Quality Management Plan - IN.gov · 2012/9/21 · IDEM Office of Water Quality Quality Management...

Office of Water Quality

Quality Management Plan

September 21, 2012

Indiana Department of Environmental Management

Indiana Government Center-North

IDEM Office of Water Quality


September 21, 2012

100 N. Senate Ave.

Indianapolis, IN 46204

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September 21, 2012



September 21, 2012

Table of Contents

Introduction 6

1.0 Management and Organization ...................................................................... 11

1.1. QA Policy ............................................................................................................... 11

1.1.1. Importance of the QA System ............................................................................. 11

1.1.2. QA System Goals ................................................................................................ 12

1.1.3. QA Resources ..................................................................................................... 12

1.2. QA Org Chart ......................................................................................................... 14

1.3. QA Staff Contacts and Roles ................................................................................. 16

1.4. Programs Covered by QA System ......................................................................... 30

1.4.1. Technical Programs Subject to QA/QC Processes ............................................. 30

1.4.2. Internal Coordination ........................................................................................... 31

1.4.3. Oversight of Contractors and Extramural Organizations ..................................... 31

1.5. Communication ...................................................................................................... 35

2.0 Quality System Components .......................................................................... 37

2.1. Quality System Description .................................................................................... 37

2.1.1. Documentation .................................................................................................... 37

2.1.2. Planning and Annual Review .............................................................................. 37

2.1.3. Management Assessments ................................................................................. 37

2.1.4. Training ............................................................................................................... 38

2.1.5. Systematic Planning of Projects .......................................................................... 38

2.1.6. Project-specific Quality Documentation ............................................................... 38

2.1.7. Project and Data Assessments ........................................................................... 39

2.2. Quality System Tools ............................................................................................. 39

2.3. Quality Assurance Project Plans (QAPPs) ............................................................. 39

2.3.1. Environmental Programs that Use QAPPs .......................................................... 39

2.3.2. Review and Approval Procedures ....................................................................... 40

3.0 Personnel Qualification and Training .............................................................. 41

3.1. Description of Training Policy ................................................................................. 41

3.2. Training QA Procedures ......................................................................................... 41

3.2.1. Ensuring Appropriate Training ............................................................................. 41

3.2.2. Meeting Requirements for Formal Training ......................................................... 42



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3.2.3. Identifying Need for Retraining ............................................................................ 42

4.0 Procurement of Items and Services ................................................................ 43

4.1. Reviewing and Approving Procurement Documents .............................................. 43

4.2. Post-procurement Product/Service QA Procedures ............................................... 46

5.0 Documents and Records ................................................................................ 46

5.1. Identification of QA-related Documents and Records ............................................. 46

5.2. Record Handling Processes ................................................................................... 48

5.3. Ensuring that Documents Accurately Reflect Completed Work .............................. 48

5.4. Document Maintenance ......................................................................................... 49

5.5. Compliance with Statutory/U.S. EPA Recordkeeping Requirements. .................... 49

5.6. Procedures for Implementing Chain of Custody for Evidentiary Records ............... 49

6.0 Computer Hardware and Software ................................................................. 51

6.1. Hardware/Software QA Processes ......................................................................... 51

6.2. Hardware/Software Usage Assessment and Documentation ................................. 69

6.3. Hardware/Software Evaluation ............................................................................... 69

6.4. Data QA/QC ........................................................................................................... 70

7.0 Planning ......................................................................................................... 72

7.1. Systematic Planning Process Description .............................................................. 72

7.1.1. Quality Assurance Project Plans (QAPPs) .......................................................... 72

7.1.2. Policies ................................................................................................................ 72

7.1.3. Standard Operating Procedures (SOPs) ............................................................. 72

7.2. QAPP Development Process ................................................................................. 72

7.3. Processes Associated with Using External Data .................................................... 74

8.0 Implementation of Work Processes ................................................................ 75

8.1. Processes for Ensuring Work Follows Planning and Technical Documents ........... 75

8.2. Identification of Operations Needing SOPs/Technical Documents ......................... 76

8.3. Handling of SOPs/Technical Documents ............................................................... 77

9.0 Assessment and Response ............................................................................ 77

9.1. Assessment ............................................................................................................ 77

9.1.1. Assessment Tools ............................................................................................... 77

9.1.2. Frequency of Assessments ................................................................................. 78

9.1.3. Selection of Assessment Personnel .................................................................... 79

9.1.4. Assessment Personnel Authority and Organizational Independence .................. 79



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9.1.5. Assessment Planning .......................................................................................... 79

9.1.6. Implementation .................................................................................................... 80

9.1.7. Documentation .................................................................................................... 80

9.1.8. Reporting Results to Management ...................................................................... 80

9.2. Response ............................................................................................................... 80

9.2.1. Corrective Actions ............................................................................................... 80

9.2.2. Dispute Resolution .............................................................................................. 80

9.2.3. Corrective Actions ............................................................................................... 80

9.2.4. Dispute Resolution .............................................................................................. 80

10.0 Quality Improvement ...................................................................................... 81

10.1. Point of Contact ...................................................................................................... 81

10.2. Process(es) for Continuous Quality Improvement .................................................. 81

10.3. Process(es) for Preventing or Ameliorating Conditions Averse to Quality .............. 81

10.3.1. Prevention ........................................................................................................... 81

10.3.2. Identification ........................................................................................................ 82

10.3.3. Correction ............................................................................................................ 82

11.0 BIBLIOGRAPHY ............................................................................................. 83

Definitions: 84



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Introduction

Watershed Assessment and Planning Branch (WAPB)

Pursuant to Sections 106, and 305 of the Clean Water Act (CWA), the Watershed Assessment and Planning Branch (WAPB) of the IDEM Office of Water Quality (OWQ) collects environmental data from Indiana rivers and streams each year, to assess water quality. The OWQ also submits a biennial Integrated Water Monitoring and Assessment Report to the U.S. EPA that includes the 303(d) list, which identifies waters that are not meeting Indiana‘s water quality standards. Environmental data it collects also supports other water quality management programs such as National Pollutant Discharge Elimination System (NPDES) Permits, and 319 Nonpoint Source (NPS) Management in partnership with external customers and stakeholders.

To help accomplish these major water quality monitoring tasks, the WAPB has developed a Water Quality Monitoring Strategy and the Indiana Surface Water Quality Monitoring and Total Maximum Daily Loads (TMDLs) Program Quality Assurance Project Plan (QAPP) to ensure the collection of environmental data that are reliable for their intended uses. In addition, WAPB, reviews QAPPS submitted by 319/205(j) grantees collecting environmental samples.

The WAPB QMP documents the policies, goals/objectives, procedural criteria, areas of application, roles, and responsibilities that complement or add to the agency wide QMP and the Surface Water Quality Monitoring and TMDLs Program QAPP. The responsibilities of the WAPB are implemented by the four sections of the branch as follows:

Integrated Report and External Data Coordinator

Coordinates the assessment team for analysis of water quality monitoring data

Coordinates the biennial Integrated Report

Prepares the biennial 303(d) List of Impaired Waters

Manages the external data project

Probabilistic Monitoring Section

Conducts monitoring at locations selected by probabilistic design to meet CWA Sections 305(b) and 303(d) needs

Conducts probabilistic monitoring for E. coli

Monitors biological communities and habitat evaluations, water chemistry, pathogens and field parameters

Assists with data analysis and water quality assessments

Targeted Monitoring Section

Conducts monitoring at fixed stations

Conducts monitoring at targeted locations based on specific water quality management needs

Monitors biological communities and habitat evaluations, fish tissue and sediment chemistry, water chemistry, pathogens, field parameters, and flow measurement

Assists with data analysis and water quality assessments

Technical and Logistical Services Section

Provides technical services to the Branch including:

Quality assurance/quality control



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Database management

GIS-related services

Water quality modeling and load calculations

Logistics across programs

Special projects

Operational support

Management of Web/IS related projects

Watershed Planning and Restoration Section

Manages NPS Grant Program and provides assistance to grant projects

Develops TMDLs

Assists watershed groups with watershed planning & restoration

Collaborates with external partners through the External Data Framework

Develops performance measures and other reports to U.S. EPA

Compliance Branch

Roles and Responsibilities

The goal of the Compliance Branch is to ensure that the terms of permits and other enforceable agreements are met.

The primary functions of the Compliance Branch are to support the Office of Water Quality in the management of the National Pollutant Discharge Elimination System (NPDES) Permit Compliance Program (CWA 308, 327 IAC 5), and the Wastewater Operator Certification and Continuing Education Program (327 IAC 5-22). The Branch is supported by the following:

Compliance Data Section

Facilities Inspection Section

Wastewater Certification Program Staff

Compliance Data Section

The Compliance Data Section is responsible for maintaining Indiana‘s input into the federal ICIS-NPDES database, evaluating the compliance of wastewater treatment facilities with their NPDES permits, and addressing instances of effluent limit and permit schedule non-compliance.

Facilities Inspection Section (includes Operator Assistance Group)

This group is responsible for conducting on-site inspections of facilities holding NPDES permits as well as responding to complaints to assure facility compliance with state and federal water quality regulations. The Operator Assistance Group provides operational and laboratory technical assistance to wastewater treatment plant operators and facilities.

Wastewater Certification Program staff provide the administration of operator certification exams; operator certification and renewal; and approval of wastewater courses to be offered for technical and general operator continuing education credits.

Permits Branch



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The Permits Branch issues NPDES permits to help ensure that Indiana‘s wastewater dischargers; including municipalities; industries; state, semi-public, and federally owned wastewater treatment systems; industrial discharges into municipal wastewater treatment systems, and storm water runoff control discharges each complies with the CWA. The Permits Branch also issues construction permits for municipal facilities needing to construct, install, or modify any water pollution treatment control facility or sanitary sewers. In addition, the Branch performs wasteload allocation studies, anti-degradation reviews, issues NPDES variances, reviews and approves water body total maximum daily load (TMDL) calculations. The Permits Branch implements the following programs:

Sewer Construction

Industrial NPDES Permits

General Industrial Permit-by-Rules 7-12

Municipal NPDES permits (and semi-publics)

Industrial pretreatment program

Wastewater facility construction permitting

Wasteload Allocations / TMDL reviews

Combined Sewer Overflow (CSO) Long Term Control Plans

Drinking Water Branch

The IDEM OWQ Drinking Water Branch (DWB) regulates Indiana drinking water systems, or public water systems (PWSs). The PWSs all are ―self-reporting‖, and provide the IDEM DWB with data generated by in-house or contract labs. Water sample collection is the responsibility of the public water system, not the OWQ Drinking Water Branch. Certified laboratories and methods are entered into the Safe Drinking Water Information Systems (SDWIS) database. If a system submits results for a lab or method that are not certified, the database rejects the results.

Certification of these labs is done by Indiana State Department of Health (ISDH). The laboratory certification program is administered directly by U.S. EPA. ISDH staff perform on-site evaluations of the labs, that include a review of QMPs or quality manuals, and lab SOPs. Each three year cycle, ISDH staff evaluates approximately 65 microbiology labs (of which 55 are in-state), 65 chemistry labs (of which 25 are in-state), and 25 labs (of which 20 are in-state) that do both biological and chemical analyses. ISDH relies on the certifications of the home state of the various out-of-state labs. ISDH staff also review proficiency testing implemented under the Small System Laboratory Assistance Program where ISDH sends out bottles for total coliform and nitrate to a group of small not-for-profit systems (list managed by IDEM) and analyzes the results (as a certified laboratory – certified by EPA).

Activities of the IDEM Drinking Water Branch

Compliance Section

Maintain Drinking Water Program Primacy

Maintain Public Water Supply Supervision Program

Collect annual drinking water fees

Field Inspection Section

Ensure compliance by public water supply systems through a system of surveillance

Permits, Capacity Development and Certification Section

Review permits for public water systems

Continue implementing current Operator Certification Program

Compliance (capacity development) assistance at public water systems



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Review of new system management plans at new community and nontransient noncommunity public water systems

Ground Water Section

Promote source water protection of public water systems

o

Other Activities

Assist public water systems in complying with the new Arsenic Rule, Radionuclides Rule, the Enhanced Surface Water Treatment Rule, and the Disinfection/Disinfection Byproducts Rule

Promote the security of Indiana‘s community water supplies from terrorist attacks

Implement the Cross Connection Control Program

Streamline regulatory requirements for small systems

Surface Water, Operations and Enforcement Branch

Storm Water

Storm Water Construction Permits (Rule 5 (permit-by-rule))

The Branch administers a general permit program that targets construction activities that result in land disturbance of one acre or more. Rule 5 (327 IAC 15-5) is designed to reduce pollutants, principally sediment, that are a result of soil erosion and other activities associated with land-disturbing activities.

Storm Water Industrial Permits (Rule 6 and Individual NPDES industrial storm water runoff permits)

The Branch administers a general permit program that targets storm water runoff associated with industrial activities. Requirements of this rule apply to specific categorical industrial facilities, which are exposed to storm water.

Municipal Separate Storm Sewer System (MS4) Permits (Rule 13)

Under Phase I, this general permit rule was not necessary. Phase I applied to areas with a population greater than 100,000. Only the City of Indianapolis met Phase I criteria, and was issued a storm water permit. Under Phase II, Rule 13 regulates MS4 entities (cities, towns, universities, colleges, correctional facilities, hospitals, conservancy districts, homeowner's associations, and military bases) located within urbanized areas, as delineated by the U.S. Census Bureau, or for those MS4 areas outside of urbanized areas, serving a population greater than 7,000.

Wetlands

Wetland certifications under Section 401 or the Clean Water Act

When a project is planned in Indiana that will impact a wetland, stream, river, lake, or other water of the U.S., IDEM must issue a Section 401 Water Quality Certification (401 WQC). A Section 401 WQC is a required component of a federal permit and must be issued before a federal permit or license can be granted.

