Preparing for Accreditation

Jerry L. ParrCatalyst Information Resources, L.L.C.

TNRCC Trade FairMay 7, 2002

NELAC Accreditation: Start to Finish

1. Deciding to apply2. Understanding the requirements3. Getting ready4. Accreditation process

Key Documents

NELAC Standards Assessor Training Manual National Standards for Water PT

NELAC PT Tables State Requirements State Fields of Testing

STEP 1: Deciding to Apply

Your state’s requirements

Improve data quality

Customer expectations

Marketing advantage

NELAC Improves Data Quality

Implementation of a Quality SystemImproved documentationStandardized policies and

proceduresEthics programImproved technical procedures

Customer Expectations

EPASDWAOSWEROIG

DODIndustry

Marketing Considerations

Recognized standard of excellenceUse of logoReciprocity = geographic expansion

The Application

20 detailed items

Certificate of compliance

Fields of testing

Quality manual

Fee

State options

Required Elements in Application

Legal name of lab

AddressOwner (and

address)LocationName and phone

of TD, QAO, contact

Hours of operation

Primary AAFields of testingMethods

employed (with analytes)

Lab type

Certificate of Compliance

Attest to compliance to NELAC standards

Signed by Technical Director & QA Director

Fields of Testing

Area: Chemistry, Microbiology, WET, Radiochemistry,

Field Activities

ProgramSDWA, CWA, RCRA, CAA (TSCA, FIFRA, CERCLA)Changes to be made in 2002

Method/AnalyteChange to technology? Include analyte group?

STEP 2 - Understanding the Requirements

Proficiency TestingQuality SystemPersonnel Qualifications

PT Program Review

Two PT samples per year per field of testing where available

Purchase from any approved supplier

Uniform acceptance criteriaPass 2 out of last 3

NELAC QUALITY SYSTEM

Elements documented in quality manual

Policies and objectives and commitment to accepted laboratory practices and quality of testing services

Annual internal audit and management review

NELAC Quality Manual

Policies and operational procedures established to meet NELAC standard.

Probably most significant up-front investment

Must address all QS elements Template available from Catalyst

Elements of a Quality System

Personnel

Physical facilities

Equipment and reference materials

Measurement traceability and calibration

Test methods and SOPsMethod verification (Appendix C)

Elements of a Quality System (2)

Sample handlingRecords and storage of records Laboratory report format and contentSubcontractingComplaint proceduresEssential QC Procedures (Appendix D)

Chemical, WET, Micro, Radiochemistry, Air

Sample Handling

Sample tracking

Sample acceptance

Sample receipt

Sample storage

Legal chain of custody

Sample disposal

Calibration

Traceability of calibration

Reference standards

General requirements

Analytical support equipment

Instrument calibration

QA/QCDocument controlAcceptable permitting departures from

documented policies, procedures, & specifications

Corrective actionComplaint handlingPreventive action Internal auditsDeveloping acceptance criteria when no

method or regulatory requirement exists

Data Review and Reporting

Data reviewReporting analytical resultsElectronic reportingRecord retentionRecords transferData integrityData security

Test Methods

May be copies of published methodsMust address 23 elements

Essential Quality Control

Required activities, acceptance criteria and corrective action for: D.1 Chemistry D.2 WET Testing D.3 Microbiology D.4 Radiochemistry D.5 Air

Chemistry QC

Method BlanksLCSMSSurrogatesDetection LimitsSelectivityMajor revision in 2001 Standards

Detection Limit Determination

Appropriate (e.g., MDL)

Limited exceptions (e.g., temperature)

Each Matrix (see Glossary)

Link to Quantitation Limit

Redo if “significant change”

Link to instrument calibration

Demonstration of Capability

All methods

4 replicates at 10 X DL

Compare X and s to acceptance criteria

Limited exceptions

“Work cell” provision

Certification statement

Exception in 2001 standards for methods in use before July 1999

Analyst Proficiency

One of the following at least once per year:

Single blindDOCPT sample4 LCSSample analyzed by another

STEP 2 - Understanding the Requirements

Proficiency Testing

Quality System

Personnel Qualifications

Technical Director

Full time employeeOversee all lab operations

QA/QCData being generatedSufficient qualified personnel

“One or more” may be appointed

TD for Chemical AnalysisBachelor’s degree in chemical,

environmental, biological sciences, physical sciences, or engineering

24 college semester credit hours in chemistry

2 years of experience in environmental analysis

Master’s or Ph.D. may be substituted for 1 year experience

TD for Inorganic Analysis (non metals)

