Procedure Manual For The Environmental Laboratory .

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Procedural Manual for theEnvironmental LaboratoryAccreditation ProgramSeptember 2010Publication No. 10-03-048

Publication InformationThis manual is available on the Department of Ecology’s website Pages/1003048.htmlThis document replaces the 2002 version of this manual, Publication No. 02-03-055.The Activity Tracker Code for this document is 10-209.Contact InformationLab Accreditation UnitWashington State Department of EcologyPO Box 488Manchester, WA 98353-0488Phone: (360) 871-8840Web site: ons ConsultantWashington State Department of EcologyOlympia, WA 98504-7600Phone: (360) 407-6764Washington State Department of Ecology – https://ecology.wa.govLocation of Ecology OfficeHeadquarters, LaceyNorthwest Regional Office, BellevueSouthwest Regional Office, LaceyCentral Regional Office, Union GapEastern Regional Office, 9-575-2490509-329-3400Any use of product or firm names in this publication is for descriptive purposes onlyand does not imply endorsement by the author or the Department of Ecology.If you need this document in a format for the visually impaired, call 360-407-6764.People with hearing loss can call 711 for Washington Relay Service.People with a speech disability can call 877-833-6341.

Procedural Manualfor theEnvironmental LaboratoryAccreditation ProgrambyLab Accreditation Unit staffEnvironmental Assessment ProgramWashington State Department of EcologyManchester, Washington 98353-0488

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Table of ContentsPagePurpose of This Manual .3Introduction .5The Meaning of Accreditation .5Contents of This Manual .6Requirements for Participating in the Laboratory Accreditation Program .7Initial Accreditation .7Continuing Accreditation .7How to Apply for Accreditation and Pay Fees .8Quality Assurance Manual .9Why Is a QA Manual Required and Who Uses It? .9Formatting a QA Manual .9Suggested Outline for a QA Manual .10QA Manual Requirements for Drinking Water Labs .12Proficiency Testing .13How Many Proficiency Testing (PT) Study Results Are Required? .13Other Allowed Proficiency Testing Studies .15Questions About Proficiency Testing Studies .16On-Site Audit .18Typical Agenda .19Critical Elements for Accreditation .21Analytical Methods .21Equipment and Supplies .22Quality Assurance and Quality Control .22Sample Management .24Data Management .24Recommended Practices .28Personnel .28Lab Director .28Facilities .30Safety .31Evaluation and Issuance of Certificate .32List of Participating Labs .32Interim and Provisional Accreditation .33Interim Accreditation .33Provisional Accreditation.34Accreditation Categories .35Requirements for Maintaining Accreditation .36Page 1

Denying, Suspending, or Revoking Accreditation .37Denying Accreditation .37Suspending or Revoking Accreditation .37Recognition of Accreditation by Third Party.39Appeals .40Enforcement .41Ecology Assistance to Labs .42Special Requirements for Drinking Water Certification Officers .43Appendices .44Appendix A. Glossary and Acronyms .46Appendix B. Summary of Requirements to Use Accredited Laboratories .52Appendix C. Contacts at the Washington State Department of Ecology .54Page 2

Purpose of This ManualThis manual explains procedures for implementing the Washington State EnvironmentalLaboratory Accreditation Program, administered by the Washington State Department ofEcology. The manual provides guidance to laboratories participating in the program andto users of data from these laboratories.Chapter 173-50 WAC, Accreditation of Environmental Laboratories, establishes the stateprogram for accreditation of environmental laboratories, including labs that analyzedrinking water. The rule was last revised in 2002. Since then, the fee scheduleestablished by the rule has lost ground to inflation, preventing the program from beingrevenue neutral as intended by the Washington State Legislature.In 2010 we revised the rule to: Increase fees to meet the actual costs of conducting business. Our new fee structurealigns fees with the level of services required to accredit different types of labs. Clarify the grounds for revoking or suspending accreditation so that our rulesexpressly state that suspension or revocation can occur for failure to pay mandatoryfees and for failure to maintain third-party accreditation. Eliminate reciprocity agreements with other states and the exemption provisions forcertain wastewater discharge laboratories.A revised rule addressing the above issues became effective on September 9, 2010. Thisversion of the Procedural Manual for the Environmental Laboratory AccreditationProgram recognizes those revisions.Page 3

