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Preparing for Accreditation Jerry L. Parr Catalyst Information Resources, L. L. C. TNRCC Trade Preparing for Accreditation Jerry L. Parr Catalyst Information Resources, L. L. C. TNRCC Trade Fair May 7, 2002

NELAC Accreditation: Start to Finish 1. 2. 3. 4. Deciding to apply Understanding the NELAC Accreditation: Start to Finish 1. 2. 3. 4. Deciding to apply Understanding the requirements Getting ready Accreditation process

Key Documents Ø NELAC Standards Ø Assessor Training Manual Ø National Standards for Water Key Documents Ø NELAC Standards Ø Assessor Training Manual Ø National Standards for Water PT v. NELAC PT Tables Ø State Requirements Ø State Fields of Testing

STEP 1: Deciding to Apply Ø Your state’s requirements Ø Improve data quality Ø STEP 1: Deciding to Apply Ø Your state’s requirements Ø Improve data quality Ø Customer expectations Ø Marketing advantage

NELAC Improves Data Quality Ø Implementation of a Quality System Ø Improved documentation Ø NELAC Improves Data Quality Ø Implementation of a Quality System Ø Improved documentation Ø Standardized policies and procedures Ø Ethics program Ø Improved technical procedures

Customer Expectations Ø EPA v. SDWA v. OSWER v. OIG Ø DOD Ø Industry Customer Expectations Ø EPA v. SDWA v. OSWER v. OIG Ø DOD Ø Industry

Marketing Considerations Ø Recognized standard of excellence Ø Use of logo Ø Reciprocity = Marketing Considerations Ø Recognized standard of excellence Ø Use of logo Ø Reciprocity = geographic expansion

The Application q 20 detailed items q Certificate of compliance q Fields of testing The Application q 20 detailed items q Certificate of compliance q Fields of testing q Quality manual q Fee q State options

Required Elements in Application q. Legal name of lab q. Address q. Owner (and Required Elements in Application q. Legal name of lab q. Address q. Owner (and address) q. Location q. Name and phone of TD, QAO, contact q. Hours of operation q. Primary AA q. Fields of testing q. Methods employed (with analytes) q. Lab type

Certificate of Compliance Ø Attest to compliance to NELAC standards Ø Signed by Technical Certificate of Compliance Ø Attest to compliance to NELAC standards Ø Signed by Technical Director & QA Director

Fields of Testing Ø Area: ü Chemistry, Microbiology, WET, Radiochemistry, Field Activities Ø Program Fields of Testing Ø Area: ü Chemistry, Microbiology, WET, Radiochemistry, Field Activities Ø Program Ø SDWA, CWA, RCRA, CAA (TSCA, FIFRA, CERCLA) Ø Changes to be made in 2002 Ø Method/Analyte Ø Change to technology? Ø Include analyte group?

STEP 2 - Understanding the Requirements Ø Proficiency Testing Ø Quality System Ø Personnel STEP 2 - Understanding the Requirements Ø Proficiency Testing Ø Quality System Ø Personnel Qualifications

PT Program Review Ø Two PT samples per year per field of testing where PT Program Review Ø Two PT samples per year per field of testing where available Ø Purchase from any approved supplier Ø Uniform acceptance criteria Ø Pass 2 out of last 3

NELAC QUALITY SYSTEM Ø Elements documented in quality manual Ø Policies and objectives and NELAC QUALITY SYSTEM Ø Elements documented in quality manual Ø Policies and objectives and commitment to accepted laboratory practices and quality of testing services Ø Annual internal audit and management review

NELAC Quality Manual Ø Policies and operational procedures established to meet NELAC standard. Ø NELAC Quality Manual Ø Policies and operational procedures established to meet NELAC standard. Ø Probably most significant up-front investment Ø Must address all QS elements Ø Template available from Catalyst

Elements of a Quality System Ø Personnel Ø Physical facilities Ø Equipment and reference Elements of a Quality System Ø Personnel Ø Physical facilities Ø Equipment and reference materials Ø Measurement traceability and calibration Ø Test methods and SOPs Ø Method verification (Appendix C)

Elements of a Quality System (2) Ø Sample handling Ø Records and storage of Elements of a Quality System (2) Ø Sample handling Ø Records and storage of records Ø Laboratory report format and content Ø Subcontracting Ø Complaint procedures Ø Essential QC Procedures (Appendix D) Ø Chemical, WET, Micro, Radiochemistry, Air

Sample Handling Ø Sample tracking Ø Sample acceptance Ø Sample receipt Ø Sample storage Sample Handling Ø Sample tracking Ø Sample acceptance Ø Sample receipt Ø Sample storage Ø Legal chain of custody Ø Sample disposal

Calibration Ø Traceability of calibration Ø Reference standards Ø General requirements Ø Analytical support Calibration Ø Traceability of calibration Ø Reference standards Ø General requirements Ø Analytical support equipment Ø Instrument calibration