Associate’s degree in chemical, physical or environmental sciences

or2 years college education

and16 semester credit hours in chemistry2 years of experience

TD for MicrobiologyBachelor’s degree in microbiology,

biology, chemistry, environmental sciences, physical sciences, or engineering

16 semester credit hours in general microbiology and biology

2 years of experienceMaster’s or Ph.D. may be substituted

for 1 year experience

Exception for MicrobiologyAssociate’s degree in science (or 2

years college) with 4 hours in general microbiology and 1 year experience in environmental analysis

Limited to fecal coliform, total coliform, & standard plate count

Grandfather Clause

Does not meet educational requirements

Is the TD on date laboratory “applies” or “becomes subject to” NELAC standards AND has been TD for one year (new for 2001)

Can be TD at any other comparable laboratory

Limited to first year of program

Exceptions

Full-time employee: Of drinking water or sewage treatment facility

with valid treatment plant operator’s certificate appropriate for that facility is approved to serve as director of accredited lab devoted to samples taken within facility

Of industrial waste treatment facility with 1 year supervised experience is approved as director of accredited lab devoted to samples taken within facility

Quality Assurance Officer

May be TD or deputy TD if limited staffResponsible for quality system

management & implementationFocal point for QA/QC Documented training and/or experience in QA/QCKnowledge of the test methodsArrange for or conduct internal audits annuallyNotify lab management of deficiencies in quality

system & ensure corrective action No educational or experience requirements

STEP 3 - Getting Ready

Organizational DecisionsTechnical DirectorQuality Assurance Officer

Data GenerationPT Sample DataMethod Performance Data

DocumentationQuality ManualSOPsAdministrative Information

Organizational Options

Multiple TD(s), QAOSinge TD, QAOTD = QAO

Quality Assurance Officer

Title is optionalDirect access to managementMay be technical directorSpecific job functions

Recommendations for TD/QAO

Have TD and QAO as 2 positions, if organization will allow

Have single TD, if qualifications allowHave deputy TDs for

contingency/growthConsider grandfather clause

Summary of Data Needed

2 PT samples resultsDetection limitsDemonstration of capability (not

required for methods already in use, but a good idea)

Administrative Information

Laboratory organizationPersonnel trainingEquipment & reference materialsStandards & reagentsOther

Laboratory Organization

Organization chartIdentification of major units

Lines of responsibility

Personnel Records

Job descriptionsDocumentation of

education/technical backgroundDocumentation for each employee

relating to quality manualTraining recordsAnalyst proficiency

Equipment & Reference MaterialsName of equipmentManufacturer & serial numberDate received/placed into servicedCurrent locationCondition when receivedCopy of manufacturer’s instructionsDates of calibrationDetails of maintenanceHistoryCalibration certifications

Standards and Reagents

Certificate of analysisDate of receiptManufacturer/vendorStorage conditionsExpiration datesOther information (e.g., sample

disposal records)

STEP 4: The Assessment Process

Understand the Assessment Process

Assessors (i.e. auditors)FrequencyPre-AssessmentOn-site Assessment (i.e. the Audit)Assessment ReportCorrective ActionClosure

Steps to Take

Review assessor training manual

Review checklistInternal/contractor reviewPreliminary record submittal

SOPsData packageOther information

Review due process rules

Your Rights Before the On-Site

Checklist(s)Confidentiality noticeConflict of interest formAssessor credentialsMutually agreeable date

Award of Accreditation

CertificateSigned by AA, effective dates, NELAC

logoIncludes fields of testingMust be posted

Staying Accredited

Compliance with Chapter 5PTs (twice a year)On-site (every 2 years)Notification of key changes (< 30

days)OwnershipLocationKey personnelInstrumentation

Other Important Information

EH&S not includedUse of logoNo supplemental requirementsMobile laboratoriesRecord retention: 5 years

Accredited!

Know the standards

Decide to apply

Get ready

Collect information

Plan for the On–Site

Stay accredited!

SUMMARY

NELAC

HELP?

NELAC Website www.epa.gov/ttn/nelac EPA QA Documents www.epa.gov/quality

QAMS 005 (print only)QA/G-5QA/R-5

EPA SOP GuidanceOW Streamlining Appendix F (3/28/97 FR)QA/G-6

Catalyst www.catalystinforesources.comTemplate Quality ManualSOP GuidanceMany other related documents

Jerry L. Parr

Catalyst Information Resources, L.L.C. The Information Resource for Environmental Professionals

817-598-1155catalyst@eazy.net

www.CatalystInfoResources.com