Spectrum Analytical Inc. FL Division Quality Manual – V7

SPECTRUM ANALYTICAL, INC.
Featuring
HANIBAL TECHNOLOGY
Florida Division
8405 Benjamin Road Suite A
Tampa, Fl 33634
QUALITY MANUAL
Responsible Parties
Name
Brian C. Spann
Mark Gudnason
Function (Unit)
Laboratory
Director
Technical Director
Quality Manager
Technical Director
Revision Number:
Signatures
Phone
Date
813.888.9507
Brian C
Spann
Digitally signed by Brian C Spann

DN: cn=Brian C Spann, o=Lab Director,
Tampa Division, ou=Spectrum Analytical,
email=bspann@pelab.com, c=US
Date: 2012.01.04 14:30:31 -05'00'
813.888.9507
Mark
Gudnason
Digitally signed by Mark

Gudnason
DN: c=US, cn=Mark
Gudnason
Date: 2012.01.04 14:35:54
-05'00'
Effective Date:
02/03/2011
03/18/2011
05/12/2011
05/27/2011
10/28/2011
01/04/2012
page 1 of 75
01/04/2012
04/27/2010
Spectrum Analytical Inc. FL Division

Quality Manual V7
01/04/2012
Last Saved on 1/4/2012
SECTION 2 - TABLE OF CONTENTS

SECTION 3 INTRODUCTION AND SCOPE..................................................................................................6
3.1
Scope of Testing ......................................................................................................................................7
3.2
Table of Contents, References and Appendices.........................................................................................8
3.3
Glossary and Acronyms Used ..................................................................................................................9
SECTION 4 ORGANIZATIONAL ROLES AND RESPONSIBILITIES......................................................10

4.1
Laboratory Organizational Structure .....................................................................................................10
4.2
Responsibility and Authority ..................................................................................................................10
4.2.1
President........................................................................................................................................10
4.2.2
Laboratory Director........................................................................................................................10
4.2.3
Information Services Director (ISD or IT) ......................................................................................11
4.2.4
Quality Assurance Officer (QAO) ..................................................................................................11
4.2.6
Project Managers ...........................................................................................................................11
4.2.7
Departmental Managers .................................................................................................................11
4.2.8
Chemists, Analysts and Technicians...............................................................................................12
SECTION 5 QUALITY SYSTEMS.................................................................................................................13
5.1
Quality Policy .......................................................................................................................................13
5.2
Quality Manual .....................................................................................................................................13
SECTION 6 DOCUMENT MANAGEMENT.................................................................................................14

6.1
Controlled Documents ...........................................................................................................................14
6.1.1
Document Changes to Controlled Documents.................................................................................15
6.1.1.1 Paper Document Changes...............................................................................................................15
6.1.1.2 Electronic Document Changes........................................................................................................15
6.2
Obsolete Documents..............................................................................................................................15
6.3
Standard Operating Procedures.............................................................................................................16
6.3.1
Test Method SOPs .........................................................................................................................16
SECTION 7 REVIEW OF REQUESTS, TENDERS AND CONTRACTS ....................................................17
7.1
Procedure for the Review of Work Requests ...........................................................................................19
7.2
Documentation of Review ......................................................................................................................19
SECTION 8 SUBCONTRACTING OF TESTS..............................................................................................19

SECTION 9 PURCHASING SERVICES AND SUPPLIES ...........................................................................19
SECTION 10 SERVICE TO THE CLIENT ...................................................................................................20
10.1
Client Confidentiality.............................................................................................................................20
SECTION 11 COMPLAINTS .........................................................................................................................20

SECTION 12 CONTROL OF NON-CONFORMING WORK.......................................................................21
SECTION 13 CORRECTIVE ACTION .........................................................................................................21

Quality Manual V7
page 2 of 75
13.1
Selection and Implementation of Corrective Actions...............................................................................22
13.2
Monitoring of Corrective Action ............................................................................................................22
13.3
Technical Corrective Action...................................................................................................................22
13.4
Exceptionally Permitting Departures from Documented Policies and Procedures...................................22
SECTION 14 PREVENTIVE ACTION ..........................................................................................................23

SECTION 15 CONTROL OF RECORDS ......................................................................................................23
15.1
Records Management and Storage .........................................................................................................23
15.2
Legal Chain of Custody Records............................................................................................................24
SECTION 16 AUDITS AND MANAGEMENT REVIEW .............................................................................26

16.1
Internal Audits.......................................................................................................................................26
16.2
External Audits......................................................................................................................................26
16.3
Performance Audits ...............................................................................................................................27
16.4
System Audits and Management Reviews................................................................................................27
SECTION 17 PERSONNEL, TRAINING, AND DATA INTEGRITY ..........................................................27

17.1 Job Descriptions....................................................................................................................................27
17.1.1 President Hanibal C. Tayeh (resume(s) in section 25)...................................................................27
17.1.2 Laboratory Director Brian C. Spann (resume(s) in section 25)......................................................27
17.1.3 Technical Director(s) - Brian C. Spann and Mark Gudnason (resume(s) in section 25) ....................28
17.1.4 Quality Manager - Mark Gudnason (resume(s) in section 25)..........................................................28
17.1.5 Information Services Director (ISD) Jakub Rehacek ....................................................................28
17.2
Data Integrity and Ethics.......................................................................................................................28
17.4
General Training...................................................................................................................................30
SECTION 18 ACCOMMODATIONS & ENVIRONMENTAL CONDITIONS............................................31

SECTION 19 TEST METHODS AND METHOD VALIDATION ................................................................32
19.1
Demonstration of Capability (DOC) ......................................................................................................32
19.2
On-Going (or Continued) Proficiency ....................................................................................................32
19.3 Initial Test Method Evaluation...............................................................................................................32

19.3.1 Limit of Detection (LOD) ..............................................................................................................32
19.3.2 Limit of Quantitation (LOQ) ..........................................................................................................33
19.3.3 Precision and Bias..........................................................................................................................33
19.3.4 Selectivity......................................................................................................................................33
19.4
Estimation of Uncertainty ......................................................................................................................33
19.5
Laboratory-Developed or Non-Standard Method Validation...................................................................34
19.6
Control of Data .....................................................................................................................................34
SECTION 20 EQUIPMENT............................................................................................................................35
20.1 General Equipment Requirements..........................................................................................................35
Table 20.1
Laboratory Equipment.........................................................................................................36
20.2
Support Equipment ................................................................................................................................42

Quality Manual V7
page 3 of 75
20.2.1
20.2.2
Support Equipment Maintenance....................................................................................................43

Support Equipment Calibration ......................................................................................................43
20.3 Analytical Equipment.............................................................................................................................43

20.3.1 Maintenance for Analytical Equipment...........................................................................................43
20.3.2 Initial Instrument Calibration..........................................................................................................43
20.3.3 Continuing Instrument Calibration..................................................................................................44
20.3.4 Unacceptable Continuing Instrument Calibration Verifications .......................................................45
SECTION 21 MEASUREMENT TRACEABILITY.......................................................................................45
21.1
Reference Standards..............................................................................................................................45
21.2
Reference Materials...............................................................................................................................46
21.3
Transport and Storage of Reference Standards and Materials ................................................................46
21.4
Labeling of Reference Standards, Reagents, and Materials.....................................................................46
Standard Receipt and Traceability.....................................................................................................................46

SECTION 22 SAMPLE MANAGEMENT......................................................................................................47
22.1
Sample Receipt ......................................................................................................................................47
22.2
Sample Acceptance................................................................................................................................47
22.3
Sample Identification.............................................................................................................................47
22.4
Sample Storage......................................................................................................................................47
22.5
Sample Disposal....................................................................................................................................48
22.6
Sample Transport ..................................................................................................................................48
22.7
Sampling Records..................................................................................................................................48
SECTION 23 QUALITY OF TEST RESULTS ..............................................................................................48

23.1
Essential Quality Control Procedures ....................................................................................................48
23.2
Internal Quality Control Practices.........................................................................................................49
Table 23.2-1
Essential Quality Control Elements for Chemistry ................................................................51
23.3
Method Blanks.......................................................................................................................................51
23.4
Laboratory Control Samples..................................................................................................................51
23.5
Matrix Spikes and Matrix Spike Duplicates ............................................................................................52
23.6
Surrogate Spikes....................................................................................................................................53
23.7
Proficiency Test Samples or Inter-laboratory Comparisons....................................................................54
23.8
Data Review..........................................................................................................................................54

Quality Manual V7
page 4 of 75
SECTION 24 REPORTING OF RESULTS....................................................................................................55

24.1
Test Reports ..........................................................................................................................................55
24.2
Supplemental Test Report Information ...................................................................................................56
24.3
Environmental Testing Obtained from Subcontractors............................................................................56
24.4
Electronic Transmission of Results.........................................................................................................56
24.5
Amendments to Test Reports ..................................................................................................................56
SECTION 25 APPENDICES ...........................................................................................................................58

25.1 - Resumes..................................................................................................................................................58
Hanibal C. Tayeh, Ph.D. President / CEO.......................................................................................................58
Brian C. Spann Lab Director...........................................................................................................................66
Mark Gudnason Sr. Project Manager.............................................................................................................68
Raymond Ortiz, III Semi-Volatiles Group Manager ......................................................................................70
Troy L. Roberts Inorganics Group Manager ..................................................................................................72
SPECTRUM ANALYTICAL, INC. FL DIVISION Organization Chart..........................................................74
Review.................................................................................................................................................................75

Quality Manual V7
page 5 of 75
SECTION 3 INTRODUCTION AND SCOPE

The purpose of this Quality Manual is to outline the quality system for the laboratory. The
Quality Manual defines the policies, procedures, and documentation that assure analytical
services continually meet a defined standard of quality that is designed to provide clients
with data of known and documented quality and, where applicable, demonstrate regulatory
compliance. As a NELAP certified laboratory, SPECTRUM ANALYTICAL, INC. FL DIVISION
will follow prescribed NELAP, Florida Department of Environmental Protection (FDEP), United
States Environmental Protection Agency (USEPA), or other applicable approved standard
methods, and will maintain quality assurance documentation as outlined in this plan.
The Quality Manual sets the standard under which all laboratory operations are performed
including the laboratory's organization, objectives, and operating philosophy. This Manual
was developed by following the guidelines discussed in the EPA Requirements for Quality
Assurance Project Plans for Environmental Data Operations, EPA QA/R-5, Reissued May
2006: EPA Requirements for Quality Management Plans, EPA QA/R-2, Reissued May 2006:
Department of Defense (DOD QSM) Quality Systems Manual for Environmental Laboratories
Version 4.2: and the National Environmental Laboratory Accreditation Conference (NELAC)
standards, June 5, 2003 (Effective July 1, 2003). Plans are underway to adopt The NELAC
Institute (TNI) Standards by July 2011.
SPECTRUM ANALYTICAL, INC. FL DIVISION's environmental capabilities include:
preparation and analysis for physical properties, trace metals, volatile organic, and
extractable organic and inorganic parameters. SPECTRUM ANALYTICAL, INC. FL DIVISION
shall follow good QA/QC management practices and is committed to consistently generating
data of verifiable quality.
The management of SPECTRUM ANALYTICAL, INC. FL DIVISION is committed to providing
our clients with quality and timely data for their regulatory needs. The management ensures
that all personnel are properly trained and knowledgeable in the analyses they perform, and
that the staff is committed to reporting only the highest quality data that they can provide.
The Lab Director/QAO and department managers meetings are held weekly to discuss
upcoming projects, new methodologies, and safety concerns within the lab, meetings are
held to keep the communication lines open between the departments.
Certain documents used at SPECTRUM ANALYTICAL, INC. FL DIVISION must be controlled
to ensure that QA/QC in the laboratory is in compliance with generally accepted QA
principles and requirements. Most notable among these documents are Standard Operating
Procedures (SOP) and Quality Manual.
One of the requirements of a valid QA/QC program is that the data generated in the
laboratory is not affected by non-random variability. In order to assure this, all factors that
may cause variability must be minimized. One factor that can be controlled is how the
samples are processed. The Quality Manual defines in the broadest sense how samples are
processed in the laboratory. SOPs describe in detail how each individual process is applied
to the samples. In the event that the Quality Manual and an SOP differ the SOP takes
precedence over the Quality Manual. All controlled documents are signed by laboratory
management, and may not be used until they are signed. In so doing, the laboratory
assures the clients, and other users of the data generated in the laboratory that the data
was generated using the steps described in the controlled document.

Quality Manual V7
page 6 of 75
3.1
Scope of Testing
The laboratory scope of analytical testing services includes those listed in our
certifications from various agencies. The list of Fields of Accreditation, FOAs, may
vary from agency to agency and are verified during review of work request by the
Project Management Team at SPECTRUM ANALYTICAL, INC. FL DIVISION. Any
variances are communicated to the client following SPECTRUM ANALYTICAL, INC.
FL DIVISION SOP00118, Profile Set-up and Management.
SPECTRUM ANALYTICAL, INC. FL DIVISION is a NELAP recognized Laboratory and
maintains their primary accreditation through the State of Florida DOH. If you have
questions regarding certification please contact our Project management team; who
has access to the most current copies of the current certification and Fields of
Accreditation (FOA). SPECTRUM ANALYTICAL, INC. FL DIVISION has been audited
and approved for AFCEE, USACE, and US Navy work. Additionally, SPECTRUM
ANALYTICAL, INC. FL DIVISION is an EPA CLP participant.
State of Florida
State of Texas
State of South Carolina
State of North Dakota
State of California
State of Louisiana
State of Kansas
State of Arkansas
DoD ELAP
EPA CLP Contracted

Quality Manual V7
page 7 of 75
3.2
Table of Contents, References and Appendices

The table of contents is in Section 2 of this Manual. This Quality Manual uses the
references from the 2003 NELAC Standard, Chapter 5, Appendix A.
SPECTRUM ANALYTICAL, INC. FL DIVISION Quality SOPs
SOP Number SOP Title
SOP00002
Training
SOP00003
Controlled Documents
SOP00004
SOP for SOPs
SOP00005
Corrective/Preventive Actions
SOP00009
Internal COC
SOP00010
Sample Receipt, Storage, Preserv and Verification
SOP00014
Subcontracting
SOP00049
Intralaboratory Performance Evaluation Samples
SOP00058
MDL and RL Establishment
SOP00059
Method Validation
SOP00072
Glassware Cleaning
SOP00085
Data review and verification
SOP00091
Manual integration for GC, GC/MS and LC
SOP00095
Ordering supplies and services
SOP00098
Waste Disposal
SOP00118
Profile Set-up and Management
Shewart Charts, Control Limits, Marginal
SOP00138
Exceedances
SOP00139
Doc. Of Analyst Capability
SOP00141
Project Management: General Duties
SOP00151
Data Quality and Reporting Ethics
SOP00168
Solvent and Reagent lot checks
SOP00171
Internal Audits/Reviews
SOP00172
In-House Data reporting Validation

Quality Manual V7
page 8 of 75
3.3
Glossary and Acronyms Used

Quality control terms are generally defined within the section that describes the
activity.
Glossary
Appendix A, Chapter 1, 2003 NELAC Standards
Acronyms
A list of acronyms used in this document and their definitions are:
AA
AFCEE
ANSI
ASQC
ASTM
Blk
C
cal
CAS
CCV
COC
DO
DOC
DOD
EPA
FOA
g/L
GC/MS
GLP
ICP
ICV
ISO/IEC
lb/in2
LCS
LCSD
LFB
LIMS
LOD
LOQ
MDL
mg/Kg
mg/L
MS
MSD
NELAC
NELAP
NIST
PT
PTOB
PTPA
QA
QC
QS
QAM
Accrediting Authority
Air Force Center for Engineering and the Environment

American National Standards Institute
American Society for Quality Control
American Society for Testing and Materials
Blank
degrees Celsius
calibration
Chemical Abstract Service
Continuing calibration verification
Chain of custody
Dissolved oxygen
Demonstration of Capability
Department of Defense
Environmental Protection Agency
Fields of Accreditation
grams per liter
gas chromatography/mass spectrometry
Good Lab Policies
inductively coupled plasma
Initial calibration verification
International Organization for Standardization/International Electrochemical
Commission
pound per square inch
Laboratory control sample
Laboratory control sample duplicate
Laboratory fortified blank
Laboratory Information Management System
Limit of Detection
Limit of Quantification
method detection limit
milligrams per kilogram
milligrams per liter
matrix spike
matrix spike duplicate
National Environmental Laboratory Accreditation Conference
National Environmental Laboratory Accreditation Program
National Institute of Standards and Technology
Proficiency Test(ing)
Proficiency Testing Oversight Body
Proficiency Testing Provider Accreditor
Quality Assurance
Quality Control
Quality Manual
Quality Assurance Manager/officer

Quality Manual V7
page 9 of 75
QAO
RL
RPD
RSD
SOPs
Spectrum
spk
std
TNI
ug/L
USACE
UV
VOC
WET
Quality Assurance Manager/officer

Reporting level
Relative percent difference
Relative standard deviation
Standard operating procedures
SPECTRUM ANALYTICAL, INC. FL DIVISION or Spectrum Analytical, Inc.
spike
standard
The NELAC institute
micrograms per liter
United States Army Corps of Engineers

Ultraviolet
Volatile organic compound
Whole effluent toxicity
SECTION 4 ORGANIZATIONAL ROLES AND RESPONSIBILITIES

The laboratory is a legally identifiable organization. Through application of the policies and
procedures outlined in this chapter, the laboratory assures that it is impartial and that
personnel are free from undue commercial, financial, or other undue pressures that might
influence their technical judgment. The laboratory is responsible for carrying out testing
activities that meet the requirements of the NELAC Standard and that meet the needs of the
client. See SPECTRUM ANALYTICAL, INC. FL DIVISION Organization chart in Section 25.
4.1
Laboratory Organizational Structure

The organizational structure indicated minimizes the potential for conflicting or
undue interests that might influence the technical judgment of analytical personnel.
The laboratory is a commercial testing laboratory. The tax number is available upon
request, if applicable.
The laboratory operates in Tampa, FloridaSPECTRUM ANALYTICAL, INC. FL DIVISION
is a division of Spectrum Analytical in Agawam MA. The Sales manager, Lab Director
and IT manager report directly to the President, Hanibal Tayeh. Although the
laboratories do share benefits such as purchasing, the two laboratories function
independently under separate certification, Quality Manuals, SOPs and accreditation.
4.2
Responsibility and Authority

Every staff member has the authority to stop work that is not compliant and if a
safety issue is found. The President, Lab Director, QAO, and Department managers
have the authority to resume work once the issue has been properly corrected. All
stop work issues must be communicated to the Lab Director and/or the QAO for
proper documentation and communication to the client if required.
4.2.1
President
The President ensures that the necessary equipment, material, and personnel are
available to accomplish scheduled projects. The President also ensures that
corrective actions are being conducted, assuring QA goals. The president also
communicates with clients on all aspects of their projects and recommends solutions.
4.2.2
Laboratory Director

Quality Manual V7
page 10 of 75
The Laboratory Director is responsible for oversight of all laboratory operations. The
Laboratory Director will communicate with clients on all aspects of their projects and
recommend solutions. The Laboratory Director will also work with the Quality
Assurance Officer, section and team leaders, and analytical staff in reviewing
progress reports, analytical reports, and quality control reports.
4.2.3
Information Services Director (ISD or IT)
The ISD is responsible for all electronic records and deliverables. He also ensures
that all electronic back-up records are properly stored and easily retrieved. He
manages the LIMS system, and is responsible for all levels of reporting/forms
generation programs.
4.2.4
Quality Assurance Officer (QAO)
The QAO assists the laboratory in the production of accurate, valid, reliable data by
monitoring the implementation of the QA program. The QA officer is responsible for
executing quality control procedures and techniques to ensure that the laboratory
achieves established standards of quality. The QAO is also responsible for evaluating
data quality and maintaining records to ensure adherence to QA programs, and will
administer inter-laboratory QA efforts, review performance evaluation results, ensure
corrective actions take place, and prepare QA reports for management.
The QAO reports directly to the Laboratory Director for administrative and personnel
related issues, but has full authority to stop work on any project or in any analytical
area if QC problems arise that may compromise data quality. If a conflict arises with
the Laboratory Director, the QAO can refer the related issue to the President.
4.2.6 Project Managers
The Project Managers are responsible for establishing and maintaining good client
relations. They act as a liaison between the client and analytical operations of the
laboratory, aiding in defining the scope of the work, determining the needs of the
client, and circumventing or solving clients problems. The Department manager of
this team also manages the Login team and is responsible for sample tracking,
storage, and disposal.
4.2.7 Departmental Managers
At SPECTRUM ANALYTICAL, INC. FL DIVISION, Section and Team Leaders serve as
supervisors for the preparation, semi-volatiles, volatiles, and in-organics groups in
the Laboratory. They provide technical direction and project scheduling for
conducting laboratory analyses and resolving day to day problems, and ensure that
proper QA /QC is followed in their respective departments. They also review data for
clarity, validity and adherence to quality control standards. They review and forward
to the QAO all corrective action reports, and ensure that the corrective actions have
been implemented. They also advise the Laboratory Manager and QAO of progress,
needs, and potential problems associated with their groups. They routinely perform
final data review.