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IntroductionThis manual explains procedures for implementing the Washington State EnvironmentalLaboratory Accreditation Program. The program was established under provisions ofRCW 43.21A.230 and satisfies the intent of RCW 43.20.020.Chapter 173-50 WAC, Accreditation of Environmental Laboratories, establishes the stateprogram for accreditation of environmental laboratories, including labs that analyzedrinking water. These laws and rule provide the legal basis for the program.This manual is provided as an aid to labs affected by the Laboratory AccreditationProgram and to users of data from those labs. The manual is not intended forenforcement purposes.All enforcement actions are based on Chapter 173-50 WAC or on rules requiring the useof accredited laboratories. Chapter 173-50 WAC does not require labs to be accredited.This requirement is in other state, federal, or regulatory agency rules. Other documentssuch as permits, grants, or contracts also may stipulate that analytical data come fromaccredited labs. Requirements for use of accredited labs are summarized in Appendix Bof this manual.The Laboratory Accreditation Program is an important component of the effort to ensurethe accuracy and defensibility of analytical data used by the Washington StateDepartment of Ecology (Ecology), the Washington State Department of Health, and otherdata users. The process described in this manual ensures that accredited labs have thedemonstrated capability to provide accurate, defensible data for the parameters specifiedin their Scope of Accreditation.The Meaning of AccreditationAccreditation means: The lab's quality system, staff, facilities and equipment, test methods, records, andreports have been evaluated. The evaluation indicates the lab has the capability to provide accurate, defensibledata.Accreditation does not authorize use of a specific method for any specific program orproject. It is the responsibility of the laboratory to ensure that methods used to analyzeclient samples meet the requirements of the program or project for which the data areintended.Accreditation does not mean that any specific report or set of data originating in anaccredited lab is accurate or defensible. To ensure data quality, data users must requirePage 5

labs to provide sufficient evidence, usually in the form of results of quality control (QC)tests, with each set of data.Contents of This ManualThis procedural manual describes the following.For environmental laboratories Procedures for applying for participation in Ecology’s Laboratory AccreditationProgram. Process for developing a quality assurance (QA) program of the type expected in anaccredited lab and suggestions for preparing an effective QA manual. Requirements for participating in PT studies. Preparation for and conduct of the on-site audit. Special provisions for gaining accreditation for drinking water analyses.For Ecology’s Lab Accreditation Unit Criteria for recognizing third-party accreditation. Criteria for granting, denying, suspending, or revoking accreditation. Procedures for accrediting out-of-state laboratories. Mechanisms for notifying laboratories and data users of accreditation actions. Mandatory training requirements for Drinking Water Certification Officers.Page 6

Requirements for Participating in theLaboratory Accreditation ProgramInitial AccreditationTo become accredited, a lab must: Submit a complete application and pay the appropriate fee. Submit an acceptable QA manual. Submit documentation of initial QC procedures required by the methods. Successfully analyze required PT samples. Pass an on-site audit by Ecology or another recognized accrediting authority.Continuing AccreditationTo retain accreditation, a participating lab must: Submit results of PT sample analyses. Make required improvements in its QA program. Report significant changes in facility, equipment, personnel, or QA/QC procedures. Submit a renewal application and pay annual fees. Submit to required audits and implement any required corrective actions.Page 7

How to Apply for Accreditationand Pay FeesA lab obtains an application by contacting the Lab Accreditation Unit (see Appendix C)or from the Lab Accreditation web site: certifications/Laboratory-AccreditationIn addition to serving as a formal request for accreditation, the application providesinformation on personnel, equipment, and facilities available to conduct the testsrequested by the lab. All information submitted in the application is subject toverification by the Lab Accreditation Unit during the on-site audit or through othermeans. The accreditation fee is determined by (1) the number and complexity of therequested tests and (2) whether accreditation is through recognition of accreditation by athird party.For a large, multi-discipline laboratory, completing an application for initial accreditationcan be a daunting exercise. Labs are encouraged to submit a draft for review prior tosubmitting the final application with payment of fee.For out-of-state labs that require an on-site audit for initial accreditation, the LabAccreditation Unit will send the lab an estimate of travel costs for the on-site audit. Theout-of-state lab must sign and return the estimate prior to scheduling the on-site audit.After completion of the visit, Ecology will send an invoice to the lab for the actual travelcosts.Completed applications and the associated fee should be sent to the Ecology CashieringUnit (see Appendix C). Payment may be made by check, money order, or purchaseorder.A list of parameters with associated analyte and method codes and a fee calculator areavailable on our web site.Page 8

