Quality management plan

              QUALITY MANAGEMENT PLAN







October 1,1999







EQR00-01







ARIZONA DEPARTMENT OF ENVIRONMENTAL QUALITY QUALITY MANAGEMENT PLAN



Approval and Concurrences Agency Approval: Jacqueline E. Schafer, Director Phone: (602) 207-2203 Signature: ___________________________________________ Date:_________________ Concurrences: Charles Matthewson, Acting Deputy Director Phone: (602) 207-2204 Signature: ___________________________________________ Date:_________________ John Timko, Director, Administration Division Phone: (602) 207-4867 Signature: ___________________________________________ Date:_________________ Nancy Wrona, Director, Air Quality Division Phone: (602) 207-2308 Signature: ___________________________________________ Date:_________________ Jean Calhoun, Director, Waste Programs Division Phone: (602) 207-2382 Signature: ___________________________________________ Date:_________________ Karen Smith, Director, Water Quality Division Phone: (602) 207-2306 Signature: ___________________________________________ Date:_________________ David St. John, Director, Northern Regional Office Phone: (520) 773-2718 Signature: ___________________________________________ Date:_________________







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ARIZONA DEPARTMENT OF ENVIRONMENTAL QUALITY QUALITY MANAGEMENT PLAN



Approval and Concurrences (Continued) Matt Matthewson, Director, Southern Regional Office Phone: (520) 628-6883 Signature: ___________________________________________ Date:_________________ Mark Santana, Administrative Counsel Phone: (602) 207-4251 Signature: ___________________________________________ Date:_________________ Tara Roesler, Manager, General & Laboratory Services Phone: 602/207-4719 Signature: ___________________________________________ Date__________________ Kenyon Carlson, Supervisor, ADEQ Quality Assurance/Quality Control Unit Phone: 602/207-4866 Signature: ___________________________________________ Date:__________________ Vance Fong, EPA Region IX Quality Assurance Manager Phone: 415/744-1492 Signature: ___________________________________________ Date:__________________







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EXECUTIVE SUMMARY



The Arizona Department of Environmental Quality (ADEQ) Quality Management Plan (QMP), prepared in accordance with the requirements of the U.S. Environmental Protection Agency (EPA) Order 5360.1, defines the ADEQ Quality Management System. The QMP describes specific quality management practices employed by the Agency for the following types of data generation and monitoring activities: 1. 2. 3. Data generated by field sampling and laboratory analysis; Data generated and used for design, construction and operation of engineered remediation/treatment systems; and, Data acquired from sources outside ADEQ through databases, publications, etc.







The primary goal of the ADEQ Quality Management System is to ensure that all of the agency environmental programs produce results that are of known quality, and that the results are of the type and quality needed and expected for their intended uses. Because environmental data collected by the ADEQ are frequently used for regulatory decision making, that data must be appropriately documented, and scientifically and legally defensible. The ADEQ organization and management principles, as identified in this document, rely on staff empowerment and the encouragement of "quality" performance to attain the goals of this QMP. The ADEQ has empowered its Quality Assurance/Quality Control (QA/QC) Unit to assist in QA assessment and response activities. The ADEQ QA/QC Unit is ultimately responsible for oversight of the ADEQ's Quality Management System, and for preparation and presentation of specialized training to staff within the Agency programs. The QMP specifies the general and program-specific quality systems required by EPA Region IX to implement the principles outlined in the previous paragraphs.







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TABLE OF CONTENTS



APPROVAL AND CONCURRENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i EXECUTIVE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii TABLE OF CONTENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv CHAPTER 1 1.1 1.2 1.3 1.4 1.5 ORGANIZATION AND MANAGEMENT . . . . . . . . . . . . . . . . . . . . . . . 1







QUALITY ASSURANCE (QA) POLICY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 SCOPE OF THE QUALITY MANAGEMENT PLAN (QMP) . . . . . . . . . . . . . . . 5 ORGANIZATIONAL STRUCTURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 ROLES AND RESPONSIBILITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 COMMUNICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13







CHAPTER 2







QUALITY MANAGEMENT SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . 14







2.1 PRINCIPAL COMPONENTS OF THE QUALITY MANAGEMENT SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 2.2 PRINCIPAL TOOLS AND PRACTICES OF THE QUALITY MANAGEMENT SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 2.3 OPTIONAL PRACTICES FOR THE CONTROL OF DATA COLLECTION . . 19







CHAPTER 3 CHAPTER 4







PERSONNEL QUALIFICATIONS AND TRAINING . . . . . . . . . . . . . 21 PROCUREMENT OF ITEMS AND SERVICES . . . . . . . . . . . . . . . . . 23







4.1 CONTRACTS WITH EXTERNAL PARTIES . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 4.2 AGREEMENTS WITH GOVERNMENTAL ENTITIES . . . . . . . . . . . . . . . . . . . 28 4.3 SMALL PURCHASES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 CHAPTER 5 DOCUMENTATION AND RECORDS MANAGEMENT . . . . . . . . . . . . . 30 5.1 DEFINITION OF PUBLIC RECORDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 5.2 MATERIALS EXCLUDED FROM THE DEFINITION OF PUBLIC RECORDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30







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TABLE OF CONTENTS (Continued)



5.3 5.4 5.5 5.6 CONFIDENTIAL DOCUMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ROUTINE QUALITY ASSURANCE AND RECORDS MANAGEMENT . . . . IN-HOUSE QUALITY ASSURANCE GUIDANCE DOCUMENTS . . . . . . . . . MAINTAINING DOCUMENT INTEGRITY . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 31 33 33







CHAPTER 6 6.1 6.2 6.3 6.4 6.5 6.6 6.7







INFORMATION TECHNOLOGY AND DATA MANAGEMENT . . . 34 34 37 38 38 38 39 40







MANAGEMENT PRACTICES FOR ENVIRONMENTAL DATA . . . . . . . . . . INFORMATION MANAGEMENT PLAN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . LEVELS OF DOCUMENTATION FOR ENVIRONMENTAL PROJECTS . . . COMPUTER HARDWARE/SOFTWARE REQUIREMENTS . . . . . . . . . . . . . . SYSTEM DEVELOPMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DATA STANDARDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . INFORMATION SECURITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .







CHAPTER 7 7.1 7.2 7.3 7.4 7.5 7.6 7.7







PLANNING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 41 41 42 44 45 45 45







AGENCYWIDE PLANNING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PROGRAM-SPECIFIC PLANNING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PROJECT-LEVEL PLANNING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ANALYTICAL REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DATA TRANSLATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DATA INTERPRETATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HEALTH AND SAFETY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .







CHAPTER 8







IMPLEMENTATION OF QUALITY WORK PROCESSES . . . . . . . . 47







8.1 AGENCYWIDE IMPLEMENTATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 8.2 PROGRAM LEVEL IMPLEMENTATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 8.3 PROJECT LEVEL IMPLEMENTATION' . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49







CHAPTER 9 9.1 9.2 9.3 9.4







QUALITY ASSESSMENT AND RESPONSE . . . . . . . . . . . . . . . . . . . . 51 51 51 54 54







ANNUAL REVIEW OF THE ADEQ QUALITY MANAGEMENT PLAN . . . . QUALITY AUDITS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PERFORMANCE EVALUATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DATA QUALITY EVALUATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .







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TABLE OF CONTENTS (Continued)



CHAPTER 10 REFERENCES APPENDICES A. B. C. D. E. F. G. H. I. J. K. List of Acronyms Terms and Definitions EPA Order 5360 Public Access to Records Policy (ADEQ) Confidential Records Policy (ADEQ) Information Technology Standards Development Policy (ADEQ) Policy Development and Implementation Policy (ADEQ) Addressing Spike and Surrogate Recovery as They Relate to Matrix Effects in Water, Air, Sludge and Soil Matrices Policy (ADEQ) Analytical Methods Having Provisions for a One-Point Calibration and Continuing Calibration Verification Constraints Policy (ADEQ) Locational Data Policy (ADEQ) Job Skills CONTINUOUS IMPROVEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58







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CHAPTER 1 ORGANIZATION AND MANAGEMENT



1.1 QUALITY ASSURANCE (QA) POLICY 1.1.1 Document Purpose







The Quality Management Plan (QMP) describes the quality management processes the Arizona Department of Environmental Quality (ADEQ) uses to maintain a Quality Management System consistent with the U.S. Environmental Protection Agency (EPA) requirements. The QMP was prepared in accordance with the August 1996 edition of the internal EPA requirements document numbered EPA QA/R-2, and entitled "Requirements for Quality Management Plans," and to comply with EPA Order 5360.1, entitled "Policy and Program Requirements for the Mandatory EPA Quality System." 1.1.2 Definition of Quality Assurance/Quality Control (QA/QC) Quality Assurance (QA) is an integrated system of management activities involving planning, implementation, assessment, reporting and quality improvement to ensure that a process, item, or service is of the type and quality needed and expected by the customer. Quality Control (QC) is the overall system of technical activities that measures the attributes and performance of a process, item or service against defined standards to verify that they meet the stated requirements established by the customer. The QC system includes operational techniques and activities that are used to fulfill requirements for quality. At the ADEQ, the Quality Management System is implemented largely through the following Agency functions: 1. 2. 3. 4. 5. 6. Mandated QA/QC training for certain identified job functions (with ADEQ QA/QC assistance); Mandated use of Agency QA Program Plans (QAPrPs); Mandated use of Agency QA Project Plans (QAPjPs); Clearly defined ADEQ QA/QC Unit oversight responsibilities; Periodic Management Systems Reviews (MSRs) and Technical System Audits (TSAs) performed by the ADEQ QA/QC Unit; and, A QA forum to focus continuous improvement efforts.







Each of these systems is discussed in more detail in the appropriate location within this document. The document officially establishes these requirements as components of the ADEQ Quality Management System. Quality Control (QC) is largely implemented on a project by project basis through the mandated use of Quality Assurance Project Plans (QAPjPs) and required data assessment viii







activities. Designated Agency Project Managers, through a review and approval process involving the ADEQ QA/QC Unit, are individually responsible for assuring that the QAPjP is capable of producing reliable work, of known quality, which meets stated project needs. 1.1.3 Importance of QA/QC to the ADEQ Managers and staff at the Arizona Department of Environmental Quality (ADEQ) make daily decisions which affect the lives and livelihoods of millions of people who reside within the State. The quality of air, land and water as they affect public health and the environment is the focus of our mission. The quality of decisions made by the ADEQ depends heavily on the quality of information used to make those decisions. While other factors such as the law, public opinion, and Court direction also influence our judgment, nothing is more fundamental to our daily decisions than environmental data. If those data are not of adequate quality to support its intended use, then subsequent decisions will suffer commensurately. Environmental data are used for setting priorities; strategic direction; targeting inspections; measuring compliance; identifying enforcement actions; measuring progress and trends; certifying laboratories and for many other uses. Environmental data are frequently critical because they can impact our programs' direction and emphasis, determine whether an enforcement case can be successful, or dictate which of several cleanup options will be implemented at a contaminated waste site. The consequences of "poor" data (that which does not meet the user requirements) are that our individual and collective decisions are not as sound as they could or should be. However, the effects of data can be of extreme significance, such as when an enforcement case has to be withdrawn because our own underlying compliance data are successfully challenged by defendants. The ADEQ is involved in conducting studies that have goals in four broad categories: Identifying the presence of environmental contaminants in areas of potential exposure to humans or the environment; Determining the impacts of environmental contaminants on human health and ecosystems; Determining whether, how, and by whom such threats to human health and the environment should be remediated; and, Monitoring compliance with environmental regulations.







