracy. All laboratory instrumentation and testing planned for the future equipment is maintained in accordance with standard
- History of any damage, malfunction, modification or operating procedures (SOPs).
- repair Instrumentation and equipment is used in a manner 5.2 Instrumentation and Support Equipment that assures, where possible, that measurement Appendix G lists the instruments we use for the uncertainty is known and consistent with specified quality analysis of environmental, radiochemical and bioassay requirements. Instruments and equipment are taken out samples. Where feasible, our instruments are equipped of service and segregated or labeled as such under the with autosamplers* that improve efficiency and facilitate following conditions: consistent sample introduction to the sample detector.
- Mishandling and/or overloading They are also connected to an area network to facilitate
- Results produced are suspect data transfer.
- Demonstrated defect or malfunction Devices that may not be the actual test instrument Tagged or segregated instruments and equipment but are necessary to support laboratory operations are remain out of service until repaired and shown by test, referred to as support equipment. We also maintain this calibration, or verification to perform satisfactorily. equipment in proper working order. Support equipment Instruments that are in service and normally calibrated utilized at GEL includes:
prior to and during use are not tagged.
- balances Each item of equipment, including reference
- ovens materials is, if appropriate, labeled, marked or otherwise
- refrigerators 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 23 of 109
- freezers described in GL-RC-E-002 for Material Requisition.
- incubators These requests typically include:
- water baths
- The date and name of person(s) requesting
- temperature measuring devices materials
- volumetric dispensing devices
- Account, department, project number to which the
- muffle furnaces material is to be billed
- distillation apparatus e Recommended supplier or vendor
- grinders and homogenizers
- Additional information necessary to expedite the
- hot plates and heating mantles purchase request
- ultraviolet sterilizers.
- Specifications that could affect the quality of Guidelines for the required calibration and products and services evaluation of this equipment are discussed in Section 7.
- Vendor's material part number We perform radiochemical and bioassay analytical
- Amount of material needed services in accordance with the instrumentation and
- Description of material reference methods approved by the Department of
- Cost per unit Energy (DOE), the Environmental Measurements Lab
- Person(s) authorizing the purchase (EML), the Environmental Protection Agency (EPA),
- Time frame in which the material is needed ASTM, and Los Alamos Health and Environmental The equipment, instruments, and reference Chemistry (LAHEC). Modifications to these methods materials we purchase are inspected upon receipt in may be appropriate as a result of Performance Based accordance with GL-RC-E-001 for the Receipt and Measurement Systems (PBMS). Inspection of Material and Services. This inspection is to SOPs are used to describe our procedures for all verify that procured items meet the acceptance criteria routine analyses performed by our labs. These defined in the procurement documentation. Staff procedures include step-by-step instructions for sample performing initial inspection routinely:
collection, storage, preparation, analysis, instrument
- Open and inspect all items for damage calibration, quality control, disposal, and data reporting.
- Compare the items with the issued purchase order 5.3 Procurement and Control of Purchased Items or contract for catalog or part number, description or Materials, equipment, and services that affect the procurement specification, quality requirement, and quality of our products are designated as Quality acceptance criteria Materials, Equipment, and Services and are only
- Label items with a limited shelf life with the date purchased from approved suppliers. We approve and received document suppliers according to GL-QS-E-001 for the
- Determine if the items conform to the specifications Conduct of Quality Audits. agreed to by the vendor.
At GEL, we maintain documentation of specific quality
- The individual responsible for the technical requirements for Quality Materials and Services. Records acceptance of the item provides procurement and that document the quality of a product or service may receiving staff with the proper acceptance documentation.
include: Items found not to conform to quality standards are
- certificates of analysis and traceability returned to the supplier, identified as nonconforming or
- verifications of chemical quality disposed according to the established procedures in GL-
- inspections of equipment or materials QS-E-004 for Documentation of Nonconformance
- verifications or inspections of vendor product Reporting and Dispositioning and Control of specifications Nonconforming Items. These nonconforming items may Our procedure for requisitioning supplies, also include those identified as suspecUcounterfeit items instruments, equipment and other common use material is as identified in DOE guide DOE G 414.-3 for use with DOE 414.18, C and D.
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (I).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 24 of 109.
SECTION 6 HEALTH AND SAFETY Section 6
- Health and Safety also provide respirators when needed to those who have GEL maintains a safe work environment and completed training in the use of this specialized promotes healthy work practices. Our corporate Safety, equipment.
Health, and Chemical Hygiene Plan was developed by a Eyewashes and overhead showers are located resident certified industrial hygienist. Procedures outlined throughout the laboratory. We routinely inspect these as in the plan are consistent with Occupational Safety and directed in GL-FC-E-002 for Testing Emergency Health Administration, CERCLA, the Environmental Eyewash and Shower Equipment.
Protection Agency, and SCDHEC. 6.4 Radiation Safety All employees are trained in the safety practices Since GEL specializes in the handling of radioactive applicable to their job functions. This training is material, we have health physics procedures to ensure conducted in accordance with GL-HR-E-002 for Employee its safe handling. While lab personnel do not encounter Training. significant levels of radiation requiring personal Discussed in the section are: monitoring, a Dosimetry Program is in effect utilizing
- Fire safety and safety equipment personal dosimeters for designated personnel. These dosimeters are exchanged quarterly and records of
- Safety equipment and procedures related to exposure are maintained. Instructions for the proper use handling radioactive samples of dosimeters are addressed in GL-RAD-S-009 for 6.1 Fire Safety Personnel Dosimetry.
Our facility is equipped with a fire alarm system We take special precautions to ensure that samples designed to detect smoke in all areas of the facility. are safely processed. Upon receipt, trained personnel Certain high-risk areas, such as, the cold and ambient use a survey meter to screen all samples for the presence storage areas, organic sample preparation lab, hazardous of radioactivity. Protocols for the receipt of radioactive waste lab, and solvent storage are additionally equipped samples and for surveying suspected or known
/
with automatic halon systems. Fire blankets and dry radioactive samples are detailed in GL-RAD-S-007 for chemical extinguishers are located at strategic points Receiving Radioactive Packages and GL-RAD-S-001 for throughout the lab. We routinely inspect these Radiological Surveys. This process is described in extinguishers in accordance with GL-FC-E-004. Lab Section 9.
personnel are trained in the proper use and selection of Upon leaving a radiologically controlled area, fire extinguishers.
personnel check their hands and feet for potential In order to decrease the risk of fire, bulk solvents contamination. This is done utilizing detection are stored in a halon-protected storage room. instrumentation that employs Geiger-Mueller or 6.2 Evacuation scintillation technologies. In addition, stations with In the unlikely event of a fire (or other emergency), we portable detection instruments are set up for personnel have defined evacuation routes depicted in Appendix H. frisking and in-process contamination surveys.
This diagram is posted in pertinent areas of the facility and Key areas throughout the facility are surveyed:
designated staff members serve as evacuation leaders for
- Laboratory analytical areas (Monthly smears)
- the work groups.
- Radioactive Sample Storage Areas (Monthly 6.3 Safety Equipment smears and exposure rate)
Safety equipment, including s.afety glasses, lab coats,
- Sample Receipt and Waste Handling Areas safety goggles, protective gloves, hard hats, and (Monthly smears and exposure rate) coveralls, is* available to all employees as needed. We
- Unrestricted and Radioactive Material Prohibited Areas (Quarterly smears) 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (l).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 25 of 109 SECTION 7 MEASUREMENT, TRACEABILITY, AND CALIBRATION Section 7
- Traceability and Calibration 7.1 Calibration Criteria for Support Equipment Traceability of measurements and the calibration of This section addresses calibration protocols for testing equipment are imperative to our ability to support equipment; including balances, temperature -
produce accurate and legally defensible data. As such, sensitive equipment, and air displacement pipets. The we have implemented procedures to ensure that general criteria applicable to the calibration of support equipment calibration and measurement verification equipment are as follows:
are traceable to nationally recognized standards
- Equipment is maintained in proper working order.
obtained from the National Institute of Standards and Records of all maintenance activities including
- Technology (NIST) or accredited reference material service calls are kept.
producer (RMP) with traceability to NIST. Reference materials purchased outside the United States must be *
- Calibrations or re-verifications over the entire traceable back to each country's national standards range of use, using NIST-traceable references laboratory or another national or international reference when available, are conducted annually.
organization such as ILAC, APLAC and/or IMC. The
- The laboratory is allowed to re-verify some RMP may also have established acceptability by its standards, sources and reagents to extend their approval as an ISO Guide 34 RMP. Commercial expiration dates. However these reverifications suppliers of radiochemistry reference must meet method acceptance criteria for their standards/sources must conform to ANSI N42.22 and specific method and intended use. This has been must be accompanied by a certificate of calibration GEL's process for numerous years and the consistent with ANSI N42.22-1995, section 8. laboratory has established a track record for both Where possible, calibration certificates provide the reference materials and the producers. The traceability lo national and/or international standards of reference materials verified/reverified by the measurement. process have been subjected to numerous Calibration certificates provide measurement interlaboratory comparisons and cross-checked by results and any associated uncertainty of measurement, use of different methods over a period of many and/or a statement of compliance with the identified years.
specification. Calibration certifications are maintained as
- If results of calibration and verification are not within quality records.
the specifications for the equipment's application, When traceability to a national standard is not then:*
applicable, verification of measurement is achieved
- 1. The equipment is removed from service until through inter-laboratory comparisons, proficiency tests, repaired or independent analyses.
- 2. Under certain conditions, a deviation curve may The following measurement and traceability be. prepared. All measurements are corrected practices are described in this section:
for the deviation, recorded and maintained.
- Calibration criteria for support equipment
- Prior to use each day, balances, ovens, freezers,
- General requirements refrigerators, incubators, and water baths are
- Balances checked with NIST-traceable references (where
- Temperature-sensitive devices and temperature possible) in the expected use range .
monitoring
- If prescribed by the test method, additional
- Air displacement pipets monitoring is performed for a device used in a
- Calibration criteria for instruments critical test( such as an incubator or water bath) .
- Calibration verification
- Initial calibration verification
- Continuing calibration verification*
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
I 09-Apr-2015 Quality Assurance Plan GL-QS-B-001 Rev 29 Page 26 of l 09
- Support equipment is used only if the reference calibration criteria are still not met, the balance is standard specifications (provided by the supplier or removed from service and tagged as such.
described in the analytical method) are met. 7.1.2 Refrigerators, Freezers, Incubators, Ovens,
- Reference standards of measurement such as Water Baths, and Similar Devices Class Sor equivalent weights or traceable Careful control of temperature is often central to the thermometers may be used for calibration when production of acceptable data. Temperature excursions demonstrated that their performance as reference beyond the established limits may invalidate a standards will not be invalidated. procedure and the associated data. Constant
- Reference standards of measurement are monitoring in accordance with GL-LB-E-004 for calibrated by a body that can provide, where Temperature Monitoring and Documentation possible, traceability to a national standard. Requirements for Refrigerators, Freezers, Ovens, Incubators, and Other Similar Devices assures us that
- Reference standards and measuring and testing regulatory and/or method temperature requirements ar~
equipment are, subject to in-service checks being met.
between calibrations and verifications, in accordance with ANSl/ISO/IEC 17025-2005. We measure temperatures with thermometers that are verified annually against a NIST-traceable
- Reference materials, where possible, are traceable thermometer. The NIST traceable thermometers are to national or international standards of independently verified at least annually by a verification measurement, or to national or international service that meets the requirements of the standard reference materials. ANSl/ISO/IEC 17025-2005 standard. The protocol for
- Mechanical volumetric dispensing devices, except thermometer verification is described in GL-QS-E-007.
Class A glassware, are checked monthly for We monitor the temperature of the following equipment accuracy. according to GL-LB-E-004:
7.1.1 Balances .
- Refrigerators and freezers used to store samples, Our balances are under a service contract for standards, and other temperature-sensitive annual calibration, maintenance, and cleaning. Each materials balance is labeled with a serial number, service date,
- Incubators date of next service, and signature of the service
- Ovens technician.
- Water baths Balances are set up, calibrated, and operated in the
- Autoclaves range required by the analytical method in accordance We monitor the temperatures of refrigerators and with GL-LB-E-002 for Balances. Prior to using a freezers prior to use on each working day. The balance, the analyst is responsible for checking its temperatures of ovens, water baths, and other devices calibration. used as part of an analytical process must be Calibration and calibration verification are monitored prior to, during, and immediately after use.
performed using weights that are or have been Incubators and other devices used for microbiological calibrated against Class S or equivalent weights. or other specialized analytical methods may require These weights are traceable to NIST and calibrated more frequent monitoring as specified in the annually by a calibration service provider that meets corresponding SOP.
the requirements of the ANSl/ISO/IEC 17025-2005 Temperature measurements are documented on standard. logs specific to each piece of equipment. The logs are Calibration and calibration verification are recorded posted on or near each refrigerator, freezer, water bath, in the balance calibration logbook. If the calibration or oven, or other temperature control device. Logbooks for calibration verification does not meet the specified refrigerators, freezers, ovens and incubators with acceptance criteria, the. balance is recalibrated. If the temperature probes are found in AlphaLIMS. Each log includes the following information:
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID.number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 27 of 109
- Date and time of each measurement demonstrates compliance after being cleaned and/or
- Initials of person taking measurement repaired. Analysts whose jobs may require the use of air
- Acceptance limits for device being monitored displacement pipets are trained in their proper use and calibration.
- Whether device conforms with specifications at time of measurement 7.2 Instrument Calibrations
- Name, location, and number of device being To ensure that the data generated by an instrument monitored are accurate, we calibrate the instrument using
- Notation of any out-of-control condition standards containing known concentrations of target analytes. We verify the accuracy of calibration ..
The sterilization pressure of each autoclave run standards by analyzing an additional standard containing must be documented in addition to the sterilization the target analytes. This initial calibration verification temperature. When the process to maintain and standard (ICV) originates from a second source.
document temperatures within acceptance limits does Verification that the instrument response is reliable and not conform to specifications, a nonconformance report has not changed significantly from the current calibration (NCR) is issued. Appropriate action is then taken to curve is accomplished by the analysis of a continuing disposition the nonconformance according to GL-~S-E-calibration verification (CCV) standard. Some analytical 004 for Documentation of Nonconformance Reporting methods employ the use of CCVs at varying and Dispositioning and Control of Nonconforming Items.
concentrations.
Examples of nonconformances are:
Traceability of calibration, calibration verification, and
- Failure to maintain process temperature within other quality control standards to the recognized standard acceptance limits is documented per GL-LB-E-007 for Laboratory
- Failure of device to achieve calibration Standards Documentation. Preparation and Verification
- Total failure of temperature control device of Radioactive Standards is described in GL-RAD-M-001.
- Failure to monitor the temperature as required Individual identification numbers are assigned to each 7.1.3 Air Displacement Pipets source standard and each subsequent intermediate and working standard prepared.
Air displacement pipets offer a level of precision and accuracy exceeded only by Class A transfer The identification number makes it possible to pipets. Due to disposable tips, these pipets eliminate trace a standard to a parent standard and ultimately to the possibility of cross-contamination. the source standard. The date each standard is prepared, the protocol used in the preparation, the We calibrate air displacement pipets monthly using person preparing the standard, and the standard's five replicate measurements of a frequently used volume expiration date are documented in the appropriate setting in accordance with GL-LB-E-010 for M.ainte.nance standards log, usually maintained in AlphaLIMS. The and Use of Air Displacement Pipets. As specified 1n the information is accessible via the standard ID number.
SOP, the calibration of an air displacement pipet is verified daily prior to use, based on a single point We record standard and reagent ID numbers on measurement. instrument run logs, analytical logbooks, sample preparation logs, and instrument raw data. Calibration The acceptance criteria for each measurement are standards that are used in the analysis of a particular based on the standard deviation of the five calibration sample or group of samples can be traced to NIST, US measurements. Tolerance limits for commonly used EPA, or other nationally recognized standards.
- verification volumes and accuracy and precision checks are included in the pipet calibration logbook. Calibration procedures for specific instruments, Calibrations and daily calibration verifications are and the frequencies of performance for defined methods, traceable to each pipet using the unique identification are described in the applicable operating or analytical found on its label. SOP. Calibration is discussed in general terms in GL-QS-E-014 and includes standard laboratory practices and If a pipet does not meet the calibration tolerance formulas used for determinations made by these limits, it is removed from service until it again practices. General guidelines include:
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (I).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 28 of 109
- Verification of initial calibrations with a standard outside the acceptance criteria before the next obtained from a second source (unless one is not
- calibration, the frequency is increased.
available). CCVs may be from the same source as the
- Analysis of verification standards (ICV and CCV) calibration standards or from a second source. The with each initial calibration within 15% of the true concentration is determined by the anticipated or value unless historical data have demonstrated that known concentration of the samples and/or method-wider limits are applicable. specified levels. At least one CCV shall be at a low-
- Preparation of calibration curves as specified in level concentration.
the reference method. To the extent possible, we bracket the samples in If a test method does not specify the number of each interval (every 20 samples or every 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br />) with calibration standards, the minimum number is two, CCV concentrations closely representing the lower and not including blanks, with one at the lowest *middle range of reported sample concentrations. If this is quantitation limit. The reference SOP must establish not possible, the standard calibration checks should vary the initial calibration requirements. DoD QSM projects in concentration throughout the range of the data being have additional requirements as discussed in GL-QS- acquired.
B-002. If the recovery of a CCV does not meet the 7.3 Calibration Verification acceptance criteria and routine corrective actions fail to Unless otherwise specified by*the method or produce a second consecutive check within acceptance demonstrated through historical data, the recovery of criteria, a new initial calibration curve should be target analyte(s) in calibration verification standards constructed. Analytes of interest found in corresponding shall be between 85 -115%. We discuss additional environmental samples may be reported, however, only requirements below. if all of these criteria are met:
7.3.1 Initial Calibration Verification (/CV) 1. CCV recovery for target analyte exceeds the acceptance criteria (biased high)
- If an initial calibration curve is not established on the day of analysis, the integrity of the curve should 2. Target analyte in the environmental sample is not be verified each day of use or every 24-hour detected at a concentration exceeding the level period. Verification requires the initial analysis of a required by client contract (i.e., MDL, PQL).
blank and standard from a second source. The Non-detects that meet these criteria are also standard concentration should be at the method- referred to as "passable non-detects."
defined level. If not specified, a standard at a mid-If samples are found to contain target analytes that level concentration may be used.
exceed the associated quantitation limits, and the CCV
- If the initial calibration verification does not meet recovery does not meet the acceptance criteria, the acceptance criteria, the analytical procedure is affected samples are re-analyzed. This occurs only after stopped and evaluated, and appropriate corrective a new calibration curve has been established, evaluated, measures are taken. Initial calibration verification and accepted.
must be acceptable before any samples are 7.4 Bioassay Instrument Calibration and Frequency analyzed.
Our Bioassay instruments are calibrated at the 7.3.2 Continuing Calibration Verification (CCV) frequency of the instrument's use, stability, and method Additional standards called CCVs are analyzed requirements. The calibration procedure for each after the initial calibration curve or the integrity of the instrument is described in the corresponding analytical initial calibration curve is accepted. CCVs are analyzed SOP and is performed by those individuals proficient in at a frequency of 5% or every 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br />, whichever is the analyses described in the SOP.
more frequent. If an instrument consistently drifts 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (I).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 29 of 109 SECTION 8 ANALYTICAL METHODS AND STANDARD OPERATING PROCEDURES Section 8
- Analytical Methods and Standard A Project Management AlphaLIMS Manual (GL-CS-Operating Procedures (SOPs) M-001) is available to assist PMs and PMAs in selecting We provide a wide array of parameters including test codes and methods and communicating the client's volatile organics, extractable organics, metals, general analytical and data reporting specifications.
inorganic/wet chemistry, radiochemistry, radiobioassay 8.2 Standard Operating Procedures (SOPs) and limited microbiology. The procedures we use to We determine each parameter by the protocol determine these parameters are consistently executed detailed in the corresponding SOP. The defined protocol due to our extensive system of SOPs and our training originates from the analytical method or methods requirements for analytical staff. referenced in the SOP and may incorporate regulatory A list of our SOPs and the analytical methods they and client requirements. Descriptions of the methods we represent (if applicable) is provided in Appendix I. employ can be found in:
Discussed here are:
- EPA SW-846
- Selection of analytical methods
- EPA/600/479/020
- Standard operating procedures
- Official Methods of Analysis of the Association of
- Method validation and initial demonstration of Official Analytical Chemists (AOAC) capability
- American Society for Testing and Materials (ASTM)
- Sample aliquots
- Standard Methods for the Examination of Water and
- Data verifications Wastewater (SM)
- Standard and reagent documentation and labeling
- South Carolina Department of Health and (Refer to Section 10.1) Environmental Control (SCDHEC)
- Computers and data requirements
- Code of Federal Regulations (CFR) Titles 40 and 49 8.1 Selection of Analytical Method
- Department of Energy Environmental Project Managers are ultimately responsible for Measurements Laboratory (EML) selecting the test codes and methods assigned to a
- Los Alamos Health and Environmental Chemistry client based on client requirements and sample (LAH EC) collection techniques. In selecting methods, our goal is
. . to meet the specific needs and requirements of the client
- HASL while providing data that are scientifically valid.
- EPA CLP When the use of a specific test method is mandated, In addition to these references, a number of our only that method is used. If the analysis cannot be radiochemistry procedures were developed in performed by the client-requested method, we notify the conjunction with Florida Sate University (FSU) under the client. We do not perform method substitutions without guidance of Dr. Bill Burnett.
the client's consent. We recommend that clients who submit data to regulatory agencies also obtain the Laboratory sections have access to GEL's SOPs to agency's approval of method modifications. ensure that each operational system and analytical procedure is performed in a uniform manner. SOPs are When clients have specific process or reporting controlled according to GL-DC-E-001 for Document deviations from GEL's standard practices, the laboratory Control and are posted on the Intranet by the Document may document the deviations in contracts, case Control Officer.
narratives and/or with specific work instructions from the Project Management Team to the laboratory. Approval We write and issue SOPs in accordance with GL-of the deviations is made after consideration of all safety ADM-E-001 for the Preparation, Authorization, Change, and quality concerns have been resolved by GEL's Revision, and Release of Standard Operating management.
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page(!).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 30 of 109 Procedures. A technical and/or quality review is made of
- corrective actions for out of control or unacceptable each new or revised SOP prior to its implementation. data Technical reviews ensure that procedures are
- waste management technically sound and method-compliant, and are
- references conducted by a senior analyst, group leader, or data
- tables, diagrams, flowcharts, validation data reviewer. The quality review is an independent review
- identification of any modifications we have made to by a member of the Quality Systems team and ensures the published procedure that the quality requirements of the method, regulatory 8.3 Method Validation and Initial Demonstration of agencies, and GEL are adequately and accurately Capability identified.
Method validation requirements for Radiochemistry SOPs are modified when: are documented and maintained in accordance with GL-
- Instruments or equipment change RAD-D-002, Analytical Methods Validation for
- An *error is identified Radiochemistry.
- Improvements in technology and/or reagents need An initial demonstration of method performance is to be incorporated required before a new analytical method is implemented and any time that there is a significant change in
- Reference methods are revised or discontinued instrumentation or methodology. Exempted from this Proposed revisions are submitted for review on requirement are microbiological analyses and any tests Documentation Initiation and Revision Request (DIRR) for which spiking solutions are not available. Analyses forms. Changes are not implemented without a technical that are exempt include those for determining:
and quality review.
- total dissolved, total suspended, total volatile, and We review our SOPs annually and revise them as total solids necessary. Analytical SOPs either contain or reference
- pH other SOPs that contain:
- odor
- reference method
- color
- applicable matrix or matrices
- . free liquids
- method detection limit
- scope and application including parameters to be
- temperature analyzed
- dissolved oxygen
- method summary
- turbidity
- definitions We conduct the initial demonstration as described*in
- interferences and limitations Section 8.3.1. Records of initial demonstration are
- specific safety requirements maintained in accordance with GL-QS-E-008 for Quality
- required equipment and supplies Records Management and Disposition. These records
- reagents and standards are available upon request.
- sample collection, preservation, shipment, and After we demonstrate our ability to perform a storage specific analysis, we continue to demonstrate method
- quality control performance through the analysis of laboratory control
- calibration and standardization samples and performance evaluation samples ..
- procedure If spiking solutions or quality control samples are not
- calculations available, an analyst is trained by a qualified trainer to
- method performan_ce conduct the analysis. Analyst capability and proficiency
- pollution prevention is evaluated by the appropriate Group Leader before the
- data assessment and acceptance criteria for quality analyst is qualified to perform the analysis on client control measures samples. The evaluation is documented and maintained 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (I).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 31 of 109 according to GL-QS-E-017 for Maintaining Technical Other options for successful IDOCs are the following:
Training Records.
- PT Study- successful analysis of a PT Sample. The 8.3.1 Procedure for Initial and Continuing PT sample may be single-blind to the analyst or Demonstrations of Capability (/DOC and CDOC) double blind to the laboratory.
We conduct initial demonstrations of capability for
- Supervised Analysis- where other options are not mandated analytical or EPA reference test methods practical, supervised analysis of a procedure may following the procedure outlined below. This procedure is be used to demonstrate capability.
adapted from the EPA test method published in 40 CFR
- Analysis of authentic sample with results statistically part 136, Appendix A and the 2003 NELAC and 2009 matching those obtained by another trained analyst.
TNI Standards. IDOCs are completed whenever there is a change in instrument type, method or personnel.
- Other - this option may be used for certain CDOCs are completed annually. personnel having sufficient analytical skills to develop a new procedure, as deemed appropriate Step 1: A quality control sample is obtained from an by the supervisor or Quality Assurance personnel.
outside source (if possible). If one is not available, the 8.4 Sample Aliquots sample may be prepared internally using stock standards that are prepared independently from those When obtaining aliquots from a sample, it is used in instrument calibration. The concentration is not imperative that the subsamples be representative of the known to the analyst. parent sample. This ensures that the results obtained Step 2: The QC sample is diluted in a volume of clean from the analysis of the aliquots are representative of the matrix. Sufficient volume of the diluted QC sample is entire parent sample, not just the subsample. We employ prepared so that at least four aliquots of the required different techniques to obtain subsamples. GEL's SOP method are analyzed. Alternatively, four matrix spike for subsampling is GL-LB-E-029.
samples may be evaluated for levels of precision and We can obtain representative aliquots of soil accuracy. samples for the determination of metals through Step 3: Four aliquots of the diluted quality control sample quartering. This involves the repeated quartering of the are prepared and analyzed according to the analytical test sample until .the resulting quarter is equivalent to the method. This may occur concurrently or over a period of amount of sample needed for analysis. Quartering may days. not be appropriate for obtaining subsamples for volatiles Step 4: With the results obtained from the analysis of or other analyses where potential contamination or loss the diluted QC sample, the average recovery (x) in the of target analytes is a concern.
appropriate reporting units (such as µg/L) and the Water samples are inverted several times prior to standard deviation of the population sample (n-1) (in the the collection of a subsample. This ensures a thorough same units) are calculated for each parameter of mix and is absolutely required for the accurate interest. determination of analytes like total and total suspended Step 5: For each parameter, the standard deviation (s) solids.
and the average recovery (x) are compared to the The appropriate techniques for obtaining sample corresponding acceptance criteria for precision and aliquots for designated analyses are discussed in the accuracy in the test method (if applicable) or in applicable SOPs.
laboratory-generated acceptance criteria. If "s" and "x" 8.5 Data Verification for all parameters meet the acceptance criteria, analysis of samples may begin. If any one parameter exceeds All of the data we include in final reports to our the acceptance range, the performance is unacceptable clients undergoes extensive data verification. At GEL, we
- for that parameter. have a multi-level review process that takes place in all Step 6: When one or more tested parameters fail one or areas of the laboratory beginning with sample login. This more of the acceptance criteria, we locate and correct process and the responsibilities of each level of review the source of the problem and repeat the test for every are delineated in a number of procedures, including GL-parameter of interest. GC-E-092 for General Chemistry Data Review and Packaging, GL-MA-E-017 for Metals Data Validation, 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (I).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 32 of 109 and GL-RAD-D-003 for Data Review, Validation, and
- Raw data are in agreement with the computer Data Package Assembly. generated batch sheets and data reports.