Quality Manual V7
page 11 of 75
4.2.8 Chemists, Analysts and Technicians

The chemistry staffs, titled chemists and analysts as appropriate, are responsible for
performing all aspects of inorganic and organic sample preparation and analysis,
using Standard Methods, EPA, CFR 40, DoD and SW-846 methodologies. They are
responsible for instrument maintenance and calibration, data reduction, data review
and reporting any anomalies within their areas. They report directly to the
appropriate Team or Section Leader.
Login technicians act as surrogate sample custodians for the laboratory, and report
to the Project Manager lead. They are responsible for the preparation and shipment
of sample kits to the clients. They are also responsible for receiving samples,
checking them in, reviewing all associated paper work, sending samples to Sub-labs
if required and maintaining the internal chain-of-custody. Login technicians, under
the supervision of the lead project manager are responsible for custody of all
samples stored in the walk-in refrigerator, warehouse and sample disposal.
Management has overall responsibility for the technical operations and authority
needed to generate the required quality of laboratory operations.
Managements commitment to quality and to the Quality System is stated in the
Quality Policy, which is upheld through the application of related policies and
procedures. The management of SPECTRUM ANALYTICAL, INC. FL DIVISION is
committed to providing our clients with quality and timely data for their regulatory
needs. The management ensures that all personnel are properly trained and
knowledgeable in the analyses they perform, and that the staff is committed to
reporting only the highest quality data that they can provide. Staff meetings are
held to discuss upcoming projects, new methodologies, and safety concerns within
the lab, and supervisors meetings are held to keep the communication lines open
between the departments.
Management ensures technical competence of personnel operating equipment,
performing tests, evaluating results, or signing reports, and limits authority to
perform laboratory functions to those appropriately trained and/or supervised.
The assignment of responsibilities, authorities, and interrelationships of the
personnel who manage, perform, or verify work affecting the quality of
environmental tests is documented in detailed job descriptions maintained by the
Lab Director.
Management bears specific responsibility for maintenance of the Quality System.
This includes defining roles and responsibilities to personnel, approving documents,
providing required training, providing a procedure for confidential reporting of data
integrity issues, and periodically reviewing data, procedures, and documentation.
Management ensures that audit findings and corrective actions are completed within
required time frames.
Designated alternates are appointed by management during the absence of the
Laboratory Manager, Technical Director or the Quality Manager, and always if the
absence is more than 15 days.

Quality Manual V7
page 12 of 75
Management is responsible for defining the minimal level of education, qualifications,

experience, and skills necessary for all positions in the laboratory and assuring that
technical staff have demonstrated capabilities in their tasks.
Training is kept up to date as described in SPECTRUM ANALYTICAL, INC. FL
DIVISION SOP0002, Training, by periodic review of training records and through
employee performance review.
SECTION 5 QUALITY SYSTEMS

The laboratory's Quality System is documented in this Quality Manual and associated quality
system documents. Together they describe the policies, objectives, principles,
organizational authority, responsibilities, accountability, and implementation plan of the
organization for ensuring quality in its work processes, products, and services.
5.1
Quality Policy
A Quality Policy statement, including objectives and commitments by top management is

required in the Quality Manual. The quality policy contained in this document is signed and
dated, and is issued under the authority of the highest level of laboratory management,
which demonstrates managements commitment to integrity, ethics, the quality system and
associated standards.
Quality Policy Statement
The objective of the quality system and the commitment of management are to
consistently provide our customers with data of known and documented quality
that meets their requirements. Our policy is to use good professional practices,
to maintain quality, to uphold the highest quality of service, to comply with the
NELAC Standard and a commitment to continually improve in these practices.
This policy is implemented and enforced through the unequivocal commitment
of management, at all levels, to the Quality Assurance (QA) principles and
practices outlined in this manual. The laboratory ensures that personnel are
free from any commercial, financial, and other undue pressures, which might
adversely affect the quality of work. However, the primary responsibility for
quality rests with each individual within the laboratory organization. Every
laboratory employee must ensure that the generation and reporting of quality
analytical data is a fundamental priority. Every laboratory employee is required
to familiarize themselves with the quality documentation and to implement the
policies and procedures in their work. All employees are trained annually on
ethical principles and procedures surrounding the data that is generated. The
laboratory maintains a strict policy of client confidentiality.
5.2
Quality Manual
The Laboratory Director and or the Quality Officer ensures that the laboratorys
policies and objectives for quality are documented by reference or by inclusion in the
Quality Manual, and that the Quality Manual is communicated to, understood by, and
implemented by all personnel concerned.

Quality Manual V7
page 13 of 75
Where the Quality Manual documents laboratory requirements, a separate SOP or

policy is not required. SPECTRUM ANALYTICAL, INC. FL DIVISION will state general
policies within this manual and in SPECTRUM ANALYTICAL, INC. FL DIVISION SOPs,
however; specific policies and clients specific statement of works when presented in
written form may take precedence over this document. All variance requests are
maintained by the project management team.
All employees sign a form, kept with in accordance to SPECTRUM ANALYTICAL,
INC. FL DIVISION SOP00002, Training, that states that they have read,
understood and will adhere to the Quality Manual, including the quality policy.The
Quality Manual is maintained and up-to-dated by the Laboratory Director and or the
Quality Officer.
SECTION 6 DOCUMENT MANAGEMENT

This Section describes procedures for document management, which includes controlling,
distributing, reviewing, and accepting modifications. The purpose of document management
is to preclude the use of invalid and/or obsolete documents.
The laboratory manages three types of documents, 1) controlled, 2) approved, and 3)
obsolete.
A CONTROLLED DOCUMENT is one that is uniquely identified, issued, tracked, and kept current
as part of the quality system. Controlled documents may be internal documents or external
documents.
APPROVED means reviewed, and either signed and dated, or acknowledged in writing or
secure electronic means by the issuing authority(ies).
OBSOLETE DOCUMENTS are documents that have been superseded by more recent versions.
All documents that affect the quality of laboratory data are managed appropriate to the
scope and depth required.
6.1
Controlled Documents
Documents will be reviewed and approved for use by The Laboratory Director and or
the Quality Officerprior to issue at a minimal. See SPECTRUM ANALYTICAL, INC.
FL DIVISION SOP00003, Controlled Documents for details.
Certain documents used at SPECTRUM ANALYTICAL, INC. FL DIVISION must be
controlled to ensure that QA/QC in the laboratory is in compliance with generally
accepted QA principles and requirements. Most notable among these documents
are standard operating procedures (SOP) and Quality Manual.
One of the requirements of a valid QA/QC program is that the data generated in the
laboratory is not affected by non-random variability. In order to assure this, all
factors that may cause variability must be minimized. One factor that can be
controlled is how the samples are processed. The Quality Manual defines in the
broadest sense how samples are processed in the laboratory. SOPs describe in detail
how each individual process is applied to the samples. In the event that the Quality
Manual and an SOP differ the SOP takes precedence over the Quality Manual. All

Quality Manual V7
page 14 of 75
controlled documents are signed by laboratory management, and may not be used
until they are signed. In so doing, the laboratory assures the clients and other users
of the data generated in the laboratory that the data was generated using the steps
described in the controlled document.
Documents are reviewed annually to ensure their contents are suitable and in
compliance with the current quality systems requirements, and accurately describe
current operations.
Approved copies of documents are available at all locations where operations are
essential to the effective functions of the laboratory.
Controlled internal documents are uniquely identified with 1) date of issue, 2)
revision identification, 3) page number, 4) the total number of pages (or a mark to
indicate the end of the document), and 5) the signatures of the issuing authority (i.e.
management).
A master list of controlled internal documents is maintained that includes
distribution, location, and revision dates. The controlled document list is maintained
by the QAO. The controlled document list is updated as needed and reviewed
annually at a minimum.
6.1.1 Document Changes to Controlled Documents
6.1.1.1
Paper Document Changes

Document changes are approved by the Lab Director and/or the QAO.
The document management process does not allow for handwritten
modifications to documents. All document changes must be approved. The
modified document is then copied and distributed, and obsolete documents
are removed. Amendments to documents are incorporated into a new
revision and reissued as soon as practicable.
6.1.1.2
Electronic Document Changes

Suggested revisions to electronic documents are presented to the Lab
Director and/or the QAO for review and approval. Changes to electronic
documents are approved either on an accompanying form or through
electronic means (such as email, change tracking functions, or
memoranda). Where practicable, the altered text or new text in the draft is
identified during the revision or review process to provide for easy
identification of the modifications.
6.2
Obsolete Documents
All invalid or obsolete documents are removed from general distribution, or
otherwise prevented from unintended use. Obsolete documents retained for legal
use or historical knowledge preservation are appropriately marked and retained.
See SPECTRUM ANALYTICAL, INC. FL DIVISION SOP00003, Controlled
Documents, for details concerning Controlled Documentation procedures.

Quality Manual V7
page 15 of 75
6.3
Standard Operating Procedures

STANDARD OPERATING PROCEDURES (SOPs) are used to ensure consistency of application
of common procedures, are written procedures that describe in detail how to
accurately reproduce laboratory processes, and are of two types: 1) test method
SOPs, which have specifically required details, and 2) general use SOPs which
document the more general organizational procedures. SOPs do not have to be
formal documents with predefined section headings and contents. They can be less
formal descriptions of procedures described in the Quality Manual or other
documents. Copies of all SOPs are accessible to all personnel.
Each SOP indicates the date signed and its effective date, the revision number, and
the signature(s) of the Lab Director and/or the QAO at a minimum. See SPECTRUM
ANALYTICAL, INC. FL DIVISION SOP00004, SOP for SOPs, for additional details.
6.3.1 Test Method SOPs

The laboratory has SOPs for all test methods within its scope, located in the company
Back Office intranet, and for procedures that are part of the Quality System that
accurately reflect how the analytical process is performed. Where equipment
manuals or published methods accurately reflect laboratory procedures in detail, a
separate SOP is not required.
Standard operating procedures (SOPs) are essential for a successful QA/QC program and
are required by certifying agencies.
SOPs document the specific activities that make up routine operations and the
recommended sequence of those activities. In so doing, SOPs provide a uniform
approach to routine tasks.
Any deviation from a test method is documented, including both a description of the
change made and a technical justification. The deviation from a test method is reported
to the client.
SOPs are useful as a tool to train new personnel how to properly perform an activity.
Therefore, SOPs provide a consistent basis for training.
SOPs provide criteria that allow someone who is independent of the activity being
performed to verify that the activity is being performed correctly. SOPs provide a
consistent basis for auditing.
SOPs can provide a basis for the development of other SOPs for similar or related
activities. As routine operations are carried out, the steps outlined in the SOP should be
followed. However, if new or improved practices are discovered, the SOP can and
should be revised to reflect the incorporation of the improvement.
SOPs written to describe analytical or sampling procedures should contain static

information about that method, i.e., information that will change in small ways over
several revisions. Dynamic information such as method detection limits, QC control
limits, dynamic ranges and such can vary over time and are best handled elsewhere
(updates to Quality Manual and the LIMS).

Quality Manual V7
page 16 of 75
Analytical SOPs should contain all the information needed so that a skilled operator may
perform the method.
As routine operations are carried out, new and different practices may be developed and
implemented. The controlled documents are updated - with a new revision number - to
reflect the new practices, and are distributed to all persons with access to the
documents.
SOPs are assigned to personnel within each section according to their job descriptions.
All staff are required to review the SOPs assigned to them prior to performing the task
during training and once a year or if there are any revisions issued. The SOPs online
database in Back Office serves as the place where staff can document compliance with
the yearly SOP review. The department manager and QAO will supervise this process to
ensure that all staff are kept current in their knowledge of the system and methods
officially approved in the lab.
All SOPs are reviewed by staff once a year to insure that the information in the SOP is
up to date. In the event a revision is needed, the department manager will ask the QAO
for an editable copy of the SOP (Word format). The last page of the SOP will be a
REVIEW LOG, where the writer will outline the changes to the SOP. After the SOP is
revised, it shall be submitted to the QAO and Lab Director for approval. After approval,
the SOP will be placed online, and pertinent staff shall be informed of the revision.
Only approved SOPs may be utilized. Obsolete SOPs should be discarded immediately.
Previous copies of SOPs are maintained on file by the QA officer and may be reviewed if
needed.
QA/QC requirements
Before any SOP or subsequent revision can be released, they must be reviewed and signed
by the responsible manager, the QA officer, and the laboratory director.
SOPs must be controlled to ensure that only the latest approved version is being used. SOPs
will be controlled according to SPECTRUM ANALYTICAL, INC. FL DIVISION SOP00003.
SOPs are used to ensure consistency of application of common procedures, are written
procedures that describe in detail how to accurately reproduce laboratory processes.
Test method SOPs are formal and require the following elements in this exact order. If the
element is not applicable then a NA annotation is acceptable. If the information is cited
elsewhere and is easily referenced then refer to Document name is acceptable.
If there is an immediate change that needs to occur to an SOP then an email may
serve as temporary notice to deviate from the SOP until the documentation is
updated. This email MUST be from the QAO or Lab Director and the effective date
will be the date of the email.
SECTION 7 REVIEW OF REQUESTS, TENDERS AND CONTRACTS

The review of all new work assures that oversight is provided so that requirements are
clearly defined, the laboratory has adequate resources and capability, and the test method
is applicable to the customer's needs. This process assures that all work will be given
Quality Manual V7
page 17 of 75
adequate attention without shortcuts that may compromise data quality. Contracts for new
work may be formal bids, signed documents, verbal, or electronic. See SPECTRUM
ANALYTICAL, INC. FL DIVISION SOP00118, Profile Set-up and Management.
All new work bid on, and / or accepted, by SPECTRUM ANALYTICAL, INC. FL DIVISION is
reviewed by the senior management team and a Go / No Go decision is made by the
team prior to commencing the work. The senior management team includes the Project
management Team, the Quality Assurance Officer, the Laboratory Director, and the ISD.
The following seven factors are evaluated and discussed in order to determine the labs
readiness for accepting the work. This evaluation is completed after a thorough review of
the project specifications:
Current backlog in the laboratory and the new projects schedule.
Current personnel by department versus the projects requirements.
Current equipment resources versus the new projects needs.
The projects analytical method requirements versus SPECTRUM ANALYTICAL, INC. FL
DIVISIONs current methods.
E-data and database delivery requirements for the project relative to SPECTRUM
ANALYTICAL, INC. FL DIVISIONs systems configuration and ability to meet the project
requirements.
The level of QC documentation requirements for the project relative to SPECTRUM
ANALYTICAL, INC. FL DIVISIONs ability to produce the required forms.
Possible financial requirements for project specific needs (i.e. equipment or software
upgrades, temporary labor, or additional supply costs).
A separate determination is made for each of the above seven factors as follows:
1. Acceptable - the proposed project can be handled with little or no negative impact on
the lab.
2. Prep required Some level of significant project preparation is required.
3. Not possible Requirements are beyond the short-term capabilities of the Lab.
If any of the seven factors are determined to be Not Possible, a No Go decision is made,
and SPECTRUM ANALYTICAL, INC. FL DIVISION will not bid on, or accept the work. If any
of the factors are determined to be Prep Required the senior management team prepares
a list of the preparation requirements and each requirement is determined to be
acceptable or Not Possible. If the any the preparation requirements, are determined to
be Not Possible, a No Go decision is made and SPECTRUM ANALYTICAL, INC. FL
DIVISION will not accept or bid on the project. If all the preparatory requirements are
determined to be Acceptable, then a Go decision is made for the project.

Quality Manual V7
page 18 of 75
7.1
Procedure for the Review of Work Requests

The Project Management Team, QAO and/or Lab Director determines if the
laboratory has the necessary accreditations, resources, including schedule,
equipment, deliverables, and personnel to meet the work request.
The Project Management Team, QAO and/or Lab Director informs the client of the
results of the review if it indicates any potential conflict, deficiency, lack of
accreditation, or inability of the lab to the complete the work satisfactorily.
The client is informed of any deviation from the contract including the test method or
sample handling processes. All differences between the request and the final
contract are resolved and recorded before any work begins. It is necessary that the
contract be acceptable to both the laboratory and the client.
The review process is repeated when there are amendments to the original contract
by the client. The participating personnel are given copies of the amendments.
7.2
Documentation of Review
Records are maintained for every contract or work request, when appropriate. This
includes pertinent discussions with a client relating to the client's requirements or
the results of the work during the period of execution of the contract.
SECTION 8 SUBCONTRACTING OF TESTS

A SUBCONTRACT LABORATORY is defined as a laboratory external to this laboratory, or at a
different location than the address indicated on the front cover of this manual, that
performs analyses for this laboratory. See SPECTRUM ANALYTICAL, INC. FL DIVISION
SOP00014, Subcontracting.
When subcontracting analytical services, the laboratory assures work requiring accreditation
is placed with an appropriately accredited laboratory or one that meets applicable statutory
and regulatory requirements for performing the tests.
A list of subcontractors is maintained. A copy of the certificate and analyte list for
subcontractors may be maintained as evidence of compliance. The laboratory notifies the
client of the intent to subcontract the work in writing. When possible, the laboratory gains
the approval of the client to subcontract their work prior to implementation, preferably in
writing.
The laboratory performing the subcontracted work is identified in the final report. The
laboratory assumes responsibility to the client for the subcontractors work, except in the
case where a client or a regulating authority specified which subcontractor is to be used.
SECTION 9 PURCHASING SERVICES AND SUPPLIES

The laboratory ensures that purchased supplies and services that affect the quality of
environmental tests are of the required or specified quality by using approved suppliers and
products.
Quality Manual V7
page 19 of 75
The laboratory has procedures for purchasing, receiving, and storage of supplies that affect
the quality of environmental tests.
SPECTRUM ANALYTICAL, INC. FL DIVISION SOP00095, ordering supplies and
services, addresses reviews and approvals of supplier of services and supplies and approval
of required certification, (if applicable) prior to ordering. Evaluation of suppliers is
accomplished by ensuring the supplier ships the product or material ordered and that the
material is of the appropriate quality by signing packing slips or other supply receipt
documents. The purchasing documents contain the data that adequately describe the
services and supplies ordered. The laboratory keeps a list of approved suppliers in the
purchasing database.
SECTION 10 SERVICE TO THE CLIENT

The laboratory collaborates with clients and/or their representatives in clarifying their
requests and in monitoring of the laboratory performance related to their work. Each
request is reviewed to determine the nature of the request and the laboratory's ability to
comply with the request within the confines of prevailing statutes and/or regulations without
risk to the confidentiality of other clients.
10.1
Client Confidentiality
The laboratory confidentiality policy is to not divulge or release any information to a
third party without proper authorization. All electronic data (storage or
transmissions) are kept confidential, based on technology and laboratory limits, as
required by client or regulation.
SECTION 11 COMPLAINTS
The purpose of this section is to assure that customer complaints are addressed and
corrected. This includes requests to verify results or analytical data. The laboratory
reviews all complaints and determines appropriate action. See SPECTRUM ANALYTICAL,
INC. FL DIVISION SOP00141, Proj. Mgt.: General Duties.
Whenever a client questions a result, or has a complaint about the laboratory, SPECTRUM
ANALYTICAL, INC. FL DIVISION follows a simple protocol. The complaint, client, date, and
company are documented. The client is informed with the results of the research. If a
report has to be resubmitted to the client, a copy of it is saved and filed in the archived data
along with an explanation of the change.
All customer complaints are documented by the person receiving the complaint and
addressed by appropriate personnel. If it is determined that a complaint is without merit, it
is documented, and the client is contacted. If it is determined that the complaint has merit,
a corrective action is initiated. See Section 13 for corrective action procedures.