The bulk of federal permits requiring Section 401 Water Quality Certification from IDEM are Section 404 Dredge and Fill Permits, which are issued by the U.S. Army Corps of Engineers (Corps). However, applicants for a license to operate a hydroelectric dam from the Federal Energy Regulatory

Commission (FERC) must also receive Section 401 Water Quality Certification from IDEM.

Operations

Contracts and grants management

Financial operations



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Regional water and sewer districts

Enforcement

All water Clean Water Act and Safe Drinking Water Act-related violations



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1.0 Management and Organization

Purpose: To document the overall policy, scope, applicability, and management responsibilities of the Office of Water Quality‘s quality system.

1.1. QA Policy

1.1.1. Importance of the QA System

Watershed Assessment and Planning Branch QA/QC activities are integrated into Water Quality WAPB monitoring programs to provide a measurement of

environmental data quality and its usability for IDEM decision making processes and to provide legal defensibility of analytical data collected and water quality assessments made there from.

The Watershed Assessment and Planning Branch reorganized in 2011 to optimize staff and financial resources and to implement its revised Water Quality Monitoring Strategy (WQMS). This strategy identifies IDEM‘s key water quality monitoring objectives and monitoring approaches used to collect the data necessary to meet the objectives.

In the last quarter of 2010, the Watershed Assessment and Planning Branch convened an interdisciplinary work group comprised of staff from several programs to devise a revised WQMS. The group met regularly to analyze data gaps and identify efficiencies that will enable the agency to better meet more of its primary water monitoring objectives. The revised WQMS was submitted to the U.S. Environmental Protection Agency (U.S. EPA) in May of 2011.

The most notable revision is scaling back, on an annual basis, the probabilistic monitoring program aimed at assessing all waters of the state so that resources can be deployed on targeted monitoring projects that are designed to answer specific questions such as, ―Have our waters improved?‖ The probabilistic monitoring design, which divides the state into river basins and employs a random selection of sampling locations, allows IDEM to meet the requirements of Sections 305(b) and 303(d) of the Clean Water Act to assess all waters of the state and to determine what waters are impaired for (not meeting) their designated uses. This approach, while efficient for assessment purposes, required the expenditure of a significant portion of IDEM‘s monitoring resources and did not help determine whether or not waters have improved in quality over time.

To advance IDEM‘s ability to monitor Indiana‘s waters for multiple water management objectives, the revised WQMS reduces the probabilistic monitoring from two river basins every year to one. This approach reduces the number of randomly selected sites to be sampled by 50%, meaning that IDEM will complete monitoring of the entire state on a ‗probabilistic‘ basis every nine years. Reducing our probabilistic monitoring rate to a nine year complete assessment of state waters will allow IDEM to conduct other, more specifically targeted, monitoring such as baseline monitoring for Section 319 watershed groups, more intensive total maximum daily load monitoring, monitoring to support public health advisories (cyanobacteria and algal toxins), and performance measurement monitoring to determine if waters have improved in locations where 319 or other watershed improvement projects have been implemented. This monitoring will help IDEM to better understand the efficacy of IDEM‘s strategies for improving waters.

Compliance Branch QA/QC activities are of critical importance to the Wastewater Compliance Branch to make determinations

daily as to the compliance status of NPDES permitted facilities. These determinations are based on observations made and documented during on-site compliance inspections and pretreatment audits; compliance reviews and investigations conducted in the office; and the review of self-monitoring data submitted by NPDES permit holders (e.g., discharge monitoring reports (DMR), monthly reports of operation (MRO), monthly monitoring reports (MMR)).



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Permits Branch QA/QC activities are vital to ensure that permits issued to regulated facilities comply with state rules and

federal regulations. QA/QC is also vital for establishing proper limits and assessing relationship of water quality standards to limits.

Drinking Water Branch The DWB is responsible for implementation of the federal Safe Drinking Water Act (SDWA) in the state. To

implement the SDWA, the Branch ensures that all public water systems understand the requirements of the SDWA and take those steps necessary to make sure that water served to the public is safe in quality and adequate quantity. In addition to activities associated with the SDWA, the Branch also assesses the quality of ground water within the state. Quality assurance and quality control (QA/QC) activities help the Branch ensure the activities performed in the Branch meet agency goals and expectations and that activities are carried out in a manner that protects human health.

1.1.2. QA System Goals

Watershed Assessment and Planning Branch Program QA system objectives and goals for internal sample collection are described in the WAPB-OWQ

―Quality Assurance Project Plan for Indiana Surface Water Quality Monitoring and Total Maximum Daily Load (TMDL) Program.‖ Specific goals and objectives for each project are detailed in individual sampling and analysis project work plans. The main purpose of water quality monitoring is to conduct water quality assessments of Indiana‘s rivers, streams, lakes, and reservoirs for designated uses. Additionally, targeted monitoring includes baseline monitoring for Section 319 watershed groups, more intensive total maximum daily load monitoring, monitoring to support public health advisories (fish tissue, cyanobacteria and algal toxins), and performance measurement monitoring to determine if waters have improved in locations where 319 or other watershed improvement projects have been implemented..

Compliance Branch The Branch has developed written standard operating procedures (SOPs) for the majority of branch

processes and provided classroom training on these SOPs with regular refreshers (i.e., at routine staff meetings.

Adherence to these SOPs is specifically noted in performance criteria for all Compliance Branch staff. Fact files are maintained on each staff to document adherence to applicable SOPs.

Permits Branch The Permits branch‘s QA goals are:

To ensure that every NPDES permit issued or submission reviewed by OWQ staff complies with all state rules, federal regulations and program policies.

To document branch operations with appropriate SOPs and policies

Drinking Water Branch The IDEM Office of Water Quality Drinking Water Branch will continue to develop the SOPs and other quality

system tools needed to incorporate a quality systems approach into all Drinking Water Branch activities.

1.1.3. QA Resources

Watershed Assessment and Planning Branch Field staff from the Targeted Monitoring and Probabilistic Monitoring Sections collects QC samples for

laboratory analyses and perform QA/QC of field samples per QAPP and individual Sampling and Analysis Project Work plan requirements. Three chemists from the Technical and Logistical Services Section plus the QA manager (Section Chief) perform the quality assurance work of analytical data received from all internal water quality monitoring programs or projects in the WAPB. One environmental manager in the Technical and Logistical Services Section reviews and approves project QAPPs from 319/205(j) grantees.



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There are a total of 5.0 FTEs for the Watershed Assessment and Planning Branch. The Technical and Logistical Services Section devotes 2.5 FTEs to QA/QC activities. About 1 FTE is devoted to QA/QC activities by the Probabilistic Monitoring Section staff. The Targeted Monitoring Section devotes about 1 FTE among its staff to QA/QC activities. The Watershed Planning and Restoration Section devotes about 0.5 FTE to QA/QC activities.

Compliance Branch The branch chief and two section chiefs are responsible for QA/QC activities. One SEM 1 position in the

Facilities Inspection Section also is dedicated to issues relating to laboratory proficiency of permitted facilities and certified wastewater treatment plant operators and serves as branch representative for QMP-related matters. One SEM 1 in the Compliance Data Section also serves as point-of-contact for QMP-related matters.

For details regarding the calculation of Compliance QA resources, refer to the FTE table in Appendix A.

Drinking Water Branch DWB dedicates 11.85 FTE staff to quality assurance and quality control issues. A detailed delineation of

these QA tasks can be found in the Drinking Water FTE Table in Appendix A of the OWQ QMP Appendices.



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1.2. QA Org Chart

QA Organizational Chart for the OWQ Watershed Assessment and Planning Branch

External to Agency

Assistant Commissioner (OWQ)

IDEM QA Manager(s)

Branch Chief WAPB, OWQ

Project QA Officer

Contract Analytical Laboratory

Technical Staff

External Programs Managers/Project Coordinators

(Permits, Compliance, or 319/205(j) Grantees)

Technical Staff

Technical Staff

QA Staff

Project Officers/Section Chiefs:• Technical & Logistical Services Section

• Targeted Monitoring Section • Probabalistic Monitoring Section • Watershed Planning & Restoration

Section

Branch QA Manager

Assessment QA Officer

Laboratory Director

NPS/External DataQA Officer

QA Organizational Chart for OWQ Compliance Branch

Agency QA managers

Wastewater Certification Program Staff

Facilities Inspections Section

OWQ Compliance Branch Chief

Compliance DataSection



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QA Organizational Chart for the OWQ Permits Branch

Agency QA managers

Facility Construction and Engineering

Section

Permits Administration

Section

Industrial Section

Office of Water Quality:Permitting Branch Chief

Municipal Section

QA Organizational Chart for the OWQ Drinking Water Branch

InspectionSection

Compliance Section

OWQ Drinking Water Branch

Chief

Groundwater Sedction

Permits,Operator

Certifications, and Capacity Development

Agency QA managers



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1.3. QA Staff Contacts and Roles

Water Assessment Planning Branch QA roles:

Name/Title Section Role

Marylou Renshaw

Branch Chief and Branch

QA Coordinator (QAC)

OWQ WAPB Manages all WAPB surface water quality monitoring programs and projects, including those conducted by agency staff and grant projects conducting monitoring under an approved QAPP.

Branch QA Coordinator

Cyndi Wagner

Section Chief


Supervises environmental data collection projects and provides guidance to the Project Officer, who is responsible for quality control procedure implementation, and project data collection activities.

Supervises and approves all Supplemental 106 reports and supervises and/or manages those grants

C.L. Bridges

Section Chief


Supervises environmental data collection projects and provides guidance to the Project Officer, who is responsible for quality control procedure implementation, and project data collection activities.



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Chuck Bell

Section Chief,

QA Manager


Supervises and coordinates all quality assurance and laboratory activities for the WAPB water quality monitoring programs and projects. Supervises and approves all quality assurance project plans and QA guidance and QA activities of QA Manager for the 319/205(j) program.



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Bonny Elifritz

Section Chief


Supervises and approves all 319(h) and 205(j), reports and supervises and/or manages those grants.



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Tim Bowren

QA Officer (QAO), (Chemist)


Section QA Contact

Custodian of the Quality Assurance Project Plan (QAPP) for Indiana Surface Water Quality Monitoring and Total Maximum Daily Load (TMDL) Program.

Conducts data validation review, data assessment, data qualification, and internal performance and system audits for the project under the direction of the QAC.

Assigned QA personnel review all individual sampling and analysis work plans for the water quality monitoring projects for compliance with the QAPP and to verify that data quality objectives have been addressed by the respective project work plan.

Reviews any standard operating procedures (SOPs) prepared by WAPB sections to ensure they meet U.S. EPA-based agency requirements for preparing SOPs.

QAO for Probabilistic Monitoring and WAPB Special Projects.

Reviews electronic data import (EDI) lab data files submitted by contract, OWQ, and external laboratories for import into the Assessment Information Management System (AIMS) database.



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Kimberly White

QA Staff Chemist



Assigned QA personnel review individual sampling and analysis project work plans for the water quality monitoring projects to determine compliance with the QAPP and to verify that data quality objectives have been addressed by the respective project work plan.

Reviews any SOPs prepared by WAPB sections to ensure they meet U.S. EPA-based agency requirements for preparing SOPs.

QAO for Fish Tissues and Sediment Contaminants Monitoring Program, Source Identification Program, TMDLs Sampling Program, Compliance Evaluations Inspections Program and special projects from NPDES Programs.

Reviews EDI lab data files submitted by contract and OWQ laboratories for import into the AIMS database.



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David Jordan

QA Staff Chemist



Assigned QA personnel review individual project sampling and analysis work plans for the water quality monitoring projects to determine compliance with the QAPP and to verify that data quality objectives have been addressed by the respective project work plan.

Reviews any SOPs prepared by WAPB sections to ensure they meet U.S. EPA-based agency requirements for preparing SOPs.

QAO for Fixed Station Monitoring and Trace Metals Monitoring Programs.

Reviews EDI lab data files submitted by contract and OWQ laboratories for import into the AIMS database.



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Cindy Martin

Senior Environmental Manager


Program manager for special projects.

Reviews field data entered into AIMS for QC.



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Vacant

Environmental Manager 2


QA Contact for Targeted Monitoring Section GIS mapping.

Calibrates Trimble Juno geo-locating units.

Tim Beckman



Program manager for Fixed Station Monitoring Program

Program manager for Baseline Monitoring for Watershed Planning

Coordinates monthly sampling

Evaluates Fixed Station Lab and Field Data for Trend Analyses




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Kris Kehoe



Project manager for E. coli sampling and analyses projects using mobile E. coli Lab #1. This includes the Probabilistic Monitoring Program.

QC Manager for IDEM OWQ mobile E. coli Lab #1 (1 of 2 E. coli mobile labs)


John Prast



Program manager for TMDLs sampling projects.

QC Manager for IDEM OWQ mobile E. coli Lab #2 (1 of 2 E. coli mobile labs)




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David Arnold

Environmental Scientist 3


Conducts sampling for Fixed Station Monitoring Program


Joel Armstrong

Environmental Scientist 3


Conducts sampling for Fixed Station Monitoring Program




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Jim Stahl



Section QA Contact

Coordinates QA/QC for Fish Communities and Habitat Assessments.

Coordinates sample collection of fish tissues and sediments for submission to contract laboratory.

QC Manager for IDEM OWQ Microcystin Laboratory

Tim Fields



Head of sampling team for collection of water samples for Probabilistic Monitoring Projects.

Manages nutrient data collection.




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Stacy Sobat



Coordinates QA/QC for Fish Communities and Habitat Assessments.

Todd Davis



Coordinates QA/QC for Macroinvertebrate Assessments.

Jody Arthur

Technical Environmental Specialist

OWQ WAPB Integrated Report and 303(d) List Coordinator.

QA/QC manager for ADB.

External Data Coordinator.



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Laura Bieberich



Manages contract with IU SPEA for Lakes Water Quality Assessment Program



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Betty Ratcliff


QA Manager for 319/205(j) grant projects


Reviews & Approves Project QAPPs for compliance to U.S. EPA requirements.

Conduct data validation reviews and assigns data quality assessment levels for 319 and 205(j) grant projects

Serves as a contact for QAPP development.