8.5.1 Sample Login:
- The calculations, dilution factors, concentration Samples are analyzed by the methods and for the reported, and nominal concentrations are verified.
target analytes identified when samples are logged into
- Comments, qualifiers, or nonconformances for our database. If there is an error in this entry that is not noncompliant or questionable data are promptly identified, the incorrect.analytical method may documented.
be used or certain analytes may not be determined.
- Data generated when the analytical process To prevent this, the person who enters the appears to be out of statistical control are not information into the database is generally the client's reported.
assigned Project Manager or PM Assistant. This entered 8.5.3 Validation of Data Reports and Packages information is reviewed against the client confirmation Before we report data to the client, we review the letter and/or chain of custody. If errors are identified, requested data report for package accuracy, they are immediately corrected. completeness, and client-specifications.* Responsibilities 8.5.2
- Data Validation in the Laboratory for review are dependent upon the type of report or The multi-level review process in our laboratory package being generated. (Refer to Section 11 for includes initial review by the analyst, a second r~view by Laboratory Report Formats.)
a peer, and a final review by a group leader or data When a client is receiving a certificate of analysis or reviewer. Where appropriate based on personnel and certificate of analysis and Quality Control Summary client needs, the industrial division institutes two levels of Report, the Project Manager (PM) or Project Manager review. Assistant (PMA) reviews the information for accuracy, Our analytical data reviews ensure that: completeness and the addition of pertinent comments made by the laboratory about the analysis or sample.
- The analytical procedures comply with current The PM or PMA also reviews data for consistency as SOPs. described in the Project Management AlphaLIMS
- Quality control samples are analyzed at the Manual, GL-CS-M-001. For Bioassay results, the frequency specified in the SOP or client package is then reviewed for completeness by validator, specifications. team or group leader as described in GL-RAD-B-026.
- The acceptance criteria for quality control If a client requests a case narrative, our data samples are met, including recoveries of matrix validators review the analyst-prepared case narrative for spikes and laboratory control samples, the relative accuracy and to assure its consistency with the percent difference for matrix duplicates, matrix information included on the certificate of analysis and spike duplicates, laboratory control sample Quality Control Summary Report. If a client requests a duplicates, and concentrations of target analytes more detailed level of data package up to and including in the method blank. a CLP-like package, every laboratory fraction of data is
- Instrument data, run logs, and logbooks are reviewed by that fraction's data validator. The data are reviewed to ensure that all method quality control then compiled into a final data package.
criteria were met (e.g., calibration, initial 8.6 Standard and Reagent Documentation and calibration verifications, and continuing calibration Labeling verifications).
The documentation and labeling of standards and
- Documentation is sufficient to reconstruct the reagents is addressed in GL-LB-E-007 and GL-RAD-M-analytical procedure.
001 for Laboratory Standards Documentation, and in
- Data are maintained according to GL-LB-E-008 Section 10.1 of the QAP, Recordkeeping *System and for Basic Requirements for the Use and Design.
Maintenance of Laboratory Notebooks, Logbooks, Forms, and Other Recordkeeping Devices.
2040 Savage Road Charleston* SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 33 of 109 8.7 Computer and Electronic Data Related revision software or other procedures prior to production Requirements use.
Our Information Management System (IT) SOPs Analytical software that is purchased from a vendor describe the way in which we manage our software is validated and verified in accordance with GL-IT-E-005 programs and hardware systems. Control of software for Requirements, Design, Operation, Validation, and development and modification activities is described in Removal of Applications Used by The GEL Group, Inc.
GL-IT-E-003 for Requirements, Design, Operation, Documentation requirements are also described in this Validation, and Removal of Hardware and Software SOP.
Systems Used by the GEL Group, Inc. All development Electronic signature requirements for confidentiality and revision activities are validated, and revision of records are described in GL-IT-E-001 for Instrument activities are validated, verified, and controlled with Technology Program for Good Laboratory and Good Manufacturing Practices.
- 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page(!).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 34 of 109 SECTION 9 SAMPLE HANDLING, ACCEPTANCE, RECEIPT, AND INTERNAL CHAIN OF CUSTODY Section 9 - Sample Handling, Acceptance, Receipt,
- Contractual agreement for analytical services over a and Internal Chain of Custody designated time period or project that delineates the The way we receive and handle samples is critical specifications agreed upon.
to providing our clients with data that are of the highest
- When the laboratory agrees to perform analyses quality and are legally defensible. We have strict policies with exceptional departures from normal processes, th.at govern the acceptance and receipt of a sample, these exceptions are clearly defined in the client-sample handling and integrity, maintenance of the laboratory agreement.
internal chain of custody, and storage of the sample 9.2 Sample Labels and Chain of Custody Forms upon completion of the required analytical processes.
This section describes the policies and practices that we Once an agreement is established, we assume joint employ, including the following: responsibility with the client to ensure that the samples submitted are properly labeled and accompanied by full
- Agreements to perform analysis and complete documentation that includes chain of
- Proper labeling of submitted samples custody and, where possible, material safety data
- Chains of custody sheets. Samples that are submitted without proper
- Sample receipt procedures documentation may be refused.
- Sample receipt procedures for radioactive samples Sample labels should include the:
- Sample tracking
- client's sample identification
- Sample storage
- location, date, and time of collection
- Sample disposal
- collector's name 9.1 Agreement to Perform Analysis
- chemical preservatives used Before we accept samples, we should have an
- constituents of interest (if space permits) agreement with the client that specifies the analytical When requested, we ship labeled sample containers methods, the number of samples to be analyzed, the with appropriate preservatives and a chain of custody to price for the analysis, the date by which the client must the client for use during sample collection. There are receive results, and the reporting format. Any special several advantages to using these containers .. including:
requirements the client may have, such as non-routine
- Dedication of appropriate type sample container for methods and reporting limits, should be part of that the intended analyte or analytical method.
agreement.
- Proper sample preservation for analytical test An agreement to perform analysis should be in one of three forms, further detailed in our Analytical Services
- Traceability of bottle lot number to the Reference Manual and the SOPs for Delegated Authoriity manufacturer's certification that the containers are to Commit the Company and Request for Proposal (RFP) clean and show no signs of contamination.
and Contract Review (GL-CO-E-002 and GL-CO-E-003): Chain of custody forms include the following
- Client confirmation letter (CCL) between the client information and are initiated at the time of sample and project manager for a specific group of samples. collection:
This letter includes the cost, turn-around time,
- name and address of client requested analysis, sample matrix, number of *
- client sample identification samples, and type of client report.
- date and time of sample collection
- Sample acceptance by the Project Manager from an
- sample matrix established client based on previously agreed
- description of sampling site location conditions and confirmed by the client's submission of the sample(s). * .number of containers 2040 Savage Road Charleston SC 29407 (843) 556-~ 171 This document is controlled only when an original Set ID number appears on the cover page (I).
Uncontrolled documents do not bear.an original Set ID number.
Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 35 of 109
- methods, chemical and physical constituents for of custody and the Sample Review Receipt form. As which the analyses are to be conducted detailed in GL-SR-E-001, the sample custodian should:
- preservatives
- Inspect all sample containers for integrity.
- date and signature of person who collected the
- Document any unusual physical damage or signs of sample tampE;lring with custody seals.
- date of transfer and signature of person
- Place any samples that appear to be leaking or relinquishing sample to the laboratory. have unusual odor under the fume hood while When our Field Services personnel collect samples, notifying the responsible project manager.
our standard chain of custody form and certified
- Review the chain of custody submitted by the client containers are automatically used. Our standard chain of for completeness.
custody forms are also available to our clients and are
- Compare descriptions and other information on the included with each shipment of pre-labeled and sample container labels to that listed on the chain of preserved containers. GEL chain of custody forms custody.
should always be used unless otherwise agreed to by contract.
- Verify the sample is within the regulatory holding time for the analyses.
9.3 Sample Conditions
- Measure and record the temperature of sample In addition to properly documenting sample aliquots that are to be used for analyses requiring container labels and the chain of custody form, we need thermal preservation.
to make sure that samples meet the established requirements for analytical testing. This is particularly
- Measure and record the pH of all sample aliquots critical for samples that are being analyzed to meet submitted for analyses that require chemical regulatory requirements. preservation to a specific pH.
- Verify that there are adequate sample aliquots for Samples should be collected in the appropriate type the requested analyses.
of container, preserved as directed, and stored in the conditions specified in the analytical method or
- Verify that appropriate sample containers were used established regulatory guidelines. In add_ition, samples for requested analyses.
should be submitted with sufficient time to conduct the If the sample custodian discovers any abnormalities specified analysis within the regulatory or method or departures from standard conditions, the PM is holding time. Aliquots should be of sufficient volume to informed immediately. The PM will then notify the client perform the requested analyses. A summary of these as quickly as possible so that a decision can be made to conditions and holding times for routine analyses can be proceed with the analysis or submit another sample or found in Appendix J. additional sample aliquots.
9.4 Sample Receipt Common abnormalities or departures from standard Samples submitted to us are received in a central conditions include:
sample receiving area by our sample custodian or login
- Sample containers with signs of damage, leaking, or clerk. Every sample is subject to the protocols established tampering.
in GL-SR-E-001 for Sample Receipt, Login and Storage.
- Incomplete/missing chain of custody.
Our sample custodian acknowledges receipt of a NOTE: If a nonradioactive sample has no chain of sample by signing the chain of custody and recording the custody, the sample custodian should initiate one.
date and time custody was transferred from the client to "INITIATED ON RECEIPT" should be documented on the laboratory. The date, time, and person receiving the the chain of custody.
sample are also recorded on a standard or client-specific Sample Receipt Review (SSR) form.
- Discrepancies between the information on the chain of custody and the sample container labels.
The sample custodian is also responsible for noting the condition of a sample upon its arrival. This
- Method or regulatory holding time is exceeded.
information may be recorded on both the sample chain
- Sample is not preserved to the method or regulatory-required pH.
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 36 of 109
- The sample container does not meet metho.d or
- If a sample is labeled as radioactive, the custodian regulatory criteria. will immediately inform the Radiation Safety Officer
- The sample temperature exceeds or falls below the (RSO) before opening the sample.
- thermal preservation regulation or method
- The radioactivity of the sample will be measured by requirement of 0° ~ 6° C. scanning the exterior surface of the cooler using a NOTE: If a sample is hand delivered to the laboratory survey meter calibrated in mR/hr. Refer to GL-RAD-immediately after collection with evidence that the S-001 for our Radiological Survey Procedures.
chilling process has begun (arrival on ice), the sample
- If the radioactive level of the.exterior of the cooler shall be deemed acceptable. exceeds 0.5 mR/hr, the RSO will be notified before the cooler is opened.
- Radioactivity that exceeds that allowed by our radioactive license. (The handling of radioactive
- If the radioactivity level of a sample or group of samples is discussed in 9.5.) samples is found to exceed 25 mR/hr, the RSO will be notified immediately. The client will be contacted Samples that are not appropriate for the requested and arrangements will be made to return the analyses or have no full test specifications require: sample(s) or reduce the per sample exposure.
- Retention of all 'correspondence and records of
- If a chain of custody is not submitted with a sample, conversations concerning the final disposition of the it will be placed on hold until a chain of custody is sample. submitted.
- . Full documentation on the chain of custody and
- The inside of the cooler will be surveyed to ensure Sample Receipt Review form of the nonconforming that no leakage or contamination has occurred.
condition and a decision to proceed with analysis.
- Each sample container will be surveyed and the
- Documentation that the analysis is qualified highest reading will be documented on the appropriately on the final report. Radioactive Shipment Inventory.
9.5 Receipt of Radioactive Samples 9.6 Sample Tracking The radioactive samples we receive are subject to We track the samples we receive by a unique the same monitoring identified in 9.4 when radioactivity laboratory identification number that is automatically levels do not exceed the level permitted by our license. assigned when information pertaining to the sample is Special procedures governing the receipt of radioactive first entered into our database. Pursuant to GL-SR-E-samples are described in the GL-RAD-S-007 for the 001, the following information is entered for each sample Receiving Radioactive Packages. These procedures received:
prevent the inadvertent spread of radioactive contamination.
- client and/or project code
- client sample ID Because we cannot exceed the limits of our
- sample matrix radioactive license, it is imperative that our clients notify
- equivalent laboratory sample matrix us of impending shipments of radioactive samples. We
- type of report format specified by client reserve the right to refuse and return any radioactive sample where the radioactivity:
- date and time of collection
- date received
- Exceeds our permitted level by itself or in
- initials of person making entries combination with other samples already on site; or
- number of containers submitted for the sample
- Exceeds our administrative level of 25 mR/hr.
- requested analyses The following special requirements for receiving
- pertinent observations or comments affecting the radioactive samples are applicable:
- sample analysis or rejection
- Only designated staff trained in the proper handling As soon as this information is entered, AlphaLIMS of radioactive materials handle radioactive samples. automatically assigns a unique number to the sample and its containers. We use the number to track the location of a sample container and to link to any subsamples and subsequent digestates and extracts.
2040 Savage Road Charleston SC 29407 (843) 556-817 l This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 37of109 The unique laboratory identification number is
- Provide evidence that the sample was stored in printed on a durable barcode label that contains the accordance with method and regulatory protocols client identification, sample date and time. Once The electronic internal chain of custody is stored in labeled, the sample container's identification number is AlphaLIMS so that information demonstrating the proper uploaded into the database by scanning the barcode. maintenance of custody can be provided to the client on Information included in the database at the time of the data reports or electronic data deliverables.
sample scanning is the container's storage location, bottle type and volume, physical characteristics of the 9.8 Sample Storage bottle, preservative, and the initials of the person In order to ensure the maintenance of sample entering this information. Entering of this information integrity, all aliquots are stored in secured areas into the database is an important part of initiating our designated for sample storage. The storage location of electronic internal chain of custody. each sample aliquot can be tracked using the internal 9.7 Internal Chain of Custody chain of custody. Areas designated for sample storage include:
Chain of custody procedures ensure traceability and sample integrity. Our legal and evidentiary chain of
- Main cooler where most samples requiring custody protocol establishes a continuous record of the maintenance at a temperature range of 0° ,'.: . 6° C are physical possession, storage, and disposal of sample stored.
containers, collected samples and aliquots, and sample
- Volatile coolers for samples to be analyzed for digestates or extracts. volatile contaminants.
The internal chain of custody starts with the
- Radioactive cooler for segregation of radioactive scanning of a container's barcode label into an electronic sample aliquots requiring refrigeration.
database while identifying the location of the sample and
- Ambient storage for non-radioactive samples not the person having custody, or placing the sample in a requiring refrigeration.
secured storage area. If we supply the containers, the
- Ambient storage for radioactive samples.
chain of custody may begin when the containers are
- Refrigerators for the storage of samples requiring provided to the client.
bacteriological analysis and temporary storage for With regard to the internal chain of custody, a those requiring the determination of biochemical sample is defined as being in someone's custody if: oxygen demand.
- It is in one's actual physical poss~ssion The temperature of each refrigerated storage unit is
- It is in one's view after being in one's physical monitored daily and documented per GL-LB-E-004 for possession Temperature Monitoring and Documentation
- It is in one's possession and then is locked up so Requirements for Refrigerators Freezers, Ovens that no tampering may occur Incubators, and Other Similar Devices. In addition, the main and radioactive coolers are monitored twenty-four
- It is kept in a secured area restricted to authorized hours a day by temperature sensors that are connected personnel only to our main security system. If the temperatures exceed The protocol for ensuring sample integrity using the the required range, an alarm is sounded and the security internal chain of custody is detailed in GL-LB-E-012 for system notifies the facilities manager or his designee Verifying the Maintenance of Sample Integrity. The* immediately. This allows corrective actions to be electronic internal chain ,of custody works in conjunction initiated promptly.
with the chain of custody submitted by the client with a Prior to and immediately after analysis, samples and sample to:
their digestates and extracts are stored in compliance
- Account for all time associated with a sample, its with the requirements of the requested analytical subsamples, and extracts or digestates from the methods and GL-SR-E-001 for Sample Receipt, Login, time the sample is received at GEL to its disposal and Storage. If a single aliquot is supplied for analyses
- Identify all individuals who physically handled the by several methods, the most stringent analytical storage sample requirements are applied to the sample.
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 38 of 109 If samples are to be analyzed for volatile organic LB-G-001 and can be divided into two categories: those compounds, they are stored in designated volatile governing the disposal of sample laboratory waste, and coolers that are maintained at a temperature range of 0° those governing the disposal of residual client sample .
< 6° C. No sample aliquots are stored in these after the completion of all analyses.
refrigerators unless they are to be analyzed for volatiles. 9. 9. 1 Sample Laboratory Waste These storage units are monitored on a weekly basis for contamination by the analysis of volatile cooler storage Unless otherwise r~quested by contract, laboratory blanks. . waste is collected in designated satellite containers found in sample collection and accumulation areas.
At the beginning of each month, two 40 ml vials are . These areas are monitored by both the waste
- filled with treated deionized water, which is used for department and analysts trained in waste collection.
volatile method blanks and placed in each monitored Wastes are segregated based on the type of hazard they cooler. Each week, two vials may be analyzed by EPA present. I.e. radioactive, acid, base solvent, etc. when 8260B and the data are reported to the Quality containers are full, the waste department is notified and Department. If the analysis reveals evidence of potential the containers are removed from the laboratory for contamination, appropriate corrective actions are disposal. Direction for disposal activities, such as immediately implemented. SOP GL-OA-E-058 discusses packaging, shipping, and disposal site selection are the laboratory practices pertaining to monitoring and provided in the Laboratory Waste Management Plan testing for VOA contamination. (GL-LB-G-001).
Sample aliquots for non-volatile analysis, which also 9.9.2 Residual Client Sample should be maintained at 0° < 6° C, are stored in the main cooler unless they areradioactive. In order to Unused client sample material that is not consumed reduce the chance of contamination, radioactive samples during the sample preparation or analytical procedures is are stored in a designated cooler. either disposed of in accordance with the Laboratory Waste Management Plan (GL-LB-G-001) or at the client's request, Sample aliquots designated for the determination of returned in accordance with GEL's SOP GL-SR-E-002 for total coliform bacteria, fecal coliform bacteria, or total Transportation and Shipping of Samples.
plate count are delivered to the bacteriology laboratory and stored in the designated refrigerator at a temperature It is our policy to hold samples for a minimum of range of 0° ~ 6° C. This allows easy access f?r th.e sixty days after invoicing and before disposal, unless analyst ensuring that the short regulatory holding times otherwise specified by contract or if the sample is part of are met. After analysis is complete, the remaining litigation. If the sample is part of litigation, disposal of sample aliquot is disposed of in accordance with the the physical sample shall occur only with concurrence of Laboratory Waste Management Plan. the affected legal authority, sample data user, and/or client.
Sample aliquots to be analyzed for biochemical
. oxygen demand (BOD) are also delivered to the When sample analyses are complete and regulatory bacteriology laboratory and stored in the designated and/or contractual holding times have expired, samples BOD cooler. This cooler is also maintained at 0° ~ 6° C. are moved from their storage locations to the radioactive After initiation of this analysis, the sample aliquots are or non-radioactive archives. Samples that are to be returned to the main cooler. returned to the client or held for an extended time period are segregated from the other samples. Radioactive and After all analyses are complete and results are non-radioactive samples remain segregated.
submitted to the client, sample aliquots are transferred to the sample archive area. They are stored in this area When internal or client-specified storage time expires, until they are disposed. samples with like matrices are composited into .
appropriate containers. The composites are then subject Radioactive and non-radioactive samples remain to the same treatment and disposal protocol. Samples segregated in archive to reduce the risk of contamination. that are approved for disposal are scanned into our LIMS 9.9 Sample Disposal and assigned the status of "Disposed."
Our policies concerning sample disposal are described in the Laboratory Waste Management Plan, GL-2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 39 of 109 SECTION 10 RECORDS Section 10
- Records 10.1 Recordkeeping System and Design Our quality records provide the documentation we We manage, maintain and store our quality records need to support analytical results and conclusions. according to GL-QS-E-008 for Quality Records Documented evidence that quality assurance and quality Management and Disposition. The protocols established in control requirements have been met is critical to *this document work in conjunction with those for specific providing data that fulfill the specifications of applicable* types of records addressed in other SOPs to govern our procedures, programs, and contracts. record keeping system. Our record keeping system allows As described in Section 3 of this Quality Assurance the historical reconstruction of all laboratory activities that Plan (QAP), quality records include but are not limited to: produced analytical data.
We facilitate historical reconstruction by maintaining
- Observations the following records and information, from the time a
- Calculations sample is received until it is disposed.
- Calibration data
- Certificates of analysis
- A master list of all employee signatures and initials is
- Certification records maintained in Human Resources. This allows the
- Chains of custody identification of any GEL personnel who accept, handle, analyze, prepare, review, store, or dispose of
- External, supplier, and internal audits a sample, its subsamples, associated data and
- Run logs reports, and other related documentation ..
- Instrument data and analytical logbooks
- If we provide bottles and containers to a client or
- Instrument, equipment and building maintenance sampling personnel, these records are kept in logs accordance with GL-SR-E-002 Transportation and
- Material requisition forms Shipping of Sample and Pre-preserved Sample
- Monitoring logs Containers. These electronic and paper records
- Nonconformance reports include: *
- Corrective actions
- Supplier and lot numbers of containers and/or
- Method development and start-up procedures bottles provided including MDL studies
- Training records
- Certifications that the containers are free of .
contaminates that may bias the analyses
- Waste management records
- Standard logs
- Addition of preservatives and identity of person
- Software validation responsible for this preservation.
- Standard operating procedures (SOPs)
- Barcode of containers supplied to a particular
- Sample collection and field data client or for a specific field-sampling event.
Our procedures provide a legal and evidentiary The person or agency responsible for collecting a chain of custody and are described in Section 9 of this sample is documented on the chain of custody and QAP. Described in this section are: entered into AlphaLIMS. Other records supporting the acceptance of a sample include:
- Record keeping system and design
- Records management and storage
- Date and time of sample receipt
- Sample handling records
- Person accepting sample
- Records of support activities
- Condition of sample upon receipt
- Analytical records
- Client-confirmation letter and/or sample quote
- Administrative records
- Client chain of custody 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (I).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 40 of 109
- Electronically generated sample ID numbers specific is performed on equipment or instruments is recorded in to each sample aliquot and linked to the client's the maintenance log specific to the instrument. We sample description, sample collection and receipt document these records in accordance with GL-LB-E-information, and analyses to be performed. 008 for Basic Requirements for the Use and
- Identification of each person who has custody of a Maintenance of Laboratory Notebooks, Logbooks, Forms sample, its subsamples, extracts, or dig estates. and Other Recordkeeping Devices.
(This is provided through the internal chain of The standards containing known quantities of target custody procedures described in Section 9.) analytes that we use in instrument calibration, calibration Documentation that materials purchased for use in verification, and as quality control samples, such as matrix the analysis or preparation of samples meet spikes and laboratory control samples, are documented specifications is maintained in accordance with GL-RC- according to GL-LB-E-007 and GL-RAD-M-001 for E-001 for Receipt and Inspection of Material and Laboratory Standards Documentation. These records Services. contain the following information.
Records of equipment calibrations are maintained
- Protocol by which each standard was prepared and traceable by date and ID number to a specific
- Traceability of each child standard to its parent analysis. These records include certifications of
- Date each standard was prepared calibration and service that have been initialed or signed.
- Initials of person preparing the standard Our thermometers are verified against the NIST
- Expiration dates traceable thermometer and records of this verification are
- Concentration of *each standard maintained as described in GL-QS-E-007 for This information allows us to document that the Thermometer Verification. Records of the daily and standards used were prepared in accordance with the monthly calibration verifications of our analytical balances established protocol, produced using source standards are kept in accordance with GL-LB-E-002 for Balances. that meet the method and regulatory criteria, and used The calibration records for our air-displacement pipets are prior to their expiration date.
maintained in pipe! calibration logs specific to each pipe! If required, reagents used in the preparation, according to GL-LB-E-010 for Maintenance and Use of Air dilution, and analysis of samples are verified to be free of Di~placement Pipets.
- interferences or target analytes. We record these When methods and/or regulations specify that verifications in the reagent logs in accordance with GL-samples, subsamples, extracts, and/or digestates be LB-E-008 for Basic Requirements for the Use and stored at designated temperatures, or when the method, Maintenance of Laboratory Notebooks, Logbooks, Forms itself, has temperature sensitive steps, we document and Other Recordkeeping Devices.
those temperatures on monitoring logs at the frequency Analytical and sample preparation methods applied defined in the corresponding SOPs. We can trace the to each sample aliquot are documented via the internal specific storage location of a sample through the internal chain of custody, method information, and information chain of custody. recorded in lab notebooks, sample preparation logs, run We require that the initials of all personnel logs, and instrument data. The laboratory protocol we responsible for monitoring temperatures be recorded in employ during analysis is dictated by the SOP in effect at the temperature monitoring logs pursuant to GL-LB-E- the time the sample was analyzed or prepared by a 004 for Temperature Monitoring and Documentation specific method.
Requirements for Refrigerators, Freezers, Ovens, Run logs, laboratory notebooks, instrument data and Incubators and Other Similar Devices. The logs are sample preparation logs are used to document the reviewed for completeness in accordance with GL-QS-E- preparation and analysis of samples and the associated 005 for Review of Monitoring Device Logs. instrument calibrations. These logs and notebooks are Documentation on the instruments and equipment governed by GL-LB-E-009 for Run Logs and GL-LB-E-used for the analysis of samples is recorded in run logs, 008 for Basic Requirements for the Use and laboratory logbooks, instrument data and/or sample Maintenance of Laboratory Notebooks, Logbooks, preparation logs. Routine or corrective maintenance that Forms, and Other Recordkeeping Devices. As stated in 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 41 of 109 these SOPs, sample preparation and analytical records Records of samples being disposed or returned to that are not electronically generated should be: the client are documented in accordance with GL-SR-E-
- Legible 002 for Transportation and Shipping of Samples and Pre-Preserved Sample Containers. Such records
- Recorded in permanent ink include the date samples are returned or disposed, the
- Corrected using one line marked through the error, destination of the samples, and name of the person initialed and dated transferring the samples.
- Initialed by the responsible party 10.2 Record Storage We maintain electronic records for each analytical batch. These records include the ID numbers of each We store quality records in compliance with GL-QS-client and quality control sample prepared and/or E-008 for Quality Records Management and Disposition.
analyzed together, the method of preparation and The records are:
analysis, and the matrix of the samples included in the
- Stored in a secured area to maintain data integrity batch. and protect client confidentiality, including any Through our electronic statistical process control national security concerns.
system (SPC), the acceptance criteria applied for all
- Kept in areas where they are protected from fire quality control (QC) samples are stored and maintained. loss, environmental deterioration, and, in the case of The acceptance limits for target analytes are method, electronic records, electronic or magnetic sources.
matrix, and time-period specific; which allow us to
- Indexed and filed in a manner allowing for ready regenerate the criteria applied to QC samples associated retrieval.
with identified client samples.
- Accessible to the client for whom the record was Our Quality Systems Team maintains the records of generated.
nonconformances and corrective actions associated with
- Retained for an identified period of time that equals specific samples, batches, and processes. We maintain or exceeds ten years as determined by applicable these records according to GL-QS-E-004 for the law and client contract requirements.
Documentation of Nonconformance Reporting and Dispositioning and Control of Nonconforming Items; and Electronic data records are stored on compact GL-QS-E-002 for Conducting Corrective/Preventative disks.
Action and Identifying Opportunities for Improvement.