Quality Manual V7
page 20 of 75
SECTION 12 CONTROL OF NON-CONFORMING WORK

NON-CONFORMING WORK is work that does not meet acceptance criteria or requirements. Nonconformances can include: unacceptable quality control results, see Section 24, or
departures from standard operating procedures or test methods. Requests for departures
from laboratory procedures are approved by the Lab Director and/or the Project
management Team and documented. Clients are notified of issues. If a client requests a
departure from laboratory procedures, the request is maintained by the Project
Management Team and may not be required to specifically note in each report.
The policy for control of non-conforming work is to identify the non-conformance, determine
if it will be permitted, and take appropriate action. All employees have the authority to stop
work on samples when any aspect of the process does not conform to laboratory
requirements.
The responsibilities and authorities for the management of non-conforming work are to
notify the department manager verbally and or electrically, i.e. email. The department
manager will evaluate the issue and apply corrective action if applicable. The nonconformance is then communicated to the Project Management Team/Lab director and the
QAO. Before the report is released to the client and soon as possible, the non-conformance
is communicated to the client either verbally or electronically. If the client requests
additional or alternative corrective action, this is documented and retained by the project
management team. All non-conformances are summarized in the case narratives that
accompany each report.
The laboratory evaluates the significance of the nonconforming work, and takes corrective
action immediately. The client is notified if their data has been impacted. Resumption of
work after non-conformance is authorized by the Lab Director, QAO and/or the department
manager depending on the severity. An example of when the department manager may
authorize resumption of work is to order a re-preparation of the samples to meet nonconforming quality control samples such as blanks or spikes.
SECTION 13 CORRECTIVE ACTION

CORRECTIVE ACTION is the action taken to eliminate the causes of an existing nonconformity,
defect, or other undesirable situation in order to prevent recurrence (NELAC, 2003).
Deficiencies cited in external assessments, internal quality audits, data reviews, complaints,
or managerial reviews are documented and require corrective action. Corrective actions
taken are appropriate for the magnitude of the problem and the degree of risk.
Any employee may initiate corrective action on routine data reviews. The QAO is
responsible for monitoring and recording corrective actions.
All deficiencies are investigated and a corrective action plan developed and implemented if
determined necessary. The implementation is monitored for effectiveness.
Specific corrective action protocols specified in test methods may over-ride general
corrective action procedures specified in this manual. See SPECTRUM ANALYTICAL, INC.
FL DIVISION SOP00005, Corrective/Preventive Actions.

Quality Manual V7
page 21 of 75
13.1
Selection and Implementation of Corrective Actions

is the condition or event that, if corrected or eliminated, would prevent
the recurrence of a deficiency.
ROOT CAUSE
Once an exceedance or nonconformance is noted, the first action is an investigation

to determine the root cause. Records are maintained of nonconformances requiring
corrective action to show that the root cause(s) was investigated, and includes the
results of the investigation. Where uncertainty arises regarding the best approach
for analysis of the cause of exceedances that require corrective action, appropriate
personnel will recommend corrective actions to be initiated. The appropriate
department manager ensures that corrective actions are discharged within the
agreed upon time frame.
13.2
Monitoring of Corrective Action

Appropriate personnel will monitor implementation and documentation of the
corrective action to assure that the corrective actions were effective.
13.3
Technical Corrective Action

CAUSE ANALYSIS in corrective action investigates the root cause of the problem.
Sample data associated with a failed quality control are evaluated for the need to be
reanalyzed or qualified. Unacceptable quality control results are documented, and if
the evaluation requires cause analysis, the cause and solution are recorded. The
analyst is responsible for initiating or recommending corrective actions and ensuring
that exceedances of quality control acceptance criteria are documented.
Analysts routinely implement corrective actions for data with unacceptable QC
measures. First level correction may include re-analysis without further assessment.
If the test method SOPs addresses the specific actions to take, they are followed.
Otherwise, corrective actions start with assessment of the cause of the problem.
Department managers review corrective action reports and suggest improvements,
alternative approaches, and procedures where needed.If the data reported is
adversely affected by the nonconformance, the client is notified in writing.
The discovery of a non-conformance for results that have already been reported to
the client must be immediately evaluated for significance of the non-conformance, its
acceptability to the client, and determination of the appropriate corrective action.
13.4
Exceptionally Permitting Departures from Documented Policies and

Procedures
The laboratory allows the release of non-conforming data only with approval by the
appropriate Technical Director or their designee on a case-by-case basis. Planned
departures from procedures or policies do not require audits or investigations.
Permitted departures for non-conformances, such as QC failures, are fully
documented and include the potential reason for the departure, the impact of the
departure on the data, and the data. This is performed via the case narratives
including with the reports as a minimal.

Quality Manual V7
page 22 of 75
SECTION 14 PREVENTIVE ACTION

PREVENTIVE ACTION, rather than corrective action, aims at minimizing or eliminating inferior
data quality or other non-conformance through scheduled maintenance and review, before
the non-conformance occurs.
Preventive action includes, but is not limited to: review of QC data to identify quality
trends, annual budget reviews, annual managerial reviews, scheduled column trimming, and
other actions taken to prevent problems.
All employees have the authority to recommend preventive action procedures, however
management is responsible for implementing preventive action.
SECTION 15 CONTROL OF RECORDS

RECORDS are a subset of documents, usually data recordings that include annotations, such
as daily refrigerator temperatures posted to a laboratory form, lists, spreadsheets, or
analyst notes on a chromatogram. Records may be on any form of media, including
electronic and hard copy. Records allow for the historical reconstruction of laboratory
activities related to sample-handling and analysis.
The laboratory maintains a record system appropriate to its needs, records all laboratory
activities, and complies with applicable standards or regulations as required.
15.1
Records Management and Storage

Data Storage
All electronically generated data from GC, GC/MS, HPLC, and IC are stored on
network drives, backed up daily on NAS device (RAID 5) with additional copy kept on
backup NAS. All metals and wet-chem raw data in the form of computer printouts,
plots, and laboratory notebook entries are scanned and stored electronically in batch
analysis work sheet files. All metals instrument data is maintained by the metals
department in CD format. All instrument maintenance log books, analysis run log
and prep log books are maintained in bound controlled binder or book formats.
All sample login, internal chain of custody records, and analytical data is maintained
in the LIMS. Once accessed, all client information, test information, and raw data
associated with each sample can be retrieved. Data from the programs also
references the hard copies of the raw data, final reports, etc. making it easy to
retrieve all information associated with a specific project. Electronic backups are
conducted daily on NAS device (RAID 5) with additional copy kept on backup NAS.
Electronic copies of all final reports are stored in batch files. The files are maintained
in CD format and as Backup tape by the Information Services section. These files
are maintained for a period of five years unless the client specifies a longer term.
Archived records are indexed and accessed via the LIMS. Via this system, a client,
specific project, or sample ID number can be accessed and retrieved.

Quality Manual V7
page 23 of 75
Archived information and access logs are protected against fire, theft, loss,
environmental deterioration, vermin, and in the case of electronic records, electronic
or magnetic sources.
Contingency Plans for Transfer of Client Records
Transfer of ownership of records from SPECTRUM ANALYTICAL, INC. FL DIVISION,
would be required if the laboratory is sold of goes out of business.
In the event of that SPECTRUM ANALYTICAL, INC. transfers the ownership of the
laboratory to a new owner, SPECTRUM ANALYTICAL, INC. FL DIVISION, would expect
that record retention would be negotiated and made part of any purchase contract,
and that the new company would maintain all required NELAC documentation. Since
NELAC certification would likely be one of the attractive aspects of the laboratory to
any purchaser it is unlikely that a new owner would not want to maintain the
appropriate records and certifications. In the event a new owner did not want to
maintain past records, SPECTRUM ANALYTICAL, INC. FL DIVISION, would notify their
clients and make these records available to them for a reasonable fee.
Clients
would be given a minimum of 30 days to determine if documents are needed our
not.
Essential electronic records are backed-up daily/weekly and one set is kept off site at
all times. Access to protected records is limited to laboratory management or their
designees to prevent unauthorized access or amendment.
15.2
Legal Chain of Custody Records

EVIDENTIARY SAMPLE DATA are used as legal evidence.
SPECTRUM ANALYTICAL, INC. FL DIVISION maintains records, which are designed to
ensure traceability of samples from point of collection to final disposal. Personnel
associated with the steps of sample receipt, preparation, analysis, and disposal may
be traced through these records. Possession of samples can be accomplished by
sample custody and/or legal chain-of-custody.
Special types of sample custody in which all events associated with a specific sample
must be documented in writing. Copies of SPECTRUM ANALYTICAL, INC. FL
DIVISION's Chain of Custody Forms are maintained with project records.
Legal Chain of Custody includes the sample custody information. In addition, the
following information may be included:
1)
Sample transmittal forms.
2)
Laboratory storage logs that identify date, time, and individuals who
remove samples from storage.
3)
Secure limited-access storage areas.

Quality Manual V7
page 24 of 75
Sample Receipt
When samples are received at SPECTRUM ANALYTICAL, INC. FL DIVISION, coolers
are opened and samples are inspected for damage. The temperature-blank sample
containers are checked to ensure that samples have been held at the appropriate
temperature. Caps are checked for integrity, and samples are checked for evidence
of any water intrusion. Documentation is reviewed to determine that the proper
samples and identifications were received. Once inventoried and verified, samples
are checked to insure that preservatives were added correctly to appropriate
samples. Samples are then logged in and transferred to refrigerated storage.
Samples may be rejected for the following criteria:
1.
Improper sample labeling
2.
Improper completion of the chain of custody record
3.
Improper selection of sampling containers and/or preservation

protocols
4.
Sample integrity violated during transit. Sample leakage or spillage

resulting in reduced sample volume or cross contamination
Sample rejection will consist of informing the client that the deficiency will be noted
on the final report. The option of re-sampling is also presented.
Sample Log In
Samples are logged into the LIMS and assigned a unique SPECTRUM
ANALYTICAL, INC. FL DIVISION laboratory identification number. A sample
label is generated and affixed to the sample. Sample labels are generated via
the LIMS. The SPECTRUM ANALYTICAL, INC. FL DIVISION laboratory ID
numbers are assigned sequentially and automatically by the LIMS.
Sample Security and Accessibility
Samples are stored in the laboratory walk-in cooler refrigerator at 4C, except
for the volatile samples, which are stored in the designated volatile sample
storage cooler/freezer in the VOLs area at 4 C for water and 0C for solids.
The analysts and/or login personnel must log these samples in and out of the
coolers. All sample movement is documented on the internal chain of custody
log. All refrigerators in the laboratory are accessible only to Spectrum
laboratory personnel. The laboratory is locked when unattended.
Sample extracts are kept in the refrigerator and the freezer (organic solvents)
as required, and are tracked from department to department. Standards are
stored in a separate refrigerator/freezer from samples.
Sample Storage and Disposition Logs
Normal samples that are under analysis ("active samples") are stored in
refrigerators within the main laboratory buildings. Once analysis is complete,
samples are transferred into the sample holding area, where they are stored
for at least for 30 days. After this time, they are discarded. All waste disposal
manifests are maintained on file at Spectrum.
Quality Manual V7
page 25 of 75
All samples are signed out of the designated coolers by the analysts, and
enough is taken to run the particular analysis. The samples are then signed
back into the designated coolers or marked consumed. These samples are not
stored in the work areas when they are not being used. After the samples are
processed, and the organic samples exceed their hold times, the samples are
moved to the monitored and secured warehouse for storage until the client
requests them to be disposed. The samples are signed out of the internal
chain-of-custody, and logged into the sample disposal log. See SPECTRUM
ANALYTICAL, INC. FL DIVISION SOP00009, Internal COC.
SECTION 16 AUDITS AND MANAGEMENT REVIEW

AUDITS measure laboratory performance and verify compliance with accreditation/
certification and project requirements. Audits specifically provide management with an ongoing assessment of the quality system. They are also instrumental in identifying areas
where improvement in the quality system will increase the reliability of data. Audits are of
four main types: internal, external, performance, and system.
Notification of clients for events that cast doubt on the validity of the results is completed
within 5 working days of confirmation of the issue by the Lab Director and/or QAO.
Refer to SPECTRUM ANALYTICAL, INC. FL DIVISION SOP000171, Internal
Audits/Reviews.
16.1
Internal Audits
The laboratory conducts internal audits of its quality systems activities, including
data integrity, and the use of trained and qualified personnel at least annually.
Personnel may not audit their own activities except when it can be demonstrated
that an effective audit will be carried out.
Annually, the laboratory prepares a schedule of internal audits to be performed
during the year. These audits verify compliance with the requirements of the quality
system, including analytical methods, SOPs, ethics policies, other laboratory policies,
and the NELAC Standard.
It is the responsibility of the Quality Manager to plan and organize audits as required
by the schedule and requested by management.The area audited, the audit findings,
and corrective actions are recorded. All investigations that result in findings of
inappropriate activity are documented and include any disciplinary actions involved,
corrective actions taken, and all appropriate notifications of clients.
Clients are notified promptly, in writing, when audit findings cast doubt on the
validity of the data. Audits are reviewed after completion to assure that corrective
actions were implemented and effective.
16.2
External Audits
It is the laboratorys policy to cooperate and assist with all external audits, whether
performed by clients or an accrediting authority. All external audits are fully
documented and tracked to closure. Management ensures that all areas of the

Quality Manual V7
page 26 of 75
laboratory are accessible to auditors as applicable and that appropriate personnel are
available to assist in conducting the audit. Any findings related to an external audit
follow corrective action procedures, as defined by SPECTRUM ANALYTICAL, INC. FL
DIVISION SOP00005, Corrective/Preventive Actions. Management ensures that corrective
actions are carried out within the timeframe specified by the auditor(s).
16.3
Performance Audits
Performance audits may be Proficiency Test Samples, internal single-blind samples,
double-blind samples through a provider or client, or anything that tests the
performance of the analyst and method.
The policy and procedures for Proficiency Test Samples are discussed in Section
23.7.
16.4
System Audits and Management Reviews

The QAO and Lab Director review the quality system and maintain records of review
findings and actions. The quality system is reviewed annually, and findings are
recorded. Managers assure that actions are performed within agreed time frames.
Findings from management reviews are recorded. These records ensure that
corrective actions are completed in as defined by SPECTRUM ANALYTICAL, INC. FL
DIVISION SOP00005, Corrective/Preventive Actions.
SECTION 17 PERSONNEL, TRAINING, AND DATA INTEGRITY

17.1
Job Descriptions
Job descriptions are available for all positions that manage, perform, or verify work
affecting data quality, and are located in the controlled documents folder managed
by the QAO and/or Lab Director. See SPECTRUM ANALYTICAL, INC. FL
DIVISION SOP00003, Controlled Documents.
Job descriptions include the specific tasks, minimum education and qualifications,
skills, and experience required for each position.
17.1.1 President Hanibal C. Tayeh (resume(s) in section 25)

SPECTRUM ANALYTICAL, INC. President ensures that the necessary equipment,
material, and personnel are available to accomplish scheduled projects. The
President also ensures that corrective actions are being conducted, assuring QA
goals. The president also communicates with clients on all aspects of their projects
and recommends solutions.
17.1.2 Laboratory Director Brian C. Spann (resume(s) in section 25)
The Laboratory Director is in charge of all laboratory activities, and is the highest
level manager. The laboratory director signs the Quality Manual.

Quality Manual V7
page 27 of 75
17.1.3 Technical Director(s) - Brian C. Spann and Mark Gudnason (resume(s) in section 25)
Day to day supervision of technical laboratory operations is the responsibility of the
Technical Directors who are full-time members of the staff and who assure reliable
data through the following activities: monitoring quality control, corroborating the
analysis performed, and signing demonstrations of capability.
The Technical Directors certify that personnel with appropriate educational and/or
technical background perform all tests for which the laboratory is accredited.
17.1.4 Quality Manager - Mark Gudnason (resume(s) in section 25)
The Quality Manager has the authority and responsibility for ensuring that the quality
system is implemented and followed.
The Quality Manager has direct access to the Laboratory President and is
independent of operations where the Quality Manager has oversight.
The Quality Manager:
Is the focal point for the quality system and has oversight of quality control data.
Evaluates data objectively and performs assessments without managerial

influence.
Arranges for, or conducts, internal audits annually; and,
notifies laboratory management of deficiencies (or opportunities for continuous

improvement) and monitors corrective actions.
Keeps the Quality Manual current.
Signs the demonstrations of capability.
17.1.5 Information Services Director (ISD) Jakub Rehacek

The ISD is responsible for all electronic records and deliverables. He also ensures
that all electronic back-up records are properly stored and easily retrieved. He
manages the LIMS system, and is responsible for all levels of reporting/forms
generation programs.
17.2
Data Integrity and Ethics

DATA INTEGRITY is the result of the processes that together assure valid data of known
and documented quality. Data integrity and ethics procedures in the laboratory
include training, signed, and dated integrity documentation for all laboratory
employees, periodic monitoring of data integrity, and documented data integrity
procedures. See SPECTRUM ANALYTICAL, INC. FL DIVISION SOP00002,
Training and SOP00151, Data Quality and Reporting Ethics.
Technical managers uphold the spirit and intent by supporting integrity procedures,
by enforcing data integrity procedures, and by signing and dating the data integrity
procedure training forms. Data integrity procedures and evidence of inappropriate
actions are reviewed annually or through regularly scheduled internal audits, and are

Quality Manual V7
page 28 of 75
updated by management. The mechanism for confidential reporting of ethics and

data integrity issues is: (1) unrestricted access to senior management, (2) an
assurance that personnel will not be treated unfairly for reporting instances of ethics
and data integrity breaches, and (3) anonymous reporting. Employees are required
to understand, through training and review of quality systems documents, that any
infractions of the laboratory data integrity procedures will result in a detailed
investigation that could lead to very serious consequences such as immediate
termination, or civil/criminal prosecution.
Any potential data integrity issue is handled confidentially until a follow-up
evaluation, full investigation, or other appropriate actions have been completed and
the issues clarified. Inappropriate activities are documented, including disciplinary
actions, corrective actions, and notifications of clients, if applicable. These
documents are maintained for a minimum of 5 years. Any determination for detailed
investigation of data integrity issues must be communicated to senior management.
Allegations are investigated and remain confidential to the extent necessary.
Documentation for all investigations that result in findings of inappropriate activity
include any disciplinary actions involved, corrective actions taken, and all appropriate
notifications of clients.
Data integrity procedures are reviewed annually and are periodically monitored
through in-depth data review, records review, or other thorough check processes.
Corporate and Individual Ethics
SPECTRUM ANALYTICAL, INC. FL DIVISION depends upon the quality of the data and
services produced and the integrity of the people who generate them. We recognize
the need for and have responded with an ethics program that is designed to
establish a meaningful context within the environmental laboratory. Our objective is
to provide an effective ethics program that involves training, managerial leadership
and active dialogue between our staff. All new employees are trained within the first
two weeks of employment and signed documentation is maintained with the
employees training records.
The policy for reporting Ethical and Data Integrity issues follows the Grievance
Procedures located in the Employee Handbook along with the Whistleblower Policy to
provide confidentiality and protect the employee against retaliation. The Manager or
Section Team Leader will investigate the issue and report the findings of their
investigation in the form of a documented Memo to the Laboratory Director and
Quality Assurance Section Team Leader within 48 hours. Continued employee and
managerial training will occur once a year.
Periodic monitoring of data integrity is conducted through departmental management
review. Any employee who displays unethical behavior or intentionally jeopardizes
data integrity will be subject to discipline up to and including termination.
We, at SPECTRUM ANALYTICAL, INC. FL DIVISION, believe that we share common
goals and values. These goals and values include protection of the environment,
quality of product and personal integrity.
We strive to be honest when we interact with each other and our clients.
We work to achieve high standards in our procedures and with our final product.

