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Metropolitan Government of Nashville and Davidson County,
Public Health Department,
Pollution Control Division,
Quality Management Plan
Prepared by Gillian Walshe-Langford Ph.D.
6/5/2019
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2.0 Table of Contents
1.0 Quality Management Plan Identification and Approvals ...................................................1
2.0 Table of Contents .............................................................................................................2
3.0 Introduction .....................................................................................................................6
4.0 Management and Organization ........................................................................................7
4.1 Organizational Structure ...............................................................................................8
4.2 Director of Pollution Control .........................................................................................8
4.2.1 Permitting and Compliance ..................................................................................10
4.2.2 Administrative staff..............................................................................................10
4.3 Air Monitoring Program ..............................................................................................10
4.3.1 Air Monitoring Manager ......................................................................................10
4.3.2 Quality Assurance Technician ...............................................................................11
4.3.3 Field Technicians ..................................................................................................12
5.0 Quality Systems components..........................................................................................13
5.1 Quality Documents .....................................................................................................13
5.1.1 Quality Management Plan (QMP).........................................................................14
5.1.2 Quality Assurance Project Plan (QAPP) .................................................................14
5.1.3 Standard Operating Procedures (SOPs) ................................................................14
5.1.4 Annual Network Plan (ANP) .................................................................................15
5.2 Quality Control checks ................................................................................................15
5.2.1 Biweekly checks ...................................................................................................15
5.2.2 Internal Audits .....................................................................................................16
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5.2.3 External Audits .....................................................................................................16
5.3 Data Quality Assessments ...........................................................................................17
6.0 Personnel Qualifications and Training .............................................................................17
6.1.1 Employee Selection ..............................................................................................17
6.1.2 Performance Evaluation .......................................................................................18
6.1.3 Program specific training .....................................................................................18
6.1.4 Additional Training ...............................................................................................20
6.1.5 Employee Training Needs .....................................................................................20
7.0 Procurement Policy ........................................................................................................20
7.1 Procurement of Equipment and Supplies ....................................................................21
7.2 Grant and Contract Agreements .................................................................................22
7.2.1 Laboratory Services ..............................................................................................23
7.2.2 Third party Audits ................................................................................................23
8.0 Computer technology .....................................................................................................24
8.1 Computer Hardware and Software ..............................................................................24
8.2 Agilaire Airvision .........................................................................................................26
8.3 Data Information Requirements and Standards ..........................................................27
8.4 System Safeguards ......................................................................................................28
8.4.1 System Access ......................................................................................................28
8.4.2 Backup and Recovery ...........................................................................................28
9.0 Documents and Records .................................................................................................29
9.1 Quality Related Documents .........................................................................................30
10.0 Planning .........................................................................................................................32
10.1 Systematic Project Planning ........................................................................................33
10.2 Permitting and Compliance Planning ...........................................................................34
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11.0 Implementation of Work Processes ................................................................................35
11.1 SOP maintenance ........................................................................................................36
11.2 Distribution and Storage .............................................................................................37
12.0 Assessments and Response Actions ................................................................................37
12.1 Assessments ...............................................................................................................39
12.1.1 Annual Network Plan (ANP) and 5-year Network Assessment ..............................41
12.1.2 Technical Systems Audit .......................................................................................42
12.1.3 EPA Field Audits ...................................................................................................43
12.1.4 Quality systems Assessments ...............................................................................43
12.2 Response ....................................................................................................................43
12.2.1 Corrective Actions ................................................................................................44
12.2.2 Dispute resolution................................................................................................45
13.0 Quality Improvements ....................................................................................................45
13.1 Quality Management Plan Review...............................................................................46
13.2 Communication...........................................................................................................46
13.3 Processes for Continuous Improvement ......................................................................47
13.4 Processes for Preventing Conditions Adverse to Quality .............................................47
13.4.1 Identification of Conditions Adverse to Quality ....................................................48
13.4.2 Correction of Conditions Adverse to Quality ........................................................48
13.4.3 Deficiencies and Non-conformance (Informal Corrective Actions) ........................48
13.4.4 Formal Corrective Actions ....................................................................................49
14.0 References .....................................................................................................................50
Appendix A ................................................................................................................................52
Acronyms and Abbreviations .....................................................................................................52
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List of Figures
Figure 4-1 MPHDPCD Organization Work Chart ...........................................................................9
List of Tables
Table 1 Quality Documents MPHDPCD ......................................................................................13
Table 2 Audit and Assessment Commitments ............................................................................40
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3.0 Introduction
This quality management plan (QMP) outlines the quality management system utilized by the
Metro Public Health Department Pollution Control Division (MPHDPCD). The quality assurance
goals, policies, procedures, organizational responsibilities, evaluation and reporting
requirements and other attributes of MPHDPCD’s quality management system are addressed
within these pages. This data is entered into the Environmental Protection Agency’s Air Quality
Sub-System (EPA AQS) database.
The MPHDPCD has developed this QMP for data to achieve the following objectives/goals:
● Provide office support and context for programmatic quality assurance activities;
● Create an avenue for interdivisional communication on quality assurance issues;
● Create a primary source of information for data quality assurance at MPHDPCD;
● Comply with Environmental Protection Agency (EPA) requirements.
MPHDPCD is responsible for implementing all aspects of Nashville and Davidson County’s
Ambient Air Monitoring program; Stationary Source Permitting and Compliance Program; and
Asbestos Demolition/Renovation Permitting and Compliance Program, such as quality
assurance, data collection and data processing.
Environmental data are a critical input to MPHDPCD’s decisions to protect human health and
the environment. Most of the decisions which are made in the region concerning the
management of the environment and the reduction of risk ultimately require the use of
environmental data which are generated by EPA or by the state, tribal, local government,
and/or private sector organizations and regulated facilities. Therefore, it is critically important
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that decision makers know the origin and quality of the data used in these decisions. The
quality of environmental data is known when all components associated with their derivation
(precision, bias, completeness, comparability, sensitivity, representativeness, and usability) are
documented. In cases where data (e.g. emissions data) are generated by regulated facilities,
reproducibility of calculated data through qualified and accepted engineering practices is
verified by MPHDPCD prior to its acceptance for distribution to state, federal, or public users.
A technical glossary of terms and acronyms used in this QMP can be found in Appendix A.
4.0 Management and Organization
The MPHDPCD is a small local organization and does not have a Quality Assurance/Quality
Control (QA/QC) department independent of the Air Monitoring Program. The Air Monitoring
Program (AMP) generates the monitoring data and the QA Technician within the AMP ensures
the quality of the data collected, with further oversight of the data coming from the Air
Monitoring Manager (AMM). The Permitting and Compliance Program (PCP) generates
emission inventory data, issues permits, conducts compliance evaluations and deals with
enforcement. The MPHDPCD has a contract PM2.5 laboratory, Intermountain Laboratories
(IML). This contract laboratory follows an internal QMP and QAPP for the project and provides
an initial quality assurance of the data collected from the filters the MPHDPCD sends to it. The
Air Monitoring Manager (AMM) and the QA Technician review all data provided by the contract
laboratory when it is received and provide a final quality assurance review of the data.
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4.1 Organizational Structure
The MPHDPCD falls within the Environmental Public Health Bureau at the Metro Public Health
Department, and is organized as shown in figure 4.1. It consists of one Director, one Program
Manager, one Administrator, three Engineers, and 7 Environmental Health Specialists. The
program does not have a designated QA Manager, however we have an independent QA
Technician who focuses on ensuring that all data collected and reported meets the guidelines
for the program that have been laid out in the QAPP and SOPs (See Table 1). The QA Technician
is not involved in any daily data collection duties. They have direct access to the Air Monitoring
Manager to discuss any issues that may arise. In many respects the Air Monitoring Manager
(AMM) functions as the Quality Manager. Many of the duties of the AMM revolve around
ensuring that the program is adhering to the QAPP, SOPs and that the data collected, certified
and reported to the EPA is of an acceptable standard. The AMM and QA Technician work
together to assess and improve the MPCHPCD’s quality system. Details of tasks related to each
position within the division are detailed below.