- All of the hardware and software we need to Electronic data records are maintained in a secured reconstruct data is maintained according to GL-IT-E-003 database designed to protect th.e integrity of the data. for Requirements, Design, Operation, Validation and Data that are uploaded directly from instruments and that Removal of Hardware and Software Systems Used by are manually entered are backed up by a second the GEL Group, Inc. Records that are stored or system. generated by network or personal computers have either hard copy or write-protected backup.
Permanent records of electronic data deliverables are maintained along with the corresponding sample 10.3 Sample Handling Policy preparation and analytical data review records. This Records of all procedures applicable to samples are documentation includes the initials of the reviewer and maintained in our possession. These records include date of the review. documents that pertain to:
Records of the data we report to our clients are
- Preservation, including sample container and maintained in a manner that protects client confidentiality, holding time as well as any potential national security concerns. These
- Sample identification, receipt, acceptance or records include copies of certificates of analysis, quality rejection, and login control summary reports, case narratives, CLP forms, and *.
Sample storage and tracking including shipping other information we provided to the client. The copies receipts, transmittal forms, routing and assignment may be paper or electronic. The majority of the data records packages submitted to Federal clients are stored electronically prior to being submitted to the client.
2040 Savage Road Charleston SC 29407 (843) 556-817 I This document is controlled only when an original Set ID number appears on the cover page(!).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 42 of 109
- Sample preparation (ID codes, cleanup and 10.5 Analytical Records separation protocols, volumes, weights, instrument We document and maintain analytical records, such printouts, meter readings, calculations, reagents) as strip charts, tabular printouts, computer data files,
- Sample analysi~ analytical notebooks, and run logs according to GL-LB-
- Standard and reagent origin, receipt, preparation, E-008 for Basic Requirements for the Use and and use Maintenance of Laboratory Notebooks, Logbooks,
- Equipment receipt, use, specification, operating Forms, and Other Recordkeeping Devices, and GL-LB-conditions and preventative maintenance E-009 for Run Logs.
- Instrument calibration frequency and acceptance The information that is documented in analytical criteria records includes:
- Data and statistical calculations, review,
- Laboratory sample ID code confirmation, interpretation, assessment and
- Date and time of analysis reporting conventions
- Instrument ID and operating conditions/parameter
- Method performance criteria including expected (or reference to such data) quality control requirements
- Method of analysis
- Quality control protocols
- All calculations
- Electronic data security, software documentation
- Dilutions and verification, software and hardware audits,
- Initials of analyst or operator backups and records of any changes to automated
- Units of measurement data entries Our policy is to produce and maintain analytical
- Automated sample handling systems records that are:
- Disposal of hazardous samples
- Accurate 10.4 Records of Laboratory Support Activities
- Reviewed and verified In addition to sample handling records,_ we maintain
- Legible and understandable the following:
- Traceable and authentic to their source
- Original raw data for calibrations, samples and
- Grouped in a contemporary manner with data quality control measures, including worksheets and entered and information recorded as it is obtained data output records (chromatograms, strip charts, 10.6 Administrative Records and other instrument readout records)
A number of pertinent records are maintained by
- A written description of or reference to the specific Human Resources or Quality Systems, including:
method used, including the computational steps used to translate parameter observations into a
- Staff qualifications and experience.
reportable analytical value
- Training records, including initial demonstrations of
- Copies offinal reports proficiency. (Refer to procedure GL-HR-E-002 for
- Archived standard operating procedures Employee Training.) '
- Correspondence relating to project-specific
- A log of names, initials and signatures for individuals laboratory activities having responsibility for initialing laboratory records.
- Corrective action reports, audits and audit We monitor continuing demonstrations of proficiency responses through AlphaLIMS per GL-HR-E-002 for Employee
- Proficiency test results Training.
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 43 of 109 SECTION 11 LABORATORY REPORT FORMAT AND CONTENTS Section 11
- Laboratory Report Format and Contents
- Types of data packages and reporting formats Accurate data are of little benefit to a client unless
- Review of data packages and reports they are reported in a format that is easy to interpret and 11.1 Certificates of Analysis provides all pertinent information relating to the analysis We have two primary C of A report formats, Level 1 of a sample. At GEL, we have developed certificate of and Level 2. Both contain the following information analysis report formats that meet the different needs of when applicable:
our clients, yet provide all of the information necessary to satisfy regulatory requirements while allowing for the
- Title interpretation of the data. Each format provides
- GEL address and phone number accurate, clear, unambiguous and objective data.
- Name of PM or person serving as the primary client In addition to a certificate of analysis, a client can contact request and receive an extended data package. This
- Barcode identification of the C of A package may include any of the following: certificates of
- Number of page and total number of pages analysis; summaries of quality control; case narratives; * . Name and address of client, where appropriate instrument data; sample preparation data; measurement
- Project name or code if applicable traceability and calibration information; and electronic
- Client-provided sample description data deliverables. If clients require the reporting of data
- Unique laboratory ID number for the sample following the established contract laboratory protocol
- Sample matrix (CLP), we can provide a CLP-like data package that will
- Characterization and condition of the sample where meet their needs. relevant It is important that the certificate of analysis format
- Date of receipt of sample and data package requirements be discussed with the
- Date and time of sample collection, if provided
.client prior to our acceptance of the samples. Project
- Date and time of sample analysis, reanalysis, and/or Managers and contract staff are responsible for sample preparation establishing an agreement with the client concerning
- Initials of analyst and person responsible for sample data reporting and the potential cost to the client for data prep packages and/or specialized reporting. Our analytical
- Analytical batch number data are reported to three significant figures unless ** Sample analysis and preparation methods (or otherwise required by client contract. unambiguous description of any non-standard Laboratory reports and data packages are stored method used) and transmitted in a manner that protects client
- Reference to sampling procedure confidentiality and potential matters of national security.
- Additions to or deviations or exclusions from the test No reports or data packages are released to persons or method, and other information relevant to a specific organizations outside GEL without the expressed test, such as environmental conditions and the use consent of the client. If directed by a regulatory agency and meaning of data qualifiers or subpoenaed to submit documents to a court of law, we will notify the client of the demand and the records
- Nonconformances that affect the data being released.
- Whether data are calculated on a dry weight or wet The following elements of report formats and data weight basis packages are described in this section:
- Identification of the reporting units, such as µg/L or mg/kg *
- Certificates of analysis (C of A)
- Quality control summary reports (QCSR)
- Statement of the estimated uncertainty of the test
- Analytical case narratives result, if applicable
- Electronic data deliverables (EDDs)
- Signature and title of the person(s) accepting responsibility for the content of the C of A 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 44 of 109
- Date C of A was issued
- Percent recoveries. for LCS and matrix spikes
- Clear identification of data provided by outside
- Relative percent differences for the matrix spike sources, such as air temperature or ambient water duplicates, matrix duplicates, and LCS duplicates temperature
- Analytical batch number with which the quality
- Identification of the reporting detection limit (RDL) or control data is associated practical quantitation limit (PQL) for each analyte, if
- Parent sample numbers for matrix spikes, matrix applicable. duplicates, and matrix spike duplicates If a portion of the sample analysis is subcontracted,
- Sample or sample delivery group ID the C of A will identify the subcontractor or applicable
- Project code accreditation number, and the data that was determined
- Date issued, page numbers/total number of pages by the subcontracting laboratory
- Identification of recoveries or relative percent Level 2 Certificates of analysis contain the following differences that do not meet the acceptance criteria additional information:
11.3 Analytical Case Narratives
- Dilution factors Analytical case narratives are written by an analyst
- Method detection limits or data validator to describe the overall conditions
- Surrogate recoveries and the acceptance criteria for affecting the analysis of a batch or a specific sample in all. organic analyses the batch. Case narratives usually include:
- Estimated concentrations determined for nondetects
- Sample delivery group ID number and appropriate "U" and "J" qualifiers for nondetects and concentrations that fall between the MDL and
- Analytical batch number PQL respectively.
- Methods of preparation and analysis Once issued, a C of A is.not altered unless a
- Sample matrix subsequent C of A is identified as a revised report.
- Initial of person preparing and/or reviewing the 11.2 .Quality Control SummarY Report (QCSR) narrative We prepare and analyze samples in groups of twenty
- Specific sample ID numbers or less. The quality control data that demonstrate the
- Identification and description of batch quality control sample preparation and/or analytical efficiency of the . samples including parent sample identification batch are summarized on a QCSR. The data reported on
- Affirmation that all sample preparation conditions
- the QCSR may be limited to a sample delivery group specified by the method or regulatory agencies were contained in the batch or may include all quality control for met or identification of specific deviations the batch. Information reported on.QCSR includes:
- Affirmation that all analysis criteria specified by the
- Quality control sample ID number method or regulatory agencies were met or identification of specific deviations
- Type of quality control sample
- Concentrations determined, where applicable, for
- Instrumentation employed if applicable and method blanks, matrix spikes, matrix spike verification of its calibration duplicates, matrix duplicates, laboratory control
- Summary of batch quality control as compared to samples, serial dilutions, and laboratory control acceptance criteria sample duplicates
- Identification of nonconformances
- Acceptance criteria for matrix spikes, matrix spike
- Pertinent comments and observations of factors that duplicates, matrix duplicates, laboratory control affect sample data quality samples, and laboratory control sample duplicates 11.4 Electronic Data Deliverables (EDDs)
- Nominal concentrations of matrix spikes, matrix Electronic data deliverables are generated spike duplicates, LCSs, and LCS duplicates according to client specifications. EDDs use programs
- Concentration of parent sample for the matrix supplied by the client or created internally by our EDD spikes, matrix spike duplicates, or sample duplicates 2040 Savage Road Charleston SC 29407 (843) 556-817 I This document is controlled only when an original Set ID number appears on the cover page(!).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 ~--'----~~~~~~~~~~~~------,
Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 45 of I 09 team. Internally generated EDDs are usually written in If a client requests a CLP-like data package, and we Perl and/or PUSQL. agree to provide one, it is compiled in accordance with 11.5 Types of Data Packages and Reports GL-LB-E-013 for CLP-Like/DOE Data Package Assembly and Revision. If a client does not request a full CLP-like We offer three levels of data reports and the ability data package but asks for data to be provided on CLP to design packages to meet the needs of our clients. forms generated from software, we follow the applicable The levels of data reports are summarized in Table 1. procedures in GL-LB-E-013.
Table 1: Data Report Formats 11.6 Review of Data Reports, EDDs, and Data
- Contents Packages 1 Level 1C of A Level 1 and Level 2 data reports are reviewed for accuracy and completeness by the PM or PMA. Level 3 2 Level 2 C of A plus QCSR and CLP-like data packages are reviewed in the 3 Level 2 plus Case Narrative laboratory by a data reviewer, who is responsible for If a client so requests, the above reports can be reviewing specific fractions of the data package for accompanied by EDDs, case narratives, copies of accuracy, consistency, and completeness in accordance associated nonconformance reports, and other support with the SOP for that lab area.
documentation. The client's specific requirements are No data package fraction is to be provided to the communicated to the laboratory and data reviewers data packaging team without the approval of the through AlphaLIMS. appropriate data reviewer.
GEL's SOP GL-CS-E-002 for The Internal Review of CLP-like data packages are reviewed in compliance Contractually Required Quality Criteria for Client Package with the basic protocol. Specific requirements are Delivery defines preparation and review of the package. described in GL-LB-E-013 for the CLP-Like/DOE Data Package Assembly and Revision.
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
- Uncontrolled documents do not bear an original Set ID number.
'--~~~~~~~~~~~~~____J
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 46 of I 09 SECTION 12 SUBCONTRACTING ANALYTICAL SAMPLES AND OUTSIDE SUPPORT SERVICES Section 12 *Subcontracting Analytical Samples and
- NELAP, or ISO/IEC 17025 accreditation for the Outside Support Services analysis if required by the client.
We provide a full array of organic, inorganic, and We audit potential subcontractors for technical and radiochemical analyses. The subcontracting of samples administrative compliance as directed in GL-QS-E-001 to other facilities, while infrequent, may occur when: for Conduct of Quality Audits. An audit may be in. the*
- The client has requested analytical services for form of a book audit or an on-site review.
which we are not certified or do not offer as a If there is evidence of a technical, administrative, or
- routine product. quality deterioration, the laboratory is removed from our
- The regulatory or method holding times and/or client list of approved subcontractor laboratories pending due dates are in danger of not being met as the further evaluation, which may include an on-site audit.
result of instrument malfunction or. the unexpected Once the laboratory again demonstrates compliance with influx of a large group of samples. GEL's standards, it can be reclassified as an approved subcontractor laboratory.
No samples are subcontracted without the client's consent. The laboratories selected to receive At GEL, we have a multi-faceted and trained staff.
subcontracted samples are expected to meet the There are occasions, however, when it may be necessary following criteria: to obtain the services of professionals outside of GEL.
This may be due to such things as sample workload,
- Demonstrated technical capability to provide data introduction of a new instrument or method requiring that meet and conform to our quality standards. special knowledge, or employee leaves of absence.
- Established certification, if available, for the Any outside support services or service personnel are requested analyses.
subject to the same scrutiny as a subcontract laboratory. If
- Successful proficiency evaluation results, if a service fails to meet our standards for excellence, the available. appropriate parties are promptly notified. If immediate
- Commitment to meet time requirements for delivery corrections are not implemented and services are not of of results to the client.
- adequate quality to maintain confidence, the contract is
- Agreement to provide all documentation requested canceled.
in conjunction with the analysis.
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-OOl Rev 29 Revision 29 Effective March 2015 Page 47of109 SECTION 13
'=II CLIENT SATISFACTION S~e=c~tio~n:=:t:13~.~C~l~ie=nt~S~a~ti~s~fa~ct~io~n===~~~~~~~~~W~e~u~se~A~l~ph~a~L~IM~S~t~o~m~o~ni~to~r~cl~ie~nt~c~o~m-p~la=in-ts-,~,JI Meeting the needs and expectations of our clients is nonconformances and corrective actions. Every complaint essential to meeting our commitment to be the is entered into the system upon receipt and assigned an environmental laboratory of first choice. An important internal and external due date. The external due date is part of meeting this commitment involves receiving and often established by client contract. The internal due date resolvi_ng client concerns and complaints. allows time for the Quality Systems Team to review the response and transmit it to the client on or before the due Client complaints that question the quality of date.
laboratory data or data deliverables are directed to Quality Systems. These concerns are responded to with If we notice a trend that significantly affects the quality input from the laboratory, EDD team or data packaging of our data, a corrective action is initiated following GL-QS-group as may be needed.
- E-002 for Conducting Corrective/Preventive Action and Identifying Opportunities for Improvement. The The types of complaints, area(s) affected, and any implementation and verification of the corrective action impacts on quality are trended on a quarterly basis. This affirms an effective and permanent solution.
information is available to members of the Leadership Team and other managers and group leaders. The Quality Systems Team promptly audits those areas of activity or responsibility for which a complaint or concern has been stated.
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (I).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 .
Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 48 of 109 II APPENDIX A: REFERENCES
- National Environmental Laboratory Accreditation Program, NELAC, 2003.
- The NELAC Institute, TNI Standard, 2009.
- 10 CFR 50, Appendix B, US Code of Federal Regulations.
- 40 CFR Part 136, May 18, 2012 Part VII, EPA 600 Series Methodologies for the Analysis of Organic Contaminants.
- DOE Orders 414.1B414.1C, and 414.D Quality Assurance, U.S. Department of Energy.
- Model Statement of Work for Analytical Laboratories, Prepared for Department of Energy NNSA Service Center by Analytical Quality Associates, Rev 7, November 2006.
- Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs, American National Standard ANSl/ASQC E4-1994.
- Measurement Associated Instrument Quality Assurance for Radiobioassay Laboratories ANSI N42.23-1995.
- US Department of Defense Quality Systems Manual for Environmental Laboratories, Version 4.2, October, 2010.
- US Department of Defense Quality Systems Manual for Environmental Laboratories, Version 5.0, July 2013.
- US Department of Energy Quality Systems for Analytical Services, Version 3.0, July 2013.
- MARLAP- Multi-Agency Radiological Laboratory Analytical Protocols
- 10 CFR Part 21- Reporting of Defects and Noncompliance
- 10CFR Part 50 Appendix B -Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants
- 10 CFR Part 61- Licensing Requirements for Land Disposal and Radioactive Waste
- NRC REG Guide 4.15 and NRC REG Guide 4.8
- ANSl/ISO/IEC 17025-2005
- DOE G 414/1-3, 11-3-04, Suspect/ Counterfeit Items Guide for use with 10 CFR 830 Subpart A. Quality Assurance Requirements, and DOEO 414.B, Quality Assurance.
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
- Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 49 of 109
~
APPENDIX 8: DEFINITIONS The following definitions are used throughout the text of our Quality Systems Plan. These definitions were reprinted from "Definitions for Quality Systems," NELAC, July 1, 1999. For most entries, the original source of each definition is provided.
AlphaLIMS: GEL's Laboratory Information Management System.
Acceptance Criteria: s'pecified limits placed on characteristics of an item, process, or service defined in the requirement documents. (ASQC)
Accreditation: The process by which an agency or organization evaluates and recognizes a program of study or an institution as meeting certain predetermined qualifications or standards, thereby accrediting the laboratory. In the context of the National Environmental Laboratory Accreditation Program (NELAP), this process is a voluntary one.
(N~LAC)
Accuracy: The degree of agreement between an observed value and an accepted reference value. Accuracy includes a combination of random error (precision) and systematic error (bias) components which are due to sampling and analytical operations; a data quality indicator. (Glossary of Quality Assurance Terms, QAMS, 8/31/92)
Aliquot: A discrete, measured, representative portion of sample taken for analysis. (DoD, EPA QAD Glossary)
Analyst: The designated individual who performs the "hands-on" analytical methods and associated techniques and who is the one responsible for applying required laboratory practices and other pertinent quality controls to meet the required level of quality. (NELAC)
Analyte: The specific chemicals or components for which a sample is analyzed; may be a group of chemicals that belong to the same chemical family, and are analyzed together. (EPA Risk Assessment Guide for Superfund, OSHA Glossary)
Analytical Detection Limit: The smallest amount of an analyte that can be distinguished in a sample by a given measurement procedure throughout a given confidence interval. (NELAC Quality Systems Committee)
Analytical Reagent (AR} Grade: Designation for the high purity of certain chemical reagents and solvents given by the American Chemical Society. (NELAC Quality Systems Committee)
ANSI: American National Standards lnstitute--this consensus standards body approves standards as a guide to aid the manufacturer, the consumer and the general public who may be concerned with its scope and provisions.
Audit: A systematic evaluation to determine the conformance to quantitative and qualitative specifications of some operational function or activity. (EPA-QAD)
Batch: Environmental samples prepared and/or analyzed together with the same process and personnel using the same lot(s) of reagents. A preparation batch is composed of one to 20 environmental samples of the same NELAC-defined matrix, meeting the above mentioned criteria and with a maximum time between the start of processing of the first and last sample in the batch to be 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. An analytical batch is composed of prepared environmental samples (extracts, digestates or concentrates) that are analyzed together as a group using the same calibration curve or factor. An analytical batch can include prepared samples originating from various environmental
. matrices and can exceed 20 samples. (NELAC Quality Systems Committee)
Blank: A sample that has not been exposed to the analyzed sample stream in order to monitor contamination during sampling, transport, storage or analysis. The blank is subject to the usual analytical and measurement process to establish a zero baseline or background value and is sometimes used to adjust or correct routine analytical results.
(ASQC)
Blind Sample: A subsample for analysis with a composition known to the submitter. The analyst/laboratory may know the identity of the sample but not its composition. It is used to test the analyst's or laboratory's proficiency in the execution of the measurement process. (NELAC) 2040 Savage Road Charleston SC 29407 (843) 556-8171
- This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 50of109 Calibrate: To determine, by measurement or comparison with a standard, the correct value of each scale reading on a meter or other device, or the correct value for each setting of a control knob. The levels of the applied calibration standard should bracket the range of planned or expected sample measurements. (NELAC)
Calibration: The set of operations that establish, under specified conditions, the relationship between values indicated by a measuring device, or the correct value of each setting of a control knob. The levels of the applied calibration standard should bracket the range of planned or expected sample measurements. (NELAC)
Calibration Curve: The graphical relationship between the known values, such as concentrations, of a series of calibration standards and their analytical response. (NELAC)
Calibration Standard: A substance or reference material used to calibrate an instrument. (QAMS)
Certified Reference Material (CRM): A reference material one or more of whose property values are certified by a technically valid procedure, accompanied by or traceable to a certificate or other documentation that is issued by a certifying body. (ISO Guide 30 - 2.2)
Chain of Custody: A record that documents the possession of the samples from the time of collection to receipt in the laboratory. This record generally includes: the. number of and types of containers; the mode of collection; collector; time of collection; preservation; and requested analyses. (NELAC Quality Systems Committee)
Commercial Grade Items: When applied to analytical services provided to nuclear power plants licensed pursuant to 10 CFR Part 50, commercial grade item means a structure, system, or component, or part there of that affects its safety function, that was not designed and manufactured as a basic component. In the laboratory operations, commercial grade items may include calibration standards, quality control standards, reagents, instrument software conducting calculations, calibration services for support instrumentation, and other process controls, verifying their acceptability by inspections, tests, validation, or analyses by the purchaser or third-party dedicating entity (such as NIST, A2LA, NPL and TNI). This activity assures that a critical characteristic is acceptable. Commercial grade items do not include items where the design and manufacturing process require in-process inspections and verifications to ensure that defects or failures to comply are identified and corrected. These types of items are considered Consumables.
When applied to facilities and activities licensed pursuant to 10 CFR Parts 50, commercial grade item means an item that is:
(i) Not subject to design or specification requirements that are unique to those facilities or activities; (ii) Used in applications other than those facilities or activities; and (iii) To be ordered from the manufacturer/supplier on the basis of specifications set forth in the manufacturer's published product description (for example, a catalog).
It-is the responsibility of the purchaser to identify the vendor type, grade, and use of the purchased item Confirmation: Verification of the presence of a component through the use of an analytical technique that differs from the original test method. These may include: (NELAC)
Second column confirmation Alternate wavelength Derivatization Mass spectral interpretation Alternative detectors or Additional cleanup procedures Corrective Action: Action taken to eliminate the causes of an existing nonconformity, defect, or other undesirable situation in order to prevent recurrence. (ISO 8402) 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 51 of 109 Data Audit: A qualitative and quantitative evaluation of the documentation and procedures associated with environmental measurements to verify that the resulting data are of acceptable quality (i.e., that they meet specified acceptance criteria). (NELAC)
Data Reduction: The process of transforming raw data by arithmetic or statistical calculations, standard curves, concentration factors, .etc., and collation into a more useful form. (EPA-QAD)
Detection Limit: The lowest concentration or amount of the target analyte that can be determined to be different from zero by a single measurement at a stated degree of confidence. Refer to Method Detection Limit. (NELAC)
Document Control: The act of ensuring that documents (and revisions thereto) are proposed, reviewed for accuracy, approved for release by authorized personnel, distributed properly, and controlled to ensure use of the correct version at the location where the prescribed activity is performed. (ASQC)
Duplicate Analyses: The analyses or measurements of the variable of interest performed identically on two subsamples of the same sample. The results from duplicate analyses are used to evaluate analytical or measurement precision but not the precision of sampling, preservation or storage internal to the laboratory. (EPA-QAD)
Environmental Detection Limit (EDL): The smallest level at which a radionuclide in an environmental medium can be unambiguously distinguished for a given confidence interval using a particular combination of sampling and measurement procedures, sample size, analytical detection limit, and processing procedure. The EDL shall be specified for the 0.95 or greater confidence interval. The EDL shall be established initially and verified annually for each test method and sample matrix. (NELAC, Radioanalysis Subcommittee)
Holding Times (Maximum Allowable Holding Times): The maximum times that samples may be held prior to analysis and still be considered valid. (40 CFR Part 136)
Initial and Continuing Demonstrations of Capability: Procedures to establish the ability of the laboratory to generate acceptable accuracy and precision which is included in many of the EPA's analytical test methods. In general, the procedure includes the addition of a specified concentration of each analyte in each of four separate aliquots of laboratory pure water.or authentic samples. These are carried through the analYtical procedure and the percentage recovery and the standard deviation are compared to specified limits. (40 CFR Part 136, 2003 NELAC)
Internal Standard: A known amount of standard added to a test portion of a sample and carried through the entire measurement process as a reference for evaluating and controlling the precision and bias of the applied analytical test method. (NELAC)
ISO/IEC 17025: The International Organization for Standardization and International Electrotechnical Commission form this specialized system for worldwide standardization. Members of ISO or IEC participate in the development of International Standards through technical committees established by their organization to deal with particular fields of activity. Other international organizations, government and non-government, also take part in development of these standards. The ANSl/ISO/IEC 17025-2005 is approved as an American National Standard and covers general requirements for the competence of testing and calibration laboratories.
Laboratory: A body that calibrates and/or tests.
- 1. In cases where a laboratory forms part of an organization that carries out other activities besides calibration and testing, the term "laboratory" refers only to those parts of that organization that are involved in the calibration and testing process.
- 2. As used herein, the terni "laboratory" refers to a body that carries out calibration or testing at or from a permanent location, from a temporary facility, or a mobile facility. (ISO 25)
Laboratory Control Sample (LCS): A sample matrix, free from the analytes of fnterest, spiked with verified known amounts of analytes from a source independent of the calibration standards or a material containing known and verified amounts of analytes. It is generally used to establish intra-laboratory or analyst specific precision and bias to assess the performance of all or a portion of the measurement system. (NELAC) 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page(!).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 52of109 Laboratory Duplicate: Aliquots of a sample taken from the same container under laboratory conditions and processed and analyzed independently. (NELAC Quality Systems)
Limit of Detection (LOO): The lowest concentration level that can be determined by a single analysis and with a defined level of confidence to be statistically different from a blank. See also Method Detection Limit. (Analytical Chemistry, 55, p.2217, Dec. 1983, modified)
Limit of Quantitation (LOQ): The lowest concentration level of the initial calibration curve used to quantitate an analyte. (DoD clarification) The LOQ must be~ 3X the LOO, and is usually not more than 1OX the LOO.
Matrix: The component or substrate that contains the analyte of interest. For purposes of batch determination, the following matrix types shall be used:
0 Aqueous: Any aqueous sample excluded from the definition of a drinking water matrix or saline/estuarine source. Includes surface water, groundwater, and effluents.
0 Drinking Water: Any aqueous sampl_e that has been designated a potable or potential potable water source.
O Saline/Estuarine: Any aqueous sample from an ocean or estuary, or other salt-water source.
O Non-aqueous liquid: Any organic liquid with <15% settleable solids.
O Biological Tissue: Any sample of a biological origin such as fish tissue, shellfish, or plant material. Such samples shall be grouped according to origin.
O Solids: Includes soils, sediments, sludges and other matrices with >15% settleable solids.
O Chemical Waste: A product or by-product of an industrial process.
O Air Samples: Media used to retain the analyte of interest from an air sample such as sorbent tubes or summa canisters. Each medium shall be considered as a distinct matrix. (Quality Systems)
Matrix Spike (MS): Prepared by adding a known mass of target analyte to a specified amount of matrix sample for which an independent estimate of target analyte concentration is available. Matrix spikes are used, for example, to determine the effect of the matrix on a method's recovery efficiency. (Glossary of Quality Assurance Terms, QAMS, 8~1ffi~ . . .
Matrix Spike Duplicate (spiked sample/fortified sample duplicate): A second replicate matrix spike is prepared in the laboratory and analyzed to obtain a measure of the precision of the recovery for each analyte. (Glossary of Quality Assurance Terms, QAMS, 8/31/92)
May: Denotes permitted action, but not required action. (NELAC)
Method Blank (MB): A sample of a matrix similar to the batch of associated samples (when available) that is free from the analytes of interest and is processed simultaneously with and under the same conditions as samples containing an analyte of interest through all steps of the analytical procedures, and in which no target analytes or interferences are present at concentrations that impact the analytical results for sample analyses. (NELAC)
Method Detection Limit (MDL): The minimum concentration of a substance (an analyte) that can be measured and reported with 99% confidence that the analyte concentration is greater that zero and is determined from analysis of a sample in a given matrix containing the analyte. (40 CFR Part 136 Appendix B)
Must: Denotes a requirement that is required to be met. (Random House College Dictionary)
Negative Control: Measures taken to ensure that a test, its components, or the environment does not cause undesired effects, or produce incorrect test results. (NELAC)
NELAC: National Environmental Laboratory Accreditation Conference. A voluntary organization of state and federal environmental officials and interest groups purposed primarily to establish mutually acceptable standards for accrediting environmental laboratories. A subset of National Environmental Laboratory Accreditation Program (NELAP).