QA/QC Ø Document control Ø Acceptable permitting departures from documented policies, procedures, & specifications QA/QC Ø Document control Ø Acceptable permitting departures from documented policies, procedures, & specifications Ø Corrective action Ø Complaint handling Ø Preventive action Ø Internal audits Ø Developing acceptance criteria when no method or regulatory requirement exists

Data Review and Reporting Ø Data review Ø Reporting analytical results Ø Electronic reporting Data Review and Reporting Ø Data review Ø Reporting analytical results Ø Electronic reporting Ø Record retention Ø Records transfer Ø Data integrity Ø Data security

Test Methods Ø May be copies of published methods Ø Must address 23 elements Test Methods Ø May be copies of published methods Ø Must address 23 elements

Essential Quality Control Required activities, acceptance criteria and corrective action for: D. 1 Chemistry 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 Ø Method Blanks Ø LCS Ø MS Ø Surrogates Ø Detection Limits Chemistry QC Ø Method Blanks Ø LCS Ø MS Ø Surrogates Ø Detection Limits Ø Selectivity Major revision in 2001 Standards

Detection Limit Determination Ø Appropriate (e. g. , MDL) Ø Limited exceptions (e. g. Detection Limit Determination Ø Appropriate (e. g. , MDL) Ø Limited exceptions (e. g. , temperature) Ø Each Matrix (see Glossary) Ø Link to Quantitation Limit Ø Redo if “significant change” Ø Link to instrument calibration

Demonstration of Capability ØAll methods Ø 4 replicates at 10 X DL ØCompare X Demonstration of Capability ØAll methods Ø 4 replicates at 10 X DL ØCompare X and s to acceptance criteria ØLimited exceptions Ø“Work cell” provision ØCertification statement Exception in 2001 standards for methods in use before July 1999

Analyst Proficiency One of the following at least once per year: Ø Single blind Analyst Proficiency One of the following at least once per year: Ø Single blind Ø DOC Ø PT sample Ø 4 LCS Ø Sample analyzed by another

STEP 2 - Understanding the Requirements Proficiency Testing Quality System Ø Personnel Qualifications STEP 2 - Understanding the Requirements Proficiency Testing Quality System Ø Personnel Qualifications

Technical Director Ø Full time employee Ø Oversee all lab operations üQA/QC üData being Technical Director Ø Full time employee Ø Oversee all lab operations üQA/QC üData being generated üSufficient qualified personnel Ø “One or more” may be appointed

TD for Chemical Analysis Ø Bachelor’s degree in chemical, environmental, biological sciences, physical sciences, TD for Chemical Analysis Ø Bachelor’s degree in chemical, environmental, biological sciences, physical sciences, or engineering Ø 24 college semester credit hours in chemistry Ø 2 years of experience in environmental analysis Ø Master’s or Ph. D. may be substituted for 1 year experience

TD for Inorganic Analysis (non metals) Ø Associate’s degree in chemical, physical or environmental TD for Inorganic Analysis (non metals) Ø Associate’s degree in chemical, physical or environmental sciences or Ø 2 years college education and Ø 16 semester credit hours in chemistry Ø 2 years of experience

TD for Microbiology Ø Bachelor’s degree in microbiology, chemistry, environmental sciences, physical sciences, or TD for Microbiology Ø Bachelor’s degree in microbiology, chemistry, environmental sciences, physical sciences, or engineering Ø 16 semester credit hours in general microbiology and biology Ø 2 years of experience Ø Master’s or Ph. D. may be substituted for 1 year experience

Exception for Microbiology Ø Associate’s degree in science (or 2 years college) with 4 Exception for Microbiology Ø Associate’s degree in science (or 2 years college) with 4 hours in general microbiology and 1 year experience in environmental analysis Ø Limited to fecal coliform, total coliform, & standard plate count

Grandfather Clause Ø Does not meet educational requirements Ø Is the TD on date Grandfather Clause Ø Does not meet educational requirements Ø Is the TD on date laboratory “applies” or “becomes subject to” NELAC standards AND has been TD for one year (new for 2001) Ø Can be TD at any other comparable laboratory Ø Limited to first year of program

Exceptions Full-time employee: Ø Of drinking water or sewage treatment facility with valid treatment Exceptions Full-time employee: Ø 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 Ø 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 Ø May be TD or deputy TD if limited staff Ø Quality Assurance Officer Ø May be TD or deputy TD if limited staff Ø Responsible for quality system management & implementation ü Focal point for QA/QC ü Documented training and/or experience in QA/QC ü Knowledge of the test methods ü Arrange for or conduct internal audits annually ü Notify lab management of deficiencies in quality system & ensure corrective action Ø No educational or experience requirements

STEP 3 - Getting Ready ØOrganizational Decisions § § Technical Director Quality Assurance Officer STEP 3 - Getting Ready ØOrganizational Decisions § § Technical Director Quality Assurance Officer ØData Generation § § PT Sample Data Method Performance Data ØDocumentation § § § Quality Manual SOPs Administrative Information