QA/QC is integral to the functions of this State Agency because quality data ensure the scientific credibility of the data on which decisions are based. Proper QA enhances proper planning, reducing the likelihood of duplicative and repetitive sampling, thereby reducing costs to the taxpayers. ix







1.1.4 General Goals and Objectives of the ADEQ The ADEQ's Quality Management System is designed to avoid occasions where the environmental data collected fall short of meeting the data quality objectives (DQOs) established by the users of the data. The primary goal of the ADEQ Quality Management System is to ensure that all environmentally related data collection and processing activities performed by or under the Agency's oversight will result in the production of data that are both documented and of known quality, and can be used with a high degree of certainty by the intended user to support specific decisions or actions. The ADEQ Quality Management System applies to those monitoring and measurement activities supported by EPA through grants, contracts or interagency agreements. The ADEQ Quality Management System will be achieved by ensuring that appropriate resources are made available and that the proper procedures are followed throughout the entire process of planning, collecting, analyzing and interpreting environmental data. The goals of the ADEQ QA System are to: Encourage the use of QA/QC principles in the management of environmental projects; Facilitate the timely identification of problems and implement corrective actions, Identify training needs; Identify and correct systemic weaknesses; and, Provide for continuous improvement in Agency operations. The primary management principles that the ADEQ uses in its QA System are: Empowerment of staff, and Encouragement of good performance. Specifically, it is ADEQ's policy that: 1. All programs generating, using, or requiring the collection of environmental data will follow the requirements outlined in this Quality Management Plan (QMP) and subsequent ADEQ policies and Standard Operating Procedures (SOPs). The objectives for generating any new environmental data will be determined prior to data collection activities so that appropriate resources, and QA/QC control methods can be applied to ensure a level of data quality commensurate with the intended use(s) for the data. A comprehensive QAPrP will be used to detail activities under the regulatory program. Each program or activity that generates environmental data will develop and implement a QA Program Plan (QAPrP) and/or a QA Project Plan (QAPjP) containing SOPs which specify the detailed procedures required to assure production of quality data. The QAPrPs shall be prepared by the Divisions, under the direction of the ADEQ QA/QC Unit, in conjunction with the technical programs. Effective organizational QAPjPs and SOPs shall be developed and implemented as required x







2.







3.







and will be approved as shown in number 5 below. 4. All new environmental data generated by the Agency will be of known and documented quality, as defined by pre-established data quality objectives (DQOs). The process of defining DQOs should be accomplished using a systematic planning process. The DQO planning process should be consistent with EPA's "Guidance for the Data Quality Objective Process," EPA QA/G-4, September 1994, or an equivalent document. The ADEQ QA/QC Unit will be the focal point for interaction between EPA's Regional IX QA Office and the ADEQ. Technical authority for QA matters will be assigned to the ADEQ QA/QC Unit. The QAPjPs developed for sites funded by EPA monies shall be prepared by the originating ADEQ program and reviewed and approved by either EPA or the ADEQ QA/QC Unit prior to the start of any data collection effort. If the ADEQ QA/QC Unit lacks the resources to provide a timely review of a QAPjP, then the originating program has the option to utilize the services of a private contractor or an independent reviewer from another program within the Division. This option is contingent upon EPA's prior written approval. A separate stand alone QAPjP will be developed, as appropriate, for site-specific projects undertaken by the organization utilizing non-EPA resources and shall be reviewed by the ADEQ QA/QC Unit. QAPjPs developed for sites independent of EPA monies shall be submitted initially to the ADEQ QA/QC Unit for review and approval. If the ADEQ QA/QC Unit lacks the resources to provide a timely review, then the originating program has the option to either utilize the services of a qualified contractor or other independent ADEQ staff as deemed appropriate. Shortterm projects and one-time events (e.g. emergency response) do not require QAPjPs as the sampling protocols and objectives are addressed in the program's QAPrP. 6. Regular technical systems audits (TSAs) will be conducted by the ADEQ QA/QC Unit on contractors and ADEQ projects involving environmental data collection to ensure that they comply with the ADEQ Quality Management System requirements. The TSA is a process used to measure the conformance of a measurement system to the criteria defined by the ADEQ. Additionally, the ADEQ Quality Management System may involve periodic management systems reviews (MSRs). Deficiencies highlighted in these assessments will be addressed in a timely manner. The requirements of the QMP may be waived only under exceptional circumstances. Each waiver will be considered by the ADEQ QA/QC Unit on its own merits upon receipt of a written request from the program. The waiver must also be approved by the EPA Region IX Quality Assurance Manager. The waiver request will be addressed to the ADEQ QA/QC Unit and must address the requirement to be waived, the rationale and the consequences of non-approval. When a waiver is xi







5.







7.







granted, the actual procedures for the data management activities will be documented and available for review and assessment during the decision-making associated with the project. 1.1.5 Resources for the QA System







The resources necessary to conduct the various QA and QC activities within the ADEQ are provided by the ADEQ Management and, in some cases, by the program staff who require assistance in order to successfully implement their programs. QA is viewed as an integral part of the programs and activities to which QA applies (i.e., any program which deals with environmental measurements and data generation). This includes all monitoring activities. The level of QA resources needed for any given program or project is determined initially by the relevant program or project manager based upon experience with similar QA efforts. The ADEQ provides in-house and contracted expertise in quality assurance and technical support in several scientific disciplines to all programs within the Agency. These support services include data quality assessments, data validation and evaluation provided by chemists, toxicologists, engineers and others. Personnel to provide these services are located either in the ADEQ itself, or within other State Agencies such as the Arizona Department of Health Services (ADHS). 1.2 SCOPE OF THE QUALITY MANAGEMENT PLAN







The ADEQ QMP is intended to establish the foundation for implementing an effective QA program within ADEQ and cover at a minimum internal and external activities which involve the generation of environmental data for programs funded by EPA. At a minimum, the QMP applies to ADEQ programs, activities, grants, contracts and interagency agreements that generate environmental data which is used to make decisions or support actions related to the Agency's defined mission and responsibilities funded by EPA. Environmental data are defined as information or measurements resulting from field data collection activity, laboratory analyses or models involving the assessment of chemical, physical or biological factors relating to the environment. Therefore, any programs, activities, etc. which generate such data are required to comply with the requirements of this QMP. 1.2.1 Types of Activities Specifically Covered by the ADEQ QMP







There are three types of data generation and monitoring activities covered under this QMP. The three categories are as follows: 1. 2. 3. Data generated by field sampling and laboratory analysis; Data generated and used for design, construction and operation of engineered remediation/treatment systems; and Data acquired from sources outside ADEQ through databases, publications, etc. (ex. data quality indicators are identified and evaluated). xii







Activities that fall under one of these three categories must be implemented in accordance with the QA requirements of EPA Order 5360.1. Health and Safety monitoring data are specifically not included and is not subject to the requirements herein. Whenever these activities are performed directly by the ADEQ or State contractors under the State's supervision, the ADEQ Project Manager, with support from the ADEQ QA Unit, has full responsibility for ensuring that all ADEQ QA requirements are met. When such activities are performed with EPA funds through an external funding mechanism such as Inter-Agency Government Agreements, Grants or Program funds given to the State, the ADEQ Project Manager, with support from the ADEQ QA Unit, is responsible for ensuring that the State complies with all relevant EPA QA requirements. Since ADEQ employs a primarily decentralized approach to quality management, each ADEQ Division is responsible for determining the specific environmental programs and activities to which the ADEQ Quality Management System will apply. However, the following is a sampling of the types of environmental programs, grants and activities within each of the Divisions which may be covered by the ADEQ Quality Management System. AIR QUALITY DIVISION: Air Assessment Section Monitoring Unit Special Projects Unit Evaluation Unit Permits Section New Source Unit Existing Source & General Permit Unit Compliance Section Inspections & Field Services Unit Technical Services Unit WASTE PROGRAMS DIVISION: Waste Programs Capacity Development Section Voluntary Sites Unit Superfund Programs Section Site Assessment Unit Remedial Projects Unit Federal Projects Unit Remedial Investigations Hydrology Unit Hazardous Waste Section Hazardous Waste Inspections and Compliance Unit Emergency Response Unit Underground Storage Tank (UST) and Program Support Section UST Inspections & Compliance Unit Underground Storage Tank Corrective Action Section State Lead Unit Site Investigations and Remediation Units xiii







Enforcement Unit Technical Support Unit Claims Review Unit Solid Waste Section Inspections & Compliance Unit WATER QUALITY DIVISION: Water Permits Section Municipal Wastewater and Recharge Unit Industrial and Storm Water Unit Mining Unit Domestic Wastewater Unit Reuse and Federal Permits Unit Water Quality Compliance Section Drinking Water Compliance, Tracking & Enforcement Unit Water Quality Enforcement Unit Water Quality Data Unit Hydrologic Support & Assessment Section TMDL and Assessment Unit Groundwater Monitoring Unit Surface Water Monitoring and Standards Unit Drinking Water Section Monitoring/Assessment Unit Technical Engineering Unit Water Quality Planning Section Watershed Unit Data Management & Analysis Group NORTHERN REGIONAL OFFICE: Field Services East Field Services West SOUTHERN REGIONAL OFFICE: Field Service Group Border Programs Unit Superfund Program Unit Water Systems Unit 1.2.2 Data Generated by Field Sampling and Laboratory Analysis







Some examples of activities covered under the ADEQ QMP are the generation of environmental data, including field work for the purposes of collecting samples for chemical, physical or biological analyses; the collection of in situ measurements; field work for site characterization and remediation; and, compliance inspections. Environmental media samples for chemical, physical or biological analyses are commonly xiv







collected by, or for, the ADEQ and analyzed to accomplish the following goals: Confirmation of the presence or absence of pollutants or contaminants; Determination of contaminant concentration levels of various sample components; Determination of the sources of contamination; Delineation of the horizontal and vertical distribution; Evaluation of the rate and direction of transport; Determination of the eventual fate of the identified pollutants; Determination of the effectiveness of treatment; and, Establishment of time trends, monitor changes, evaluate progress, and to evaluate compliance with environmental laws and regulations. The above sampling activities may be conducted for site characterization, for ongoing monitoring programs, or during remediation and removal activities. Any data collected for the State may also be potentially used as an input for risk screening and/or assessment calculations incorporating exposure to humans, wildlife and the environment. Data collection activities conducted for the ADEQ must be adequately addressed in a Quality Assurance Project Plan (QAPjP), which most likely will include a project specific Sampling and Analysis Plan (SAP). Activities covered under this category include collecting media samples in the field, observing and recording field observations, performing analyses in the field and in field (mobile) laboratories, and analyzing samples in fixed laboratory settings. Examples of media include solid or liquid waste, fluid discharges or emissions, groundwater, surface water, soil, sediment, air, and biota. Measurements include physical measurements and observations made in the field such as flow rates, water levels, particle sizes, geological matrices, etc. Biological monitoring and sampling activities such as habitat evaluation, species identification and diversity assessments are also covered under this category. Portable equipment can be used to make field chemical determinations of such parameters as pH, temperature and specific conductance. The QAPjPs shall describe methods of collection, methods of analyses, methods of transportation, and methods of documentation for each of these activities. 1.2.3 Technical Activities Not Covered by the ADEQ QMP







Two types of data collection activities that are generally not covered by the QMP are indicated and clarified below: 1. Data collected only for safety or workplace regulations are not covered in the QMP. However, if the same data are used to identify hot spots for subsequent investigation, the collection is covered by the QMP. Collection of employee medical monitoring data are generally not covered under the QMP. However, if that data are used to determine risk factors related to work exposure, it would generally be covered. xv







2.







1.3







ADEQ ORGANIZATIONAL STRUCTURE







The ADEQ employs a decentralized approach to QA management, whereby each Division and Regional Office is responsible for deciding how they will specifically implement the general policies and procedures of this QMP. The ADEQ Director has delegated day-to-day responsibility for overseeing the Quality Management System to the ADEQ QA/QC Unit. The Leadership Team is that group of ADEQ Management assembled and under the direction of the ADEQ Director. The Leadership Team consists of the following members: ADEQ Director; Deputy Director; Waste, Water, Air and Administrative Directors; Northern and Southern Regional Managers; Communications Officer; ADEQ Administrative Council and the Manager of General and Laboratory Services. Currently, the ADEQ QA/QC Unit is managed by a QA/QC Program Supervisor and staffed with two QA Program Specialists and a half-time Administrative Assistant. The QA/QC Program Supervisor has direct access and reporting authority to the General and Laboratory Services Section Manager. The General and Laboratory Services Manager has direct access and reporting authority to the ADEQ Director. The QA/QC Unit maintains an independence in both location and function from any offices or programs which generate environmental data. The ADEQ is composed of three major program Divisions (Air, Waste and Water) that generate environmental data as well as an Administration Division. The ADEQ QA/QC Unit provides support to each of the three ADEQ Divisions that generate environmental data and functions as the Agency technical QA expert and assists with a variety of QA functions. 1.4 ROLES AND RESPONSIBILITIES







Anyone in the ADEQ who is either directly or indirectly involved with environmental data collection or laboratory analyses has some responsibility for ensuring data quality. This may include staff level personnel, program supervisors, unit managers, section managers, deputy division directors, division directors, the deputy director and the ADEQ Director. The following is an overview of the QA responsibilities of some of the ADEQ Agency personnel: 1.4.1 ADEQ QA/QC Program Supervisor Authority