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 53of109 Performance Audit: the routine comparison of independently obtained quantitative measurement system data with routinely *obtained data in order to evaluate the proficiency of an analyst or laboratory. (NELAC)
Performance Based Measurement System (PBMS): A set of processes wherein the data quality needs, mandates, or limitations cif a program or project are specified and serve as criteria for selecting appropriate test methods to meet those needs in a cost-effective manner. (NELAC)
Positive Control: Measures taken to ensure that a test and/or its components are working properly and producing correct or expected results from positive test subjects. (NELAC)
Precision: Th.e degree to which a set of observations or measurements of the same property, obtained under similar conditions, conform to themselves; a data quality indicator. Precision is usually expressed as standard deviation, variance, or range, in either absolute or relative terms. (NELAC)
Preservation: Refrigeration and or reagents added at the time of sample collection to maintain the chemical and or biological integrity of the sample. (NELAC)
Proficiency Test Sample (PT): A sample, the composition of which is unknown to the analyst and is provided to test whether the analyst/laboratory can produce analytical results within specified acceptance criteria. (Glossary of Quality Assurance Terms, QAMS, 8/31/92)
Proficiency Testing: A means of evaluating a laboratory's performance under controlled conditions relative to a given set of criteria through analysis of unknown samples provided by an extermal source. (NELAC, Section 2.1)
Proficiency Testing Program: The aggregate of providing rigorously controlled and standardized environmental samples to a laboratory for analysis, reporting of results, statistical evaluation of the results in comparison to peer laboratories and the collective demographics and results summary of all participating laboratories. (NELAC)
Protocol: A detailed written procedure for field and/or laboratory operation (e.g., sampling, analysis) that must be strictly followed. (EPA-QAD)
Pure Reagent Water: Shall be water in which no target analytes or interferences are present at a concentration that would impact the results when using a particular analytical test method. (NELAC)
- Quality Assurance: An integrated system of activities involving planning, quality control, quality assessment, reporting and quality improvement to ensure that a product or service meets defined standards of quality within a stated level of confidence. (Glossary of Quality Assurance Terms, QAMS, 8/31/92)
Quality Control: The overall system of technical activities whose purpose is to measure and control the quality of a product or service so that it meets the need of users. (Glossary ofQuality Assurance Terms, QAMS, 8/31/92)
Quality Manual: A document stating the quality policy, quality system and quality practices of an organization. This may also be called a Quality Assurance Plan or a Quality Plan. NOTE: The quality manual may call up other documentation relating to the laboratory's quality arrangements. (Quality Systems Committee)
Quality System: A structured and documented management system describing the policies, objectives, principles, organizational authority, responsibilities, accountability, and implementation plan of an organization for ensuring quality in its work processes, products (items), and services. The quality system provides the framework for planning, implementing, and assessing work performed by the organization and for carrying out required QA and QC.
(ANSl/ASQC E-41994) .
Quantitation Limits: The value at which an instrument can accurately measure an analyte at a specific concentration that includes the maximum or minimum levels, concentrations, or quantities of a target that can be quantified with the accuracy required by the data user. These values establish the upper and lower limits of the calibration range. (NELAC with DoD clarification)
Range: The difference between the minimum and the maximum set of values. (EPA_QAD)
Raw Data: Any original factual information from a measurement activity or study recorded in a laboratory notebook, worksheets, records, memoranda, notes, or exact copies thereof that are necessary for the reconstruction and 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (I).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 54of109 evaluation of the report of the activity or study. Raw data may include photography, microfilm or microfiche copies, computer printouts, magnetic media, including dictated observations, and recorded data from automated instruments.
If exact copies of raw data have been prepared (e.g., tapes that have been transcribed verbatim, dated and verified accurate by signature), the exact copy or exact transcript may be submitted. (EPA-QAD)
Reagent Blank (method reagent blank): A sample consisting of reagent(s), without the target analyte or sample matrix, introduced into the analytical procedure at the appropriate point and carried through all subsequent steps to determine the contribution of the reagents and of the involved analytical steps. (Glossary of Quality Assuran.ce Terms, QAMS, 8/31/92)
Reference Material: A material or substance one or more properties of which are sufficiently well established to be used for the calibration of an apparatus, the assessment of a measurement method, or for assigning values to materials. (ISO Guide 30 -2.1)
Reference Standard: A standard, generally of the highest metrological quality available at a given location, from which measurements made at that location are derived. (VIM - 6.08)
Requirement: Denotes mandatory specification; often designated by the term "shall." (NELAC)
Sample: Portion of material collected for chemical analysis, identified by a single, unique term. A sample may consist of portions in multiple containers, if a single sample is submitted for multiple or repetitive analysis. (DoD)
Safety Related Procured Items: As specified in 10CFR Part 50 and other Nuclear Power related activities, a basic component includes safety-related analytical services that are associated with the component information in support of an early site permit application or other safety related services identified by the client, whether the services are performed by the laboratory or others. GEL has identified the primary safety related basic component item for these services as:
O Calibration Standards for Radiochemical Analyses used in the direct issuance of analytical data reported to a Nuclear Facility. These standards are the primary sources (critical characteristic) of calibration for instruments that will provide the analytical results to our client. All Safety Related Procured Items are considered Type I procurement and must meet all specifications as identified in SOP GL-RC-E-002.
Selectivity: The capability of a test method or instrument to respond to a target substance or constituent in the presence of non-target substances. (NELAC Quality Systems)
Sensitivity: The capability of a test method or instrument to discriminate between measurement responses representing different levels (e.g., concentrations) of a variable of interest. (NELAC Quality Systems)
Shall: Denotes a requirement that is mandatory whenever the criterion for conformance with the specification requires that there will be no deviation. This does not prohibit the use of alternative approaches or methods for implementing the specification so long as the requirement is fulfilled. (ANSI)
Should: Denotes a guideline or recommendation whenever noncompliance with the specification is permissible.
(ANSI)
Spike: A known mass of target analyte added to a blank sample or subsample; used to determine recovery efficiency or for other quality control purposes.
Standard Operating Procedure (SOP): A written document that details the method of an operation, analysis or action whose techniques and procedures are thoroughly prescribed and is accepted as the method for performing certain routine or repetitive tasks. (Glossary of Quality Assurance Terms, QAMS, 8/31/92)
Standard Reference Material (SRM): A certified reference material produced by the U.S. National Institute of Standards and Technology and characterized for absolute content, independent of analytical test method. (NELAC)
Surrogate: A substance with properties that mimic the analyte of interest. It is unlikely to be found in environmental samples and is added to them for quality control purpo*ses. (Glossary of Quality Assurance Terms, QAMS, 8/31/92) 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 55 of 109 Test: A technical operation that consists of the determination of one or more characteristics or performance of a given product, material equipment organism, physical phenomenon, process or service according to a specified procedure. The result of a test is normally recorded in a document sometimes called a test report or a test certificate. (ISO/IEC Guide 2-12.4)
Test Method: An adoption of a scientific technique for a specific measurement problem, as documented in a laboratory SOP. (NELAC)
Tolerance Chart: A chart in which the plotted quality control data is assessed via a tolerance level (e.g.+/-. 10% of a mean) based on the precision level judged acceptable to meet overall quality/data use requirements instead of a statistical acceptance criteria (e.g.+/-. 3 sigma). (ANSI N42.23-1995, Measurement and Associated Instrument Quality Assurance for Radiochemistry* Laboratories)
Traceability: The property of a result of a measurement whereby it can be related to appropriate standards, generally international or national standards, through an unbroken chain of comparisons. (VIM-6.12)
Validation: The process of substantiating specified performance criteria.
Verification: confirmation by examination and provision of evidence that specified requirements have been met.
(NELAC)
NOTE: Verification provides a means for checking that the deviations between values indicated by a measuring instrument and corresponding known values of a measured quantity are consistently smaller than the maximum allowable error defined in a standard, regulation, or specification peculiar to the management of the measuring equipment.
The result of verification leads to a decision either to restore in service, to perform adjustments, or to repair, or to downgrade, or to declare obsolete. In all cases it is required that a written trace of the verification performed shall be kept on the measuring instrument's individual record.
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL~QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 56 of 109 APPENDIX C: CORPORA TE ORGANIZATION CHART Kathleen H Stelling Chairman and Secretary James M. Stelling, President and Chief Executive Officer Joseph M. Hodgson, Vice President The GEL Group, lnc. Douglas E. Earns!, Chief Financial Officer John Crawford, Human Resources Director Robert Pullano, Quality Systems Director James B. Westmoreland, IT Director George R. McAbee, Environmental Manager I I I GEL Laboratories, LLC GEL Engineering, LLC GEL Geophysics, LLC I
Carey J. Bocklet Keith D. McCullock Scott D. Carney, P.E.
Chief Operating Officer (COO) Director Director I I I I Environmental Industrial Engineering Stack Corporate Chemistry Radiochemistry Services Services Services Sampling Services Division Division Services Carey J. Bocklet James B.
Division Director Westmoreland I~--~------------!
Division Director GEL Engineering, LLC Greenville, SC of NC Office Affiliate Robert 0. MacPhee Keith D. McCullock Business Unit Manager 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page(!).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 57 of 109 II APPENDIX D: CERTIFICATIONS GEL Laboratories, LLC maintains environmental laboratory certification in many states, including primary NELAP in Utah and secondary in Florida, Illinois, Kansas, Louisiana, New Hampshire, New Jersey, New York, Pennsylvania, Texas and Virginia. We expand our list of certification as needed.
Original Scope of Accreditations are maintained in the Quality Assurance work area. Electronic copies are available in
.pdf form on the GEL intranet. Please call to confirm the status of any certification of interest to you.
- U.S. Department of Energy (DOE)
- Established Basic Ordering Agreement (BOA) in support of ICPT, for use by DOE and its eligible subcontractors. Audited by DOE's Office of Environmental Management under the Department of Energy Consolidated Audit Program (DOECAP)
- Department of Defense Environmental Laboratory Accreditation Program (DoD ELAP) through American Association for Environmental Laboratory Accreditation (A2LA) (A2LA 2567.01)
- U.S. Department of Agriculture* Foreign soil importation permit# P330-09-00191
- U.S. Department of Agriculture
- Permit to import prohibited plant material #PDEP-12-00260 National Environmental Laboratory Accreditation Program (NELAP)
- Primary issued through the State of Utah, Department of Health; Secondary issued through the States of Florida, Illinois, Kansas, Louisiana, New Hampshire, New Jersey, New York, Pennsylvania, Texas and Virginia
- Clinical Laboratory Improvement Amendments (CUA)* U.S. Department of Health and Human Services, Certificate of Compliance for Acceptance of Human Specimens (GEL ID: 42D0904046)
- Alaska Department of Environmental Conservation for Contaminated Sites (GEL ID: UST-110)
- Arkansas Department of Environmental Quality Laboratory Certification Program for Wastewater, Groundwater, Solid Waste Reciprocal Certification to SC DHEC (88-0651) *
- California Environmental Laboratory Accreditation Program Certification, ELAP (GEL ID: 2940 Interim)
- Colorado Department of Public Health and Environment, Reciprocal Certification to SC DHEC Environmental Laboratory Certification Program for Safe Drinking Water Chemistry and Radiochemistry
- Connecticut Department of Public Health - Potable Water, Waste Water and/or Trade Waste, Sewage and/or Effluent, Soil and Radiochemistry Reciprocal Certification (GEL ID: PH-0169)
- Florida Department of Health, Bureau of Laboratories, Secondary NELAP (GEL ID E87156)
- Georgia Department of Natural Resources, Reciprocal Certification to SC DHEC Environmental Laboratory Certification Program for Safe Drinking Water (GEL ID: 967) 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page(!).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 58of109
- Hawaii Department of Health, Safe Drinking Water, reciprocal to Utah NELAP
- Idaho Department of Health and* Welfare, SC00012
- Illinois EPA Environmental Laboratory Accreditation for Drinking Water, Wastewater, and Hazardous and Solid Waste, Secondary NELAP (GEL ID: 200029)
- Indiana State Department of Health (C-SC-01)
- Kansas Department of Health and Environmental Laboratory, Non-potable Water and Solid and Hazardous Waste, Secondary NELAP (GEL ID: E-10332)
- Kentucky Department of Environmental Protection for Drinking Water and Waste Water (GEL ID: 90129)
- State of Louisiana Department of Health and Hospitals (LA 120008), Safe Drinking Water, Secondary NELAP
- State of Louisiana Department of Environmental Quality, (03046, Al 33904), Non-drinking water, Secondary NELAP
- Maryland Department of Health and Mental Hygiene, Laboratories Administration, Reciprocal Certification to SC DHEC En~ironmental Laboratory Certification Program for Safe Drinking Water-Radiochemistry (GEL ID: 270)
- Massachusetts Department of Environmental Protection, Division of Environmental Analysis - Potable Water, Radiochemistry (GEL ID: M-SC012)
- Michigan Department of Environmental Quality - Potable Water, Radiochemistry (GEL ID: 9976)
- Mississippi State Department of Health NELAP reeiprocity
- Nevada Department of Human Resources, Health Division, Bureau of Licensure and Certification, Radiologicals and Non-Radiologicals (GEL ID: SC000122011-1 ), Nevada Mining
- State of New Hampshire Environmental Laboratory Accreditation Program, Secondary NELAP (2054)
- New Jersey Department of Environmental Protection, Safe Drinking Water, Solid and Hazardous Waste, and Water Pollution Certification, Secondary NELAP (GEL ID: SC002)
- State of New Mexico Environment Department, Drinking Water Bureau, reciprocal to NELAP
- New York Department of Health, Environmental Laboratory Approval Program Certification, Potable Water, Non-potable Waters and Solids/Hazard.ous Wastes, Secondary NELAP (GEL ID: 11501)
- North Carolina Division of Water Quality Lab Certification Program, Waste Waters/Ground Waters. (GEL ID: 233)
- North Carolina Department of Health and Human Services, North Carolina State Laboratory Public Health Environmental Sciences, Safe Drinking Water. (GEL ID: 45709)
- Oklahoma Department of Environmental Quality, General Water Quality/Sludge Testing Laboratory Dual Certification (GEL ID: 9904, SC00012) 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is*controlled only when an original Set ID number appears on the cover page ( 1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 201°5 Page 59 of 109
- Pennsylvania Department of Environmental Protection - Bureau of Laboratories, Secondary NELAP (GEL ID: 68-00485)
- South Carolina Department of Health and Environmental Control - Environmental Laboratory Certification Program, Clean Water, Safe Drinking Water, Radiological, and Solid/Hazardous Wastes (GEL ID: 10120001/10120002)
- South Carolina Department of Health and Environmental Control (DHEC) Radioactive Material License (License
- 362)
- Tennessee Department of Health - Division of Laboratory Services, Reciprocal Certification to SC DHEC Environmental Laboratory Certification Program, Safe Drinking Water-Radiochemistry and Non-radiochemistry (GEL ID: 02934)
- Texas Commission on Environmental Quality, Secondary NELAP (GEL ID: T104704235-12-7)
- Utah Department of Health, Division of Epidemiology and Laboratory Services, Safe Drinking Water, Clean Water and Resource and Conservation and Recovery Act Certifications Primary NELAP (Customer ID: SC00012)
- Vermont Department of Environmental Conservation, Water Supply Division, Secondary NELAP (VT87156)
- Commonwealth of Virginia Department of General Services - Division of Consolidated Laboratory Services, Safe Drinking Water, Clean Water Act and Resource and Conservation Act Certifications, Secondary NELAP (GEL ID:
460202) .
- Washington State Department of Ecology, Safe Drinking Water, Clean Water and Resource and Conservation and Recovery Act Certifications (GEL ID: C780) 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
O~-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 60of109 APPENDIX E: ESSENTIAL QUALITY CONTROL REQUIREMENTS I At GEL, we enforce strict adherence to quality control measures. Quality control measur~s for each type of analysis are delineated in the associated standard operating procedure and include those specified in the identified analytical method. Client requests for additional quality control agreed to by us will be communicated to the laboratory by the Project Manager and performed accordingly.
All quality control measures are assessed and evaluated on an ongoing basis. We use these measures to establish statistically derived quality control acceptance criteria. The acceptance criteria are used to evaluate whether the analytical process is in control and to assist us in establishing the validity of the data. Our procedures for handling out- of-control situations are written in the analytical standard operating procedure.
Method-specific quality measures are described in the appropriate standard operating procedure. Essential but general quality control requirements are summarized in the sections below for chemical testing, including inorganic and organic analyses, microbiological analyses, and radiochemical testing.
E1 Chemical Testing This section includes our quality control requirements for inorganic and organic analyses, and discusses:
- Negative controls*
- Positive controls
- Analytical variability and reproducibility
- Method evaluation
- Method detection limits
- Data reduction
- Quality of standards and reagents
- Selectivity
- Constant and consistent test condition E1.1 Negative controls We implement a negative control at least once per analytical batch of samples having the same matrix, and where, if applicable, the same extraction or preparation method is employed. The negative control is a method blank that we use to determine the presence of contamination. If discovered, we must investigate the source of contamination and take measures to correct, minimize, or eliminate the source if:
- 1. The concentration of target analyte exceeds the established practical quantitation limit and exceeds a concentration greater than 1/10 of the measured concentration of any sample in the anaiytical batch;
- 2. The concentration of a target analyte in the method blank exceeds that present in the samples and is greater than 1/10 of the specified regulatory limit.
If a method blank is indicative of contamination, we must assess each sample in that batch against the above criteria to determine if the data are acceptable. Any sample associated with a contaminated method blank shall be reprocessed for analysis, as needed, or we will report the results with appropriate data qualifiers.
E1.2 Positive Control - Method Performance E1.2.1 Laboratory Control Sample (LCS)
Purpose:
The LCS is used to evaluate the performance of the total analytical system, including all preparation and analysis steps. Results of the LCS are compared to e~tablished criteria and, if found to be outside of these criteria, indicates that the analytical system is "out of control." Any affected samples associated with an out-of-control LCS shall be reprocessed for re-analysis or the results reported with appropriate data qualifying codes, as necessary.
Frequency: The LCS is analyzed at a minimum of 1 per preparation batch. Exceptions would be for those 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page(!).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 61 of 109 analytes for which no spiking solutions are available such as total suspended solids, total dissolved solids, total volatile solids, total solids, pH, color, odor, temperature, dissolved oxygen or turbidity. In those instances for which no separate preparation method is used (example:
volatiles in water) the batch shall be defined as environmental samples that are analyzed together with the same method and personnel, using the same lots of reagents, not to exceed the analysis of 20 environmental samples. .
Composition: The LCS is a controlled matrix, known to be free of analytes of interest, spiked with known and verified concentrations of analytes. NOTE: The matrix spike may be used in place of this control as long as the acceptance criteria are as stringent as for the LCS. Alternatively the LCS may consist of a medium containing known and verified concentrations of analytes or as Certified Reference Material (CRM). All analyte concentrations shall be within the calibration range of the methods. The following shall be used in choosing components for the spike mixtures:
The components to be spiked shall be as specified by the mandated test method or other regulatory requirement or as requested by the client. In the absence of specified spiking components the laboratory shall spike per the following:
For those components that interfere with an accurate assessment such as spiking simultaneously with technical chlordane, toxaphene, and PCBs, the spike should be chosen that represents the chemistries and elution patterns of the components to be reported.
For those test methods that have extremely long lists of analytes, a representative number may be chosen. The analytes selected should be representative of all analytes reported. The following criteria shall be used for determining the minimum number of analytes to be spiked.
a) For methods that include 1-1 Otargets, spike all components; b) For methods that include 11-20 targets, spike at least 10 or 80%, whichever is greater; c) For methods with more than 20 targets, spike at least 16 components.
NOTE: Unless otherwise noted in project quality assurance plans or if components interfere with an accurate assessment, all Department of Defense projects will have LCS, MS, and MSD that contain all target analytes.
Evaluation The results of the individual batch LCS are calculated in percent recovery. The laboratory shall Criteria and document the calculation for percent recovery. The individual LCS is compared to the Corrective acceptance criteria as published in the mandated test method. Where there are no established Action: criteria, the laboratory determines internal criteria or utilizes client specified assessment criteria.
An LCS that is determined to be within the criteria effectively establishes that the analytical system is in control and validates system performance for the samples in the associated batch.
Samples analyzed along with a LCS determined to be "out of control" should be considered suspect and the samples reprocessed and re-analyzed or the data reported with appropriate data qualifying codes as necessary.
E1.2.2 Sample Specific Controls The laboratory must document procedures for determining the effect of the sample matrix on method performance.
These procedures relate to the analyses of matrix specific Quality Control (QC) samples and are designed as data quality indicators for a specific sample using the designated test method. These controls alone are not used to judge laboratory performance. Examples of matrix specific QC include: Matrix Spike (MS); Matrix Spike Duplicate (MSD);
Post Spike (PS) and Post Spike Duplicate (PSD) sample duplicates; and surrogate spikes.
E1.2.3 Matrix Spike; Matrix Spike Duplicates, Post Spike; Post Spike Duplicates:
Purpose:
Matrix specific QC samples indicate the effect of the sample matrix on the precision and accuracy of the results generated using the selected method. The information from these controls is 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (I).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 62 of 109 sample/matrix specific and would not normally be used to determine the validity of the entire batch.
Frequency: The frequency of the analysis of matrix specific samples shall be determined as part of a systematic planning process (e.g. Data Quality Objectives) or as specified by the required mandated test method.
- Composition: The components to be spiked shall be as specified by the mandated test method. Any permit specified analytes, as specified by regulation or client requested analytes shall also be included. If there are no specified components, the laboratory shall spike per the following:
For those components that interfere with an accurate assessment such as spiking simultaneously with technical chlordane, toxaphene and PCBs, the spike should be chosen that represents the chemistries and elution patterns of the components to be reported. .
For those test methods that have extremely long lists of analytes, a representative number may be chosen using the following criteria for choosing the number of analytes to be spiked. However, the laboratory shall insure that all targeted components are included in the spike mixture over a 2-year period.
- a) For methods that include 1-10 targets, spike all components; b) For methods that include 11-20 targets, spike at least 1Oor 80%, whichever is greater; c) For methods with more than 20 targets, spike at least 16 components. .
Evaluation The results from matrix spike/matrix spike duplicate and post spike/post spike duplicate are Criteria and primarily designed to assess the precision and accuracy of analytical results in a given matrix and Corrective are expressed as percent recovery (%R) and relative percent difference (RPO).
Action:
Results are compared to the acceptance criteria as published in the mandated test method. Where there are no established criteria, the laboratory should determine internal criteria and document the method used to establish the limits. For matrix spike or post spike results outside established criteria, corrective action shall be documented or the data reported with appropriate data qualifying codes.
E1.2.4 Matrix Duplicates:
Purpose:
Matrix duplicates are defined as replicate aliquots of the same sample taken through the entire analytical procedure. The results from this analysis indicate the precision of the results for the specific sample using the selected method. The matrix duplicate provides a usable measure of precision only when target analytes are found in the sample chosen for duplication.
Frequency: The frequency of the analysis of matrix duplicates may be determined as part of a systematic planning process (e.g. Data Quality Objectives) or as specified by the mandated test method.
Composition: Matrix duplicates are performed on replicate aliquots of actual samples. The composition is usually not known.
Evaluation The results from matrix duplicates are primarily designed to assess the precision of analytical Criteria and results in a given matrix and are expressed as relative percent difference (RPO) or another Corrective statistical treatment (e. g., absolute differences). The laboratory shall document the calculation for Action relative percent difference or other statistical treatments.
Results are compared to the acceptance criteria as published in the mandated test method. Where there are no established criteria, the laboratory shall determine internal criteria and document the method used to establish the limits. For matrix duplicates results outside established criteria corrective action shall be documented or the data reported with appropriate data qualifying codes.
E1.2.5 Surrogate Spikes:
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an origina.l Set ID numbe~ appears on the cover page (I).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 63 of 109 Purpose Surrogates are used most often in organic chromatography test methods and are chosen to reflect the chemistries of the targeted components of the method. Added prior to sample preparation/extraction, they provide a measure of recovery for every sample matrix.
Frequency Except where the matrix precludes its use or when not available, or is not a method requirement, surrogate compounds are added to all samples, standards, and blanks for all appropriate test methods.
Composition: Surrogate compounds are chosen to represent the various chemistries of the target analytes in the method. They are often specified by the mandated method and are deliberately chosen for their being unlikely to occur as an environmental contaminant. Often this is accomplished by using deuterated analogs of select compounds.
Evaluation The results are compared to the acceptance criteria as published in the mandated test method or Criteria and determined using statistical process controls (SPC). Where there are no established criteria, the Corrective laboratory determines internal criteria and documents the method used to establish the limits.
Action:
Surrogates outside the acceptance criteria must be evaluated for the effect indicated for the individual sample results. The appropriate corrective action may be guided by the data quality objectives or other site specific requirements. Results reported from analyses with surrogate
- recoveries outside the acceptance criteria include appropriate data qualifiers.
E1.3 Method Evaluation The following procedures, as described in the other sections of the OAP, are in place in order to ensure the accuracy of the reported result:
- Procedure for initial demonstration of analytical capability performed initially (prior to the analysis of any samples) and if there is a significant change in instrument type, personnel, matrix or test method. Refer to Section 8.
- Procedures for initial and continuing calibration protocols as specified in Section 7.
- Procedures for utilizing proficiency test samples to evaluate the ability of a procedure and/or analyst laboratory to produce accurate data as specified in Section 3.
E1.4 Method Detection Limits Method detection limits (MDLs) are determined as described in GL-LB-E-001 for The Determination of Method Detection Limits. This procedure is based on that established in 40 CFR Part 136, Appendix B.
Where possible, MDL studies are conducted for both aqueous and solid matrices and biological tissues using a clean matrix appropriate to the test method (such as laboratory pure reagent water or Ottawa sand). MDL studies for the majority of routine parameters are conducted by:
- analyzing a minimum of seven replicates of the lowest calibration standard
- determining the standard deviation of the seven replicates
- multiplying the standard deviation by 3.143 (based on six degrees of freedom and representing a 99%
confidence level) to obtain the calculated MDL.
If the MDL study is being conducted for a new method or target analyte, the following steps are taken:
- the MDL is estimated based on information provided in the method or analytical experience
- a standard with a concentration three to five times the estimated MDL is prepared and analyzed a minimum of seven times
- the MDL is calculated as above based on the standard deviation and degrees of freedom
- the MDL is evaluated for reasonableness by verification through analysis of a prepared standard solution two to three times the calculated MDL.
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015
.Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 64 of 109 MDL studies are not performed for any target analyte for which spiking solutions are not available such as total volatile solids, pH, color, odor, temperature, dissolved oxygen, or turbidity.
Practical quantitation limits (PQLs) are determined by either multiplying the MDL by approximately 2 to 10 or are equal to that of the lowest calibration standard. Concentrations of a target analyte determined to be greater that its PQL are defined as quantitative results. All quantitative reported results are bracketed by calibration or calibration verification standards.
All MDL studies conducted by the laboratory are submitted to the Quality Group for an independent review. Upon acceptance of the MDL study, the MDLs reported to clients via our computer system are updated unless otherwise specified by contract. PQLs are also updated as directed by the new MDLs or changes to procedures.
All data pertaining to the study and the calculation of MDLs is stored on the production file system for data packages for four years and. then archived to DVD.
