THE NEW TNI NATIONAL LABORATORY ACCREDITATION...
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THE NEW TNI NATIONAL LABORATORY ACCREDITATION STANDARDS Jerry Parr August 10, 2009
Transcript of THE NEW TNI NATIONAL LABORATORY ACCREDITATION...
THE NEW TNI NATIONALLABORATORY ACCREDITATION
STANDARDS
Jerry Parr
August 10, 2009
WHO IS TNI?
A 501(c)3 non-profit organization.
A member organization managed by aBoard of Directors.
A voluntary consensus standardsdevelopment organization accredited bythe American National Standards Institute(ANSI).
OUR HERITAGESDWA
CertificationProgram
1978
StatePrograms
expand intoother media
CLP De-factoNationalProgram
19951999 2002 2004
20032001 2006
NELACRestructure
Explore SelfSufficiency
ExploreSelf
Sufficiency2003
NELACStandard
November 6, 2006
1980’s
MISSION AND VISION
To foster the generation of environmental dataof known and documented quality through anopen, inclusive and transparent process thatis responsive to the needs of the community.
All entities generating environmental data in theUnited States will be accredited to consensusnational standards.
Board of Directors
Self-Governing Programs
Consensus StandardsDevelopment
National EnvironmentalLaboratory Accreditation
Laboratory AccreditationSystem
Technical Assistance
Proficiency Testing
Advocacy
Stationary Source AuditSample
Administrative Committees
Policy
Advocacy
Website
Conference Planning
Finance
Staff
Individual Members
TNI STRUCTURE
WHAT DO WE PROVIDE?
Infrastructure for stakeholders
Consensus building for establishingrequirements for:
Organizations that accredit
Organizations that are accredited
Proficiency testing programs
Recognition of organizations that operateaccreditation programs
Assistance to members and the public
ACCREDITATION OFENVIRONMENTAL LABORATORIES
TNI’s National EnvironmentalLaboratory Accreditation Program(NELAP)
PURPOSE OFACCREDITATION
Accreditation isdesigned to ensure thatlaboratories aretechnically competentand are able togenerate technicallyvalid results.
Corollary: An accreditedlaboratory will more likelygenerate data of appropriatequality for a particularanalysis because of itsquality system.
FUNDAMENTAL CONCEPTS
TNI develops consensus requirements (i.e.,standards) that are voluntarily adopted bystates agencies approved as accreditationbodies (ABs).
TNI’s NELAP Board oversees accreditationbodies to assure uniformity.
State grants accreditation, which isunconditionally recognized, by otherparticipating ABs.
Laboratories can voluntarily apply to anyapproved NELAP AB, if their home state doesnot participate.
NELAP ABs
NELAP Accreditation Body
Application Being Processed
Working on Program/Application
Require Program
Recognize Program
Incorporated Program Components
NELAP CHARACTERISTICS
Implemented by state government agenciesformally recognized by TNI as AccreditationBodies (ABs);
Based on internationally recognized standardsadapted by TNI for environmental testing;
Implemented with respect to a specific scope oftesting;
Includes periodic inspection of the laboratory byqualified assessors; and
Involves review of proficiency testing results.
NELAP STANDARDS
Developed using a consensus process thatincluded the perspectives of multiplestakeholders.
Used recognized international standard for thecompetency of laboratories (ISO 17025) as thebasis.
Added additional specificity to address specificissues associated with environmental testing.
Focus is on generation of authentic data(i.e., data of known and documented qualitygenerated according to accepted professionalpractices of the industry).
CHOICES: 1997 - 2003
EPA Drinking Water Program
ISO 17025 only
Various home-grown state programs
Some combination of the above
GUIDING PRINCIPLES Flexible: Allow laboratories freedom to use their experience and
expertise in performing their work and allow for new and novelapproaches. specify the What and avoid where possible the HowTo.
Auditable: Sufficient detail included so that the assessors canevaluate laboratories consistently.
Practical and Essential: Necessary policies and procedures thatshould not place an unreasonable burden upon laboratories.
Widely Applicable: Applicable to laboratories regardless of sizeand complexity.
Appropriate: Ensure that data is of known quality and that thequality is adequate for the intended use.