4.2 Director of Pollution Control
The Director of Pollution Control (DPC) is the senior administrative official accountable for all
the quality of all operations performed by MPHDPCD staff. They delegate QA management
for the Air Monitoring program (AMP) to the Air Monitoring Manager (AMM). Their duties
include, but are not limited to the following:
• Manage and review grants, budgets, proposals and allocation of resources;
• Authorizes purchasing of equipment;
• Has stop work authority for AMP if AMM reports issues;
• Ensures adequate staffing for the MPHDPCD;
• Ensures the implementation of the permitting and compliance QA programs;
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• Prepares and reviews calculation and permitting templates for conformity;
• Reviews all compliance evaluation reports;
• Reviews developed emission inventory data to verify accuracy for modelling;
• Conducts quality review of permits and emission inventory data for submittal to the EPA;
• Conducts annual review of stationary source and compliance data entered into EPA’s ICIS-
(Integrated Compliance Information System) Air database.
Figure 4-1 MPHDPCD Organization Work Chart
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4.2.1 Permitting and Compliance
Staff members in the permitting and compliance group have a wide variety of duties; they
include but are not limited to the following:
• Preparing permits and conducting compliance evaluations of stationary sources;
• Calculating emissions from stationary sources;
• Reviewing source generated data for accuracy and quality control (e.g., stack testing
reports, emission reports, compliance reports etc.);
• Conducting compliant investigations;
• Preparing compliance evaluations reports;
• Recommending corrective actions for non-compliance to the Director;
• Preparing emissions inventory data for submittal to EPA;
• Entering stationary source and compliance data into EPA’s ICIS-Air database.
4.2.2 Administrative staff
The Division administrator is responsible for the following:
• Providing a first line of communication between MPHDPCD and the public;
• Providing secretarial support to the division;
• Procurement for the division;
• Tracks payments for gasoline dispensing and source emission inventories.
4.3 Air Monitoring Program
4.3.1 Air Monitoring Manager
The Air Monitoring Manager (AMM) spends a significant amount of time on QA related tasks as
part of their duties. The duties of the AMM include but are not limited to the following:
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• Ensuring the air monitoring network is operated in accordance with QAPP;
• Ensures implementation of the Air Monitoring QA program including meeting data
quality objectives;
• Reports safety issues and non-adherence to QAPP and SOPs to DPC who has stop work
authority;
• Develops/revises QA documentation such as QMP, QAPP and SOPs;
• Conducts final review of environmental and QA data prior to submittal to AQS to ensure
the data is precise and accurate;
• Facilitates the resolution to disputes arising from discrepancies in audit findings and
QA/QC issues;
• Supervises technical staff;
• Prepares annual network plan; annual site evaluations and annual data certification
package for submittal to the relevant agencies;
• Supervises corrective actions.
4.3.2 Quality Assurance Technician
The QA technician within the Air monitoring program is tasked with the following duties (100%
of work load is QA/QC related):
• Validating all data produced by the AMP by reviewing log books, all QA and QC
documentation, all data collected by the program and external laboratory QC;
• Assessing QA/QC quality by tracking frequency, standard certifications, and adherence
to SOPs;
• Reviewing all audits, internal and external, for standard certifications and data quality;
• Applying proper validation codes in AirVision and keeping a log of any coding/flagging
activities;
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• Reporting to AMM results and/or observations of audits;
• Notifying AMM when QC issues have occurred that will lead to a loss of data.
4.3.3 Field Technicians
The field technicians in the AMP are responsible for the running and maintenance of both
gaseous and particulate ambient air monitors. Their duties include, but are not limited to the
following:
• Operates the monitoring network in accordance with the SOPs and QAPP;
• Maintains equipment and inventories;
• Collecting, and calculating environmental data in adherence with the relevant SOP;
• Performing all QC activities to meet the measurement quality objectives set forth in the
QAPP;
• Documenting all deviations from established procedures and methods;
• Testing all new hardware and associated software.
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5.0 Quality Systems components
The MPHDPCD was established as a Primary Quality Assurance Organization (PQAO) for all of its
data collection activities in 2015. This provides a quality system specific to the equipment,
resources and needs of MPHDPCD. The MPHDPCD quality management system centers on
quality documents, quality control procedures, quality assurance activities, data quality
assessments, and corrective actions. Section 4.3 discussed the individual roles and
responsibilities of the Air Monitoring Manager, QA Technician and Field Technicians of the Air
Monitoring program in regards to environmental data collection activities.
5.1 Quality Documents
Table 1 Quality Documents MPHDPCD
Quality Document Approved
PCD-AM-QAPP EPA approved 2019
PCD-AM-QMP EPA review 2018-2019
PCD-AM-100 Thermo 42i NOx SOP MPHDPCD approved 2019 (submitted to EPA)
PCD-AM-200 Thermo 43i SO2 SOP MPHDPCD approved 2019 (submitted to EPA)
PCD-AM-300 Data Handling SOP MPHDPCD approved 2019 (submitted to EPA)
PCD-AM-400 Thermo 2025i SOP MPHDPCD approved 2019 (submitted to EPA)
PCD-AM-500 Thermo TEOM 1405 MPHDPCD approved 2019 (submitted to EPA)
PCD-AM-600 Thermo 49i O3 SOP MPHDPCD approved 2019 (submitted to EPA)
PCD-AM-700 Thermo 48i CO SOP MPHDPCD approved 2019 (submitted to EPA)
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5.1.1 Quality Management Plan (QMP)
MPHDPCD’s quality system includes the organizational arrangements, documents, and
processes described in the QMP. This plan documents the approach used to assure the quality
of work conducted by MPHDPCD, lines of report and communication, and coordination
mechanisms. The quality system includes planning, implementing, and assessing the quality
assurance and quality control operations as they are applied to MPHDPCD environmental data
programs. The MPHDPCD QMP and its revisions are developed by the AMM with general
oversight by the DPC. When approved, the QMP is located on a protected shared drive
accessible to all MPHDPCD employees.
5.1.2 Quality Assurance Project Plan (QAPP)
The QAPP is developed as a guide for implementation of the QA and QC policies and procedures
for a program. The QAPP for Ambient Air Quality Monitoring of Criteria Pollutants is the
primary quality document for the Air Monitoring Program. The QAPP serves as a reference,
sets quality benchmarks to achieve, and incorporates standard operating procedures to be
followed. The MPHDPCD will adhere to the principles and procedures set forth in the QAPP.
The QAPPs should be reviewed at least every year and revised at least every five years or more
frequently if the project objectives change. The Air Monitoring QAPP was approved by the EPA
in February 2019.
5.1.3 Standard Operating Procedures (SOPs)
SOPs are developed and revised by the responsible program manager and reviewed by the
Director (See Table 1 for a list of current MPHDPCD SOPs). SOPs are reviewed every year to
ensure they are kept up to date and capture current practices. They should be revised
accordingly whenever significant changes occur. From a fundamental prospective, SOPs provide
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staff members with step-by-step directions for completing each work activity within a QAPP or
a project plan. SOPs limit the variability between individuals and available resources (e.g.,
equipment, time, etc.). The AMM is responsible for ensuring the development of SOPs and
directs the staff to produce, verify and test the SOPs. The draft SOP is reviewed and approved
by the AMM and the Director. Air Monitoring SOPs are then sent in electronic formats to the
Region 4 EPA Science and Ecosystem Support Division (SESD) Management for their review and
final approval. When final approval has been met, the approved SOP and all the associated
documentation (written correspondence, letters of approval, etc.) become a part of the
MPHDPCD’s library.
5.1.4 Annual Network Plan (ANP)
The ANP is prepared annually in accordance with 40 CFR Part 58 Sub B 58.10(a)(1) by the AMM.
