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Spectrum Analytical Inc. FL Division page 1 of 75 Last Saved on 1/4/2012

Quality Manual – V7

8405 Benjamin Road Suite A

Tampa, Fl 33634

QUALITY MANUAL

Responsible Parties

Name Function (Unit) Phone Signatures Date

Brian C. Spann

LaboratoryDirectorTechnical Director

813.888.9507 01/04/2012

Mark Gudnason

Quality ManagerTechnical Director 813.888.9507 01/04/2012

Revision Number: 1 Effective Date: 04/27/2010

2 02/03/2011

3 03/18/2011

4 05/12/2011

5 05/27/2011

6 10/28/2011

7 01/04/2012

SPECTRUM ANALYTICAL, INC.Featuring

HANIBAL TECHNOLOGY

F lori da Division

Brian C

Spann

Digitally signed by Brian CSpann

DN:cn=Brian CSpann,o=LabDirector,

Tampa Division,ou=Spectru m Analytical,

[email protected],c=US

Date:2012.01.0414:30:31 -05'00'

Mark

Gudnason

Digitally signed by Mark

Gudnason

DN: c=US, cn=Mark

Gudnason

Date: 2012.01.04 14:35:54

-05'00'


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Spectrum Analytical Inc. FL Division page 2 of 75 Last Saved on 1/4/2012Quality Manual – V7

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


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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


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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


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3.1 Scope of Testing

The laboratory scope of analytical testing services includes those listed in ourcertifications from various agencies. The list of Fields of Accreditation, FOAs, mayvary from agency to agency and are verified during review of work request by theProject Management Team at SPECTRUM ANALYTICAL, INC. FL DIVISION. Anyvariances 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 andmaintains their primary accreditation through the State of Florida DOH. If you havequestions regarding certification please contact our Project management team; whohas access to the most current copies of the current certification and Fields ofAccreditation (FOA). SPECTRUM ANALYTICAL, INC. FL DIVISION has been auditedand approved for AFCEE, USACE, and US Navy work. Additionally, SPECTRUMANALYTICAL, 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


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3.2 Table of Contents, References and Appendices

The table of contents is in Section 2 of this Manual. This Quality Manual uses thereferences from the 2003 NELAC Standard, Chapter 5, Appendix A.

SPECTRUM ANALYTICAL, INC. FL DIVISION Quality SOPsSOP Number SOP Title

SOP00002 TrainingSOP00003 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 LCSOP00095 Ordering supplies and services

SOP00098 Waste Disposal

SOP00118 Profile Set-up and Management

SOP00138Shewart Charts, Control Limits, MarginalExceedances

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


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3.3 Glossary and Acronyms Used

Quality control terms are generally defined within the section that describes theactivity.

Glossary

Appendix A, Chapter 1, 2003 NELAC Standards

Acronyms

A list of acronyms used in this document and their definitions are:

AA – Accrediting Authority

AFCEE - Air Force Center for Engineering and the Environment ANSI – American National Standards InstituteASQC – American Society for Quality ControlASTM – American Society for Testing and MaterialsBlk – Blank°C – degrees Celsiuscal – calibrationCAS – Chemical Abstract ServiceCCV – Continuing calibration verificationCOC – Chain of custodyDO – Dissolved oxygenDOC – Demonstration of CapabilityDOD - Department of DefenseEPA – Environmental Protection AgencyFOA - Fields of Accreditation g/L – grams per literGC/MS – gas chromatography/mass spectrometryGLP - Good Lab PoliciesICP – inductively coupled plasmaICV – Initial calibration verificationISO/IEC – International Organization for Standardization/International Electrochemical

Commissionlb/in2 – pound per square inchLCS – Laboratory control sampleLCSD – Laboratory control sample duplicateLFB – Laboratory fortified blankLIMS - Laboratory Information Management SystemLOD - Limit of DetectionLOQ - Limit of QuantificationMDL – method detection limitmg/Kg – milligrams per kilogrammg/L – milligrams per literMS – matrix spikeMSD – matrix spike duplicateNELAC – National Environmental Laboratory Accreditation ConferenceNELAP – National Environmental Laboratory Accreditation ProgramNIST – National Institute of Standards and TechnologyPT – Proficiency Test(ing)PTOB – Proficiency Testing Oversight BodyPTPA – Proficiency Testing Provider AccreditorQA – Quality AssuranceQC – Quality ControlQS – Quality Manual QAM – Quality Assurance Manager/officer


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QAO - Quality Assurance Manager/officerRL – Reporting levelRPD – Relative percent differenceRSD – Relative standard deviationSOPs – Standard operating proceduresSpectrum SPECTRUM ANALYTICAL, INC. FL DIVISION or Spectrum Analytical, Inc.spk – spikestd – standard

TNI - The NELAC instituteug/L – micrograms per liter

USACE - United States Army Corps of Engineers UV – UltravioletVOC – Volatile organic compoundWET – Whole effluent toxicity

SECTION 4 – ORGANIZATIONAL ROLES AND RESPONSIBILITIES

The laboratory is a legally identifiable organization. Through application of the policies andprocedures outlined in this chapter, the laboratory assures that it is impartial and thatpersonnel are free from undue commercial, financial, or other undue pressures that might

influence their technical judgment. The laboratory is responsible for carrying out testingactivities that meet the requirements of the NELAC Standard and that meet the needs of theclient. 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 orundue interests that might influence the technical judgment of analytical personnel.

