National Environmental Laboratory Accreditation Conference

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Preparing for Accreditation
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NELAC Accreditation Start to Finish

• 1. Deciding to apply
• 2. Understanding the requirements
• 3. Getting ready
• 4. 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 states requirements
• Improve data quality
• Customer expectations
• Marketing advantage

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NELAC Improves Data Quality

• Implementation of a Quality System
• Improved documentation
• Standardized policies and procedures
• Ethics program
• Improved technical procedures

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Customer Expectations

• EPA
• SDWA
• OSWER
• OIG
• DOD
• Industry

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Marketing Considerations

• Recognized standard of excellence
• Use of logo
• Reciprocity 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
• Address
• Owner (and address)
• Location
• Name and phone of TD, QAO, contact

• Hours of operation
• Primary AA
• Fields of testing
• Methods 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
• Program
• SDWA, CWA, RCRA, CAA (TSCA, FIFRA, CERCLA)
• Changes to be made in 2002
• Method/Analyte
• Change to technology?
• Include analyte group?

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STEP 2 - Understanding the Requirements

• Proficiency Testing
• Quality System
• Personnel 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 criteria
• Pass 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 SOPs
• Method verification (Appendix C)

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Elements of a Quality System (2)

• Sample handling
• Records and storage of records
• Laboratory report format and content
• Subcontracting
• Complaint procedures
• Essential 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/QC

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

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Data Review and Reporting

• Data review
• Reporting analytical results
• Electronic reporting
• Record retention
• Records transfer
• Data integrity
• Data security

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Test Methods

• May be copies of published methods
• Must 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 Blanks
• LCS
• MS
• Surrogates
• Detection Limits
• Selectivity
• Major 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 blind
• DOC
• PT sample
• 4 LCS
• Sample 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 employee
• Oversee all lab operations
• QA/QC
• Data being generated
• Sufficient qualified personnel
• One or more may be appointed

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TD for Chemical Analysis

• Bachelors degree in chemical, environmental,
  biological sciences, physical sciences, or
  engineering
• 24 college semester credit hours in chemistry
• 2 years of experience in environmental analysis
• Masters or Ph.D. may be substituted for 1 year
  experience

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TD for Inorganic Analysis (non metals)

• Associates degree in chemical, physical or
  environmental sciences
• or
• 2 years college education
• and
• 16 semester credit hours in chemistry
• 2 years of experience

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TD for Microbiology

• Bachelors degree in microbiology, biology,
  chemistry, environmental sciences, physical
  sciences, or engineering
• 16 semester credit hours in general microbiology
  and biology
• 2 years of experience
• Masters or Ph.D. may be substituted for 1 year
  experience

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Exception for Microbiology

• Associates 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 operators 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 staff
• Responsible for quality system management
  implementation
• Focal point for QA/QC
• Documented training and/or experience in QA/QC
• Knowledge of the test methods
• Arrange for or conduct internal audits annually
• Notify lab management of deficiencies in quality
  system ensure corrective action
• No educational or experience requirements

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STEP 3 - Getting Ready

• Organizational Decisions
• Technical Director
• Quality Assurance Officer
• Data Generation
• PT Sample Data
• Method Performance Data
• Documentation
• Quality Manual
• SOPs
• Administrative Information

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Organizational Options

• Multiple TD(s), QAO
• Singe TD, QAO
• TD QAO

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Quality Assurance Officer

• Title is optional
• Direct access to management
• May be technical director
• Specific 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 allow
• Have deputy TDs for contingency/growth
• Consider grandfather clause

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Summary of Data Needed

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

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Administrative Information

• Laboratory organization
• Personnel training
• Equipment reference materials
• Standards reagents
• Other

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Laboratory Organization

• Organization chart
• Identification of major units
• Lines of responsibility

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Personnel Records

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

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Equipment Reference Materials

• Name of equipment
• Manufacturer serial number
• Date received/placed into serviced
• Current location
• Condition when received
• Copy of manufacturers instructions
• Dates of calibration
• Details of maintenance
• History
• Calibration certifications

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Standards and Reagents

• Certificate of analysis
• Date of receipt
• Manufacturer/vendor
• Storage conditions
• Expiration dates
• Other 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)
• Frequency
• Pre-Assessment
• On-site Assessment (i.e. the Audit)
• Assessment Report
• Corrective Action
• Closure

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Steps to Take

• Review assessor training manual
• Review checklist
• Internal/contractor review
• Preliminary record submittal
• SOPs
• Data package
• Other information
• Review due process rules

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Your Rights Before the On-Site

• Checklist(s)
• Confidentiality notice
• Conflict of interest form
• Assessor credentials
• Mutually agreeable date

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Award of Accreditation

• Certificate
• Signed by AA, effective dates, NELAC logo
• Includes fields of testing
• Must be posted

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Staying Accredited

• Compliance with Chapter 5
• PTs (twice a year)
• On-site (every 2 years)
• Notification of key changes (lt 30 days)
• Ownership
• Location
• Key personnel
• Instrumentation

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Other Important Information

• EHS not included
• Use of logo
• No supplemental requirements
• Mobile laboratories
• Record retention 5 years

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SUMMARY
Know the standards Decide to apply Get
ready Collect information Plan for the
OnSite Stay accredited!
NELAC
Accredited!
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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-5
• QA/R-5
• EPA SOP Guidance
• OW Streamlining Appendix F (3/28/97 FR)
• QA/G-6
• Catalyst www.catalystinforesources.com
• Template Quality Manual
• SOP Guidance
• Many other related documents

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