Develops QAPP guidance documents to customer.

External Data (future).

Compliance Branch QA roles:


Mark Stanifer Branch Chief

Branch QA Coordinator

Becky Ruark, Facilities Inspection Section Section QA Contact

Rose McDaniel Compliance Data Section Section QA Contact

Permits Branch QA roles:

Name Section Role

Paul Higginbotham OWQ Permits Branch Chief

Steve Roush OWQ Permits Branch QA Coordinator

Stan Rigney Industrial Permits Section QA Contact

Leigh Voss Municipal Permits Section QA Contact

Jerry Dittmer Municipal Permits Section Chief

Catherine Hess Permits Administration Section QA Contact

Don Worley Facility Construction and Engineering

Section QA Contact



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Support


Stacy Jones Drinking Water Branch Branch QA Coordinator

Mary Hoover Permits, Cap. Dev. and Op. Cert Section

Section QA Contact

April Swift Compliance Section QA Contact

Larey Conquergood Field Inspection Section QA Contact

Mitt Denney Ground Water Section QA Contact

1.4. Programs Covered by QA System

1.4.1. Technical Programs Subject to QA/QC Processes

WAPB Virtually all of WAPB‘s programs involve the collection or analysis of quantitative data.

Technical Programs Subject to Quality Assurance/Quality Control Processes

Fixed Station Monitoring

Probabilistic Monitoring Program

Baseline Monitoring for Watershed Planning

Monitoring to Identify Improvements (Performance Measures) in Water Quality

Monitoring to Support TMDL Development

Special Studies / Compliance Evaluations Inspections Program

Monitoring to Support development of Public Health Advisories

Fish Tissues and Sediment Contaminants Monitoring Program for Fish Consumption Advisories

Cyanobacteria and Microcystin Monitoring

Lakes Monitoring

319/205(j) Project Monitoring

Compliance The following Compliance Branch activities involve QA/QC processes:

Review of DMRs, MROs and MMRs

Data collection, entry and maintenance

Providing compliance assistance and outreach

Inspection protocol

Complaint Response protocol

Evaluation of operator certification applicants and trainers

Permits The following Permits Branch activities involve QA/QC processes:

Sewer construction

Industrial NPDES Permits

General Industrial Permit-by-Rules 7-12

Municipal NPDES permits (and semi-publics)

Industrial pretreatment program



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Wastewater facility construction permitting

Wasteload allocations / TMDL reviews

Long Term Control Plans


The following DWB activities involve QA/QC processes:

Permit Application Review

Rules Development

Data collection, entry and maintenance

Providing compliance assistance and outreach

Inspection protocol

Complaint Response protocol

Sampling protocol

Evaluation of operator certification applicants and trainers

1.4.2. Internal Coordination

Watershed Assessment and Planning Branch The WAPB Technical and Logistical Services Section coordinates with, and provides QA/QC support to the

OWQ NPDES Permits Program, and to Inspections, Compliance, Enforcement, and Emergency Response.

Compliance Branch The Branch coordinates compliance-related QA/QC activities through the OWQ enforcement program; and

the Integrated Compliance Information System (ICIS-NPDES) upkeep and maintenance with U.S. EPA.

Permits Branch The Branch coordinates permitting-related QA/QC activities through the:

OWQ Watershed Assessment and Planning Branch

OWQ Compliance Branch

Office of Land Quality

Office of Legal Counsel

OWQ Enforcement Program

Drinking Water Branch The Branch coordinates drinking water-related QA/QC activities through:

Laboratory analysis protocol

Complaint Clearinghouse

State Revolving Loan Fund (SRF)

Office of Land Quality (OLQ) – cleanup (State Cleanup and Superfund)

OLQ – Emergency Response

OWQ – Inspections and NPDES

1.4.3. Oversight of Contractors and Extramural Organizations

Watershed Assessment and Planning Branch Environmental samples collected from different matrices (water, sediments, and fish tissues), are sent to

contract laboratories for chemical analyses. All contracts with laboratories require that an U.S. EPA approved QA/QC system is in place and acceptable to IDEM. A copy of the current quality assurance manual of each contracted laboratory is reviewed and kept in the contract manager‘s files. Additionally, assessment activities in the field may be conducted in cooperation with non-IDEM groups such as U.S. Geological Survey (USGS), Indiana University School of Public and Environmental Affairs (IU SPEA), or volunteer monitoring groups. Lakes assessments may be conducted by IU SPEA.

All contract labs are prequalified by IDEM which reviews and approves their Quality Management Plans, SOPs, and other technical documents in response to IDEM Requests for Proposals (RFPs). Labs submitting bid responses to IDEM also include details about each facility, staffing, staff



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qualifications, and lab audit reports performed by other groups or organizations as well as state or federal accreditations. Consequently, IDEM does not require a site visit or audit of any contract lab. Site visits may occur to resolve laboratory quality assurance problems that may occur or to verify that the proper corrective action has been taken.

The WAPB performs a vigorous quality check of data provided to IDEM by contract laboratories. Each lab data set is checked for compliance to the IDEM WAPB QAPP and contract requirements for QA/QC. Contract labs also submit data in electronic format which is reviewed for accuracy and completeness and assigned to a specific level of data quality assessment (DQA) indicating the quality of data and its usefulness in water quality assessments which are suitable for regulatory decision-making.

319 and 205(j) grant project managers in the Watershed Planning and Restoration Section are responsible for review of tasks, deliverables, and schedules during quarterly site visits with contractors or grant sponsors. The contractors or grant sponsors are required to submit progress reports with every invoice, or at least quarterly progress reports if they don‘t invoice as often. The project managers review reports and invoices to ensure all tasks are on schedule, expenses and match are eligible, and deliverables are acceptable. Invoices are signed by the senior project manager or section chief for submittal to the accounting office.

Contract/Extramural entity name Data or Service provided Means of oversight Heritage Environmental Services

Indianapolis, IN Provides analytical services for water and sediment

samples collected by IDEM. Analyses may include general chemistries, nutrients, metals, and organic parameters. These services support multiple WAPB Projects, including the Probabilistic and Baseline Monitoring Programs, Source ID, TMDL development, and special projects

Data Reports / Packages are reviewed for QA/QC in compliance to a template check list developed for project specific Water Quality Monitoring Programs. This QA/QC template has been designed to be consistent with IDEM RFP and WAPB QAPP requirements, so that each QA/QC review is consistent with agency standards.



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Contract/Extramural entity name Data or Service provided Means of oversight Underwriters Laboratory

South Bend, IN Provides analytical services for water samples

collected by IDEM. Samples may be analyzed for general chemistries, nutrients, metals, organic, and bacteriological parameter. These services supports IDEM‘s Probabilistic and Baseline Monitoring Programs, TMDL development, and special projects

Data reports / packages are reviewed for QA/QC in compliance to a template check list developed for project specific Water Quality Monitoring Programs. This QA/QC template has been designed to be consistent with IDEM RFP and WAPB QAPP requirements, so that each QA/QC review is consistent with agency standards.

Indiana State Department of Health (ISDH) Environmental Laboratory Indianapolis, IN

Samples Provides analytical services for water samples collected by IDEM. Analyses may include metals, inorganic chemicals, organic chemicals, physical properties, and E. coli bacteria. These services support IDEM‘s Fixed Station and Baseline Monitoring Programs, TMDL Development, and special projects.

Data Reports / Packages are reviewed for QA/QC in compliance to a template check list developed for project specific Water Quality Monitoring programs. This QA/QC template has been designed to be consistent with IDEM RFP and WAPB QAPP requirements, so that each QA/QC review is consistent with agency standards.



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Contract/Extramural entity name Data or Service provided Means of oversight Pace Analytical Services,

Madison, WI and Minneapolis, MN

Provides analytical services for fish tissues and sediment samples collected by IDEM staff. Samples are analyzed for general chemistries, nutrients, and organic parameters in support of Fish Tissues and Sediments Contaminants Monitoring Project, Fish Consumption Advisories, and special projects.

Data reports / packages are reviewed for QA/QC in compliance to a template check list developed for project specific Water Quality Monitoring programs. This QA/QC template has been designed to be consistent with IDEM RFP and WAPB QAPP requirements, so that each QA/QC review is consistent with agency standards.

US Geological Survey Indiana Water Science Center

5957 Lakeside Blvd. Indianapolis, IN 46278-1996

Conducts analyses of chlorophyll for nutrient criteria development using data collected by IDEM monitoring staff and conducts sampling and analysis for mercury using ultra clean techniques.

Data reports / packages are reviewed for QA/QC in compliance to a template check list developed for project specific Water Quality Monitoring programs. This QA/QC template has been designed to be consistent with IDEM RFP and WAPB QAPP requirements, so that each QA/QC review is consistent with agency standards.

IU SPEA Conducts water quality monitoring in lakes and reservoirs through the Clean Lakes Program and implements a volunteer monitoring program which provides more limited data. Clean Lakes Program data is submitted to IDEM for use in Clean Water Act Assessments, and volunteer data is submitted for potential use in these processes. Contractor also conducts data analyses, submitting the results in a report to IDEM annually.

Data reviewed by IU SPEA for compliance to 319 IDEM approved QAPP

Only qualified data are submitted to IDEM. Data which would be assessed as rejected are maintained according to the IU retention schedule by IU SPEA.

Data undergo internal QA review in accordance with the approved QAPP prior to reporting to IDEM.

IU SPEA submits a QA to IDEM report annually



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Contract/Extramural entity name Data or Service provided Means of oversight 319/205(j) Grantees Environmental sample collection and analyses.

Nature and scope of monitoring efforts vary from project to project but may include biological, bacteriological, and chemical parameters. Grantees also conduct outreach; develop watershed management plans, which include watershed characterization, source identification of pollutants, and information on cause and effect relationships. Grantees also install and may monitor best management practice with the goal of improving water quality.

Quarterly site visits by project managers

Progress reports with every invoice submitted or at least quarterly

Quality assurance project plan submission and approval required before sample collection can begin

Any changes to the monitoring plan must be approved prior to their implementation. Data submission with final project report for final review and evaluation

Compliance Branch Laboratory technical assistance with NPDES approved test methods or with other laboratory issues, is

available. The Branch assists U.S. EPA in the administration of the DMR-QA program.

Permits Branch Permits does not delegate or contract out any work.

Drinking Water Branch The Drinking Water Branch is not currently contracting out any work.

1.5. Communication

Watershed Assessment and Planning Branch 1. Senior staff conducts in-house and peer training of newly hired staff about WAPB

programs/projects SOPs and QA/QC processes. 2. Each employee from the WAPB reviews and is oriented with the Surface Water Quality

Monitoring Strategy and its requirements. 3. Copies of the QAPP and project work plans are made available to appropriate IDEM staff

for planning and QA/QC procedures. 4. Project managers implement the U.S. EPA data quality objective (DQO) process in

planning and execution of projects and in reviewing and assessing the quality of the environmental data collected.

5. Work plans are reviewed and approved by QA officers, section chiefs, and branch chiefs as program managers.

6. 319/205(j) QAPPs, Watershed Management Plans (WMPs), and contract changes are reviewed and approved by project managers, senior project manager, and section chief.

Compliance Branch To ensure that applicable QA/QC elements and activities are understood by staff, Office of Water Quality

Wastewater Compliance conducts initial classroom instruction concerning any new written procedures followed by routine updates and refreshers at monthly staff meetings. Wastewater Compliance also communicates regularly within the Branch via monthly reports and individual meetings with staff.

Permits Branch All section chiefs and senior staff provide on the job training to their staff using SOPs, state rules, federal

regulations, permit templates, and policies. Staff communicates using e-mail, telephone, and personal conversations.



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Drinking Water Branch OWQ Drinking Water program managers and quality assurance managers conduct the following activities to

assure that staff understands applicable QA/QC elements: 1. Implement and oversee Drinking Water Branch (DWB) QA policy within the Branch. 2. Act as a conduit for QA information. 3. Assist in the development of QA policies and procedures. 4. Assist in solving QA related problems at the lowest possible organizational level. 5. Provide policy guidance for the DWB program. 6. Train staff and provide information concerning agency QA-related training

opportunities.



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2.0 Quality System Components

Purpose: To document how the Office of Water Quality manages its quality system and defines the primary responsibilities for managing and implementing each component of the system.

2.1. Quality System Description

2.1.1. Documentation

Watershed Assessment and Planning Branch The primary WAPB QA documents are listed in Appendix B.

Compliance Branch The Branch has a documented quality system with written SOPs for conducting wastewater inspections. A

major update of these procedures currently is underway, with completion projected in early 2012. Compliance Data staff currently are updating and writing SOPs concerning section operations.

The Compliance Branch QA documents are listed in Appendix B.

Permits Branch The Branch uses SOPs, other policy and technical documents (See Appendix B), and state rules and federal

regulations to ensure quality permits are written and issued.

Drinking Water Branch The Branch is continuing to develop additional QA documents. Appendix B lists both current QA-related

documents, and those still under development.

2.1.2. Planning and Annual Review

Watershed Assessment and Planning Branch Planning for environmental data collection is a systematic planning process which includes developing a

detailed sampling and analysis work plan specific to a project. Each work plan describes key elements of:

Project task organization

Project goals and objectives

Project schedule

Project resources

Identification of type and quantity of data needed to support each project DQO

See section 7.3 for additional details of these elements. The WAPB performs assessment of the quality system on an ongoing basis. QA practices associated with data collection are refined and updated as needed or reviewed at least annually.

Permits Branch The Branch does not have a centralized quality system and does not conduct annual QA/QC reviews and/or

assessments.

Drinking Water Branch The Branch reviews or assesses SOPs and policies frequently, as is specified in each such document.

2.1.3. Management Assessments

Watershed Assessment and Planning The management also ensures personnel conducting assessments have sufficient training and authority,

access to programs, managers, documents, and records to identify both quality problems and to propose recommendations for solving quality problems. Assessment tools include peer reviews, technical reviews, and performance evaluations.