The laboratory is a commercial testing laboratory. The tax number is available uponrequest, 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 Directorand IT manager report directly to the President, Hanibal Tayeh. Although thelaboratories do share benefits such as purchasing, the two laboratories functionindependently 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 asafety issue is found. The President, Lab Director, QAO, and Department managershave the authority to resume work once the issue has been properly corrected. Allstop work issues must be communicated to the Lab Director and/or the QAO forproper documentation and communication to the client if required.

4.2.1 President

The President ensures that the necessary equipment, material, and personnel areavailable to accomplish scheduled projects. The President also ensures thatcorrective actions are being conducted, assuring QA goals. The president alsocommunicates with clients on all aspects of their projects and recommends solutions.

4.2.2 Laboratory Director


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The Laboratory Director is responsible for oversight of all laboratory operations. TheLaboratory Director will communicate with clients on all aspects of their projects andrecommend solutions. The Laboratory Director will also work with the QualityAssurance Officer, section and team leaders, and analytical staff in reviewingprogress 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 ensuresthat all electronic back-up records are properly stored and easily retrieved. Hemanages the LIMS system, and is responsible for all levels of reporting/formsgeneration programs.

4.2.4 Quality Assurance Officer (QAO)

The QAO assists the laboratory in the production of accurate, valid, reliable data bymonitoring the implementation of the QA program. The QA officer is responsible forexecuting quality control procedures and techniques to ensure that the laboratoryachieves established standards of quality. The QAO is also responsible for evaluatingdata quality and maintaining records to ensure adherence to QA programs, and will

administer inter-laboratory QA efforts, review performance evaluation results, ensurecorrective actions take place, and prepare QA reports for management.

The QAO reports directly to the Laboratory Director for administrative and personnelrelated issues, but has full authority to stop work on any project or in any analyticalarea if QC problems arise that may compromise data quality. If a conflict arises withthe 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 clientrelations. 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 theclient, and circumventing or solving clients’ problems. The Department manager ofthis 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 assupervisors for the preparation, semi-volatiles, volatiles, and in-organics groups inthe Laboratory. They provide technical direction and project scheduling forconducting laboratory analyses and resolving day to day problems, and ensure thatproper QA /QC is followed in their respective departments. They also review data forclarity, validity and adherence to quality control standards. They review and forward

to the QAO all corrective action reports, and ensure that the corrective actions havebeen implemented. They also advise the Laboratory Manager and QAO of progress,needs, and potential problems associated with their groups. They routinely performfinal data review.


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4.2.8 Chemists, Analysts and Technicians

The chemistry staffs, titled chemists and analysts as appropriate, are responsible forperforming all aspects of inorganic and organic sample preparation and analysis,using Standard Methods, EPA, CFR 40, DoD and SW-846 methodologies. They areresponsible for instrument maintenance and calibration, data reduction, data reviewand 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 reportto the Project Manager lead. They are responsible for the preparation and shipmentof sample kits to the clients. They are also responsible for receiving samples,checking them in, reviewing all associated paper work, sending samples to Sub-labsif required and maintaining the internal chain-of-custody. Login technicians, underthe supervision of the lead project manager are responsible for custody of allsamples stored in the walk-in refrigerator, warehouse and sample disposal.

Management has overall responsibility for the technical operations and authorityneeded to generate the required quality of laboratory operations.

Management’s commitment to quality and to the Quality System is stated in theQuality Policy, which is upheld through the application of related policies andprocedures. The management of SPECTRUM ANALYTICAL, INC. FL DIVISION iscommitted to providing our clients with quality and timely data for their regulatoryneeds. The management ensures that all personnel are properly trained andknowledgeable in the analyses they perform, and that the staff is committed toreporting only the highest quality data that they can provide. Staff meetings areheld to discuss upcoming projects, new methodologies, and safety concerns withinthe lab, and supervisors meetings are held to keep the communication lines openbetween the departments.

Management ensures technical competence of personnel operating equipment,

performing tests, evaluating results, or signing reports, and limits authority toperform laboratory functions to those appropriately trained and/or supervised.

The assignment of responsibilities, authorities, and interrelationships of thepersonnel who manage, perform, or verify work affecting the quality ofenvironmental tests is documented in detailed job descriptions maintained by theLab 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 dataintegrity issues, and periodically reviewing data, procedures, and documentation.

Management ensures that audit findings and corrective actions are completed withinrequired time frames.

Designated alternates are appointed by management during the absence of theLaboratory Manager, Technical Director or the Quality Manager, and always if theabsence is more than 15 days.


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Management is responsible for defining the minimal level of education, qualifications,experience, and skills necessary for all positions in the laboratory and assuring thattechnical staff have demonstrated capabilities in their tasks.

Training is kept up to date as described in SPECTRUM ANALYTICAL, INC. FLDIVISION SOP0002, Training, by periodic review of training records and throughemployee performance review.

