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In any calculation, any error which can creep in will do so.

The Recommended Practices Committee of the International Society of Philosophical Engineer’s Universal Laws. In any calculation, any error which can creep in will do so. Any error in any calculation will be in the direction of most harm

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In any calculation, any error which can creep in will do so.

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  1. The Recommended Practices Committee of the International Society of Philosophical Engineer’s Universal Laws • In any calculation, any error which can creep in will do so. • Any error in any calculation will be in the direction of most harm • If more than one person is responsible for a miscalculation, no one will be at fault.

  2. Looking Ahead:DMRQA & 62-160, F.A.C Silky S. Labie Florida Department of Environmental ProtectionStandards and Assessment Section 2009 FSEA Spring Meeting St. Petersburg Beach, FL

  3. DMRQAPresent and Future

  4. “Established technology tends to persist in spite of new technology”- Blaauw’s Law

  5. DMRQA - Historical Perspective • Began Before Wastewater Certification • Targets: • Labs – Accuracy of Date • Permittees – Accuracy in Reporting Data • EPA Delegates Coordination to States through MOUs

  6. DMRQA - Current Process • DMRQA Notice Sent to Selected Set of Permittees w/NPDES Permits • Permittees Acknowledge Receipt • Permittee Notifies Laboratory(s) of Study Time Frames and Makes Arrangements for Appropriate Analyses • Laboratory Reports Results to Permittee

  7. DMRQA - Current Process • Permittee Reports Results to PT Provider • PT Provider “Grades” Results and Sends Report to Permittee & State Coordinator • “Unacceptable” Results require Corrective Action • Sent by the Lab to the Permittee to be Reported to the State Coordinator Performance may be used to Schedule Audits

  8. DMRQA - Limitations • Current Process is Awkward w/ Probability of Transcription Errors • Uses a Paper Trail when Electronic Reports are more Common • DMRQA is Duplicative & Not As Effective as Certification

  9. DMRQA – Current Status • Florida Requires Certification • Requested that DEP no Longer Coordinate DMRQA • In the Current MOU, DEP Does not Coordinate DMRQA • Edward SimsUS EPA Region IVWater Program Enforcement Branch16th Floor61 Forsyth Street, S.W.Atlanta, GA 30303-8960(404) 562-9768 sims.edward@epa.gov

  10. DMRQA – Proposed Streamlining • Accept WP Results from Any Time During the Calendar Year • Must be Performed before DMRQA Closes • Labs Report Results to PT Provider • Labs Report Results to Permittee and State Coordinator • Labs Report Permittee ID w/Results – PT Provider Reports to Permittee and State Coordinator • Permittees Using Certified Labs could be Exempt • Must show proof of certification to State Coordinator

  11. 62-160, F.A.C.Quality Assurance Rule

  12. Lilly’s Metalaw: • All laws are simulations of reality. • Copper’s Metalaw: • A proliferation of new laws creates a proliferation of new loopholes.

  13. Just the Facts . . . 12-3-08 • December 3, 2008– Official ImplementationDate • Immediate Implementation except Compliance with MUR • June 3, 2009 – Labs must have changed Certification to Methods that are consistent with MUR • EX: TSS must be certified by SM 2540D, not 160.2) December 3, 2008 June 3, 2009

  14. 62-160.110 - Scope • Clarifies Rule Scope& Applicability • Applies to all entities and activities that are a part of the sample collection and laboratory analysis process • Exempts Common Carriers and Commercial Vendors

  15. Common Carriers Commercial Vendors Electronic Signature Secondary-use data • 62-160.120 – Definitions • Adds: • Revises/Clarifies: • Deletes: Data Rejection Data Quality Objectives Method Detection Limit Determine for each reported matrix/analyticaltechnology/analyte combination Allows Determination by any Technically Justifiable & Scientifically Sound Method NELAC NELAP TCLP Certification Requirements

  16. Field • 62-160.210 • DEP SOPs apply to allOrganizations that are Actively are Involved in or Support Any Field Activity • 62-160.220 – Approved Procedures • Add 3 SOPs to List of Methods for which Modifications or Alternative Methods cannot be Considered • Requires DEP to Publicly Notice All Final Actions (approval, disapproval, rescission) • Adds Administrative Hearing Rights for any action

  17. Field • 62-160.240 - Records • Applies to all entities that conduct or support field activities and field measurements • Records Must have Sufficient Information to Allow Independent Reconstruction of all Activities • DEP may request specified field records for a sampling site or facility at any time.

