NELAP- How Do I Comply?
Presented at
the MPCA Annual Wastewater Operator’s Training
March 24, 2010
by
Sharon Dahl, Flint Hills Resources
Marni Karnowski, MPCA
Susan Wyatt, MDH
welcome
• agenda
• presenters:
– Sharon Dahl, Flint Hills Resources
– Susan Wyatt, MN-ELAP
– Marni Karnowski, MPCA
Objectives
• Review the history of laboratory
accreditation
• Discuss the development of national
standards
• Provide compliance assistance for two
requirements in the national standards
– technical director
– management review
NELAC – NELAP – TNI
history of lab accreditation and
development of national standards
History of lab accreditation in
the U.S.
SDWA
Certification
Program
Explore Self
Sufficiency
CLP De-facto
National
Program
1978
1980’s
State
Programs
expand into
other media
1995
NELAC
Restructure
1999
2001
2002
November 6, 2006
2003
2004
2003
NELAC
Standard
2006
Explore
Self
Sufficiency
structure of TNI
Board of Directors
Self-Governing Programs
Consensus Standards Development
(CSDP)
NELAP
Laboratory Accreditation System
(LASP)
Technical Assistance (TAP)
Proficiency Testing (PTP)
Staff
Admin. Committees
Policy
Website
Conference Planning
Finance
Advocacy
Forum
Individual Members
structure of TNI
(indicating involvement of MDH staff)
Board of Directors
Self-Governing Programs
Consensus Standards Development
(CSDP)
NELAP
Laboratory Accreditation System
(LASP)
Technical Assistance (TAP)
Proficiency Testing (PTP)
Staff
Admin. Committees
Policy
Website
Conference Planning
Finance
Advocacy
Forum
Individual Members
Member Demographics
Other: 4%
PT Providers: 4%
Vendors: 7%
EPA: 3%
Other Federal Agencies: 3%
Commercial laboratories: 39%
State agencies: 15%
Regulated industry: 3%
Municipalities: 22%
NELAP Assessments
technical requirements
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Technical competence of staff;
Validity and appropriateness of test methods;
Traceability of measurements;
Instrument calibration;
Testing environment;
Sampling, handling of samples;
Quality assurance of test data; and
Reporting.
These requirements focus on ensuring reliable and
accurate data.
NELAP Assessments
managerial requirements
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Implement a quality system;
Management requirements;
Documents and records;
Internal assessments; and
System controls and improvements.
Comparable to ISO 9000, these requirements are good
management practices to ensure analyses are
performed in an orderly and structured way.
Laboratory Personnel
Technical Director
Basic qualifications of staff
• Must be initially trained
• Must demonstrate continued
understanding of testing requirements and
regulations
• Must meet qualifications, if performing
specific tasks required by the national
standard or regulations
Clean Water Act (NPDES)
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40 CFR 136
MN Statutes 115.73
Basic operator responsibilities
Guidelines for contract operators
Operations of the Facility
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Collection
Maintenance & Repair
Monitoring
Reporting (Monthly DMR)
Operation of the plant includes responsibility
for accurate lab testing!
Laboratory-Named job
descriptions
• Technical director/technical manager
• Quality manager
• Owner
• Managing agent
• Laboratory director
Any person designated by the laboratory may be
the primary contact on the application.
Who is the technical director?
• Any person who meets qualifications
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Operator of responsible charge
Signatory for laboratory reports/DMRs
Laboratory director
Lead operator
Quality manager/QAO
• More than one person may qualify
• Must be present in the facility on a day-to-day
basis
• Must conduct the activities related to the job
Technical director
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Exemption
Experience (‘grandfathering’)
Education
Recognition (reciprocity)
Temporary absence
• MPCA and MDH operator of responsible
charge = 24/7 phone contact
• Lab technical director = no more than 15
days consecutive absence.
• Operator certification requirements are
more stringent than the laboratory
requirements
Examples of Assigned Tasks
Responsibility
Application—supply name and
phone number along with primary
contact (4740.2050, subp1C)
Sign application form
Notification of change— (4740.2050,
subp15)
Appeals –requires signature
(4740.2050 subp17B)
Daily supervision of lab activities
Training of lab personnel
Keep QAM up-to-date; plan and
organize audits (may be performed
by anyone qualified to audit)
Assure continual compliance with
regulations/standards; monitor
corrective actions
Owner
Managing
Agent
Lab
Director
Technical
Director
Quality
Manager
Participation Exercise
• Am I the director?
Common issues
• Application—plant operator designated for all job
positions except owner
• Documents—lack appropriate signatures
• Primary contact lacks daily operations
information (inappropriately designated as
contact?)
• Primary contact does not communicate with
managing agents and owners on enforcement
issues
Management Reviews
personnel, frequency,
implementation, and
documentation
What is included in a management
review?
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volume and type of work
customer feedback and complaints
review of internal audits
MDH or client assessment reports
PT studies planned and completed
resources needed
Personnel
• persons with authority to approve budgets
and authorize spending
– city administrator
– utilities superintendent
• quality manager
• technical directors
• any other interested persons invited by the
laboratory
Frequency and documentation
• compile information annually
• evaluate the effectiveness of laboratory
systems
• present written report to parties identified
– includes goals for the coming year
– assigns timelines to specific tasks to be
performed
Implementing the national
standard requirements in your lab
relating the national standard to
the former MN Rules
requirements
crosswalk document
NELAP vs. 2006 MN Rules
• review of 2003 NELAC standard
– Chapter 1: Policy
– Chapter 2: PTs
– Chapter 3: Onsite assessment
– Chapter 4: Accreditation Process
– Chapter 5: Quality Systems
– Chapter 6: Accrediting Authority
• review crosswalk document
what changes are required?
MDH-accredited labs
• identify technical director and quality manager
• add to quality manual
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quality policy statement
address and phone number of lab
protection of confidential information; review of contracts
uncertainty measurement
data integrity training
document conflicts of interest
• display certificate
• two PTs/year
A laboratory’s implementation
• Time involved for maintaining
documentation
• How to comply
• Using templates available
Next steps: 2010 and beyond
repeal of current rule; new
national standards; training
sessions
Current NELAP-recognized
accrediting bodies
2009 Applications:
• Virginia* (approved)
• Minnesota
2010 Applications?:
• Oklahoma
NELAP-like regulations:
• South Carolina
• Arizona
• Georgia • Vermont
• Washington
• Maine
• Wisconsin
• Nevada
future national standards
• 2009 TNI Standard for accreditation of
environmental laboratories
• effective July 1, 2011
• potential schedule (every 5 years)
• re-organization of information but no major
changes
participation of laboratories
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standards development
small laboratory advocate group
technical assistance program
general training session on 2009 TNI
Standard coming soon!
Small Laboratory Advocate
• Keith Chapman, Oregon
– Replaces Len Schantz, City of Rochester, NY
• 32 members currently
• discussion board
more information
Environmental Laboratory Accreditation Program
MN Department of Health
601 Robert Street North
St. Paul MN 55155
651-201-5323 (Susan Wyatt, program supervisor)
Email: [email protected]
• www.health.state.mn.us/accreditation
State Register publication
• www.comm.media.state.mn.us/bookstore/bookstore.asp
National accreditation program
• www.nelac-institute.org
• www.health.state.mn.us/divs/phl/cert/faqnelap.html