SECTION 5 – QUALITY SYSTEMS

The laboratory's Quality System is documented in this Quality Manual and associated qualitysystem documents. Together they describe the policies, objectives, principles,organizational authority, responsibilities, accountability, and implementation plan of theorganization 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 anddated, and is issued under the authority of the highest level of laboratory management,which demonstrates management’s commitment to integrity, ethics, the quality system andassociated standards.

Quality Policy Statement

The objective of the quality system and the commitment of management are toconsistently provide our customers with data of known and documented qualitythat meets their requirements. Our policy is to use good professional practices,to maintain quality, to uphold the highest quality of service, to comply with theNELAC Standard and a commitment to continually improve in these practices.

This policy is implemented and enforced through the unequivocal commitmentof management, at all levels, to the Quality Assurance (QA) principles andpractices outlined in this manual. The laboratory ensures that personnel arefree from any commercial, financial, and other undue pressures, which mightadversely affect the quality of work. However, the primary responsibility forquality rests with each individual within the laboratory organization. Everylaboratory employee must ensure that the generation and reporting of qualityanalytical data is a fundamental priority. Every laboratory employee is requiredto familiarize themselves with the quality documentation and to implement thepolicies and procedures in their work. All employees are trained annually onethical principles and procedures surrounding the data that is generated. Thelaboratory maintains a strict policy of client confidentiality.

5.2 Quality Manual

The Laboratory Director and or the Quality Officer ensures that the laboratory’spolicies and objectives for quality are documented by reference or by inclusion in theQuality Manual , and that the Quality Manual is communicated to, understood by, andimplemented by all personnel concerned.


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Where the Quality Manual documents laboratory requirements, a separate SOP orpolicy is not required. SPECTRUM ANALYTICAL, INC. FL DIVISION will state generalpolicies within this manual and in SPECTRUM ANALYTICAL, INC. FL DIVISION SOPs,however; specific policies and client’s specific statement of works when presented inwritten form may take precedence over this document. All variance requests aremaintained 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.TheQuality Manual is maintained and up-to-dated by the Laboratory Director and or theQuality Officer.

SECTION 6 – DOCUMENT MANAGEMENT

This Section describes procedures for document management, which includes controlling,distributing, reviewing, and accepting modifications. The purpose of document managementis 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 currentas part of the quality system. Controlled documents may be internal documents or externaldocuments.

APPROVED means reviewed, and either signed and dated, or acknowledged in writing orsecure 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 thescope and depth required.

6.1 Controlled Documents

Documents will be reviewed and approved for use by The Laboratory Director and orthe 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 becontrolled to ensure that QA/QC in the laboratory is in compliance with generallyaccepted 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 thelaboratory is not affected by non-random variability. In order to assure this, allfactors that may cause variability must be minimized. One factor that can becontrolled is how the samples are processed. The Quality Manual defines in thebroadest sense how samples are processed in the laboratory. SOPs describe in detailhow each individual process is applied to the samples. In the event that the QualityManual and an SOP differ the SOP takes precedence over the Quality Manual. All


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6.3 Standard Operating Procedures

STANDARD OPERATING PROCEDURES (SOPs) are used to ensure consistency of applicationof common procedures, are written procedures that describe in detail how toaccurately reproduce laboratory processes, and are of two types: 1) test methodSOPs, which have specifically required details, and 2) general use SOPs whichdocument the more general organizational procedures. SOPs do not have to be

formal documents with predefined section headings and contents. They can be lessformal descriptions of procedures described in the Quality Manual or otherdocuments. Copies of all SOPs are accessible to all personnel.

Each SOP indicates the date signed and its effective date, the revision number, andthe signature(s) of the Lab Director and/or the QAO at a minimum. See SPECTRUMANALYTICAL, 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 thataccurately reflect how the analytical process is performed. Where equipment

manuals or published methods accurately reflect laboratory procedures in detail, aseparate SOP is not required.

Standard operating procedures (SOPs) are essential for a successful QA/QC program andare required by certifying agencies.

• SOPs document the specific activities that make up routine operations and therecommended sequence of those activities. In so doing, SOPs provide a uniformapproach to routine tasks.

• Any deviation from a test method is documented, including both a description of thechange 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 beingperformed to verify that the activity is being performed correctly. SOPs provide aconsistent basis for auditing.

• SOPs can provide a basis for the development of other SOPs for similar or relatedactivities. As routine operations are carried out, the steps outlined in the SOP should befollowed. However, if new or improved practices are discovered, the SOP can andshould be revised to reflect the incorporation of the improvement.

• SOPs written to describe analytical or sampling procedures should contain staticinformation about that method, i.e., information that will change in small ways overseveral revisions. Dynamic information such as method detection limits, QC controllimits, dynamic ranges and such can vary over time and are best handled elsewhere(updates to Quality Manual and the LIMS).


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• Analytical SOPs should contain all the information needed so that a skilled operator mayperform the method.

• As routine operations are carried out, new and different practices may be developed andimplemented. The controlled documents are updated - with a new revision number - toreflect the new practices, and are distributed to all persons with access to thedocuments.