Quality Assurance ManualWhen a lab submits an initial application and pays the fee to the Ecology CashieringUnit, the lab must submit their QA manual to the Lab Accreditation Unit. The detail andscope of the QA manual should be commensurate with the size and mission of the lab.For example, a multi-discipline commercial lab may have a QA manual consisting ofseveral volumes, while a small wastewater treatment plant lab or health district water labmay have a manual of only a few pages.Why Is a QA Manual Required and Who Uses It?The purpose of the QA manual is to identify policies, organization, objectives, functionalactivities, and QA and QC activities designed to achieve quality goals desired foroperation of the lab. The manual is also intended to give confidence to users of the lab'sreports by indicating specific methods and procedures by which the lab achieves itsquality objectives.The QA manual documents how the lab ensures the quality of results reported by the lab.QA is important during sampling and transport of samples to the lab, while samples arebeing analyzed, and when data are reported. Because this is a lab accreditation program,the emphasis in reviewing the QA manual is on the analysis of samples and reporting ofresults, but documentation regarding sample management and data management is alsoaddressed.The QA manual is primarily intended for use by lab personnel to ensure reliability ofresults, and the manual must be readily available to analysts. Secondarily, it is used bypersonnel outside the lab to gain insight and confidence in the overall QA measures usedby the lab.Formatting a QA ManualA standard format is not required for QA manuals to meet the requirements of Ecology’sLaboratory Accreditation Program. The only requirement is that the manual describesadequately the QA procedures followed by the lab.An outline of a QA manual is presented on the following pages. While it is not necessaryto follow this format, all applicable items in the outline should be addressed. Aspreviously stated, the detail provided should be commensurate with the size of the laband scope of analyses performed. A model QA manual for a typical, small wastewatertreatment plant lab is available from our web site.The U.S. Environmental Protection Agency (EPA) has not specified a format for a QAmanual, but has specified requirements and content for a QA plan. Some labs haveprepared QA program plans and/or QA facility plans according to EPA guidelines. ThesePage 9

plans often include standard operating procedures (SOPs), each of which instructssomeone how to perform a specific task. A QA plan can fulfill the requirements of a QAmanual, as long as it includes information on each of the elements described below.Suggested Outline for a QA ManualThe following is an outline for a typical QA manual.1. Title Page and Table of ContentsThese are not required for short manuals.2. GlossaryBecause some QA/QC terms are not universally accepted, a list of frequently usedQA/QC terms is a necessary part of a QA manual. Appendix A is a glossary of terms asused by Ecology’s Laboratory Accreditation Program. The Model QA Manual availablefrom our web site also includes an abbreviated glossary.3. Organization and ResponsibilitiesThis section identifies (1) managers who establish QA policy, (2) analysts/technicianswho implement QA policy, and (3) the QA officer/coordinator if one exists.Large labs should include an organization chart. If organization and responsibilities arealready identified in a QA facility plan or other document, they need not be replicated inthe QA manual, but the supplemental document should be submitted for review.4. Policy for QA/QCThe overall policy and philosophy of the lab with respect to objectives for data qualityshould be included in the QA manual. Include a description of how data qualityobjectives are established for samples analyzed by the lab. Address both qualitative(e.g., completeness, representativeness, defensibility, accuracy) and quantitative(numerical objectives for precision and lack of bias) objectives. Include policy fortraining lab personnel in QA/QC.5. Sample ManagementThis section (1) describes those aspects of sampling which relate to or are theresponsibility of the lab, (2) specifies procedures for requesting sample analyses (neededby users of the lab) and receipt, logging, storage, and handling of samples, (3) includesPage 10

procedures for chain-of-custody (if not in a separate SOP or appendix to the QA manual),and (4) includes criteria for acceptance or rejection of samples submitted to the lab.For compliance monitoring under the Safe Drinking Water Act or the Clean Water Act,required containers, preservation techniques, and holding times are specified in theFederal Register or Code of Federal Regulations (CFR).6. MethodsThis section lists all analytical methods used in the lab with references to publishedmethods. For compliance monitoring under the Safe Drinking Water or the Clean WaterAct, required methods are specified in the Federal Register or CFR.7. Calibration and Quality Control ProceduresThis section includes procedures for calibration, standardization, and QC for eachanalytical method used in the lab. Specify the QC samples included with each

activities, and QA and QC activities designed to achieve quality goals desired for operation of the lab. The manual is also intended to give confidence to users of the lab's reports by indicating specific methods and procedures by which the lab achieves its quality objectives.

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