COMPARISON TO DW PROGRAM
Drinking Water Certification
DW Certification Manual Technical Requirements
Records
QA Plan
Personnel
Guidance and 95% Should
205 pages
Successfully analyze PTsample each year
Audit every 3 years
NELAP Accreditation
NELAC Standard Technical Requirements
Records
QA Manual
Personnel
Regulation and 100% Must
289 pages
Analyze 2 PT samples peryear and pass 2 out of 3
Assessment every 2 years
DOCUMENT COMPARISON
NELAC Standard
100% Requirements
Requirements focusedon:
Quality System
Changes in language
Should to must
Specific to general
Increasedrequirements
Drinking Water Manual
Mainly guidance
Requirements focusedon:
Method compliance
Time & temperature
Reagents/media
Lab ware
Enumeration
SHOULD TO MUST
NELAC Standard
Records of autoclaveoperations shall bemaintained for everycycle. Records shallinclude: date, contents,maximum temperaturereached, pressure, timein sterilization mode,total run time (may berecorded as time inand time out), andanalyst’s initials.
Drinking Water Manual
The date, contents,sterilization time andtemperature, total timefor each cycle, andanalyst’s initials shouldbe recorded each timethe autoclave is used.
SPECIFIC TO GENERAL
NELAC Standard
The graduation of thetemperaturemeasuring devicesmust be appropriatefor the requiredaccuracy ofmeasurement.
Drinking Water Manual
Thermometers mustbe graduated in 0.5 Cincrements (0.2 Cincrements for testswhich are incubated at44.5 C) or less.
INCREASED REQUIREMENTS
NELAC Standard
Prior to use on eachworking day,balances shall bechecked in theexpected use range,with NIST traceablereferences wherecommerciallyavailable.
Drinking Water Manual
Balances should becalibrated monthlyusing ASTM type 1, 2,or 3 weights (minimumof three traceableweights which bracketlaboratory weighingneeds).
COMPARISON TO ISO 17025
ISO 17025
ManagementRequirements
Technical Requirements
35 pages
Includes CalibrationLaboratories
NELAC Chapter 5
ManagementRequirements
TechnicalRequirements
121 pages
DOCUMENT COMPARISON
NELAC Standard
17025 TestingLaboratoryRequirements
PLUS
Specific Requirementsfor EnvironmentalLaboratories
AND
Data Integrity
QC Appendices
ISO 17025
Generic Requirements
Testing Laboratories
Calibration Laboratories
EXAMPLE: INSTRUMENTCALIBRATION
NELAC Standard
3 pages of specificdetails related to initialcalibration andcalibration verification.
ISO 17025
Before being placedinto service, equipmentshall be calibrated toestablish that it meetsthe laboratory'sspecificationrequirements andcomplies with therelevant standardspecifications. It shallbe checked and/orcalibrated before use.
THE 2003 NELAC STANDARD
Strengths: Uses ISO 17025 quality system approach,
Adds specificity to improve clarity and help withconsistency for environmental testing,
Allow flexibility in meeting requirements,
Represents best professional practice, and
Allows for multiple Accreditation Bodies to implementconsistently.
Summary: NELAC 2003 is the best accreditation program for
environmental laboratories currently in use.
THE 2003 NELAC STANDARD
Weaknesses: 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 forAccreditation Bodies, and
Muddled and outdated version of ISO 17025.
A NEW APPROACH
Start with the purpose of an accreditationprogram
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
BASIS OF NEWSTANDARDS
International Standards
ISO 17025
ISO 17011
ISO Guide 43
Work of NELAC from 1994 - 2003
Significant input from TNI membershipduring consensus voting process
Reorganized to facilitate understanding
THE NEW TNI LABORATORYSTANDARD
138 pages (versus 289 for 2003 NELACStandard)
Uses current version of ISO 17025 Increased clarity. Everything in one place:
Proficiency testing, Quality systems, and Personnel.
Discipline specific quality control modules greatlyimproved.
Very few new requirements. Greater flexibility
BENEFITS OF NEWLABORATORY STANDARDS
Removal of outdated NELAC language
Incorporation of ISO 17011
Incorporation of current version of ISO17025
Volume/Modular approach simplifiesunderstanding
Improved clarity on TechnicalRequirements
True consensus standard!!!
PLAN FOR IMPLEMENTINGLABORATORY STANDARDS
August 2009 Adoption by NELAP Board;
January 2010 Changes in state regulations;
Spring 2010 Training and outreach;
August 2010 Replace NELAC 2003.