• 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 taskduring training and once a year or if there are any revisions issued. The SOPs onlinedatabase in “Back Office” serves as the place where staff can document compliance withthe yearly SOP review. The department manager and QAO will supervise this process toensure that all staff are kept current in their knowledge of the system and methodsofficially approved in the lab.

• All SOPs are reviewed by staff once a year to insure that the information in the SOP isup to date. In the event a revision is needed, the department manager will ask the QAOfor 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 ifneeded.

QA/QC requirements

Before any SOP or subsequent revision can be released, they must be reviewed and signedby 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. SOPswill be controlled according to SPECTRUM ANALYTICAL, INC. FL DIVISION SOP00003.

SOPs are used to ensure consistency of application of common procedures, are writtenprocedures 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 theelement is not applicable then a “NA” annotation is acceptable. If the information is citedelsewhere 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 mayserve as temporary notice to deviate from the SOP until the documentation isupdated. 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 areclearly defined, the laboratory has adequate resources and capability, and the test methodis applicable to the customer's needs. This process assures that all work will be given


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adequate attention without shortcuts that may compromise data quality. Contracts for newwork may be formal bids, signed documents, verbal, or electronic. See SPECTRUMANALYTICAL, INC. FL DIVISION SOP00118, Profile Set-up and Management.

All new work bid on, and / or accepted, by SPECTRUM ANALYTICAL, INC. FL DIVISION isreviewed by the senior management team and a “Go” / “No Go” decision is made by theteam 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 lab’sreadiness for accepting the work. This evaluation is completed after a thorough review ofthe project specifications:

Current backlog in the laboratory and the new project’s schedule.

Current personnel by department versus the project’s requirements.

Current equipment resources versus the new project’s needs.

The project’s analytical method requirements versus SPECTRUM ANALYTICAL, INC. FL

DIVISION’s current methods.

E-data and database delivery requirements for the project relative to SPECTRUMANALYTICAL, INC. FL DIVISION’s systems configuration and ability to meet the projectrequirements.

The level of QC documentation requirements for the project relative to SPECTRUMANALYTICAL, INC. FL DIVISION’s ability to produce the required forms.

Possible financial requirements for project specific needs (i.e. equipment or softwareupgrades, 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 onthe 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 anyof the factors are determined to be “Prep Required” the senior management team preparesa list of the preparation requirements and each requirement is determined to be

“acceptable” or “Not Possible.” If the any the preparation requirements, are determined tobe “Not Possible”, a “No Go” decision is made and SPECTRUM ANALYTICAL, INC. FLDIVISION will not accept or bid on the project. If all the preparatory requirements aredetermined to be “Acceptable,” then a “Go” decision is made for the project.


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7.1 Procedure for the Review of Work Requests

The Project Management Team, QAO and/or Lab Director determines if thelaboratory 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 ofaccreditation, 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 orsample handling processes. All differences between the request and the finalcontract are resolved and recorded before any work begins. It is necessary that thecontract be acceptable to both the laboratory and the client.

The review process is repeated when there are amendments to the original contractby 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. Thisincludes pertinent discussions with a client relating to the client's requirements orthe 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 adifferent location than the address indicated on the front cover of this manual, thatperforms analyses for this laboratory. See SPECTRUM ANALYTICAL, INC. FL DIVISIONSOP00014, Subcontracting.

When subcontracting analytical services, the laboratory assures work requiring accreditationis placed with an appropriately accredited laboratory or one that meets applicable statutoryand regulatory requirements for performing the tests.

A list of subcontractors is maintained. A copy of the certificate and analyte list forsubcontractors may be maintained as evidence of compliance. The laboratory notifies theclient of the intent to subcontract the work in writing. When possible, the laboratory gainsthe approval of the client to subcontract their work prior to implementation, preferably inwriting.

The laboratory performing the subcontracted work is identified in the final report. Thelaboratory assumes responsibility to the client for the subcontractor’s 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 ofenvironmental tests are of the required or specified quality by using approved suppliers andproducts.


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The laboratory has procedures for purchasing, receiving, and storage of supplies that affectthe quality of environmental tests.

SPECTRUM ANALYTICAL, INC. FL DIVISION SOP00095, ordering supplies andservices, addresses reviews and approvals of supplier of services and supplies and approvalof required certification, (if applicable) prior to ordering. Evaluation of suppliers isaccomplished 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 receiptdocuments. The purchasing documents contain the data that adequately describe theservices and supplies ordered. The laboratory keeps a list of approved suppliers in thepurchasing database.

SECTION 10 – SERVICE TO THE CLIENT

The laboratory collaborates with clients and/or their representatives in clarifying theirrequests and in monitoring of the laboratory performance related to their work. Eachrequest is reviewed to determine the nature of the request and the laboratory's ability tocomply 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 athird party without proper authorization. All electronic data (storage ortransmissions) are kept confidential, based on technology and laboratory limits, asrequired by client or regulation.