The ADEQ QA/QC Program Supervisor has the authority and responsibility for managing the QA activities within the ADEQ Quality Management System. The ADEQ QA/QC Unit may recommend suspension of environmental data collection projects and request corrective action in the event that data quality/environmental technology QA activities do not meet the Agency QA policy or requirements. If the ADEQ QA/QC Program Supervisor and Project Manager are unable to resolve the QA issues at the staff level, those concerns shall be elevated to the appropriate ADEQ upper-management. There shall be a seven day period in which management must respond in writing to the ADEQ QA/QC Unit informing the QA/QC Unit of the program's xvi







final decision. The ADEQ QA/QC Unit is specifically responsible for ensuring that: All internal and external projects involving the generation of environmental data are performed in accordance with the ADEQ QMP and an approved QAPjP; Adequate procedures required to implement QA management requirements are identified and provided; Laboratory audits are performed and analytical data are validated as necessary; Formal reviews and assessments of QA and QC activities are conducted and reports on such assessments are prepared and forwarded to Section Managers. The ADEQ QA/QC Unit will make recommendations for appropriate corrective action as indicated by audit findings; Technical assistance to ADEQ programs and contractors is provided and EPA guidance documents, policies and procedures are distributed as appropriate; ADEQ training needs are assessed. The ADEQ QA/QC Unit shall arrange, develop and/or present training courses on QA topics; and, An adequate degree of auditing by the ADEQ QA/QC Unit [ i.e., management system reviews (MSR) and technical system audits (TSAs) ] is performed to assess compliance with the ADEQ QA requirements for monitoring and evaluating overall project implementation. # 1.4.2 The QAPjPs specifically address the technical adequacy of DQOs. Line Management and Staff Authority 1.4.2.1 ADEQ Director: The ADEQ Director has overall responsibility for the ADEQ QA Program as outlined in EPA Order 5360.1. More specifically, the ADEQ Director is responsible for ensuring that QA is an identifiable activity having adequate resources allocated for the accomplishment of the mission goals for the ADEQ centralized programs as well as its satellite (Northern and Southern) regional offices. These goals include providing the resources for the collection of the right type, quantity and quality of data for all in-house and external projects. 1.4.2.2 ADEQ Division Directors: The Division Directors have the overall responsibility for managing the QA Program within their organization in accordance with the ADEQ QMP. The Directors are specifically responsible for ensuring that adequate resources are provided to support the ADEQ xvii







QA program responsibilities. 1.4.2.3 ADEQ Section Managers: Section Managers must ensure that: To the extent required, a Project Manager is designated to coordinate and assist the ADEQ QA/QC Unit to ensure implementation of the ADEQ Quality Management System when environmental measurements are to occur. This coordination may also occur through the designated program staff with the QA/QC Unit. All ADEQ environmental data collection activities involve appropriate planning and documentation regarding data quality objectives (DQOs), quality assurance program plans (QAPrPs), and standard operating procedures (SOPs); ADEQ site-specific QAPjPs are written by program personnel, contractors or responsible parties and are approved by the ADEQ QA/QC Unit, or by the ADEQ program if authorized by EPA, to ensure effective implementation for all those projects which generate environmental data; Deficiencies identified in audits are corrected expeditiously; and, Program-specific QA-related training needs are identified. Section Managers may delegate some or all of these tasks to Unit Managers. 1.4.2.4 ADEQ Project Managers: Project Managers may be assigned the responsibility for specific projects supported through contracts, grants or interagency agreements (IGSs). The ADEQ QA requirements shall be followed for those internal activities and external oversight projects which generate environmentally related data. In addition to the ADEQ QMP, the relevant QA requirements for external projects are specified in 40 CFR 30 and 31, and 40 CFR 15. The ADEQ Project Manager has the principal responsibility for ensuring that the project data quality objectives are met. Paramount among those requirements are that an approved Quality Assurance Project Plan (QAPjP) is established prior to initiating any data collection efforts. ADEQ Project Managers must ensure: That at a minimum, all EPA funded projects performed either internally or through external contracts must be brought to the attention of the ADEQ QA/QC Unit and that QAPjPs are approved prior to data environmental collection activities as specified in section 1.1.4.5; xviii







That Data Quality Objectives (DQOs), specification, and acceptance criteria for the projects have been prepared by the program and approved prior to data collection activities as specified in section 1.1.4.5; Their availability to participate in conducting QA system/performance audits of projects as necessary with the ADEQ QA/QC Unit; That appropriate corrective action is taken if indicated in the audit findings; and, That unresolved data quality problems are reported to the ADEQ QA/QC Unit and designated program staff.







1.5







COMMUNICATIONS







To be effectively implemented, the QMP must not only be approved, circulated and regularly updated, but understood by those responsible for its implementation. Two means will be used to ensure that this occurs. The ADEQ QA/QC Program Supervisor will keep Division and Agency Management apprised of QA issues as new information, policies, or other QA procedures develop. The ADEQ QA/QC Unit will also provide training on an on-going basis in order to ensure that personnel responsible for QA functions understand QA requirements and practices related to their responsibilities.







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CHAPTER 2



2.1







QUALITY MANAGEMENT SYSTEM







PRINCIPAL COMPONENTS OF THE QUALITY MANAGEMENT SYSTEM







The Quality Management System consists of staff, defined functions, tools and quality assurance (QA) procedures which are used to ensure that appropriate quality of environmental data are generated for the needs of ADEQ users and decision makers. The ADEQ QA/QC Unit has suggested the following twelve essential elements which comprise an effective QA System: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. A statement of the ADEQ QA Goals and Policy (identified in the ADEQ QMP); Adhering to applicable ADEQ QA requirements and criteria (EPA Orders, regulations and guidelines); Defining the ADEQ QA organizational structure; Describing ADEQ programs and activities covered by the QA requirements; Outlining the roles and responsibilities of those involved with ADEQ QA functions; Utilizing QA tools and procedures; Identifying resource allocations; Establishing a communications process (internal and external); Affording QA training opportunities; Dictating documentation and record keeping requirements; Implementing review and evaluation procedures to ensure continuous improvement; and, Defining of key QA terminology.







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2.2







PRINCIPAL TOOLS OF THE QUALITY MANAGEMENT SYSTEM







The successful implementation of the ADEQ Quality Management Program requires a consistent and graded approach for QA practices commensurate with the intended uses of the data and degree of confidence needed in the results. The ADEQ QMP requires that a variety of tools and procedures be utilized for planning, implementing and evaluating the Quality Management System. ADEQ Managers and staff members will be informed of the availability and use of these tools through the ADEQ QA/QC Unit training. The primary QA planning and implementation tools include a Quality Management Plan (QMP), establishment of Data Quality Objectives (DQOs), Quality Assurance Program Plans (QAPrPs), Quality Assurance Project Plans (QAPjPs), Standard Operating Procedures (SOPs) and Sampling and Assessment Plans (SAPs) or Field Sampling Plans (FSPs). Most of these tools are currently employed directly by the ADEQ program staff, with technical assistance as necessary from the ADEQ QA/QC Unit. The primary QA evaluation and assessment tools comprising the ADEQ Quality Management System include Management System Reviews (MSRs), Technical System Audits (TSAs), Performance Evaluation (PE) Studies, and Data Quality Assessments (DQAs). Most of these are either arranged and/or performed by the ADEQ QA/QC Unit. All environmental data collection activities conducted by, or on behalf of EPA Region IX, must be addressed in a Quality Assurance Project Plan (QAPjP). All QAPjP's must be developed as specified in EPA QA/R-5, EPA Requirements for Quality Assurance Project Plans for Environmental Data Operations. The ADEQ requires that all twenty-four elements be addressed appropriately before the ADEQ QA/QC Unit may approve a QAPjP. These elements consist of the following: Group A: A1 A2 A3 A4 A5 A6 A7 A8 A9 Group B B1 B2 B3 B4 B5 Project Management Title and Approval Sheet Table of Contents Distribution List Project/Task Organization Problem Definition/Background Project/Task Description Quality Objectives and Criteria for Measurement Data Special Training Requirements/Certification Documentation and Records Measurement/Data Acquisition Sampling Process Design Sampling Methods Requirements Sample Handling and Custody Requirements Analytical Methods Requirements Quality Control Requirements xxi







B6 B7 B8 B9 B10 Group C C1 C2 Group D D1 D2 D3







Instrument/Equipment Testing, Inspection, and Maintenance Requirements Instrument Calibration and Frequency Inspection/Acceptance Requirements for Supplies and Consumables Data Acquisition Requirements Data Management Assessment/Oversight Assessments and Response Actions Reports to Management Data Validation and Usability Data Review, Validation and Verification Requirements Validation and Verification Requirements Reconciliation with User Requirements







These elements explicitly require the development of Data Quality Objectives (DQOs) for each planned data collection activity and also require that data assessments be conducted to evaluate the validity of the results. Every field investigation should be constructed in accordance with an approved ADEQ QAPjP to ensure that DQOs will be met. ADHS State statutes require that all laboratories generating analytical data for submission to the ADEQ for regulatory purposes must be licensed by the ADHS Office of Laboratory Licensure. 2.2.1 Quality Management Plan (QMP)







The ADEQ QMP describes the policies, procedures and systems governing Agency data collection activities. It serves as the "umbrella" document for all QA operations. Future revisions and updates to this QMP will be prepared by the ADEQ QA/QC Program Supervisor. The proposed revisions will be submitted to the ADEQ Leadership Team for comment within 10 working days. The ADEQ QA/QC Program Supervisor will forward the revised QMP, and applicable comments, to the Director for adoption within 15 working days. 2.2.2 Data Quality Objectives Process (DQO)







The ADEQ is committed to sound science and thus, the generation of environmental data that are technically and legally defensible, and of adequate quality and quantity to support regulatory decisions. The Data Quality Objectives (DQO) process is used in the planning phase of all Agency data collection activities. The "Guidance for the Data Quality Objectives Process," EPA QA/G-4 is used, as appropriate, for the development of DQOs by the Agency. DQOs are a required element of any Quality Assurance Project Plan (QAPjP) submitted to the ADEQ QA/QC Unit for review and approval. This requirement is applicable to all parties that generate environmental data for use by the ADEQ.







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Each program within the ADEQ is responsible for establishing DQOs for projects where ADEQ takes the lead role in gathering environmental data or for those projects where ADEQ provides oversight. The ADEQ QA/QC Unit will provide technical assistance as warranted in determining the appropriateness of the DQO process relative to the intended use of the data. The development of data quality objectives (DQOs) is outlined in QA/R-5. For many projects, DQOs may be a simple statement of why data are being collected and what data outputs will be considered significant. For other projects, the complete statistical hypothesis testing approach as described in Agency Guidance QA/G-4, "Guidance for the Data Quality Objectives Process," may be appropriate. The ADEQ QA/QC Unit must assure that the QAPjP specifically addresses the technical adequacy of DQOs. Compliance with QA/G-4 is highly recommended but is not mandatory. Data Quality Objectives are intended to accomplish the following Clarify the project objectives; Define the most appropriate types of data to collect; Determine the most appropriate conditions under which to collect the data; and, Specify the level of uncertainty that is acceptable as the basis for establishing the quantity and quality of data needed. 2.2.3 Quality Assurance Project Plans (QAPjP)







The QAPjP dictates the policies and procedures; project organization and objectives; and, QA requirements and quality control activities designed to achieve the desired type and quality of environmental data necessary to support the project objectives. In the ADEQ, for regulatory purposes, and those activities funded by EPA, no collection or analyses for long-term or large scale projects will occur without the approval of a supporting QAPjP. Short-term projects and one-time events (e.g. emergency response) do not require QAPjPs as the sampling protocols and objectives are addressed in the program's QAPrP. Additionally, all contractors for the ADEQ must meet the quality assurance and program requirements established by the ADEQ QMP. 2.2.4 Quality Assurance (QA) Status Reports







Each QAPjP for environmental data collection must include a section discussing the frequency, content, and format of the required QA status report(s). These factors will be determined by the relevant ADEQ Program Project Manager or designated program staff and the ADEQ QA/QC Unit. Any status reports will be submitted by the ADEQ Project Manager to the ADEQ QA/QC Unit and will be used to help track the project's progress. Each status report must address, as a minimum, the following elements: Status of the project; Changes that occurred in project activities (sampling, QC control measures, analytical methods); Results of performance and system audits as they apply; xxiii







Any corrective actions taken; Any project organizational changes; and, Results of the assessment of data quality indicators (precision, accuracy, completeness, representativeness and comparability). 2.2.5 Standard Operating Procedures (SOP)