It evaluates the monitoring needs of the area, ensures that appropriate siting criteria is met and
that the network is adequate to assess the attainment of air quality standards. The ANP is
submitted to the State of Tennessee as part of the Tennessee Annual Network Plan. The
Tennessee Division of Environment and Conservation (TDEC) will place the Tennessee Annual
Network Plan on public notice for comments; it will then be submitted to EPA region 4.
5.2 Quality Control checks
5.2.1 Biweekly checks
Quality control checks enable the AMP to review and access the precision and bias of the
monitors within the network. Field technicians perform flow, temperature, pressure and leak
checks biweekly on each PM2.5 monitor within the network. Temperature, pressure, leak check
and flow rate check are also carried out on the PM10 TEOM biweekly. Precision checks in the
form of a precision check/zero and span are performed biweekly on each gaseous monitor
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(ozone, sulfur dioxide, nitrogen dioxide and carbon monoxide). These checks involve pushing a
known concentration of gas through the monitor and evaluating its response. The only
exception to the precision check frequency is with the ozone monitors, the ozone season runs
from March 1st to October 31st each year. Verifications/calibrations are performed each quarter
on the gaseous monitors. Recalibrations are also performed after maintenance, repairs or any
occurrence that causes a change in the monitor.
5.2.2 Internal Audits
The particulate monitors of the air monitoring network are audited by the AMM every 6
months; they are carried out using independent equipment. An audit report is prepared and
given to the QA technician for filing and reporting to AQS.
5.2.3 External Audits
TDEC performs periodic performance audits of the monitors in the air monitoring network. The
resulting findings are sent to the AMM and the QA technician for review and validation. All
reports are saved to the S drive; all valid audits are reported to AQS.
An annual audit of our network is also carried out by Environmental Engineering &
Measurement Services Inc. (EE&MS), an independent third party. The resulting report is sent to
the AMM and the QA technician for review and validation; it is also saved to the S drive. All
valid audits are uploaded to AQS.
The EPA Region 4 performs a Technical Systems Audit (TSA) of the AMP at least every 3 years.
These are thorough reviews that include but are not limited to, field activities, data
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management, staff development, and conformity to the QAPP. These are not performance
audits, but are audits of documentation and procedures.
5.3 Data Quality Assessments
The QA technician performs review of the data quality by performing precision and bias
calculations, reviewing outliers, generating reports through the AQS database and reviewing all
data points for validity and flags quarterly. The QA technician also reviews all biweekly and
precision check reports generated by the field technicians, they also review polled data from
field sites on AQS daily to ensure that any issues that may be occurring in the field can be dealt
with promptly. All validation decisions resulting in void data which are not clear are annotated
in the void data log.
The AMM reviews all the quarterly data review packages produced by the QA technician, the
void data log, and the data submitted to the AQS database for accuracy. Any discrepancies are
investigated and annotated. The AMP also submits the Annual Data Certification package to the
EPA.
6.0 Personnel Qualifications and Training
6.1.1 Employee Selection
The qualifications of air monitoring personnel are assessed and assured through the
requirements and operation of the Metro Public Health Department (MPHD) hiring process. If
the applicant meets the minimum criteria for the vacant position, their name is placed on a
roster of those eligible for interview. The greater the applicant’s educational level and/or
relevant work experience, the greater the likelihood that the applicant would be interviewed.
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The MPHDPCD receives a list of those who have been rated and approved by the MPHD Human
Resources Office for that job class. Interviews are conducted and candidate is selected, offered
the position and hired. During the interview process, the applicants are questioned not only
about their technical expertise but also their organizational, interpersonal and communication
skills, as well as their work habits. References may be contacted for confirmation of work
experience.
6.1.2 Performance Evaluation
Each employee is evaluated on an annual basis on his/her work performance in accordance
with documents and forms provided by MPHD Human Resources. The evaluation includes an
assessment of job duties, completeness, thoroughness, and timeliness of duties performed. The
evaluation process allows management to assess the employee’s understanding of their duties,
MPHDPCD policies and procedures, and to determine potential future training needs. All
evaluations are carried out by the line manager and approved by the Director.
6.1.3 Program specific training
All employees are actively encouraged to pursue training opportunities whenever possible
when funding allows. Training is essential to ensure the adequate running of the programs
within MPHDPCD. Vendor based training is available at times for personnel, when new
equipment is obtained or as funds allow for new members of staff. Additionally, employees are
encouraged to identify, request and attend pertinent courses and seminars. These courses and
seminars may be provided as web based real-time interactive formats, and/or live instruction.
Such training may be provided by the EPA, Local air pollution agencies, vendors, Southeastern
States Air Resource Managers, Inc. (Metro 4 – SESARM). Training opportunities include:
• Web-based EPA sponsored training
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• EPA Region 4 Air Monitoring Workshops
• National Air Quality conferences
• Agilaire Airvision Software Training
• EPA Annual Quality Assurance Conferences
• NESHAP – Asbestos Certification Training
• National Association of Clean Air Agencies (NACAA) conference
The AMP Field Technicians will follow the specific directions within the Operations Manual
supplied by the monitor vendor when servicing or performing QC and/or remedial checks on
the monitors. All staff have access to SOPs, QMP, QAPP, operation manuals and technical
service contacts and will follow directions as specified in the EPA-approved SOPs. Employees
are aware of the EPA website http://www.epa.gov/ttn/amtic/ where QA/QC and technical
guidance documents can be obtained. Reading and keeping up to date with these quality
documents is an essential part of ongoing training in the AMP.
Each new employee is partnered with a senior employee to receive on the job training so that
the new employee understands their job responsibilities, and both the quality and quantity of
work required. Each employee in the AMP will undergo a proficiency test with regards to
carrying out their day to day duties, after their training period, to ensure they can adequately
carry out their duties without supervision. All air monitoring personnel have sufficient training
to currently perform necessary functions at an acceptable level.
Each individual tracks their own training, within the AMP, training is also tracked on the
monthly report created by the QA Technician.
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6.1.4 Additional Training
The employees of MPHDPCD will also carry out any training deemed essential by the MPHD.
These will include but are not limited to Defensive Driving, Substance Abuse, Sexual
Harassment and Cyber security training. Other training courses may be offered by MPHD HR at
any time and may be compulsory.
6.1.5 Employee Training Needs
It is the responsibility of the AMM and the Director to ensure that all personnel performing
tasks and functions related to data quality have the necessary education, training, and
experience. Training needs, including QA Training, are determined on an individual basis by the
supervisors in consultation with employees. Training determinations are based on statutory
requirements, management directives, audit findings, and midyear/annual employee
performance appraisals. The quality-related training needs are not static, but are a dynamic
function of program requirements and are addressed on an as-needed basis by the AMM and
the Director. The AMM may, in consultation with the Director, require staff to participate in
specific QA related training as a result of an internal audit, significant modification to program
procedures, or other quality-related issue. In addition, staff are encouraged to communicate
training needs to the AMMM or to the Director.
7.0 Procurement Policy
The procurement of equipment, supplies and services for environmental operations shall be
planned and controlled to ensure that the quality of obtained goods is documented and meets
the technical requirements for the project. Procurement of goods shall abide by the procedures
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described in Procurement Code provided by the Metropolitan Government of Nashville and
Davidson County.
7.1 Procurement of Equipment and Supplies
Procurement of supplies, equipment and services is done through the Metropolitan
Government of Nashville and Davidson County according to the Procurement Code which is
located in Title IV, Sections 4.04.010 – 4.04.081. All purchases made by MPHDPCD must adhere
to this Procurement code.