SECTION 11 – COMPLAINTS

The purpose of this section is to assure that customer complaints are addressed andcorrected. This includes requests to verify results or analytical data. The laboratoryreviews 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, SPECTRUMANALYTICAL, INC. FL DIVISION follows a simple protocol. The complaint, client, date, andcompany are documented. The client is informed with the results of the research. If areport has to be resubmitted to the client, a copy of it is saved and filed in the archived dataalong 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, itis 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.


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SECTION 12 – CONTROL OF NON-CONFORMING WORK

NON-CONFORMING WORK is work that does not meet acceptance criteria or requirements. Non-conformances can include: unacceptable quality control results, see Section 24, ordepartures from standard operating procedures or test methods. Requests for departuresfrom laboratory procedures are approved by the Lab Director and/or the Projectmanagement Team and documented. Clients are notified of issues. If a client requests a

departure from laboratory procedures, the request is maintained by the ProjectManagement 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, determineif it will be permitted, and take appropriate action. All employees have the authority to stopwork on samples when any aspect of the process does not conform to laboratoryrequirements.

The responsibilities and authorities for the management of non-conforming work are tonotify the department manager verbally and or electrically, i.e. email. The departmentmanager will evaluate the issue and apply corrective action if applicable. The non-conformance is then communicated to the Project Management Team/Lab director and theQAO. 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 requestsadditional or alternative corrective action, this is documented and retained by the projectmanagement team. All non-conformances are summarized in the case narratives thataccompany each report.

The laboratory evaluates the significance of the nonconforming work, and takes correctiveaction immediately. The client is notified if their data has been impacted. Resumption ofwork after non-conformance is authorized by the Lab Director, QAO and/or the departmentmanager depending on the severity. An example of when the department manager mayauthorize resumption of work is to order a re-preparation of the samples to meet non-conforming 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 actionstaken 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 isresponsible for monitoring and recording corrective actions.

All deficiencies are investigated and a corrective action plan developed and implemented ifdetermined necessary. The implementation is monitored for effectiveness.

Specific corrective action protocols specified in test methods may over-ride generalcorrective action procedures specified in this manual. See SPECTRUM ANALYTICAL, INC.FL DIVISION SOP00005, Corrective/Preventive Actions.


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13.1 Selection and Implementation of Corrective Actions

ROOT CAUSE is the condition or event that, if corrected or eliminated, would preventthe recurrence of a deficiency.

Once an exceedance or nonconformance is noted, the first action is an investigationto determine the root cause. Records are maintained of nonconformance’s requiring

corrective action to show that the root cause(s) was investigated, and includes theresults of the investigation. Where uncertainty arises regarding the best approachfor analysis of the cause of exceedances that require corrective action, appropriatepersonnel will recommend corrective actions to be initiated. The appropriatedepartment manager ensures that corrective actions are discharged within theagreed upon time frame.

13.2 Monitoring of Corrective Action

Appropriate personnel will monitor implementation and documentation of thecorrective 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 bereanalyzed or qualified. Unacceptable quality control results are documented, and ifthe evaluation requires cause analysis, the cause and solution are recorded. Theanalyst is responsible for initiating or recommending corrective actions and ensuringthat exceedances of quality control acceptance criteria are documented.

Analysts routinely implement corrective actions for data with unacceptable QCmeasures. 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 isadversely affected by the nonconformance, the client is notified in writing.

The discovery of a non-conformance for results that have already been reported tothe client must be immediately evaluated for significance of the non-conformance, itsacceptability to the client, and determination of the appropriate corrective action.

13.4 Exceptionally Permitting Departures from Documented Policies andProcedures

The laboratory allows the release of non-conforming data only with approval by theappropriate Technical Director or their designee on a case-by-case basis. Planneddepartures from procedures or policies do not require audits or investigations.

Permitted departures for non-conformances, such as QC failures, are fullydocumented and include the potential reason for the departure, the impact of thedeparture on the data, and the data. This is performed via the case narrativesincluding with the reports as a minimal.


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SECTION 14 – PREVENTIVE ACTION

PREVENTIVE ACTION, rather than corrective action, aims at minimizing or eliminating inferiordata quality or other non-conformance through scheduled maintenance and review, beforethe non-conformance occurs.

Preventive action includes, but is not limited to: review of QC data to identify qualitytrends, annual budget reviews, annual managerial reviews, scheduled column trimming, andother actions taken to prevent problems.

All employees have the authority to recommend preventive action procedures, howevermanagement 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, oranalyst notes on a chromatogram. Records may be on any form of media, includingelectronic and hard copy. Records allow for the historical reconstruction of laboratoryactivities related to sample-handling and analysis.

The laboratory maintains a record system appropriate to its needs, records all laboratoryactivities, 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 onnetwork drives, backed up daily on NAS device (RAID 5) with additional copy kept onbackup 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 batchanalysis work sheet files. All metals instrument data is maintained by the metalsdepartment in CD format. All instrument maintenance log books, analysis run logand prep log books are maintained in bound controlled binder or book formats.

All sample login, internal chain of custody records, and analytical data is maintainedin the LIMS. Once accessed, all client information, test information, and raw dataassociated with each sample can be retrieved. Data from the programs alsoreferences the hard copies of the raw data, final reports, etc. making it easy toretrieve 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 maintainedin CD format and as Backup tape by the Information Services section. These filesare 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.


