Road Map • Who am I? • NEFAP – A History • What is NEFAP? • Why NEFAP? • The Standard and the FDEP SOPs • How does a FSMO get accredited?
Who Are You? • How many are, or collect samples as part of a Lab? • How many of you work with other organizations that collect samples? • How many ONLY collect samples? • How Many “Others”?
NEFAP Program Structure • TNI Board • Supervises/controls/directs affairs of TNI; determine its policies; and actively pursues its mission. • NEFAP Executive Committee • Created as Separate Board Under TNI • Policy coordinating and approval • Responsible for Recognition of AB’s • Field Activities Committee • Performs Development of Standards/Policies/Procedures • ABs • Recognized by NEFAP, Accredit to FSMO Standards
What does Field Accreditation Mean to the Community • Improved data quality • Assurance of the competence of field sampling and testing organizations • Accountability of all organizations in the measurement process • Generating data of known and documented quality Do you know where your samples came from?
Will this program be required? • Not in regulation • Yes - contracts • When it is important for the data user to assure field activities are performed competently • When data of known and documented quality are required by the user
Standard for FSMO’s • The standard was developed, voted and adopted by FSMOs, regulators and others in the stake holder community. • It is one of a kind! • Different than NELAP Standard for Labs • Written for any type of field sampling and testing • Builds on the foundation of ISO/IEC 17025!
Standard for FSMO’s (cont.) • What Standards is it based on? • ISO 17011 and 17025 • Equate roughly to V1-Mod.2 And V2-Mods. 1 & 3 of NELAP standard • Base language same as NELAP but with additional NEFAP specifications • “laboratory” = “FSMO”
The Standard • Adopted May 2007 – TNI Board • Volume 1: General Requirements for FSMOs (FSMO-V1-2007 Rev 0.1 ) • Volume 2: General Requirements for Accreditation Bodies Accrediting FSMOs • (FSMO-V2-2007 Rev 0.1)
The Standard • Current Status: • Standard has been developed through consensus process and Interim Standard is in final stages of review prior to finalization. • Anticipated final approval and publication of final Standard in January 2014
Volume I: General Requirements for Field Sampling and Measurement Organizations “FSMO Competency Standard” • Management System • Technical Requirements • Fundamentals of Quality System • Specifications Less Prescriptive than Labs • Flexibility Based On User Need • Specifications Designed for FSMO Applications
Volume II: Requirements for Accreditation Bodies Accrediting FSMO’s • Accreditation Body Recognition • Recognition of Systems Required • Defines Program Manual Specifications • Defines Program Organization • Personnel and Training Requirements • Assessment Performance Documentation
Volume II – Assessment of FSMO • AB-FSMO Accreditation Process • Matrix Specific Accreditation Award – Broad Basis • Detailed Application Specifications • Describes Allowances for Third Party Assessments • Assessment Conduct Specified
Accreditation ProcessOrganizational Qualification • Accreditation Process – Single Site Organization • Application Review • Quality System Documentation Verification • Field On-site Assessment • Application Process – Multi-Site Organizations • Employs the “Umbrella Approach” • Common Organizational Quality System • Applicant Identifies Facilities for Assessment Verification • Field Assessments of Quality System
FSMO Accreditation • Applicant Defines Scope Of Accreditation • SOPs Provided for Sampling/Measurement Technologies • Specific Techniques Defined by SOPs and Practices • Sampling Accreditation • Accreditation by Media - Broad Category Accreditation • Generic Media Requirements
FSMO Accreditation (Cont.) • Measurement Accreditation • Technology Driven Accreditation • Method SOPs By Specified Technology - Drive Accreditation • Compliance with Base Standard Simplifies Accreditation Expansion.
Why TNI… • Why chose the TNI standard and not others • ISO 9000 (general QMS) • ISO/IEC 17020 (inspection bodies) • ISO 14000 • ASTM, USGS, EPA, Etc.
Why TNI… • FSMO Standards Vol 1 and Vol 2 were designed : • to address the specific needs of the FSMOs and their customers • Contain elements not covered in the other Standards
BENEFITS: Laboratories and Data Users REDUCE DATA VARIABILITY AND UNCERTAINTY!!!