All purchases relating to the collection and reporting of air quality monitoring data must be
preapproved by the AMM and PCD. All purchases are initiated by the AMM who ensures that
any technical or QA/QC specifications required are included in the procurement document. This
means in practice that the AMM will contact the company in question for a quote. Once that is
received, if it is under $1000, the AMM will forward it to the admin for the department who
enters it into the iProcurement system where it will be approved by the DPC and then by
finance. If the quote is more than $1000, the AMM will obtain two other quotes and prepare
the Request For Purchase for the finance department who will then deal with the purchase. It is
the responsibility of the AMM to review and ensure that all documents related to purchasing
are correct and complete before they are sent to Admin or Finance.
When equipment meeting comparable technical and quality requirements is available from
multiple vendors, bids are obtained to leverage the best value and warranty agreements. Once
received, the equipment is tested to ensure that the technical and QA/QC specifications are
met. If the equipment fails to meet specifications after testing (this includes working with the
Vendor where their assistance is needed) the equipment is returned to the Vendor for refund
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or replacement with equipment that meets the specifications expected. In cases where this
process is delayed, older but functional equipment may be returned to service until an
appropriate replacement has been purchased and tested.
Metro maintains contracts with specific vendors, items must be purchased from that vendor if a
contract for the item or service exists. All suppliers must be registered in Metro’s iSupplier
system so that purchases can be made through Metro’s iProcurement portal.
Purchases under $1,000 can be placed through iProcurement by MPHDPCD. Purchases over
$1,000 must be routed through Metropolitan Government of Nashville and Davidson County
Finance Department. Three (3) verbal quotes are required for items that cost between $1,000-
$4,000. Three (3) written quotes are required for items that cost between $4,000-$10,000.
Purchases of $10,000 and above must go through competitive sealed bids for proposals, unless
the item will be purchased as a sole source. Regulations regarding Sole Source procurement is
dealt with in Title IV, 4.12.060. Emergency procurement purchases are in Title IV, 4.12.070.
The Procurement Code for Metropolitan Government of Nashville and Davidson County can be
accessed online at:
https://library.municode.com/tn/metro_government_of_nashville_and_davidson_county/code
s/code_of_ordinances?nodeId=CD_TIT4PRCO
7.2 Grant and Contract Agreements
Federal Grants require a grant application and follow-up grant reporting to be submitted on
specific dates. The MPHDPCD maintains two EPA funding grants. The annual Federal 105 grant
application is prepared by the MPHDPCD Director. The PM2.5 103 Grant application is also
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prepared by the MPHDPCD Director. When funds are granted, they are placed into the
MPHDPCD’s budget which is under the supervision of the MPHD’s Department of Finance.
7.2.1 Laboratory Services
IML is the contract weigh lab for filter-based PM2.5 sample analysis. IML has its own Quality
Assurance Manual and QAPP. Copies of these documents are kept electronically and are
located at S:\AIRPOLLUTION\Air Pollution Lab\IML and are accessible from any computer
assigned to the Air Monitoring Program. The Quality Assurance Manual lists the functions and
responsibilities of each person involved in the weigh lab. The QAPP details the procedures that
are in place to insure analytical accuracy. Sampling analysis carried out by IML adheres to the
federal reference method (FRM) requirements as set out in 40 CFR Part 50, Appendix L.
Currently the AMP does not have a back-up laboratory in place in the event that IML cannot
complete sample analyses.
7.2.2 Third party Audits
The requirements and frequency for performance audits are specified in 40 CFR Part 58,
Appendix A. Gaseous analyzer audits are required annually. The AMP contracts this work out to
an independent third party on an annual basis and the audits are carried out through the
probe. For low-volume particulate samplers, auditing is required twice yearly, with these audits
spaced ideally between 5-7 months apart. The same independent third party carries this work
out for the AMP once per year. Since 2016, the company used for this independent Audit is
Environmental Engineering & Measurement Services, Inc. (EE&MS).
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8.0 Computer technology
Information technology is critical to the performance of the mission of the Department.
Computer systems are used to gather, store, analyze, retrieve, visualize, archive, and publish
data for use by MPDHPCD staff, interested parties, and the general public. Computer software
and hardware used to calculate or develop data for environmental programs included in the
MPHDPCD programs are managed to ensure that data are of acceptable precision and accuracy
and that data are not corrupted or lost. Equipment and systems covered under this section
include
• Desktop hardware and software used by MPHDPCD staff;
• Server hardware and software used to store and access environmental data and
documents;
• Communications hardware and software used to interconnect desktop and server
equipment including local area networks (LANs), the Internet, and other remote
networks.
8.1 Computer Hardware and Software
The Metro Public Health Department Information Technology Services (IT) is responsible for
managing computer hardware, software, and data telecommunication infrastructure for the
MPDHPCD. All purchases of computer hardware are approved and carried out by IT and abide
by the purchasing requirements of the Metro Finance Department. IT installs and repairs
computer hardware issues. Due to the specific nature of air monitoring software, the IT
department may aid in the purchasing and problem support. However, the AMM typically act as
a liaison with the software vendor and support department staff with the repair of software
issues.
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It is the policy of the MPHDPCD to provide a computerized data retrieval system with computer
hardware available that meets technical requirements and has sufficient capabilities to ensure
that data and information produced from or collected by the system, meet applicable EPA
information requirements. The computer network, including the secured AMP folders on the S
drive, is backed up nightly.
The AMM is ultimately responsible for evaluating hardware and determining if it meets user
requirements and complies with applicable contractual requirements for the AMP. Specific
processes, procedures, and individuals responsible for determining the quality of
environmental data residing in MPHDPCD databases and information systems are available in
program area QAPPs and SOPs. Some programs utilize computer models to perform
environmental data analysis. The individuals and their responsibilities regarding quality related
activities are identified in the QAPPs. MPDHPCD data quality is frequently assessed, and various
policies and procedures have been implemented to assure computer software and hardware
purchases conform to a standard that ensures environmental data integrity.
IT is responsible for the following technical services:
• The planning and procurement of the Department's LAN infrastructure (firewalls,
routers, switches, hubs, etc.);
• Installation, operation and maintenance of the LAN infrastructure including oversight of
any contracted services that ensure infrastructure meets the goals and needs of MPHDPCD;
• PC hardware and software maintenance, printer maintenance, and other IT hardware
and software maintenance including VOIP phone systems and wireless routers for building web
access. MPDHPCD staff request software and hardware maintenance by use of the IT Help Desk
available through email or by telephone;
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• Installation, maintenance, and operation of servers used by MPHDPCD up to the operation
system layer. This includes database servers, file and print servers, system management
servers, endpoint security servers, geographic information servers (GIS), and web servers.
8.2 Agilaire Airvision
The AMP central computer is currently operating AirVision software. A software support and
upgrade agreement is renewed annually. The continuous ambient air monitoring data network
is controlled by a central computer. This specialized software program was designed exclusively
for processing ambient air quality data and to automate data processing events. This program
allows the user to:
• Configure the data retrieval process;
• Discriminate data;
• Formulate and construct formats for various air quality data reports;
• Submit to Air Quality Subsystems (AQS).
The AMM is responsible for setting up the data retrieval tasks, monitoring sites and instrument
information, and files for data archiving. Only trained or experienced users of the AirVision
software should attempt the above configurations or any reconfiguration of the program.
Otherwise, consulting an Agilaire service representative to obtain instructions is advised. The
ESC instruction manual (for datalogger) is also recommended as a guide to perform tasks in
addition to the ESC service information. Data logger set up and configuration follows the
pollutant SOP and QAPP.
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The data logger has a multiple-level password-protected menu system that allows access based
on the password configuration and allowable level of the user. All continuous monitoring air
quality data is stored in permanent files on the shared network drive and is backed up daily on
a separate drive located outside of AMP Air Laboratory.
8.3 Data Information Requirements and Standards
Responsibility for the quality of data produced from or collected by computers, computer
systems, and/or databases lies with the related program staff. Depending on the age and design
of the database, the system may have fields within the data records documenting the conduct
of applicable data review and validation processes. Guidance documents (QAPPs, SOPs and
other operational documents) set forth the procedures and means of managing data to ensure
their quality during their useful life.
