preparing for accreditation
DESCRIPTION
Jerry L. Parr Catalyst Information Resources, L.L.C. TNRCC Trade Fair May 7, 2002. Preparing for Accreditation. NELAC Accreditation: Start to Finish. 1. Deciding to apply 2. Understanding the requirements 3. Getting ready 4. Accreditation process. Key Documents. NELAC Standards - PowerPoint PPT PresentationTRANSCRIPT
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
www.CatalystInfoResources.com