certification update new and some not-so-new items of interest [email protected]...
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Certification Update
New and Some Not-So-NewItems of Interest
[email protected][email protected]
http://www.doh.state.fl.us/lab/EnvLabCert/WaterCert.htm
Topics
The NELAC Institute (TNI) Proficiency Testing (PT) Rules Certification clarifications
Current Status of TNI Standards
Field Activities and AB General Requirements and OSA modules are Final Standards
Draft Interim Standards (QS and PT) vote held in July Comments discussed at The Forum in Cambridge Committees modify the modules as a result of persuasive
comments received, and the membership will have the opportunity to change their votes
Resulting IS will be discussed at the Jan 2008 meeting Voting follows Final QS and PT Standards by about May 2008 2-yr implementation schedule, if current system followed
TNI Update New Policies
Conflict-of-InterestEthical Conduct
Transition from NELAC almost complete (only AARB remains)
QM template available Standards w/ISO coming out for sale
TNI Cambridge Forum presentations Activities of the NELAC Institute EPA's Drinking Water Certification Program:
History, Status and Direction Who Accredits the Accreditors? Identifying Deficiencies and Implementing Corrective Actions Accreditation Body Fee Structures Comparison Table of Accreditation Body Fees Advocacy Committee On-Site Assessment Committee Laboratory Accreditation System Committee Mentoring Session NELAP Board Technical Assistance Committee
Proficiency Testingtiming
2 per year (July 1-June 30) per FoPT (matrix-technology-analyte)
No more than 7 months (closing to closing) between studies
No less than 15 days (closing to shipping) between subsequent studies for each FoPT
Every certified DW method once per year No more than 45 days from shipping to
closing (supplemental studies included!)
Proficiency Testingsuccess measures
Pass two of the latest three attempts Participate in experimental PTs Choose Florida as recipient of results on
or prior to study closing date (exception: FoPTs applied for)
Stay on schedule - missed studies (>7 months between) count as failures
Proficiency Testingrestrictions
Don’t transfer PTs Don’t exchange information Handle and analyze PTs like samples Complete PTs by the time of an
assessment for pending FOAs Use the PT Tables as your guide to
selecting required FoPTs
Conditions on PT as DOC
The "4-replicate" procedure outlined in Appendix C.1 to NELAC Chapter 5 is not required by regulation or the method.
The method does not specify a DOC procedure. Quality Manual documents that using a PT to
demonstrate initial capability is an adequate approach.
The PT is in the correct matrix. Reported results fall within any QC acceptance
criteria of the method.
PT News New tables in effect posted at
http://www.nelac-institute.org/ Some “experimental” analytes moved to
“accreditation” status New Solids table lists two levels for Volatiles and
PAHs (NELAP Board is deliberating on this) ELCP now tracking PT electronically
Use your EPA ID when reporting Report the certified method
TNI PT Committee considering reverting to one PT per year – Stay tuned!
Certification Application Form
DW methods listed are not necessarily “approved” for compliance testing
Every FOA available is not listed Consolidate applications, if possible Pages 1-6 needed (instructions on page 3) Submit QM or modified pages Off-site documentation review possible
Rule Updates
MUR 62-160 DBPR
Methods Update Rule
SM online and SM 21st Edition are the same Method flexibility in 136.6 is not applicable to DW Method modifications must meet requirements of
136.6 Nitrate CR method now shown as calculation Discrete analyzers
May have EPA letter or have 136.6 documentation May reference automated methods
DEP Rule 62-160 Post-Workshop Update
Added a provision to use DW methods NPW where no other method exists.
Removed additional mandatory reporting requirements and added a clarification about the use of data qualifier codes by entities other than the data originator.
Simplified and generalized electronic signatures. Removed Table 2 (DQIs) and incorporated its
contents into DEP-EA-001/07 with substantial revision. Clarified data assessment criteria.
Clarified the intent and procedures for data rejection. Clarified the definitions for qualifier codes J, V, X.
Disinfection By-ProductsStage 2 DBPR
MRLs defined for TTHM, HAA5, Chlorite, Bromate
Calibration curve must encompass MRL Check standard run at < 110% of MRL Must achieve + 50% recovery to report
results < 5X MRL DEP will reject data if the reported
MDL > MRL and a non-detect is reported
Recent Clarifications
Sample preservation Sample duplicates SM 21st Edition Distillation Method version
Cooling as Sample Preservation
Samples must be collected in “wet” ice Same-day delivery
Off-temp sample acceptable if chilling process has begun
Still record temperature and document “on-ice”
Microbiology Sample Preservation
Recommend all samples be checked for TRC Chlorine check as a part of determining proper
preservation when sodium thiosulfate is used DEP rules require the use of thiosulfate "in the
presence of residual chlorine" for preservation of Microbiology samples
Measure the TRC and add preservative if necessary
NELAC 5.5.8.3.1(a)(3) exemptions
Duplicates
Microbiology duplicates are to be analyzed on 10% of samples, not plates, or at least one per run (an uninterrupted series of analyses)
Chemistry MS/MSD does not qualify as a sample duplicate when one is required by method
SM 21st Edition News
CBODAllylthiourea (ATU) allowed as nitrification
inhibitor Inhibitor not added to water quality check
(blank) Microbiology media in screw-cap tubes
may be stored at 25oC for up to 2 weeks
Distillation
EPA Region 4 requires distillation of samples for fluoride and ammonia unless a comparative study has been performed to demonstrate that the distillation is not necessary
Statistically compare values on at least 7 samples If the comparative data shows no difference, then the
variance of not distilling is acceptable Comparison must be performed on representative
effluents If the waste stream changes and is no longer
representative then another study must be performed
Method Version “Most recent” revisited
NELAC 5.5.4.2.1 - Methods published in international, regional or national standards shall preferably be used. The laboratory shall ensure that it uses the latest valid edition of a standard unless it is not appropriate or possible to do so
NELAC 5.5.2.6 - technical personnel … perform the most recent version of the test method (the approved method or standard operating procedure as defined by the laboratory document control system)
Plain Language
A perissodactyl ungulate may be propelled toward a body of aqueous fluid, but such ungulates cannot be forcibly induced to imbibe such fluid.
Plain Language
You can lead a horse to water, but you can’t make it drink.
Thank You!