Organizational Options Ø Multiple TD(s), QAO Ø Singe TD, QAO Ø TD = QAO Organizational Options Ø Multiple TD(s), QAO Ø Singe TD, QAO Ø TD = QAO

Quality Assurance Officer Ø Title is optional Ø Direct access to management Ø May Quality Assurance Officer Ø Title is optional Ø Direct access to management Ø May be technical director Ø Specific job functions

Recommendations for TD/QAO Ø Have TD and QAO as 2 positions, if organization will Recommendations for TD/QAO Ø Have TD and QAO as 2 positions, if organization will allow Ø Have single TD, if qualifications allow Ø Have deputy TDs for contingency/growth Ø Consider grandfather clause

Summary of Data Needed Ø 2 PT samples results Ø Detection limits Ø Demonstration Summary of Data Needed Ø 2 PT samples results Ø Detection limits Ø Demonstration of capability (not required for methods already in use, but a good idea)

Administrative Information Ø Laboratory organization Ø Personnel training Ø Equipment & reference materials Ø Administrative Information Ø Laboratory organization Ø Personnel training Ø Equipment & reference materials Ø Standards & reagents Ø Other

Laboratory Organization Ø Organization chart üIdentification of major units Ø Lines of responsibility Laboratory Organization Ø Organization chart üIdentification of major units Ø Lines of responsibility

Personnel Records Ø Job descriptions Ø Documentation of education/technical background Ø Documentation for each Personnel Records Ø Job descriptions Ø Documentation of education/technical background Ø Documentation for each employee relating to quality manual Ø Training records Ø Analyst proficiency

Equipment & Reference Materials Ø Name of equipment Ø Manufacturer & serial number Ø Equipment & Reference Materials Ø Name of equipment Ø Manufacturer & serial number Ø Date received/placed into serviced Ø Current location Ø Condition when received Ø Copy of manufacturer’s instructions Ø Dates of calibration Ø Details of maintenance Ø History Ø Calibration certifications

Standards and Reagents Ø Certificate of analysis Ø Date of receipt Ø Manufacturer/vendor Ø Standards and Reagents Ø Certificate of analysis Ø Date of receipt Ø Manufacturer/vendor Ø Storage conditions Ø Expiration dates Ø Other information (e. g. , sample disposal records)

STEP 4: The Assessment Process STEP 4: The Assessment Process

Understand the Assessment Process Ø Assessors (i. e. auditors) Ø Frequency Ø Pre-Assessment Ø Understand the Assessment Process Ø Assessors (i. e. auditors) Ø Frequency Ø Pre-Assessment Ø On-site Assessment (i. e. the Audit) Ø Assessment Report Ø Corrective Action Ø Closure

Steps to Take Ø Review assessor training manual Ø Review checklist Ø Internal/contractor review Steps to Take Ø Review assessor training manual Ø Review checklist Ø Internal/contractor review Ø Preliminary record submittal ü SOPs ü Data package ü Other information Ø Review due process rules

Your Rights Before the On-Site Ø Checklist(s) Ø Confidentiality notice Ø Conflict of interest Your Rights Before the On-Site Ø Checklist(s) Ø Confidentiality notice Ø Conflict of interest form Ø Assessor credentials Ø Mutually agreeable date

Award of Accreditation Ø Certificate üSigned by AA, effective dates, NELAC logo üIncludes fields Award of Accreditation Ø Certificate üSigned by AA, effective dates, NELAC logo üIncludes fields of testing üMust be posted

Staying Accredited Ø Compliance with Chapter 5 Ø PTs (twice a year) Ø On-site Staying Accredited Ø Compliance with Chapter 5 Ø PTs (twice a year) Ø On-site (every 2 years) Ø Notification of key changes (< 30 days) ü Ownership ü Location ü Key personnel ü Instrumentation

Other Important Information Ø EH&S not included Ø Use of logo Ø No supplemental Other Important Information Ø EH&S not included Ø Use of logo Ø No supplemental requirements Ø Mobile laboratories Ø Record retention: 5 years

SUMMARY Know the standards Decide to apply Get ready Collect information Plan for the SUMMARY Know the standards Decide to apply Get ready Collect information Plan for the On–Site Stay accredited! NELAC Accredited!

HELP? Ø NELAC Website www. epa. gov/ttn/nelac Ø EPA QA Documents www. epa. gov/quality HELP? Ø NELAC Website www. epa. gov/ttn/nelac Ø EPA QA Documents www. epa. gov/quality v. QAMS 005 (print only) v. QA/G-5 v. QA/R-5 Ø EPA SOP Guidance v. OW Streamlining Appendix F (3/28/97 FR) v. QA/G-6 Ø Catalyst www. catalystinforesources. com ü Template Quality Manual ü SOP Guidance ü Many other related documents

Jerry L. Parr Catalyst Information Resources, L. L. C. The Information Resource for Environmental Jerry L. Parr Catalyst Information Resources, L. L. C. The Information Resource for Environmental Professionals 817 -598 -1155 [email protected] net www. Catalyst. Info. Resources. com