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Compliance, Permits, and Drinking Water branches conduct management assessments in similar fashion as the Watershed Assessment and Planning Branch, using peer reviews, technical reviews, and performance evaluations, with specific applications to their separate responsibilities.

2.1.4. Training

Watershed Assessment and Planning Individualized QA training in Quality Assurance procedures is provided to key staff by section personnel.

Sampling staff, especially the new hires, are oriented with the Water Quality Monitoring Strategy for sampling activities and with relevant SOPs (listed in program QAPP sections B and C, and project sampling and analysis work plans) before the start of each field season for collecting water, sediments, fish tissues, fish community, macroinvertebrate, and habitat assessments (See section 3.1 for further details).

The Compliance, Permits, and Drinking Water Branches do not conduct management assessments.

2.1.5. Systematic Planning of Projects

Watershed Assessment and Planning The WAPB uses program QAPPs as a broad scope for the planning of sampling projects. At the project level,

the WAPB uses sampling and analysis work plans in conjunction with the program QAPP, and in lieu of project QAPPs. Before the start of a project, sampling and analysis project work plans are developed and approved by the assigned QAO for the program area followed by the upper management (section chief and branch chief). The sampling and analysis project work plans use the U.S. EPA DQO process to specify study objectives and acceptable criteria for the collection, evaluation, and use of environmental data.

The Compliance, Drinking Water, and Permits Branches do not produce QAPPs or use the associated systematic planning process.

2.1.6. Project-specific Quality Documentation

Watershed Assessment and Planning At the project level, WAPB uses Sampling and Analysis Work plans in conjunction with the IDEM WAPB

QAPP in lieu of individual project QAPPs.

In addition, the WAPB uses the following documents to record project QA/QC activities.

QA/QC review reports are created after all laboratory analytical data are reviewed and QA/QC‘d. The formats of QA/QC review reports have been described earlier in the table in the content of section 1.4.3. Each QA/QC review report assesses QA/QC performance and compliance to contract and IDEM WAPB QAPP requirements (sections C – D). Each report details the appropriate QC requirements reviewed for each parameter reported.

Laboratory data in the AIMS database includes QA flags for acceptable, estimated, and rejected results. Acceptable laboratory data are qualified for data quality assessment (DQA) levels 3 or 4 which are suitable for regulatory decision making.

Field sheets generated by the AIMS database system provides space to track QA checks as data are reviewed by project personnel.

Project sampling and analysis work plans and final assessment reports include QA/QC sections indicating the overall quality of data and its usefulness in water quality assessments.

319 and 205(j) grant projects that have developed QAPPs, report data to the project manager in a spreadsheet format. The QA Manager reviews the reports for compliance to the project QAPP requirements. Data meeting the requirements for DQA levels 2 or above can be imported into the AIMS database and designated as NPS program data.

The Compliance and Permits Branches do not produce QAPPs or use the associated systematic planning process.



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Drinking Water Branch The Ground Water Section has a QAPP that establishes the laboratory analyses standards it expects all

water samples to achieve.

2.1.7. Project and Data Assessments

Watershed Assessment and Planning WAPB performs assessment of project activities and the data collected during, and upon completion of the

project by comparisons of procedures and processes used to those specified in the relevant SOP, QAPP, QMP, and project specific sampling and analysis work plan. Field data is reviewed for QA/QC compliance. Electronic data received from contract labs are reviewed for accuracy and completeness prior to being imported into the AIMS database. Corrective actions for QA/QC deviations are implemented during the course of a project when possible or documented for action at a later time. Reports resulting from project activities contain QA/QC sections summarizing QC of field and laboratory data and possibly a list of applicable QA/QC review reports.

Data from 319 and 205(j) projects are collected following quality assurance procedures outlined in their pre-approved QAPPs. Data received in the NPS AIMS spreadsheet with mandatory elements completed are uploaded into AIMS with NPS data quality assessment levels assigned by the NPS QA Manager. All data submitted by projects are stored electronically in the project file folders. Project managers are responsible for the receipt of all information, including data, collected from their projects.


2.2. Quality System Tools

In addition to the agency and OWQ Quality Management Plans, the branches of OWQ also rely on the following quality system tools:

Watershed Assessment and Planning Branch uses the following QA tools: Program QAPPs (program specific documentation)

Project-specific sampling and analysis work plans (project specific quality documentation)

Data verification and validation (data assessments)

SOPs and user manuals

Peer training of personnel in QA/QC procedures and quality system audits

Compliance Branch uses the following QA tools: Data verification and validation (data assessments)

Permits Branch uses the following QA tools: Data verification and validation (data assessments) (None of the data submitted in the

applications are verified.)

Other quality system tools o Standardized checklists is used for CSO LTCP reviews o Previously issued permits are used as model permits o Permit and letter templates o Permit application review checklists

Drinking Water Branch uses the following QA tools: QA Project Plans (QAPPs)

Standard operating procedures (SOPs)

Data verification and validation (data assessments)

2.3. Quality Assurance Project Plans (QAPPs)

2.3.1. Environmental Programs that Use QAPPs

Watershed Assessment and Planning Branch



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A. A Program QAPP (the Indiana Surface Water Monitoring and TMDPL Program QAPP) is used by the following Surface Water Quality Monitoring Programs:

Fixed Station Monitoring Program

Probabilistic Monitoring Program (Watershed Monitoring Program)


Monitoring to identify improvements in water quality

TMDL development

Source identification studies

Special Studies Compliance Evaluations Inspections Program

Monitoring to support development of public health advisories

Fish Tissues and Sediment Contaminants Monitoring Program


Lakes Assessments Program B. Watershed groups develop QAPPs under their 319 or 205(j) grant projects.

The DWB does not develop or implement QAPPs because they are not directly involved in sampling, which is the responsibility of the public water systems (PWS) it regulates, or of the contracted laboratories of those PWS. Both PWS and PWS contracted laboratories are certified by the Indiana State Department of Health. The Compliance and Permits Branches also do not produce QAPPs or use the associated systematic planning process.

2.3.2. Review and Approval Procedures

Watershed Assessment and Planning Branch A. The QAPP is reviewed and approved by WAPB management. Project specific, sampling

and analysis project work plans developed by project managers are reviewed for completeness and compliance to applicable SOPs and QAPP requirements. The work plans are reviewed and approved by the project QA officer, QA coordinator, the section chief, and the WAPB chief. SOPs developed for WAPB programs are reviewed and approved by the QA officer, Branch QA coordinator, the section chief, the WAPB chief, and IDEM QA managers.

B. QAPPs developed by watershed groups under 319 or 205(j) grants are reviewed and approved by the Nonpoint source QA manager and the Technical and Logistical Services section chief.

C. Projects for TMDL development which are funded by U.S. EPA have contractors which write QAPPs that are approved by U.S. EPA.




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3.0 Personnel Qualification and Training

Purpose: To document the procedures for assuring that all personnel performing work for the IDEM Office of Water Quality have the necessary skills to effectively accomplish their work.

3.1. Description of Training Policy

Watershed Assessment and Planning Branch Targeted Monitoring Section has written SOPs and its staff is trained by experienced peers on how to collect

surface water samples, operate equipment, and perform QA/QC procedures, etc. The Probabilistic Monitoring Section has several written SOPs and the staff has training requirements in position descriptions. New staff is trained by experienced peers on how to collect fish and macro invertebrate samples from Indiana rivers and streams. All field staff has annual refresher training in field procedures before the beginning of the sampling season in May. Some training may not be timely in all cases.

Compliance Branch Position descriptions and performance standards for each manager and employee require that employee

adhere to written agency personnel policies and other SOPS (agency Inspection Protocol Policy, Compliance and Enforcement Referral Policy, OWQ Inspections COP). Personnel policies include adherence to agency Health and Safety Policy. All staff required to have such training have received OSHA required initial health and safety training and receive annual 8-hour refresher courses as applicable to their job.

Branch and section chiefs provide notice to employees in writing when any other special training opportunities are mandatory

Permits Branch OWQ Permits Branch does not have a written policy regarding training for management and staff. Training is

provided on an as-needed basis to ensure that staff understands new rules, regulations or policies. New staff are mentored by a senior permit writer until they are able to function on their own.

Training for OWQ Industrial and Municipal NPDES Staff Staff who are involved in the development and issuance of Industrial and Municipal NPDES permits attend

the U.S. EPA NPDES Permit Writers Training Course, when available. As a part of required on the job training, new Industrial/Municipal NPDES staff are given existing permits to use as examples. In addition, new staff is partnered with experienced permit writers for on-the-job training.

Drinking Water Branch At present, OWQ Drinking Water Branch does not have written policies regarding training for branch

management and staff.

3.2. Training QA Procedures

3.2.1. Ensuring Appropriate Training

What is each program‘s process for identifying, ensuring, and documenting that personnel have and maintain the appropriate knowledge and skills?

Watershed Assessment and Planning Branch The WAPB identifies the training needs for its staff and ensures that personnel follow appropriate policies and

procedures established in the WAPB. Training records are placed in personnel folders as staff complete training. Managers accompany staff periodically to observe procedures, etc. Targeted Monitoring Section has written SOPs and staff are trained by experienced peers on how to collect surface water samples, operate equipment, QA/QC procedures, etc. Probabilistic Monitoring staff has several written SOPs. New staff is trained by experienced peers on how to collect fish and macroinvertebrate samples from Indiana rivers and streams.



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Compliance Branch OWQ Compliance Branch does not have a systematic means of ensuring appropriate training. Presently,

training needs are documented in staff performance expectations/work plans and it is the responsibility of supervisory staff to ensure that employees have opportunity to receive, and do receive mandated trainings.

Permits Branch OWQ Permits Branch does not have a formal process for identifying, ensuring, and documenting that

personnel have and maintain the appropriate knowledge and skills.

Drinking Water Branch OWQ DWB does not have a systematic means of ensuring appropriate training. Presently, training needs are

documented in staff performance expectations/work plans and it is the responsibility of supervisory staff to ensure that employees have opportunity to receive, and do receive mandated trainings.

3.2.2. Meeting Requirements for Formal Training

For those offices that have staff that must be professionally certified; what is each program‘s process for ensuring and documenting that all statutory, regulatory, professional, or other certification, accreditation, licensing, or other formal qualification requirements necessary to their position are met?

Watershed Assessment and Planning Branch Each OWQ WAPB section hires staff with appropriate background as much as possible which meet program

or project needs. New hires are required to undergo additional formal training as necessary in policies and procedures established in the WAPB.

The Compliance and Permits Branches do not employ professionally certified staff.

Drinking Water Branch OWQ DWB does not employ staff that requires professional certification. DWB employs staff that is certified

Professional Engineers and Geologists; however, the Branch does not require the staff to maintain certification.

3.2.3. Identifying Need for Retraining

Watershed Assessment and Planning Branch The WAPB provides training to staff after identifying the need for retraining based on evolving changes in set

policies and procedures. Training may be done internally by experienced people or by outside organizations.

Compliance Branch OWQ Compliance, Permits, and Drinking Water Branches do not have a means of determining when staff

should be retrained or be provided with training updates. Training needs for individual staff are typically identified during performance evaluations.



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4.0 Procurement of Items and Services

Purpose: To document the procedures for purchased items and services that directly affect the quality of the IDEM Office of Water Quality environmental programs.

4.1. Reviewing and Approving Procurement Documents

Watershed Assessment and Planning Brach 1. Supplies, equipment, and services greater than $500 or on a State Quantity Purchase

Agreement (QPA): Requisitions are created using standard Indiana Department of Administration (IDOA) requisition forms.

WAPB personnel provide specific technical specifications for purchase of equipment, supplies, etc. Requisitions are reviewed and approved by section chiefs and the WAPB branch chief. Requisitions are sent to the IDOA Operations Section for procurement of approval from the OWQ Assistant Commissioner; entry into PeopleSoft; and purchase in accordance to State of Indiana Procurement Regulations. Operations staff selects the vendor and orders the material or services. The selected supplier is responsible for satisfying the technical requirements of the original requisition.

2. Supplies, equipment, and services less than $500 that are not on a state QPA: These items follow the above process except that entry of the requisition into PeopleSoft is not required.

Operations staff selects the vendor and orders the material or services. 3. Requisitions for Information Services (IS) items require the approval of the IS director in

addition to other approvals. Procurement follows the same process as supplies greater than $500.

4. Petty Cash Purchases: Petty cash purchases by WAPB personnel are restricted to $30 and permitted only in an emergency. An

additional exception is permitted to allow WAPB personnel to purchase ice while sampling in the field. All petty cash purchases require prior approval of the appropriate section chief, WAPB branch chief, and the program director for Finance Division/Accounting.

5. Contracted Laboratory Services: a. Laboratory services are contracted through an RFP process in accordance to IDOA

and Department of Administration (DOA) contract requirement for selection and awards of competitive bids. Contractor bids are reviewed for their ability to provide the services detailed in the RFP technical requirements, and to satisfy requirements for facilities, personnel qualifications, performance in Performance Evaluation Studies, an acceptable QA/QC program, pricing, lab audit reports performed by other groups as well as state or federal accreditations, and meeting required IDOA business requirements. QA and project management staff from the WAPB provides the RFP technical requirements, bids evaluations, and recommend contract awards to IDOA using the procedures, forms, and documentation required by IDOA and DOA.

b. Delivery orders for services from contracted labs are initiated with the completion by a project manager of a ―Sample Collection Request Form‖ and a ―Sample Analysis Request Form‖. These two forms contain the following information: 1. IDEM sample set number, sample numbers, and personnel conducting the

sample collection. 2. Purpose and location of the sample collection event. 3. Required DQA level, media, and parameters to be analyzed. 4. Identifies the contract lab, contract, or purchase order (PO) number, required

reporting time, and estimated cost.

The Sample Analysis Request Form is project and lab specific, detailing specific lab contract and analytical method information. This form is included as an attachment to the Sampling and Analysis Work Plan.

