developing and maintaining iso 17025 accreditation quality, management...developed specialized iso...
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Developing and Maintaining ISO 17025 Accreditationfor the U.S. National Guard Weapons of Mass Destruction Civil Support TeamsLeslie KearbySignature Science, LLC
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Weapons of Mass Destruction—Civil Support Team (WMD‐CST) Overview
57 specialized, active duty, full‐time Guard units (one in every state and US Territory (and two in NY, CA, and FL) Staffed by 22 ARNG and ANG team members
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WMD‐CST Mission and Organization
Command
Operations Communications Admin/Logistics Medical/Analytical Survey
Identify agents and substances, Assess consequences, Advise on response measuresAssist with additional military support
CSTs support intentional and unintentional releases of chemical, biological, radiological and nuclear (CBRN) or other hazardous agents and natural or manmade disasters that could result in catastrophic loss of life or property
ISO 17025 Accreditation applicable to the Analytical Laboratory System (ALS)
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Chemical and biological threat detection Glovebox isolation chamber Polymerase chain reaction (PCR) Electrochemiluminescence (ECL) Gas Chromatography – Mass
Spectroscopy (GC‐MS) Fourier Transform Infrared
Spectroscopy (FTIR) Polarized Light Microscopy (PLM) Fluorescence Microscopy (FM)
WMD‐CST ALS Capabilities
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Launched in 2006 to support the CST mission by Standardizing analytical tactics, techniques, and
procedures (TT&P) and enforcing scientific rigor Bolstering technical credibility and defensibility of
analytical data generated by the WMD‐CST laboratories
A fully accredited program embodies the WMD‐CST motto:
“Always Ready, Always There”
The ISO/IEC 17025 Accreditation Initiative
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Complex joint state and federal military command structure • Federally funded, state controlled• Equipment procurement and supply chains belong to DoD Joint Program Office
• Training responsibilities spread among DoD entities• High turnover due to military staffing procedures
Unconventional analytical request and contracting process• Not a fee‐for‐service model• Customers may not be familiar with ALS capabilities or analytical processes required to meet mission objectives
• Rapid response time essential
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Accreditation Challenges
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Low throughput, high complexity analysis• CSTs might analyze only few samples per response action, but variety of sample types and possible targets are almost unlimited
• Analysts must be proficient with chemical, biological, and microscopical methods and instrumentation
Military incident response paradigm focuses on rapid identification and characterization of chemical and biological threats• Emphasis on correct presence/absence calls rather than quantitative results
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Accreditation Challenges (continued)
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Worked with A2LA to develop the conceptual approach • Adapted a “branch laboratory” accre‐ditation model with centralized and de‐centralized components
• Quality Manager functions split between NGB and WMD‐CSTs
Set up “Beta Teams” to determine what already existed and what had to be developed
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ACCREDITATION APPROACH
Collaboration
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ISO 17025‐compliant Quality Manual and Quality Procedures
Person
nel
Education/ Selection
Training Records
Authorization Records
Equipm
ent
Control Charts
Preventive Maintenance
Records
Equipment Records
Reagen
ts Reagent Log
Purchasing Records
Approved Suppliers
Admin Tasks
Mgmt Review Internal Audits
PT Results Review
Sample Receipt Log
Customer Feedback Tool Analytical
Request Form Electronic Data Files
ALS Test ReportALS Lab Notebook
(Operators) (Samples)(Reagents)(Equipment)
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ACCREDITATION APPROACH
Standardization Standardized
forms and tools
Secure website for document control, training records storage, and proficiency test (PT) reporting
Deviation Form, Corrective Action Form, Risk and Opportunities Tool
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Developed specialized ISO 17025 training course conducted on an ongoing basis that includes: Overview of ISO 17025 requirements Instruction on WMD‐CST specific procedures,
forms, tools, and checklists Auditor training Exercises for performing all quality system activities
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ACCREDITATION APPROACH
ISO Training
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Standardization, Evaluation, and Assistance Team (SEAT) performs internal audit function for entire WMD‐CST• Each team audited biannually at a minimum• ALS portion ensures conformance to ISO 17025 and operator competence
31 Teams21 Teams
5 Teams
A2LA Deficiencies per Audit
Zero
One to Three
Four or more
Readiness reviews conducted as needed• Ensure team is ready for external accreditation body audits
• Support teams with significant turnover
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ACCREDITATION APPROACH
SEAT Audits and Readiness Reviews
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Comprehensive PT program conducted under the SigSci ISO 17043 PT accreditation PTs performed monthly to collectively cover all methods and matrices • GC‐MS, FTIR, PCR, ECL, and polarized light (PLM) and fluorescence microscopy
• Liquid, soil/solid, sludge, powder, vegetation, and wipe matrices
• Radiological data interpretation capabilities
All analysts participate in each round
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ACCREDITATION APPROACH
Proficiency Testing
PROVICIENCY TESTING PROVIDERCERT #3076.01
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0
20
40
60
80
100
APAT
1601
APAT
1603
APAT
1702
APAT
1901
PPAT
1701
PPAT
1801
GPA
T160
1
GPA
T170
2
GPA
T190
1
IPAT
1602
IPAT
1801
IPAT
1901
FPAT
1701
FPAT
1802
MPA
T160
1
MPA
T170
2
MPA
T190
1
RPAT
1602
RPAT
1801
Biological Chemical Microscopy Radiological
Detection Rate
Skills Pass Rate
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ACCREDITATION APPROACH
Proficiency Testing
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UPDATES
ISO/IEC 17025:2017 Transition
Train teams on updated
procedures
Renewal audits to verify
compliance
Update QMS
procedures
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Updating QMS to apply to both current and updated systems throughout the three‐year transition – no QA gaps
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UPDATES
ALS Upgrade
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In the process of enhancing website functionality to allow increased automation of ISO 17025 activities
8/11/2019Slide 16
UPDATES
Website Upgrade