In the case of Emissions and Compliance Data (data related to the Permitting Program), data
accuracy and completeness responsibilities lie with the DPC. Facility data is reviewed on a
routine basis and reports are sent to the DPC when data is inaccurate or incomplete.
Quarterly reviews are performed on data submitted to EPA's ICIS database to assure data was
transmitted accurately and completely to ICIS by MPHDPCD.
In the case of Air Monitoring data, data accuracy and completeness responsibilities lie with
the Field Technicians, QA Technician and the AMM. Data is checked for accuracy on a daily,
weekly and monthly basis, with the Field Technicians and QA Technician reporting any
inconsistencies such as inaccuracy or incompleteness to the AMM. Quarterly reviews are
performed on data submitted to EPA's AQS database to assure the data were
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transmitted accurately and completely to AQS by the QA Technician on behalf of the MPCHPCD.
A detailed review of the process for ensuring that the data collected by the Air Monitoring
program meets applicable standards, and the processes by which the quality of the data
collected is verified can be located in the Data Handling SOP. This document also covers the
responsibilities of the QA Technician and the AMM in regards to ensuring the capture of quality
environmental data.
8.4 System Safeguards
Systems and data are protected against malicious and unintended loss and corruptions through
measures designed to restrict access, detect threats, and reduce the probability of loss.
8.4.1 System Access
Access to systems is administered through the IT department in consultation with MPHDPCD's
Director and the AMM. Users are set up to access only the systems they need to do their work.
Access is controlled by user id/password authentication both at the desktop level and program
application level. Individual database systems may have additional safeguards to provide access
to sensitive levels of data for management purposes.
8.4.2 Backup and Recovery
Server backup and recovery are the responsibility of IT. Server operating configurations,
software, and data are backed up on a daily basis. Multiple generations of media are
maintained to support rollback to prior versions. Backups are scheduled, tested and media
stored according to standardized procedures. Users are directed to store all nonvolatile data on
servers that are covered by the backup plan or to create and maintain a system with equivalent
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safeguards. Only temporary copies of data are to be stored on hard drives not covered by a
backup plan.
9.0 Documents and Records
Documents that specify requirements and instructions affecting the quality of environmental
programs shall be adequate for the intended purpose and shall be controlled as required by
federal or state programs. Documents are controlled by the use of information such as title,
date, version, etc. Quality assurance records should be produced, controlled, and maintained so
as to reflect the achievement of the required quality for completed work and to fulfill statutory,
regulatory, and contractual requirements. The most current version of controlled documents
shall be made readily available to staff. MPHDPCD programs follow a policy and procedure for
access/inspection and storage of records based 2 CFR §200.333 “Retention requirements for
records”. Records relating to personnel issues are confidential and may not be subject to public
inspection. Documents identified to be older versions or obsolete will be archived according to
each program's document retention schedule. The process for maintaining chain of-custody
and confidentiality is a component of QAPPs and SOPs (see Table 1 for a list of current
MPHDPCD SOPs). As such, they are addressed in these documents, including identifying the
individuals responsible for maintaining and protecting this information. A further discussion
regarding the policies and procedures for maintaining documents and records can be found in
the QAPP.
In most instances, most records are retained for at least 4 years to provide a buffer period that
allows for end-of-cycle reporting and TSAs. If any litigation, claim, designation, audit, or other
action involving the records has been started before the expiration of the three-year period,
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the records will be retained until completion of the action and resolution of all issues which
arise from it, or until the end of the regular three-year period, whichever is later. After the
archive storage period has passed, the storage utility may be over-written, disposed of or
recycled.
The AMP staff files all monitoring data, documents, and data support records in a central
location within the Air Monitoring Lab. These files are sorted by year and parameter. All
electronic records are copied on a shared secure network drive that is backed up to a drive
located outside of the Air Monitoring Lab. The permitting and compliance program staff file all
permitting and compliance records in file cabinets located in the MPHDPCD located at the Lentz
Building of MPDH. These files are sorted by source and file type. All electronic records are
copied on a shared network drive that is backed up to a drive located outside of the MPHDPCD.
Access to all shared drives is controlled as discussed in Section 8.4.1 of this QMP.
9.1 Quality Related Documents
Quality-related documents and records that are outlined in the records retention policy,
federal/state regulations or identified by AMM and DPC are controlled. The quality-related
documents listed below currently require control:
• Quality Management Plan (QMP);
• Quality Assurance Project Plans (QAPP’s);
• Standard Operating Procedures (SOP’s);
• Annual Network Plan; and
• Technical Guidance Documents
The following may also be controlled as required based on the program QAPP:
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• QA/QC Records
• Audit Records
• Calibration Records
• Maintenance Records
QAPPs and SOPs are prepared, reviewed, approved, issued, distributed, maintained, and
revised per the policy located within the MPDHPCD Criteria Pollutant QAPP, Section 9. This
section follows the requirements and guidance set by EPA. Each document undergoes a peer
and chain-of command review process. In general the ultimate responsibility for preparing and
reviewing quality documents lies with the AMM. Each document undergoes a peer
and chain-of-command review process.
The process for reviewing and revising quality documents is as follows: Quality Documents
valid for more than one year generally undergo an annual review process to ensure applicability
and are revised as needed using the same peer and chain-of-command review process. As per
SOPs regarding development of QAPPs and SOPs, critical revisions to QAPPs, SOPs, and
Sampling Plans are tracked in the Change Tracking table located in each document. The AMM is
responsible for distributing QAPP/QMP/SOPs with critical revisions to each person listed in the
QAPP Distribution List. Critical SOP revisions, as well as new SOPs are listed in either program
specific or Department-wide emails distributed to appropriate Departmental staff when the
documents are posted to the MPDHPCD shared drive location.
The AMM is responsible for ensuring the appropriate use of quality-related documents by
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Technical staff and that these documents and records accurately reflect the completed work.
The AMM are responsible for documenting that those implementing the SOPs have
documented that they have read and understand the new SOP or the revisions to an existing
SOP. This documentation is maintained by the AMM.
The current versions of the QMP, QAPP and SOPS are maintained on the MPDHPCD’s shared
drive, clearly labeled and in a location that they are accessible to relevant staff members. A
hard copy of each is also kept in the AMP lab. Hard copies of relevant SOPs are kept at each
individual air monitoring site. Electronic versions of previous quality documents are archived on
the S drive.
10.0 Planning
Environmental data generating programs shall be planned in accordance with Local, State, and
federal laws and rules, MPHD guidelines and contractual requirements. Environmental
programs and projects are planned through the development of the Departmental program
plans/strategies and budgets, grant work plans, QAPPs, this QMP, and contracts/cooperative
agreements executed by MPHDPCD and external organizations. These documents translate
requirements and expectations into measurable specifications, commitments, and performance
criteria.
Planning is an integral part of each MPHDPCD program; however, the frequency and mode of
the planning process varies between programs and Divisions in the wider MPHD. Many Division
programs conduct planning as part of the annual grant continuation/commitment process or
conduct ongoing program planning/strategy development sessions as part of their routine
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activities. Execution of this QMP and achieving the Data Quality Objectives (DQOs) will help
ensure that the goals identified in the strategic plan are met. Periodic reviews are conducted to
evaluate goals and resources to determine if adjustments are needed.