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Archived information and access logs are protected against fire, theft, loss,environmental deterioration, vermin, and in the case of electronic records, electronicor 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 thelaboratory to a new owner, SPECTRUM ANALYTICAL, INC. FL DIVISION, would expectthat record retention would be negotiated and made part of any purchase contract,and that the new company would maintain all required NELAC documentation. SinceNELAC certification would likely be one of the attractive aspects of the laboratory toany purchaser it is unlikely that a new owner would not want to maintain theappropriate records and certifications. In the event a new owner did not want tomaintain past records, SPECTRUM ANALYTICAL, INC. FL DIVISION, would notify theirclients and make these records available to them for a reasonable fee. Clientswould be given a minimum of 30 days to determine if documents are needed ournot.

Essential electronic records are backed-up daily/weekly and one set is kept off site atall times. Access to protected records is limited to laboratory management or theirdesignees 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 toensure traceability of samples from point of collection to final disposal. Personnelassociated with the steps of sample receipt, preparation, analysis, and disposal may

be traced through these records. Possession of samples can be accomplished bysample custody and/or legal chain-of-custody.

Special types of sample custody in which all events associated with a specific samplemust be documented in writing. Copies of SPECTRUM ANALYTICAL, INC. FLDIVISION's Chain of Custody Forms are maintained with project records.

Legal Chain of Custody includes the sample custody information. In addition, thefollowing 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.


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Sample Receipt

When samples are received at SPECTRUM ANALYTICAL, INC. FL DIVISION, coolersare opened and samples are inspected for damage. The temperature-blank samplecontainers are checked to ensure that samples have been held at the appropriatetemperature. Caps are checked for integrity, and samples are checked for evidenceof any water intrusion. Documentation is reviewed to determine that the proper

samples and identifications were received. Once inventoried and verified, samplesare checked to insure that preservatives were added correctly to appropriatesamples. 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 preservationprotocols

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 notedon the final report. The option of re-sampling is also presented.

Sample Log In

Samples are logged into the LIMS and assigned a unique SPECTRUMANALYTICAL, INC. FL DIVISION laboratory identification number. A samplelabel is generated and affixed to the sample. Sample labels are generated viathe LIMS. The SPECTRUM ANALYTICAL, INC. FL DIVISION laboratory IDnumbers are assigned sequentially and automatically by the LIMS.

Sample Security and Accessibility

Samples are stored in the laboratory walk-in cooler refrigerator at 4ºC, exceptfor the volatile samples, which are stored in the designated volatile samplestorage cooler/freezer in the VOLs area at 4 ºC for water and 0ºC for solids.The analysts and/or login personnel must log these samples in and out of thecoolers. All sample movement is documented on the internal chain of custodylog. All refrigerators in the laboratory are accessible only to Spectrumlaboratory 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 inrefrigerators within the main laboratory buildings. Once analysis is complete,samples are transferred into the sample holding area, where they are storedfor at least for 30 days. After this time, they are discarded. All waste disposalmanifests are maintained on file at Spectrum.


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All samples are signed out of the designated coolers by the analysts, andenough is taken to run the particular analysis. The samples are then signedback into the designated coolers or marked consumed. These samples are notstored in the work areas when they are not being used. After the samples areprocessed, and the organic samples exceed their hold times, the samples aremoved to the monitored and secured warehouse for storage until the clientrequests them to be disposed. The samples are signed out of the internal

chain-of-custody, and logged into the sample disposal log. See SPECTRUMANALYTICAL, 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 on-going assessment of the quality system. They are also instrumental in identifying areaswhere improvement in the quality system will increase the reliability of data. Audits are offour main types: internal, external, performance, and system.

Notification of clients for events that cast doubt on the validity of the results is completedwithin 5 working days of confirmation of the issue by the Lab Director and/or QAO.

Refer to SPECTRUM ANALYTICAL, INC. FL DIVISION SOP000171, InternalAudits/Reviews.

16.1 Internal Audits

The laboratory conducts internal audits of its quality systems activities, includingdata integrity, and the use of trained and qualified personnel at least annually.Personnel may not audit their own activities except when it can be demonstratedthat an effective audit will be carried out.

Annually, the laboratory prepares a schedule of internal audits to be performedduring the year. These audits verify compliance with the requirements of the qualitysystem, 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 requiredby the schedule and requested by management.The area audited, the audit findings,and corrective actions are recorded. All investigations that result in findings ofinappropriate 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 correctiveactions were implemented and effective.

16.2 External Audits

It is the laboratory’s policy to cooperate and assist with all external audits, whetherperformed by clients or an accrediting authority. All external audits are fullydocumented and tracked to closure. Management ensures that all areas of the


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laboratory are accessible to auditors as applicable and that appropriate personnel areavailable to assist in conducting the audit. Any findings related to an external auditfollow corrective action procedures, as defined by SPECTRUM ANALYTICAL, INC. FLDIVISION 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 theperformance of the analyst and method.

The policy and procedures for Proficiency Test Samples are discussed in Section23.7.

16.4 System Audits and Management Reviews

The QAO and Lab Director review the quality system and maintain records of reviewfindings and actions. The quality system is reviewed annually, and findings arerecorded. Managers assure that actions are performed within agreed time frames.