The Sample Collection Request Form is reviewed and approved by the designated contract gatekeeper, and section chief. If the cost is above $15,000, the branch chief has to approve the



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request. Costs above $25,000 require approval from the OWQ Assistant Commissioner. Costs above $2,000 require approval from the Chief of Staff. The original copy of the request is sent to the Lab Contracts Coordinator, Office of Management, Budget, and Analysis (OMBA). Copies are retained by the contract gatekeeper and project manager.

The Sample Analysis Request Form is delivered to the contract laboratory with the sample set and completed chain-of-custody form. This form details sample set information, test parameters, data quality, and test methods requested, IDEM points of contact, contract, or PO numbers, and required report delivery time and location. The original Water Sample Analysis Request Form and the completed chain-of-custody are returned to IDEM with the hardcopy laboratory analytical report. In addition, electronic data deliverable files are e-mailed or provided on a CD or downloaded from the contractor‘s website to the contract gatekeeper or their designee. c. Contract lab reports undergo a QA/QC review for conformance to contract and the

IDEM Surface Water QAPP requirements. Logs are maintained to document, dates delivered to the laboratory, laboratory reporting times, and completeness of deliverables received for each sample set submitted to a contract lab. Invoices are approved only after the deliverables are complete. A copy of the invoice and invoice approval is forwarded to the IDEM OWQ Operations Section Lab Accounts Coordinator.

6. Contracted Services for Grants: If 319 or 205(j) grant funds are passed through via a contract or grant agreement, staff in this section

review quarterly progress reports during the contract or grant agreement term and the final report to ensure all tasks were completed and all grant funds were spent appropriately. The contractors or grant sponsors are required to submit progress reports with every invoice, or at least quarterly progress reports if they don‘t invoice as often. The project managers review reports and invoices to ensure all tasks are being done, expenses and match are eligible, and deliverables are acceptable. Invoices are signed by the senior project manager or section chief for submittal to the accounting office.

Compliance Branch One Branch staff deals specifically with the procurement of necessary equipment and supplies. The

Inspections Section is responsible for working with the OWQ Operations Section in procuring these items. A senior environmental manager 1 is responsible for preparing the initial requisition for field equipment and supplies. Staff begins by looking at state or agency Quantity Purchasing Awards for selected particular items or vendors.

Permits Branch The originator reviews the request and the requisitions are routed through the originator, section chief, branch

chief and as needed the Assistant Commissioner for review and approval. The requisitions are reviewed against the current spending plan to ensure the funding was budgeted and is available. Funding is augmented as needed. Branch chief approval is needed for all petty cash and requisitions below $500. Assistant Commissioner approval is needed for any requisition over $500.

Drinking Water Branch The Branch requestor reviews the request and the requisitions are routed through the requestor, section

chief, branch chief and as needed the Assistant Commissioner for review and approval. The requisitions are reviewed against the current spending plan to insure the funding was budgeted and is available. Funding is augmented as needed. Branch chief approval is needed for all requisitions below $500. Assistant Commissioner approval is needed for any requisition over $500. DWB procurement requests are under the same review process as outlined in the IDEM 2007 QMP at section 4, and in the associated flowchart.

Technical staff develops requisitions for all sampling, testing, and monitoring equipment. DWB does not procure a great deal of data gathering/analysis equipment because drinking water systems are ―self-reporting‖ and all OWQ DWB lab services are performed by laboratories certified by either the Indiana State Department of Health or U.S. EPA. Laboratory audits are performed



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by U.S. EPA and /or the State Department of Health. When samples are drawn, they are sent to a certified lab for analysis. Only data analyzed by a certified lab may be used for compliance purposes. However, DWB does procure some sampling equipment and field testing kits for chlorine, hardness, and arsenic. DWB also procures diagnostic samples to assess accuracy of field testing equipment and lab services.

Request for

Product

Requestor

fills out IDEM

internal request form

# 42484

Form e-mailed to

Section Chief Approved?

Form e-mailed to

Branch Chief

Approved?

Form / Req.

mailed to OWQ Operations

Quality

check

Funding in budget?

Internal Request form

complete?

Is procurement Sole

Source? If yes, is additional question

sheet filled out?

Record entered

into PeopleSoft

Requisition

OK?

Operations

works with

requestor to resolve

problems

Substantive

changes?No

Yes

No

Yes

PeopleSoft requisition

generated and sent,

along with the internal request form to OWQ

Operations SC

Requitition

involves IT?

Yes

Yes

Approved? Yes

IT

Consultant notified

Yes

Requisition packet

routed to OWQ ACNo Approved?

Requisition packet

electronically

routed to

Accounting

Yes

NoNo



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46

4.2. Post-procurement Product/Service QA Procedures

Watershed Assessment and Planning Brach The WAPB procurement process ensures that all procured items, equipment, and services are of acceptable

quality and supplies received are examined. Deviations are reconciled with the vendor or through IDEM Operations Section, whichever is appropriate. Items or services procured are generally inspected by the requisitioner for conformance to the requisition technical and quality requirements. Services from contract labs undergo rigorous QA/QC check for conformance to written laboratory contracts and to IDEM‘s Surface Water QAPP requirement for QA/QC of analytical data. The QA/QC check follows procedures outlined in the ―QAPP for Indiana Surface Water Quality Monitoring and Total Maximum Daily Load (TMDL) Program‖, section D, on Data Validation and Usability. Finally, a QA/QC review report is attached to the original copy of the laboratory report and forwarded to the individual project manager.

Compliance Branch The Compliance Branch procurement process does not include policies to ensure that procured items and

services are of acceptable quality. However, staff works with the Operations Section to ensure that procured items and services are of acceptable quality.

Permits Branch OWQ Permits does not have or use standardized post-procurement product/service QA procedures. OWQ

Permits does not procure technical equipment that necessitates a post-procurement evaluation.

Drinking Water Branch The OWQ DWB procurement process does not include policies to ensure that procured items and services

are of acceptable quality.

The DWB procurement process does not include written policies that ensure that procured items, equipment, and services are of acceptable quality. However, supplies received undergo an examination of deliverables. Deviations are reconciled with the vendor or through IDEM Operations Section, whichever is appropriate. Items or services procured are generally inspected by the requisition author for conformance to the requisition technical and quality requirements. Services from contract labs undergo QA/QC check for conformance to written laboratory contract.

5.0 Documents and Records

Purpose: To document appropriate controls for quality-related documents and records determined to be important to the mission of the OWQ.

5.1. Identification of QA-related Documents and Records

As is clarified in the IDEM agency QMP, QA-related documents can include QMPs, QAPPs, SOPs, policies, checklists, and other quality system tools, all of which are dynamic in that they are subject to continuous improvement, and therefore may be revised, and must be managed for version control. Nearly all OWQ QA documents are developed in accordance with agency standards, and are maintained in the agency QA library housed on the agency Extranet, and managed as a service of the agency quality management team.

QA related ‗records‘ are, by U.S. EPA‘s own definition, completed documents that provide objective evidence of an item or process. Records can include photographs, drawings, magnetic tape, CDs, or other storage media. QA-related records cannot be revised, because doing so would alter the record.

Watershed Assessment and Planning Branch WAPB generally retains all data quality related documents, and observes a branch-wide records retention

policy of at least seven years prior to discarding of paper-based records. The WAPB also retains any document bearing an original signature and all records used as the basis for decision making. WAPB is careful to retain records pertaining to field sampling conditions,



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such as field reports.

Post-1990 data are mostly electronic, and are stored indefinitely in the WAPB AIMS database. Numerical data from contracted laboratories are also stored in the AIMS database.

The WAPB does not use the IDEM Public Records Office at IGCN. All documents and records are stored locally at the Shadeland Office by individual project managers.

Numerous QA documents that are generated internally for various programs in the WAPB are listed and identified in Appendix D of this QMP.

Compliance Branch The Branch does not use a systematic process for identifying QA-related records subject to control. Records

retention needs are taken into consideration when Compliance engages in any new compliance/enforcement activity.

Compliance staff works with the director of the Office of Public Records to maintain the Compliance document retention schedules consistent with applicable rules/statutes. Regarding QA-related documents, as stated above in 2.1.1, the Branch uses SOPs that all staff have in paper copy format and available in SharePoint.

Permits Branch OWQ Permits Branch does not use a systematic process for identifying QA-related records subject to control.

Records retention needs are taken into consideration upon promulgation of new rules or laws that have potential to affect Branch operations. OWQ Permits works with the IDEM Office of Legal Counsel to comply with document storage requirements specified in new and existing legislation.

In general, OWQ Permits Branch retains any document bearing an original signature and all records used as the basis for decision making. The Branch secretary and the chief of the Permits Administration Section work with the Public Records Office to maintain document retention policy. The section chiefs identify QA related records in consultation with OLC, and the branch QA coordinator and the section QA contacts. The handling and maintenance of Permits Branch documents and records is described in Appendix D of this QMP.

Drinking Water Branch OWQ Drinking Water Branch (DWB) maintains records pursuant to the OWQ retention schedule. Records

retention needs are reviewed when DWB engages in any new environmental activity. Many of the records retained in VFC by the DWB are documents required for Safe Drinking Water Act compliance. The retention requirements for these documents are set forth in 40 CFR Part 142.

In general, DWB retains any document bearing an original signature and all records used as the basis for decision-making. The branch retains all self-reported drinking water data based on the requirements in the retention schedule and 40 CFR 142. All laboratory certification documentation is maintained by the Indiana State Department of Health. For self-reported drinking water data, Branch staff verifies that a properly certified laboratory was used when a certified laboratory is required.

For individual sections within the Branch, the section chiefs work with OWQ Operations staff to maintain a document retention policy. For individual sections within the Branch, the section chief identifies QA related records for their section in consultation with branch QA coordinator, the OWQ quality coordinator, OLC, and applicable SOPs, rules/statutes, and guidance. These policies are changing with implementation of our electronic file room and the agency Virtual File Cabinet (VFC).

The DWB records retention schedule is currently under revision. Until the new retention schedule is finalized, DWB is storing hard copies of all documentation. All previous records have been scanned and imported into the VFC.

All DWB documentation has been imported into the VFC. Hard copies of previous data are stored in boxes in the old DWB file room while waiting for a final retention schedule. New documents coming in



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are scanned at the mailroom and stored at a central location. Documents which arrive at IDEM via e-mail or facsimile are scanned into VFC and the original documents are also stored.

The DWB maintains records of data collected by public water systems for compliance with state and federal drinking water regulations. The data collected by the public water systems is analyzed using certified laboratories for most parameters. There are some parameters where the analysis can be done by a qualified individual (usually a certified operator). All of these records are QA-related. Documents are maintained according to the records retention and disposal schedule and requirements set forth in 40 CFR 141.14 (Records Kept by States). The handling and maintenance of DWB documents and records is described in Appendix D of this QMP.

5.2. Record Handling Processes

Office of Water Quality (OWQ) QA documents (SOPs, QAPPs, work plans, etc) generally are handled (developed and used) consistent with agency requirements, and are maintained on the agency Extranet, where they are accessible to all IDEM staff.

Nearly all OWQ document that are program area work products in some stage of development (draft permits, draft report, data, enforcement documents, etc) that will, once they are finalized, become OWQ records, are maintained electronically on OWQ shared drives, individual PCs and within the agency‘s Outlook™ e-mail management system. Once development (the work process) is completed (generally meaning they are approved by signature), they will be OWQ records, and will be loaded into the agency‘s VFC. Once in the VFC, OWQ records with confidential or proprietary information are only accessible to IDEM staff or even a limited number of IDEM staff, while other OWQ records are accessible to the public. OWQ document and record handling procedures are described in greater detail in Appendix D.

5.3. Ensuring that Documents Accurately Reflect Completed Work

Each OWQ program branch periodically reviews its SOPs, QAPPs (for those programs that use them), and associated work plans to ensure that these QA documents match the work processes that were implemented and conversely, that the work was done as documented in the applicable QA document. Each Branch further ensures consistency by checking records it generated to ensure the final result or data reflected that the applicable QA document was properly followed. For example:

Watershed Assessment and Planning Branch The WAPB compiles scientific reports and documents after the data have been collected and QA/QC‘d. Each

scientific report or document reflects the entire process of data collection that includes material, methods, results, data evaluation, discussion, and ensures that each document accurately reflects the complete work in compliance with project sampling and analysis work plan and program objectives.

Compliance Branch The Facilities Inspection Section follows U.S. EPAs guidance of conducting NPDES inspections. All reports

are reviewed by the section chief and branch chief.

The Compliance Data section chief reviews all written work products completed by section staff.

Permits Branch All draft and final work products are reviewed by the section chief and in many cases the work is also

reviewed by a senior staff member. All draft NPDES permits are placed on public notice for a minimum of 30 days. During this period of time, the public and the permit applicant review the draft permit and fact sheet for errors or misinterpretations of the applicable laws and rules.

Drinking Water Branch The Compliance Section has a compliance strategy in place that has been approved by U.S. EPA. Also, the

section utilizes the numerous technical guidances provided by U.S. EPA for implementing the



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drinking water rules to ensure that work is accurately completed. Further, the section has created or is in the process of creating SOPs for the state mandated activities and cases where U.S. EPA guidance is not clear. Use of those SOPs is a required component of employee performance, which is evaluated regularly by the section chief.

The Field Inspection Section follows U.S. EPAs guidance on conducting sanitary surveys. All reports are reviewed by the section chief.

The Ground Water Section reviews information received based on site specific knowledge of geological/hydrogeological information. Susceptibility determinations are based on known or expected natural and manmade sources of contamination.

Permits, certification, and capacity development documents are reviewed by the section chief prior to being sent out of the agency.

5.4. Document Maintenance As stated in 5.2, OWQ QA documents generally are maintained and controlled on the agency Extranet, where

they are accessible to all IDEM staff. Nearly all OWQ records are maintained in the agency‘s VFC, where records with confidential or proprietary information are only accessible to IDEM staff or even a limited number of IDEM staff, while other OWQ records are accessible to the public. OWQ document and record maintenance are described in greater detail in Appendix D.