Quality Manual V7
page 29 of 75
We will continue to create an environment for personal and professional growth

that provides employees with an opportunity to excel and develop new skills and
meet new challenges.
We will continue to enhance our internal procedures that provide a well defined
background that is both educational and supportive to both our employees and
our clients.
We strive to respect one another for our differences and our similarities.
We strive to respect one another for our origins, our beliefs, our looks and our
gender.
SPECTRUM ANALYTICAL, INC. FL DIVISION and its leadership support the

maintenance of the facility, the equipment and instrumentation and, by example
demonstrate a willingness to invest in new instrumentation.
17.3 Data Integrity and Ethics Training

Data integrity training is provided for all employees initially upon hire and annually
thereafter. Attendance at an initial data integrity training (part of new employee
orientation) and the annual refresher training is recorded with a signature
attendance sheet or other form of documentation that demonstrates all staff have
participated and understand their obligations related to data integrity.
Training records regarding data integrity and ethics are signed by each staff member
annually and verified by the Lab Director or QAO. Topics covered are provided in
writing and provided to all trainees.
17.4
General Training
All personnel are appropriately trained and competent in their assigned tasks before
they contribute to functions that can affect data quality. It is managements
responsibility to assure personnel are trained. Only trained personnel are authorized
to perform specific tasks. Training records are kept on individual training forms.
New staff members are given introductory training and orientation upon arrival.
Training is documented and records are maintained by the QAO. Attendance at
training sessions is documented on signature sheets. SPECTRUM ANALYTICAL,
INC. FL DIVISION SOP00002, Training, addresses the initial and continued
training program.
The initial training for a new task contains the following steps:
All documentation involved with a new and unfamiliar task is read and
understood by the trainee.
Training is under the direct supervision of a qualified senior analyst. During the
time the analyst is training, the trainee may sign laboratory notebooks or
logbooks, but laboratory notebooks must be cosigned by the senior analyst, who
is responsible for the data generated.
The trainee demonstrates competency in the new task before they can operate
independently. The competency for a test method is accomplished by a
demonstration of capability as indicated in Section 19. Approval of competency is

Quality Manual V7
page 30 of 75
noted by the initials or signature of the qualified senior analyst on the training
form.
Each step of the training process is documented.
Ongoing training will consist of the following:
The analyst attests, through signature that they have read, understood, and
agreed to perform the latest version of the Quality Manual and any method SOPs
that the analyst performs.
Annually, the analyst shows continued proficiency in each method they perform.
Other training as determined by management.
Proof of acceptable on-going training is documented by the annual

demonstrations of capability for each analyst and each method.
SECTION 18 ACCOMMODATIONS & ENVIRONMENTAL CONDITIONS

Laboratory facilities are designed and organized to facilitate testing of environmental
samples. Environmental conditions are monitored to ensure that conditions do not
invalidate results or adversely affect the required quality of any measurement.
Environmental tests are stopped when the environmental conditions jeopardize the results.
Access to, and use of areas affecting the quality of the environmental tests is controlled by
restriction of areas to authorized personnel only. The laboratory work spaces are adequate
for their use, and appropriately clean to support environmental testing and ensure an
unencumbered work area.
SPECTRUM ANALYTICAL, INC. FL DIVISION provides comprehensive analytical services, and
is capable of performing a wide variety of analyses. The laboratory is equipped with
advanced analytical equipment, including gas chromatographs / mass spectrometers, gas
chromatographs, atomic absorption spectrometers, inductively coupled plasma atomic
emission spectrometer, high pressure liquid chromatograph, and ancillary analytical
equipment essential to a quality environmental laboratory.
SPECTRUM ANALYTICAL, INC. FL DIVISION occupies a facility in Tampa, Florida. Employees
are expected to maintain a clean workspace to reduce any possibility of contamination. In
addition, SPECTRUM ANALYTICAL, INC. FL DIVISION, uses a sub-contracted cleaning service
to ensure major housekeeping chores are performed regularly. The cleaning staff is also
informed about the proper cleansers to use for each building, and which buildings they
should clean before any others.
Laboratory space is arranged to minimize cross-contamination between incompatible areas
of the laboratory. The VOA section is segregated and has its own air handling system. Only
required staff is allowed entry.

Quality Manual V7
page 31 of 75
SECTION 19 TEST METHODS AND METHOD VALIDATION

A method is validated before it is put into use. All methods are published or documented.
19.1
Demonstration of Capability (DOC)

A DEMONSTRATION OF CAPABILITY (DOC) is a procedure to establish the ability of the
analyst to generate data of acceptable accuracy and precision.
WORK CELLS consist of analysts with specifically defined tasks who together perform
the method. Work cells together meet specified acceptance criteria and
demonstrations of capability. The laboratory confirms that it is capable of generating
data of acceptable accuracy and precision on all methods before employing them.
The DOC is documented on the form in Appendix C of the 2003 NELAC Standard, and
these completed forms are kept in the training files for each analyst. A DOC is
performed for each analyte whenever the method, analysts, analytes, or instrument
type is changed.
A Technical Director certifies that technical staff members in their area of expertise
are trained and authorized to perform all tests for which we are accredited by signing
the DOC form. The process for DOC is documented in the employees training files
and maintained by the QAO. Refer to SPECTRUM ANALYTICAL, INC. FL
DIVISION SOP00002, Training and SPECTRUM ANALYTICAL, INC. FL
DIVISION SOP00139, Doc. Of Analyst Capability.
19.2
On-Going (or Continued) Proficiency

After the demonstration of capability is completed, on-going proficiency is maintained
and demonstrated at least annually through the analysis of either single-blind
samples, performing another DOC, or use of four consecutive laboratory control
samples compared to pre-determined acceptance limits for precision and
accuracy.This is documented in the training file of each analyst. Refer to
SPECTRUM ANALYTICAL, INC. FL DIVISION SOP00002, Training and
SPECTRUM ANALYTICAL, INC. FL DIVISION SOP00139, Doc. Of Analyst
Capability.
19.3
Initial Test Method Evaluation

For chemical analyses, the INITIAL TEST METHOD EVALUATION involves the determination
of the Limit of Detection (LOD), confirmation of the Limit of Quantitation (LOQ), an
evaluation of precision and bias, and an evaluation of the selectivity of the method.
See SPECTRUM ANALYTICAL, INC. FL DIVISION SOP00059, Method Validation.
19.3.1 Limit of Detection (LOD)

The LIMIT OF DETECTION (LOD) is an estimate of the minimum amount of a substance
that an analytical process can reliably detect. An LOD is analyte and matrix specific
and may be laboratory dependent (NELAC Glossary 2003). See SPECTRUM
ANALYTICAL, INC. FL DIVISION SOP00058, MDL and RL Establishment.

Quality Manual V7
page 32 of 75
19.3.2 Limit of Quantitation (LOQ)

The LIMIT OF QUANTITATION (LOQ) is an estimate of the minimum amount of a
substance that can be reported with a specified degree of confidence (NELAC
Glossary 2003).
If an LOD study is not performed, concentrations less than the Limit of Quantitation
are not reported. If results are not reported outside of the calibration range (low),
the LOD determination is not required. The lowest calibration standard is equal to
the LOQ. The LOQ will always be greater than the LOD. LODs are determined from
a quality system matrix using all sample processing steps, and are verified annually
or when there is a change in the test method or instruments affects sensitivity. The
LOQ is verified using a quality systems matrix sample spiked at 1-2, times the
determined LOQ that returns a concentration within the acceptance criteria for
accuracy, according to the requirements of the method or client data quality
objectives. See SPECTRUM ANALYTICAL, INC. FL DIVISION SOP00058, MDL
and RL Establishment.
19.3.3 Precision and Bias
PRECISION is the degree to which a set of observations or measurements of the same
property, obtained under similar conditions, conform to themselves. Precision is
usually expressed as standard deviation, variance, or range, in either absolute or
relative terms.
BIAS is the systematic error that contributes to the difference between the mean of a
significant number of test results and the accepted reference value.
Precision and Bias are determined for standard and non-standard methods. See
SPECTRUM ANALYTICAL, INC. FL DIVISION SOP00138, Shewart Charts,
Control Limits, Marginal Exceedances for additional details.
Precision and Bias are determined for standard methods through the performance of
a Demonstration of Capability. Precision and Bias using non-standard, modified
standard or laboratory-developed methods are compared to the criteria established
by the client (when requested), the method, or the laboratory.
Replicate spikes in a quality system matrix are analyzed according the procedures
outlined in the 2003 NELAC Standard, Appendix C.3.3.b. where applicable.
19.3.4 Selectivity
SELECTIVITY is the capability of a test method or instrument to respond to a target
substance or constituent in the presence of non-target substances (EPA-QAD). The
laboratory evaluates selectivity through procedures defined in the test method SOPs.
19.4
Estimation of Uncertainty
ESTIMATION OF UNCERTAINTY consists of the sum (combining the components) of the
uncertainties of the numerous steps of the analytical process, including, but not
limited to, sample plan variability, spatial and temporal sample variation, sample
heterogeneity, calibration/calibration check variability, extraction variability, and
weighing variability.

Quality Manual V7
page 33 of 75
Estimation of Uncertainty in Measurements (Laboratory portion) shall be provided to

clients upon request. Calculation of this uncertainty estimation will be done using
the Quality Control-based nested approach Uncertainty Spreadsheet (DoD Navy
document).
19.5
Laboratory-Developed or Non-Standard Method Validation

Laboratory developed, modified standard methods, and non-standard methods
require method validation follows the same procedures as normal test methods
outlined above in this section unless the method is a client specific requested
modification and will be noted in the SOP/ report. An example is SPECTRUM
ANALYTICAL, INC. FL DIVISION SOP00164, HPLC Benzoic Acids, where this is a
specific method for a client and certification has not been required.
19.6
Control of Data
All calculations and all relevant data are subject to appropriate checks in a
systematic manner. Commercial off-the-shelf software (e. g. word processing,
database and statistical programs) used within the designed application range is
considered sufficiently validated when in-house programming is not used. Spectrum
does have an in-house created LIMS system and validates the accuracy by following
the procedures outlined in SPECTRUM ANALYTICAL, INC. FL DIVISION
SOP00172, In-House Data reporting Validation.
The laboratory assures that computers and software are protected, maintained, and
secure through measures such as documentation, locked access, and control of the
laboratory environment.
The laboratory procedure to insure that reported data are free from transcription and
calculation errors is found in SPECTRUM ANALYTICAL, INC. FL DIVISION
SOP00085, Data review and verification, as well as the laboratory procedure that all
quality control measures are reviewed and evaluated before data are reported. The
laboratory procedure to address manual calculations, including manual integrations is
found SPECTRUM ANALYTICAL, INC. FL DIVISION SOP00091, Manual
integration for GC, GC/MS and LC.
The laboratory assures that computers, user-developed computer software,
automated equipment, or microprocessors used for the acquisition, processing,
recording, reporting, storage, or retrieval of environmental test data are:
a) Documented in sufficient detail and validated as being adequate for use.
b) Protected for integrity and confidentiality of data entry or collection, data storage,
data transmission and data processing.
c) Maintained to ensure proper functioning and are provided with the environmental
and operating conditions necessary to maintain the integrity of environmental
test data.
d) Held secure including the prevention of unauthorized access to, and the
unauthorized amendment of, computer records.

Quality Manual V7
page 34 of 75
SECTION 20 EQUIPMENT
20.1
General Equipment Requirements

The laboratory provides all the necessary equipment required for the correct
performance of the scope of environmental testing presented in this Quality Manual.
All equipment and software used for testing and sampling is capable of achieving the
accuracy required and complies with the specifications of the environmental test
method as specified in the laboratory SOP. Equipment is operated only by
authorized personnel. The laboratory procedure for safe handling, transport,
storage, use and planned maintenance of measuring equipment to ensure proper
functioning and in order to prevent contamination or deterioration is found in the
individual SPECTRUM ANALYTICAL, INC. FL DIVISION SOPs for each test method.
Up-to-date instructions on the use and maintenance of equipment (including any
relevant manuals provided by the manufacturer of the equipment) are readily
available for use by laboratory personnel.
All equipment is calibrated or checked before being placed into use to ensure that it
meets laboratory specifications and the relevant standard specifications. Test
equipment, including hardware and software, are safeguarded from adjustments
which would invalidate the test results measures by limiting access to the equipment
and using password protection where possible.
Equipment that has been subject to overloading, mishandling, given suspect results,
or been shown to be defective or outside specifications is taken out of service,
isolated to prevent its use, or clearly labeled as being out of service until it has been
shown to function properly. If it is shown that previous tests are affected, then
procedures for non-conforming work are followed.
When equipment is needed for a test that is outside of permanent control of the
laboratory, the lab ensures the equipment meets the requirements of this manual
prior to its use by inspecting or otherwise testing it.
In the event of major failure of equipment in the laboratory, SPECTRUM
ANALYTICAL, INC. FL DIVISION, has two essential concerns, which must be
considered throughout the process of repairing the equipment. These priorities are:
1.
Preventing samples to exceed holding times. Samples will be rushed to another

certified laboratory as required to insure integrity of holding times. At request of
our clients, samples requiring special turnaround times may also be sent to
another certified laboratory. The certified lab will have an approved QM for
analysis, and checks will be made with the client regarding work being done for
a site-specific plan. All normal sample custody protocols are followed. Daily
reassessment of holding times is necessary.
2.
SPECTRUM ANALYTICAL, INC. FL DIVISION, shall initiate immediate steps to

troubleshoot the source of the problem. If practical, in-house parts and
manpower will be utilized to repair the equipment. In cases where redundancy
exists, additional samples may be added to other equipment utilizing extra
capacity, overtime, or varied working hours as required. If repairs are beyond
in-house resources, a service call will be scheduled and repairs made as rapidly
as prudently possible. Temporary reassignment of hours, shipping of samples to

Quality Manual V7
page 35 of 75
other certified labs, or other measures will continue until the equipment is
repaired and passes all instrument checkout and normal QC criteria. Service
Agreements covering all major pieces of equipment are, and will remain, in
place.
3.
Samples, which may have been in process at the time of failure, will be
repeated. Incomplete batch data accumulated during the failure will be
considered invalid.
4.
If possible, a sampling event may be delayed if critical equipment could place

the project in jeopardy.
Each item of equipment and the software used for testing and significant to the
results is uniquely identified and records of equipment and software are maintained.
Table 20.1
Quant
Dept /
System ID
MET
FIMS1
MET
GFAA1
MET
ICAP2
1
1
1
MET
MET
MET
MET
IC-02
Wet Chem
IC-01
Wet Chem
Laboratory Equipment
Component
Company
Description
serial #
FIMS
Control / Analysis
Software
GFAA
PE chiller for AA
Control / Analysis
Software
ICP
polyscience chiller for
ICP
Control / Analysis
Software
Spec
Conductivity meter
pH meter
water bath for Hg
digest
A SYSTEM
Autosampler
chrom enclosure
Detector
gradient pump
Control / Analysis
Software
A SYSTEM
Autosampler
Detector/system
Control / Analysis
Software
PE
FIMS 100
1465
PE
AA WinLab
Version 2.50
PE
PE
8081
2031
PE
Aanalyst 800
Chiller
WinLab32 for
AA
ICP
PE
Chiller

Quality Manual V7
PE
Version 6.4.0.0191
077N3112401
Hach
Symphony
OAKTON
Dionex
Dionex
Dionex
Dionex
AS40-1
LC20-1
ED40-1
GP40-1
96040408
95030259
95030417
96020200
Dionex
Chromeleon
Version 6.80SR10
Dionex
Dionex
AS1
ICS2100
8080638
10110917
Dionex
Chromeleon
Version 6.80SR10
page 36 of 75
2004
107C00266
WinLab32 for
ICP
DR/3000
SB40C
pH 11 Series
PE
Date
manf
Version 4.0.0.0305
900902634
4940
1353764
1999
2010
GPC Clean-up
Module
1
Semi
GPC1
SV
HPLC03
SV
HPLC04
SV
SVECD01
J2
Scientific
J2
Scientific
J2
Scientific
J2
Scientific
AGILENT
AGILENT
AGILENT
AGILENT
AUTOSAMPLER
Syringe Module
Control / Analysis
Software
AUTOSAMPLER
DAD
DEGASSER
PUMP
THERMOSTATTED
COLUMN
AGILENT
Control Software
HP
Analysis Software
Target
AUTOSAMPLER
DAD
DEGASSER
FLD
PUMP
THERMOSTATTED
COLUMN
AGILENT
AGILENT
AGILENT
AGILENT
AGILENT
Control Software
HP
Analysis Software
Target
AGILENT
AUTOSAMPLE
TRAY
CONTROLLER
ECD DETECTOR 01
ECD DETECTOR 02
GC
INJECTOR-7673A
GPC1121-1.0
2011
PrepLinc AS
AS-1158-1.3
2011
PrepLinc ASM
ASM-1154-1.1
2011
PrepLinc
Software
G1313A
G1315A
G1322A
G1311A
G1316A
Chemstation
for LC 3D
ThermoQuest
Thru-Put
G1313A
G1315A
G1322A
Version 1.0.0.25
US82404115
DE91607297
JP73019811
DE91608240
1998
1999
1997
1999
DE91612203
1999
Version A.08.03
Version 4.14
G1311A
DE11114783
DE11111753
JP05032300
DE03002347
DE11116179
1998
1999
1997
1999
1999
G1316A
DE11119723
1999
Chemstation
for LC 3D
ThermoQuest
Thru-Put
Version A.08.03
Version 4.14
AGILENT
18596M
3339A33298
AGILENT
AGILENT
AGILENT
AGILENT
AGILENT
18594B
G1223A
G1223A
5890 SERIES2
18593B
Chemstation
for GC
ThermoQuest
Thru-Put
3338A33242
K5525
K5524
3336A51861
3013A21877
Control Software
HP
Analysis Software
Target

Quality Manual V7
PrepLinc GPC
page 37 of 75
A.08.01
Version 4.14
1994
1990
1999
1999
1993
1995
SV
SVECD03
SV
SVECD04
SV
SVFID01
SV
SVFID02
SV
SVFID03
AUTOSAMPLE
TRAY / INJECTOR
ECD DETECTOR 01
ECD DETECTOR 02
GC
CTC
GC PAL
161108
2003
AGILENT
AGILENT
AGILENT
U6225
U6473
CN10343033
2003
2003
Control Software
HP
Analysis Software
Target
G2397A
G2397A
6890 N
Chemstation
for GC
ThermoQuest
Thru-Put
A.08.01
Version 4.14
AUTOSAMPLE
TRAY / INJECTOR
ECD DETECTOR 01
ECD DETECTOR 02
GC
CTC
GC PAL
161108
AGILENT
AGILENT
AGILENT
U8766
U8767
CN10534107
Control Software
HP
Analysis Software
Target
G2397A
G2397A
6890 N
Chemstation
for GC
ThermoQuest
Thru-Put
AGILENT
18596B
3435A36416
1993
AGILENT
AGILENT
AGILENT
18594B
5890 SERIES2
18593B
Chemstation
for GC
ThermoQuest
Thru-Put
3018A21716
3310A49396
3337A36214
1990
1993
1992
AUTOSAMPLE
TRAY
CONTROLLER
GC / FID
INJECTOR-7673
Control Software
HP
Analysis Software
Target
AUTOSAMPLE
TRAY
CONTROLLER
GC / FID
INJECTOR-7673
Version A.08.03
Version 4.14
18596M
2942A11929
1993
AGILENT
AGILENT
AGILENT
G1512A
5890 SERIES2
18593B
Chemstation
for GC
ThermoQuest
Thru-Put
US81205249
US00063223
3230A31543
1998
2000
1993
HP
Analysis Software
Target
Version A.08.03
Version 4.14
AGILENT
18596M
3330A32679
AGILENT
AGILENT
AGILENT
G1512A
5890 SERIES2
18593B
Chemstation
for GC
ThermoQuest
Thru-Put
US81205249
3235A44900
3337A36218
Control Software
HP
Analysis Software
Target