Findings from management reviews are recorded. These records ensure thatcorrective actions are completed in as defined by SPECTRUM ANALYTICAL, INC. FLDIVISION 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 workaffecting data quality, and are located in the controlled documents folder managedby the QAO and/or Lab Director. See SPECTRUM ANALYTICAL, INC. FLDIVISION 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. ThePresident also ensures that corrective actions are being conducted, assuring QAgoals. The president also communicates with clients on all aspects of their projectsand 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 highestlevel manager. The laboratory director signs the Quality Manual .


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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 theTechnical Directors who are full-time members of the staff and who assure reliabledata through the following activities: monitoring quality control, corroborating theanalysis performed, and signing demonstrations of capability.

The Technical Directors certify that personnel with appropriate educational and/ortechnical 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 qualitysystem is implemented and followed.

The Quality Manager has direct access to the Laboratory President and isindependent 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 managerialinfluence.

• Arranges for, or conducts, internal audits annually; and,

• notifies laboratory management of deficiencies (or opportunities for continuousimprovement) 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 ensuresthat all electronic back-up records are properly stored and easily retrieved. Hemanages the LIMS system, and is responsible for all levels of reporting/formsgeneration programs.

17.2 Data Integrity and Ethics

DATA INTEGRITY is the result of the processes that together assure valid data of knownand documented quality. Data integrity and ethics procedures in the laboratory

include training, signed, and dated integrity documentation for all laboratoryemployees, periodic monitoring of data integrity, and documented data integrityprocedures. 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 integrityprocedure training forms. Data integrity procedures and evidence of inappropriateactions are reviewed annually or through regularly scheduled internal audits, and are


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updated by management. The mechanism for confidential reporting of ethics anddata integrity issues is: (1) unrestricted access to senior management, (2) anassurance that personnel will not be treated unfairly for reporting instances of ethicsand data integrity breaches, and (3) anonymous reporting. Employees are requiredto understand, through training and review of quality systems documents, that anyinfractions of the laboratory data integrity procedures will result in a detailedinvestigation 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-upevaluation, full investigation, or other appropriate actions have been completed andthe issues clarified. Inappropriate activities are documented, including disciplinaryactions, corrective actions, and notifications of clients, if applicable. Thesedocuments are maintained for a minimum of 5 years. Any determination for detailedinvestigation 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 activityinclude any disciplinary actions involved, corrective actions taken, and all appropriatenotifications of clients.

Data integrity procedures are reviewed annually and are periodically monitoredthrough 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 andservices produced and the integrity of the people who generate them. We recognizethe need for and have responded with an ethics program that is designed toestablish a meaningful context within the environmental laboratory. Our objective isto provide an effective ethics program that involves training, managerial leadershipand active dialogue between our staff. All new employees are trained within the firsttwo weeks of employment and signed documentation is maintained with the

employees training records.

The policy for reporting Ethical and Data Integrity issues follows the GrievanceProcedures located in the Employee Handbook along with the Whistleblower Policy toprovide confidentiality and protect the employee against retaliation. The Manager orSection Team Leader will investigate the issue and report the findings of theirinvestigation in the form of a documented Memo to the Laboratory Director andQuality Assurance Section Team Leader within 48 hours. Continued employee andmanagerial training will occur once a year.

Periodic monitoring of data integrity is conducted through departmental managementreview. Any employee who displays unethical behavior or intentionally jeopardizesdata integrity will be subject to discipline up to and including termination.

We, at SPECTRUM ANALYTICAL, INC. FL DIVISION, believe that we share commongoals 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.


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• We will continue to create an environment for personal and professional growththat provides employees with an opportunity to excel and develop new skills andmeet new challenges.

• We will continue to enhance our internal procedures that provide a well definedbackground that is both educational and supportive to both our employees andour 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 ourgender.

• SPECTRUM ANALYTICAL, INC. FL DIVISION and its leadership support themaintenance of the facility, the equipment and instrumentation and, by exampledemonstrate 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 employeeorientation) and the annual refresher training is recorded with a signatureattendance sheet or other form of documentation that demonstrates all staff haveparticipated and understand their obligations related to data integrity.

Training records regarding data integrity and ethics are signed by each staff memberannually and verified by the Lab Director or QAO. Topics covered are provided inwriting 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 management’sresponsibility to assure personnel are trained. Only trained personnel are authorizedto 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 attraining sessions is documented on signature sheets. SPECTRUM ANALYTICAL,INC. FL DIVISION SOP00002, Training, addresses the initial and continuedtraining program.

The initial training for a new task contains the following steps:

• All documentation involved with a new and unfamiliar task is read andunderstood by the trainee.

• Training is under the direct supervision of a qualified senior analyst. During thetime the analyst is training, the trainee may sign laboratory notebooks orlogbooks, but laboratory notebooks must be cosigned by the senior analyst, whois responsible for the data generated.

• The trainee demonstrates competency in the new task before they can operateindependently. The competency for a test method is accomplished by ademonstration of capability as indicated in Section 19. Approval of competency is


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noted by the initials or signature of the qualified senior analyst on the trainingform.