5.5. Compliance with Statutory/U.S. EPA Recordkeeping Requirements.

Watershed Assessment and Planning Branch The WAPB follows the Indiana Access to the Public Records Act (IC 5-15). However, public records not

subject to IC 5-15 after a period of five to seven years may be discarded. Travel vouchers are shredded after three years.

Upon promulgation of any new legislation that has potential to alter or present new recordkeeping requirements, WAPB will form a workgroup of program staff to analyze regulatory requirements. The WAPB will then identify documents used as the basis for decision-making under such legislation and works with Office of Legal Counsel (OLC) to develop or use an existing retention schedule for such documents.

Compliance Branch Upon promulgation of new legislation that has potential to alter or present new recordkeeping requirements,

designated OWQ Compliance Branch staff analyze regulatory requirements. OWQ Compliance Branch then identifies documents used as the basis for decision-making under such legislation and works with OLC to develop or use an existing retention schedule for such documents.

Permits Branch Upon promulgation of new legislation that has potential to alter or present new recordkeeping requirements,

Permits Branch forms a workgroup of program staff to analyze regulatory requirements. The Branch then identifies documents used as the basis for decision making under such legislation and works with OLC to develop or use an existing retention schedule for such documents.

Drinking Water Branch DWB relies on U.S. EPA oversight to ensure that the program complies with statutory U.S. EPA

recordkeeping requirements. DWB produces an exhaustive annual Branch activity plan – the Annual Resource Deployment Plan (ARDP) – and annually reports to U.S. EPA progress toward attaining the goals laid out in the plan. The ARDP includes recordkeeping and reporting requirements and the annual report to U.S. EPA facilitates U.S. EPA oversight and indicates whether DWB was able to meet these requirements.

5.6. Procedures for Implementing Chain of Custody for Evidentiary Records

Chain of custody requires an unbroken trail of accountability that ensures the physical security of samples, data, and records.



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Field Activities Sample custody procedures for field testing and sample acquisition in the WAPB are described in the

―Biological Studies Section Standard Operating Procedures Manual‖ WQSSB/ SOP 2004 and in the ―Surveillance Group Standard Operating Procedures Manual,‖ WQSSB/ SOP 1063. The manuals contain field chain-of-custody procedures for all field collection samples.

Laboratory Activities

Each contract laboratory performing analyses for the WAPB water quality monitoring programs is responsible for implementing chain-of-custody procedures that meet IDEM chain-of- custody requirements for enforcement actions. Compliance with the IDEM RFQs, and RFPs ensure that acceptable laboratory chain-of-custody procedures are in place before samples are collected.

Data collected for water quality assessment and characterization is maintained by the WAPB. Reports are assessed, qualified, and entered into a database with hard copy of the database to maintain accuracy and backup. Reports containing raw data are cataloged and stored for a minimum of seven years at which time future need for the raw data is determined. Electronic and hard copy database files are maintained indefinitely.

Compliance Branch Processes for establishing and implementing appropriate chain-of-custody are documented in Wastewater

Inspections SOPs.

Permits Branch The Branch does not engage in sampling or other activities that require chain of custody procedures, but does

follow IDEM policy regarding confidentiality.

Drinking Water Branch The process for establishing and implementing appropriate chain of custody and confidentiality procedures for

evidentiary records is included in the Ground Water -Section SOP for the Ground Water Monitoring Network.



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6.0 Computer Hardware and Software

Purpose – To document how the IDEM OWQ will ensure that computer hardware and software satisfies the organization‘s requirements.

6.1. Hardware/Software QA Processes


Name Type (Hardware or Software)

Testing requirements

Usage requirements

Maintenance requirements

Control Documentation

Statistica Software N/A Data evaluation and project reports

Software Updates Access by user id authorization

Manufacturer‘s Instruction



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Usage requirements



ArcGIS Software N/A Project work plan development, fieldwork documentation, data evaluation, and project reports

Software Updates Access by user id authorization

Manufacturer‘s Instruction



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Usage requirements



AIMS Software Beta testing by users, fixes made as

AB projects, data management, and reporting

Maintenance Updates Access to modules controlled by user id and role authorization

User manual under development



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Usage requirements



GPS devices Hardware N/A Fieldwork and creation of sampling and analysis projects

Access controlled by equipment custodian

Manufacturer‘s Instruction and SOPs



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Usage requirements



Automated data acquisition devices

Hardware N/A Field sampling events Calibration and maintenance or replacement of probes

Calibration with reference standards




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Usage requirements



Hydrolab and YSI Data sondes

Hardware N/A Field sampling events Calibration and maintenance or replacement of probes

Calibration with reference standards




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Name of Hardware or Software

Type (Hardware or Software)


Usage requirements Maintenance requirements


SDWIS/State Software Developed and tested by EPA

All documentation provided by EPA


Handled by OIT Installation manual, administration manual, user manual (all provided by EPA)



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SDWIS/FED-REP Software Developed and tested by EPA



Handled by OIT Installation manual, administration manual, user manual (all provided by EPA)

Drinking Water Watch Software Developed and tested by SAIC using


All documentation provided by

Handled by OIT Installation manual, administration manual, user



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IDEM and U.S. EPA grant money.

EPA

manual (all provided by EPA)

GPS devices Hardware (Trimbl

Follow manufacturer‘s directions and meet state government

Follow manufacturers recom

Trimble units are locked in a storeroom whe

Manufacturer‘s directions and recommended maintenance



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e) and software

requirements for GIS data gathering

mendations

n not in use

procedures



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(TerraSync)

Scanning hardware and software

Teleform Application is tested to ensur

Forms have separate usage requir

Handled by OIT Software and server are cont

Manufacturer‘s directions and



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e that proper data is captured for migration to the SDWIS database.

ements – verification data is standardized for specific forms

rolled by OIT. Application is maintained by DWB staff.

recommended maintenance procedures. User manual.



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Permit Database Access and Oracle

Adding information, retrieving information, querying information

Handled by OIT Handled by OIT All information that is on Application for permits and NOI‘s.

Certified Operator Database

Access Adding information, retrieving information, queryi

Handled by OIT Handled by OIT All information that is on certified operator‘s application all



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ng information

info for the certified operator, Certified Education Unit (CEU) information and all approved CEU



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classes.



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Capacity Development Database

Access Adding information, retrieving information, querying information

Handled by OIT Handled by OIT Contact with the SDWIS database to show all systems violation history and corrective action that‘s been taken by the Branch.



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Drinking Water Academy Electronic Sanitary Survey

Access Tested by the Manufacturer

Follow developer‘s instructions and Inspection SOP

Manufacturer Handled by OIT Manufacturer‘s instructions



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6.2. Hardware/Software Usage Assessment and Documentation

Watershed Assessment and Planning Branch WAPB does not assess and document impacts to hardware/software performance due to altered user

requirements and/or changes to the hardware/software. Assessment addresses usage assessment and documentation on a case-by-case basis.

Compliance Branch The Branch does not assess and document impacts to hardware/software performance due to altered user

requirements and/or changes to the hardware/software. No professionally built database has existed in the OWQ long enough to go through a post construction requirements change process.

Permits Branch The Branch does not have a formal process for hardware or software usage assessment and documentation.

The hardware and software are provided by IS. Permits addresses usage assessment and documentation on a case-by-case basis.

Drinking Water Branch DWB does not have a formal process for hardware or software usage assessment and documentation. DWB

addresses usage assessment and documentation on a case-by-case basis. DWB only uses two specialized databases. The primary Branch database, Safe Drinking Water Information System (SDWIS), is a state-specific clone of a thoroughly documented and assessed federal system. The second system is IDEM‘s Virtual File Cabinet.

6.3. Hardware/Software Evaluation

Watershed Assessment and Planning Branch OWQ WAPB does not have a formal process for hardware or software evaluation. WAPB evaluates

specialized database software (and upgrades to such software) during the design stages. OWQ relies on the Office of Chief of Staff Business Services Division to coordinate software testing. OWQ WAPB evaluates lab hardware used for data collection or analysis, but does not have a standardized methodology for doing so.

Compliance Branch OWQ Compliance Branch evaluates specialized database software (and upgrades to such software) during

the design stages. The Branch relies on the Office of Chief of Staff Business Services Division to coordinate software testing. OWQ Compliance Branch does not have a formal process for hardware or software evaluation. Additionally, the OWQ Compliance Branch does not evaluate hardware, as the Branch does not purchase equipment used for data collection or analysis.

Permits Branch Permits Branch evaluates specialized database software (and upgrades to such software) during the design

stages. OWQ relies on the Office of Chief of Staff Business Services Division to coordinate software testing. OWQ Permits does not have a formal process for hardware or software evaluation. Permits does not evaluate hardware; as the Branch does not purchase equipment used for data collection or analysis.

Drinking Water Branch DWB does not have a formal process for hardware or software evaluation. The Branch evaluates specialized

database software (and upgrades to such software) during the design stages. DWB evaluates changes to SDWIS; however the changes that DWB can make to SDWIS are limited in order to maintain data exchange compatibility with the federal system. DWB relies on the Office of Chief of Staff Business Services Division to coordinate software testing.



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6.4. Data QA/QC


Data reports/packages are reviewed for QA/QC in compliance to a template developed for project specific water quality monitoring programs. Each report assesses QA/QC performance and compliance to contract and IDEM WAPB QAPP requirements (sections C – D). Each QA/QC review report details the appropriate QC requirements reviewed for each parameter reported. The QA/QC review follows procedures outlined in the ―QAPP for Indiana Surface Water Quality Monitoring and Total Maximum Daily Load (TMDL) Program‖, section D3. A QA/QC. Review report is attached to the original copy of the laboratory report and forwarded to the individual project manager.

Laboratory data is received electronically from contract laboratories, imported into the WAPB AIMS database, and reviewed for completeness and accuracy by the QA Officer assigned to an individual project. All other data are manually entered into AIMS by project team members.

Field data are QA/QC‘d for completeness and accuracy by a Targeted Monitoring Section or Probabilistic Monitoring Section project team member who did not participate in the sampling and collection of the field data. Further details for QA/QC of field data and Probabilistic Monitoring Section data are contained in the Probabilistic Monitoring Section SOPs and Targeted Monitoring Section SOPs.

Fish communities, habitat assessments, and macroinvertebrate assessment data are also QA/QC‘d for completeness and accuracy by a Probabilistic Monitoring Section project team member who did not participate in the sampling and collection of the assessment data.

The WAPB Technical and Logistical Services Section is responsible for uploading AIMS data into U.S. EPA STORET (Storage and Retrieval of Water-Related Data) or WQX (Water Quality Exchange) and any issues arising from this process.

Compliance Branch All information collected electronically is designed to fill the data needs of a program area and to meet the

data quality requirements and standards set forth by the U.S. EPA. All data collection is designed for eventual upload to federal databases such as ICIS NPDES.

Data Stream QA/QC methods and acceptance criteria % of total data undergoing QA/QC

Operator Certification Exams Any test with a score within 2 points of the pass/fail score is reviewed for accuracy. Any question or answer disputed by an examinee is reviewed for authenticity.

Surface Water NPDES Compliance:

National Pollutant Discharge Elimination System (NPDES) related data provided by the agency to U.S. EPA for inclusion in the Integrated Compliance Information System (ICIS), Enforcement and Compliance History Online (ECHO), and/or U.S. EPA Envirofacts database is first reviewed by the IDEM OWQ Compliance Branch, Compliance Data Section. The quality assurance process for data going to U.S. EPA is as follows:

National Pollutant Discharge Elimination System (NPDES) related data provided by the agency to U.S. EPA for inclusion in the ICIS, ECHO, and/or U.S. EPA Envirofacts database is first reviewed by the IDEM OWQ Compliance Branch, Compliance Data Section. The section uses at least two SOPS to ensure data quality:



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1. The ―Data Entry SOP‖ ensures the quality of NPDES data as it is initially entered into the ICIS database.

2. The ―NPDES Data QC SOP‖ describes methods used to regularly (monthly) check and correct data, and thereby further ensure the high quality of the Indiana NPDES data within the above mentioned databases. This regular review also diminishes the need to respond to concerns about incorrect data.

Permits Branch

No comments from Permits


Data Stream QA/QC methods and acceptance criteria % of total data undergoing QA/QC

Compliance Report Scanning Scanned records are individually verified through the database and reviewed by staff to ensure that all required data elements contain quality data.

100%

Drinking Water Compliance Reporting SDWIS provides the initial QA/QC built into the application. Technical staff performs queries to evaluate quality data that are out of range or not meeting set elements are rejected or re-evaluated.

100%

Monthly Reports of Operation Reviewed by inspector 90%

Operator Certification Exams Any test with a score within 2 points of the pass/fail score is reviewed for accuracy. Any question or answer disputed by an examinee is reviewed for authenticity.

The IDEM Drinking Water program transfers data to U.S. EPA by way of the Safe Drinking Water Information System (SDWIS) databases. Data is uploaded from the agency‘s ―SDWIS-State‖ database to the ―SDWIS-ODS‖ using an Extensible Markup Language (XML) schema. The data is then verified by U.S. EPA and extracted for use in its databases, including Envirofacts (www.epa.gov/safewater/dwinfo.html) and Safe Drinking Water Accession and Review System (SDWARS). The agency‘s data is verified by the Drinking Water Branch and any validation errors identified by U.S. EPA during the data transfer are reviewed and corrected.

http://www.epa.gov/safewater/dwinfo.html



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7.0 Planning

Purpose: To document how individual data operations will be planned within OWQ to ensure that data or information collected are of the needed and expected quality for its desired use.

7.1. Systematic Planning Process Description

U.S. EPA has developed, and recommends the use of the data quality objectives (DQO) process as a tool for planning individual data operations.