10.1 Systematic Project Planning
Projects involving the generation, acquisition, and use of environmental data should be planned
using a systematic process. A systematic planning process such as the one outlined in the
document, Guidance on Systematic Planning using the Data Quality Objectives Process, EPA
QA/G-4, or other comparable process, may be used for MPHDPCD programs or projects. DQOs
are qualitative and quantitative statements of the quality of data needed to support specific
decisions or regulatory actions. The DPC or the AMM is responsible for initiating a systematic
planning process, as appropriate. During the early phases of planning the PCD or the AMM
clearly establishes the intended use of the data needed. The process requires interaction
between the DPC or the AMM and technical staff with significant expertise in the type of
activities planned for the program/project. These Planning activities are conducted to:
• Ensure that data collected are of the type and quality appropriate to their intended use,
and therefore support decision-making, by defining the project goal{s) and objective(s);
• Generate the sampling design to include the type and quantity of data needed, a project
schedule, resource requirements and availability, milestones, and any applicable
requirements (e.g., what, how many, when, where, and how to collect samples);
• Determine what and if any existing data could be used to support decision-making; and
• Optimize the data collection efforts by ongoing evaluation of the program needs, data
collection activities that support these program needs, and technology advancements
available for generating data; and by promoting communication among all involved
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parties before, during and after project completion. This method is used to assess the
effectiveness of the systematic planning process.
If expertise in sampling, statistics, risk assessment (both human health and ecological),
laboratory analytical services, engineering, or other services are not internally available,
external expertise may be sought. Contractors are only utilized when sufficient resources are
available in accordance with Metropolitan Government of Nashville & Davidson County’s
Procurement Policy. The outputs of the systematic planning process are used for the
detailed design of the program/project and preparation of the associated QAPP(s). QAPP
documents shall be developed following the procedures outlined in current EPA guidance. The
QAPP is prepared by the AMM, peer reviewed and compared to the QAPP Requirements
Checklist. Upon concurrence, the QAPP prepared for MPHDPCD’s environmental data collection
operations/programs funded through EPA cooperative agreements, etc., must be approved by
EPA in Region 4.
10.2 Permitting and Compliance Planning
The Director supervises the planning for permit writing and compliance evaluations. Permitting
and Compliance Program staff plan their own work schedules to ensure annual compliance
evaluations of each assigned stationary source are conducted, each new stationary source is
inspected, at least 25% of asbestos projects are inspected, complaints are investigated in a
timely manner, and permits are issued on an annual basis, with the exception of Part 70
Operating Permits (5 years).
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11.0 Implementation of Work Processes
The QAPPs and MPHDPCD policies provide staff members with information and directions for
completing a project or task but do not provide specific directions for completing each work
assignment that is a part of the overall project/task. Consistency in completion of work
assignments is important in meeting QA/QC data requirements. Defining uniform & standard
work processes help achieve data quality goals. A written SOP is required for all monitoring
activities at MPHDPCD including PM2.5, PM10, Ozone, Nitrogen Dioxide, Sulfur Dioxide, Carbon
Monoxide and Data Handling. The development of the SOP is an important activity in the
implementation of work processes. SOPs assure that work is done in a consistent and defined
manner. Moreover, SOPs are revised periodically to reflect that documented work activities are
current with agency practices.
The MPHDPCD QAPP is a data focused plan written and designed to ensure that data collected
or generated to support decisions at the MPHDPCD are scientifically sound. The
implementation of these plans is the responsibility of the AMM and generally involves the AMP
technical staff being advised of all the QA/QC requirements specified in the QAPP. MPHDPCD
ensures that environmental work is performed according to QAPP by the:
• Implementation of a quality assurance program;
• Program and project planning;
• Staff development and training; and
• Ongoing oversight of performance.
The approved QAPP is available on the shared drive for easy access for all members of
MPHDPCD, all members of the Air Monitoring Program staff must read the QAPP and sign the
lab copy to indicate that it has been read and understood.
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The AMM is responsible for assuring that the QAPP is implemented properly. Additionally, the
AMM and the QA Technician are responsible for documenting any significant departures from
the QAPP requirements. The latter may be recorded as part of an internal technical audit which
is conducted quarterly as part of the review of data prior to quarterly upload. In general the
QAPP is reviewed annually, and whenever any changes are made to an existing QAPP, these
changes are approved by the EPA and transmitted to all staff on the QAPP distribution list. Any
new SOPs or modifications to existing SOPs required to correctly document procedures used in
a QAPP are prepared/modified and approved. Current SOPs and guidelines are maintained on
the Department's shared drive.
11.1 SOP maintenance
Work activities are subject to change with purchase of updated equipment, regulatory changes,
analytical methodology changes, new information, etc. The AMM is responsible for ensuring
that periodic updates of SOPs take place. The formal changes are incorporated through the
regular review process.
On a rotating schedule, SOPs are reviewed for applicability and accuracy. If no change is
necessary the AMM will notate the review was completed. When an air monitoring SOP
revision is made, the revision must be first approved by the DPC and then submitted to the
Region 4 EPA SESD for review and final approval.
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11.2 Distribution and Storage
Approved SOPs, approved revisions of SOPs, approved QAPP and revision of said QAPP, and
approved QMPs plus revisions are filed electronically on the secured folder for the AMP on the
shared drive. Previous versions are kept indefinitely, to ensure that a document trail exists for
the data produced by the AMP.
12.0 Assessments and Response Actions
Assessments are intended to provide an objective basis for improving the quality of the system.
Performing timely and appropriate corrective action in response to an assessment will maintain
the integrity of the quality system. An internal quality audit is carried out by the QA Technician
during quarterly routine data validation. This will include such functions as ensuring data
completeness, verification that calibrations are up to date, verification that all precision checks
have been carried out in a timely manner and that all results are reviewed. Documentation in
logbooks is reviewed to ensure it is up to date and complete. Any issues that are found during
this routine data validation are discussed with the AMM and the Field Technician in question to
ensure that a consistent approach to data collection and data validation is in place. In this
scenario the QA Technician is assumed to be independent as they have no function in day to
day collection of data or running/maintaining field equipment. The AMM may act as a back up
to field technicians to run their equipment in cases where they are unable to do so, however in
general, the AMM is also removed from the generation of data and maintenance of equipment
and so can maintain as independent as possible so as to be effective assess the quality of data
being produced and the methods by which is it being collected.
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An assessment and response program designed to monitor conformance to and assess the
effectiveness of the Department's quality system continues to be developed and implemented
as resources allow. Program development information is available in EPA Quality Documents
such as Guidance on Assessing Quality Systems (EPA QA/G-3). An assessment is designed to
provide objective feedback about the quality system. It evaluates and documents the
management policies and procedures that are used to plan, implement, assess, and
correct the technical activities for environmental programs. It may include a quality system
document review, file review, and discussions with managers and staff responsible for
environmental data operations.
Assessments can be conducted for specific MPHDPCD environmental programs or can apply to
the entire Bureau. Some assessments are regularly scheduled (e.g. Internal Audits, Quarterly Air
Monitoring Performance audits) or may be specifically scheduled as the result of a trend noted
during a data validation procedure. Assessments generally follow a prepared checklist. The
assessment results are documented in formal reports and provided to the AMM and the
Director for review. The AMM in general has the responsibility of deciding if a response is
necessary, and what follow-up corrective actions are appropriate. Various assessments may be
used by the Bureau, as appropriate, to assist in determining the status of measurement
systems, the adequacy of the data collection systems, the completeness of data collection
activity documentation, and the abilities of program management to meet mandated data
collection and data quality objectives.
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12.1 Assessments
The environmental monitoring operations covered by this QMP are subject to internal and
external assessments that may include, but are not limited to the following:
• Network reviews
• Technical Systems Audits
• Data Quality Assessments
• Data Quality Audits
The MPHDPCD QMP is reviewed at least once during its five year review cycle. Program QAPPs
are submitted for approval every five years. In addition, the MPDHPCD relies on several tools or
processes to assist with the review of its Quality System.
• The AMM and QA technician conduct periodic evaluations of various quality system
components to ensure continued application and expansion of quality system
principles.
• The AMM conducts ongoing assessment of the quality of work product. Significant
problems with work products trigger a re-evaluation of any associated quality system
tools. In such instances, the DPC does not intend that program areas await scheduled
assessments and corrective actions, but instead recommends the immediate correction
of problems discovered during real time surveillance.