Quality Manual V7
Version 4.14
AGILENT
Control Software
AUTOSAMPLE
TRAY
CONTROLLER
GC / FID
INJECTOR-7673
A.08.01
page 38 of 75
Version A.08.03
Version 4.14
SV
SVMS01
SV
SVMS02
SV
SVMS03
SV
SVMS04
SV
NPD01
AUTOSAMPLE
TRAY
GC
MSD
INJECTOR 6890
PUMP
AGILENT
G2614A
CN31523736
2003
AGILENT
AGILENT
AGILENT
AGILENT
6890N
5973
G1513A
Q1099-80023
EnviroQuant
Chemstation
G1701BA
ThermoQuest
Thru-Put
CN10444036
US446447027
US02513888
46290379
2001
1994
2000
Control Software
HP
Analysis Software
Target
AUTOSAMPLE
TRAY
CONTROLLER
GC
INJECTOR-6890
MSD
PUMP
18596M
3319A32062
1993
AGILENT
AGILENT
AGILENT
AGILENT
AGILENT
18594B
5890 SERIES2
G1513A
5972
E2ME
EnviroQuant
Chemstation
G1701BA
ThermoQuest
Thru-Put
3338A33242
3336A51435
US00001713
3329A00893
31734
1993
1993
2000
1993
HP
Analysis Software
Target
US84902841
1998
AGILENT
AGILENT
AGILENT
AGILENT
6890
G2613A
5973
G1099-49023
EnviroQuant
Chemstation
G1701BA
ThermoQuest
Thru-Put
US00025386
US84803747
US82311409
982179528
2000
1998
1998
Analysis Software
Target
Version B.01.00
Version 4.14
AGILENT
7693
CN11100101
2011
AGILENT
AGILENT
AGILENT
AGILENT
7890A
G4513AA
5975C
G3170-80025
EnviroQuant
Chemstation
G1701BA
ThermoQuest
Thru-Put
CN111211125
CN11120095
US11152721
21594557
2011
2011
2011
Control Software
HP
Analysis Software
Target

Quality Manual V7
Version 4.14
G2614A
HP
AUTOSAMPLE
TRAY / INJECTOR
GC / NPD
Version B.01.00
AGILENT
Control Software
AUTOSAMPLE
TRAY
GC
INJECTOR-7693
MSD
PUMP
Version 4.14
AGILENT
Control Software
AUTOSAMPLE
TRAY
GC
INJECTOR-7683
MSD
PUMP
Version B.01.00
Version B.01.00
Version 4.14
CTC
GC PAL
161147
2011
AGILENT
6890
US00021243
2000
page 39 of 75
VOLS
VGC3
VOLS
VMS01
VOLS
VMS02
VOLS
VMS03
VOLS
VMS04
VOLS
VMS05
CONCENTRATOR
TEKMAR
GC
AUTOSAMPLER
Control Software
AGILENT
TEKMAR
HP
Analysis Software
HEADSPACE
7050
5890 SERIES2
A/S
91169010
1991
1993
1993
Chemstation GC
3336A50956
93061012
Version A.06.01
Target
ThermoQuest
Thru-Put
Version 4.14
AUTOSAMPLER /
CONCENTRATOR
GC
MSD
PUMP
Control Software
TEKMAR
ATOMX
US11350005
2011
AGILENT
AGILENT
AGILENT
HP
7890A
5975C
PUMP
2011
2011
1993
Chemstation GC
CN11401126
US11462913
E2M2 31902
Version A.06.01
Analysis Software
Target
ThermoQuest
Thru-Put
Version 4.14
AUTOSAMPLER
CONCENTRATOR
GC
MSD
PUMP
Control Software
ARCHON
OI
AGILENT
AGILENT
AGILENT
HP
ARCHON
4560
5890 SERIES2
5971A
PUMP
12433
C301270
3029A30246
3022A01099
E2M2 40604
Version A.06.01
Analysis Software
Target
AUTOSAMPLER
CONCENTRATOR
GC
MSD
PUMP
Control Software
ARCHON
OI
AGILENT
AGILENT
AGILENT
HP
Analysis Software
Target
AUTOSAMPLER
CONCENTRATOR
GC
MSD
PUMP
Control Software
TEKMAR
TEKMAR
AGILENT
AGILENT
AGILENT
HP
Analysis Software
Target
AUTOSAMPLER
CONCENTRATOR
GC
MSD
PUMP
Control Software
EST
EST
AGILENT
AGILENT
AGILENT
HP
Analysis Software
Target

Quality Manual V7
page 40 of 75
Chemstation GC
ThermoQuest
Thru-Put
ARCHON
4560
6890
5973
G1099
Chemstation GC
ThermoQuest
Thru-Put
Solatek
Velocity
5890 SERIES2
5972
PUMP
Chemstation GC
ThermoQuest
Thru-Put
CENTURIAN
ENCONEV
6890
5973
G1099
Chemstation GC
ThermoQuest
Thru-Put
1990
1990
1990
1990
1990
Version 4.14
13098
JG13460651
US00021446
US81211114
982177230
Version A.06.01
2000
2000
2000
2000
Version 4.14
US01159008
US06131001
3336A50935
3341A00925
E2M2 31734
Version A.06.01
Version 4.14
CENTS107062309
EV202070909
US10511073
US10442285
17192927
Version A.06.01
Version 4.14
1993
1993
VOLS
VMS06
VOLS
VOLBTX
AUTOSAMPLER
EST
CENTURIAN
CENT188012606
CONCENTRATOR
GC
MSD
PUMP
EST
AGILENT
AGILENT
AGILENT
506071006
US00023648
US70820505
17192927
Control Software
HP
Analysis Software
Target
AUTOSAMPLER
CONCENTRATOR
GC
PID
Archon
OI
AGILENT
OI
Control Software
HP
Analysis Software
Target
Encon
6890
5973
G1099
Chemstation
GC
ThermoQuest
Thru-Put
Archon
4560
5890 SERIES2
4430
Chemstation
GC
ThermoQuest
Thru-Put
Met
Met
MET
Met
3
15
5
MET
MET
multiple
Met
Met
multiple
Semi
prep
6
1
3
2
1
Semi
Met
SEMI
Semi
Semi
prep
Met
prep
prep
prep
Semi
prep
9
2
Semi
Semi
prep
prep
5 foot hoods
Air Dryer for
Sheargas
hot block
TCLP ZHE extractors
misc balance
4 position Sep Funnel
shaker
6 foot hoods
6 foot hoods
desicators
Drying Oven
Muffle furnace
Recipricating shaker
table
Solvent/Acid cabinets
Steam Tables
Semi
Prep
Mechanical Grinder
1
1
1
1
1
1
1
1
1
1
2
1
VOLS
VOLS
VOLS
Semi
Semi
Semi
Semi
Semi
Semi
Semi
Semi
Semi
prep
vols
vols
prep
prep
prep
prep
prep
prep
Prep
prep
prep
hot plate
leak detector
sonicating bath
Turbo-Vap
Turbo-Vap
Turbo-Vap
ASE 200
ASE 200
Centrifuge
Dual Head Sonicator
horn sonicator
sonic bath

Quality Manual V7
Version A.06.01
Version 4.14
12575
D310222
3223A42731
90-643
1992
1992
1992
Version A.06.01
Version 4.14
Dayton
EE
Glascol
Eberbach
BICO, Inc.
Zymark
Zymark
Zymark
Dionex
Dionex
Heraeus
Misonix
Tekmar
page 41 of 75
Puck/ring
Grinder
ASE 200
ASE 200
Megafuge
CL4
--
72095
TV 0206N10754
TV9805R7940
TV0840N14824
99120769
98090227
C7674
3663
2008
1
1
1
1
1
1
1
1
1
1
1
1
1
WC
WC
WC
WC
WC
WC
WC
WC
WC
WC
WC
WC
WC
Lachat 1
WC
1
1
WC
WC
WC
WC
WC
WC
WC
WC
WC
WC
WC
WC
WC
TOC Analyzer
WC
WC
WC
20.2
WC
WC
lachat card
lachat card
lachat card
lachat card
lachat card
lachat card
lachat card
lachat card
lachat card
lachat card
lachat card
vacum pump
vacum pump
Autosampler
Sample pump
Lachat
Lachat
Lachat
Lachat
Lachat
Lachat
Lachat
Lachat
Lachat
Lachat
Lachat
Gast
Gast
Lachat
Lachat
10-124-13-1-a
10-107-06-2-e
10-107-05-1-a
10-117-07-1-b
10-115-01-1-a
10-116-29-1-a
10-107-06-1-c
10-115-01-1-c
10-204-00-1-a
10-107-04-1-c
10-116-10-1-a
1893
409604674
A81010-1023
A82000-1211
Lachat
Chrom 6
TKN
NO2
Chloride
o-phos
sulfide
Ammonia
TKP
Cyanide
NO2-NO3
Sulfate
DOA-P104-AA
DOA-P704
Autosampler
Type ISM1135
QuickChem
series 2
PDS200
QuickChem series 2
Lachat
Auto Diluter
Control / Analysis
Software
TOC-V CPH
Autosampler
Soil sampler
Control / Analysis
Software
Digestion Block
CN Digestion Block
Lachat
Omnion
Version 3.0.222.1
Shimadzu
Shimadzu
Shimadzu
TOC-V CPH
ASI-V
SSM-5000A
H51304635161 CS
H52104602848SA
H52504600507NK
Shimadzu
TOC Control V
Version 2.00
Lachat
Lachat
BD-46
1800-938
81200001030
8090001027
60700000400
Support Equipment
SUPPORT EQUIPMENT includes, but is not limited to: balances, ovens, refrigerators,
freezers, water baths, temperature measuring devices, and volumetric dispensing
devices.
All support equipment is maintained in proper working order and records are kept of
all repair and maintenance activities, including service calls. All raw data records are
retained to document equipment performance. These records include logbooks, data
sheets, or equipment computer files.
All support equipment is calibrated or verified annually over the entire range of use
using NIST traceable references where available. If the results of the calibration of
support equipment are within specifications or (1) the equipment is removed from
service until repaired, or (2) records are maintained of correction factors to correct
all measurements.
Support equipment such as balances, ovens, refrigerators, freezers, and water baths
are checked with a NIST traceable reference if available, each day prior to use, to
ensure they are operating within the expected range for the application for which the
equipment is to be used.

Quality Manual V7
page 42 of 75
Mechanical volumetric dispensing equipment, including burettes (except Class A

glassware), is checked for accuracy quarterly.
Glass micro-liter syringes have a certificate attesting to the established accuracy. If
the certificate of accuracy for glass micro-liter syringes is not available, the accuracy
of the syringe is demonstrated upon receipt and documented.
20.2.1 Support Equipment Maintenance
Regular maintenance of support equipment, such as balances and fume hoods is
conducted at least annually. Maintenance on other support equipment, such as
ovens, refrigerators, and thermometers is conducted on an as needed basis.
Records of maintenance to support equipment are documented in Instrument
Maintenance Logs. Each piece of support equipment does not necessarily have its
own logbook. Maintenance logbooks may be shared with equipment that is housed
in the same laboratory area.
20.2.2 Support Equipment Calibration
Calibration requirements for analytical support equipment and analytical
instrumentation are found in the individual SOPs.
20.3
Analytical Equipment
20.3.1 Maintenance for Analytical Equipment

All equipment is properly maintained, inspected, and cleaned. Maintenance of
analytical instruments and other equipment may include regularly scheduled
preventive maintenance or maintenance on an as-needed basis due to instrument
malfunction and is documented in Instrument Maintenance Logs, which become part
of the laboratorys permanent records. All maintenance is defined in the individual
SOP and documented in the instrument logbooks.
20.3.2 Initial Instrument Calibration
Initial instrument calibration and continuing instrument calibration verification are an
important part of ensuring data of known and documented quality. If more stringent
calibration requirements are included in a mandated method or by regulation, those
calibration requirements override any requirements outlined here or in laboratory
SOPs. Generally, instrument calibrations are provided in test methods.
All initial instrument calibrations are verified with a standard obtained from a second
source traceable to a national standard when commercially available. If a second
source is not available, a standard prepared from a separate lot may be used as long
as the manufacturer can demonstrate the lot was prepared independently from other
lots purchased.
If the reference or mandated method does not specify the number of calibration
standards to use, the minimum number is defined in the SPECTRUM ANALYTICAL,
INC. FL DIVISION method SOP.
Any samples that are analyzed after an unacceptable initial calibration are reanalyzed or the data is reported with qualifiers, appropriate to the scope of the
Quality Manual V7
page 43 of 75
unacceptable condition. Quantification is always determined from the initial

calibration unless the test method or applicable regulations require quantification
from the continuing calibration.
The lowest calibration standard is the lowest concentration for which quantitative
results can be reported without qualification. The lowest calibration standard is
equal to the Limit of Quantitation and is greater than the limit of detection. The
highest calibration standard is the highest concentration for which quantitative
results can be reported. Data reported that are greater than the highest calibration
standard without dilution are considered to be an estimate and are reported with a
qualifier code and explained in the case narrative. Initial instrument calibration
includes calculations, integrations, acceptance criteria, and associated statistics
referenced in the test method SOP. If the client request in writing other criteria or a
specific protocol is requested the lab may deviate from this policy, but only after
approval from the client. Any other deviations are noted in the case narrative
reported with the data. In the event a test method does not require calibration,
SPECTRUM ANALYTICAL, INC. FL DIVISION will follow GLP in establishing the LOQ.
Sufficient raw data records are collected to allow reconstruction of the initial
instrument calibration. These include, at a minimum, calibration date, test method,
instrument, analysis date, analyte names, analysts signature or initials,
concentration and response, calibration curve or response factor, or unique equation
or coefficient used to reduce instrument responses to concentration.
Calibration date and expiration date (when recalibration is due) is recorded for
equipment requiring calibration, where practicable.
Acceptance criteria are listed in each individual SOP as certain agencies or method
revisions may vary.
Corrective actions are performed when the initial calibration results are outside
acceptance criteria. Calibration points are not dropped from the middle of the curve
unless the cause is determined and documented. If the cause cannot be determined,
the calibration curve is re-prepared. If the low or high calibration point is dropped
from the curve, the working curve is adjusted and sample results outside the curve
are qualified. Results that are less than the lower calibration standard are
considered to have increased uncertainty, and are either reported with a qualifier
code or explained in the case narrative. Results that are greater than the highest
calibration standard are either diluted to within the calibration range, or considered
to be an estimate; and are reported with a qualifier code and explained in the case
narrative.
20.3.3 Continuing Instrument Calibration
Individual test methods define the criteria for the use of CCV/ICV and calibration.
SPECTRUM ANALYTICAL, INC. FL DIVISION follows the criteria set forth in the
methods and are defined in the individual SPECTRUM ANALYTICAL, INC. FL DIVISION
SOP. Corrective action is initiated for continuing instrument calibration verification
results that are outside of acceptance criteria. Continuing instrument calibration
verification is performed for all analytical systems that have a calibration verification
requirement.

Quality Manual V7
page 44 of 75
Calibration is verified for each compound, element, or other discrete chemical

species. The calculations and associated statistics for continuing instrument
calibration are included or referenced in the test method SOP.
Sufficient raw data records are retained to allow reconstruction of the continuing
instrument calibration verification. Continuing instrument calibration verification
records connect the continuing verification date to the initial instrument calibration.
20.3.4 Unacceptable Continuing Instrument Calibration Verifications
If routine corrective action for continuing instrument calibration verification fails to
produce a second consecutive (immediate) calibration verification within acceptance
criteria, then a new calibration is performed. For any samples analyzed on a system
with an unacceptable calibration, some results may be useable, if qualified and under
the following conditions: See also client specified instructions for the project.
Spectrum performs work for various agencies that may designate different
procedures. This is reviewed and noted and communicated to all staff during profile
set up. See SPECTRUM ANALYTICAL, INC. FL DIVISION SOP00118, Profile Setup and Management.
a) If the acceptance criteria are exceeded high (high bias) and the associated
samples are below detection, then those sample results that are non-detects may
be reported as non-detects.
b) If the acceptance criteria are exceeded low (low bias) and there are samples that
exceed the maximum regulatory limit, then those exceeding the regulatory limit
may be reported.
SECTION 21 MEASUREMENT TRACEABILITY

Measurement quality assurance comes in part from traceability of standards to certified
materials. All equipment used that affects the quality of test results are calibrated prior
being put into service and on a continuing basis. These calibrations are traceable to
national standards of measurement where available. Measurements from laboratory
equipment provide the uncertainty required by test method or client. If traceability of
measurements to SI units is not possible or not relevant, evidence for correlation of results
through inter-laboratory comparisons, proficiency testing, or independent analysis is
provided. All equipment that affects the quality of test results are calibrated according to
the minimum frequency suggested by the manufacturer, by regulation, by method, or as
needed.
21.1
Reference Standards
REFERENCE STANDARDS are standards of the highest quality available at a given
location, from which measurements are derived.
Equipment used for measurements in the laboratory are calibrated traceable to
industry standards. Balances are calibrated every day before being used with
weights traceable to an NIST certified set. Balances are serviced and calibrated
twice a year by an NIST certified vendor. Thermometers are checked twice a year
by comparison to NIST certified thermometers. Certificates and documentation of

Quality Manual V7
page 45 of 75
calibrations are maintained onsite. All reagent solutions and internal standards used
are traced to certified standards from industry certified vendors. Logbooks
(including LIMS databases) are maintained to document traceability.
21.2
Reference Materials
REFERENCE MATERIALS are substances that have concentrations that are sufficiently well
established to use for calibration or as a frame of reference.
21.3
Transport and Storage of Reference Standards and Materials

The laboratory handles and transports reference standards and materials in a way
that protects their integrity. Reference standard and material integrity is protected
by separation from incompatible materials and/or minimizing exposure to degrading
environments or materials. Reference standards and materials are stored according
to manufacturers recommendations and separately from samples.
21.4
Labeling of Reference Standards, Reagents, and Materials

Reference standards and materials are tracked from purchase, receipt, and storage
through disposal. Expiration dates can be extended if the reference standard or
materials integrity is verified.
Standard Receipt and Traceability
Upon arrival, standards are logged into the LIMS with supplier, lot number, date of
receipt and expiration date. The date of receipt is also written on each container for
reference along with the date opened. The certificates of analysis (C of A) are stored
indefinitely in each department in three ring binders. This ensures that research can
be done all the way back to the standard C of A if any questions ever arise regarding
the data. The date the standard is received is written on the C of A and initialed by
the analyst.
All analytical standards are purchased in "neat form or as prepared solutions
designed for the analytical methods from commercial suppliers. Aqueous standards
are prepared using Eppendorf pipettes and Class A volumetric glassware. Organic
standards are similarly prepared using syringes. VOLs working standards are
prepared daily and consumed, but Semi-Vols working standards and VOLs
intermediate standards are dated, labeled with identification number, concentration,
and preparer's initials. Preparation is noted in the analyst's notebook or LIMS
specifying stock used, lot numbers, manufacturer and other traceability information.
Reagent quality is verified during routine blank analysis as a minimal. See
SPECTRUM ANALYTICAL, INC. FL DIVISION SOP 00168. Records for all
standards, reagents, reference materials, and media include:
1. The manufacturer/vendor name (or traceability to purchased stocks or neat
compounds)
2. The manufacturers Certificate of Analysis or purity (if supplied)
3. The date of receipt
4. Preparers initials (if prepared)

Quality Manual V7
page 46 of 75
In methods where the purity of reagents is not specified, analytical reagent grade is
used. If the purity is specified, that is the minimum acceptable grade. Purity is
verified and documented according to Section 9, Purchasing, Services, and Supplies.
All containers of standards, reagents, or materials, whether original or prepared, are
labeled with an expiration date. All containers of prepared standards and reference
materials have a preparation date and unique identifier. This laboratory uses our
LIMS system.
SECTION 22 SAMPLE MANAGEMENT

