road map who am i? nefap – a history what is nefap? why nefap? the standard and the fdep sops how...
TRANSCRIPT
![Page 1: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/1.jpg)
![Page 2: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/2.jpg)
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?
2
![Page 3: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/3.jpg)
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”?3
![Page 4: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/4.jpg)
What is NEFAP?
4
![Page 5: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/5.jpg)
Where Have We Been?
Our Heritage . . .SDWA
Certification Program
1978
State Programs
expand into other media
CLP De-facto National Program
19951999 2002 2004
20032001 2006
NELAC Restructure
Explore Self Sufficiency
Explore Self
Sufficiency2003
NELAC Standard
November 6, 2006
1980’s
5
![Page 6: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/6.jpg)
NEFAP Focus
Our Heritage . . .SDWA
Certification Program
1978
State Programs
expand into other media
CLP De-facto National Program
19951999 2002 2004
20032001 2006
NELAC Restructure
Explore Self Sufficiency
Explore Self
Sufficiency2003
NELAC Standard
November 6, 2006
1980’s
6
![Page 7: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/7.jpg)
7
![Page 8: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/8.jpg)
8
![Page 9: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/9.jpg)
9
![Page 10: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/10.jpg)
10
![Page 11: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/11.jpg)
11
![Page 12: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/12.jpg)
12
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
![Page 13: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/13.jpg)
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
13
Do you know where your samples came from?
![Page 14: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/14.jpg)
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
14
![Page 15: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/15.jpg)
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!15
![Page 16: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/16.jpg)
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”
16
![Page 17: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/17.jpg)
•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)
17
The Standard
![Page 18: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/18.jpg)
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
18
The Standard
![Page 19: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/19.jpg)
“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 I: General Requirements for Field Sampling and
Measurement Organizations
19
![Page 20: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/20.jpg)
• Accreditation Body Recognition
• Recognition of Systems Required
• Defines Program Manual Specifications
• Defines Program Organization
• Personnel and Training Requirements
• Assessment Performance Documentation
Volume II: Requirements for Accreditation Bodies Accrediting
FSMO’s
20
![Page 21: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/21.jpg)
• AB-FSMO Accreditation Process
• Matrix Specific Accreditation Award – Broad Basis
• Detailed Application Specifications
• Describes Allowances for Third Party Assessments
• Assessment Conduct Specified
Volume II – Assessment of FSMO
21
![Page 22: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/22.jpg)
• 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
Accreditation ProcessOrganizational Qualification
22
![Page 23: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/23.jpg)
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
23
![Page 24: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/24.jpg)
FSMO Accreditation (Cont.)
• Measurement Accreditation
• Technology Driven Accreditation
• Method SOPs By Specified Technology - Drive Accreditation
• Compliance with Base Standard Simplifies Accreditation Expansion.
24
![Page 25: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/25.jpg)
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.
25
![Page 26: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/26.jpg)
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
26
![Page 27: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/27.jpg)
REDUCE DATA VARIABILITY AND UNCERTAINTY!!!
BENEFITS: Laboratories and Data
Users
27
![Page 28: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/28.jpg)
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
28
![Page 29: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/29.jpg)
BENEFITS: Laboratories and Data
Users• Better coordination / communication between
samplers and lab
• QC samples
• Commitment to quality will (should) reduce sample and measurement error
29
![Page 30: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/30.jpg)
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
30
![Page 31: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/31.jpg)
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
31
![Page 32: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/32.jpg)
• 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.)
32
![Page 33: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/33.jpg)
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.)
33
![Page 34: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/34.jpg)
• 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.)
34
![Page 35: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/35.jpg)
Structure for Dealing with Equipment
• Maintenance
• Tracking/Performance
• Evaluation of equipment needed
• Training
• Documentation
BENEFITS: FSMO (cont.)
35
![Page 36: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/36.jpg)
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
36
![Page 37: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/37.jpg)
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
37
![Page 38: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/38.jpg)
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.
38
![Page 39: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/39.jpg)
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
39
![Page 40: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/40.jpg)
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)*
40
![Page 41: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/41.jpg)
What does it take to become accredited…
41
![Page 42: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/42.jpg)
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
42
![Page 43: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/43.jpg)
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
43
![Page 44: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/44.jpg)
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
44
![Page 45: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/45.jpg)
45
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
![Page 46: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/46.jpg)
46
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
![Page 47: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/47.jpg)
47
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!
![Page 48: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/48.jpg)
“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.
Quality
48
![Page 49: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/49.jpg)
For more information on the Program please contact:
FAC Chair Justin Brown - [email protected]
NEFAP EC Chair Kim Watson - [email protected]
www.nelac-institute.org49
Contact Information
![Page 50: 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? 2](https://reader031.vdocuments.us/reader031/viewer/2022020801/5697bf771a28abf838c8159d/html5/thumbnails/50.jpg)
50