The use of standard operating procedures (SOPs) in the ADEQ serves as one mechanism to ensure comparability across programs and individual environmental data collection projects. SOPs must be incorporated either in full or by reference in the QAPjPs. SOPs developed by the ADEQ must be peer reviewed and receive approval by the ADEQ QA/QC Unit as appropriate. 2.2.6 Technical Systems Audit (TSA)







All ADEQ programs that employ environmental sample collection and analyses are subject to a TSA. The TSA involves a thorough review of the field equipment; sampling and analyses procedures; documentation; data validation; and, training procedures for collecting or processing environmental data. TSAs may be routinely planned by the ADEQ QA/QC Unit, specifically requested by the ADEQ Project Manager, or result from the findings of another audit or review. The ADEQ QA/QC Unit Program Supervisor is responsible for assembling the audit team. Results will be reported to the audited organization in the form of a written report within 14 calendar days of the completion of the audit or a mutually agreed upon alternative. Written comments by the ADEQ Project Manager must be supplied to the ADEQ QA/QC Unit within 14 calendar days of receipt of the audit findings or a mutually agreed upon alternative. Copies of the TSA Audit Final Report will be stored in the project file and also with the ADEQ QA/QC Unit. Additional copies will be distributed as appropriate. 2.2.7 Management System Reviews (MSR)







Management System Reviews (MSRs) will be performed periodically within the ADEQ for all programs. The MSR will qualitatively assess a program's data collection procedures to determine if the ADEQ Quality Management System is adequate to ensure the quality of the program's data. The ADEQ QA/QC Program Supervisor is responsible for assembling the audit team and coordination of the audit activities. Guidance for performing MSRs is contained in EPA Guidance Document QA/G-3. All MSRs will result in the production of a written report. A draft of this report is due within 30 days of the completion of the observation phase of the audit. The draft will be sent for comments to the program's senior management. Comments must be supplied by the program's senior management within 30 days of the receipt of the draft. Final reports are to be completed within 30 days of receipt of comments by the program's senior management 2.3 OPTIONAL PRACTICES FOR THE CONTROL OF DATA COLLECTION xxiv







ACTIVITIES 2.3.1 Field Audits







These are "real-time" observation, review and critical appraisal of field sampling activities. Field audits consist of an on-site visit to the sampling location; observation of sampling practices; review of project records and sampling SOPs; and, documentation of findings. The primary intention of such audits is to ascertain whether QAPjP specified practices are being followed. When sampling is being performed by ADEQ personnel or ADEQ contractors, the lead auditor must be an ADEQ employee. In these circumstances, audits may be requested through the ADEQ QA/QC Unit, and are performed by non-project personnel to avoid the appearance of bias. All field auditing activities will result in the production of a written report. A draft of this report is due within 7 days of the completion of the observation phase of the audit. The drafts will be sent for comments to the ADEQ Project Manager responsible for the activity observed prior to completion of the report. Written comments by the ADEQ Project Manager must be supplied to the ADEQ QA/QC Unit within 7 days of the receipt of the draft. Final reports generated by the ADEQ QA/QC Unit are to be completed within 30 days of receipt of comments from the ADEQ Project Manager. Copies of the Final Report will be stored in the Project file and also with the ADEQ QA/QC Unit. Additional copies will be distributed as appropriate. 2.3.2 Laboratory Audits







These are audits of laboratory operations. Such audits may be "real-time" (i.e. performed while project samples are under analysis, or performed after analysis is completed). Laboratory audits will consist of an on-site visit to the laboratory; observation of analytical practices when possible; review of project records and laboratory SOPs; and, documentation of findings. A laboratory audit is conducted to determine and document whether laboratory practices and analytical procedures used are consistent with QAPjP requirements and laboratory tasking instructions. When analyses are being performed by ADEQ contractors, the lead auditor must be an ADEQ employee. In these circumstances, audits may be requested through the ADEQ QA/QC Unit, and are performed by non-project personnel to avoid the appearance of bias. All laboratory auditing activities will result in the production of a written report. A draft of this report is due within 7 calendar days of the completion of the observation phase of the audit or a mutually agreed upon alternative. The draft will be sent for comments to the ADEQ Project Manager responsible for the activity observed prior to completion of the report. Written comments must be supplied by the ADEQ Project Manager to the ADEQ QA/QC Unit within 7 calendar days of the receipt of the draft or a mutually agreed upon alternative. Final reports generated by the ADEQ QA/QC Unit are to be completed within 30 calendar days of receipt of comments by the ADEQ Project Manager or a mutually agreed upon alternative. Copies of the xxv







Final Report will be stored in the Projects file and also with the ADEQ QA/QC Unit. Additional copies will be distributed as appropriate.







xxvi







CHAPTER 3







PERSONNEL QUALIFICATIONS AND TRAINING







3.1







POLICY FOR QUALITY ASSURANCE (QA) RELATED TRAINING







The purpose of this Chapter is to explain the processes used by ADEQ to ensure that staff and managers working in various environmental programs are trained and qualified to perform their required QA responsibilities. This includes project managers, field personnel, ADEQ QA/QC staff, data processors and the individuals who supervise these personnel. 3.1.1 Responsibilities







The ADEQ Program Unit Managers are responsible for ensuring that each staff member involved with collecting or analyzing environmental data has the necessary technical, quality assurance and project management training required for their assigned tasks and functions. Section Managers are also responsible for ensuring that technical staff maintain the necessary level of proficiency to effectively meet the ADEQ QA responsibilities. The ADEQ QA/QC Unit will provide QA training on a semi-annual basis to update program staff with developing QA issues. Maintaining staff proficiency in critical technical disciplines (e.g., environmental engineers, geologists, hydrologists, hydrogeologists, chemists and microbiologists) is the joint responsibility of the individuals filling those positions and the program manager and/or supervisor. 3.1.2 Identification of Training Needs







Generally, QA-related training needs are assessed by first identifying which personnel within each program have QA-related responsibilities, what specific types of QA functions they perform, and at what frequency. These estimates are generally performed by the program's Unit or Section Manager. The program Unit or Section Managers convey the specific QA training needs to the ADEQ QA/QC Unit. The ADEQ QA/QC Unit will develop an appropriate training program as a response to the training request. 3.1.3 Implementation of Training Requirements







ADEQ staff are encouraged by supervisors to draw upon their educational background, experience, technical training, and on-the-job training to enhance their understanding and performance of QA-related procedures.







The ADEQ QA/QC Unit will offer, or arrange for through a third-party vendor, the following four courses on a schedule and frequency suited to meet the needs of the ADEQ staff with QA responsibilities:







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12. 13. 14. 15.







An Orientation to Quality Assurance Management Establishing Data Quality Objectives Preparing Quality Assurance Project Plans How to Perform a Preliminary Data Review







Based upon ADEQ training requirements, no less than three of the four courses will be offered during the year and will be open to anyone responsible for QA functions. The ADEQ QA/QC Unit will also schedule impromptu QA training designed to address the specific QA needs of program staff. ADEQ Program staff responsible for QA functions are expected to take, or have taken, all of the above courses within two years from their employ. In addition, they are encouraged to attend meetings and seminars, and to take formal training, in accordance with the ADEQ training policy, to enhance their understanding of program specific QA requirements within the programs they work. 3.1.4 Documentation of Training







The ADEQ Training Unit will maintain a record of all QA training taken by staff and managers responsible for environmental data generation. The ADEQ Management Team will provide resources for QA training for ADEQ program staff. This training will be provided, through internal training and/or external sources, to staff at all levels to ensure that QA requirements and responsibilities are understood and implemented at all stages of projects. Some of the training required to support the ADEQ Quality Management System program will come from EPA.







xxviii







CHAPTER 4







PROCUREMENT OF ITEMS AND SERVICES







It is ADEQ policy that all activities involving ADEQ external oversight agreements and procurements for items and services be handled in the following manner: Procurement of Items- The ADEQ Programs are required to define the quality of performance specification required of instruments and reagents. Although the ADEQ QA Unit is not generally involved in defining the performance objectives, the QA Unit will be consulted and provide input as appropriate. Procurement of Services- Prior to the employment of outside contractor services to Agency programs arranged by the ADEQ Procurement Section, the ADEQ QA Unit will evaluate the prospective contractor to ensure said contractor has demonstrated a QA system and has a QA plan in place. The ADEQ QA Unit will define or evaluate QA systems and plans on a case-by-case basis. For example, the QA system in place may consist of Quality Assurance Program Plans (QAPrPs), Quality Assurance Project Plans (QAPjPs), SOPs, various types of audit procedures or a QA Officer. In general, a Quality Management Plan (QMP) or its equivalent must be reviewed and approved by the ADEQ QA/QC Unit before the formal execution of any agreement or related action. As applicable, the contractors and subcontractors must also submit a Quality Assurance Project Plan (QAPjP) for the ADEQ QA/QC Unit's review and approval before any environmental measurements or data collection activities can be performed. Procurement activities may range from general and scientific supplies to highly sophisticated scientific instrumentation and services which directly affect the quality of environmental measurements. The procurement process is also governed by State statutes and rules, and depending on the circumstances of the procurement, may involve the approval of other agencies within the State. Within ADEQ, identified equipment needs are submitted to management who prioritize, rank and approve items for proposed procurement. This process allows ADEQ to identify particular equipment needs relative to other needs in order to facilitate quality in measurement processes. Specific monitoring, sampling and analytical equipment are procured only after quality requirements have been discussed between procurement officials, the ADEQ QA/QC Unit and program personnel. 4.1 CONTRACTS WITH EXTERNAL PARTIES







The ADEQ conducts and oversees assessment (site characterization), remedial, and removal activities at solid and hazardous waste sites in Arizona. For some of these activities, the ADEQ may contract directly for environmentally related measurements or data generation. Under a program mandated by Arizona Revised Statutes 49-360, ADEQ contracts with contractors to take samples and perform necessary analyses for approximately 900 small drinking water systems xxix







within the State of Arizona. Other areas where contractors and subcontractors are utilized include: ambient surface water analyses for both chemical and microbiological indices, air quality analyses, etc. 4.1.1 The ADEQ/State of Arizona Procurement Process







The ADEQ public procurement process is guided by the Arizona Procurement Code (Arizona Revised Statutes 41-2501 et seq., and administrative rules and regulations A.A.C. R2-7101 et seq.). This procurement code has modeled itself on the "Model Procurement Code" as provided by the American Bar Association. The formal solicitation process at ADEQ and at the State Procurement Office, for statewide solicitations over $25,000, is generally as follows: Pre-Solicitation Phase: A need is identified by a customer and an initial meeting with Procurement is scheduled. A request is made for a vendor bid list from the State Procurement Office. Procurement personnel are required to use this bid list for all procurements over $25,000. In addition to the bid list, the solicitation is advertised. Letters of Intent are mailed to vendors who are on the Bid List. This letter of intent contains a brief description of the solicitation and other appropriate information. The Scope of Work is completed by the customer with input from Procurement as needed and incorporated into a Solicitation Package. Solicitation Phase: Evaluation committee members are selected/assigned. The make-up of this committee is comprised of the ADEQ customer(s), other state personnel with knowledge of the services and or products to be procured and if possible at least one individual from outside the Agency. An ADEQ Contract Officer chairs the meeting and may or may not be an evaluator. An evaluation planning meeting is scheduled. Evaluation committees come to consensus on all decisions regarding evaluation. This meeting involves discussing the method of scoring the relative importance of each evaluation factor and other related topics. The solicitation is mailed to vendors who have requested it. The solicitation states that any questions shall be forwarded to Procurement by a specific date and time. A meeting with the customer is set up to discuss the questions and answers. If a pre-proposal conference is scheduled, these questions and answers along with any other questions brought up at this meeting are discussed. Vendors are informed that the only official change to the solicitation will be forwarded in the form of an amendment and that they shall not rely on verbal changes/answers. If required, an amendment is forwarded to all vendors who requested the solicitation. Proposals are formally opened (with at least two procurement personnel in attendance) at the date and time stated in the solicitation. Late proposals are not allowed. Pre-Award/Award Phase:







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Procurement reviews the offers for compliance with requested information. At the first evaluation meeting, the proposals are distributed and evaluation committee assignments are assigned as appropriate. The members are given guidance regarding what to look for, how to score etc. Committee members are informed that they need to thoroughly evaluate all proposals and a second meeting is scheduled to discuss the proposals in detail. At the next evaluation committee meeting, the committee discuss their comments, scores and rankings of the offerors. A consensus regarding these comments and scores is reached. If appropriate, a Short List of the vendors who are most susceptible for award are selected. Discussions are held with these short listed offerors and the committee. These discussions may be written or oral. The evaluation committee discuss the answers and they may or may not change an offeror's score. When the committee is satisfied that all questions are answered or clarified, discussions are ended and Best and Final Offer (BAFO) requests are sent to these vendors. The evaluation committee reviews and approves the BAFO. The Procurement Officer writes up all appropriate documents and awards the contract. Post-Award Phase: For blanket requirements contracts, the ADEQ Procurement Office issues Task Assignments to the appropriate Contractor. These Task Assignments are issued upon receipt of individual project assignments developed by an ADEQ Project Manager and approved by the ADEQ QA/QC Unit. In the event that the contractor does not perform in accordance with the contract, the state has several clauses to attempt to get the contractor to perform such as: 1) "Right to Assurance" clause where procurement may demand in writing that the contractor give a written assurance of intent to perform. 2) "Termination for Convenience" 3) "Termination for Default" and 4) "Right of Offset" which allows the state to collect monies due to a contractor's failure to perform or due to non-conforming performance. 4.1.2 The Role of the ADEQ QA/QC Unit in the Procurement Process







Where contracts and related actions involve the collection of environmental data, the ADEQ QA/QC Unit and designated program staff shall be involved in the procurement process as follows: # Pre-Solicitation Phase: The ADEQ QA/QC Unit and designated program staff shall review statements of work and resources and provide language regarding QA tasks where appropriate and required. The ADEQ QA/QC Unit and designated program staff will provide information that incorporates, as needed, QA activities into the evaluation of sample work assignments, Quality Management Plan, and Quality Assurance Project Plans. The ADEQ QA/QC Unit also ensures that any laboratory solicitations adhere to the statutory requirement that all environmental laboratories performing compliance testing be licensed by the ADHS Office of Laboratory Licensure. Pre-Award/Award Phase: The ADEQ QA/QC Unit shall serve on the evaluation committee for formal solicitations of laboratory services to evaluate the proposals xxxi







in general and to specifically evaluate and comment on specified QA submissions. Post-Award Phase (Task Assignments): The ADEQ QA/QC Unit and designated program staff assist in monitoring task assignments which require Quality Assurance Project Plans and monitors QA activities. All task assignments related to the collection of environmental data shall be consistent with the program data quality objectives (DQOs). 4.1.3 The Role of the ADEQ Project Managers in the Procurement Process







The responsibility for monitoring contract performance within the ADEQ's Quality Management System includes, at a minimum, the following: 1. 2. The ADEQ Program assigns a Project Manager. The Project Manager or designee develops the project's Scope of Work. Project Manager edits if appropriate and forwards to the ADEQ QA/QC Unit for final review. After award of a task assignment by the ADEQ Procurement Office, the Project Manager determines the relevancy of a post award meeting with the contractor. All deliverables shall be sent by the contractor to the Project Manager to review, and approve/disapprove deliverables. If the deliverables are disapproved by either the Project Manager, designee, or the ADEQ QA/QC Unit, the disapproving authority shall contact the contractor and request clarification or a change in the deliverable in keeping with the contract. Assuming that the contractor has made good on its contractual obligations to the satisfaction of ADEQ, an invoice is generally issued to the Project Manager or designee who authorizes the payment of the invoice.







3. 4.







5.







6.







If the contractor refuses or is unable to fulfill their contractual obligations to the ADEQ, the Project Manager or designee contacts the ADEQ Contract Officer who then either initiates actions to compel the contractor to perform or takes steps to terminate and reassign the task assignment. Laboratory Licensure Requirements







4.1.4







In addition to the requirements of the Arizona Procurement Code (A.R.S. ?41-2501 et. seq.) and the Arizona Administrative Code (A.A.C. R2-7-101 et. seq.), Arizona Revised Statutes require that the ADHS Office of Laboratory Licensure shall license environmental laboratories xxxii







engaged in compliance testing. "Compliance testing has been defined by Arizona State Law pursuant to A.R.S. ? 36-495(1) as any: "laboratory analysis of any matter, pollutant, contamination, hazardous substance or other substance subject to regulation pursuant to: A.R.S. ? 36-495(1b) Federal environmental statues or regulations administered or enforced by the United States environmental protection agency relating to the safe drinking water act (42 United States code ?? 300f through 300j), the clean air act (42 United States code ?? 7401 through 7642), the clean water act (33 United States code ?? 1251 through 1376), the resource conservation and recovery act (42 United States code ?? 6921 through 6939B), the comprehensive environmental response, compensation, and liability act (42 United States code ?? 9601 through 9657) and the toxic substance control act (42 United States code ?? 2601 through 2654) as they relate only to the regulation of polychlorinated biphenyls and asbestos". (emphasis added) Samples analyzed for regulatory or enforcement decisions by non-ADHS licensed laboratories will be considered unacceptable for compliance purposes, as statutorily mandated, and will be rejected. Upon application for an environmental laboratory license, ADHS shall issue the license if after investigation, the department determined that the application conforms with the standards established by the department. The ADHS director shall prescribe rules providing for minimum standards of proficiency, methodology, quality assurance, operation and safety for environmental laboratories and may prescribe standards for personnel education, training and experience to meet Federal environmental statutes or regulation, or enabling reciprocity with other states and the manner and form in which compliance testing results are reported. The rules shall be developed in cooperation with the Director of the Department of Environmental Quality and shall be consistent with Title 49 (Section 49-101 et seq.) and rules administered or enforced by the Director of the Arizona Department of Environmental Quality. Unless exempted by A.R.S. ?36-495.02, no person may operate or maintain an environmental laboratory without a license issued by the ADHS pursuant to A.R.S. ??36495.03 through 36-495.14. The ADHS State Laboratory Services (SLS) provides support for the ADEQ as necessary by testifying in court as to the validity of results generated by the State Laboratory on compliance samples submitted by ADEQ. Use of SLS eliminates any potential conflict of xxxiii







interest on the part of the contracted laboratory. 4.2 AGREEMENTS WITH GOVERNMENTAL ENTITIES







The ADEQ also utilizes governmental agreements with EPA and other Federal, State and local agencies. A.R.S. ?41-2501 exempts governmental agreements from the Arizona Procurement Code. Agreements between ADEQ and other state agencies or universities to provide or receive a service are authorized under A.R.S. ?35-148, and agreements between ADEQ and another state agency or political sub-division or other governments to share joint authority (authority possessed by both parties) is authorized by A.R.S. ?? 11-951 through 11952. In the event that a governmental agreement scope of work would include environmentally related measurements or data generation, the ADEQ QA/QC Unit's role would be substantially the same as described in 4.1.2. of the Pre-Solicitation Phase and the Post-Award Phase of this Chapter. Procurement's role would include coordination with the ADEQ QA/QC Unit, the ADEQ Project Manager and the outside political subdivision, and final negotiation of the governmental agreement. 4.3 SMALL PURCHASES







Procurement of environmentally related measurements or data generation (laboratory services) which qualify for small purchases will be subject to Quality Assurance requirements by the ADEQ QA/QC Unit. In ADEQ, these actions are generally for specialized analytical services under which the laboratory is not currently under ADEQ contract. The Project Manager from the applicable ADEQ program shall contact the ADEQ QA/QC Unit and relate the needs and rationale for requiring outside analytical services. The ADEQ QA/QC Unit contacts the laboratory(s) and determines that the data quality objectives of the specific project as they relate to analytical requirements can be achieved by the laboratory. The ADEQ QA/QC Unit will also request that the laboratory submit a current Quality Assurance Program Plan (or similar documentation) for review before the contract is awarded by Procurement. Additionally, the Procurement Contract Officer will assure that there is a stipulation in the procurement action that a Quality Assurance Program Plan shall be submitted and approved by the ADEQ QA/QC Unit and designated program staff before any environmental measurements or data collection activities are performed. 4.3.1 Equipment Maintenance







The ADEQ field personnel are responsible for their respective maintenance of field equipment and instrumentation. The ADEQ has either service contracts or in-house capabilities for the repair and maintenance of field equipment and instrumentation. Schedules for preventive and/or corrective maintenance are determined and carried out through service contracts or in-house capabilities. xxxiv







CHAPTER 5







DOCUMENTATION AND RECORDS MANAGEMENT







Maintaining important quality assurance (QA) documents and records is a continuous process at ADEQ. This process serves as a vehicle for identifying quality-related documents and records requiring management control. Moreover, this process serves to assure that QA documents and records are accessible and protected in storage from damage and deterioration. Finally, the ADEQ Records Management Process ensures compliance with all statutory and contractual requirements for records involving environmental programs. The ADEQ Records Management System also provides adequate preservation of key records necessary to support the mission of ADEQ. 5.1 DEFINITION OF PUBLIC RECORDS







ADEQ policy #0033.001 Public Access to Public Records (see Appendix D) defines public records as all records reasonably necessary or appropriate to maintain an accurate knowledge of the official activities of the department. Public records are made or received in the conduct of Agency business. They relate directly to the function of an office and they documents those functions. A record is any recorded information relating to the work of your office -- regardless of who created it or how the information was recorded. Most records are paper documents, such as letters, memos, completed forms, directives, and reports. Records may also be non-paper such as: photographs, maps, microfilm, audiotapes, videotapes, and computer tapes or disks, etc. All these require special care, particularly information created or stored on a computer or word processor. These records can only be disposed of using authorized records control schedules. 5.2 MATERIALS EXCLUDED FROM THE DEFINITION OF PUBLIC RECORDS







Materials excluded from the definition of public records include reference material, extra copies of articles, periodicals, reports, documents, blank forms, extra copies of documents preserved for convenience of reference, studies, vendor catalogs, and similar materials that are needed for convenience or reference but are not part of the official file. Such items should be destroyed as soon as they are no longer needed. Other materials excluded from the definition of public records include draft documents including electronic and marked up copy drafts.







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5.3







CONFIDENTIAL DOCUMENTS







Some documents collected, received, or generated may, by nature and content, be documents which require special handling procedures. Documents of this category may be, but are not limited to, enforcement sensitive/enforcement confidential, attorney client, or confidential business information (CBI). Confidential documents are handled in accordance with the ADEQ Policy #0032.001 Confidential Records (see Appendix E). Only ADEQ staff are allowed to see documents classified as enforcement confidential. Confidential documents shall be maintained separately from other QA documents. Only those ADEQ staff and others who have been trained and authorized can access CBI files. In most cases criminal sanctions exist for unauthorized disclosure of CBI. Nothing in the requirements put forward in this QMP shall be construed to supersede any existing requirements for handling enforcement sensitive or confidential documents. 5.4 ROUTINE QUALITY ASSURANCE AND RECORDS MANAGEMENT







The ADEQ Records Management Process addresses the system employed by the Agency for handling documents. This plan outlines the roles and responsibilities for management and staff concerning chain of custody procedures and records management. ADEQ document control procedures require that documents generated by or obtained by our Agency personnel will be accounted for when a project is completed. The ADEQ's Records Management System dictates the procedures for checking-in and checking-out files for ADEQ staff as well as for external clients and the public. A unique identification code is created by ADEQ for each investigation or project and a cross reference to the codes generated by those entities which submit data and other records to which ADEQ is assigned. Any custody tags, custody records, field notes and analytical records are labeled with the ADEQ generated codes. Each record is required to have a project number, date, the Agency Project Manager's initials or signature and the ADEQ INDEX and PCA codes. Data packages generated by laboratories which are requested by Project Managers and submitted to the ADEQ QA/QC Unit will be maintained by the ADEQ QA/QC Unit. Project or site specific QA documents and other records generated are stored in the applicable program offices within the ADEQ or in the Central Records Management Office. ADEQ is in the process of transitioning to centralized agency record management. However, only Phase I of the transition has been completed. Regardless of physical location of a file, records and documents associated with a given project are the responsibility of the Division Program that has primary responsibility for that project. Hard copies of site or project specific information such as sample field sheets, chain of custody records, laboratory notes, and instrument/equipment readings shall be maintained in the official project file. The ADEQ Project Manager is responsible for assuring that all field and analytical identification codes referencing the project are maintained in the project file. The ADEQ Director represents the final custodian of xxxvi







that information. Projects involving the generation of environmental data shall include, as a minimum, the Quality Assurance Project Plan (QAPjPs) and final laboratory reports. QAPjPs submitted to ADEQ are peer reviewed by the respective Project Manager, the ADEQ QA/QC Unit staff and designated program staff. Approved copies having the approving signatures are retained by the program's Project Officer and the ADEQ QA/QC Unit. The QAPjP and the final analytical reports will be stored together, thereby allowing a subsequent analyzer (ADEQ QA/QC Unit or designated program staff) or investigator to understand the full context of the data produced and the conclusions reached. The ADEQ QA/QC Unit in conjunction with EPA Region IX ensures that all Quality Management Plans and Quality Assurance Project Plans are current. Should one of these documents become outdated, the ADEQ QA/QC Program Supervisor and EPA Region IX, in conjunction with the ADEQ Project Manager, shall determine the status of the plan and initiate appropriate action. The Division Program and the ADEQ QA/QC Unit shall be responsible for maintaining copies of the ADEQ revised/approved QAPjP for five years after completion of the project. The ADEQ management will assure that the objectives of the Records Management Process are achieved. These objectives include the following: Prevent the creation of unnecessary records in any media; Promote the continuous development of filing systems and structures that allow for the efficient organization, maintenance and retrieval of records; Ensure that records of continuing value are preserved but that valueless or noncurrent information are disposed of or transferred to storage in a timely manner in accordance with ADEQ disposition schedules or ADHS records retention requirements; Ensure that the acquisition and use of all direct paper to microform systems and equipment or electronic digital image are technically feasible, cost-effective, and most importantly, satisfy program needs; and, Preserve and protect information that is vital to the essential functions or mission of the organization. Preserve and protect information that is essential to the legal rights and interests of individual citizens and the government. 5.5 IN-HOUSE QUALITY ASSURANCE GUIDANCE DOCUMENTS