GEL uses an industry standard approach to establishing radiochemistry and radiobioassay MDA (minimum detectable activity). This approach is based on MARLAP guidance for posteriori determination of MDA. The approach incorporates real time events that affect the observed sensitivity for every measurement performed in the laboratory.
GEL recognizrs for EPA radiological drinking water samples, that a MDL study is required similar to chemical constituents tested for drinking water.
GEL will follow the source document EPA 815-R-05-004 EPA Manual for the Certification of Laboratories Analyzing Drinking Water. In Chapter VI Critical Elements for Radiochemistry, section 1.5 of this document and alternate procedure is given for radiological constituents.
The analyst should prepare and measure a sample set of at least four reagent blanks and four laboratory fortified blanks that have the radioanalyte of interest added to quantitation levels appropriate for drinking water samples, the activity level added to the laboratory fortified blnks should be between the radioanalyte's MCL and its required detection limit. To be deemed an acceptatble demonstration of proficiency, the mean recoveries and the statndard deviation of the recoveries of the replicate measurements should be consistent with the requiremnemts for accuracy and precision described in Section 7.7, and reagent blank measurements must have a mean result below the.
detection limit for each analyte measured with the method.
E1.5 Data Reduction The procedures for data reduction, such as use of linear regression, are documented in the individual analytical standard operating procedures. GEL's policy governing the manual integration of chromatographic_ data is detailed in GL-LB-E-017, Procedure and Policy for Manual Integration. Manual integrations of chromatographic peaks can only be performed in accordance with GL-LB-E-017. This ensures that the integrations are done in a consistent and technically justifiable manner while meeting the requirements set forth under the Good Automated Laboratory Practices.
SOP GL-QS-E-014, Quality Assurance Measurement Calculations and Processes, discusses the use of laboratory data in statistical determinations and includes discussion of Estimation ofTotal Analytical Uncertainty, Statistical Process Control (SPC) Limits, and Calibration of Instrumentation. Understanding of the procedures used for data generation and reduction is an important part of an analyst demonstrating proficiency in an analytical procedure. All analysts and technicians responsible for generating curves and using curve-generated data are trained to this SOP per GEL annual and interim training requirements.
E1.6 Quality of Standards and Reagents The quality of standards used in instrument calibration or quality control samples and reagents used in sample preparation and/or analysis must meet the criteria described in Section 7. In methods where the purity is not specified, analytical grade reagents are used. Reagents of lesser purity than those specified by the test method are never used. Upon receipt and prior to use, the labels on the container are checked to verify that the purity of the reagents meets the documented requirements of the particular test method.
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (I).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-BcOOl Rev 29 Revision 29 Effective March 2015 Page 65of109 The quality of water sources is monitored and documented as described in Section 4. The quality of water used in sample preparation or analysis meets the method-specified requirements. The type of water available in the laboratory is described in Section 4.
E1.7 Selectivity Absolute and relative retention times aid in the identification of components in chromatographic analyses and in evaluation of the effectiveness of a column in separating constituents. The procedures governing retention time widows are documented in the applicable analytical SOP and meet all regulatory and method requirements.
In addition to retention time windows, the acceptance criterion for mass spectral training is also documented in the appropriate analytical SOP. In all cases, the acceptance criteria meet or exceed those specified in the analytical methods.
Unless stipulated in writing by the client, confirmations are performed to verify the compound identification of positive results detected on a sample from a location that has not been previously tested by our laboratory. Such confirmations are performed on a second column for organic tests such as pesticides, herbicides, or acid extractable or when recommended by the analytical test method except when the analysis involves the use of a mass spectrometer. All conformation is documented.
E1.8 Constant and Consistent Test Conditions GEL's implementation of standard operating procedures that specify quality criteria including initial and continuing calibrations assures that our test instruments consistently operate within the specifications required of the application for which the equipment is used.
In addition to the specifications applied to instrumentation, glassware used for sample preparation or analysis is cleaned in a manner that reduces the potential for positive or negative interferences. Glassware is prepared in accordance with GL-LB-E-003 for Glassware Preparation.
This SOP details the procedures used to clean the following groups of glassware:
- That used for the determination of metals
- Reusable bottles and plasticware
- Bottles sued for the determination of biochemical oxygen demand (BOD)
- Glassware used in the determination of organic compounds
- That used for the determination of methylene blue active substances (MBAS)
- Glassware used in the determination of total organic halides {TOX)
- Glassware used in the analyses of samples for total Kjeldahl nitrogen (TKN) and total phosphorous
- Generic glassware used in all other analyses If the method specifies that the glassware be stored in a particular manner, this requirement is documented in the appropriate analytical SOP.
Section E2 Microbiology The quality control elements included in this section apply to microbiological analyses performed at GEL. The analyses include the determination of both total and fecal coliforms and standard plate counts.
Discussed in this section are:
- Negative controls
- Positive controls
- Test variability and reproducibility
- Method evaluation
- Test performance
- Data reduction
- Quality of standards, reagents, and media 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (I).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 66 of 109
- Selectivity
- Test conditions E2.1 Negative Controls We demonstrate that the cultured samples have not been contaminated during sampling handling and analysis or environmental exposure by the use of negative controls. These negative controls include both sterility checks bf
- media and method blanks.
All blanks and non-inoculated controls specified by the test methods are prepared and analyzed at the frequency stated in the method and in the corresponding standard operating procedure.
A minimum of one non-inoculated control is prepared and analyzed with analytical batches containing only one sample. If the analytical batch contains multiple samples, a series of method blanks is prepared. This series includes least one beginning and ending negative control with additional controls inserted after every 10 samples.
If the method blanks show evidence of contamination, the data obtained for the associated samples are not reported and the client is advised that resampling will be necessary.
Prior to initial use, each lot of medium is subjected to a sterility check by analyzing an aliquot of sterile buffer water. If there is any evidence of contamination, the medium .is not utilized for the analysis of samples and is either returned to the supplier or disposed of in accordance with the Laboratory Waste Management Plan.
E2.2 Positive Controls Positive controls are used to demonstrate that the medium can support the growth of the target organism and that it produces the specified or expected reaction to that organism. Prior to initial use and then on a monthly basis, each lot of medium is tested using least one pure culture of with a known positive reaction. If the positive reaction does not occur, the medium is not used for sample analysis and is either returned to the supplier or disposed of according to the Laboratory Waste Management Plan.
E2.3 Test Variability and Reproducibility We demonstrate reproducibility of our data by analyzing sample duplicates for least 5% of the suspected positive samples. Each analyst performing microbiological analyses makes parallel analyses on at least one positive sample per month.
For analysis requiring sample volumes of less than 100 ml or where the clients submit duplicate sample aliquots, a sample duplicate is analyzed with each analytical batch.
E2.4 Method Evaluation Our ability to perform a specified analysis successfully for its intended purpose is demonstrated and documented in meeting at a minimum the acceptance criteria specified by the method, by the EPA, and by state programs under which we are certified. The acceptance criteria demonstrate that the test method as performed at GEL provides correct and expected results with respect to specified detection capabilities, selectivity, and reproducibility.
Proficiency of the analysis is demonstrated prior to the test method through the use of positive and negative controls.
The validation of microbiological test methods is conducted under the same conditions as those for routine analysis.
All validation data are recorded in a logbook specified by the appropriate SOP. We maintain the data as long as the analysis is being conducted and for a minimum of five years after the retirement of an analytical method.
E2.5 Test Performance Test performance is demonstrated for all growth and recovery media used by the appropriate growth and reaction of target organisms to the test media through the use of positive controls as discussed in E2.2.
E2.6 Data Reduction All data are calculated and subjected to data reduction and statistical interpretations as specified by the method's SOP. These specifications incorporate those found in the associated analytical method.
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original* Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 67of109 For test methods specifying colony counts, such as membrane filter or colony counting, the ability of individual analysts to count colonies is verified at least once per month. This verification includes having two or more analysts count colonies from the same plate.
E2.7 Quality of Standards, Reagents and Media In addition to the performance of positive and negative controls, we ensure that the quality of the reagents and media meets or exceeds the requirements specified in the analytical methods. The commercially dehydrated powders used to prepare certain culture media as well as the media that are purchased ready for use are both subjected to positive and negative controls. In addition, all reagents, commercial dehydrated powders; and media a_re used within the shelf life of the product as documented in Section 8.
We retain all manufacturer supplied "quality specification statements" which may contain such information as shelf life of the product, storage conditions, sampling regimen/rate, sterility check including acceptability criteria, performance checks including the organism used, their culture collection reference and acceptability criteria, date of issue of specification, or statements assuring that the relevant product batch meets the product specifications.
All media and buffers are prepared using deionized water that has been demonstrated to be free from bacterial contamination. The deionized water used for microbiological analyses and the monitoring of the deionized water is discussed in Section 4.
Media, solutions and reagents are prepared, used and stored in accordance with the appropriate SOP. As described in 2.2, all laboratory media are evaluated at least monthly to ensure they support the growth of specific microbial cultures. In addition, selective media are checked to ensure they suppress the growth of non-target organisms.
The laboratory detergent is be checked by use of the inhibitory residue test to ensure that its residues do not inhibit or promote growth of microorganisms.
E2.8 Selectivity We perform all confirmation and verifications tests specified by the test method according to the procedures outlined in our SOPs.
In order to demonstrate traceability and selectivity, we use reference cultures of microorganisms obtained from a recognized national collection. We do not subculture bacterial working stocks. The storage and maintenance of all working and reference stocks are specified in the applicable analytical SOP.
E2.9 Test Conditions We monitor background levels by the use of method blanks and other negative controls. The acceptable background counts for each analysis and how to deal with situations in which these levels are exceeded are specified in the applicable SOP.
Walls, floors, ceilings, and work surfaces of our microbiological laboratory are non-absorbent and easy to clean and disinfect. Measures are taken to avoid accumulation of dust by the provision of sufficient storage space and daily cleaning of exposed surfaces.
The temperature measuring devices such as liquid-in-glass thermometers used in incubators, autoclaves, and other equipment are of the appropriate quality to achieve the specification in the test method.
The graduation of the temperature measuring devices is appropriate for the required accuracy of measurement. Each device is verified at least annually to national or international standards for temperature in accordance with GL-QS-E-007 for Thermometer Verification.
The temperatures of incubators, refrigerators, autoclaves, and water baths are monitored and documented in accordance with GL-LB-E-004 for Temperature Monitoring and Documentation Requirements for Refrigerators, Freezers, Ovens, Incubators, and Other Similar Devices. While in use, each piece of equipment is maintained in the temperature range specified by the applicable SOP and test method.
Records of autoclave operations including temperature and time are maintained for every cycle.
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 68of109 Volumetric equipment such as automatic dispensers, air displacement pi pets and disposal pipets are all used in the microbiology laboratory. This equipment is routinely checked for accuracy as discussed in Section 7.
Conductivity meters, pH meters, and other similar measurement instruments are calibrated according to the methods specified requirements detailed in the SOP.
Mechanical timers are checked regularly against electronic timing devices to ensure accuracy.
Section E3 Radiochemical Analysis This section describes the general quality control applied to radiochemical analysis. The specific quality control criteria applied to each analysis are delineated in the corresponding SOP. Detector Capabilities, Relative Bias, Relative Precision, and methods of calculating results for periodic Quality Control Determinations are discussed in the appropriate SOPs.
Discussed in this section are:
- Negative controls
- Positive controls
- Test variability/reproducibility
- Tracers and carriers
- Method evaluation
- Radiation measurement system calibration*
- Data reduction
- Quality of standards and reagents
- Test conditions E3.1 Negative Controls Method blanks serve as the primary negative controls providing a means of assessing the existence and magnitude of contamination introduced via the analytical scheme. A method blank is analyzed at a frequency of one per preparation or analytical batch and is one of the quality control measures used to assess batch acceptance.
The activity level determined for each target in the method blank is assessed against the specific acceptance criteria specified in the applicable SOP. These criteria are based on a designated sample aliquot size and include appropriate calculations to compare the blank to activity levels determined for different sizes of sample aliquots.
The activity level of any target analyte in the. method blank should be less than or equal to the contract required detection limit. The method blank may exceed this limit if the activity is less than 5% that of the lowest sample activity in the batch.
- If the method blank acceptance criteria are not met, the specified corrective action and contingencies delineated in the SOPs are followed. Any failures of method blanks to meet the acceptance criteria are documented in the laboratory report and through GEL's nonconformance reporting system specified in GL-QS-E-004 for the Documentation of Nonconformance Reporting and Dispositioning and Control of Nonconforming Items.
The activity levels determined for method blanks are not subtracted from those obtained for the samples in the associated preparation or analytical batch. Correction factors such as instrument background and analyte presence in the tracer may, however, be applied to all analyzed samples including both client samples and internal quality
- control samples.
E3.2 Positive Controls Positive controls routinely employed in radiochemical analyses include both laboratory control samples (LCS) and matrix spikes (MS).
The laboratory standards used to prepare LCS and MS are from a different source than those used in instrument calibration, except when the calibration has been verified with a different source. This requirement may be superseded by client specific contract requirements. The activity levels of target analytes in the LCS and MS exceed 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (I).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015
- Page 69of109 ten times the prior detection limit and are less than one hundred times this detection limit. If a radiochemical method, however, has more than one reportable analyte isotope, the LCS and MS need to only include one of the analyte isotopes.
Gamma spectroscopy is the exception to this guideline requiring the LCS and MS to contain isotopes representing the low, medium, and high-energy range of the analyzed gamma spectra.
E3.2.1 Laboratory Control Sample (LCS)
Laboratory control samples are analyzed at a minimum of once per preparation or analytical batch containing twenty or less samples.
The recovery of target analytes in the LCS is compared to the acceptance criteria specified in the applicable analytical SOP. If the recovery of the LCS does not fall within the acceptance range, the corrective actions and
- contingency steps specified in the SOP are implemented. These steps include the completion of an internal nonconformance report in accordance with GL-QS-E-004 and noting the failure on the laboratory report.
E3.2.2 Matrix Spike (MS)
Matrix spikes are analyzed at a minimum of once per preparation or analytical batch containing twenty samples or less under the following conditions:
- The analytical method does not utilize an internal standard or carrier
- There is a physical or chemical separation process *
- There is sufficient sample volume provided for the analysis.
The target analyte recoveries are one of the quality control measures used to assess batch acceptance. The recovery of target analytes in the MS is compared to the acceptance criteria specified in the applicable analytical SOP. If the recovery of the MS does not fall within the acceptance range, the data associated with that matrix spike are qualified accordingly.
E3.3 Test Variability/Reproducibility The reproducibility of measurements is evaluated by the use of matrix duplicates. Matrix duplicates are analyzed once per preparation or analytical batch of twenty samples. The relative percent difference (RPO) obtained between the activity levels obtained for the sample and its duplicate is evaluated against the range in the SOP.
E3.4 Tracers and Carriers Two additional quality control measures specific to radiochemical analysis are tracers and carriers. If the analytical method. requires a tracer or carrier, each sample result will be associated with a tracer recovery that is calculated and reported. For radiochemistry procedures requiring gravimetric or radiometric recovery (tracer yields), the acceptable limits are 15% - 125%. These limits may vary for specific clients and/or projects. If the applicable limits are not met, the corrective actions delineated in the SOP are implemented.
E3.5 Method Evaluation GEL evaluates the radiochemical preparation and analytical methods to ensure the accuracy of the reported result.
This evaluation includes initial demonstrations of capability as described in Section 8 and the analysis of proficiency test samples as described in Section 3. The suppliers of proficiency test samples conform to the requirements of ANSI N42.22 and ISO/IEC 17025-2005. .
E3.6 Radiation Measurement System Calibration It is not generally necessary or practical to calibrate radiochemical instrumentation each day of use due to its stability and the time-consuming nature of some of the measurements. There are, therefore, significant differences in the calibration requirements for radiochemical instrumentation from that used for chemical analyses.
Calibration differences include but are not limited to the following:
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page(!).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 70of109
- The requirement in Section 7 for the determination of the appropriate number of standards for initial calibration is not applicable to radiochemical methods. If the radiochemical method requires multiple standards for initial calibration, the number of standards is included in the applicable SOP.
- If linear regression or non-linear regression is used to fit standard response or calibration standard results to a calibration curve, the correlation coefficient is determined. This differs from Section 7.
- The requirement identified in Section 7 for the bracketing of quantitative results by calibration. or calibration verification standards is not applicable to radiochemical analyses due to the non-correlated event nature of decay counting instrumentation.
- As indicated in Section 7, the LCS may fill the requirements fpr the performance of an initial calibration and continuing calibration verification standard. The calibration verification acceptance criteria are the same as specified for the LCS (75 -125%).
- Background calibration measurements are made on a regular basis and monitored using control charts.
These values are subtracted from the total measured activity in the determination of the sample activity. The frequency of these measurements is indicated in the SOP GL-RAD-1-010.
- Instrument calibration shall be performed with reference standards as defined in Section E3.8.
- The frequency of calibration shall be addressed in the governing SOPs.
E3.7 Data Reduction All sources of method uncertainties and their propagation must be traceable to reported results. This is performed under the guidance of the ISO "Guide to the Expression of Uncertainty in Measurement" and the NIST Technical Note 1297 on "Guidelines for Evaluating and Expressing the Uncertainty of NIST Measurement Results." Details of calculations and equations used in reporting Radiochemistry analytical results may be found in GL-RAD-D-003 for Data Review, Validation and Data Package Assembly.
E3.8
- Quality of Standards and Reagents The reference standards we use are obtained from the National Institute of Standards and Technology (NIST), EPA, or suppliers providing NIST standards. Reference standards should be accompanied by a certificate of calibration whose content is described in ANSI N42.22 - 1995, Section 8, Certificates. All reagents used shall be analytical reagent grade or better.
E3.9 Test Conditions GEL adheres to written procedures that minimize the possibility of cross contamination between samples. This prevents incorrect analysis results from the cross contamination. Procedures are in place, for example, to separate known radioactive and nonradioactive samples from the time of sample receipt to analysis and sample disposal.
Instrument performance checks are performed on a regular basis and monitored with control charts. This ensures that the instrument is operating properly and that the calibration has not changed. The same check source used in the preparation of the control chart at the time of calibration is used in the performance checks of the instrument. The sources must provide adequate counting statistics for a relatively short count time and should be sealed or encapsulated to provide loss of activity and contamination of the instrument and laboratory personnel.
Instrument performance checks indude checks on the counting efficiency and the relationship between channel number and alpha or gamma ray energy.
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page ( 1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 71 of 109 APPENDIX F: ETHICS AND DATA INTEGRITY AGREEMENT The GEL Group Inc.
ETHICS and DATA INTEGRITY AGREEMENT I. I, (Name), state that I understand the high standards of integrity required of me with regard to the duties I perform and the data I report in connection with my employment at The GEL Group, Inc.
II. I agree that in the performance of my duties at The GEL Group, Inc.:
A. I shall not intentionally report data values that are not the actual values obtained, B. I shall not intentionally report data that does not meet method or procedural specifications unless that data is properly qualified through comments or other notations in the analytical report.
C. I shall not intentionally report dates and times of data analyses that are not the actual dates and time of data analyses; and D. I shall not intentionally represent another individual's work as my own.
III. I agree to inform a Group Leader, Manager, Director, or member of the Executive Committee of The GEL Group, Inc. of any accidental or intentional reporting of non-authentic data by myself or other employees in a timely manner.
IV. I will not knowingly participate in any questionable activities or violations of the Procurement Integrity Act during purchasing or sales activities. I will report any questionable activities to a Group Leader, Manager, Director, or member of the Executive Committee of The GEL Group, Inc. This includes discussions on analytical, consulting, and geophysical services pricing and contracts, vendor pricing, or other essential business information to anyone outside of The GEL Group, Inc. family.
This Ethics and Data Integrity Agreement has been explained to me by the Director of Quality Systems, my Group Leader, or at a training session, at which time I have been provided the opportunity to ask questions on any part of this agreement that I did not understand. It has also been explained to me that any violation of this agreement conducted during work performed under a subcontract or direct contract to a government agency could subject me to potential prosecution.
I understand that violation of this policy subjects me to disciplinary action, up to and including termination of my employment with The GEL Group Inc.
Employee Signature: Date:
Trainer Signature: Date:
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page(!).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 72 of 109 II APPENDIX G: EQUIPMENT LIST List of Equipment and Instrumentation ORGANICS EXTRACTIONS I # I Equipment Model# Purchase Date ID/Serial#
3 Tekmar Sonic Distribution 600 224610 I I 1 J2 Scientific GPC Accup-MP5 Jul-05 05C-1159-4-0 I I TV9612N6726 TV9631 N6975 .
TV9628N6939 TV9809R7994 8 Zymark Turbovap TUrbovap II May-96 TV0146N10597 TV0146N10596 TV0146N10598 TV0146N10595 4041427 4040014 4 Soxtherms SOX416/SE416 Jan-05 4040019 4040018 2812 115 Jun-93 3 N-Evaps Organomation 6184 1205 Jun-95 2038 1 Sartorius Toploading Balanc-= CP 323S NIA 19350208 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on.the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 73 of 109 LIQUID CHROMATOGRAPHY/HPLC' /
I # I Equipment I Model# Purchase Date ID/Serial#
D99SM9012R (LC) VB150 (MS)
Quattro Ultima May-02 DE91608981 (LC) V04290402 LC/MS/MS-Water HPLC ABSCiex 4000 Sep-05 (MS) 4 MicroMass Mass Spectrometer ABSciex 4000 April-07 141417 (LC) V113820703 (MS)
ABSciex 4000 Dec-14 L20235255304(LC)AU21281403 (MS) 1 Agilent 1100 Bianary Pump 1100 Apr-07 DE43619731 1 Aglient 1100 ALS 1100 Jun-07 US64401050 I 1 I Agilent 1100 DAD 1100 Jun-07 DE43603083 1 Aglient 1100 Quantum Pump 1100 Jun-07 DE23919852 1 LEAP Technologies PAL Auotsampler Apr-07 141417 Hewlett Packard HPLC with Diode 1 1100 Oct-99 DE14913984 Array Detector 1 Hewlett Packard 11 00 ALS 1100 Oct-99 DE91607770 I 1 I Hewlett Packard 11 00 Quantum Pump I 1100 Oct-99 DE23919817 1 Agilent 1100 ALS 1100 Sep-05 DE91604756 Hewlett Packard HPLC with Diode DE54627302 1 Array Detector and Fluoresence 1100 Nov-99 DE92001137 Detector Hewlett Packard HPLC with Diode DE91608331 1 Array Detector and Fluoresence 1100 Jun-05 DE14904242 Detector 1 OHAUS Analytical Balance CQ1 OR11-2E1 N/A 00119266EK VOLATILE ORGANIC ANALYSIS Equipment I' Model# Purchase Date* ID/Serial #
Hewlett Packard Gas Chromatograph/Mass 5973 Oct-99 US71191096(US00030386)VOA1 Spectrometer Chemstation with 01 4560/Arcon Autosam ler 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-00 l Rev 29 Revision 29 Effective March 2015 Page 74 of 109 VOLATILE ORGANIC ANALYSIS {continued)
Hewlett Packard Gas Chromatograph/Mass 1 5973 Nov-98 US71191097{US00023264)VOA9 Spectrometer chemstation with 01 Eclipse/Arcon Autosampler Hewlett Packard Gas Chromatograph/Mass 1 5973 Apr-09 US71191093/US00026073 Spectrometer Chemstation with 01 4560/Arcon Autosampler Hewlett Packard Gas Chromatograph/Mass 1 5975 Aug-06 US61332879(CN10848050)(VOA5)
Spectrometer Chemstation with 01 4560/Arcon Autosampler Hewlett Packard Gas Chromatograph/Mass 1 . 5973 Jan-98 US71191112(US00010331 )VOA8 Spectrometer Chemstation with 014560/Arcon Autosampler Hewlett Packard Gas Chromatograph/Mass (CN10848050) VOA2 1 5975C Apr-09 Spectrometer Chemstation with 01 US83131318/CN10606080 Eclipse/Arcon Autosampler Hewlett Packard Gas Chromatograph/Mass 1 5973 Jul-04 US71191113(US00028288)VOA3 Spectrometer Chemstation with 01 4560/Arcon Autosampler Hewlett Packard Gas Chromatograph/Mass 1 5973 Jul-05 US10442045(US10150081 )VOA?
Spectrometer Chemstation with 01 4560/Arcon Autosampler Hewlett Packard Gas Chromatograph/Mass 1 5975 Sep-05 . US52430466(CN10525054)VOA6 Spectrometer Chemstation with 01 4560/Arcon Autosampler 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GELLaboratories, LLC GL~QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 7 5 of 109 Hewlett Packard Gas Chromatograph/Mass CN10848117 (VOAA) 5975 Apr-09 Spectrometer Chemstation with 01 US83131219 Eclipse/Arcon Autosampler Hewlett Packard Gas Chromatograph/Mass US0026725 (b431466149) (VOAB)
Spectrometer Chemstation with 01 6890 June-11 FID=1471 Eclipse/Arcon Autosampler PID/FID PID=54500 Detectors Agilent Flame lonizationDetector
- 6890N Aug-08 CN10813002 (VOC4)
/Chemstation with 01 4560 SEMIVOLATILE ORGANIC ANALYSIS
- Equipment Model# Purchase Date ID/Serial#
Hewlett Packard 6890N Gas Chromatograph/
5973 September-05 5973 Mass Spectrometer w/ 7683 CN10521005/US52440275 MSD1 Autosampler Tower Hewlett Packard 7890A Gas Chromatograph/
5975 April-09 CN10848121/US83131300 MSD2 5975C Inert Mass Spectrometer w/
7683 Autosampler Tower Hewlett Packard 7890A Gas Chromatograph/
5975 April-09 CN10821032/US83131355 MSD3 5975C Inert Mass Spectrometer w/
7683 Autosampler Tower Hewlett Packard 7890A Gas Chromatograph/5975C Inert Mass
. 5975 November-07 CN10727001/US90704000 MSD4 Spectrometer w/ 7683 Autosampler Tower Hewlett Packard 6890 Gas Chromatograph/
5973 May-97 US00023050/US82311233 MSD5 5973 Mass Spectrometer w/ 7683 Autosampler Tower 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 76of109 Hewlett Packard 6890 Gas Chromatograph/
5973 May-97 US00025502/US82311417 MSD6 5973 Mass Spectrometer w/ 7683 Autos ampler Tower Hewlett Packard 6890 Gas Chromatograph/
5973 . May-97 US00007297/US70810371 MSD7 5973 Mass Spectrometer w/ 7673 Autosamoler Tower Hewlett Packard 6890 Gas Chromatograph/
5973 May-97 US00028102/US82311610 MSD8 5973 Mass Spectrometer w/ 7683 Autosampler Tower Hewlett Packard 6890N Gas Chromatograph-FID w/ CTCH5500 6890 July-08 US00009213 FID9 Headspace Autosampler Hewlett Packard 6890N Gas CN10805007 FID8 Chromatograph-FID w/ CTCH5500 6890 July-08 126292 Headsoace Autosamoler Hewlett Packard 6890N Gas Chromatograph-FID w/ 7683B 6890 March-08 CN10805005 FID6 Autosampler Hewlett Packard 6890N Gas Chromatograph-FID w/ 7683B 6890 June-08 CN10811015 FID7 Autosampler Hewlett Packard 6890N Gas Chromatograph-FID w/ 7683B 6890 July-07 US10604037 FID5 Autosampler Hewlett Packard 6890 Gas Chromatograph-Dual ECO w/ 7683 6890 March-98 US00023402 ECD1 Autosampler Hewlett Packard 6890 Gas Chromatograph-Dual ECO w/ 7683 ' 6890 March-98 US00028911 ECD2 Autosamoler Hewlett Packard 6890 Gas Chromatograph-Dual ECO w/ 7683 7890A March-10 CN10842125 ECD3 Autosampler Hewlett Packard 6890 Gas I 6890 November-97 US00009591 ECDS Chromatograph-Dual ECO w/ 7673 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-~015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 77 of 109 Autos ampler I I Hewlett Packard 6890 Gas 1 Chromatograph-Dual ECO w/ 7683 6890 November-97 US00023343 ECD6 Autosampler D Hewlett Packard 6890 Gas Chromatograph-Dual ECO w/ 7673 Autosampler 6890 November-97 US00010134 ECO?