Watershed Assessment and Planning Branch WAPB uses a systematic planning process for environmental data gathering activities. First and foremost,

WAPB has developed a Water Quality Monitoring Strategy (WQMS) which includes the U.S. EPA recommended ten elements of water quality monitoring and assessments. Secondly, in implementing this WQMS and to build a framework of environmental data gathering efforts, WAPB has developed a program Quality Assurance Project Plan (QAPP) as a primary quality system tool for a wide variety of water quality monitoring programs. Finally, each year WAPB develops multiple sampling and analysis work plans. Each work plan is prepared in conformance to the key elements from four major sections of the WAPB Program QAPP. The main purpose of this extended planning process, is to develop a monitoring strategy, a QAPP and work plans, and ensure that the data and information gathered are of good quality which not only supports the specific project‘s objectives but also the desired use of the data for water quality assessment.

Compliance Branch Compliance Branch does not develop QAPPs and therefore does not use the U.S. EPA DQO process.

However, the Compliance Branch does develop and rely on SOPs to conduct its programs.

Permits Branch Office of Water Quality Permits Branch performs ongoing permitting activities, which do not warrant the use of

Quality Assurance Project Plans and the associated Systematic Planning Process.

Drinking Water Branch The DQOs for the Compliance Section are regulatorily specified. The Ground Water Section has defined data

quality levels (DQLs). DQLs specify the general QC requirements for sample collection and analysis. DQLs also are used to classify data supplied by third parties. Project sampling objectives can be identified through the use of the DQL‘s.

7.1.1. Quality Assurance Project Plans (QAPPs)

The DWB does not have any QAPPs.

7.1.2. Policies

All of the sections within the DWB are in the process of writing policies where needed.

7.1.3. Standard Operating Procedures (SOPs)

All of the sections in the DWB are in the process of documenting SOPs which will be reviewed on a regular basis (every four years) and revised as necessary.

7.2. QAPP Development Process

Watershed Assessment and Planning Branch WAPB uses a standardized process for developing, revising, and approving the program QAPP. The QAPP

is developed and revised using the U.S. EPA Guidance for Quality Assurance Project Plans – USEPA QA/G-5. The WAPB QAPP is prepared for environmental data collection for the following water quality monitoring programs:

Fixed Station Monitoring Program

Probabilistic Monitoring Program


Monitoring to Identify Improvements in Water Quality (Performance Measures monitoring)



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Monitoring to Support TMDL Development

Source Identification Studies

Special Studies / Compliance Evaluations Inspections Program

Monitoring to Support development of Public Health Advisories

Fish Tissues and Sediment Contaminants Monitoring Program


Lakes Monitoring Program

The WAPB program QAPP (the Indiana Surface Water Quality Monitoring and TMDL Program QAPP) was reviewed and approved by the section chiefs, WAPB QA coordinator, branch chief, and OWQ Assistant Commissioner or Deputy Assistant Commissioner.

Sampling and Analysis Work plans Each program in the WAPB has one or more focused projects which are revised and updated annually. For

these project-level activities, the WAPB uses sampling and analysis project work plans in lieu of individual program or project quality assurance project plans. WAPB prepares each sampling and analysis project work plan in adherence to four major sections of QAPP and their respective elements that describe specific details pertaining to each water quality monitoring project.

Individual sampling and analysis project work plans are prepared to supplement elements of the WAPB program QAPP. Work plans are reviewed and approved by section chiefs, the Project QA Officer, the QA Coordinator, and the branch chief.

Sampling and analysis project work plans generally contain the following:

Project Management/Planning

Title and Approval Sheet (QAPP Element A1)

Foreword (Relates the work plan to branch QMP and program QAPP)

Table of Contents (QAPP Element A2)

List of Acronyms

Program Objective

Distribution list (QAPP Element A3)

Project/Task Organization and Schedule (QAPP Element A4)

Background and Project/Task Description (QAPP Elements A5, A6)

Project Data Quality Objectives (QAPP Element A7)

1. State the Problem

2. Identify the Goals and Decisions of the Study

3. Identify Information Inputs

4. Define the Boundaries of the Study Area

5. Develop a Decision Rule

6. Specify Tolerable Limits on Decision Error and Performance or Acceptance Criteria

7. Optimize the Design for Obtaining Data

Training and Staffing Requirements (QAPP Element A8)

Measurement/Data Acquisition

Sampling Sites/Sampling Design (QAPP Element B1)

Sampling Methods and Sample Handling (QAPP Elements B2, B3)

Analytical Methods (QAPP Element B4)

Laboratory Procedures and Methods (if applicable)

Field Parameters Measurements



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Quality Control and Custody Requirements (QAPP Element B5)

Field Instrument Testing and Calibrations (QAPP Elements B6, B7)

Assessment Oversight (QAPP Elements C1, C2)

Data Quality Assessment (DQA)

Data Validation and Usability (QAPP Elements D1, D3)

Quality Assurance/Data Qualifiers and Flags

Data Usability

Laboratory and Estimated Costs

Reference Manuals and Personnel Safety

Specific SOPs to be utilized in the project

References

Compliance Branch

Compliance Branch does not develop QAPPs and therefore does not use the U.S. EPA DQO process.

Permits Branch Office of Water Quality Permits Branch performs ongoing permitting activities, which do not warrant the use of

Quality Assurance Project Plans and the associated Systematic Planning Process.

Drinking Water Branch At one time, the IDEM DWB had a QAPP in place for ground water sampling and analysis that was required

for 319 grants. However, the DWB no longer is involved with the 319 grant program, and so that QAPP has been retired.

7.3. Processes Associated with Using External Data

Watershed Assessment and Planning Branch External data received from sources other than contract laboratories are not usually imported and stored in

the AIMS database. Any consideration for import into AIMS is evaluated on a case by case basis. The data quality, age, traceability, reliability, and data source are considered. Evaluation criteria used include conformance to QA/QC in applicable IDEM QAPP or U.S. EPA guidance documents. Should that data be imported or manually entered by project team members, it is reviewed for completeness and accuracy by the QA Officer assigned to an individual project. Such data is marked as external data in notes or comments fields.

Any consideration for use of non-AIMS data in statistical analysis or methods is evaluated on a case by case basis. The evaluation criterion includes data quality, age, traceability, reliability, data source(s), and conformance to QA/QC in applicable IDEM QAPP or U.S. EPA guidance documents.

Drinking Water Branch Because OWQ Drinking Water Branch receives external data exclusively through labs certified by the Indiana

State Department of Health (ISDH), the quality of external data is assured without additional procedures. The ISDH laboratories are responsible for certifying laboratories under the Safe Drinking Water Act. This task includes conducting on-site evaluations plus distributing and evaluating proficiency test samples. Admittance to one of the programs is accomplished by submitting an application to the certification officer at the ISDH laboratories.

Any external data received by the Ground Water Section goes through an internal QA/QC process. Contracted data is reviewed based on the QAPP (if laboratory analysis) or contract specifications (if other data). If data is received from another IDEM program area, DWB accepts its QA/QC process and does not review its data.

Compliance Branch Large amounts of external data are received each month by the Compliance Data Section from external

parties, particularly the Discharge Monitoring Reports (DMRs) and accompanying Monthly



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Reports of Operation (MROs) and Monthly Monitoring Reports (MMRs). This information is manually entered into the Federal ICIS system to demonstrate NPDES compliance. Permittees are encouraged to use an Excel spreadsheet developed within the branch to assure that all calculations are performed correctly and that data is accurately transferred from the MRO or MMR to the DMR. Several staff are assigned the full time task of reviewing the data contained in these reports to see that it makes sense and to look identify violations. Particular emphasis is placed on violations that appear to be due to mathematical errors (transposed numbers, misplacement of decimals, etc.) or due to other administrative errors not associated with actual NPDES effluent violations. This QA/QC process is very detailed and time consuming, but the results is a far more accurate picture of reality as well as a significantly improved overall compliance rate as compared to simply accepting all of the submitted data.

Permits Branch In addition to utilizing the DMR/MRO data discussed in the Compliance Branch Section above, the Permits

Branch may use outside data (non-AIMS). Any consideration for use of outside data in statistical analysis or methods is evaluated on a case by case basis. The evaluation criterion includes data quality, age, traceability, reliability, data source(s), and conformance to QA/QC.

8.0 Implementation of Work Processes

Purpose: To document how work processes will be implemented within the OWQ to ensure that data or information collected are of the needed and expected quality for their desired use.

8.1. Processes for Ensuring Work Follows Planning and Technical Documents

Watershed Assessment and Planning Branch WAPB develops individual sampling and analysis project work plans before initiation of a project. Overall, for

quality and performance of a project, SOPs and QAPPs serve as primary major documents to the individual sampling and analysis project work plans. The project QA officer reviews and approves the Sampling and Analysis Project Work plans to ensure that the current QAPP and SOPs requirements for QA/QC are satisfied in the project work plan. Contract laboratory reports are reviewed for compliance to QA/QC procedures and performance of field QC Samples (field blanks, equipment blanks, field duplicates). When field calibration verification is performed the relative percent difference (RPD) of data sonde vs. independent test method is evaluated and included in the QA/QC review report. Deviations noted in this process are noted and investigated.

Compliance Branch Staff expected to adhere to written SOPS. Section chiefs review and sign off on the majority of written

documentation prepared by staff to confirm adherence to agency and branch SOPs.

Permits Branch The section chiefs are responsible for ensuring that the permit writers are working on the permit applications

that are targeted for renewal during each planning year. The section chiefs review the quality of the draft and final work products to determine if the technical documents have been followed. In addition, the Permits Branch follows established SOPs for for the issuance of permits to ensure planning and technical documents have been followed and to ensure consistency in the work product.



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Drinking Water Branch Processes for ensuring that work is performed according to approved planning and technical documents are

as follows:

Environmental Activity Process(es) for Ensuring Work Performance

Construction Permits SOP

Certification of Capacity SOP

Drinking Water Operator Certification SOP

File Room SOP

Drinking Water Fee Billing SOP

Compliance – Consumer Confidence Reports (CCRs)

SOP and U.S. EPA Guidance

Compliance – Data Entry SOP

Compliance – SDWIS Management SDWIS guidance

Contracted Drinking Water Labs Indiana State Department of Health Laboratory Certification Manual

Public Water System Sampling SOP in progress

Field Inspections SOP in progress; U.S. EPA guidance

Well Site Surveys SOP in progress

Complaint Inspections Internal SOP in progress; agency SOP

Source Water Protection SOP

Ground Water Sampling SOP and QAPP

Private Well Sampling SOP and QAPP

Each SOP should include a discussion in Section 8 of the SOP; ―Quality Assurance/Quality Control‖ of review and approval procedures that would verify that the SOP was followed.

8.2. Identification of Operations Needing SOPs/Technical Documents

Each of the various branches of the OWQ considers the following questions before deciding to write an SOP or technical guidance for an activity: 1. Is the process of sufficient complexity to warrant the use of an SOP? Does the process

require some degree of expertise or training? If yes, the process may need an SOP. 2. Is the process repetitive? Non-repetitive processes are difficult to document with SOPs 3. Does the process have a high potential impact to a work product and/or customer? (i.e.,

are there potentially environmental or litigious repercussions for performing the task incorrectly?)

4. Will the office benefit from standardizing the activity?

Watershed Assessment and Planning Branch The WAPB requires the development of a sampling and analysis work plan for all sampling activities.

Drinking Water Branch The Branch also considers activities that are repetitive, that occasionally are problematic, and that elicit staff

questions as prime candidates for documentation using SOPs.

Compliance Branch As with the other branches, Compliance Branch maintains a number of SOPs for tasks that commonly

encountered or repetitive. All staff persons conducting similar activities need to work from a common understanding of what is expected.

Permits Branch The Branch also considers activities that are repetitive, that occasionally are problematic, and that elicit staff



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questions as prime candidates for documentation using SOPs.

8.3. Handling of SOPs/Technical Documents Each of the branches of the IDEM Office of Water Quality (OWQ) follows, and conforms to the agency Policy,

Standard Operating Procedure (SOP), and Quality Assurance Project Plan (QAPP) Documentation Policy, April 9, 2009, which established the agency standards for the development, approval, maintenance, use, and retirement of all agency quality assurance related documents.

9.0 Assessment and Response

Purpose: To document how the IDEM OWQ will determine the suitability and effectiveness of the implemented quality system and the quality performance of the environmental programs to which the quality system applies.

9.1. Assessment

9.1.1. Assessment Tools

Watershed Assessment and Planning Branch The OWQ WAPB reserves the right to request assistance from the agency QA Managers for an overall

assessment of the branch quality system.

Meanwhile, for quality system and quality performance of environmental programs, the WAPB primarily relies on the following documents:

Water Quality Monitoring Strategy (2011 – 2019)

Quality Assurance Project Plan (QAPP) for Indiana Surface Water Quality Monitoring and Total Maximum Daily Load (TMDL) Program

Project Specific Sampling and Analysis Work plans

Standard operating procedures (SOPs) and user manuals for collection of surface water samples, field samples, fish tissues, and sediments samples, E. coli, fish, and macroinvertebrates from Indiana streams and rivers

Branch Level QMP

At the end of each field season (after sample collection, data analysis, and data collection), all chemical and biological data are QA/QC‘d for completeness and accuracy. Data quality of chemical analytical data and its usability is further established to each specific project data quality objective (DQO) by assigning it to one of four data quality assessment (DQA) levels as outlined in the QAPP from the WAPB. Technical reviews, scientific or project reports prepared for each environmental program are then subjected to technical, peer, management review process and approval for its usability in decision-making. IDEM QA managers serves as quality systems audits for SOPs, QAPPs and Branch Level QMP.

Permits Branch

The Permits Branch relies on peer, Environmental E7 and section chief review of work products generated by the staff (specifically permits, fact sheets, WLAs and related correspondence). Permit staff are all trained on current SOPs. Additionally, permits and facts sheets are reviewed periodically by EPA as part of the State Review Framework.

Compliance Branch The Compliance Branch relies on peer and section chief review of work products generated by the staff

(specifically inspection reports and related correspondence). Inspectors and data staff are all trained on current SOPs. Additionally, this work is reviewed periodically by EPA as part of the State Review Framework.



