preparing for accreditation jerry l. parr catalyst information resources, l.l.c. tnrcc trade fair...
TRANSCRIPT
![Page 1: Preparing for Accreditation Jerry L. Parr Catalyst Information Resources, L.L.C. TNRCC Trade Fair May 7, 2002](https://reader038.vdocuments.net/reader038/viewer/2022110206/56649d145503460f949e99bd/html5/thumbnails/1.jpg)
Preparing for Accreditation
Jerry L. ParrCatalyst Information Resources, L.L.C.
TNRCC Trade FairMay 7, 2002
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NELAC Accreditation: Start to Finish
1. Deciding to apply2. Understanding the requirements3. Getting ready4. Accreditation process
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Key Documents
NELAC Standards Assessor Training Manual National Standards for Water PT
NELAC PT Tables State Requirements State Fields of Testing
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STEP 1: Deciding to Apply
Your state’s requirements
Improve data quality
Customer expectations
Marketing advantage
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NELAC Improves Data Quality
Implementation of a Quality SystemImproved documentationStandardized policies and
proceduresEthics programImproved technical procedures
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Customer Expectations
EPASDWAOSWEROIG
DODIndustry
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Marketing Considerations
Recognized standard of excellenceUse of logoReciprocity = geographic expansion
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The Application
20 detailed items
Certificate of compliance
Fields of testing
Quality manual
Fee
State options
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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
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Certificate of Compliance
Attest to compliance to NELAC standards
Signed by Technical Director & QA Director
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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?
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STEP 2 - Understanding the Requirements
Proficiency TestingQuality SystemPersonnel Qualifications
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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
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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
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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
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Elements of a Quality System
Personnel
Physical facilities
Equipment and reference materials
Measurement traceability and calibration
Test methods and SOPsMethod verification (Appendix C)
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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
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Sample Handling
Sample tracking
Sample acceptance
Sample receipt
Sample storage
Legal chain of custody
Sample disposal
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Calibration
Traceability of calibration
Reference standards
General requirements
Analytical support equipment
Instrument calibration
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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
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Data Review and Reporting
Data reviewReporting analytical resultsElectronic reportingRecord retentionRecords transferData integrityData security
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Test Methods
May be copies of published methodsMust address 23 elements
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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
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Chemistry QC
Method BlanksLCSMSSurrogatesDetection LimitsSelectivityMajor revision in 2001 Standards
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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
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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
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Analyst Proficiency
One of the following at least once per year:
Single blindDOCPT sample4 LCSSample analyzed by another
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STEP 2 - Understanding the Requirements
Proficiency Testing
Quality System
Personnel Qualifications
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Technical Director
Full time employeeOversee all lab operations
QA/QCData being generatedSufficient qualified personnel
“One or more” may be appointed
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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
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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
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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
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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
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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
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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
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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
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STEP 3 - Getting Ready
Organizational DecisionsTechnical DirectorQuality Assurance Officer
Data GenerationPT Sample DataMethod Performance Data
DocumentationQuality ManualSOPsAdministrative Information
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Organizational Options
Multiple TD(s), QAOSinge TD, QAOTD = QAO
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Quality Assurance Officer
Title is optionalDirect access to managementMay be technical directorSpecific job functions
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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
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Summary of Data Needed
2 PT samples resultsDetection limitsDemonstration of capability (not
required for methods already in use, but a good idea)
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Administrative Information
Laboratory organizationPersonnel trainingEquipment & reference materialsStandards & reagentsOther
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Laboratory Organization
Organization chartIdentification of major units
Lines of responsibility
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Personnel Records
Job descriptionsDocumentation of
education/technical backgroundDocumentation for each employee
relating to quality manualTraining recordsAnalyst proficiency
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Equipment & Reference MaterialsName of equipmentManufacturer & serial numberDate received/placed into servicedCurrent locationCondition when receivedCopy of manufacturer’s instructionsDates of calibrationDetails of maintenanceHistoryCalibration certifications
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Standards and Reagents
Certificate of analysisDate of receiptManufacturer/vendorStorage conditionsExpiration datesOther information (e.g., sample
disposal records)
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STEP 4: The Assessment Process
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Understand the Assessment Process
Assessors (i.e. auditors)FrequencyPre-AssessmentOn-site Assessment (i.e. the Audit)Assessment ReportCorrective ActionClosure
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Steps to Take
Review assessor training manual
Review checklistInternal/contractor reviewPreliminary record submittal
SOPsData packageOther information
Review due process rules
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Your Rights Before the On-Site
Checklist(s)Confidentiality noticeConflict of interest formAssessor credentialsMutually agreeable date
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Award of Accreditation
CertificateSigned by AA, effective dates, NELAC
logoIncludes fields of testingMust be posted
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Staying Accredited
Compliance with Chapter 5PTs (twice a year)On-site (every 2 years)Notification of key changes (< 30
days)OwnershipLocationKey personnelInstrumentation
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Other Important Information
EH&S not includedUse of logoNo supplemental requirementsMobile laboratoriesRecord retention: 5 years
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Accredited!
Know the standards
Decide to apply
Get ready
Collect information
Plan for the On–Site
Stay accredited!
SUMMARY
NELAC
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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
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Jerry L. Parr
Catalyst Information Resources, L.L.C. The Information Resource for Environmental Professionals
www.CatalystInfoResources.com