Quality guidance documents developed in-house are peer reviewed by the ADEQ QA/QC Unit and the appropriate divisional program. Most of the in-house quality guidance documents xxxvii







are formatted as SOPs covering specific environmental monitoring activities such as field inspection, sample collection/handling, analytical protocols, and data review/validation. The ADEQ QA/QC Unit has developed, to date, field sampling protocols for the collection of water samples from Arizona public water systems that will be submitted to ADHS certified laboratories for the analysis of volatile organic compounds (VOCs), synthetic organic compounds (SOCs), and inorganic compounds (IOCs). These SOPs have been peer reviewed and approved by EPA and the ADHS State Laboratory for ADEQ use. Other in-house quality assurance guidance documents include policies. The ADEQ QA/QC Unit drafts quality assurance and analytical policies to express the Agency's position when interpreting analytical data generated by laboratories using EPA methods which may have multiple procedural interpretations. Two such agencywide policies are ADEQ Policy # 0154.000 Addressing Spike and Surrogate Recovery as They Relate to Matrix Effects in Water, Air, Sludge and Soil Matrices and ADEQ Policy # 0155.000 Analytical Methods Having Provisions for a One-Point Calibration and Continuing Calibration Verification Constraints. 5.5.1 Requirements for Field Documentation







Documentation of field activities establishes procedures; identifies written records; enhances and facilitates sample tracking; standardizes data entries; and, identifies and establishes authenticity of the sample data collected. Proper documentation helps to ensure that all essential and required information is consistently acquired and preserved. Timely, correct, and complete documentation establishes the chain-of-custody, a requirement for data intended for use to provide evidence for court proceedings. Field records shall be generated and stored as specified in project specific QAPjPs and SOPs. Guidance for handling field records is provided in the June 1994, Region 8, "Standard Operating Procedures for Field Sampling Activities" and its subsequent revisions. 5.6 MAINTAINING DOCUMENT INTEGRITY







Following all required ADEQ documented policies and action regarding Records Management, the file clerk and all other ADEQ staff with access to sensitive or potentially sensitive documents and records (i.e., audit reports and performance evaluation reports) will take special care to preserve the integrity of these documents. If sensitive documents are to be used at a work station, due care will be used there, too, in order to maintain the integrity of the data.







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CHAPTER 6







INFORMATION TECHNOLOGY AND DATA MANAGEMENT







In order to ensure effective and efficient use of the ADEQ's hardware and software system design, development, implementation and maintenance, the ADEQ will attempt to comply with all EPA standards and regulations pertaining to hardware, software, system development and data. It is the goal of ADEQ to achieve consistency in the way data are generated, compiled, stored and disseminated across each of the Divisional (Air, Waste and Water) programs. There are five major kinds of environmental information management activities conducted at the ADEQ: 1. 2. 3. 4. 5. Planning the project; Gathering the data; Managing the data; Disseminating the data; and, Evaluating results.







These activities occur in sequence, with the understanding that each activity can be adjusted to reflect changing conditions and project results. Other activities should occur throughout the lifetime of a project, as follows: Communication; Quality assurance; Cost control; and, Security. This section focuses on the information management aspects of Agency projectmanagement and data dissemination protocols and also identifies the roles and responsibilities that the ADEQ Office of Information and Technology (OIT) provides as an infrastructure. It does not address the other aspects of project management-planning, data gathering, and evaluation provided by the ADEQ programs which will be addressed in the QAPrPs. 6.1 MANAGEMENT PRACTICES FOR ENVIRONMENTAL DATA







Documenting the Project: ADEQ utilizes a standard System Development Lifecycle Methodology for information projects. This methodology includes a full analysis and documentation of user requirements followed by design specifications. ADEQ uses the Oracle Designer tool to document requirements and system design. Agency coding standards are published and implemented which ensure consistency and maintainability of source code. A "project team approach" is utilized which includes end user involvement throughout the project lifecycle. User documentation, including on-line help, is provided with each system as resources permit. xxxix







Establishing Back up and Archiving Procedures: Each program will coordinate with the Office of Information and Technology to establish standard procedures for data backup and archiving, system failure, and recovery. Data sets will be archived to provide a historical record of data over the lifetime of the project. Current procedures involve daily full and incremental backups of all critical agency data, that are stored on site at ADEQ. Weekly and monthly back up of all critical data are kept in perpetuity and stored off site in the State's archive facility. The agency is working with the State to identify and develop "Hot Site" hardware capabilities which will provide additional hardware located off-site that can be used to process data in the event that the primary hardware is destroyed. The "Hot Site" can be thought of as an additional server room located off the main premises. Ensuring Data Integrity: Ensuring data integrity involves addressing the vulnerability of the system to unauthorized access, data manipulation, theft, and environmental damage. Key potential threats include: 1. Inappropriate/inaccurate information - Project workers can supply inappropriate or inaccurate information accidentally or on purpose. Compromised information integrity - Documents or data can be accidentally or intentionally modified.







2.







These threats are mitigated by implementing a strong internal quality assurance/quality control process. The Central Data Management Group (CDMG) maintains the ADEQ's centralized core data for Licensing Time Frames (LTF), PLACE (the sites and facilities that ADEQ regulates or tracks), and CUSTOMER (individuals, organizations and businesses that ADEQ regulates or interacts with) databases within Arizona Unified Repository For Informational Tracking of the Environment (AZURITE). CDMG enters the core data for all license applications that are subject to the LTF statute and rule, plus all Places and Customers that ADEQ tracks expenditures for or against in the Arizona Financial Information System (AFIS). Currently, core data are entered and updated only by CDMG personnel, based on information provided by the administrative and technical programs. Data entry standards have been established to give entry users clear guidance when entering data. To assure compliance with the data entry standards, CDMG runs validation reports on new records entered into these systems to assure the data are complete and that a duplicate record for a place or customer does not exist. At the point when administrative and technical staff begin entering core data into the shared databases these records will be validated by CDMG. Any record that is not complete will be returned to the originating program for correction, and usage of that data will be restricted until it is corrected. Presenting Data In An Understandable Format: Agency projects will be presented in a way that is suitable for the intended audience. The following guidelines are implemented by xl







ADEQ, to the extent applicable, useful and possible, in designing effective approaches in agency projects: Establish a context for presenting data - methods for illustrating context include displaying data in a geographic context, combining the new data source with existing collections of monitored data, or aggregating the data collected to demonstrate a trend or ongoing view of the environmental conditions. ADEQ Programs will present the data in ways that make that data relevant and useful. Format data for easy interpretation - Environmental data can be interpreted in many different ways. The Agency will make a supreme effort to ensure that data will always be presented in a format that is easy to understand and not subject to misinterpretation. Be responsive to the users of the data - To keep abreast of changing user needs, the Agency projects are designed in ways for users to provide feedback on the projects. Ensuring Data Quality: All Agency projects will consider three key items: quality assurance analysis, systems development planning, and audits and testing. 1. Quality assurance analysis - The type of QA effort needed depends on the qualitative and quantitative criteria that the data must meet and on the complexity and magnitude of the project. The Agency will establish the ultimate needs and objectives for the data quality in the early planning stages of the project. CDMG will maintain and assure that data entry standards are followed, that locational information is provided and that a duplicate record does not exist before validating a new record as part of Agency core data. Any record that is not complete or does not meet data entry standards will be returned to the originating program for correction and the use of that data will be restricted until corrected. 2. Systems development planning - The State of Arizona utilizes a standard Information Technology (IT) project planning and justification process. The Government Information Technology Agency (GITA) reviews and approves Project Investment Justifications (PIJ) for projects with greater than $25,000 development costs and infrastructure hardware. PIJ approval must be received before budget monies can be allocated to a project. The central IT organization work in unison with the decentralized Program IT units to plan, prioritize and implement agency IT projects. 3. Audits and Testing - All IT projects involving development of systems for tracking of environmental data will be thoroughly tested to ensure that they meet the requirements in the written functional specifications. Independent audits of these systems will be conducted by the Laboratory and General Services section. The central IT organization has a UNIX and NetWare Test server environment that is in place and is xli







utilized regularly to test agency applications prior to being released into production. 6.2 INFORMATION MANAGEMENT PLAN







The ADEQ has an information management plan that documents our approach to data collection, storage, retrieval, delivery, and communication and procedures for data quality control and security, which may be incorporated, as appropriate, into our organization's Quality Assurance Program Plans. The information management plan includes the following elements: # Data Owner(s) ? ADEQ has a Centralized Data Management Group (CDMG) which has been assigned the responsibility of maintaining core data. Core data are those data which are shared across programs such as site/facility data and customer data. CDMG's ownership of these data provide a clear line of authority and responsibility for quality assurance. Non-core data are owned by the programs. This information plan provides the primary contact information of the individual and program that has overall information management responsibility and authority for Agency projects. Description Of The Data Flow Process ? The plan explains the key points in the information data flow and collection process. This can be illustrated by a flow chart or diagram depicting key information components. Description Of The Data Collection Methods ? The plan summarizes data measurement and collection methods. It also describes any emerging measurement technologies used and/or how existing systems of environmental monitoring will be augmented/up-graded to provide the proposed data. Description Of The Data Storage And Retrieval System ? ADEQ's standard relational database platform is Oracle. The ADEQ utilizes Oracle tools including Designer and Developer for application development. and Microsoft Project for planning and tracking projects to completion. The plan describes the hardware and software technologies that will be used for data management and processing systems. It specifies the components of the project architecture and also describes the archival components or storage capabilities. The plan addresses data management responsibilities among stakeholders and contractors to ensure data documentation and data standardization. For all non-ORACLE applications the agency uses a Novell NetWare and UNIX network. 6.3 LEVELS OF DOCUMENTATION FOR ENVIRONMENTAL PROJECTS Documentation is important because it helps users to make informed decisions regarding xlii







#







#







the use of the data, provides consistency and project "memory" over time, and allows the data to be shared and used in a variety of computing environments. The ADEQ has developed the following four kinds of documentation requirements for environmental projects: 16. Project Documentation: Documenting critical information about the project, including the project purpose and scope, the user requirements, the project investment justification and the project plan; 17. Data Set Documentation: Clear information about what data are collected and how to access and use it; 18. Data Element Documentation: Full definitions and specifications for each element collected and maintained in a data set; and, 19. Database System Documentation: Electronic and hard copy documentation of system design and implementation. 6.4 COMPUTER HARDWARE/SOFTWARE REQUIREMENTS







ADEQ managers and Office of Information and Technology staff will comply with all hardware and software standards delineated in the agency's software and hardware standards that are maintained by OIT. These standards address compatibility, hardware, operating systems, communication, database management, user interface/printer interface, application development and applications. The ADEQ will procure hardware and software that conforms to agencywide and EPA information management architecture. In some cases, the ADEQ will buy or develop hardware or application software that is not on the Statewide contract. All such purchases will be evaluated to ensure that they comply with ADEQ standards as outlined in the Agency's software and hardware standards. Prior to any purchases, the ADEQ Chief Information Officer, or delegated assignee, will evaluate software and hardware to determine its performance capabilities and the impact of implementation upon ADEQ and reporting requirements to EPA. 6.5 SYSTEM DEVELOPMENT







All ADEQ system development, enhancement and modernization efforts will comply with Agency standards. This compliance will include a systematic and comprehensive dialogue between the data providers, data/system users and system developers, prior to the design of the system in order to ensure successful extensive user participation and a systematic approach to the design. Systems will be designed and built to integrate to core agency data in such a manner that re-use of code is a priority and efficiencies are maximized.