D 1 Hewlett Packard 6890 Gas
. Chromatograph-Dual ECO w/ 7683 Autosampler Hewlett Packard 7890A Gas Chromatograph-Dual Micro ECO w/
6890 7890A July-98 July-10 US10133016 ECD8 CN10261088 ECD9
- 7693 Autosampler METALS ANALYSIS
- Equipment Model# Purchase Date ID/Serial#
Fims 100 Apr-09 101S9040502 2 Perkin Elmer Mercury Analyzer Fims 100 Jul-01 1536 Apr-09 2 AA WINLAB (Softwari;i) N/A Jul-01 PS Analytical Atomic Fluorescence .
1 Mercury 10.035X Sep-11 550 Analyzer 1 Millennium (Software) N/A Sep-11 N/A Apr-02 Apr-09 5 Perkin Elmer ICPMS (Software) 2.4 SP3 Apr-10 N/A May-14 Auq-14 ELAN 9000 Apr-02 P1160304 Perkin Elmer Inductively Coupled ELAN 9000 Jan-06 AJ0100590602 5 Plasma Mass ELAN 9000 Apr-10 AJ13141002 Spectrometer NexlON 300 May-14 81VN4031301 NexlON 350 Aug-14 85VN4061701 2040 Savage Road Charleston SC 29407 (843) 556-8 l 71 This document is co11trol!ed only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 78of109 D
5300DV Dec-07 077C7090601 Perkin Elmer Inductively Coupled 7300DV Mar-10 077C0022701 Plasma Spectrometer 7300DV Jun-10 077C0052701 8300DV Apr-14 07881403012 D
Apr-02 Dec-07 Winlab 32 (software) Ver 3.1.0 N/A Mar-1 O Jun-10 I I 1 Thermo Orion 3Star 3Star Aug-09 B16666 1 Thermo Orion pH meter 420 Prior to 2008 I 65576 I Feb-08 B351136892 Feb-08 B351136893 4 OHAUS Balance AV313 Jan-13 8029041072 Feb-08 8029041075 U6100+ 3~010019 CP22025 14910413 4 Sartorius Balance N/A TE313S 14509268 CP 4238 16107662 1 METTLER Balance PM4600 Prior to 2008 G97859 T 101 T 104 4 TCLP Tumblers N/A Prior to 2008 T 105 T 106 3 Environmental Express HotBlock SC100 Prior to 2008 Various Units 11 Environmental Express HotBlock .SC154 Prior to 2008 Various Units 08301024 2 Torrey Pines Scientific Hotplate HP51 Prior to 2008 08301025 1
1 1
lF U.S. Filter Modulab Water System Barnstead NANOpure Diamonqf Thermo Centrifuge M00100 011901 CL30 I Prior to 2008 Aug-02 Apr-08 LW2264 1190030186870 307070484 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents* do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 79 of 109 GENERAL CHEMISTRY
- Equipment Model# Purchase Date ID/Serial#
Dohrman Total Organic Carbon 1 DC190 May-93 9303219 Analyzer 1 01 Analytical, TOC 1010 011010 Jul-99 H935710267 1 WinTOC (software) N/A Jul-99 N/A
?
9000 Oct-01 01-337 Horizon Speed Vap II 9000 Apr-02 01-340 Jul-01 A83000-1910 2 Lachat QuikChem 8000 COOO series Jul-02 A83000-2077 1 Lachat QuikChem 8500
- 8500 series Jan-06 60900000344 3.0.218 Jul-01 3 Omnion (software) 3.0.218 Jul-02 3.0.219 Jan-06
?
Nov-03 3DUD255001 ThermoSpectronic 200+
Aug-06 3DUJ199004 Mitsubishi Total Organic Halogen 1 AOX-200 Jul-1 O E7B00117 Analyzer 1 Dionex Ion Chromatograph DX500 Oct-99 99040041 1 PeakNet (software) 5.21 Oct-99 Feb-08 07120836 3 Dionex Ion Chromatograph ICS-3000 Apr-09 09030720 Apr-09 09030721 1 Dionex Ion Chromatograph ICS-5000 Jul-10 10060501 1 Dionex Ion Chromatograph ICS-1600 Jul-14 14060002 Feb-08 Apr-09 4 Chromeleon (software) 6.80 SP2 N/A Apr-09 J.ul-10 1 Chromeleon (Software) 7.2.1 Jul-1 <+ N/A 1 Turbidimeter Orion AQ4500 Feb-11 804279 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 80 of 109 1 Mitsubishi Total Orga~ TOX-1 Osigma Jul-10 *75R03796 Analyzers 1 Titroline Karl Fischer Mo D55122 Feb-07 635172 4540A10265 2 TKN Block Digestor AIM500 Feb-06 4540A10266 0300-0171 2 Lab-Line Pyro Multi-Magnestire 59380 Prior to 2008 0300-0170 05L1915 AE 2 YSI Dissolved Oxygen Meter . 5000 Nov-05 08A100955 1 IEC Clinical Centrifuge Clinical Prior to 2008 428-17189 1 Pensky Martin Flashpoint Tester HFP 380 Prior to 200 23800146 1 Rapid Tester Setaflash RT-00001 May-1 142271 2 Baxter TDS Ovens DN63 Prior to 20 DN63 1370FM 1 VWR Oven Prior to 2008 101399 13703M 1 Linburg /Blue Muffle Furnace Box Furnace Prior to 2008 Not accessible R7U-1 2 Precision Water Baths Nov-03 602101333 911005731G 2 HACH COD Reactor COD Reactor Jan-94 I I 9807000017919 I 1 I Orion Conductivity Meter A212 May-12 X00353 I 1 I Parr 6200 Calorimeter I Parr 6200 Aug-14 M40303 1872 3410156 BP2100S 2510025 BA210S 90710197 6 Sartorius Balance Prior to 2008 BA221S 40245216 ED2200S 90606741 LC8400-P 410010032 1 OHAUS Balance PA 114 Jan-11 8331440032 1 Brookfield Viscometer LVDVE Apr-05 E6515383 019496 2 PerpHect pH Meter qrion 370 Prior to 2008 019742 1 Beckman Centrifuge TJ-6 Prior to 2008 4359.
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 81 of 109 I 1 I VWR Centrifuge I Clinical 200 Nov-11 68105001 1 ManSci PC-TitrateSip System PCM-PSDT/CA 1'.!ov-03 Mt-1 H3-696 SC6002 Apr-09 5388DIS1012 SC6002 Apr-09 5388DIS1016 4 Simple Cn Hotblocks SC6002 Jan-09 5873DIS1030 SC6002 Jan-09 5873DIS1036 2020 Jan-99 10059509 2 BOD incubator 818 Jan-10 26AW-9 1 Thermo Orion Star A 111 A111 J06078 Feb-14 Y305811 62379-531 2 Electronic Digital Caliper 030150 Prior to 2008 C00130150 RADIOCHEMISTRY/BIO ASSAY
- Equipment Model# Purchase Date ID/Serial#
Canberra Alpha Spectrometers for 96 Alpha Spectroscopy System 7401 1992 to" 1995 Various (environmental) I I Canberra Alpha Analyst Spectrometers 144 7200 1988 to 2009 Various with PIPS Detectors (environmental)
Canberra Alpha Analyst Spectrometer 144 7200 1988-2009 Various I I with PIPS Detectors (bioassay)
Perkin Elmer Automatic Gamma 1 1480 Jun-05 4800440 I I
- Counter Canberra Gamma Analyst Automatic 1 GAM-AN2 Jun-05 12069216 Sample Changer 500AU Nov-98 N183806280 Compaq/DEC Alpha Work Stations for 500AU Nov-98 N188806229 5 Alpha/Gamma 500AU Jan-04 406DP9Z106C Data Management System DS-10 May-06 AY9320655!)
DS-10 Mar-09 AY30703843 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09~Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 82 of 109 Protean Automatic Proportional EMC Oct-2003 2 Counter . WPC 9550 0329438 Jul-2004 (Bioassay) 924233 Apr-02 10751, 10752, 10753, 10754 Protean Multi-Detector (40)
Jul-2005 0525767 ,0525768 11 Proportional MDS-16 Oct-05 0531474,0531474 Counter Mar-02 31143Z311438, 0021910 Protean Multi-Detector (16) 4 Proportional MDS-16 Feb-09 9115168, 169, 170,171 Counter Tennelec LB-41 00 Proportional Jun-93 18483 2 LB4100 Counter with 32 detectors Dec-98 21938 T ennelec LB-41 00 Proportional 1 LB4100 2010 70562 Counter with 16 detectors LS6000 Jun-93 7065155 LS6500 Jun-93 7067083 LS6500 Apr-94 7067404 7 Beckman Liquid Scintillation Counters LS6000 Mar-03 7060655 LS6500 Oct-03 7070506 LS6500 Dec-98 7069123 LS6000 Dec-98 7060656 Perkin Elmer Inductively Coupled /
1 Plasma Mass ELAN9000 Jun-10 AJ13351006, AJ13271005.
Spectrometer Perkin Elmer Liquid Scintillation
. 1414 1997 4140127 2 Counter - Wallac Guardian 2010 4140421 (environmental)
Perkin Elmer Liquid Scintillation 1 1414 1998 4140299 Counter - Wallac Guardian (bioassay)
Perkin Elmer Liquid Scintillation 1 Counter - Wallac Guardian 1415 2010 4150033 (environmental)
H~98 2200082 2 Perkin Elmer Quantulus 1220 2009 DG06095168 2040 Savage Road Charleston SC 29407 (843) 556-8 l 71 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 83 of 109 10235232 2 Ortec - Alpha Spectrometers alpha ensemble-8 2010 10230971 7 Ortec - Alpha Spectrometers octete-pc 2010 177, 182,217,266,264, 144, 176 Perkin Elmer Liquid Scintillation 1 1219 2010 206147 Counter - Rackbeta 1 Perkin Elmer ICPMS ELAN 9000 2010 AJ13271005 Broad-Energy Germanium 1 BE3825 2006 3068173 Detector(Carbon Comp. Window)
High Purity Germanium Coaxial 1 GEM90210-P 1990 30-TP30546-A Detector High Purity Germanium Coaxial 1 GEM-35190 2004 CV-P122204CA Detector High Purity Germanium Coaxial CV-P042407CA 1 GEM35 2007 Detector High Purity Germanium Coaxial 1 GEM35P4-83 2008 CV-TP011608CA Detector 1 High Purity Germanium Well Detector GCW 1994 3941466 Low Energy Germanium Detector 1 GL1015 1988 488926 I I (Beryllium Window)
Low Energy Germanium Detector 1 GL1010S 1990 10902649 I I (Beryllium Window)
Low Energy Germanium Detector 1 GL2820R 1995 1954119 I I (Beryllium Window)
EB Low Energy Germanium Detector GL2820R 1998 3984452 (Beryllium Window)
Low Energy Germanium Detector GL2020R 2007 9078304 (Beryllium Window)
Low Energy Germanium Detector 1 GL2020-S 1992 12922782 I I (Carbon Comp. Window)
N-Type High Purity Germanium 1 GMX 45225-P-S 1990 37-TN11260A Coaxial Detector N-Type High Purity Germanium G.,..,,
"*~ *- ~
____ _,u-r 1 1990 30-TN10348 Coaxial Detector 1 N-Type High Purity Germanium NIG3019 1991 PGT2461 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents* do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 84 of 109 Coaxial Detector P-Type High Purity Germanium Coaxial 1 IGC3919 1993 2605 I I Detector Reverse-Electrode Coaxial Germanium 1 GR3019 1986 9861606 I I Detector (Beryllium Window)
Reverse-Electrode Coaxial Germanium 1 GR2020 1991 1912509 I I Detector (Beryllium Window)
Reverse-Electrode Coaxial Germanium 1 GR3520 1993 8932581 Detector (Carbon Comp. Window)
Standard Electrode Coaxial .
2 GC3519 1991 9912854, 11912876 Germanium Detector Standard Electrode Coaxial 1 GC3520 1992 12922955 Germanium Detector 9923035 Standard Electrode Coaxial 9923043 4 GC2018 1992 Germanium Detector 10923049 10923050 Standard Electrode Coaxial 1 GC3018 1993 5933088 Germanium Detector Standard Electrode Coaxial 1 GC3519 1994 1943234 Germanium Detector Standard .Electrode Coaxial 1 GC8021 1994 8943324 Germanium Detector I I Standard Electrode Coaxial 1 GC3519 1994 1943199 Germanium Detector 6953489
' 6953483 1995 6953542 Standard Electrode Coaxial 2001 10017452 8 GC4019 Germanium Detector 2006 10017444 2007 9069163 .
9069175 10079344 10059017 Standard Electrode Coaxial 2005 3 GC4020 10059015 Germanium Detector 2006 4069118 4 Standard Electrode Coaxial GC4520 2009 4099544 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 85 of 109 Germanium Detector 4099570 9624 I I 9639 I 1 I Sartorius Balance I A200S I 38080204 I 1 Sartorius Balance BP310S 50410272 1 . Sartorius Balance CP2201 18150253 18550299 2 Sartorius Balance CP323S 15750050 1 Sartorius Balance CP 2202S 17955156 I 1 I Sartorius Balance I GF8000 Aug-12 I 14607894 I Sartorius Balance HD 2000 D 39020004 EJ I 1 I Sartorius Balance Sartorius Balance I 112000 s L2200S 40109033
' 39039003 38110007
~
Sartorius Balance U6100 Aug-12 36040217 14607894 Sartorius Balance BP3100S 51204863 I 1 I Sartorius Balance I U5000D 36080009 1 Sartorius Balance R 3008 38110047 I 1 I Mettler Analytical Balance AE160 C31514 1 Mettler Analytical Balance AE163 F33394 F30560 2 Mettler Analytical Balance AE200 1113021018 1 Mettler Analytical Balance AE240 L28658 1 Mettler Analytical Balance AE50 1113092273 1 Mettler Analytical Balance PM16-N N39169 1 Mettler Analytical Balance PM 4600 J93763 1 OHAUS Toploader Balance RD6RM 2525244 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 86 of 109 HIGH RAD ALIQUOT ROOM I # I Equipment* I Model# I Purchase Date I ID/Serial#
1 Adventurer Pro AV2102 Oct-14 B440101411 LABORATORY INFORMATION MANAGEMENT SYSTEMS
- Equipment Model# Purchase Date ID/Serial#
DELL Poweredge 860 (vmhost01) 2 X 1 860 2007 FDBKLC1 1.86Ghz 3G ram DELL Poweredge 29SO (mailsvr01) 4 X 1 29SO 2007 DG2CNB1 3.0Ghz 2GB ram Windows NT Server, NT4, 2 CPU 2S6 MBRAM 1 N/A Aug-98 PC Server Class 10 GB Disk (rad_server), 100 Mbps Eth card, HP9000 Dclass, HP-UX 10.20, 2 cpu, 2S6 MB RAM, (hpclp1) SOGB Disk 1 N/A Nov-97 A3480A (mirrored and RAID%), Raid tower, 100 Mbps Eth card, Target Software HP9000 Dclass, HP-UX 10.20, 2 cpu, 2S6 MB RAM, (kilroy) SOGB Disk 1 N/A Nov-97 A3480A (mirrored and RAIDS), Raid tower, 100 Mbps Eth card, Target Software HP9000 Dclass, HP-UX 10.20, 2 cpu, 2S6 MB RAM, (prdsvr07) SOGB Disk 1 N/A Nov-97 A3480A (mirrored and RAIDS), Raid tower, Tarqet Software Dell Poweredge sc420 (linuxsvr02) 1 SC420 2004 H4Q9G61 I I 2X3.6GHz processors. 1GB ram Rave - Ultra AX-MP (prodsvvr04)
I I 1 2 CPU's, 1024 MB RAM, 60 GB Disk E2SO Mar-00 302971 (mirrored)
Sun V440 (prodsvr03) 4X1 .S93Ghz 1 V440 2006 OS1SAD1489 8GB ram 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Qua]jty Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 87 of 109 Sun V890 (prodsvr01) 8X1 .5Ghz) 1 V890 2007 0529AM019F 32GB ram (mirrored and raid5)
Sun V890(standbysvr01) 4X1 .35Ghz 1 V890 2008 0526AM02F 16GB (mirrored and rad5)
Aberdeen Sterling S38i (linuxsvr04) 1 4x3.1 GHz, 1.5GB RAM , 168 GB Sterling S38i 2006 F14102A3420394 (RAID5)
Aberdeen Sterling S38i (linuxsvr05) 1 4x1 .8 GHz, 1.5GB RAM , 168 GB Sterling S38i 2006 F14102A3470669 (RAID5)
Apple- Xserve G% 2x2.5 GHzCPU's ,
1 1.0 GB RAM , 3x400 GB Disks Xserve G5 2006 QP5020HKRTS (mirrored)
Apple-Xserv RAID 1 Xserve RAID 2006 QP503007R56 14x400 GB Disks (RAID5)
HP-Prolient DL360 (vmhost02) 1 DL360 2009 MXQ904A2SR 2-QuadCoreX2.83GHz 16GB HP-Prolient DL360 (vmhost03) 1 DL361 2009 MXQ903A3RA 2-QuadCoreX2.83GHz 16GB HP-Prolient DL360 (vmhost04) 1 DL362 2009 MXQ903A3KSS 2-QuadCoreX2.83GHz 16GB HP2012i (san01) DC Modular Smart 1 2012i 2009 3CL904C 108 Array 1 EMC Storage Array Network (SAN) VNX5200 Jan-2015 APM00145036951 UNIVERSAL POWER SUPPLY
- Equipment Model# Purchase Date ID/Serial#
1 Power ware 9315 9315 Jul-05 ES443ZXX57 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page ( 1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effecti ve March 20 15 Page 88 of 109 APPENDIX H: FACILITIES WITH EVACUATION ROUTES
)
FLOOR PLAr - TIRST FLOOR FLOO Pl.A.'> - SECOXD FLOOR SOUTH WDiG I~
2 0 0 SA,- AGE ROAD THE GEL GROUP 2040 Savage Road Charleston SC 29407 (843) 556-8 171 This document is con trolled only when an origi nal Set ID number appears on the cover page(!).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 89 of 109 APPENDIX I: STANDARD OPERA TING PROCEDURES AND ANAL YT/CAL METHODS II l
- \
r-ADM-E-001 *Preparation, Authorization, Advance Change, Revision, *NIA
. Release, and Retirement of Standard Op~ra~ing ~ocedure_s GL-AP-E-001 Invoicing An~lytical Lab Numbe~_s_ NIA GL-CO-E-001 Revising GEL Laboratories Catalo~ ()f _,<\nalytic:al ~~~".'~ces NIA GL-CO-E-002 Delegated ,<\uthoEity to Commit th~_~o!Ilpany__ __ NIA GL-CO-E-003 .Request for Proposal (RFP) and Contract_Revie\\' NIA GL-CS-E-002 *Internal Review of Contractually Required Quality Criteria for *NIA Client Package Delivery GL-CS-E-005 Electronic Data Deliverables NIA
[GI,-CS-E-006 Subcontracting Analy!ical S_ervic~s. NIA GL-CS-E-008 Prelogin, 1:~!?;in,_ a11d Login Re".'_i~'lv'..... _ .NIA
- Project Management AlphaLIMS Manual. NIA GL-DC-E-001 Document Control NIA GL-FC-E-001 :Facility Security NIA GL-FC-E-002 .. :J'est~n~.J:<:1.11ergenc:y.~y_e_\\'_ash a11d Shower EquipIIl~nt .NIA GL-FC-E-003 NIA GL-FC-E-004 _ _In_spection _of Fire Extinguishers NIA GL-FS-E-001 !Field pH EPA 150.1, 4500-H+ B GL-FS-E-002 Field Specific Conductance EPA 120.1, 2510B,2550B GL-FS-E-003 Field Dissolved Oxygen !EPA 360.1, 4500-0 G 1;~-~~-~=~;_:---* . . . ~i~ld.J'o!~l-~d*~;;~::~:;i~~al Chlorine 0
EPA 330.5, 4500-Cl G, HACH 8021 and 8167 GL-FS-E-007 Low Level MercuryS~IIIPJ:ill.gby EPA_ ~~t~()~ 1~()9. 1631, 1669 GL-GC-E-001 rTotal Dissolved Solids EPA 160.1, 2540C GL-GC-E-004 _G(!11eral C::h(!IIlist~y ~tan~~~_s, pefi11itio11~*..al1~!'~t!P~ration NIA GL-GC-E-007 Total Organic Halogen (TOX) and Adsorbable Organic Halides 1650C, 9020B on Liquid Samples Using the Mitsubishi TOX-10 Analyzer GL-GC-E-008 pH ~PA 150.1, 9040Bl9040C, 9041A, 9045Cl9045D, 4500-W* OLM04.2 GL-GC-E-009 Conductivity and Salinity EPA 120.1, 9050A, SM 2510B, SM2520B GL-GC-E-010 !Paint Filter Test EPA 9095A, 9095B GL-GC-E-011 Total Solids EPA 160.3, 2540B, 2540G GL-GC-E-012 rTotal Suspended Solids EPA 160.2, 2540D
~ensky~M~rtens Closed Cup Flashpoint 1010, lOlOA, AS1MD93-80
[car~~n_~C:(!O!JS. Bioc~~IIlical ()~yg_~n Q(!mand (CBOD) EPA 405.1, 5210B GL-GC-E-029 CorrosivityToward Steel 1llO(M), l llOA(M)
GL-GC-E-032 Carbon Dioxide (Total and Free) by Calculation 4500-C0 2 D GL-GC-E-033 Alkalinity: Total, Bicarbonate, Carbonate, Hydroxide, and EPA 310.l(M), 2320B
~==.:.~~~~_,&~~~....;,,..~~~~~~~
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 90of109
- - ----- _* *----- --- ----*-w**staiicfar<ropera~n9 Pro~-ediif~s--anci JfnaiYiicarnifeitioC;ls____ ---- -- ~
- c----~------
- r. ,,,,§9P.t/:, . ; 11:;;.,. . <.:_:*,,.r <- 1~-- ,§9P.J:itl~, , , :. ***.. * ,, , -*1 *. ; , rMethO~s ,** ..... .
[. _Phf:ll?lphtha_lei_f1_____ _
GL-GC-E-035 !Volatile Suspended Solids EPA 160.2, 160.4, 2540E GL-GC-E-036 ____ Cc_il()r_b_)'. Visu(ll C.?Il1Pllli~()ll ... EPA 110.2, 2120B GL-q_<;:_~.§:-:Q_3_7 _ rTurbid_i~ _ _ __ _ -----
2130-B GL-GC-E-040 Pretreatment of Cyanide Amenable to Chlorination _EPA 335.1, 9010B, 9010C,
.9012A, 9012B, 9013(M) 4500-CN- G GL-GC-E-044 Colorimetric Determination of Hexavalent Chromium 7196A, 3500-CrD,
- --- -- -*~-
3060A EPA 405.1, 5210B GL-GC-E-047 . Met~ylene Blue Active Substance EPA425.1, 5540C rGL-GC-E-048 Heating Value Determination by Bomb Calorimeter ASTM D 240-00, 4809-00, E 711-87 (M)
GL-GC-E-050 Threshold Odor EPA 140.l,2150B GL-GC-E-052 Sulfide (Methylene Blue Method) EPA 376.2(M), HACH 8131, 4500 s2-D GI:~GC-E-:,056 1 Sulfite _____,450Q~§Q{_~, El-'_A 377.1 9~.=__q_C~E'.-Q?_Z___ ____ y_~~~o~~-a~-~~~-l2:~~~-l1~L~_\.\'ii_~r_§_aE:J!J~S- - ... ____ ~~l_§Q~, ?~~Q]j__ _ __________
GL-GC-E-058 Wolatile Solids and% Ash Procedure for Solid and Semisolid 25400
____ -------- --~ Sampl~-------*--*-*--------*-----------------------------------------------------------------------
GL-GC-E-059 Dissolved O~ygen Analysis by Mf'.mbra~e Electrode Metho~ _ ~500-0-0, EPA 360.l GL-GC-E-061 GL-GC-E-062 Total Carbon and Total Organic Carbon Analysis Using the 9060 (M), 9060A(M), EPA
!Dohrmann DC-~90 Boat Sampler ~15.1, Lloyd Kahn GL-GC-E-064 Density *ASTM D5057 GL-GC-E-065 Specifi_c;_9rav~ty _____ _ ASTMD5057 GL-GC-E-066 Flashpoint by Setaflash 1020A, 1020B, ASTM D 3278-78 GL-GC-E-067 Cyanide Sample Distillation 9012A, 9012B, 9010B, 9010C, 335.3, 335.4, 335.2 CLP-M, 4500-CN-c GL-GC-E-068 _____ V:iscosity ~anufacturer's Method GL-GC-E-069 Reactive Cyanide and Sulfide 'SW-846 Chap 7.3.3, Chap 7.3.4 GL-GC-E-071 Total Phosphorous and Total Kjeldahl Nitrogen Sample EPA 365.4, 351.2, Preparation GL-GC-E-072 ~monia-Nitrogen Sample Preparation EPA 350.1, 350.2, 4500-NH3-B IFree_Cya_nid_f:_Analysis__b~ Microdiffusio_11_____ _ ASTM D 4282 GL-GC-E-074 Extractable Organic Halides (EOX) Using the Dohrmann DX- SW-846 9023
_ 2000 Analyzer GL-GC-E-076 Total Residue Chlorine 4500-Cl G GL-GC-E-077 Cyanide Weak Acid Dissociable Sample Preparation and EPA 335.4, 4500-CN-I Analy_sis GL-GC-E-079 !Bomb .::'l:'re.param1nmn Method for Solid Waste 5050 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page(!).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 91of109
- ,,, Sqp# ;
- ,, J1,,.,,,. > ** .. C,' , >1),.,SOP Title . *.* /, .* . .1* .*h ..*.r. '..l\!l~thods * ,
GL-:_c.J<::::-?-Q8~ *- _Ji\.cid-:_~ol\l.!Jl~..Sul!l~e~ .........--- . _.. _ __ -*****--* *- ..... - ................ ?Q~Ql!,_~Q.3~-*------.. ..------
GL-GC-E-086 [on Chromatography (IC) EPA 300.0, 9056A JCJ1:'.~9<::::-~=9~7 ...... {>erc~nt Water.IJy Karl Fischer Titration ASTM E203-96 GL ...-. *G*
- C-E-.0.*9*1* . 1Wavelength Calibration Verification of Therm9spectronic NIA I .. . Spe~trophotometers NIA GL-GC-E-093 Total, Total Inorganic and Total Organic Carbon (TOC) using EPA 415.1, 9060, 9060A,
. tht:_()I Analyti~~lModel lOlQ J'()C::Analyzer 53 lOB GL-GC-E-094 N'-Hexane Extractable Material (HEM; Oil and Grease) and 1664A, 1664B Silica GEL Treated N-Hexane Extractable Material (SGT-HEM
...- .. --*--*- *--*~()~:-~.?~~r :£v!~te~~D..~ Aque~~ JVI.atri£~S__ .. -*----
GL-GC-E-095 Cyanide Analysis by Lachat QuikChem 8000 FIA . CLP 335.2-M, 335.1, 335.3.