BENEFITS: Laboratories and Data Users • Standardized reporting • Documentation on sample location • Representativeness is addressed • Contamination is addressed • All done to meet specified project DQO’s
BENEFITS: Laboratories and Data Users • Better coordination / communication between samplers and lab • QC samples • Commitment to quality will (should) reduce sample and measurement error
BENEFITS: Laboratories and Data Users • Better sample documentation • Proper sample custody procedures • Better sample handling and transfer procedures • Progressing from unknown to known data quality
BENEFITS: FSMO Establishes Foundation of Management System • Clearly define roles and responsibilities /interactions • Establish clear procedures for documentation and document control • Need to have clear procedures for contracts, subcontracting, purchasing and the evaluation of these.
BENEFITS: FSMO (cont.) • Requirements Set a Clear Path to Improvement • Tools are laid out in Standard: • Corrective Actions • Preventive Actions • Complaint Tracking • Review and Control of Non-Conforming Work Following the Standard Facilitates Improved Quality!!!
BENEFITS: FSMO (cont.) Outlines Auditing and Review Process • Ensure auditing and training of field staff • Ensure performance is reviewed • Annual management review to evaluate all elements of system and determine areas for improvement
BENEFITS: FSMO (cont.) • Specifies technical requirements designed to improve quality of organizational performance • Prescribes the need to outline personnel requirements • Job Descriptions • Knowledge/Experience Requirements • Demonstration of Capability Requirements
BENEFITS: FSMO (cont.) • Structure for Dealing with Equipment • Maintenance • Tracking/Performance • Evaluation of equipment needed • Training • Documentation
BENEFITS: Managers • How is my Field Sampling Section performing? • 3rd Party Accreditation gives Management the peace of Mind that Data are of known Quality • This Translates into Defensibility and Decreased Risk • Important in light of Litigious Risk of Fraud
Biggest Differences • Third Party AB • Accreditation process is not required by State Agencies • There is no central, state run AB that will oversee the accreditation process
NEFAP-Recognized Accreditation Bodies • Organizations must apply to TNI to serve as ABs. • A FSMO seeking accreditation applies to a TNI-recognized Accreditation Body for accreditation.
NEFAP-Recognized Accreditation Bodies (cont.) • 4 third party AB’s have been preliminarily recognized • Final recognition occurs after an evaluator witnesses an on-site FSMO assessment. • 2 AB’s have undergone that process and are officially recognized
NEFAP-Recognized Accreditation Bodies (cont.) • The 4 ABs now accepting FSMO applications are: • ANSI-ASQ National Accreditation Board • American Association for Laboratory Accreditation (A2LA) • Laboratory Accreditation Bureau (L-A-B) • Perry Johnson Laboratory Accreditation, Inc. (PJLA)*
Preparing your Application • Watch TNI website for recognized ABs • Talk to different AB’s, get a feel for which suits your organization and accreditation needs • Prepare application as required by AB
Preparing for FSMO Assessment • Implement Requirements in Volume 1 • Write QM (Should have this already) • Need to add some things • Write SOPs (Should have most already) • Train Personnel and Document Training • Prepare records and perform work to demonstrate SOPs implementation
COST • Must contact NEFAP ABs and speak to them to get costs • The key is to shop around and get the AB that is the best fit for you
Next Steps… If you are an FSMO – Select and AB and Apply!!!! If you are an interested AB, contact us we can get you an application… Visit TNI website: www.nelac-institute.org
The Future…. AB’s continue accepting applications TNI FAC is completing the Standard Revision Process AB’s complete the evaluation process AB’s recognition by TNI More FSMOs accredited to Standard
The Future…. Push for continued acceptance among regulatory authorities (i.e. DoD, State Agencies, etc.) EPA funded generation of environmental data requires Certification / Accreditation Continued advocacy efforts – Spread the word about the Program!
Quality “The Quality of the Data Can Only be as Good as the Quality of the Sample” Environmental Data Quality Cannot Be Assured Unless There Are Quality Standards for All Steps of the Sample Collection AND Analysis Processes.
Contact Information For more information on the Program please contact: FAC Chair Justin Brown - email@example.com NEFAP EC Chair Kim Watson - firstname.lastname@example.org www.nelac-institute.org