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All software systems shall be operated and maintained in accordance with the written specifications or owners manual. All software systems will be subjected to acceptance testing by end users prior to being placed into a production environment. For the proper implementation and maintenance of the technology infrastructure, the ADEQ Office of Information and Technology is developing: An inventory of the computer system(s) hardware and written operating procedures for routine maintenance operations; Documents describing data management systems in use, including functional and design specifications and requirements; and, Standard Operating Procedures which describe routine operation, maintenance and testing to ensure that both the hardware and software in use are accurately performing the intended functions. These documents will be readily available in the areas where these procedures will be performed. Changes in any part of the operating procedures shall be properly authorized, reviewed and accepted in writing by the designated responsible person. 6.6 DATA STANDARDS







To take full advantage of both ADEQ's and EPA's growing technological and data standards and resources, there must be an increased emphasis on improving the compatibility of data among computer systems. Federal data policies and standards that currently are followed, including those which ADEQ is attempting to implement, include: Chemical Abstract Service Registry Number Data Standard, EPA Order 2180.1, June 26, 1987; Data Standards for the Electronic Transmission of Laboratory Measurement Results, EPA Order 2180.2, December 10, 1987; The Minimum Set of Data Elements for Ground Water Quality, Policy Order 74500.IA, September 11, 1989; Facility Identification Data Standard, U.S. EPA Office of Administration and Resources Management, Information Management and Services Division, April 9, 1990. Policy on Electronic Reporting, U.S. EPA Office of Administration and Resources Management, July 30, 1990; Site Location Identification Policy and Responsibilities, Region III, Order 5361.5, September 14, 1988; ADEQ Locational Data Policy, 0034.001 (see Appendix J); Locational Data Policy, IRM Policy Manual, Chapter 13, April 1991; and Locational Data Policy Implementation Guidance- Guide to the Policy, U.S. EPA xliv







Office of Information and Resources Management, March, 1992. 6.7 INFORMATION SECURITY







It is important that the ADEQ information resources are protected from potential loss and misuse from a variety of accidental and deliberate causes. ADEQ utilizes the following security procedures and protocols: Network Operating Systems uses log in and password controls; Internal rights to agency data are granted by local management for their employees A firewall security system exists for Internet usage; Remote access controls for employees and third parties -- uses log in and password protection; All UNIX, NetWare and Remote Access Operating Systems comply with DOD C2 security standards; and The main computer room is physically secured for access by only critical IT personnel.







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CHAPTER 7







PLANNING







A primary goal of the ADEQ's Quality Management System is to promote the effective planning for the collection, analyses and processing of environmental data. Quality planning must occur at three levels to ensure that such data meets the ADEQ programmatic and quality goals for: Agencywide Requirements; Program Specific Requirements; and, Project Level Requirements. 7.1 AGENCYWIDE PLANNING 7.1.1 Internal Strategic Planning







The ADEQ Strategic Plan is the foundation upon which all programmatic priorities and corresponding environmentally related data collection and use activities are based. Using the projected annual budget for ADEQ from the various funding sources including EPA and the State of Arizona, the ADEQ Director and senior managers usually meet early during the fiscal year to discuss and set ADEQ priorities. These priorities are then reflected in the ADEQ Strategic Planning process, which establishes overarching goals, direction, resource utilization policies and budget allocations. Yearly action plans developed by the individual ADEQ Divisions, tied to the ADEQ Strategic Plan and budget distribution process, further specify the types of environmentally-related data generation activities that will occur. The yearly action plans also dictate what decisions they are designed to support and the corresponding requirements for quality assurances and quality control procedures. 7.1.2 External Data Coordination







The ADEQ must also coordinate the collection and use of environmentally related data across numerous government agencies, and also academic and private organizations. Close coordination and planning is essential to ensure that data are of sufficient quality to support decision-makers or otherwise meet the intended uses and can be shared where Data Quality Objectives (DQOs) are similar. The ADEQ encourages data sharing whenever possible, provided that adequate data quality indicators (DQIs) are available so that the quality of data are sufficiently known to support the applicable decision(s). 7.2 PROGRAM-SPECIFIC PLANNING







The ADEQ Programs are functional areas of work authorized by Statutory reference (e.g., Air Toxics Program or Drinking Water Program) or by Agency direction (the Voluntary Remediation Program). Any of the ADEQ environmental programs which generate xlvi







environmental data are covered by the QMP, though it is acknowledged that not every program or project requires the same level of quality assurance. Generally, program managers (their grades and titles vary by Division) are responsible for program level planning, which includes the responsibility to ensure that there is agreement between the customer and the data supplier as to expected data quality. Developing Data Quality Objectives (DQOs) when initiating a new project or incorporating major statutory changes is a mandatory component of the ADEQ Quality Management System. The EPA Quality Assurance Division guidance document "Guidance for the Data Quality Objectives Process" (EPA QA/G-4) is available to assist users in developing these objectives as are resources within the ADEQ QA/QC Unit. DQOs at the project level include all sources of error (i.e., design, sampling, measurement, or indicator error) that will accumulate and affect the interpretation of data for status and trends. Program-level DQOs are defined by their ability to meet Division program objectives. Data Quality Objectives are also used as performance criteria for assessments of data quality for their adequacy in determining status and trends. It is critical to consider the QMP as part of the planning process when modifying existing programs or designing new programs. Although the QMP outlines the minimum QA requirements for the ADEQ, it is likely that most of the programs covered by the QMP will need more QA specificity and detail for implementing their programs. In these cases, supplemental QA components and procedures should be developed and described by the program in conjunction with the ADEQ QA/QC Unit. The ADEQ QA/QC Unit will serve as technical advisors in the development of these procedures and documents. All programs covered by the QMP should review their programmatic requirements within the next year to determine if the QMP adequately covers their QA needs, and develop supplemental procedures as identified. 7.3 PROJECT-LEVEL PLANNING







A project is an organized set of activities within a program. The Quality Assurance Project Plan (QAPjP) is the primary vehicle for ensuring that adequate data quality at the project level (see Chapter 2, Section 2.2 and 2.2.1 for a more complete discussion of the QAPjP development and review process). The ADEQ QMP refers to QA activities as a well-defined component of any project plan involving the collection or use of environmental data. The key to good quality planning at this level is to link the data collection or analyses to be performed directly to the environmental decision to be made. This is essential so that the ADEQ does not collect mounds of data for which there is no purpose. Achieving this key component requires dialogue between the decision maker, contractor and the data supplier. Again, the EPA Quality Assurance Division (QAD) document EPA QA/G-4, "Guidance for the DQO Process", as well as resources within the ADEQ QA/QC Unit, can be invaluable in establishing the desired data certainty requirements based on the decision to be made. The use of statistical methods to quantify data acceptability measures is highly xlvii







recommended. Members of the QA Team in EPA Region IX can provide assistance with statistical applications. The ADEQ QA/QC Unit can assist ADEQ Programs by providing the appropriate references. Planning documentation should identify the ADEQ personnel responsible for ensuring that all components of a QAPjP are addressed appropriately. Project Managers will normally be responsible for the development of these QA components, which will adhere to the requirements of EPA QA/R-5, "EPA Requirements for Quality Assurance Project Plans for Environmental Data Operations." When QAPjPs are submitted by the ADEQ Project Manager to the ADEQ QA/QC Unit for review and approval, the ADEQ QA/QC staff will be responsible to ensure that all the required elements in the QAPjP are appropriately addressed. When initiating a site-specific project, the ADEQ program staff shall develop a preliminary plan for accomplishing the required work. Through this process, specific individuals are made accountable for different aspects of the investigation. The ADEQ planning process takes into account: Identifying the regulations involved; Defining the forensic requirements of the regulations; Structuring communication between all the parties involved in the project; Defining the scope of the project to meet enforcement objectives; Identifying and scheduling activities; Identifying resources needed; Identifying health and safety issues; and, Questioning the validity of scientific models and methods proposed for use. 7.3.1 On-Site Monitoring







The determination to use on-site monitoring, and the specific type of monitoring to be conducted, is based upon the project objectives as defined by the QAPjP for a monitoring program and the type of field conditions encountered. Field screening information, combined with statistics, can be used to define the number and type of samples needed to meet the project objectives. Monitoring for personal protection might include using a specific instrument to screen the work area to determine the appropriate level of personal protection needed. These instruments can also be used for continuous monitoring while work is being performed. Quality control indicators used in on-site monitoring depend on the applicable regulations, the type of equipment, the nature of the materials monitored, and the monitoring objectives. Quality control parameters such as blanks, blank spikes, matrix spikes, field duplicates, surrogates and calibrations curve data (all QC parameters as they apply) shall be documented.







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7.3.2







Sampling Events







The sampling activity shall be focused toward meeting the regulatory, technical and analytical requirements defined during the planning phase. ADEQ sample collection activities are designed to answer questions such as: How does the material compare to a regulatory threshold? How does the material compare to another? Is a component/condition present? Are there trends or hot spots? The sampling activity requires: Coordinating field activities with laboratory activities; Maintaining sample integrity; and, Focusing on regulatory and agency defined data quality requirements. 7.3.2.1 Sample Scheduling All laboratory sample scheduling events by the ADEQ through non-ADEQ laboratories must be coordinated through the ADEQ QA/QC Laboratory Coordinator. The ADEQ QA/QC Unit will communicate with ADEQ Program Managers or with the Arizona Attorney General's Office to ensure that the analytical requirements of the Agency's data quality objectives can be fulfilled. The communications will include the matrix types, required detection limits and identification of the Federal or State statutes under which ADEQ intends to regulate. 7.4 ANALYTICAL REQUIREMENTS







Analysis involves the characterization of samples based on chemical and/or physical properties. Analysis results in generating raw data from either instrumental analysis, chemical analysis, or physical testing. The analytical methods used will be specific and sensitive enough to answer the question posed by the enforcement objectives and meet the data quality goals associated with those objectives. ADEQ Project Managers may consult with the ADEQ QA/QC Unit or research a variety of published or written materials to aid them in selecting or developing measurement technologies. The ADEQ QA/QC Unit shall maintain a file of in-house procedures and practices used in the measurement process. Data Quality Indicators (DQIs) and the ADEQ QA/QC Unit's professional knowledge are used to identify instances which require particular analytical procedures. 7.5 DATA TRANSLATION







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Data translation involves translating raw data into useable information which can include qualitative identifications, quantitative determinations, and/or statements of condition. This process can include arithmetic calculations and statistical evaluations of results from a sample or collection of samples. 7.6 DATA INTERPRETATION







The Project Manager, with input from technical staff and the ADEQ QA/QC Unit, will attempt to use sample data to form an opinion about the characteristics of a data set. The ADEQ Project Manager will use the quality control indicators incorporated into sampling and analyses to support opinions or to identify limitations of the data. The ADEQ QA/QC Unit will be available to assist the ADEQ Project Manager in assessing data quality indicators when actions have regulatory implications. The characteristics of the data set will then be compared to regulatory requirements to determine compliance. 7.7 HEALTH AND SAFETY







Health and safety are an integral part of the ADEQ Quality Management System, because the management philosophy is that a safe workplace is essential for the long term success of the Quality Management System. ADEQ Management, with the assistance of the ADEQ Health and Safety Officer, developed policies and procedures focused toward a safe working environment, and developed a program that is adequate to protect the health and safety of ADEQ staff. The ADEQ Health and Safety procedures implement applicable EPA and Office of Safety and Health Administration regulations. The ADEQ Safety Officer conducts, our contracts for, specialized training programs to meet the safety needs of ADEQ measurement activities. The ADEQ Health and Safety Environmental Management Program is the mechanism which ensures that appropriate issues are considered prior to the initiation of measurement activities. The ADEQ Health and Safety Environmental Management Program includes the following three key elements: 20. Training - Includes field and laboratory safety, first aid and CPR, driving safety, supervisory safety training, office safety, hazardous waste training, and other pertinent training. Audits, Inspections, Investigations, and Hazard Control - Includes planning reviews and associated reporting and record keeping to identify, prevent, and/or abate health and safety problems. Occupational Medical Monitoring - Includes medical monitoring of staff who may be exposed to chemical, biological, radiological or other agents, or who may experience physical stress during their work.







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22.