335.4, 9010B, 9010C, 9012A,
---*--**----------*- ----------------------*-*--------*--------~-----**----'------*-------------~
9012B, 4500-CN- C GL-GC-E-096 n:>erchlorate by Ion Chromatography (IC) .EPA
--- ______314.0 ASTM Dl 120 -(M)--
-~-
GL-GC-E-098 lro.tal Halogens ASTM D 808-00 GL-GC-E-100 rrotal Hardness by Titration EPA 130.2, 2340C GL-GC-E-101 Hydrazine ASTM D 1385-01 l~~~~C-E-10~~***** lrotal Recoverable Phenol by the Lachat QuikChem FIA+ 8000 EPA 420.4, 9066 Series GL-GC-E-103 Total Phosphorus by the Lachat Quickchem FIA+ 8000 Series EPA 365.4, 4500 PH-
[nstrument GL-GC-E-104 lrotal Kjeldahl Nitrogen (TKN) Using the Lachat QuikChem EPA 351.2, 4500 Norg D-FIA+ 8000 Series Instrument GL-GC-E-105 lrhe Volumetric Determination of Settleable Solids 2540F GL-GC-E-106 Ammonia Determination by the Lachat Quickchem FIA+ 8000 EPA 350.1 Rev 2, 4500-NH3 Series H-
-..-------..---*----------* -----------------------------*-----*----------*------*--*-*"** --~--*-------**--------*-****-** -------------------------*-------------**
GL-GC-E-123 Column Settling EM 1110-02-5027 GL-GC-E-127 Modified Elutriate Test .NIA GL-GC-E-128 Nitrate/Nitrite (N03+N02) Analysis Using The Lachat EPA 353.2, 4500-NOf F QuickChem FIA+ 8000 Series Instrument GL-GC-E-129 IAir Filter Particulates NIA GL-GC-E-130 *Percent Ash Determined at 775 C Procedure for Solid and ASTM D 482-03 (M)
Semisolid Samples GL-GC-E-131 !Water Analysis by Mantech Automax 73 EPA 150.1, 4500H, 2320B, EPA 310.1, EPA 120.1, 9040Bl9040C, 251 OB, 9050A, 2520B GL-HR-E~002 '~IJ1J:Jl()yee Trainin.g. NIA GL-IT-E-001 Information Technology Program for Good Laboratory and NIA Good M~ufacturing Pra~t!ct:8. *
- GL-IT-E-002 ICompuu:a SJuw*uu Team Roles and ResponsihilitiP< NIA 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page(!).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 92 of 109 GL-IT-E-003 Requirements, Design, Operation, Validation and Removal of NIA
_Hardware and SoftwareSystems Used bythe GEL Group, Inc.
GL-IT-E-004 GL-IT-E-005 Requirements, Design, Operation, Validation and Removal of NIA
_ ___ A.:pplicat_icms_l]s~~~Y_Tl_i_e_ GEL Gr()up,}n_~~- _ _
GL-IT-E-006 Cha11ge Control Requirements for Applications NIA GL-IT-E-007 User Roles and Responsibilities for Personnel Using Computer IN/A Services GL-IT-E-010 Backup of Computer C(mtrolled Instrumentation NIA GL-IT-E-011 SystelTI ~ec~ty and Y_~rns_ ]_)rotection N/A GL-IT-E-013 'creation and Maintenance - -***
of the LIMS Audit-***-*-*-
System-NIA GL-IT-E-014 !Disaster Recovery NI A GL-IT-E-015 Operation of L~S Data~as~ P~mary a_nd Failov_~!- Servers NIA GL-LB-E-001 *The Determination of Method Detection Limits NIA GL-LB-E-002 ~alances NIA NIA GL-LB-E-004 Temperature Monitoring and Documentation Requirements for NIA
~efrig_e_rat()!S, 9vens, I11cubati:irs, an_d ()therSjIIlil_ar_ De_v~ce~ _
GL-LB-E-005 Data Review and Validation .NIA GL-LB-E-006 SW-8461311 Laboratory Standards Documentation
~ -- --- --* -
NIA Gt,-LB-E-008 Basic Requirements for the Use and Maintenance of Laboratory NIA Notebooks, Logbooks, Forms and Other Recordkeeping Devices ------ .. ---*---- -------- -*-- --*----.----
GL-LB-E-009 lRun Logs 1N/A GL-LB-E-010 !Maintenance and Use of Air Displacement Pipets NIA GL-LB-E-012 _____ ~erifying the Maintenance ()_f S_ample Integrity _ NIA GL-LB-E-013 CLP-Like/DOE Data Packag~ Assembly and Revision NIA GL-LB-E-016 rrhe Collection and Monitoring of the m Water Sys~ems NIA GL-LB-E-017 IP:oce~u!e and Policy for Ma11ual Integration NIA GL-LB-E-018
~nstrument Clock Verification NIA GL-LB-E-020 _Tuning 0 f High Inten~it~ Ultrasonic Pr_ocessor 0
NIA GL-LB-E-022 Qene:atii:i_n of Swipe Data _NIA GL-LB-E-023 Waste Extraction--Test (WET) ---
NIA GL-LB-E-024 _Synthetic _]_)re_cip_it(ltion Leaching Preparation EPA 1312 GL-LB-E-026 _c;ontai?er Suitability Testing_ NIA GL-LB-E-027 ~iO(lSSay Kit Deliver)'_ a_11d _~etrie~al NIA GL-LB-E-028 Creation and Maintenance of Case Narratives NIA GL-LB-E-029 NIA GL-LB-E-030 -- . _,__. __. ___ NIA GL-LB-E-031 __ §_a~ple c;o_mpositing IN/A 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 93___of 109 r:--:-***-*-****::*--,-*r,*"-sian(f~r(foperi3',ing'Procedure~ and~AnalYiic.<ll ivl~thods-**:***---~--- --- ,,,,__,_,,_ ,_rn SOP://: :*+1 *.* .. "'
I
- <,\'.
~'.\(,.' *:* ... .SOP fitle
.. ... .* . ~ ",
- 11
- 'Methods "'I GL-LB-E-032 The Distribution of High Risk and Limited IN/A V()lume Samples
* ---*-------***--** _____ J:>.r.?re.~1~e.~~~e~!J.~c11ti()~_~()~_.<?~g;11n~c;s GL-LB-E-033 ___ ___
_, IN/A
1:-11._boE1t9~_Fil~a!~_11_§a_11_1p_le~---- --**----*---*--*-*--*-****-*****- *---------------------- ... --------
GL-LB-E-034 NIA GL-LB-G-001 .. . ..
La~o_ratory .VVaste ~11nage~ent Plan NIA .. --*- - -*--
GL~1:'.B-N-001 Safety, Health and Chemical Hyg~ene Plan NIA GL-LB-S-001 l)isast~r P.rep~e.~~~-ss ll?d~~c;_ove.r~J:>lan_ -- *--***
NIA *.. ... ------ ...
GL-MA-E-006 Acid Digestion of Total Recoverable or Dissolved Metals in 3005A Surface and Groundwater Samples for Analysis by ICP or ICP-MS rL-MA-E-008 Acid Digestion of Total Metals in Aqueous Samples and 3010A Extrac;ts for ~?alJ:si~_ ~y I~_J:> and ICP-MS GL-MA-E-009 Ac;id ~iges!ion_of S~diillents, Sludges,_11n~§_cii!s ____ -----
.3050B,6010B,6020 GL-MA-E-010 Mercury Analysis Using the Perkin Elmer Automated Mercury 245.1, 245.2, 245.5, 245.1 Analyzer CLP-M, 245.2 CLP-M, 245.5 CLP-M, 7470A, 7471A, 7471B GL-MA-E-013 Determination of Metals by ICP EPA 200.7, 6010C, and 200.7 CLP-M, 6010B GL-MA-E-014. Determination of Metals by ICP-MS 6020, 6020A, EPA 200.8, ASTM --- -*--.
D4698-92 ... ------ . . . . ..
GL-MA-E-016 Sample Preparation for Total Recoverable Elements by EPA EPA200.2 Method 200.2 _
GL-MA-E-017 Metals Data Validation
-*-~-----"' *-- ---- *------ -*-- -----*- ---***-*-----** -----
NIA ... ---*---- ----*--- ----- --*----*
GL-MA-E-018 Mercury Analysis using the PS Analytical Millennium ~PA 1631 Rev E
~ut_cimat~~ ~t!!.C:~12'-~!1aly3er ... .. --------- - .. .. - ----- ------ - - -*--
GL-MA-E-020
~c;i~}?jg;e~ti()~.o~P.erso_nal C_ass~tte Fil_ters for '.'ll<l!Y~is by ff:'.P . .NIOSH7303 . ---.---------*--* --- --- -*----
GL-OA-E-001 Establishing Retention Time Windows for GC and HPLC SW-846 8000 Analysis ... ..
GL-OA-E-003 Non-Volatile Total Petroleum Hydrocarbons by Flame 8000B,8000C,8015B,8015C, Ionization Detector 3541, 3580A GL-OA-E-004 Volatile Total Petroleum Hydrocarbons by Flame Ionization 5030A, 5030B, 5030C, 5035A, Detector .5035, 8000B, 8000C 8015,
*---------*-*-***--*---*--*-------------------------------~--
8015A,
8015B, ----------------
8015C, 8015D E~oA-=-E-~69____ Analysis of Semi volatile Organic Coll?pounds by Gas ,8270C, 8270D, EPA 625 Cl1fomatography/Mass Spectrometry _
GL-OA-E-010 Extraction of Semivolatile and Nonvolatile Organic Compounds *3500C, 3550C, 8270C, 8270D, from Soil, Sludge, and Other Miscellaneous Solid Samples 8081, 8081A, 8081B, 8082, 8082A, 8015A, 8015B, 8015C, 8310, FL-PRO, CT-ETPH -*----
*----------- ~11~!¥_sis_9f ChlO!()Phen~~-~~~ He!!i_ici~~.1:>1..§~Q _______ - - - - - - * - - - - -
GL-OA-E-011 8000B,8000C,8151A -- -----
GL-OA-E-013 Extraction of Semivolatile and Nonvolatile Organic Compounds 3510C,8270B,8270C,8270D, from Groundwater, Wastewater, and Other Aqueous Samples 8081, 8081A, 8081B, 8082, 8082A, 8015A, 8015B, 8015C, 8015D,8310,608,625,FL-PRO, AK102, --103, CT-ETPH GL-OA-E-015 ,The Extraction of Herbicides from Groundwater, Wastewater, 8151A
- - - - -- - -~
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (I).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 94of109 r17*---- -~: _-.,.::-,-- - --- -~ -- -. ---------- - --*. ----~ - --- ---- - *------ ------ - . --------- --- --- ------*
1 **** * )/ t>::. ::r>.'. ~tam:la~QPPe.rati11g Pr.c:>C::~Qll.rE!lJl a11d ~p~lytJc~tM.E!~ti.QQ.lJl.* i ... 1 il* -:,;, ** , .* ,.
,.SOP#-* -ll\:::;.. :1* _: ::11::-:*. *** **':1,$QRJitlE!1: :,;_,_,__ : : . *. .*.*. . *, _, ...,; i-l\Jleth.()Q~ , .
GL-OA-E-020 !Percent Moisture ASTM D2216-05 GL-OA-E-022 Volatile Organic Compounds by Gas Chromatograph/Mass *EPA524.2 StJ~C_tr?111et_l?.r~ppli~<t~l~ t?_?PA ~~~~o~-~2-4:2-GL-OA-E-026 Volatile Organic Compounds (VOC) by Gas EPA 624 Chromatograph/Mass Sp(!ctroll1eter _ _ ... l GL-OA-E-02-7 _____ !_~eE~tra:~ion of!:lerbicid_e_s from S_oil and Slud_ge Sall_l_Pl(!s _ 815 lA __ _
GL-OA-E-033 Nitroaromatics and Nitramines by High Performance Liquid 8000C, 8330, 8330A Chromatography (HPLC) _
IGL-O~~E-Q36 _ ~orisil Cle~nup of Organochlorine Pesticide Solvent Extracts '3510C, 3620C, 3550C,8081, 8081A, 8081B, GL-OA-E-037 Sulfuric ~cid/Permariganate Cleanup ?f PCB _S_olvent f:xtract 3550C,3665A,8082,8082A GL-OA-E-038 Volatile Organic Compounds (VOC) by Gas 8260A, 8260B, 8260C, 5030A, Chromatograph/Mass Spectrometer 5030B, 5030C, 5035, 5035A GL-OA-E-039 'Closed-System Purge-and-Trap Collection and Extraction .EPA 5035, 5035A Volatile Organics in Soil and Waste Samples GL-OA-E-040 Polychlorinated Biphenyls 8000B,8000C,8082,8082A, 608 GL-OA-E-041 Organochlorine Pesticides and Chlorinated Hydrocarbons 8000B,8000C,8081A,8081B, 608 1
3660B GL-OA-E-046 Common Industrial Solvents, Glycols, and Various Organic 8000A, 8000B, 8000C, 8015A, Compounds by Flame Ionization Detector ___ 8015B, 8015C, 8020A GL-OA-E-047 'Gel Permeation Cleanup of Solvent Extracts 3640A, 3510C, 3550C, 8270D, 8081B, 8082A GL-OA-E-049 Silica Gel Cleanup Using Solid Phase Silica Gel Extraction 3550C, 3510C, 3630C,3541 Cartridges GL-OA-E-050 The Extraction of Seffiivolatile and Nonvolatile Organic 3580A, 8015A, 8015B, Compounds from Oil 8015C, 8015D, 8081B, 8082, 8082A, 8180A, 8270B,
- 8270C, 8270D GL-OA-E-055 The Determination of Diesel Range and Residual Range AK102. AK 103, 3510C, Or~anincs _ ___ :3550B --- --
GL-OA-E-056 Definitive Low Level Analysis of Nitroaromatic Explosives 832l(M), 8000C, 8330, 8330A, Utilizing Liquid Chromatography/Mass Spectrometry/Mass 8330B Sepctrometry (LC/MS/MS). by SW-846 Method 8321 Modified (8321M)
GL-OA-E-058 NIA GL-OA-E-059 Analysis of 1,2-Dibromoethane (EDB) and l,2-Dibromo EPA 504.1, 8011 Chloropropane (DBCP) in Water by GC/ECD Using Methods 504.1or8011 GL-OA-E-061 Haloacetic Acids in Water -- __.. EPA 552.2 GL-OA-E-063 Massachusetts Method for the Determination fo Extractable Massechusetts EPH
__ l!'etroleum Hydrocarbons GL-OA-E-064 Dissolved Gases in-- Water by Flame Ionization Detector (FID) RSK-175 2040 Savage Road Charleston SC 2~407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (I).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 95of109
- --,*:*:----* -----~-:,:**-~siai1Ci~Fcror;0r~11119*_i:>roc.epures.anci . A-n-alYiicaf i\Jiefi1o*cr5**--***-*---- ------**-- .....,.. ** *
.** . ?Q~cfl,sr.. :.l*F;:+'-:u:;**. c::_, .. _.,*:;,._.,,.,::.$Q~[.it!~ ..*. -.;~ . ,_;,.,,:'.::" . >i' -::: lt*Z:; ;._\ Metho~s <'.* :_ :,
GL-OA~~=O?~--- __ ~~:l~~n!!§()lv~nt/Standarcls Scr~~ni11~ f()~_Qr~~~~ J>E~P- _ -NIA GL-OA-E-066 Automated Soxhlet Extraction EPA 3541, 3600 GL-OA-E-067 Definitive Low Level Perchlorate Analysis Utilizing Liquid 6850, 6850(M), 8000B Chromatography/Mass Spectrometry/Mass Spectrometry CI,<=:0'1~1fylS)~yE}J;\_~et~ocl ?850Modified(6~?9Iv!)_
GL-OA-E-068 ['he Processing, Extraction, and Analysis ofNitroaromatics,
~i_tr_()_a~11es, a11d I\Iitr_a!~_Este~~ bX §W-846 ~}30B _ _ .8330B, 3535 GL-OA-E-069 Continuous Liquid-Liquid Extraction GL-OA-E-071 The Pre-Extraction Processing EPA 8330B of Soil Samples Collected Using Multi-Incremental Sampling (MIS)
Techniques GL-OA-E-073 !Analysis of 1,4-Dioxane in Drinking .EPA 522
'Water by Solid Phase Extraction
-(SPE) and Gas Chromatography/Mass
~J:J~.C:-~~~~----------------------------------------------- --------------------------------
GL-OA-E-074 Massechusetts Volatile Petroleum Hydrocarbons by NIA Photoionization and Flame Ionization Detectors WAEPH GL-QS-B-001 Quality__~ssurance J>lan NIA NIA GL-QS-E-001 *conduct of Quality Audits GL-QS-E-002 Conducting Corrective/Preventive Action and Identifying NIA Opp()rtunjtie~ f()r_Impro\Tem~_nt __ _ ___ __ ___ __
GL-QS-E-003 fraining and Qualifying Quality Assurance Audit Personnel NIA GL-QS-E-004 AlphaLIMS Documentation ofNonconformance Reporting and NIA Dispositioning and Control of Nonconforrnin_g Items _
NIA GL-QS-E-007 Thermometer Verification NIA GL-QS-E-008
'Quality Re~ords Management and Disposition NIA GL-QS-E-011 _Method Validation and Initial and Continuing Demonstrations NIA
. of Capability GL-QS-E-012 ----~NC:~ Database ()per_ation ___ __________ ___ ___ NIA GL-QS-E-013 H_andling of Proficiency Evaluation Samples NIA GL-Q~-E-01_4 Quality Assurance Me_a~urement Calculations and Processes NIA GL-QS-E-015
-~---* - -- - ----
GL-QS-E-016 Identification and Implementation ofNe_w and Revi~ed Methods NIA GL-QS-E-017 Communication of Substantial Nonconforming Safety Related NIA
- Services GL-QS-E-019
~p-A-001 The Determination of Gross Alpha And Gross_Non=Y_olat~le _ 900.0, 9310 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page ( 1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 96 of 109 r------- -
~ k~
- _-. ~ ~tanCi~fc(6p~ratJng-_~~9~~~urei:; anc(AnilyticafM~efhods ,_!*--*- _____ .,_ ,_.,...,,,. ... """'~"'-
-~--"
L .::*""', ,, ; ,.>~;,~*: " '-k1_,,*, i' '
-. SOP. Title '*
. *:,* 1 "'\'
'ivlettlod's
'l<
<< *---* 'l
.... * .'"?QP# . .I : : ..
I -*--* *----- *---*-------*
cr3eta in Water GL-RAD-A-OOIB rrhe Determination of Gross Alpha And Gross Non-Volatile 900.0(M), 9310
!Beta in Soil, Filters, Solid Matrices and Direct Count Air Filters
- ~"*---- ----*--*-* *------ ------
GL-RAD-A-OOlC [he _[)~t~i:ini11~tio11 ()f Gro~_~_A!p~~ ill \V_at_e! __~Y. C()-p~e~ip_itation 52015-84-006 Method 00-02 l~i-~=A--001.D~:: rrhe Determination of Gross Alpha Gross Non-Volatile Beta in *60014-80-032 Method 900.0 Drinking \Vater _ __ __ _ __ __ _ ___ _ _____ -*-
GL-RAD-A-002 The Determination of Tritium 60014-80-032, 906.0(M)
-- --- ------- -- -- --- -- --* - -- ----------- --*-*-- --***- ------ --- *--*~- - - ---*--.--- --- - - *-------- ------ --- ---*------
GL-RAD-A-003 ,rrhe Determination of Carbon-14 in Water, Soil, Vegetation and NIA Other Solid Matrices
- -~-------
GL-RAD-A-004 The Determination of Strontium 89190 in Water, Soil, Milk, 905.0(M), DOE RP501
,Filters, Vegetation and Tissues !Revl(M), HASL 300(M)
GL-RAD-A-005 The Determination of Technitium-99 HASL 300(M) TC-02-RC, DOE RP550(M), ASTM C 1387-03(M), ASTM 1476-OO(M)
GL-RAD-A-006 The Determination of Radiometric Iodine 901_.l(M), HASL 300(M) I~Ol GL-RAD-A-007 The Determination ofRadon-222 in Water SM7500Rn-B GL-RAD-A-008 The Determination of Radium-226 903.l(M), HASL 300(M) Ra-04-RC GL-RAD-A-009 The Determination ofRadium-228 in Water and Solids 904.0(M)
GL-RAD-A-010 Total Alpha Radium Isotopes in Soil and Water 900.l(M)
GL~RAD-A-011 The Isotopic Determination of Americium, Curium, Plutonium, DOE RP800 1997(M), HASL-and Uranium 300 U-02-RC(M), HASL-300 Am-05-RC(M)
HASL-39D_ Pu-11-R<:_:'.(tvl) --- *--
GL-RAD-A-013 rrhe Determination of Gamma Isotopes 901.l (M), HASL-300 (M) Sec.
4.5.2.3, HASL-300 Ga-01-R GL-RAD-A-015 Dig~stion for Soi]
NIA GL-RAD-A-016 rrhe Determination of Radiometric Polonium EPA 60014-80-032 GL-RAD-A-017 rrhe Determination of Iodine-131 in Water 902.0, 75001- B GL-RAD-A-018 rThe Determination ofLead-210 in Liquid and Solid Matrices NIA-- --- ---
GL-RAD-A-019 De_!e~m~11:at~()J1 of ~h_ospho_i:us-32 in Soil and Water NIA - - --
GL-RAD-A-020 The Determination of Promethium-147 in Soil and Water NIA GL-RAD-A-021 Soil Sall1ple_Preparation for the De!ermination o~ Radionuclides. NIA ------
GL-RAD-A-021B Soil Sample Ashing for the Determination of Radionuclides NIA --- *--- ***- *--*- ---- -*-*- - *--
GL-RAD-A-022 Determination ofNi-59 and Ni-63 NIA GL-RAD-A-023 Total Uranium in Environmental Samples by Kinetic ASTM D 5174-91, 5174-97, Ph_c>s{>~_c>resce11ce 5174-02 GL-RAD-A-026 The Preparation of Special Matrices for the Determination of NIA Radionuclides GL-RAD-A-028 _ ~~d~tiJE:-22~_ ~n Drinking Water _by_ EPA Method_ 903 .1 EPA 903.1 GL-RAD-A-029 The Determination of Strontium-89190 in Diinking Water by EPA 905.0 EPA Method 905.0
~
GL-RAD-A-030
-- ******-- **-* --* - D~_t~~~i11ati_on_o! Ra_c.-liu~~~2~_ill ~qu~()_l1s S~pl~s ______
"~ ~
904.0, 9320 GL-RAD-A-031 . !fhe Determination of Selenium and Tellllrium NIA
- -* ~
2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page ( !).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 97of109
!*-*** --~****r* *** *~*- ,,, . $'tai1Ciarc[o f>er~iii19Ji~<>c;*~[ure~-ancfAili,'1Y!i'caf M~.t~C><¥5_.__..... --:.. - ~ _. **:. ----*-- *---
- , SOP tf. . ?F:*J* "" ---, ; ; .'!'!) \ SOP)"ittli' _< ., :!" - **; .- '. *-. .. -* Mettioi::ls'"-> [ -..
l9~~RAI>-~~9~J ____ lfl:(!}_s_~t()plc__!)e_te~minati()!l of_~eptllni_llm/Thoril!m lN! A GL-RAD-A-033 iDetermination ofChlorine-36 in Soil and Water Samplf!s NIA HASL-300 Pu-11-RC(M)
GL-RAD-A-036 (fhe Isotopic Determination of Americium, Curium, and DOE RP800(M)
'Plutonium in Large Soil Samples HASL-300 Am-05-RC(M)
HASL-300 Pu-11-RC(M)
HASL-300 Pu-12-RC(M)
GL-RAD-A~037 Radium-226 and Radium-228 in Drinking Water by Sulfate NIA P~ecipitation_ andSJ8:IE1:11li~~ay Spectroffi:etry GL-RAD-A-038 The Isotopic Determination of Thorium/Uranium DOE RP800(M), HASL-300(M) Pu-02-RC, Pu-03-RC
~*---*-----*------~---------------------*----*------ --------------*----
GL-RAD-A-040 The Determination ofFe-55 in Liquid and Solid Matrices by NIA
_ __ ________ ~iqui~ ~c_i11ti_llC1tionC:ot111te_r _......... __ ......... ----*---------*- ......... ____ . ___________ ............................ _
GL-RAD-A-041 _The Determination of Total Activity in Solids and Liquids NIA (9L-RAD-A-044 lfotal Alpha Radium Isoto)Jesln l>_rin~ing~ctter_ .... ****----- 903.0, 9315, HASL-- 300(M) . -----
GL-RAD-A-046 The Determination ofRadium-224 and Radium-226 by Alpha NIA
~pe_ctroscop~_
GL-RAD-A-047 48 Hour Rapid Gross Alpha Test ECLS-R-G-A, EPA 600/4 032, 900.0(M)
GL-RAD-A-048 (fhe Determination of Calcium-45 in Soils and Waters NIA Q_~~_:-~::_Oj2 __ ~~~Q_et~'!li~~_c:>!l_()f ~l1~fl1~::.~~-~-~~~~-~li~r_i_c_e_~-- _________ ~~§_:-_~~:}-~~---------------
~II.:-~:-f\~O~Q ___ Jl'~e__])_e_!_!!fll:_lil1liti_()!l_()f_]:'ijtit11Il_il1 l>_ril1:1?11g Wate_r S_amp!e_8-______ _~9_91~~80-03~,_99~*9 .. ____
GL-RAD-A-051 (fhe Rapid Determination of Strontium 89/90 by Cerenkov IN/A Counting GL-RAD-A-053 OCsotopic Determination of Plutonium in Large Water Resin HASL 300Pu-11-RC Samples GL-RAD-A-054 (fhe Determination of Strontium-90 in Brine NIA GL-RAD~A-055 (fhe Preparation of Environmental Samples NIA
_for ~S()!()pic__ Uranium An:li1y~i~:\'i1:1 ICP-MS GL-RAD-A-056 lfhe Determination of Gross Alpha and Beta NIA
~y Liquid Scintill~tion Counter GL-RAD-A-057 Rapid Determination of Radium-226 by Alpha NIA Spec ______ .... _
GL-RAD-A-058 (fhe Rapid Determination of Strontium 89/90 NIA by Gas Flow Proportional Counting GL-RAD-A-059 (fhe Determination of Technetium-99 Using lN!A
__ ~J1al ~ical Grade _1X8 -~esin GL-RAD-A-060 lfhe Preparation of Vegetation and Filter NIA Samples Via Organic Destruction and Strong
____ J-\_ci~_ !:-!!a~~ !or R_adi()_chemistry Metals ~1:11X_si~_
IGL~RA:°_-A~06? The Determination of Tritium by C_ombu~tio11_ NIA GL-RAD-A-063 (fhe Determination ofRadium-228 NIA GL-RAD-A-065 (fhe Determination ofCarbon-14 in Atmospheric Screening NIA
- cartridges 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (I),
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 98of109 r"~-" ***~*F:: *:";***:c*****,~**:*~sianci~r:a oileratr11*9"P-rq~eaiires;~nl:f¥Kil~1yficai:-rJt~iii<:ras*:**,"'~ ~7~,,- ' ,, -- :--;*:.- , ~: , * . 'I 1
- *s0Ptt**::1~;* :::***:' :'"' **' ;::soPTitle .,: ,,*.:**,:*J' .+ ..*;*. 1_.:.11* ii,_; Metl)p~s '..: ~'- I GL-RAD-A-066 IThe Determination of Radiometric Polonium Using DGA NIA Cartridges GL-RAD-B-001 The Sequential Determination oflsotopic Americium, Curium, NIA Californium, Plutonium, Strontium and Uranium in Urine GL-RAD-B-002 The Determination of Polonium-210 or Radium-226 in NIA Bioassay Sa1!1pl~s __
GL-RAD-B-003 The Determination oflsotopic Thorium and Uranium in Urine NIA
~-~mrl_e_s__ . . ........ _ .. ... ... ..................... .