Any EPA Region 4 assessments, such as a program review, serve as a highly-valued critique of
the MPDHPCD's quality system. The EPA Region 4 staff review, provide comments, and
approve Departmental program/project QAPPs.
The AMP does not have a specific established assessment plan in place. This section
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demonstrates that the program has a reliable inventory of assessment tools available for use.
As demonstrated in Table 2, the AMP also has a basic schedule under which assessments are
carried out. The AMP communicates assessment/audit findings during weekly lab meetings and
in some cases through email. Findings are discussed openly as a group to better train and
inform other site operators and maximize cross-training opportunities. Corrective actions are
also discussed as a plan for implementation may involve more than one person.
The table below details the schedule of assessments and audits carried out at the MPDHPCD
and who is tasked with carrying it out:
Table 2 Audit and Assessment Commitments
Assessment Type Assessment Agency Frequency
Technical Systems Audit EPA Region 4 Every 3 Years
Monthly Data Review MPHD monthly
Network Assessment MPHD Every 5 Years
Data Quality Assessment MPHD Quarterly
Data Certification MPHD Annually
Data Qualifiers/Flags Review MPHD Quarterly
Standard Operating Procedures Review
MPHD Annually
QAPP Review MPHD Annually (Revised every 5 years minimum)
Annual Network Plan MPHD Annually
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Assessment Type Assessment Agency Frequency
Annual Site Assessment (40 CFR Part 58, Appendix E
criteria)
MPHD Annually
PM2.5 Performance Evaluation Program (PEP)
EPA-Designated Contractor 5 valid performance audits annually/100% of sites every
6 years
National Performance Audit Program (NPAP)
EPA-Designated Contractor 20% of sites annually/100% of sites every 6 years
Annual Performance Evaluation (Gaseous
Monitors)
Third party Every monitor 1/year
Internal Systems Audit QA Technician Quarterly
Flow Rate Audits (Particulate Monitors)
Third party, MPHD and TDEC Third party: 1/year; MPHD: 1/six months (goal); TDEC:
1/quarter"
12.1.1 Annual Network Plan (ANP) and 5-year Network Assessment
Conformance with network requirements of the Ambient Air Quality Monitoring Network as set
forth in 40 CFR Part 58, Appendices D and E are determined through annual network reviews of
the ambient air quality monitoring system, as required by 40 CFR Section 58.20(d). This review
will be done by the AMM or QA technician and checked by the AMM. The network review is
used to determine if a particular air monitoring network is collecting adequate, representative,
and useful data in pursuit of its air monitoring objectives. The network review may identify
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possible network modifications to enhance the system or correct deficiencies in attaining
network objectives.
Additionally, every 5 years included in the Annual Network Plan, a 5-year assessment is made
on the network’s representativeness and ability to meet monitoring objectives. This 5-year
assessment not only looks at the monitoring network, but also the changes in demographics of
the community served, the financial aspects of maintaining stations, and historical significance
of data sets. The 5-year assessment is not only an important assessment but also a useful
planning tool for evaluating and prioritizing the networks and the objectives.
Upon completion the documents are reviewed internally by the AMM and the DPC. They are
then sent to the State of Tennessee and put on public notice. This usually occurs at the end of
April each year. If comments are received they are documented and addressed. After
comments are addressed, or if no comments the document is sent to the EPA for review and
approval.
12.1.2 Technical Systems Audit
A Technical Systems Audit (TSA) is a thorough and systematic on-site qualitative audit
conducted by US EPA Region 4 staff that have been trained to EPA standards and have no
vested interest in the MPHDPCD AMP. Facilities, equipment, personnel, training procedures,
protocols, and record keeping are examined for conformance with the QAPP. A TSA will be
performed during the early stage of the project to assist in identifying deficiencies and
providing timely corrective actions. The audit team will prepare a written summary of findings
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and present those to the Director. TSAs are performed at least every 3 years or as scheduled by
the USEPA staff.
12.1.3 EPA Field Audits
Performance evaluations are a type of audit in which the quantitative data generated in a
measurement system is obtained and implemented at the federal level. Only qualified and
authorized personnel, who have no vested interest in MPHDPCD Air Monitoring Program
execute performance audits. These audits are the National Performance Audit Program (NPAP)
and Performance Evaluation Program (PEP). They are carried out on the both the PM2.5
network monitors (5 valid audits per year) and the gaseous network monitors (20% of sites
annually/100% of sites every 6 years). The results are reported directly to AQS.
12.1.4 Quality systems Assessments
System assessments (i.e., audits) are typically conducted as part of a corrective action or when
a significant problem is identified or suspected. Program practices and procedures may be
assessed by management through a routine random performance evaluation when the
quarterly data evaluations indicate that certain program objectives are not being met.
Additional information is available in the EPA document Guidance on Assessing Quality Systems
(EPA QA/G-3).
12.2 Response
Responses to the findings of an audit or assessment are anticipated at several levels. The
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AMM has the responsibility to review the assessment findings and take the necessary
corrective action(s) if any deficiencies are found during an audit.
12.2.1 Corrective Actions
Each type of assessment from section 12.1 may result in failures or discrepancies which require
corrective action. Additionally, the regular collection, analysis, quality control checks and report
generating may also find problems requiring corrective action. In each scenario, it is the AMM’s
responsibility to assess the need for corrective action.
For internal assessments, once deemed necessary, the AMM shall delegate the completion of
the corrective action to the appropriate ambient air staff member. The ambient air staff
member shall thoroughly document in the logbooks all action taken and complete a corrective
action form to be given to the QA technician for inclusion in the quality assurance data review
file.
For external assessments, all of the procedures for internal assessments shall be followed, as
well as the AMM preparing a written response to the external assessor including corrective
actions taken, planned, and timeline for completion. Formal corrective actions are documented
and tracked through completion by the QA Technician and AMM. Follow-up review of all
corrective actions should be conducted to confirm that the prescribed action was adequate to
address any deficiencies noted in the audit report. Some corrective actions are initiated and
completed immediately by the AMM. Significant problems with work products trigger re-
evaluation of any associated quality system tools. In such instances, the Department does not
intend that program areas await scheduled assessments and corrective actions, but instead
recommends the immediate correction of problems discovered during real-time surveillance.
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Corrective actions written and presented to MPHDPCD by EPA Region 4 QA Managers (such as
the Technical Systems Audit) are always a priority for the program. The AMM with the oversight
of the DPC will implement the EPA-recommended corrective actions.
12.2.2 Dispute resolution
Any disagreement by staff with respect to a corrective action recommended by the AMM or
EPA Region 4 that cannot be resolved through the chain of command are mediated by the
Director. The Director takes the lead in resolving any resource or policy issues that inhibit
pursuit of corrective action measures by any Department program area. Similarly, the Director
could modify the assessment recommendation.
13.0 Quality Improvements
Previous sections of this document have discussed specific mechanisms for bringing about the
continual improvement of the quality management system. These mechanisms include, but are
not limited to, QA planning, Quality Assessments, employee training, document integrity and
corrective action procedures. This section addresses additional mechanisms for ensuring
continual improvements in the quality management system: Review and revision of the QMP
itself, and communication of QA concerns and recommendations among staff.
Quality system deficiencies shall be prevented wherever possible. Identified deficiencies shall
be documented and corrected in a timely manner as resources allow. Corrective actions should
be verified to ensure timely and effective implementation. Efforts are made to continuously
improve the MPHDPCD's quality system. Systems, documents, and tools described in preceding
sections summarize the approach taken by MPDHPCD to plan, organize, implement, monitor,
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and assess quality systems for environmental programs. All personnel working on
environmental programs are encouraged to identify, plan, implement, and evaluate quality
improvement activities for their areas of responsibility. Examples of communication may
include: coordination meetings, conference calls, email, letters and memos, etc. Personnel
should prevent quality problems wherever possible and report opportunities for improvement
as well as quality problems as they are identified.