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Drinking Water Branch The Compliance Section and the Ground Water Section of the DWB rely on system audits, management

system reviews, technical reviews, data quality assessments and technical audits to assess the quality of the environmental data received by those sections.

9.1.1.1. Quality system audit Because agency QA managers serve agency program areas such as the DWB in a supporting role,

there is no set schedule for quality system audits, and agency QA managers will not initiate an audit unless requested. At its discretion, the DWB or its sections may request agency QA managers to conduct such an audit.

9.1.1.2. Management System Review (MSR) Any management system review would have to be conducted by U.S EPA.

9.1.1.3. Peer Review There are no areas in Drinking Water that conduct peer reviews.

9.1.1.4. Technical Review There are no areas in Drinking Water that conduct technical reviews.

9.1.1.5. Performance Evaluation There are no areas in Drinking Water that conduct performance evaluation.

9.1.1.6. Data quality assessment The Ground Water Section provides an internal verification of data, but each laboratory has its own

QA/QC procedures which they are required to meet to be in compliance with our QAPP.

9.1.1.7. Readiness review DWB does not typically rely on readiness reviews as a quality system assessment tool.

9.1.1.8. Technical systems audit DWB does not typically rely on technical systems audits as a quality system-related assessment tool or

for evaluation of quality systems or quality system features.

9.1.1.9. Surveillance Surveillance is done at the section level by the section chiefs and at the Branch level by the branch

chief. Additional surveillance of quality related activities is done by the Assistant Commissioner and Deputy Assistant Commissioner as well as agency QA managers.

9.1.2. Frequency of Assessments

Watershed Assessment and Planning Branch The WAPB continually reviews and assesses its processes and procedures and makes changes as needed.

Most processes are reviewed at least annually.

Compliance Branch This is included in the Branch planning document to be accomplished at least once each year. This usually

happens during August-September as the Compliance Branch plans and prepares for the upcoming new federal fiscal inspection year on October 1.

Permits Branch Assessments of the quality of the final work products is a continuous process.

Drinking Water Branch Violation letters are assessed daily. Data quality is assessed daily or at the end of each monitoring period,

dependent upon the type of data. Technical and management review are done daily as needed, and audits are done on an as needed basis.

Ground Water assessments are done as needed based on site-specific criteria.



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9.1.3. Selection of Assessment Personnel

Watershed Assessment and Planning Branch The WAPB‘s process determines the level of competence, experience, and training necessary for conducting

quality system assessments to ensure that the personnel are: 1. Technically knowledgeable, 2. Have no real or perceived conflict of interest, and 3. Have no direct involvement or responsibility for the work being assessed.

The WAPB hires scientifically/technically educated/trained people capable of doing QA/QC assessments. New hires have no knowledge or conflicts of interest. Staff who do QA/QC assessments are not part of the sampling teams for which they do QA/QC reviews.

Permits Branch U.S. EPA selects its assessment personnel without any input from IDEM.

Drinking Water Branch The Ground Water Section requires that staff have experience in geology, chemistry, and environmental

policy and document review prior to allowing them to do QA/QC without oversight from other section staff who are experienced in the review of that type of data.

9.1.4. Assessment Personnel Authority and Organizational Independence

Watershed Assessment and Planning Branch The WAPB‘s process for ensuring that personnel conducting quality system assessments have sufficient

authority, access (to programs, managers, documents, and records), and organizational freedom to the following: 1. Identify both quality problems and noteworthy practices, 2. Propose recommendations for resolving quality problems, and 3. Independently confirm implementation and effectiveness of solutions.

WAPB QA/QC personnel have authority to reject or accept data based on QA/QC review. They have authority to suggest ways to resolve QA/QC issues and, in subsequent data review, can evaluate/confirm implementation of proposed solutions.

Assessment Planning The WAPB‘s process for planning, implementing, and documenting assessments and reporting assessment

results to management is as follows:

Individual sampling and analysis project work plans are developed based on the program QAPP requirements. Assessment tools are evaluated and selected based on appropriateness for project goals. Work plans are implemented, data are collected, approved and assessed as to meeting DQA levels 1-4. QA/QC and project reports are developed and are often peer reviewed. Project reports are then reviewed by management and assessed as to meeting the individual project objectives.

Permits Branch U.S. EPA selects its assessment personnel without any input from IDEM.

9.1.5. Assessment Planning

Compliance Branch EnPPA branch commitments. Milestones met/percent complete.

Plan – implement – assess

Permits Branch EnPPA branch commitments. Milestones met/percent complete.



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9.1.6. Implementation

9.1.7. Documentation

9.1.8. Reporting Results to Management

Watershed Assessment and Planning Branch Management (QA Coordinator) reviews and signs off on QA/QC review documents. Senior Management

(section chiefs and branch chief) reviews and signs off on project reports or other documents developed utilizing the environmental data.

Compliance Branch The branch chief is committed to reviewing and responding to quality assessment findings if assessment

findings are presented to the branch chief for review and response.

9.2. Response

9.2.1. Corrective Actions

Compliance Branch Monthly meetings with compliance branch managers. Branch chief also regularly participates in agency

Compliance/Enforcement Team meetings; these meetings are held quarterly. OWQ branch chiefs meet together as a group with the OWQ Assistant Commissioner once each week; and during one-on-one meetings with the AC once a week.

Permits Branch Whenever U.S. EPA points out a deficiency in our program we respond promptly to its concerns.

Drinking Water Branch The DWB follows the specifications set in the agency QMP.

9.2.2. Dispute Resolution

9.2.3. Corrective Actions

Watershed Assessment and Planning Branch Data that do not meet all QA/QC requirements are flagged (both paper and electronic) to identify the problem.

Laboratory (or responsible person) is contacted with information on proposed corrective actions, if appropriate.

To ensure corrective actions are made promptly QA/QC staff review data set submissions to see if problem(s) have been corrected/resolved. Particular attention is focused on these items in subsequent data QA/QC reviews. Some instances may require confirmation from laboratory that problem has been addressed /resolved.

9.2.4. Dispute Resolution

Watershed Assessment and Planning Branch Disputes encountered as a result of assessments are resolved by meeting (or communication in some other

way—e-mail, etc.) to discuss problems and solutions. If no solutions can be agreed to, WAPB may stop sending samples to the lab, or terminate contract, etc.


Compliance/Enforcement Team meetings; these meetings are held quarterly. OWQ branch chiefs meet together as a group with the OWQ Assistant and Deputy Assistant Commissioners once a week; and during one-on-one meetings with the AC once a week

Permits Branch Speaking with the person that claims the Permits Branch has a problem.

Drinking Water Branch The DWB follows the specifications set in the agency QMP.



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10.0 Quality Improvement

Purpose: To document how the IDEM OWQ will improve the organization‘s quality system.

10.1. Point of Contact

Staff within the program area responsible for identifying, planning, implementing, and evaluating the effectiveness of quality improvement activities:

Watershed Assessment and Planning Branch Branch chiefs, section chiefs and the QA/QC coordinator.

Compliance Branch Branch chief and the two section chiefs in the Branch.

Permits Branch Branch Chief, section chief and Environmental E7s (technical experts).

Drinking Water Branch The Drinking Water Branch quality system is evaluated by the agency QA staff. Any revisions within the

Branch quality system will be addressed by the branch chief or the Branch QA coordinator.

10.2. Process(es) for Continuous Quality Improvement

Program area‘s process for ensuring continuous quality improvement (including the roles and responsibilities of management and staff):

Watershed Assessment and Planning Branch Review, and revise when necessary, the various QA/QC documents. Provide training to staff on QA/QC

requirements and procedures to assure knowledge of and adherence to the QA/QC requirements.

Compliance Branch EnPPA branch commitments. Milestones met/percent complete.

Plan – implement – assess.

Monthly meetings with compliance branch managers. Branch chief also regularly participates in agency Compliance/Enforcement Team meetings; these meetings are held at least once each quarter. OWQ branch chiefs meet together as a group with the OWQ Assistant Commissioner/Deputy Assistant Commissioner once a week; and during one-on-one meetings with the AC once a week.

Permits Branch Everyone is always looking for ways to improve our processes and our products.

Drinking Water Branch The DWB will review all quality tools on a regular basis and will revise as necessary

10.3. Process(es) for Preventing or Ameliorating Conditions Averse to Quality

10.3.1. Prevention

Program area‘s the process for ensuring that conditions adverse to quality are prevented:

Watershed Assessment and Planning Branch See response to 10.1 and 10.2.

Compliance Branch See responses to 10.1 and 10.2

Permits Branch Peer and section chief reviews of draft and final products.




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10.3.2. Identification

Process for ensuring conditions averse to quality are identified promptly including a determination of the nature and extent of the problem:

Watershed Assessment and Planning Branch Continual QA/QC review and assessment of data and problems


Compliance/Enforcement Team meetings; these meetings are held once each quarter. OWQ branch chiefs meet together as a group with the OWQ Assistant Commissioner/Deputy Assistant Commissioner once a week; and during one-on-one meetings with the AC once a week.

Permits Branch The person conducting the reviews will bring it to the attention of the appropriate section chief or the branch

chief.


10.3.3. Correction

10.3.3.1. Implementation

Processes for implementing corrective actions from start to finish. Include actions to prevent reoccurrence:

Watershed Assessment and Planning Branch See response to 9.2.1.

Permits Branch

Focus on the problem

Analyze the problem

Develop solutions to the problem

Implement the chosen solution and monitor it to determine if the solution is working.


10.3.3.2. Documentation

Processes for documenting corrective actions from start to finish:


Permits Branch E-mail and memos


10.3.3.3. Tracking to Closure

Processes for tracking corrective actions to closure:


Permits Branch E-mail and memos




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11.0 BIBLIOGRAPHY

Beckman T, Editor, 2002 Surveys Section Field Procedure Manual, Revised June 2002, Indiana Department of Environmental Management, Office of Water Quality, Assessment Branch, Surveys Section, Indianapolis, Indiana, IDEM 032/02/055/2002

CWA 1997 The Clean Water Act of 1977, Public Law 92-500, as Amended, 33 U.S.C. 1251

FR 1990 40 CFR Chapter 15, Part 1546 Quality Assurance, Oct. 1, 1990

FR 2004 40 CFR Part 136, Appendix A, Revised April 9, 2004

FR 2004 40 CFR Part 136, Appendix B, Revised June 30, 1986

IDEM 1994 ―Biological Studies Section Standard Operating Procedures Manual‖ (BSS-SOP), Dec. 1992, updated May 1994, Indianapolis, IN

IDEM 1994 ―Indiana Department of Environmental Management, Office of Water Quality, 1995 Program Plan,‖ November 1, 1994, Indianapolis, IN

IDEM 1998 ―Surveillance Group Current Operating Procedures Manual‖ (SG-SOP), Dec. 1992, updated May 1998, Indianapolis, IN

IDEM 2008 ―Indiana 305(b) Report 2008,‖ Indiana Department of Environmental Management, Office of Water Quality, Indianapolis, IN

Ohio EPA 1991 ―Quality Assurance Project Plans Integrated Work Program,‖ Ohio EPA, December 1991

U.S. EPA 1984 ―Policy and Program Requirements to Implement the Mandatory Quality Assurance Program,‖ U.S. EPA Order 5360.1, April 1984

U.S. EPA 1991 Quality Assurance Management Staff, 1991, ―Planning for Data Collection, The Data Quality Objectives Process for Environmental Decisions,‖ Draft, Oct. 16, 1991

U.S. EPA 1991 ―Region 5 Model RCRA Quality Assurance Project Plan (QAPP),‖ Office of RCRA, May 1991

U.S. EPA 1993 ―Region 5 Standard Operating Procedure for Validation of CLP Organic Data,‖ U.S. EPA Region 5, Central Regional Laboratory, 4/91, revised 8/93

U.S. EPA 1993 ―Region 5 Standard Operating Procedure for Validation of CLP Inorganic Data‖ U.S. EPA Region 5, Central Regional Laboratory, 9/93

U.S. EPA 1993. ―Using Qualified Data to Document an Observed Release and Background,‖ U.S. EPA, Office of Solid Waste and Emergency Response,‖ draft 10/93

U.S. EPA 1994 ―Functional Guidelines for Evaluating Inorganic Analyses,‖ U.S. EPA Data Review Work Group, U.S. EPA 540/R-94/013, February 1994, Washington DC

USEPA 1994 Contract Laboratory Program, ―National Functional Guidelines for Organic Data Review,‖ EPA540/R-94/012, February 1994, Washington DC

U.S. EPA 1994 ―Content Requirements for Quality Assurance Project Plans for Water division Programs‖, U.S. EPA Region 5, QA Section, Revision 0, August 1994

U.S. EPA 2002 ―Guidance for Quality Assurance Project Plans, U.S. EPA QA/G-5‖, EPA 600/R-98/018, July 2002, Washington, DC

U.S. EPA 2000 ―Guidance for Data Quality Assessment, Practical Methods for Data Analysis, U.S. EPA QA/G-9,‖ EPA 600/R-96/084, July 2000, Washington, DC

U.S. EPA 2000 ―Guidance for the Data Quality Objectives Process, U.S. EPA QA/G4,‖ U.S. EPA Region 5, EPA/600/R-96/055, September 2000, Washington, DC



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U.S. EPA 2007 ―Guidelines for the Preparation of Standard Operating Procedures (SOPs) for Field and Laboratory Measurements,‖ USEPA Region 5, QA Section, EPA/600/B-07/001, April 2007, Washington, DC

USGS 1978 National Handbook of Recommended Methods for Water Data Acquisition, Chapter 3, Sediment, (June, 1978 Revision)

Definitions:

CEU – Continuing Education Units – This refers to the wastewater and drinking water operator certification programs.

SDWIS – Safe Drinking Water Information System – this is a database created by U.S. EPA and SAIC to track drinking water inventory, compliance, and enforcement information. IDEM uses the state version (SDWIS-State). There is also a federal database (SDWIS-Fed) which IDEM reports violation and enforcement information into.

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