22.1
Sample Receipt
Procedure
When samples are received at the laboratory, their condition is documented, they
are given unique identifiers, and they are logged into the sample tracking system.
See SPECTRUM ANALYTICAL, INC. FL DIVISION SOP00010, Sample Receipt,
Storage, Preservation and Verification.
22.2
Sample Acceptance
A sample is physical evidence collected from a facility or from the environment.
Controlling evidence is an essential part of any hazardous waste investigation effort.
SPECTRUM ANALYTICAL, INC. FL DIVISION maintains a Sample Custody section that
is responsible for verifying that samples and associated documentation are in proper
order when received by the laboratory. All discrepancies are noted on the COC
and/or login forms by the Sample Custody section. The Project Managers are
notified of all exceptions and variances are acted on by the Project Management
Department.
The Team Leader of the Sample Custody Department is the Sample Custodian for SPECTRUM
ANALYTICAL, INC. FL DIVISION. All staff in the Custody section (Sample Coordinators) are
designated to perform the functions of the Sample Custodian as his designees.
22.3
Sample Identification
Samples, including subsamples, extracts, and digestates, are uniquely identified in a
permanent chronological record (such as a sample receipt log book or database) to
prevent mix-up and to document receipt of all sample containers. See SPECTRUM
ANALYTICAL, INC. FL DIVISION SOP00010, Sample Receipt, Storage,
Preservation and Verification.
22.4
Sample Storage
Samples are stored in the laboratory walk-in cooler refrigerator at 4C, except for the
volatile samples, which are stored in the designated volatile sample storage cooler in
the VOLs area at 4C for water and 0C for solids. The analysts and/or login personnel
must log these samples in and out of the coolers. All sample movement is
documented on the internal chain of custody log. All refrigerators in the laboratory

Quality Manual V7
page 47 of 75
are accessible only to SPECTRUM ANALYTICAL, INC. FL DIVISION laboratory

personnel. The laboratory is locked when unattended.
Sample extracts are kept in the refrigerator and the freezer (organic solvents) as
required, and are tracked from department to department. These samples are
accessible to SPECTRUM ANALYTICAL, INC. FL DIVISION lab personnel. Standards
are stored in a separate refrigerator/freezer from samples.
22.5
Sample Disposal Samples are disposed of according to Federal, State and local
regulations. Procedures are available for the disposal of samples, digestates,
leachates, and extracts. See SPECTRUM ANALYTICAL, INC. FL DIVISION
SOP00098, Waste Disposal.
22.6
Sample Transport
Samples that are transported under the responsibility of the laboratory, where
necessary, are done so safely and according to storage conditions. This includes
moving bottles within the laboratory.
22.7
Sampling Records
SPECTRUM ANALYTICAL, INC. FL DIVISION does not perform any field sampling.
Sub-sampling within the laboratory is performed according to test method SOPs.
SECTION 23 QUALITY OF TEST RESULTS

23.1
Essential Quality Control Procedures

All essential quality control elements are collected and assessed on a continuing
basis. The qualities of test results are recorded in such a way that trends are
detectable, and where practicable, are statistically evaluated.
For test methods that do not provide acceptance criteria for an essential quality
control element or where no regulatory criteria exist, acceptance criteria are
developed. Control limits are developed using the mean, plus or minus 3 standard
deviations; or static limits such as +/- 15 percent. These limits can be found in the
LIMS.
SPECTRUM ANALYTICAL, INC. FL DIVISION performs analytical services for various
agencies and clients that may stipulate specific Quality Control objectives.
The quality control procedures specified in test methods are followed by laboratory
personnel. The most stringent of control procedures is used in cases where multiple
controls are offered. If it is not clear which is the most stringent, that mandated by
test method or regulation is followed.
To monitor the validity of environmental tests performed, review includes any one or
combination of the techniques below:
a) use of certified reference materials or internal quality control using secondary
reference materials;

Quality Manual V7
page 48 of 75
b) participation in proficiency testing programs;

c) replicate testing using the same or different methods;
d) retesting of retained samples; and/or
e) correlation of results for different characteristics of a sample.
Written procedures to monitor quality controls including acceptance criteria are
located in the test method SOPs, except where noted, and include such procedures
as:
a) use of laboratory control samples and blanks to serve as positive and negative
controls for chemistry methods;
b) use of laboratory control samples to monitor test variability of laboratory results;
c) use of calibrations, continuing calibrations, certified reference materials and/or PT
samples to monitor accuracy of the test method;
d) measures to monitor test method capability, such as limit of detection, limit of
quantification, and/or range of test applicability, such as linearity;
e) use of regression analysis, internal/external standards, or statistical analysis to
reduce raw data to final results;
f) use of reagents and standards of appropriate quality;
g) procedures to ensure the selectivity of the test method;
23.2
Internal Quality Control Practices

Analytical data generated with QC samples that fall within prescribed acceptance
limits indicate the test method is IN CONTROL. QC samples that fall outside QC limits
indicate the test method is OUT OF CONTROL (non-conforming) and that corrective
action is required or that the data are qualified.
Detailed QC procedures and QC limits are included in text method standard operating
procedures (SOPs), or where unspecified in the SOPs, are detailed in the LIMS.
All QC measures are assessed and evaluated on an on-going basis, so that trends are
detected.
The following general controls are used:
Positive and Negative Controls such as:
a) Blanks (negative)
b) Laboratory control sample (positive)
Selectivity is assured through:
a) absolute and relative retention times in chromatographic analyses;

Quality Manual V7
page 49 of 75
b) two-column confirmation when using non-specific detectors;

c) use of acceptance criteria for mass-spectral tuning (found in test method SOPs);
d) use of the correct method according to its scope assessed during method
validation.
Consistency, Variability, Repeatability, and Accuracy are assured through:
a) proper installation and operation of instruments according to manufacturers
recommendations or according to the processes used during method validation;
b) monitoring and controlling environmental conditions (temperature, access,
proximity to potential contaminants);
c) selection and use of reagents and standards of appropriate quality; and
d) cleaning glassware appropriate to the level required by the analysis. Cleaning
procedures not provided in test method SOPs are provided in a separate
SPECTRUM ANALYTICAL, INC. FL DIVISION SOP00072, Glassware
Cleaning.
e) following SOPs and documenting any deviation, assessing for impact, and
treating data appropriately;
f) testing to define the variability and/or repeatability of the laboratory results, such
as replicates;
g) use of measures to assure the accuracy of the test method, including calibration
and/or continuing calibrations, use of certified reference materials, proficiency
test samples, or other measures;
Acceptance or rejection criteria are created according to laboratory policy where no
method or regulatory criteria exist. Acceptance criteria define the boundary for the
appropriate response from laboratory personnel, such as corrective action, reporting
with qualifiers, reanalysis, review, and others.
Test Method Capability is assured through:
a) establishment of the limit of detection where appropriate;
b) establishment of the limit of quantification or reporting level; and/or
c) establishment of the range of applicability such as linearity;
Data reduction is assured to be accurate by:
a) selection of appropriate formulae to reduce raw data to final results such as
regression;
b) periodic review of data reduction processes to assure applicability;
The following table summarizes the key elements of a quality control system.

Quality Manual V7
page 50 of 75
Table 23.2-1
Essential Quality Control Elements for Chemistry
Item
Negative Control
(Method Blank)
Frequency
1/batch
Acceptance Criteria
Method specific or
reporting limit
Corrective action
Qualify data and take
corrective action
Positive Control
(Laboratory Control
Sample)
1/batch
Method specific or
determined by laboratory
Reprocess, reanalyze, or
qualify data.
Matrix Spike;
Matrix Spike Duplicates
Per method requirement
Method specific or
Corrective action and qualify

data.
Surrogate spikes
Method specific or

data
Matrix Duplicates
Method specific or

data
Continuing Calibration
Verification
Method specific or
determined by the
laboratory
Reanalyze standard
immediately; Corrective action
Initial calibration
Verification
Start of each analytical

run
Method specific or
Reanalyze standard
immediately; Corrective action
23.3
Method Blanks
Contaminated blanks are identified according to the acceptance limits in the test method
SOPs or laboratory documentation. Samples associated with a contaminated blank are
evaluated as to the appropriate corrective action for the samples (e.g. reprocessing or
data qualifying codes).
SPECTRUM ANALYTICAL, INC. FL DIVISION identifies a blank as contaminated when
analyte results are greater than the reporting limit AND greater than 1/10 of that found
in any sample unless specified by the Client in the request for work. When a blank is
determined to be contaminated, the cause must be investigated and measures taken to
minimize or eliminate the problem. Data that are unaffected by the blank contamination
(non-detects or other analytes) are reported unqualified. Sample data that are suspect
due to the presence of a contaminated blank are re-analyzed.
Other client specified criteria may be defined and SPECTRUM ANALYTICAL, INC. FL
DIVISION will follow the protocol agreed upon with the client.
23.4
Laboratory Control Samples
LABORATORY CONTROL SAMPLES (LCS) consist of a measured amount of de-ionized, organic

free water spiked with known concentrations of the target analyte(s), and analyzed in
the exact same manner as the rest of the samples in the sample batch. For soil
methods (except metals) a measured amount of blank (Ottawa) sand is spiked and then
taken through the whole process. Laboratory control spikes - also known as blank
matrix spikes or blank spikes are used to test the laboratorys accuracy during sample
preparation and analysis. Theoretically, the blank spikes are supposed to have no
matrix interference, and are a good check for percent recovery throughout the lab
processes.
Blank spikes are prepared at a frequency of at least one per batch, and are typically
prepared at a concentration that is a middle value of the instrument calibration range.
The extra LCSs may be run when there is not a sufficient amount of field sample to
Quality Manual V7
page 51 of 75
prepare as a matrix spike or duplicate. The following equation is used to calculate

recovery:
%R = Amount Found X 100
Amount Spiked
SPECTRUM ANALYTICAL, INC. FL DIVISION typically uses a second source to spike the
LCS samples unless there is no second source available or the project specifies
otherwise (AFCEE). This ensures that every preparation and analysis batch is traceable
against another source. Any bad standard or calibration curve will be shown
immediately against this QC check.
LCS control limits (acceptance criteria) are either taken from the method, taken from
the project objectives or established using in-house recoveries. If an LCS fails to meet
acceptance criteria, then the procedure must be examined. The method specific SOP
and the Clients objectives define acceptable results and corrective action required. The
associated batch of samples may need to be re-prepared and analyzed depending on the
findings of the corrective action. If the acceptance criteria are not specified, SPECTRUM
ANALYTICAL, INC. FL DIVISION uses the established in-house limits based on historical
data, which are updated on a yearly basis. The historical data is compiled for each
analyte, per method, per matrix.
Other client specified criteria may have defined and SPECTRUM ANALYTICAL, INC. FL
23.5
Matrix Spikes and Matrix Spike Duplicates

MATRIX SPIKES (MS and MSD [duplicates]) are environmental samples fortified with a
known amount of analyte to help assess the affect of the matrix on method
performance.
Matrix spikes are used in the analyses to ensure that the required accuracy limits are
met, and to monitor for sample matrix interferences with target analytes. They consist
of a known concentration, usually at the mid-range of the curve, for the target analytes
added to a minimum of one field sample in the sample batch. The percent recovery
(%R) of each analyte is calculated using the following equation:
%R = Amount found in spiked sample Amount found in native sample
X100
Amount spiked
The %R is compared to the appropriate acceptance criteria for the project or method. If
the acceptance criteria for matrix spikes are not specified, SPECTRUM ANALYTICAL, INC.
FL DIVISION uses the established in-house limits based on historical data, which are
updated on a yearly basis. The historical data is compiled for each analyte, per method,
per matrix. The following defines the limits: three times the standard deviation +/- the
mean recovery of each analyte.
If the matrix spikes in a sample batch do not meet acceptance criteria, but the LCS does
meet acceptance criteria, then the out-of-control measurement can be attributed to
possible matrix effects. If the LCS and the matrix spikes both do not meet established
quality control limits, then the laboratory processes are considered suspect and all

Quality Manual V7
page 52 of 75
associated samples are invalidated unless there is compelling and justifiable reason
proving otherwise. The invalidated sample batch is re-prepared and reanalyzed.
Duplicate samples are used in the analyses to ensure that required precision limits are
met, and to monitor homogeneity of the samples. Duplicate samples are identical
aliquots of a field sample prepared and analyzed independently in the same sample
batch. A matrix spike duplicate is a second matrix spike performed on the same sample
as the matrix spike. Normally, MSDs are preferred to sample duplicates to assess
precision because a definite analytical value for the target analytes will be produced.
Sample duplicates have a possibility for no detections making precision calculation
impossible. Typically, only some wet chemistry analyses at SPECTRUM ANALYTICAL,
INC. FL DIVISION use sample duplicates instead of MSDs because of the nature of the
test itself (ex., TDS, TSS, pH). In cases where there is not enough sample to prepare a
duplicate or MSD, SPECTRUM ANALYTICAL, INC. FL DIVISION will instead prepare a LCS
duplicate. The MSD or D is analyzed at a frequency of one per sample batch. The
relative percent difference for each analyte is calculated using the following equation:
RPD =
Result 1 Result 2 I
X 100
Avg (Result 1, Result 2)

The RPD is compared to the appropriate acceptance criteria for the project or method.
If the acceptance criteria for matrix spikes are not specified, SPECTRUM ANALYTICAL,
INC. FL DIVISION uses the established in-house limits based on historical data, which
are updated on a yearly basis. The historical data is compiled for each analyte, per
method, per matrix. If the established control limits are not met for RPD, then
SPECTRUM ANALYTICAL, INC. FL DIVISION will investigate and may reanalyze to verify
the failure. If the RPD is still above quality control criteria, then every effort will be
made to re-prepare and reanalyze the samples within the required holding times. If this
is not possible, or the RPD does not meet criteria again, then the batch sample data will
be flagged with the appropriate qualifier.
23.6
Surrogate Spikes
SURROGATES are substances with chemical properties and behaviors similar to the
analytes of interest used to assess method performance in individual samples.
Surrogates are added to all samples (in test methods where surrogate use is
appropriate) prior to sample preparation or extraction. Surrogate recovery results
are compared to the acceptance criteria as published in the mandated test method.
Surrogate spikes are specific only to organic analyses by chromatographic
techniques. Surrogates are brominated, fluorinated, or isotopically labeled
compounds not normally found in environmental samples, chosen for properties
similar to target analytes. They are used to evaluate the efficiency of the analytical
procedure in recovering their total amount. In this respect, surrogates provide
information similar to the matrix spikes, but they are sample specific. Like the
matrix spikes, the recovery of a surrogate is subject to matrix effects. Known
amounts of the surrogate compounds are added to every field and QC sample before
sample preparation operations such as purging or solvent extraction. They are also
included in calibration standards.

Quality Manual V7
page 53 of 75
The percent recovery for surrogates is calculated using the following equation:
%R = Amount found X 100
Amount spiked
Surrogates are evaluated as percent recovery (%R). The %R is compared to the
project or method specific acceptance criteria. If no acceptance criteria are
specified, then SPECTRUM ANALYTICAL, INC. FL DIVISION uses in-house limits that
are based on historical data and are updated yearly. The historical data is compiled
for each surrogate, per method, per matrix. If a surrogate in an analytical run
exceeds the acceptance criteria, the procedure must be examined. Corrective
actions may include: instrument re-calibration, sample reanalysis, and sample repreparation and analysis. The objective is to complete sample preparation and
analysis within holding time requirements. If, upon re-preparation and analysis, the
surrogate still exceeds the limit, the problem is ascribed to possible matrix effects
and is flagged with the appropriate qualifier.
23.7
Proficiency Test Samples or Inter-laboratory Comparisons

The laboratory participates in proficiency test (PT) samples twice per year. The
laboratory institutes corrective action procedures for failed PT samples. The
laboratory does not share PT samples with other laboratories, does not communicate
with other laboratories regarding current PT sample results, and does not attempt to
obtain the assigned value of any PT sample from the PT provider. Proficiency Testing
(PT) or Proficiency Evaluation (PE) samples are treated as typical samples in the
normal production process where possible, including the same preparation,
calibration, quality control and acceptance criteria, sequence of analytical steps,
number of replicates, and sample log-in. PT samples are not analyzed multiple times
unless routine environmental samples are analyzed multiple times. See SPECTRUM
ANALYTICAL, INC. FL DIVISION SOP00049, Intralaboratory Performance
Evaluation Samples.
23.8
Data Review
The laboratory reviews all data generated in the laboratory for compliance with
method, laboratory and, where appropriate, client requirements. All data review is
documented.
Initially, the analyst reviews data for acceptability of quality control measures and
accuracy of the final result(s). After the initial review, a peer considers all manual
transfers and calculations of data in detail and spot checks all electronic transfers of
data. If a peer is not available then the Department lead may perform the review.
Final reports are compared to raw data either directly or through several reviewed
steps. Each department has procedures for reviewing data. The QAO will review a
minimum of 10% of all data packages released by the laboratory. This will be
tracked within the LIMS database. See individual SOPs and SPECTRUM
ANALYTICAL, INC. FL DIVISION SOP00085, Data review and verification.

Quality Manual V7
page 54 of 75
SECTION 24 REPORTING OF RESULTS

The result of each test carried out is reported accurately, clearly, unambiguously, and
objectively and complies with all specific instructions contained in the test method.
Data are reported without qualification if they are greater than the lowest calibration
standard, lower than the highest calibration standard, and without compromised sample or
method integrity.
24.1
Test Reports
The report format has been designed to accommodate each type of test performed
and to minimize the potential for misunderstanding or misuse.
Each test report generated contains the following information (unless not required by
the client):
a) a title, such as Test Report or Test Results;
b) the name and address of the laboratory, the location of the laboratory if different
from the address, and the phone number and name of a contact person;
c) unique identification of the test report, such as a serial number, on each page
and a pagination system that ensures that each page is recognized as part of the
test report and a clear identification of the end of the report, such as 3 of 10;
d) the name and address of the client if applicable;
e) the identification of the test method used;
f) an unambiguous identification of the sample(s), including the client identification
code;
g) the date of sample receipt when it is critical to the validity and application of the
results, date and time of sample collection, dates the tests were performed, the
time of sample preparation and analysis if the required holding time for either
activity is less than or equal to 72 hours;
h) reference to the sampling plan and procedures used by the laboratory where
these are relevant to the validity or application of the results;
i)
the test results with failures identified, units of measurement, an indication of

whether results are calculated on a dry weight or wet weight basis, and for Whole
Effluent Toxicity, an identification of the statistical package used;
j) the name, function, and signature or an equivalent electronic identification of the

person authorizing the test report, and the date of issue;
k) a statement to the effect that the results relate only to the samples;
l)
at the laboratorys discretion, a statement that the report shall not be reproduced
except in full without written approval of the laboratory;

Quality Manual V7
page 55 of 75
m) certification that the results are in compliance with the NELAC Standards if
accredited to be in compliance or provide reasons and/or justification if they do
not comply.
24.2
Supplemental Test Report Information

When necessary for interpretation of the results or when requested by the client, test
reports include the following additional information:
a) deviations from, additions to, or exclusions from the test method, information
on specific test conditions, such as environmental conditions, and any nonstandard conditions that may have affected the quality of the results, and any
information on the use and definitions of data qualifiers;
b) a statement of compliance/non-compliance when requirements of the quality
systems are not met, including identification of test results that did not meet
NELAC sample acceptance requirements, such as holding time, preservation,
etc.;
c) where applicable and when requested by the client, a statement on the
estimated uncertainty of the measurement;
d) where appropriate and needed, opinions and interpretations
e) When opinions and interpretations are included, the basis upon which the
opinions and interpretations are documented. Opinions and interpretations
are clearly marked as such in the test report.
f) additional information which may be required by specific methods or client;
g) qualification of results with values outside the working range.
24.3
Environmental Testing Obtained from Subcontractors

Test results obtained from test performed by subcontractors are clearly identified on
the test report by subcontractor name and/or accreditation number.
The test results from subcontractors are reported in writing or electronically. A copy
of the subcontractors report is be made available to the client if requested.
24.4
Electronic Transmission of Results

All test results transmitted by telephone, fax, telex, e-mail, or other electronic means
comply with the requirements of this Quality Manual and associated procedures to
protect the confidentiality and proprietary rights of the client.
24.5
Amendments to Test Reports

Material amendments to a test report after it has been issued are made only in the
form of another document or data transfer. All supplemental reports meet all the
requirements for the initial report and the requirements of this Quality Manual.
Amended test reports are titled, Supplement to Test Report Serial Number or an
equivalent form of wording to assure they can be differentiated from other test

Quality Manual V7
page 56 of 75
reports. When it is necessary to issue a complete new report, the new report is
uniquely identified and contains a reference to the original that it replaces.