13.1 Quality Management Plan Review
To ensure that the quality management system continues to meet the highest scientific and
organization standards, the QMP shall be reviewed and updated on a regular basis. The AMM
shall review the QMP annually and formulate any needed revisions and discuss with the DPC.
The AMM will then review applicable QAPPs and SOPs which could be affected and discuss
findings with the DPC.
Approximately every 5 years, a thorough review of the QMP will occur by the AMM and DPC.
Major changes will be evaluated and approved or denied and the document will be resubmitted
to EPA for review and approval.
13.2 Communication
The DPC and the AMM shall meet on an as needed basis to review and discuss quality
assurance initiatives, training needs, assessments, corrective actions and other relevant issues
to the quality management system. The AMM shall meet regularly with staff to obtain feedback
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on QA and QC issues. Often the DPC attends these meetings, but if not in attendance any
critical information exchanged shall be communicated in writing to the DPC by the AMM.
In addition to the scheduled meetings considered above, all MPHDPCD staff are encouraged to
communicate on QA and QC issues and to express any concerns or recommendations to their
direct supervisors. An ongoing exchange of ideas encourages the timely recognition of areas of
improvement and is the final piece of a healthy quality management system.
13.3 Processes for Continuous Improvement
Internal reviews per schedule in Section 12.1 provide a cycle of continuous improvement.
Ongoing interaction with EPA Region 4 managers, along with annual EPA reporting
requirements and periodic program reviews and audits performed at MPHDPCD by EPA also
enable the Department to continue steady, long-term improvement of its quality system.
Additionally, quality system issues detected during the real-time surveillance further ensures
steady improvement of the Department’s quality system development, implementation,
assessment, and improvement cycle.
13.4 Processes for Preventing Conditions Adverse to Quality
The Department's use of standard procedures/guidelines serve to ensure quality work products
and also help guarantee the effectiveness of existing and new quality system tools. Various
internal and external quality training activities are used by the Department in preventing
conditions adverse to quality.
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13.4.1 Identification of Conditions Adverse to Quality
The chain of command for review and approval serves to detect problems with the quality
system. Any perceived decline in the quality of work products triggers a review of quality
system tools and methodologies. For example, if a work product does not meet established
standards it could be an indicator that management and staff should revisit and perhaps revise
one or more of the written SOPs. The tools to ensure quality work products - the QMP, QAPPs,
and SOPs- are systematically put into place at MPDHPCD as a result of the Department's
commitment to expanding the quality system. Various assessments conducted by the QA
Technician and AMM also keep quality system development on track and help to identify
problems or gaps in the Department's quality system.
13.4.2 Correction of Conditions Adverse to Quality
The Department intends that any quality system problems flagged for review and approval by
the QA Technician, AMM, PCD or by EPA Region 4 audits will be addressed in a timely manner.
Corrective actions should be implemented by the affected program and tracked by the
appropriate staff to ensure the effectiveness of quality system tools (i.e., SOPs and QAPPs) is
addressed within a reasonable time after problems are detected and reported.
13.4.3 Deficiencies and Non-conformance (Informal Corrective Actions)
Significant deficiencies and non-conformances to QAPPs, SOPs, or Department requirements
observed outside of a formal audit or assessment process are reported by Department staff to
the AMM. The AMM reports this to the DPC who has the authority to suspend or stop work
upon detection and identification of an immediate adverse condition affecting quality or health
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and safety. The deficiency or non-conformance should be documented by the AMM who should
inform the Director. A formal Corrective Action Plan (CAP) may be required, and if so, tracked
until closure. Any documentation should be included in the project or program file(s) to ensure
that future individuals involved with the project or activity are able to trace the evolution of
procedural or policy change (including what was done, by whom, and why).
13.4.4 Formal Corrective Actions
When significant deficiencies and non-conformances to QAPPs, SOPs, or Department
requirements are observed during a formal audit or assessment process a corrective action
system should be employed. Corrective actions may be immediate or long term. Immediate
corrective actions form part of normal operating procedures such as to correct data or repair
nonconforming equipment. Long-term corrective actions may be required to eliminate the
cause(s) of nonconformance through training, or development of, or revision to, an SOP. In
either case, the occurrence of the problem, the corrective action employed, and the verification
that the problem has been eliminated should be documented. In the event quality
issues are identified, the quality staff, in consultation with the AMM, determine whether
attainment of acceptable quality requires either immediate or long-term actions, or both.
The Steps comprising a closed-loop corrective action system typically include:
• Define the problem and any programmatic impact;
• Assign the responsibility for investigating the problem;
• Document the means by which corrective action completion is documented and
verified;
• Investigate and determine the cause(s) of the problem;
• Determine a corrective action to eliminate the problem including action(s) needed to
prevent recurrence;
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• Estimate a timetable;
• Assign and accept responsibility for implementing corrective action;
• Establish effectiveness of the corrective action and implement the correction; and,
• Verify that the corrective action has eliminated the problem.
14.0 References
EPA. 2000, as amended/re-issued. Guidance on technical Audits and Related Assessments for
Data Operations (QA/G-7), EPA/600/R-99/080, Office of Environmental Information, United
States Environmental Protection Agency (EPA), Washington, DC.
EPA. 2001, as amended/re-issued. EPA Requirements for Quality Assurance Project Plans
(QA/R-5), EPA/240/B-1/003, Office of Environmental Information, United States Environmental
Protection Agency (EPA), Washington, DC.
EPA. 2001, as amended/re-issued. EPA Requirements for Quality Management Plan (QAIR-2),
EPA/240/B- 01 /002, Office of Environmental Information, United States Environmental
Protection Agency (EPA), Washington, DC.
EPA 2002, as amended/re-issued. Guidance for Quality Assurance Project Plans (QA/G-5),
EPA/240/R- 02/009, Office of Environmental Information, United States Environmental
Protection Agency (EPA), Washington, DC.
EPA 2003, as amended/re-issued. Guidance on Assessing Quality Systems (QA/G-3), EPA/240/R-
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03/002, Office of Environmental Information, United States Environmental Protection Agency
(EPA), Washington, DC.
EPA 2006, as amended/re-issued. Data Quality Assessments: A Reviewers Guide (QA/G-9R),
EPA/240/B- 06/002, Office of Environmental Information, United States Environmental
Protection Agency (EPA), Washington, DC.
EPA 2007, as amended/re-issued. Guidance for Preparing Standard Operating Procedures
(SOPs) (QAIG-6), EPA600/B-07/001, Office of Environmental Information, United States
Environmental Protection Agency (EPA), Washington, DC.
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Appendix A
Acronyms and Abbreviations
AMM – Air Monitoring Manger
AMP – Air Monitoring Program
ANP – Annual Network Plan
APTI – Air Pollution Training Institute
AQS - Air Quality System Database
CFR – Code of Federal Regulations
CO – Carbon Monoxide
DPC – Director of Pollution Control
DQA – Data Quality Assessment
DQO – Data Quality Objective
EE&MS – Environmental Engineering & Measurement Services Inc.
EPA – United States Environmental Protection Agency
HR – Human Resources
ICIS – Integrated Compliance Information System
IML – Intermountain Laboratories
MPHDPCD – Metro Public Health Department, Pollution Control Division
NACAA – National Association of Clean Air Agencies
NOx – Oxides of Nitrogen
O3 - Ozone
IT – Information Technology Department
PCD – Pollution Control Division
PCP – Permitting and Compliance Program
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PM2.5 – particulate matter 2.5 microns
PQAO – Primary Quality Assurance Organization
QA – Quality Assurance
QAPP – Quality Assurance Project Plan
QC – Quality control
QMP – Quality Management Plan
SESARM – Southeastern States Air Resource Managers
SESD – Science and Ecosystem Support Division
SOP – Standard Operating Procedures
SO2 – Sulfur Dioxide
TDEC – Tennessee Department of Environment and Conservation
TSA – Technical Systems Audit