• 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 SOP’sthat 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 annualdemonstrations of capability for each analyst and each method.

SECTION 18 – ACCOMMODATIONS & ENVIRONMENTAL CONDITIONS

Laboratory facilities are designed and organized to facilitate testing of environmentalsamples. Environmental conditions are monitored to ensure that conditions do notinvalidate 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 byrestriction of areas to authorized personnel only. The laboratory work spaces are adequatefor their use, and appropriately clean to support environmental testing and ensure anunencumbered work area.

SPECTRUM ANALYTICAL, INC. FL DIVISION provides comprehensive analytical services, andis capable of performing a wide variety of analyses. The laboratory is equipped withadvanced analytical equipment, including gas chromatographs / mass spectrometers, gaschromatographs, atomic absorption spectrometers, inductively coupled plasma atomicemission spectrometer, high pressure liquid chromatograph, and ancillary analyticalequipment essential to a quality environmental laboratory.

SPECTRUM ANALYTICAL, INC. FL DIVISION occupies a facility in Tampa, Florida. Employeesare expected to maintain a clean workspace to reduce any possibility of contamination. Inaddition, SPECTRUM ANALYTICAL, INC. FL DIVISION, uses a sub-contracted cleaning serviceto ensure major housekeeping chores are performed regularly. The cleaning staff is alsoinformed about the proper cleansers to use for each building, and which buildings theyshould clean before any others.

Laboratory space is arranged to minimize cross-contamination between incompatible areasof the laboratory. The VOA section is segregated and has its own air handling system. Onlyrequired staff is allowed entry.


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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 performthe method. Work cells together meet specified acceptance criteria anddemonstrations of capability. The laboratory confirms that it is capable of generatingdata 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, andthese completed forms are kept in the training files for each analyst. A DOC isperformed for each analyte whenever the method, analysts, analytes, or instrumenttype 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 signingthe DOC form. The process for DOC is documented in the employees training filesand maintained by the QAO. Refer to SPECTRUM ANALYTICAL, INC. FLDIVISION SOP00002, Training and SPECTRUM ANALYTICAL, INC. FLDIVISION SOP00139, Doc. Of Analyst Capability.

19.2 On-Going (or Continued) Proficiency

After the demonstration of capability is completed, on-going proficiency is maintainedand demonstrated at least annually through the analysis of either single-blindsamples, performing another DOC, or use of four consecutive laboratory controlsamples compared to pre-determined acceptance limits for precision and

accuracy.This is documented in the training file of each analyst. Refer toSPECTRUM ANALYTICAL, INC. FL DIVISION SOP00002, Training andSPECTRUM ANALYTICAL, INC. FL DIVISION SOP00139, Doc. Of AnalystCapability.

19.3 Initial Test Method Evaluation

For chemical analyses, the INITIAL TEST METHOD EVALUATION involves the determinationof the Limit of Detection (LOD), confirmation of the Limit of Quantitation (LOQ), anevaluation 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 substancethat an analytical process can reliably detect. An LOD is analyte and matrix specificand may be laboratory dependent (NELAC Glossary 2003). See SPECTRUMANALYTICAL, INC. FL DIVISION SOP00058, MDL and RL Establishment.


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19.3.2 Limit of Quantitation (LOQ)

The LIMIT OF QUANTITATION (LOQ) is an estimate of the minimum amount of asubstance that can be reported with a specified degree of confidence (NELACGlossary 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 tothe LOQ. The LOQ will always be greater than the LOD. LODs are determined froma quality system matrix using all sample processing steps, and are verified annuallyor when there is a change in the test method or instruments affects sensitivity. TheLOQ is verified using a quality systems matrix sample spiked at 1-2, times thedetermined LOQ that returns a concentration within the acceptance criteria foraccuracy, according to the requirements of the method or client data qualityobjectives. See SPECTRUM ANALYTICAL, INC. FL DIVISION SOP00058, MDLand RL Establishment.

19.3.3 Precision and Bias

PRECISION is the degree to which a set of observations or measurements of the sameproperty, obtained under similar conditions, conform to themselves. Precision isusually expressed as standard deviation, variance, or range, in either absolute orrelative terms.

BIAS is the systematic error that contributes to the difference between the mean of asignificant number of test results and the accepted reference value.

Precision and Bias are determined for standard and non-standard methods. SeeSPECTRUM 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 ofa Demonstration of Capability. Precision and Bias using non-standard, modifiedstandard or laboratory-developed methods are compared to the criteria establishedby the client (when requested), the method, or the laboratory.

Replicate spikes in a quality system matrix are analyzed according the proceduresoutlined 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 targetsubstance or constituent in the presence of non-target substances (EPA-QAD). Thelaboratory 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 theuncertainties of the numerous steps of the analytical process, including, but notlimited to, sample plan variability, spatial and temporal sample variation, sampleheterogeneity, calibration/calibration check variability, extraction variability, andweighing variability.


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Estimation of Uncertainty in Measurements (Laboratory portion) shall be provided toclients upon request. Calculation of this uncertainty estimation will be done usingthe “Quality Contro