Quality Manual V7
page 57 of 75
SECTION 25 APPENDICES
25.1 - Resumes
Hanibal C. Tayeh, Ph.D. President / CEO
PRESIDENT/CEO
Education
Madison University, Gulfport, MS
Doctorate of Philosophy in Environmental Engineering (Honors: Summa Cum
Laude), July,
2001
Functional Equivalent: Doctor of Philosophy Degree in Environmental Engineering,
2001
granted by George J. Petrello, Ph.D., M.B.A., B.C.F.E Former Dean and Professor
of the School of Business Public Administration and Information of Science at Brooklyn, NY
Campus of Long Island University and Associate Member of the American Association of
Collegiate Registrars and Admissions Offices
Madison University, Gulport, MS
Master of Science in Environmental Engineering (Honors: Summa Cum Laude), August
22,
2000
Functional Equivalent: M.S. in Chemical Engineering, 1997
granted by George J. Petrello, Ph.D., M.B.A., B.C.F.E.
College of Engineering, University of Baghdad, Iraq.
B.S. in Chemical Engineering, 1988
B.S. Thesis: Modern Manufacturing of Methanol
High School, Jbeil Public High School, Lebanon, 1979
Professional and Community Affiliations
Stockbridge School of Agriculture, University of Massachusetts, Amherst, MA 2001
Invitation to Serve as Chairman of a Reinstatement of the Environmental Technology
option and Obtained an Adjunct Professorship to Stockbridge School of Agriculture
Environmental Sciences, University of Massachusetts, Amherst, MA 2005
Obtained an Adjunct Professorship to the Environmental Sciences Department
ARAB HEALTHY WATER ASSOCIATION, 2004
Member of the ABROAD ADVISOR and EXPERT CONSULTANCY
Committee
Civil & Environmental Engineering Advisory Board, University of Connecticut,
Storrs, CT 2005
Member of the Board of the Department of Civil and Environmental Engineering
Founder of Hanibal Technology
Member of American Chemical Society, November 1998
Member of International Society of Environmental Forensics
Personal Communiqu
Pope John Paul II, Vatican City, Rome, Italy, 2001
Presented correspondence to the Pope, translated into Polish, verbalizing Dr.
Tayehs human philosophy concept referencing the return to the Origin of
Christianity. This letter was also published in Arabic and was provided to three
other major powers; namely, His Beatitude Cardinale Nasrallah Boutros-SpheirPatriarcat Maronite; His Beatitude Patriarch Ignatius IV, Hazim-Patriarcat Orthodox;
and His Holiness Pope Shenouda III, Coptic Orthodox Church

Quality Manual V7
page 58 of 75
Professional Profile
As the President/CEO/Laboratory Director/QA/QC Officer and Marketing Manager of
Spectrum
Analytical, Inc., Dr. Tayeh is responsible for overseeing all technical and administrative
policies, as
well as the enforcement of and adherence to such policies by the entire staff. He is also
responsible
for providing technical support to the Quality Assurance Plan, final review and approval of
published analytical services offered by Spectrum. Other major duties performed by the
President/CEO/Laboratory Director are:
assumed the full responsibility of negotiating, maintaining on-going communication and
ultimately the final facilitation of the acquisition of three testing laboratories as follows:
1997 X-Cel Laboratory located in North Grosvenordale, Connecticut
1998 Orchard Laboratory located in Springfield, Massachusetts
2000 Axiom Laboratories, Inc. (Environmental Division) located in
Bloomfield,
Connecticut.
overall supervision of the laboratory operations, including Quality Assurance and Quality
Control, revising protocol and methodology, ensuring proper sample response time, and
marketing.
responsible for training and monitoring the performance of the technical staff.
direct responsibility is to enforce implementation of safety and chemical hygiene
plan throughout the laboratory.
Professional Experience
UNITED STATES OF AMERICA 1991 - PRESENT
Spectrum Analytical, Inc.
1995 to Present President/CEO-Laboratory Director-QA/QC Officer and Marketing
Manager
1993 to 1995 - Technical Director/Laboratory Manager
1992 to 1993 - Quality Control Manager
1991 to 1992 - Laboratory Analyst
Technical and Quality Assurance Profile:
Dr. Tayeh has twenty-one (21) years of managerial, Quality Assurance/Quality Control
(QA/QC)
implementation of various environmental analytical methods (USEPA Methods
608//8081/8082,
610/8100/8270, various volatile hydrocarbon EPA 502.2/524.2 GC/MS and Total Petroleum
Hydrocarbons by GC). Dr. Tayeh developed analytical methods to identify and quantify total
petroleum hydrocarbons (weathered and unweathered fuel oils [#1, #2, #4, #6],
motor/waste oils,
gasoline, crude oil, and diesel) by gas chromatography (GC) in groundwater and soil using
MeCl2
as a solvent extraction. Also, Dr. Tayeh developed methods for quantitative analysis of
polynuclear aromatic hydrocarbons by gas chromatography/Mass Spectrometry (GC/MS)
and
polychlorinated biphenyls (PCBs) and chlorinated hydrocarbons pesticides by gas
chromatography/Electron Capture Detector (GC/ECD). Dr. Tayeh performed all quality
assurance/quality control (QA/QC) and method detection limit studies related to these
methods and
their implementation in the laboratory. Dr. Tayeh has also developed the new MA DEP
methods
Quality Manual V7
page 59 of 75
for petroleum hydrocarbon determination called Extractable Petroleum Hydrocarbon (EPH)

and
Volatile Petroleum Hydrocarbon (VPH) along with his direct involvement with the Mass DEP
technical team in Lawrence and Boston, Massachusetts, to support the finalization of this
particular
method.
Dr. Tayeh has been invited by several New England environmental laboratories to present
various
aspects of new methodology being introduced to the environmental analytical field. Dr.
Tayeh has
perfected EPA methods with the approval and support of the Massachusetts Department of
Environmental Protection.
Business Management and Leadership:
Spectrum Analytical was founded in 1990 and staffed two employees. From 1990 until
1993,
Spectrums average annual revenue was approximately a few hundred thousand US dollars
with an
employment base of four employees.
Hanibal Tayeh was appointed as Acting Laboratory Director in 1993 and under his
leadership,
Spectrum has grown to an average seven million dollar business and employs a staff of over
fifty
professionals. He has personally expanded the geographical presence of this laboratory in
the State
of Connecticut (Bloomfield Area) and achieved the highest standard of quality through the
National
Environmental Laboratory Accreditation Certification (NELAC) program along with twelve
other
state certifications including New England, New York, and Florida. To accommodate this
rapid
growth, Spectrum has moved into their own state-of-the-art building (12,000 square feet)
which
will provides room for continued expansion.
International Business Interest
International business interests include the countries of Puerto Rico, Brazil, and more
recently a
project in Bolivia. Spectrum has received a soils permit from the United States Department
of
Agriculture (USDA), which will allow Spectrum to accept soils from other countries.
Kuwait, Iraq, 1989 - 1990
Al Hamra Kuwait Company, Kuwait City, Kuwait 1989 - 1990
Dr. Tayeh was responsible for waterproofing project design; management and
implementation;
direct client contact; and marketing. He was appointed as director of AL Hamra Kuwait
branch in
Baghdad-Iraq (1990).
Beirut, Lebanon, 1988 - 1989
Kassab-Maroun Company, Beirut, Lebanon, 1988 - 1989
Dr. Tayehs responsibilities included research and development (R&D); and was in charge of

Quality Manual V7
page 60 of 75
quality control (QC) programs to maintain the highest quality standards of the companys
plastic
production. He conducted exclusive training sessions for the employees (Technicians and
Engineers) during his employment regarding the day-to-day quality management followed
by
several internal audits to ensure the proper implementation of various critical quality
procedures.
Research and Development
Dr. Tayeh's experience concerning research and development has been extensive. The
following
lists his accomplishments.
Petroleum Refining, Baghdad, 1987
Nuclear Industries, Arabic Student Association, Baghdad, 1987
Modern Manufacturing of Methanol, University of Baghdad, 1988
Total Petroleum Hydrocarbon by Gas Chromatography Modified EPA 8100, Spectrum
Analytical, Inc., Massachusetts, 1992
TPH Modified EPA 8015 Method by Purge and Trap, Spectrum Analytical, Inc.,
Massachusetts,
1992.
Volatile Organic Methods by EPA 502.2 and SW846 8021, Spectrum Analytical, Inc.,
Massachusetts, 1992.
Total PCBs and Pesticides by Gas Chromatography SW846 8081/8082A
Methods, Spectrum Analytical, Inc., Massachusetts, 1993.
Total Polynuclear Aromatic Hydrocarbon (PAHs) by Gas Chromatography GC/FID and Mass
Spectrometry (GC/MS)- SW846 8100/8270 Methods, Spectrum Analytical, Inc.,
Massachusetts,
1993.
Quality Control/Quality Assurance Plan, Spectrum Analytical, Inc., Massachusetts, 1994.
Inorganic Chemistry SW846 6010 and EPA Method 200.7, Spectrum Analytical, Inc.,
Massachusetts, 1996.
Feasibility and Efficiency of Petroleum Hydrocarbon Dating Preliminary Study, October,
1997.
Excerpts adopted by the Massachusetts Department of Environmental
Protection from two letters
presented by Spectrum Analytical, Inc., 10/21/97 and 2/27/98 regarding the
development of the
Massachusetts Volatile Petroleum Hydrocarbon and Extractable Petroleum
Hydrocarbon Method.
Volatile Petroleum Hydrocarbons (VPH) MA DEP Method, Spectrum Analytical, Inc.,
Agawam,
Massachusetts, 1996, Revisions 1998-1999.
Extractable Petroleum Hydrocarbons (EPH) MA DEP Method, Spectrum Analytical, Inc.,
Agawam,
Massachusetts, 1996, Revision 1998-1999.
MicroExtractable Method by EPA Method 504.1, Spectrum Analytical, Inc., 1999.
Semivolatile Organic Hydrocarbons by EPA Method 8270, Spectrum Analytical, Inc.,
1999.
Various Environmental Wet Chemistry Analyses (BOD, COD, TSS, TDS, Alkalinity and
Cyanides
Procedures) 2000.
Microbilogical Analysis for Total Coliform Bacteria, Ecoli and Standard Plate
Counts 2000.
Quality Manual V7
page 61 of 75
Environmental Toxicological Methods : Reactivity Cyanide and Sulfide, Flash

Point, Paint Filter
Test and Various TCLP Procedures 2000.
Total Petroleum Hydrocarbon Technique (TPHT): Overview,
Interferences-Constraints and New
Development of Alternative Analytical Methods (this method is under
development; remains strictly
confidential; possible future endorsement by the EPA), 2000-2001.
Variations in Analytical & Physical Parameter Values Observed Due to
Changes in Sampling
Methodology and Holding Times. Joint investigation conducted by Spectrum
Analytical, Environmental Compliance Services and the Department of Civil
and Environmental Engineering at the University of Massachusetts in
Amherst, into the causes of variability observed in field screening and
analytical data at sites undergoing frequent groundwater monitoring.
Evaluation of Shotshell Shot Pellets Impact in Soil: Physical Separation and
Lead Content
Determination. Joint Investigation with MA DEP Western Region ( June
2000).
Evaluation of MTBE in Middle Distillate Petroleum Products in the
Northeastern United States: Joint
Research conducted by Edward J. Hinchey, Jon Fox and Hanibal Tayeh.
This technical evaluation was accepted for the National Focus Conference
MTBE in Ground Water in Maryland ( June 2001).
TECHNICAL SEMINARS
Dr. Tayeh has presented several seminars in his professional career. They are listed below:
US PetroChemical Materials in the Middle East Market, Baghdad, Iraq, 1990.
This seminar was in response of marketing strategies for Chem-Stab, Inc., NY, NY. The
seminar also generated information concerning chemicals, such as: permabind; emulsion
sealer;
plush sealer; dirt sealer; cement-concrete additives/admixtures; seepage inhibitor; slope
conditioner, called "aquatain"; soil life; minezyme; supercleaner; degreaser; sewage
conditioner;
and cutrine (family).
Volatile Petroleum Hydrocarbon and Extractable Petroleum Hydrocarbon, Massachusetts,
19961997.
Dr. Tayeh was invited to present this seminar to the Western Massachusetts Licensed Site
Professional Association, Westfield, MA, December, 1996; and Fugro-ENSR, Northborough,
MA, March, 1997. This seminar involved information concerning: background and historical
overviews; distinction between EPH/VPH and corresponding EPA methods; aged petroleum
products.
EPA Environmental Methodologies and Sample Handling, Holding Time and Preservation,
- Corporate Corporation Environmental Advisors, Inc. (CEA), Worcester, MA, 1997.
- ENSR International, Northbourough, MA ,1997
Feasibility and Efficiency of Petroleum Hydrocarbon Dating, Environmental Compliance
Services, Inc. (ECS), Agawam, MA, 1997
Quality Assurance and Quality Control: Interpretation and Validation,
- CDW Consultants, Inc., Framingham, MA, 1998.
- SMC, Inc. Bethlehem, CT, 1998

Quality Manual V7
page 62 of 75
Introduction to the Environmental Testing Field, James Clark Public School, First and
Second
Grade Students, 1998, Agawam, Massachusetts.
Evaluation of Various Petroleum Hydrocarbon Methodologies, Groundwater Environmental
Services, Inc. (GES), Windsor Locks, CT, 1999.
The Use of Various Environmental Analyses: Efficiency and Sample Handling, ERM,
Framingham, CT, 1999.
Quality Management and Leadership Impact in the Environmental Industry. MI, 1999
Total Petroleum Hydrocarbon: Method Efficiency and Fingerprinting, Weston & Sampson,
Peabody, MA, 2000.
Total Petroleum Hydrocarbon Technique (TPHT): Overview,
Interferences-Constraints and New Development of Alternative
Analytical Methods, University of Massachusetts, Amherst, MA,
2000 (This method is under development; remains strictly
confidential; possible future endorsement by the EPA), 1999-2001
Total Petroleum Hydrocarbon Technique (TPHT): Data
Accuracy, Fingerprinting and Dating, Various Clients in the Boston
Metropolitan Area (This method is under development; remains
strictly confidential; possible future endorsement by the EPA), 19992001
Water Quality and Monitoring Seminar, in conjunction with the
Massachusetts Department of Environmental Protection, presented
to Western Massachusetts Public Water Supply personnel, 2002.
Political Seminar
Listed below are the various political seminars, which were held in conjunction with Dr.
Tayehs
business philosophy for the human attainment.
The Middle East Peace - Jbeil, Lebannen, 1980 seminar presented to high school and
college
students.
Lebanese Crisis and Its Impact in the Middle East Peace Process Baghdad, Iraq, April,
1984.
The Middle East Nuclear Power and the Peace Process - United Nations Branch ESCWA,
Baghdad, 1987.
The Gulf Crisis and The Future Economic Directions In The World , Iraq, 1990
Addressed a Special Delegation of the Lebanese Population in Boston, MA, presented by
the
former President of Lebanon, Amin Joumeil Boston, 1996.
Introduction To The Humanity Suitability Theory To The Idea and Scientific-Technical
Steps
(Priorities and Directions) Byblos, Lebanon 2001
Professional Teaching
Dr. Tayeh conducted the technical training on the use of US PetroChemical Materials in
Baghdad 1988-1989 (see information under Technical Seminars).
Dr. Tayeh conducted the technical training of ten analysts with bachelor degrees in
environmental sciences, biology and chemistry for the use of gas chromatography technique
and
the implementation of the methods stated which were initially developed and implemented
by
Dr. Tayeh at the facilities of Spectrum Analytical, Inc., Agawam, MA, since 1993.
Quality Manual V7
page 63 of 75
Dr. Tayeh currently conducts internship training for students who attend the University of
Massachusetts. Fifteen of these students have attained their bachelor's degree in
environmental
sciences and are currently employed by Spectrum Analytical, Inc.
Dr. Tayeh has conducted a technical training for twelve analysts with bachelors degree in
environmental science and chemistry (Total Petroleum Hydrocarbon Department) for the
extractable petroleum hydrocarbon method (MA DEP EPH), which was developed and
implemented by Dr. Tayeh in 1999 for two weeks.
Specialized Training
Dr. Tayeh has successfully completed training conducted by Perkin Elmer Technical
Training
Center in the fundamental GC and data handling of Gas Chromatography, October, 1992.
Dr. Tayeh is involved in advanced computer training to include method functions.
Professional Recognition
Letters of Recognition
Greater Springfield Chamber of Commerce (nine consecutive years) for one of the fastest
growing companies in the area.
Municipalities (Agawam, West Springfield, and Westfield, Massachusetts) for supporting
the
community.
Environmental consulting firms (CEA, Inc., ECS, Inc., Marin Environmental, SMC, Inc.,
OTO,
TGG, Recon Engineering, CDW and many others) for providing emergency response actions
and quality data deliverable.
Letters of Support
Mayor Christopher Johnson Town of Agawam, Massachusetts, 1997
Representative Daniel Keenan Massachusetts State Representative. 1997
Springfield Chamber of Commerce, Springfield, Massachusetts.
1994,1995,1996,1997,1999
and 2000
University of Massachusetts, Amherst, Massachusetts. 2000
Academic Acclamations from various professors of the University of Massachusetts,
Amherst,
MA, such as Dr. Guy Lanza, Director of Environmental Sciences, and Dr. Haim Gunner,
Emeritus Professor, Environmental Microbiology.
Others: Environmental consulting firms, law firms, insurance companies, and vendors
Special Correspondence
Participated in the development of the Massachusetts Volatile Petroleum Hydrocarbon and
Extractable Petroleum Hydrocarbon Methods (MA DEP VPH/EPH), which included a Round
Robin programs.
- Letter to Massachusetts Department of Environmental Protection regarding Round Robin
Testing Program (MA DEP VPH/EPH method) which incorporated many requirements
and/or methodologies conducted by Spectrum Analytical, Inc., 1997. .........
-. Letter to Massachusetts Department of Environmental Protection regarding Round Robin
Phase Two Testing (MA DEP VPH/EPH method), 1998.
Addressed the United Nations in New York in reference to providing technical support for
countries that do not currently have the technical expertise to address hazardous materials
contamination; to become a resource of the United Nations for research and development
Quality Manual V7
page 64 of 75
activities directed at environmental risks and hazards; and to accept internships and
conduct
technical training seminars both in the United States and in other countries in furtherance of
field training. Spectrum Analytical, Inc. under Dr. Tayehs leadership was granted an
assignment under the United Nation Programmes of Technical Cooperation.
Dr. Tayeh has contacted and corresponded with Pope John II at the Vatican in Rome,
Italy, in
reference to his Humanity Suitability Theory that was developed in accordance with his
human philosophy .
Leadership and Support Activities
Presented an Open House for clients, state, city, town officials, and vendors in order to
demonstrate the capabilities of a newly built 12,000 square foot facility with state-of-the-art
instrumentation.
Created an in-house college scholarship to a University of Massachusetts student, namely,
Steve
Wilkins in his efforts to acquire a Ph.D. His goal is to conduct experiments utilizing
microwave
to sample PCBs. This scholarship was established to substantiate all analytical testing.
Windham, New Hampshire homeowners were testing for carcinogens in drinking water. Dr.
Tayeh supplied all glassware and offered sampling at reduced pricing for the residents of
this
community.
The James Clark School, 1998, Spectrum Analytical, Inc., Agawam, MA, hosted the First
and
Second Grade students and performed experiments defining pH levels in three separate
sample
containers.
Publications
Humanity Suitability Theory to the Idea and Scientific-Technical Step (Priorities & Direction)
Dr. Tayeh developed the theory behind technical, economical and social problems in the
world,
1990 in Arabic and translated in English in 1998.
Modern Manufacturing of Methanol, 1988
Evaluation of MTBE in Middle Distillate Petroleum Products in The Northeastern United
States,
Edward J. Hinchey, Jon Fox, and Hanibal Tayeh 2001
A Quantitative Evaluation of Petroleum Hydrocarbon Techniques in Groundwater: Overview,
Interference-Constraints and New Development of Alternative Analytical Methods, presented
at ARWATEX 4
Conference June 27-30, 2005
Doctoral Dissertation
Total Petroleum Hydrocarbon Technique (TPHT) Overview, Interference-Constraints and
New
Development of Alternative Analytical Methods, presented to Dr. M.R. Mousighi of Madison
University, Gulfport, MS, 2001.
All documentation will be available upon request.

