Presentation on theme: "The Recommended Practices Committee of the International Society of Philosophical Engineer’s Universal Laws In any calculation, any error which can creep."— Presentation transcript:
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.
Looking Ahead: DMRQA & 62-160, F.A.C Silky S. Labie Florida Department of Environmental Protection Standards and Assessment Section 2009 FSEA Spring Meeting St. Petersburg Beach, FL
DMRQA Present and Future
“Established technology tends to persist in spite of new technology” - Blaauw’s Law
DMRQA - Historical Perspective Began Before Wastewater Certification Targets: Labs – Accuracy of Date Permittees – Accuracy in Reporting Data EPA Delegates Coordination to States through MOUs
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
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
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
DMRQA – Current Status Florida Requires Certification Requested that DEP no Longer Coordinate DMRQA In the Current MOU, DEP Does not Coordinate DMRQA Edward Sims US EPA Region IV Water Program Enforcement Branch 16th Floor 61 Forsyth Street, S.W. Atlanta, GA 30303-8960 (404) 562-9768 email@example.com firstname.lastname@example.org
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
62-160, F.A.C. Quality Assurance Rule
Lilly’s Metalaw: All laws are simulations of reality. Copper’s Metalaw: A proliferation of new laws creates a proliferation of new loopholes.
Just the Facts... December 3, 2008 – Official Implementation Date 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) 12-3-08 December 3, 2008 June 3, 2009
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
62-160.120 – Definitions Adds: Revises/Clarifies: Deletes: Data Rejection Common Carriers Commercial Vendors Electronic Signature Secondary-use data Data Quality Objectives Method Detection Limit Determine for each reported matrix/analytical technology/analyte combination Allows Determination by any Technically Justifiable & Scientifically Sound Method NELAC NELAP TCLP Certification Requirements
Field 62-160.210 DEP SOPs apply to all Organizations 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
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.
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
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
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
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.
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)
Laboratories 62-160.330 - New & Alternative Methods Adds the Lake Vegetation Index (DEP SOP LT 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
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)
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
62-160.405 Electronic Signature Accepted as Equivalent to Written Signature Performance Requirements
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
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
62-160.700 Tables Revisions and Additions: D - Includes Field Turbidity as Exclusion I - Value ≥MDL and
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62-160.800 Documents Incorporated by Reference Updates List Adds DEP-EA-001/07 Removes References to Analytical Methods
Thank you For Your Support and Memories S ilky S. L abie Standards and Assessment Section 850.245.8065 Silky.email@example.com T minus 39 Days and Counting....