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CHAPTER 8







IMPLEMENTATION OF QUALITY ASSURANCE WORK PROCESSES







This Chapter of the QMP describes the processes used at the ADEQ for ensuring that the QA plans and procedures which comprise the ADEQ Quality System are effectively implemented. Any changes to the QMP will be documented in revisions and will receive the same level of review and approval as the original document. As with the QA planning described in the Chapter 7, implementation of QA procedures takes place at the Agency, program and project levels. 8.1 AGENCYWIDE IMPLEMENTATION







The ADEQ utilizes a decentralized approach to ensure that environmental data are of sufficient quantity and quality for its intended purpose. Any revisions to the QMP will be processed in the same manner as was the original document. QMP revisions will be drafted by the ADEQ QA/QC Unit, and submitted to the ADEQ Leadership Team for approval. The ADEQ QA/QC Program Supervisor will provide general oversight of implementation of the ADEQ Quality Management System. The ADEQ Divisions and Programs will provide technical oversight for implementing environmental data operations through the development of Quality Assurance Program Plans (QAPrPs). 8.1.1 Divisional Quality Assurance Program Plans







Each ADEQ QAPrP will be approved by the ADEQ QA/QC Unit and will address the process for implementing environmental data operations according to the approved planning documents. Additionally, each QAPrP will identify those specific activities that will ensure the generation of quality data by: Identifying the mission elements and/or programs generating or using data for environmental decisions; Identifying criteria for collecting or selecting data sufficient to support environmental decisions; Describing procedures for the preparation, review and approval of QAPrPs; Outlining procedures to ensure that the work described in the QAPrP is being performed according to the Plan, including evaluation activities; Ensuring that individuals with QA responsibilities have been properly trained; and, Defining the level of management oversight to be provided that will be commensurate with the importance of the particular project and the intended use of the project results. li







Each ADEQ Divisional QAPrP is scheduled to be reviewed by the ADEQ QA/QC Unit each year after initial approval to ensure the plans accurately reflect how business within the program is conducted. 8.2 PROGRAM LEVEL IMPLEMENTATION 8.2.1 Operating Policies and Procedures







Any ADEQ program which generates or uses environmental data will document their responsible QA policies and procedures and will develop and/or use appropriate policy and procedures manuals for their programs. The ADEQ QA/QC Unit will provide support and oversight in the generation of such documents. The EPA Quality Assurance Division (QAD) document "Guidance for the Preparation of Operating Procedures for Quality-Related Operations" , QAD/G-6, November, 1995, should be referenced by ADEQ programs and the QA/QC Unit for developing procedures manuals for administrative and technical QA operations. Having these procedures available will ensure that program personnel are knowledgeable about their operations, and will also serve as a training guide for new staff members. The ADEQ QA/QC Program Supervisor will work with the ADEQ programs to ensure that operational QA policies and procedures developed by the programs are consistent with the ADEQ QMP. This responsibility includes defining procedures for appropriate routine, standardized, special, or critical operations, including the policies and procedures that address, but are not limited to: The identification of operations needing standardized procedures; The process for preparation of procedures, including form, content, and applicability; and, The review and approval of the adequacy of the SOPs. Any QA procedure manuals developed by the ADEQ QA/QC Unit will be made available to all personnel involved in program implementation. If implementation of the program is delegated, the manuals will be referenced in any assistance or delegation agreement consistent with the ADEQ Procurement process. Where a program uses data generated by external sources, it must develop criteria and a process by which to evaluate the acceptability of the data supplied, in the context of the environmental decision(s) to be made. The data quality assessment process described in Chapter 9.4 can be useful here. 8.3 PROJECT LEVEL IMPLEMENTATION 8.3.1 Quality Assurance Project Plan Implementation







All environmental data operations will be implemented in accordance with an approved lii







QAPjP. Any changes to the QAPjP will be documented and approved in writing through an amended QAPjP. Amendments will be reviewed and approved by the original approving officials (ADEQ Project Manager and the ADEQ QA/QC Unit). The ADEQ Project Officer should include identifiable QA milestones and target dates in the project timeline so that progress and completion of QA and QC activities can be effectively tracked. For contracts and grants involving environmental data generation, the ADEQ Project Officer and ADEQ QA/QC Unit shall ensure that the applicable Task/Work Assignment, Task/Delivery Order or similar document includes specific requirements for reports on the QA of products or services to be supplied. 8.3.2 Standard Operating Procedures (SOPs)







Many repetitive procedures that are routinely used can be standardized and documented in writing as standard operating procedures (SOPs). SOPs can be prepared for routinely conducted sampling, analytical, and quality control procedures. Once established, the SOPs can be cited in the QAPjPs, contract proposals, grant agreements, and other similar documents, thus saving time and paper by avoiding the need to write out the specific procedures in each document. ADEQ SOPs relating to QA shall be reviewed and approved by the ADEQ QA/QC Unit and maintained by the appropriate program office. Any substantive changes in the SOPs will be likewise approved by the ADEQ QA/QC Unit. Tasks or functions that may be effectively addressed within a SOP include: Sampling network design; Sampling site selection; Sampling and analytical procedures; Sample collection methods and devices, containers, preservatives, holding times, handling and transportation methods; Documentation and chain-of-custody procedures; Calibration and maintenance of instruments and equipment; Quality control procedures; Data review, reduction and validation; Safety procedures; and, Inspection and audit procedures.







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CHAPTER 9







QUALITY ASSESSMENT AND RESPONSE







This Chapter of the QMP describes how the ADEQ will assess the effectiveness of its Quality Management System. The ADEQ will use a variety of internal management and technical reviews, performance evaluations and QA audits to make sure that the procedures in this QMP are implemented successfully. The ADEQ will also utilize, as needed, independent reviews of the systems and procedures described in the ADEQ QMP by personnel from the EPA Region IX Quality Assurance Division. This chapter will also describe the ADEQ's commitment to using the results of these evaluations to make any necessary operational adjustments to the ADEQ's data collection and analytical procedures, as well as to other aspects of the Quality Management System. 9.1 ANNUAL REVIEW OF THE QUALITY MANAGEMENT PLAN







The QA practices and procedures described in the QMP will be assessed annually and revised or updated on October 1 of each year by the ADEQ QA/QC Unit. The ADEQ QA/QC Program Supervisor is responsible for coordinating this assessment, arranging for appropriate personnel to assist with the review, and for incorporating any recommended changes into the QMP. Minor changes in the QMP proposed by the ADEQ Programs should be submitted in writing to the ADEQ QA/QC Supervisor by June 30th of each year. 9.2 QUALITY AUDITS







The ADEQ employs several QA assessment tools designed to provide a better understanding of the components of the ADEQ Quality System and also to provide a basis for improving the ADEQ Quality Management System. "Internal" (programmatic) and "External" QA audits (ADEQ QA/QC Unit) are one of the principal tools for determining the effectiveness of the ADEQ QA/QC components. QA audit frequency and scheduling will vary with the type of review conducted. The following is a description of some of the evaluation tools: 9.2.1 Management System Reviews (MSRs)







An MSR is an independent assessment of a Program's QA management practices and is generally performed by the ADEQ QA/QC Unit. MSRs address the effectiveness of management controls in achieving and assuring data quality; the adequacy of resources and personnel devoted to QA functions; the effectiveness of training and assessments; and, the applicability of data quality requirements. While MSRs can identify significant QA concerns and areas of needed improvement, they also point out noteworthy accomplishments. ADEQ Program MSRs are generally conducted by an external party (typically the ADEQ QA/QC Unit) and focus on the Program's adherence to the approved Agency QMP and the liv







Quality Assurance Program Plans as well as the implementation of QA practices within a single program area. The ADEQ QA/QC Unit will attempt to conduct an MSR for every major Agency Program (including the Northern and Southern Regional Offices) once every three or four years. The ADEQ QA/QC Unit's MSRs focus on the overall structure and procedures for accomplishing the QA program. Most MSRs will examine the following elements: An assessment of the overall effectiveness of the QA management system, as measured by its adherence to the approved QMP; Procedures for developing Data Quality Objectives (DQOs); Procedures for developing and approving QAPrPs and QAPjPs; The effectiveness of existing QAPrP guidance and QAPjPs; Procedures for developing and approving SOPs; Procedures, criteria and schedules for conducting QA audits; Tracking systems for assuring that the QA program is operating and that corrective actions disclosed by QA audits have been taken; Responsibilities and authorities of various line managers and QA personnel for implementing the QA program; The degree of management support; and, The level of financial and other resources committed to implementing the QA program; MSRs performed or arranged by the ADEQ QA/QC Unit will be conducted in accordance with the "Guidance for the Management Systems Review Process," EPA QA/G-3. The ADEQ may also make occasional use of independent, outside reviews of its quality assurance practices. When electing to use an outside source, the ADEQ QA/QC Program Supervisor, in consultation with the Division Director, will make arrangements for such a review by selecting an appropriate team of qualified reviewers (i.e., EPA Region IX). The goals and objectives of this type of review will be the same as if the assessment were conducted internally. 9.2.1.1 Review of ADEQ Quality Assurance Programs The ADEQ QA/QC Unit will conduct internal assessments of the individual ADEQ Quality Assurance programs as described in the Agency QMP. All major data generating programs within the ADEQ will be reviewed every three to four years. These programs include, but are not limited to, Air Quality, Drinking Water, Superfund and RCRA Programs. These reviews will be authorized by the Director of the ADEQ and the results of the ADEQ QA/QC Unit evaluations will be transmitted to the ADEQ Division Director in a written memorandum from the ADEQ QA/QC Unit. The reviews are intended to accomplish the following objectives: Identify any data quality problems; Identify benchmark practices that could be used in other Agency programs; Propose recommendations for resolving quality problems; and, lv







Confirm implementation and effectiveness of any recommended corrective actions. The reviewed program will normally have 30 days to prepare a written response to the reviewer's memorandum. If the ADEQ QA/QC Unit recommended corrective actions, the reviewed program should address those recommendations and include a schedule for making any appropriate changes in its quality assurance procedures. These reviews will be used by the ADEQ Leadership team to gauge the effectiveness of the Agency QMP and of the programs' approaches to data quality management. 9.2.2 Technical Systems Audits (TSAs)







A Technical Systems Audit is conducted to assess the sampling and analytical quality control procedures used to generate environmental data. The ADEQ QA/QC Unit will use TSAs to evaluate laboratory and field procedures used by EPA, state personnel, and contractors. TSAs may entail a comprehensive, on-site evaluation of facilities; equipment calibration; personnel qualifications and training; record keeping procedures; and, data validation, data management and reporting of field and laboratory activities. Both laboratory and field TSAs are performed. 9.2.2.1 Laboratory TSAs TSAs will be conducted on the Arizona Department of Health Services State Laboratory, ADEQ contract laboratories, and the contract laboratories of those consultants and contractors who submit analytical data to the ADEQ. TSAs will also be conducted on other Federal agency laboratories that perform sample analysis under Interagency Agreements with the ADEQ. The primary goals of TSAs will be to review the laboratory organization, operation, and capabilities; determine the reliability of data; and, note corrective action for any apparent deficiencies. Auditors for TSAs will be selected by the ADEQ QA/QC Program Supervisor based on their technical proficiency in the subject area. The designated auditors will be responsible for planning and conducting the audit, and reporting the findings to the laboratory manager and to the ADEQ QA/QC Program Supervisor. 9.2.2.2 Field TSAs Oversight of field operations is an important part of the quality assurance process, and the ADEQ QA/QC Unit will conduct QA audits of field sampling activities, both for its own field operations, and on those contractors and other federal agencies that collect samples for programs sponsored by EPA. The Agency QMP will specify frequency and procedures for conducting field TSAs within specific program areas. The ADEQ QA/QC Program Supervisor will determine the adequacy of field TSAs when QAPjPs are reviewed, and also during any MSRs or other QA audits. 9.3 PERFORMANCE EVALUATIONS







Performance Evaluations (PEs) are conducted to assess the ability of a laboratory or field measurement system to obtain reliable data. PEs will normally be accomplished at laboratories lvi







providing analytical services directly or indirectly for the ADEQ and will be traceable, whenever possible, through the National Institute of Standards and Technology (NIST). The evaluation consists of providing a reference, "blind" or "double blind" sample to the laboratory for analysis. This PE sample contains known concentrations of chemical constituents, or pollutants, of interest and will normally be in the appropriate media (e.g., soil, water, air). The analytical results obtained by the laboratory are compared to the known concentrations of the specific parameters contained in the PE sample(s) as a means of determining if the laboratory demonstrated its ability to properly identify and quantify pollutants within established or calculated control limits. PE samples will be scheduled at a frequency specified by program requirements, or on an as-needed basis depending on the laboratory and program involved. Some national programs, such as the Public Water Supply Supervision (PWSS) and National Pollutant Discharge Elimination System (NPDES) programs, have regularly-scheduled PE stu