Quality Manual V7
page 65 of 75
Brian C. Spann Lab Director

Education:
B.A. Chemistry University of South Florida 1990
Experience:
17 plus years Environmental laboratory experience
Manage all aspects of the laboratory generating in excess of 3.2 million dollars of revenue
per year.
Obtained and maintain certifications for NELAP, DoD, Navy and Air Force (AFCEE) programs.
Maintains proficiency on all aspects of the organics instrumentation. GC, GCMS and HPLC
Sw-846 methodology Pesticides OC and OP, BNA, PCB, PAH, Volatiles, and Fuel
identification
Experienced in ICP, IC, and various wet chemistry analysis.
SPECTRUM ANALYTICAL, INC. FL DIVISION Laboratories, July 1991 current
Lab Director
Prior to assuming the current position of Laboratory Manager for SPECTRUM ANALYTICAL,
INC. FL DIVISION, served as the Organic Section Leader.
Manage the entire workflow at SPECTRUM ANALYTICAL, INC. FL DIVISION Laboratories and
ensures compliance with DoD, Navy and AFCEE QC/QA requirements.
Provide training on analysis, data reduction and equipment maintenance.
Coordinates with clients providing technical assistance.
Develop, recommend and implement plans for improving lab capabilities, quality and
productivity.
Review and implementation of SOPs.
Research and development of new methodologies to meet project and client project specific
requirements.
Utilize data quantitation and reporting system (Target, Envision, Access, Excel, and
Enviroquant software) to satisfy various deliverable formats
Southern Analytical Laboratories 1990-1991
Performed sample preparation and analysis utilizing EPA Drinking water series 500,
wastewater series 600 and SW-846 protocol.
U.S. Air Force Reserve 1983-1996
Honorable discharge SSgt.
Primary assignment - Airframe mechanic
Over seven years experience in Total Quality Management (TQM) as a certified instructor for
the Air Force phase I and II TQM program.
Responsible for processing security clearance packages for all new personnel assigned to
the 315th FMS squadron.
Project Experience includes but not limited to:
Westinghouse Remediation - Department of Transportation Maintenance Area, Fairbanks,
Florida:

Quality Manual V7
page 66 of 75
Managed organic section of laboratory to complete 110 samples/week for EPA 8270, 8240
analyses. Ten percent (10%) of the project required expanded Level III deliverables.
Samples were processed on information transferred to client allowing efficient remediation
operations. Provided on-site training of Client personnel to facilitate onsite analysis utilizing
a mobile laboratory.
Radian Corporation - MacDill Air Force Base, Tampa, Florida:
RCRA closure of hazardous waste storage facilities. Managed organic section of laboratory to
complete solvent scans (EPA 8240) on remediation process waters. Samples were processed
within 24 hours allowing uninterrupted remediation activities. Level III deliverable packages
were provided within 14 days.
Peoples Gas - Coal Tar assessment and remediation activities, Ybor City, Florida:
Oversight of organic section of laboratory for analysis of soil and groundwater samples in
support of assessment and remediation activities. Organic parameter groups included EPA
8270, 8240, and 8082. Samples were of a difficult analytical matrix; however, analytical
effort resulted in reports delivered within 48 hours -- enabling on-time project completion.

Quality Manual V7
page 67 of 75
Mark Gudnason Sr. Project Manager

Twenty years experience in the environmental and industrial hygiene analytical
chemistry industry. Extensive experience in laboratory management, as well as
chromatography, spectroscopy, and wet chemistry techniques. Proficient in technical
and operational management and communication. Skilled at working effectively with
staff at all levels and client contact personnel.
EDUCATION
B.A. Chemistry, George Mason University, Fairfax, VA 1977

EXPERIENCE
SPECTRUM ANALYTICAL, INC. FL DIVISION

(Tampa, FL)
10/2001-Present
(An environmental testing firm)
Section Leader: Project Managers and Sample Login
Coordinate the activities of the Project Management staff and sample receiving and login
personnel. Ensure the services provided to the client are consistent with the intended use
of the data. Serve as a technical resource for clients during the development of work plans
and throughout project completion. Serve as the primary contact between the client and
laboratory operations.
PACE ANALYTICAL SERVICES, INC
(Lenexa, KS; Coralville, IA; Minneapolis, MN)
(A national environmental testing firm)
Laboratory Operations Manager
2/91-8/2001
5/99-8/2001
Financial and technical management responsibilities of a full service environmental

testing laboratory, organics and inorganics. Ensure the services provided are
consistent with the criteria outlined in the Quality Manual. Serve as a technical
resource for clients. Serve as the primary contact between the laboratory operations
and project management, the customer.
Project Management Manager
9/95-5/99
Coordinate the activities of the sales and marketing staff with the project
management and client services personnel. Ensure the services provided to the client
are consistent with the intended use of the data. Serve as a technical resource for
clients during the development of work plans and throughout project completion.
Serve as the primary contact between the client and laboratory operations.
Laboratory Manager
2/92-9/95
Manage operational and technical aspects of laboratory offering

environmental organic and metals analytical services. Provide
written and verbal client support on all technical issues. Present
technical seminars to clients. Review and validate final data. Institute a quality
control program. Improve the quality of reported results. Revise all analytical
standard operating procedures to meet regulatory compliance.
Director, Sampling and Analytical Services Division, 2/91-2/92
Financial and technical management responsibilities of three operations within a full

service environmental testing laboratory, Organic and Inorganic Analytical Services,

Quality Manual V7
page 68 of 75
Groundwater Sampling Services, and Ambient Air and Stack Emission Sampling
Services.
BIOSPHERICS INC., Beltsville, MD
1979-1991
(An environmental sampling and testing; information dissemination

firm.)
Director, Laboratory Division
1/90-2/91
Direct the Laboratory Division providing environmental, agricultural, and industrial

hygiene analytical services, as well as ground water assessment services.
Responsible for the financial and technical performance of the Division. Lead a staff of
50 technical personnel to an annual revenue performance of $3.5 million. Manage
programs and contracts requiring environmental analytical services, pesticide residue
analyses, and analytical method development/validation.
Manager, Laboratory Division
2/88-1/90
Manage a laboratory performing analyses of environmental and

industrial hygiene samples. Specialize in the trace analysis of
organic and inorganic compounds in environmental and biological
matrices, research and method development/validation, as well as quality assurance
implementation. Highly skilled in multiple analytical techniques including GC (purge
and trap and direct injection techniques), AA, ICP, HPLC, Autoanalyzers, IC, wet
chemistry, UV-VIS, IR, etc. Manage major government and industry contracts for
environmental and industrial hygiene analytical services.
Bench chemist, Group Supervisor, Section Leader
7/79-2/88
As Section Leader, supervise and conduct analytical programs for organic and
inorganic parameters in multiple matrices. Streamlined the analytical programs and
analytical data review and report generation. Encourage automation and
computerization of analyses and data reduction through report generation.
Experience encompasses both sample prep and instrumental analysis of air, air
sampling media, water, soil/sediment, biological tissue, food chemical formulations,
and metal alloys. Major areas of expertise: elemental analyses by AA and ICP, waste
characterization by GC and IR, pesticides and PCBs by GC, VOAs by GC, PNAs by
HPLC and GC, water quality and industrial hygiene parameters by various techniques
including autoanalyzers, organic contaminants on
solid sorbents by GC and HPLC, and bulk asbestos by PLM and PCM.

Quality Manual V7
page 69 of 75
Raymond Ortiz, III Semi-Volatiles Group Manager

1534 Maximilian Drive, Wesley Chapel, FL 33543
813.991.9859
Ortiz_5@verizon.net
Professional Profile
Over 17 years of organic chemistry experience, including GC, GC/MS and HPLC
analyses of environmental samples for semi-volatile compounds; Management &
implementation of EPA methodologies including QA/QC protocols; Project supervision
of analytical samples to insure hold and turnaround times are met; Data validation of
semi-volatile organics; Method development and troubleshooting and maintenance of
instrumentation.
Career Highlights
GC/MS Chemist
TestAmerica -- Houma, LA -- July 2010/September 2010
Selected as a staff chemist for the TestAmerica Mobile Lab subcontracted at the BP
Command Center during the 2010 Gulf Oil Spill Crisis. Performed GC/MS analyses of
PAH and Biomarker analysis of oil and water samples relating to the oil spill.
Organics Manager
TestAmerica -- Tampa, FL -- February 2008 to October 2010
Management and implementation of EPA methodologies for analysis by GC and GC/MS.
Supervision of the daily operations of the semi-volatiles and organic prep departments,
including data validation.
Semi-Volatiles Manager
TestAmerica
(formerly Severn Trent Laboratories) -- Tampa, FL -- August 2007 to February
2008
Management and implementation of EPA methodologies for analysis by GC and GC/MS.
Technical organic analysis of all phases including preparation and analyses of soils,
waters and wastes.
Supervision of the daily operations of the semi-volatiles
department, including data validation.
GC Semi-Volatiles Supervisor
Severn Trent Laboratories Tampa -- Tampa, FL December 2002 to July 2007
Management and implementation of EPA methodologies for analyses by GC.
Proficiency in the operation and maintenance of GC/MS for EPA 8270/625. Technical
analysis of all phases including analyses of soils, waters and wastes. Supervision of
the daily operations of the semi-volatiles GC department, including data validation.

Quality Manual V7
page 70 of 75
GC Semi-Volatiles Chemist
Severn Trent Laboratories Tampa
(formerly Quanterra Environmental Services) -- Tampa, FL November 1998
to December 2002
Implementation of semi-volatile organics for analysis by GC and HPLC, all phases,
using EPA methodology, including pesticides, herbicides and PCBs as well as FL
PRO/DRO. Proficiency in the operation and maintenance of GC, ECD, FID, NPD.
GC Semi-Volatiles Chemist/Organic Prep Supervisor
Southern Analytical Laboratories -- Oldsmar, FL July 1994-November 1998
Management and implementation of semi-volatile organics by GC and organic
extractions prep, including solid phase, for analysis, all phases, including pesticides,
herbicides, PCBs, and PAHs. Data validation of semi-volatile organics. Coordination
and participation in various sampling events in the field.
Technician
Southern Analytical Laboratories -- Oldsmar, FL June 1993-July 1994
Extraction of soil, water and waste samples for all semi-volatile parameters.
Participation in sampling events in the field.
Education
Bachelors Degree: Interdisciplinary Natural Sciences
University of South Florida, December 1992
**References Available upon request

Quality Manual V7
page 71 of 75
Troy L. Roberts Inorganics Group Manager

EXPERIENCE
April 2006 Present

Spectrum Analytical, Inc. FL Division Tampa, Florida
Metals/ Wet Chem. Supervisor at present time. Duties include reviewing and
maintaining all SOPs. Final review of wet chem and metals data before
releasing to Project Managers. Being primary analyst for the PerkinElmer
Optima 4300 DV ICAP as well for the PerkinElmer AAnalyst 800 GFAA.
Maintaining and reviewing all log books associated with the Wet Chem and
Metals Departments. Cross training employees to make sure that each
employee can be utilized in every aspect of the WetChem/ Metals
department.
Senior Wet Chemistry Analyst: Analyzed samples for all EPA methods on
the Lachat as well as analyzing samples for methods 300.1/9056/314.0 on
the DX 500 and ICS 2000/ 2001.
Sample Receiving Tech: Entered samples into company system for various
test requested by clients. Also prepared out going kits for clients sampling
projects.
GC Chemist- FID/ECD: FID methods used are FL-PRO/ 8015 DRO/ ORO/
Finger print analisys/ TX 1005/1006. ECD methods used are 8082 PCB/
8081-8141 Pesticide/ 8151 Herbicide.
April 2004-October 2004 Microbac Laboratories Louisville, Ky

Extraction Technician
As a extraction technician responsibilities included liquid/liquid
extractions for water using Dichloromethane, EPA method 3510C and
3520C, soil extractions using ultra sonicators EPA method 3550B.
Extractions for both soil and water include Semi-volatile organic
compounds EPA method 8270C, PAH (polycyclic aromatic
hydrocarbons) EPA method 8270C, PCBs (polychlorinated biphenyls)
EPA method SW846 8082 and 608, Pesticides EPA method SW846
8081 and 608, DRO (diesel range organic compounds) EPA method
SW846 8015B, TCLP extractions EPA method SW846 1311, TCLP ZHE
extractions EPA method SW846 1311.
October2004-2005
Microbac Laboratories
Louisville,KY
Extraction Supervisor/GC Chemist
As extraction supervisor responsibilities include training employees on
all extraction methods, writing or updating SOPs for all extraction
methods, answering questions and giving guidance when needed,
making sure extractions are completed within allowable time frame.
As GC Chemist responsibilities include making standards for
calibration curves as well as standards for continuing calibration,
upkeep of instruments by way of maintenance or changing of gasses.
Test run GCs include PCBs, identifying and quantifying of arochlors,
Pesticides identifying and quantifying compounds, Diesel range and
extended range organic compounds, Glycols in soil and water, Fusel

Quality Manual V7
page 72 of 75
oils in alcohol, GRO (gasoline range organic compounds) in soil and

water by way of LCS Tekmar 3000 purge and trap instrument.
Wet Chemistry tests also trained in include, BOD-SM 19th edition 5210B
and EPA method 405.1, COD-SM 19th edition 5220D and EPA method
410.4. Oil and Grease analysis (Instrument-Horizon SPE-DEX 3000
XL).
1997-2004
Safety-Kleen Systems, Inc.
Smithfield, KY
Senior Laboratory Technician
As a senior laboratory technician in the hazardous waste reclamation facility, I
had to learn every job in the lab, as well as being responsible for overseeing
and helping the other lab technicians perform their duties in an appropriate and
safe manner. I am also responsible for running the shift in the absence of a
shift chemist and training new lab employees.
1992-1997
Smithfield, KY
Gas Chromatography Technician
As a gas Chromatography technician my responsibilities included prepping
inbound and outbound fuel samples for VOC and PCB analyses , as well as
identifying and labeling the various compounds found in these samples. I am
also responsible for troubleshooting and daily maintenance on the gas
Chromatography.
1991-1992
Laboratory technician
Smithfield, KY
As a laboratory technician my responsibilities included

performing wet chem. analysis on hazardous waste samples and
daily maintenance on various pieces of laboratory equipment.
Equipment trained to use

Hewlett Packard 5890 Series II duel column gas Chromatography
Perkin Elmer AAnalyst 100 Atomic Absorption Spectrophotometer
Millipore High Performance Liquid Chromatography
Buick Scientific Cold Vapor Mercury Analyzer Model 400A.
Inductively Coupled Argon Plasma Atomic Emission Spectrometer
Education
1987-1990 Lindsey Wilson College/ Business Management

Quality Manual V7
page 73 of 75
SPECTRUM ANALYTICAL, INC. FL DIVISION Organization Chart

(As of 05/04/2011)

Quality Manual V7
page 74 of 75
Review
April 2010
Revision 1: This document was created new and replaces the previous
versions of the Quality manual.
January 2011 Revision 2: Updated Equipment List, updated Organization Chart, removed
resumes for Lind Lee Gates and Priscilla Conklin, added resumes for Jedediah
Acker and Troy Roberts.
March 2011
Revision 3: Added the commitment to continually improve the practices

within the Quality Policy Statement, Section 23.8 add requirement of QAO to
review a minimum of 10% of all data packages and track via LIMS, Section
25.1, removed resume for Lara Keene, and updated organization chart with
most current available.
May 2011
Revision 4: Updated footers to include revision number on every page,

updated Equipment log to include new GPC, software information, and
removed SVECD02 and SVNPD1 as they were taken out of service. Org chart
was revised to be generic to reduce revisions due to non-management
employees. Section 3 Paragraph two indicates the references to how the
criteria for QM was established and Section 3.1, added notation that
SPECTRUM ANALYTICAL, INC. FL DIVISION is now an approved CLP Lab.
May 2011
Revision 5: Updated with Company name change, Spectrum Analytical Inc.

FL Division.
October 2011 Revision 6: Changed Key Personnel, performed review.

January 2012
Revision 7: Updated Resume section and personnel, updated Equipment

List.

Quality Manual V7
page 75 of 75

Spectrum Analytical Inc. FL Division Quality Manual – V7

Diunggah oleh

Informasi Dokumen

Deskripsi Asli:

Judul Asli

Hak Cipta

Format Tersedia

Bagikan dokumen Ini

Bagikan atau Tanam Dokumen

Opsi Berbagi

Apakah menurut Anda dokumen ini bermanfaat?

Apakah konten ini tidak pantas?

Hak Cipta:

Format Tersedia

Spectrum Analytical Inc. FL Division Quality Manual – V7

Diunggah oleh

Hak Cipta:

Format Tersedia

SPECTRUM ANALYTICAL, INC.

Digitally signed by Brian C Spann

Digitally signed by Mark

Spectrum Analytical Inc. FL Division

Last Saved on 1/4/2012

SECTION 2 - TABLE OF CONTENTS

Scope of Testing ......................................................................................................................................7

Table of Contents, References and Appendices.........................................................................................8

Glossary and Acronyms Used ..................................................................................................................9

SECTION 4 ORGANIZATIONAL ROLES AND RESPONSIBILITIES......................................................10

Laboratory Organizational Structure .....................................................................................................10

Quality Policy .......................................................................................................................................13

Quality Manual .....................................................................................................................................13

SECTION 6 DOCUMENT MANAGEMENT.................................................................................................14

Procedure for the Review of Work Requests ...........................................................................................19

Documentation of Review ......................................................................................................................19

SECTION 8 SUBCONTRACTING OF TESTS..............................................................................................19

SECTION 11 COMPLAINTS .........................................................................................................................20

Spectrum Analytical Inc. FL Division

Last Saved on 1/4/2012

Selection and Implementation of Corrective Actions...............................................................................22

Monitoring of Corrective Action ............................................................................................................22

Technical Corrective Action...................................................................................................................22

Exceptionally Permitting Departures from Documented Policies and Procedures...................................22

SECTION 14 PREVENTIVE ACTION ..........................................................................................................23

Records Management and Storage .........................................................................................................23

Legal Chain of Custody Records............................................................................................................24

SECTION 16 AUDITS AND MANAGEMENT REVIEW .............................................................................26

Performance Audits ...............................................................................................................................27

System Audits and Management Reviews................................................................................................27

SECTION 17 PERSONNEL, TRAINING, AND DATA INTEGRITY ..........................................................27

Data Integrity and Ethics.......................................................................................................................28

SECTION 18 ACCOMMODATIONS & ENVIRONMENTAL CONDITIONS............................................31

Demonstration of Capability (DOC) ......................................................................................................32

On-Going (or Continued) Proficiency ....................................................................................................32

19.3 Initial Test Method Evaluation...............................................................................................................32

Estimation of Uncertainty ......................................................................................................................33

Laboratory-Developed or Non-Standard Method Validation...................................................................34

Control of Data .....................................................................................................................................34

Support Equipment ................................................................................................................................42

Spectrum Analytical Inc. FL Division

Last Saved on 1/4/2012

Support Equipment Maintenance....................................................................................................43

20.3 Analytical Equipment.............................................................................................................................43

Transport and Storage of Reference Standards and Materials ................................................................46

Labeling of Reference Standards, Reagents, and Materials.....................................................................46

Standard Receipt and Traceability.....................................................................................................................46

Sample Receipt ......................................................................................................................................47

Sample Transport ..................................................................................................................................48

SECTION 23 QUALITY OF TEST RESULTS ..............................................................................................48

Essential Quality Control Procedures ....................................................................................................48

Internal Quality Control Practices.........................................................................................................49

Essential Quality Control Elements for Chemistry ................................................................51

Laboratory Control Samples..................................................................................................................51

Matrix Spikes and Matrix Spike Duplicates ............................................................................................52

Proficiency Test Samples or Inter-laboratory Comparisons....................................................................54

Spectrum Analytical Inc. FL Division

Last Saved on 1/4/2012

SECTION 24 REPORTING OF RESULTS....................................................................................................55

Test Reports ..........................................................................................................................................55

Supplemental Test Report Information ...................................................................................................56

Environmental Testing Obtained from Subcontractors............................................................................56