The Benefits of National Accreditation

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The Benefits of National Accreditation

• Steve Arms
• The NELAC Institute
• TNI

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The NELAC Institutes Mission

• To foster the generation of environmental data of
  known and documented quality through an open,
  inclusive, and transparent process that is
  responsive to the needs of the community

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The NELAC InstitutesVision for the Future

• A true national accreditation program, whereby
  all entities involved in the generation of
  environmental measurement data within the United
  States are accredited to one uniform, rigorous,
  and robust program that has been implemented
  consistently nationwide and focuses on the
  technical competence of the entity pursuing
  accreditation

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TNIs Accreditation Programs

• Designed to ensured competency
• Intended to ensure environmental data of known
  and documented quality

An objective way of showing clients, the
community and the government that an organization
has the demonstrated capability to conduct the
services they provide.
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National Environmental Laboratory Accreditation
Program (NELAP)
To establish and implement a program for the
accreditation of environmental laboratories

• Program components
• The recognition of accreditation bodies
• The adoption of acceptance limits for proficiency
  testing
• The adoption of consensus standards for use in
  the program
• The adoption of the laboratory accreditation
  system

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National Environmental Field Accreditation
Program (NEFAP)
To establish and implement a program for the
accreditation of field sampling and measurement
organizations (FSMOs)

• Program components
• The recognition of accreditation bodies
• The development and adoption of the accreditation
  system

TNI is also pursuing the development of standards
for assuring the competency of organizations
involved in stationary source air emissions
testing.
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NELAP AccreditationUnique

• Based on an internationally recognized standard
  expanded to focus on unique aspects of
  environmental testing
• Performed with respect to a specific scope of
  accreditation conducted by qualified assessors
• Involves review of results of periodic
  proficiency testing performed by the laboratory

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NELAP AccreditationExtensive

• Over 1500 accredited laboratories
• Over 2000 accreditations
• 48 states and 1 territory
• 8 foreign countries

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Laboratory Accreditation System Program

• Develops a system for the accreditation of
  environmental laboratories
• Policies and procedures, interpretations,
  guidance documents, and related tools for use by
  Accreditation Bodies to implement a national
  environmental laboratory accreditation program.
• Reviews standards for suitability
• Subcommittee
• National Database Committee

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Our Heritage . . .
SDWA Certification Program
Explore Self Sufficiency
CLP De-facto National Program
NELAC Restructure
November 6, 2006
1995
2003
2001
2006
1978
1980s
1999
2002
2004
Explore Self Sufficiency
State Programs expand into other media
2003 NELAC Standard
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The 2003 NELAC StandardStrengths

• Uses ISO 17025 quality system approach
• Adds specificity to improve clarity and help with
  consistency for environmental testing
• Allows flexibility in meeting requirements
• Represents best professional practice
• Allows for multiple Accreditation Bodies to
  implement consistently

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The 2003 NELAC StandardWeaknesses

• Refers to an organization that no longer exists
• Hard to find all the laboratory requirements
• Written by chemists for chemists
• Some language could be improved
• Not a true consensus standard
• Does not incorporate ISO 17011 for Accreditation
  Bodies
• Muddled and outdated version of ISO 17025

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A New Approach

• Start with the purpose of an accreditation
  program
• Ensure key elements are retained
• Consider the following goals
• Easy to use and understand
• Easy to grow and expand
• Easy to revise and implement
• Applicable to all laboratories

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Basis of the New Standard

• International Standards
• ISO 17025
• ISO 17011
• ISO Guide 43
• Work of NELAC from 1994 - 2003
• Significant input from TNI membership during
  consensus voting process

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Benefits of New Laboratory Standards

• Removal of outdated NELAC language
• Incorporation of ISO 17011
• Incorporation of current version of ISO 17025
• Volume/Modular approach simplifies understanding
• Improved clarity of Technical Requirements
• Increased flexibility
• Very few new requirements
• True consensus standard!!!

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Format of the New Standard

• Sector
• Identifiable accreditation program with unique
  requirements, e.g., NELAP
• Volume
• Key elements of an accreditation program for a
  particular sector
• Module
• Specific requirements combined with other modules
  to create a volume

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2008 TNI Standards

• Volume 1 Laboratory Requirements
• Module 1 Proficiency Testing
• Module 2 Quality Systems General Requirements
• Module 3 Asbestos Testing
• Module 4 Chemical Testing
• Module 5 Microbiological Testing
• Module 6 Radiochemical Testing
• Module 7 Toxicity Testing

• Volume 2 Accreditation Body Requirements
• Module 1 General Requirements
• Module 3 On-Site Assessment
• Module 2 Proficiency Testing
• Volume 3 Proficiency Test Provider Requirements
• Volume 4 Proficiency Testing Oversight

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Benefits for the PublicConfidence

• Health and environment are being protected using
  reliable, authentic data
• A recognized concept
• Hospitals
• Universities
• Forensic laboratories

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Benefits for Data Users Consumer Protection

• Assurance that the laboratory has been evaluated
  and has met established standards
• Reduces risks associated with unreliable data
• Expensive re-testing
• Legal or financial liability
• Regulatory acceptance of data

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Benefits for the ProfessionAdvances the Field

• Uniform standards of practice
• A venue to share knowledge
• Professional interaction in consensus
• Forum for improvement

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Benefits for AgenciesAssurance that data is
adequate for use

• Dependable environmental decisions based on data
  that is
• Accurate
• Traceable
• Reproducible
• Reduced uncertainty
• Increased public confidence in governmental
  management of the environment

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Benefits for AgenciesEfficient allocation of
resources

• A single set of standards to manage
• Cost effective
• Data can be used by multiple stakeholders
• Redundant assessments by QA oversight bodies can
  be reduced

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Benefits for AgenciesEfficient allocation of
resources

• Reduced direct costs due to problems
• Less re-testing
• Less re-sampling
• Less lost time
• Fewer false positives and negatives
• Reduced effort needed to define project
  expectations and requirements
• More constant baseline expectations for
  environmental projects
• More efficient communications regarding Data
  Quality Objectives and project deliverables

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Benefits for the OrganizationSelf-evaluation

• Improved training program and communication
• Improved processes and procedures
• Improved internal consistency
• Reduction in QC incidents, rejections and
  complaints

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Benefits for the OrganizationSelf-evaluation

• Promotes continuous improvement attitude
• Effective system for accountability
• Reputation benchmark for maintaining competence
• Improved employee quality awareness
• A Better Quality System!

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Benefits for the Organization and for
Accreditation BodiesA Nationally Consistent
Standard

• An industry hindered by political boundaries
• Opportunities for reciprocity and recognition
• Removal of barriers
• Reduced time and expense caused by redundancy

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The Florida Experience

• All environmental testing laboratories are held
  to the same standard
• Assessment consistency has improved
• Marginal labs have become acceptable
• Environmental decisions are now clearly traceable
  to documented data
• Benefits of mutual recognition realized

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A Self-Nourishing ConceptOpportunities for
Quality Improvements

• The TNI standards development process encourages
  pooling of expertise from multiple governmental
  agencies and private sector groups.
• A larger scope of expertise strengthens the
  quality concepts and practices upon which the
  standards are based.
• Having additional requirements for laboratory
  assessments facilitates the expansion of the
  scope of accreditation programs and improves the
  abilities of the assessors.
• Result better assessments and ultimately better
  laboratories and data!

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Thank You!