GL-RAD-B-005 . Manage_II1e_I1tof B Ian_~ !"()iJUl~tions NIA GL-RAD-B-008 The petermination of Gross Alpha A~ti_vity in ~asal Swipe_s NIA GL-RAD-B-009 Bioassay Countroom Alpha Spectroscopy Instrument NIA Standardization and Performance GL-RAD-B-010 GL-RAD-B-011 The Determination of Tritium in Urine EPA906 GL-RAD-B-012 h'he Ashing of~ecal, _Bone, and Tissue Samples NIA GL-RAD-B-013 Sequential Determination of Americium, Plutonium, Strontium, NI A Plutonium-241, and Uranium in Fecal, Bone, and Tissue
_ ***--- _ ... _ _ .. _* ~_amp!es ... _ __ __
GL-RAD-B-014 IThe_I?_i:ep_ar':lti_on of S¥_nthetic Urine and Fecal Material NIA GL-RAD-B-016 The Determination ofTechnetium-99 -- ---
in Urine NIA GL-RAD-B-017 The Determination _ofNeptuniulil in Urin~ NIA NIA GL-RAD-B-019 Total Uranium in Bioassay Samples by Kinetic ASTM D 5174-02, ASTM D Phosphorescence 5174-97 GL-RAD-B-020 The Determination ofNi-59 and Ni-63 in Urine NIA GL-RAD-B-022 The Determination of Gross Alpha and Gross Non-volatile Beta EPA 900.0, 9310, EERF 00-01, in Urine USGS R-1120-76 GL-RAD-B-023 The Determination ofCarbon-14 in Urine EERF C-Ol(M)
GL-RAD-B-024 Managing Statistical Data in t~e_ J?~oas~_ay Labo~a~ory NIA GL-RAD-B-025 GL-RAD-B-026 Bioassay Da!~ Review, Validation -~(f Data -~a_c~age ~s~~lllbl¥ _~!A GL-RAD-B-027 Seecific Gr~vity__in U.£.i.I1_e___ _ ____________________ .. ________ ~~-!~.1)~5~----------------
GL-RAD-B-029 The Determination of Radiometric Iodine in Urine NIA GL-RAD-B-030 h'he Preparation and Determination of Gamma Isotopes in Urine 60014-80-032 and_Fe_cal Samp~es GL-RAD-B-031 Bioassay/REMP Quality Control Package Assembly NIA GL-RAD-B-032 Concentration of Tritium by Electrolysis *HASL H-02-RC, EML-95-110 Rev2 GL-RAD-B-033 Bioassay Count Room Alpha Spectrometry Instrument NIA Calibration GL-RAD-B-034 NIA The Determinati?n of Metals in Uri11~ ~_y !CP-M~_ --*
GL-RAD-B-035 The Preparation of Urine Samples for Total Uranium Analysis NI A
. oyICP-MS 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page(!).
Uncontrolled documents do not bear an original Set ID number.
09~Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 99of109
- sQP# ' l: \' :'. , . ! .* ..$OP Title . '., . . . ..,*~11 . ! Me~s ,. ! ~j GL-RAD-B-036 Initial Installation and Returning to Service of Repaired NIA Instrumentation GL-RAD-B-038 The Determination of Neptunium in Fecal NIA
. Sall1p11;:s . .. . .......... .
GL-RAD-B-039
~----------------~------
The Determination oflron-55 in Urine NIA GL-RAD-B-040 The Determination ofRadium-224 and Radium-226 NIA
_b~. Alpha_~pectroscopy in Bioass_ay Sample .
NIA NIA GL"RAD-D-005 REMP Quality Control Package Assembly NIA NIA GL-RAD-I-001 Gamrrla ~pectroscopy System Operatio11 NIA GL-RAD-I-004 Beckman LS-600016500 NIA GL-RAD-I-006 !-_84100 Gross Alpha(Beta ~()~nter Operating Instruc.~ions NIA GL-RAD-1-007 Ludlum Lucas Cell Counter NIA NIA GL-RAD-1-009 Alpha Spectroscopy System NIA NIA GL-RAD-I-014 W ALLAC Guardian Model 1414 NIA GL-RAD-1-016 M~lti-Detector .counter: Operating I11struc.tion.s ............ ........ }l'l'!A ...
GL-RAD-1-017 ~allac 1220 Quantalus Liquid Scintillation Counter NIA GL-RAD-1-018 Operation ofWallac 1480 Gamma Wizard NIA NIA GL-RAD-M-001 Preparation and Verification of Radioactive NIA Standards GL-RAD-M-003 Restoring Data from Magnetic Tape for Bioassay and Alpha NIA Spectroscopy GL-RAD-S-000 Radiation Safety Plan for GEL Laborat01ies, LLC NIA GL-RAD-S-002 Radiation Related Emergencies NIA GL-RAD-S-003 Administration of the Radioactive Material License Inventory NIA GL-RAD-S-004 Radi(Jacti ve ~aterial Handling NIA GL-RAD-S-006 Ra~ia_tion W~rke.r T~aining NIA GL-RAD-S-007 Receiving Radioactiv.e Packages NIA GL-RAD-S-009 Personnel Dosimetry NIA GL-RAD-S-010 The Handling .of Biological Materials NIA GL-RAD-S-013 .. tur Samp)ing fo!.Radic.>activity .Guide 825 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page(!).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 100 of 109 r*-
-,-~------*..*.------- *-- -. -- Standard <f-eratin. Procedures and Anal -ical Methods--
........... .P ...........9. -... . .. .. . ... . ...... yt . ..............
~- - *- *- -
- ,,$OP# . . I; *; '>. .
- > $OP Title . !. : Methods ...
GL-RAD-S-015 tthe Acceptance and Classification of Radioactive Material NIA GL-RAD-S-018 [Laboratory Analysis of High Activity (RAD NIA
_3~--§~ple_~-- _ __ .. __
GL-RC-E-001 !Receipt and_ ~nspe~tion()fMaterial and Services NIA GL-RC-E-002 [Material Req_uisition NI A Q!:~~R_:-_§_-:Q9_!_ ______ §_~!!IP!~-~-e~i.£!...!=<J&Il:_~~-§t()!_~rce_______________________________________ ____ ~I-~--------------- _________ _
GL-SR-E-002 Transportation and Shipping of Samples and Pre-Preserved NIA Sample Contitiil~rs __ _
GL-SR-E-003 The !nspection, Cleaning and Scr_eening_()f ~ail}ple C()olers NIA GL-SR-E-004 _ 'Control of Foreign__Soil_s_ .. _ NIA Wipe Test NIA GL-SVR-D-001 Design Specifications for the Network Infrastructure NIA loL-SVR-D-002 De~ign Specifications for the Mail Server GL-SVR-D-003 Design Specifications for the Sansvr NIA GL-SVR-D-005 _ Pt!~i_gn_ Sp~cifica~ions fo! Backupsyi:91_ NIA GL-SVR-E-001 Network Infrastructure NIA GL-SVR-E-002 The Mail Server NIA GL-SVR-E-003 Sansvr NIA GL-SVR-E-005 ***- ~ackupsyri)l NIA GL-SVR-R-001 Syste_m Requi!_<?~_~nts for Net~o!k_ I_11~rastru~ttJ_~(!_ NIA GL-SVR-R-002
_,,_ - - *- - System 13:eqt1_!!ements fo~ The ]\1_ail _Server . NIA GL-SVR-R-003 System Requirements for Sansvr NIA GL-SVR-R-005 . System Requirements for BackupsvrOl NIA 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (I).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 101 of 109 APPENDIX J: SAMPLE STORAGE AND PRESERVATION REQUIREMENTS STORAGE AND PRESERVATION Parameter Container 1 Preservation Holding Time2 Min. Volume5 IN ORGANICS Acidity P,G 0:S6°C 14 days 25 mL/NA Adsorbable Organic Halides G, amber 0 :S 6° C, HN03 to pH < 2 >3days and < 6 mos 50 mL/1 g (AOX) from collection Alkalinity P,G 0:S6°C 14 days 50 mL/NA Biochemical Oxygen P,G 0:S6° c 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> SOOmL/NA Demand (BOD) and Carbonaceous Oxygen Demand (CBOD)
Boiling Point P,G 0:S6°C None 60mL/NA Bromide P,G 0 :S6° c 28 days 10mL/4g Carbon Dioxide P,G 0:S6° c Immediate SOmL/NA Chemical Oxygen Demand P,G 0 :S 6° C, H1S04 to pH < 2 28 days 2mL/NA (COD)
Chlorine by Bomb Calorimeter P,G 0 :S 6° c None NA/0.5 g Chloride P,G 0 :S 6° c 28 days 10mL/4g Color P,G 0 :S 6° c 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> SOmL/NA Conductivity. P,G 0 :S 6° c 28 days 25 mL/NA Corrosivity by pH P,G None Immediate 25mL/5g Corrosivity to Steel P,G None None 290mL/NA Cyanide amenable to P,G 0 :S 6° C, NaOH to pH> 14 days 4 50mL/NA chlorination 12, 0.6 g ascorbic acid 3 Cyanide, Reactive Releasable G, amber Zero headspace 7 days liquids, 10 mL/10 g 28 days solids
- Cyanide, total, available, free P,G 0 :S 6° C, NaOH to pH> 14 days 4 50mL/1 g or Weak Acid Dissociable 12, 0.6 g ascorbic acid 3 Dissolved Oxygen G (bottle None, Zero headspace Immediate 25mL/NA and top)
Flashpoint P,G None None 10 mL Closed Cup 2mL/2g Setaflash Fluoride P,G 0 :S 6° c 28 days 25mL/4g Fluorine by Bomb P,G 0 :S 6° c None NN0.5 g Hardness (EDT A titration) P,G 0 :S 6° C, HN03 to pH < 2 6 months 50 mL/NA Hardness (calculation) P,G HN03 to pH< 2 6 months 50 mL/NA 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page(!).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 102 of 109 Heating Value P,G 0 :s 6° c None NA/0.5 g Hydrazine G, teflon- HCl topH<2 Immediate SOmL/NA lined septum Nitrogen-Ammonia P,G 0 :S 6° C, HzS04 to pH< 2 28 days 100 mL/ 5 g Nitrate - Liquids P,G 0 :s 6° c 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> lOmL Nitrate - Solids P,G 0 :s 6° c 28 days for extraction, 4 g 48 hrs from extraction to analysis Nitrite - Liquids P,G 0 :s 6° c 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> lOmL Nitrite - Solids P,G 0 :s 6° c 28 days for extraction, 4 g 48 hrs from extraction to analysis Nitrate/Nitrite P,G 0 :S 6° C, HzS04 to pH < 2 28 days 4mL/4g Nitrogen -Total Kjeldahl and P,G 0 :S 6° C, HzS04 to pH < 2 28 days 100 mL/ 5 g Organic Odor G, teflon- 0 :S 6° C, Zero headspace Immediate SOOmL lined septum Oil and Grease G 0 ::; 6° C, HCl or H2S04 to 28 days lOOOmL pH<2 Orthophosphate -Liquids P,G. Field filter immediately, 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> 25mL 0 :s 6° c Orthophosphate - Solids P,G 0 :s 6° c 28 days for extraction, 4 g 48 hrs from extraction to analysis Paint Filter Liquids Test Any None None 100 g Percent (%) Moisture P,G 0 :s 6° c None 2mL/5g Perchlorate by Ion P,G 0 :s 6° c 28 days 10 mL/ lg Chromatography Total Phenols G, amber- 0 :S6° C, HzS04 to pH < 2 28 days 50 mL/1 g pH P,G None if within 15 mins of Immediate 25mL/Sg collection, 0 :S 6° C when shipped to lab Total Phosphorus P,G 0 :S 6° C, H1S04 to pH < 2 28 days 20mL/1 g Residual Chlorine P,G 0<6° c Immediate 25mL/NA Residue, Total P,G 0 :s 6° c 7 days 25 mL/NA Residue, Filterable (TDS) P,G 0 :s 6° c 7 days 25 mL/NA Residue, NonFilterable (TSS) P,G 0 <6°C 7 days 1000 mL Residue, Volatile and Fixed P,G 0 :s 6° c 7 days 25 mL/1 g
(%Ash) 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 103 of 109 Residue, Settleable P,G 0:S6° c 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> lOOOmL/NA Salinity P,G 0:S6° c 28 days 25 mL/NA Specific Gravity P,G 0:S6°C 7 days 50mL/NA Sulfate P,G 0:S6° c 28 days 10mL/4g Sulfide P,G 0 : : :; 6° C, add ZnAc and 7 days . 200 mL/20 g NaOHtopH> 9 Sulfide, Reactive Releasable G, amber Zero headspace 7 days liquids, lOmL/lOg 28 days solids Sulfite P,G 9 EDTA Immediate SOmL/NA Sulfur by Bomb P,G 0:S6° c None NA/0.5 g Surfactants P,G 0:S6° c 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> lOOmL/NA Total Halogens P,G O:S6° c None 1mL/1 g Total Organic Carbon G, amber 0 : : :; 6° C, HCl or HzS04 to 28 days 50mL/ 5 g pH<2 Total Organic Halides G 0 : : :; 6° C, H1S04 to pH < 2, 28 days 50mL/l g Zero headspace Total Petroleum Hydrocarbons G 0 : : :; 6° C, H1S04 to pH < 2 28 days lOOOmL/NA TCLP (Toxicity Characteristic P,G 0 :S6° C, depends on test 14days, VOA 105gor130 g leaching_Procedure) and depending on . for full TCLP list 14 days, SVOA Synthetic Precipitation test Leaching Procedure (SPLP) 28 days Mercury 18'0 days non-Hg metals Turbidity P,G 0:S6° C 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> SOmL/NA Viscosity P,G 0:::;6°C None 7mL Metals - Liquids (except P, (Gas long HN03 topH<2 *6 months 50mL chromium VI and mercury) as no B or Si is required)
Metals - Solids 8 (except P, (Gas long None 6 months 2g chromium VI and mercury) as no B or Si is required)
Chromium VI - Liquids P,G 0:S6° C 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> 2SmL Chromium VI - Liquids P,G 0:::::; 6° C, (~)2S04, 28 days 25mL pH= 9.3 to 9.7 Chromium VI - Solids8 P,G 0 :S6° c 30 days to digestion, 1g 7 days from digestion to analysis Mercury - Liquids P,G HN03 to pH <2 28 days 50mL Mercury - Solids 8 P,G 0:::;6°C 28 days 2g 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (I).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC . GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 104 of 109 Mercury - Low Level Liquids P,G HCl orBrCl 90 days when 50mL preserved w/in 48 hrs or oxidized w/in 28 days BACTERIOLOGY Coliform, fecal P,G 0 :::: 6° c, 0.008 % 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> lOOmL/NA Na2S203 3 Standard Plate Count P,G 0 :S 6° C, 0.008% 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> lOOmL/NA Na2S203 3 Coliform, total* Wastewater P,G 0:::: 6° c, 0.008% 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> lOOmL/NA Na2S203 3 Coliform, total - P,G 0:::: 6° c, 0.008% 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> 100 mL/NA Groundwater Na2S203 3 Coliform, total - Drinking P,G 0:S6° c, 0.008% 30 hours3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br /> lOOmL/NA water Na2S203 3 ORGANICS Method AKlO I-Solids7 Amber.G 4 +/- 2 °C, zero headspace, 14 days 4 oz7 methanol Method AKlOl-Liquids AmberG 4 +/- 2 °C, HCl < 2 14 days 3x40mL Method AK102-Liquids AmberG 4 +/- 2 °C, HCl or H1S04 to 14 days 1000 mL pH<2 Method AK102/103-Solids AmberG 4+/-2 °C 14 days for extraction 4oz 40 days after extraction for analysis MADEP EPH - Liquids AmberG .4 +/- 2 °C, HCl < 2 14 days 4 oz MADEP EPH - Solids AmberG 4+/-2 °C 14 days 1000 mL MADEP VPH - Liquids G, teflon- 4 +/- 2 °C, HCl < 2 14 days 3x40mL lined septum (ambient purge)
Trip Blank Required MADEP - VPH Liquids G, teflon- 4 +/- 2 °C, Add 0.40 - 0.44g 14 days 3x40mL (Heated Purge) lined septum trisodium phosphate dodecahydrate to pH> 11 Trip Blank Required MADEP VPH - Solids G, teflon- lmL MeOH/g sample at 28 days 60mL vials add lined septum sampling or within 48 hrs, 25g sample, 40 Trip Blank Required 4+/-2 °C mL vials add 15 g sample.
BTEX - Liquids G, teflon- 0 :S 6° C, zero headspace, 6 14 days 3x40 mL lined septum HCl to pH< 2, 0.008%
Na2S203 3 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 105 of 109 BTEX - Solids8 G, teflon- 0 :s 6° c 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> for 3x5 g Encores lined preservation and 14 or 2 low and 1 septum days for analysis high level vials Volatiles - Drinking Water G, teflon- 0 :S 6° C, zero headspace, 14 days 3x40 mL lined cap HCl to pH<2 Volatiles (including 2 G, teflon- 0 :S 6° C, zero headspace, 7 days 6 3x40 mL chloroethylvinylether) - lined cap unpreserved Wastewater Volatiles - G, teflon- 0 :S 6° C, zero headspace, 7 days 6 3x40 mL Wastewater/groundwater lined cap unpreserved Volatiles - Solids8 En Core 0 :s 6° c 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> for 3x5 g EnCores Sampler preservation 14 days for analysis Volatiles - Concentrated Waste G, teflon- None 14 days lx40 mL lined septum Base/Neutral and Acid AmberG, 0 :S 6° C, 7 days for extraction 1000 mL/ 50 g Extractables and 1,4-Dioxane teflon-lined 40 days after 0.008% Na2S203 3
-Liquids cap extraction for analysis Base/Neutral and Acid G, teflon- 0 :s 6° c 14 days for extraction 1000 mL/ 50 g Extractables and 1,4-Dioxane- lined cap 40 days after Solids8 extraction for analysis Base/Neutral and Acid G, teflon- None 7 days for extraction 1000 mL/ 50 g Extractables - Concentrated lined cap I 40 days after Waste extraction for analysis TPH-GRO G, teflon- 0 :S 6° C, HCl to pH < 2, 14 days 3x40mL lined cap zero headspace TPH-DRO G, teflon- 0 :S 6° C, HCl to pH < 2 14 days 1000 mL/ 50 g lined cap Chlorinated Herbicides - AmberG, 0 ::S 6° C, 0.008% 7 days for extraction 1000 mL Liquids teflon-lined 40 days after Na2S203 3 cap extraction for analysis Chlorinated Herbicides - G, teflon- 0 :s 6° c 14 days for extraction 50 g Solids 8 lined cap 40 days after extraction Organochlorine Pesticides by AmberG, 0 :S 6° C, 0.008% Na2S203 7 days for extraction 1000 mL/ 50 g SW-846 EPA 8081 teflon-lined 40 days after cap extraction for analysis Organochlorine Pesticides by AmberG, 0 :S 6° C, Unpreserved Prep lOOOmL/NA EPA 608 only teflon-lined within 72 hrs 0.008%, Na2S203 3, NaOH cap and HzS04preserve to pH Preserved prep within 5.0 to 9.0 (for prep >72 ?days hrs and <7days) 40 days after extraction for analysis 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 106 of 109 PCBs and PCB Congeners AmberG, o::::6°C, 365 days for 1000 mL/ 50 g teflon-lined extraction 365 days 0.008% Na2S203 3 cap after extraction for analysis PCBs in Oil G, teflon- None 365 days for lx40 mL lined cap extraction 365 days after extraction for analysis Total Petroleum Hydrocarbon G, teflon- 0::::6° c 14 days 1000 mL/ 50 g lined septum Industrial Solvents G, teflon- 0::;6°C 14 days lx40 mL lined septum 1,4-Dioxane in Drinking Water G, teflon- <10°C during transport,
- 28 days for extraction 100 mL to 500 by EPA 522 lined septum Sodium sulfite (SOmg/L), at 0 :::: 6° C (not mL sodium bisulfate (lg/L) frozen) and 28 days after extraction for analysis at -So C, protected from light Dioxin Screen G, teflon- 0::;6°C 7 days for extraction 1000 mL/ 50 g lined cap 40 days after extraction for analysis EDB andDBCP G, teflon- 0 ::; 6° C, HCl to pH < 2 7 or 14 days 3x40mL/NA lined septum 0.4% Na2S203 Poylnuclear Aromatic AmberG, 0::;6°C 7 days for extraction 1000 mL/30 g Hydrocarbons teflon-lined (Liquids) septum 14 days to extraction (Liquids),
(Solids)
Teflon-lined cap (Solids) 40 days to analysis after extraction Nitroaromatics and AmberG, 0::::6° c 7 days for extraction 1000 mL/2 g Nitroamines teflon-lined 40 days after septum extraction for analysis Nitroaromatics and Protect from 0 :::: 6° C until air drying 14 days for extraction, Entire Sample Nitroamines by MIS Prep light 22 +/- 4 ° C (or cooler) after 40 days after (solid samples) extraction for analysis drying RDX Breakdown AmberG, 0::::6°C 7 days to extraction 1000 mL/2g teflon-lined for liquids septum for 14 days to extraction liquids and for solids teflon-lined cap for 40 days to analysis solids after extraction 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 107 of 109 Low Level Perchlorate p 0 S 6° C , headspace 28 days 10mL/2g required Haloacetic Acids G, amber, 0 S 6° C , zero headspace, 14 days to extraction, 3x60 mL teflon-lined ammonium chloride 7 days after extraction septum for analysis Dissolved Gases G, teflon- 0 S 6° C, HCl to pH < 2, 7 days if unpreserved, 2x40 mL lined septum zero headspace 14 days if preserved Perfluorinated Alkyl Acids Poly- 0 S 6° C, Trizma at 5g/L 14 days 250mL propylene RADIOCHEMISTRY Americium - Liquids P,G HN03 or HCl to pH < 2 6 months 1000 mL Americium - Solids 8 P,G None 6 months 20 g Calcium Liquids P,G HN03 or HCl to pH< 2 6 months 500mL Calcium Solids 8 P,G None 6 months 20 g Carbon-14 Liquids & Solids8 P,G None 6 months 500 mL/20 g Cesium 134-Drinking Water P,G HCl to pH<2 6 months 2000mL 8 P,G Chlorine-36 Liquids & Solids None 6 months 500 mL/20 g Curium - Liquids P,G HN03 or HCI to pH < 2 6 months lOOOmL 8 P,G Curium - Solids None 6 months 20g Gamma Isotopes - Liquids P,G HN03 or HCI to pH < 2 6 months 2000mL Gamma Isotopes - Solids8 P,G None 6 months 200g Gross Alpha & Beta - Liquids P,G HN03 or HCI to pH < 2 6 months 500mL Gross Alpha & Beta, Rapid - P,G HN03 or HCI to pH< 2 48-72 hrs SOOmL Liquids Gross Alpha & Beta - Solids8 P,G None 6 months 20 g Iodine-129 - Liquids & Solids 8 P,G None 6 months 1000 mL/ 50 g Iodine -131 - Liquids P,G None 8 days lOOOmL Iron 55 -Liquids P,G HN03 or HCI to pH< 2 6 months 500mL 8
Iron 55 - Solids P,G None 6 months 20 g Lead-210 - Liquids P,G HN03 or HCl to pH < 2 6 months 1000 mL 8 P,G Lead-210 - Solids None 6 months 200 g Neptunium - Liquids P,G HN03 or HCl to pH < 2 6 months 1000 mL Neptunium - Solids8 P,G None 6 months 20 g Nickel Liquids P,G HN03 or HCI to pH < 2 6 months 1000 mL Nickel Solids 8 P,G None 6 months 20 g 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page(!).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001 Rev 29 Revision 29 Effective March 2015 Page 108 of 109 Nickel Liquids P,G HN03 or HCl to pH < 2 6 months 1000 mL 8 P,G Nickel Solids None 6 months 20g Phosphorus-32 -Liquids P,G HN03 or HCl to pH < 2 6 months 1000 mL 8 P,G Phosphorus Solids None 6 months 20g.
Plutonium - Liquids P,G HN03 or HCl to pH < 2 6 months 1000 mL Plutonium - Solids8 P,G None 6 months 20 g Polonium - Liquids P,G HN03 or HCl to pH < 2 6 months 1000 mL Polonium - Solids8 P,G None 6 months 20 g Promethium-147/Samarium- P,G HN03 or HCl to pH < 2 6 months 1000 mL 151*- Liquids Promethium-147/Samarium- P,G None 6 months 20 g 151 - Solids8 Radium-223 - Liquids P,G HN03 or HCl to pH < 2 6 months 2000mL Radium-224 - Liquids P,G HN03 or HCl to pH < 2 6 months 2000mL Radium-226 - Liquids P,G HN03 or HCl to pH < 2 6 months lOOOmL Radium-228 - Liquids P,G HN03 or HCl to pH < 2 6 months 1000 mL Radon-222 - Liquids G None, Zero headspace 4days 2x40 mL Selenium Liquids P,G HN03 or HCl to pH < 2 6 months 500mL 8 P,G None 6 months 20 g Selenium Solids .
Strontium-89/90 - Liquids P,G HN03 or HCl to pH < 2 6 months 1000 mL 8 P,G None 6 months 20 g Strontium-89/90 - Solids Sulfur Liquids P,G None 6 months 500mL Sulfur Solids 8 P,G None 6 months 20g Technetium Liquids P,G HN03 or HCl to pH < 2 6 months 1000 mL Technetium Solids8 P,G None 6 months 20 g Thorium - Liquids P,G HN03 or HCl to pH < 2 6 months 1000 mL Thorium - Solids8 P,G None 6 months 20g Total Activity Liquids P,G HN03 or HCl to pH < 2 6 months lOOmL 8 P,G 20 g Total Activity - Solids None 6 months Total Alpha Radium - Liquids P,G HN03 or HCl to pH < 2 6 months 500mL Total Alpha Radium - Solids8 P,G None 6 months 20 g Total Uranium - Liquids P,G HN03 or HCl to pH < 2 6 months lOOmL Total Uranium - Solids 8 P,G None 6 months 20 g Tritium - Drinking Water G None 6 months 250mL Tritium - Electrolytic Liquids P,G None 6 months 2000 mL Tritium - Liquids & Solids8 P,G None 6 months 250 mL/20 g 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1).
Uncontrolled documents do not bear an original Set ID number.
09-Apr-2015 Quality Assurance Plan GEL Laboratories, LLC GL-QS-B-001Rev29 Revision 29 Effective March 2015 Page 109 of 109 Uranium - Liquids P,G HN03 or HCl to pH< 2 6 months 1000 mL Uranium - Solids8 P,G None 6 months 20g 1P =Polyethylene; G = Glass 2
Samples should be analyzed as soon as possible after collection. The holding times listed are maximum times that samples may be held before analysis and be considered valid.
3 Used only in the presence of residual chlorine.
4 Maximum holding time is 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> when sulfide is present. All samples may be tested with lead acetate paper before pH adjustments in order to determine if sulfide is present. If present, remove by adding cadmium nitrate powder until a negative spot test is obtained. Filter sample and add NaOH to pH 12.
- 5 Minimum amount of sample needed to prepare and analyze for the parameter. Some parameters may be combined into one analysis,- others may need additional amount if quality control is being requested for site-specific samples.
Please check with GELs Project Manager for proper sample amounts based on project specific requirements.
6 Volatiles Groundwater/Wastewater: If samples are to be analyzed for vinyl chloride, styrene, or 2-chloroethylvinyl ether for soil or water, separate samples must be collected without acid preservation and analyzed within 7 days. For aqueous samples to be analyzed for acrolein and acrylonitrile, by EPA Method 624, the samples should be analyzed within 3 days.
7 Solids Method AK101 2-4 oz amber wide-mouth jars tared and labeled, 1-4 oz amber wide-mouth jar labeled (evaporative loss), 2-25 mL 2.5 ppm surrogated Pff methanol tubes.
8 Solids matrix typically applies to soils, sludges and sediments. Some tests have been developed for filters, miscellaneous solid waste, plant and animal tissue, also referred to as solids. Contact GEL to verify a particular matrix for the test of interest. . .
9 lmL of 2.5% EDTA solution per lOOmL sample 2040 Savage Road Charleston SC 29407 (843) 556-8171 This document is controlled only when an original Set ID number appears on the cover page (1) ..
Uncontrolled documents do not bear an original Set ID number.