  18. Laboratories – 62-160.300 Certification • Rearranged Certification Requirements Based on Matrix • Matrix = Condition under which Lab receives the sample • All but Non Potable Water – Requirements Unchanged: Required for All Reported Matrix/ Method/Analyte Combinations

  19. Laboratories – 62-160.300 Certification • Non-Potable Water - Flexibility in Reporting Methods & Analytes • Labs May Report Methods For Which They Are Not Certified: • When Reported Method is Specified by Program, Permit or other Agency Document • If Certified in at least one Equivalent Technology/Analyte Combination of the Reported Analyte and • All Quality Control and Calibration Requirements of the Reported Method are Met

  20. Laboratories – 62-160.300 Certification • Labs May Add Analytes to the Reported Method if Certified for the Analytes by a Method Using Equivalent Technology • Allows Use of Drinking Water Methods without being Certified in Non-Potable Water for the Method if: • No Method Exists in Non-Potable Water and • Lab is Certified for the method/analyte combination in the Drinking Water Matrix

  21. Laboratories – 62-160.300 Certification • If Certification Requirements Have Not Been Met and the Laboratory Wishes to Report the Method: • Laboratory Must submit a Written Request for Method Use • Conditions Under Which Requests will be Considered Are the Same • Additional Methods that are Exempt from Certification • Turbidity – now includes labs • Bacteria tests for Remediation Activities • Methods where the Reported Result are Calculated from other Methods • Certification is required in the Methods that are Used.

  22. Laboratories • 62-160.320 – Approved Methods • Cites Federal Register updates to EPA-approved Method Lists for Clean Water Act and Safe Drinking Water Act Compliance • Allows 6 months After the Effective Date of the QA rule (12/3/08) for Laboratories to Make Necessary Changes to Certification FOTs • Adds the Lake Vegetation Index Calculation to Procedures for BioCriteria (DEP-SOP-002/01)

  23. Laboratories • 62-160.330 - New & Alternative Methods • Adds the Lake Vegetation Index (DEP SOPLT 7500) to the List of Methods for which Modifications or Alternative Methods cannot be Considered • Requires DEP to Publicly Notice All Final Actions (approval, disapproval, rescission) • Adds Administrative Hearing Rights for any action • 40 CFR, Part 136.6 Added Federal Rules List for Approval of Alternative Analytical Methods for NPDES Permits

  24. Laboratories • 62-160.340 – Record Keeping & Reporting • Clarifies the Intent • Laboratory Documentation • Records Must have Sufficient Information to Allow Independent Reconstruction of all Activities • DEP may Request Lab Records for any Data Reported to DEP • Reporting Requirements • Adds Exemptions for in-house ("captive") labs. • When Required, Labs must Report Data in DEP-Specified Forms (Paper or Electronic)

  25. Laboratories • 62-160.340 – Record Keeping & Reporting, cont. • Amended/Corrected Reports must Follow NELAC Requirements • Prohibits Alteration of Original Data or Data Qualifiers when Data are Submitted to DEP in Reduced Form (Tables, Summaries, etc.) • Original Lab Report(s) Must be Included • Additional Qualifiers Added from Validation or other Review • Identify Person, Date and Reason • Cannot be Deleted from Subsequent Reports

  26.  62-160.405 Electronic Signature • Accepted as Equivalent to Written Signature • Performance Requirements

  27.  62-160.650 Audits • Revises the Time Line for Audit Actions • 90 Days for Preliminary • 45 Days for Response • Final Agency Action • Deletes Data Rejection • Recommendation to DEP Programs pertaining to Data Usability • Final response Issued to Audited Party and any other Substantially Affected Interest • Administrative Hearing Rights Included in Final Response

  28. 62-160.670 Data Validation • Outlines Process for Data Evaluation Based on DQIs • DQIs are Program-Specific • Lists General Criteria and Concepts • Outlines Relationship between Data Usability & Original vs. Secondary Uses Data • Outlines Process used to Assess Data Usability • "DEP Process for Assessing Data Usability", DEP-EA-001/07 incorporated by reference • Deletes Data Rejection • Circumstances • Certification Status • Notice to Reject

  29. 62-160.700 Tables • Revisions and Additions: • D - Includes Field Turbidity as Exclusion • I - Value ≥MDL and <PQL • J - Written Justification for Use & Estimate of -/+ Bias • M - Value ≥MDL • V - Blank Hits Reported if Sample Value ≤ 10 times Blank Value • Z - TNTC – Estimated Value • X - Number of Organisms Less than Ideal Range

  30. 62-160.800 Documents Incorporated by Reference • Updates List • Adds DEP-EA-001/07 • Removes References to Analytical Methods

  31. Keep the Data Right Get the Right Data Get the Data Right

  32. ?

  33. Thank you For Your Support and Memories T minus 39 Days and Counting . . . . Silky S. Labie Standards and Assessment Section 850.245.8065 Silky.labie@dep.state.fl.us

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