IDQTF Uniform Federal Policy for Implementing Environmental Quality Systems

1.0 MANAGEMENT AND ORGANIZATION

This section of a QMP defines management responsibilities and authorities of management for ensuring the quality of work products, monitoring work processes, and identifying and correcting system nonconformance. Key elements of this section include:

• Management commitment to and accountability for quality,

• Independent oversight of quality,

• Provision of resources commensurate with quality objectives, and

• Commitment to performance assessment and continuous improvement of the Quality System.

The “Management and Organization” section of the QMP establishes the framework that fosters implementation of the Quality System. Managers within each organization who are responsible for the mission and programs covered by the Quality System are held accountable for quality.

1.1 Mission and Organization

1. Define the mission(s) of the organization(s) covered by the Quality System as the mission relates to environmental data collection and use and/or environmental technology programs. Identify the programs to which the Quality System is applied (e.g., the remediation of hazardous waste as performed under the regulatory authorities of the Resource Conservation and Recovery Act [RCRA] and the Comprehensive Environmental Response, Compensation, and Liability Act [CERCLA], or compliance assurance under the Clean Water Act’s National Pollutant Discharge Elimination System [NPDES]).

   Programs Requiring Quality Management Controls:

   In this section, you are asked to give careful attention to identification of the specific programs that require quality management controls. This discussion must also address where oversight is needed to ensure data quality, and where internal coordination of quality assurance and quality control (QA/QC) activities among the group’s organizational units need to occur.

   Using Tables to Simplify the QMP:

   See Section 2.0 for an example of table headings that could be used to simplify writing of the mission and organization section of the QMP.

   Example Mission Statements:

   “The Office of Analytical Services and Quality Assurance (OASQA)...is one of 30 Federal laboratories operated by EPA to support its mission to protect the environment. OASQA’s primary function is to ensure the appropriate quality of scientific information for environmental decisionmaking in Region III.”

   “The Department of Energy Nevada Radioactive Waste Acceptance Program (RWAP) will facilitate management of radioactive waste in a safe and compliant manner to ensure the integrity of the Nevada test site disposal operations, while maintaining the protection of the public, workers, and the environment.”

   “The Army will develop and implement measures to protect and sustain the environment in support of military operations, installation management, and material development.”

2. Provide an organizational chart that shows all organizational units associated with achieving the mission(s) covered by the Quality System. Identify the communication reporting network and organizational relationships, the functions of each organizational unit in achieving the mission, and the placement of the quality management function in each organizational unit.

   Definition of Organization:

   An organization is defined by ANSI/ASQC E4 as “...a company, corporation, firm, enterprise, or institution, or part thereof...that has its own functions and administration.” When used in this document, the term “organization” refers to the entity within a Federal agency that has “its own functions and administration” and that is responsible for writing a QMP under this policy document. In some cases the term “organizational unit” is used to refer to a unit of a larger organization that may have its own Quality System responsibilities, and for which Quality System information and procedures will require documentation in the QMP.

   Using References to Readily Available Documents:

   The use of attachments, readily available references, or Internet links for organization charts and tables with specific names, addresses, and telephone numbers allows for easy updating of this part of the QMP without having to change text that is otherwise still current. Include (such as with attachments to the QMP, references in the QMP to readily available documents, or links to the Internet in the QMP) organizational unit titles and organization manager and quality manager names. Include the street and electronic mail addresses and telephone numbers for QA managers and organizational unit managers.

3. Describe the work performed by each organizational unit identified. Specify the products, services, and activities that are supported by environmental data collection and use and environmental technology programs.

4. Identify other entities that the organization will work with to achieve its mission.

   Level of Specificity in Describing Other Entities:

   You may describe these entities generically (e.g., States or contractor) or specifically (e.g., by State or contractor name), depending upon the specificity the program requires. For example, a large contractor with a multi-year contract might be listed by name, while many small contractors with short-term tasks might be listed generically as categories of contracts.

5. State the Organization’s Quality Policy.

   • Integration of the Quality System into management policies and systems;

   • A Quality System that promotes sound science, consistency, efficiency, communication, responsiveness to customers, and innovation;

   • A Systematic Planning Process that results in the generation and use of environmental data of the type, quantity, and quality needed for decision making;

   • The use of QAPPs (e.g., project-specific quality plans, however named) in documenting project-specific data collection;

   • Design, construction, and operation of environmental technologies that meet the established specifications; and

   • Provision of funding needed to accomplish the defined quality objectives.

1.2 Quality System Roles, Responsibilities, and Authorities

1. Identify the responsibilities, authority and independence, and resources associated with the management of the Quality System.

   1. Identify a Quality Assurance (QA) Manager(s), or person(s) assigned equivalent duties, however named, who is responsible for overseeing the effective implementation of the Quality System within each organizational unit identified in the QMP.

      • The QA Manager, however named, must function independently of direct environmental data generation and use, model development, and technology development.

      • The QA Manager is responsible for reporting on quality issues to executive level management.

   2. Describe the roles, responsibilities, and areas of independence of QA personnel in assessing, taking corrective actions on, and improving the Quality System.

   3. Describe the lines of communication between QA personnel and management personnel and program/project staff in the organization.

   4. Describe the corrective action process(es) including criteria used for stopping work and resource expenditure when there is cause to believe that a quality control failure or Quality System nonconformance has occurred. For each organization or organizational unit covered by this QMP, identify the responsible individual(s) authorized to stop work.

   5. Specify the QA/QC responsibilities for senior management, line managers, program and project staff, and QA personnel in planning, implementing, assessing, and improving the Quality System, and the technical activities associated with that Quality System. Describe how attention to quality requirements is incorporated into personnel performance standards.

      Accountability for the Quality System:

      Successful development and implementation of the organization’s Quality System depend upon commitments to quality by individuals at every level of management and staff throughout the organization. The success of these commitments is measured in performance standards established at the beginning of a performance evaluation year and is assessed during and at the conclusion of the year. Different types of standards are appropriate for different responsibilities. Some examples are described below:

      • For the Executive Manager: Ensure that organizational levels are aware of Quality System responsibilities. Ensure that all management and technical staff have performance standards that hold them accountable for implementation of the Quality System. Participate in an annual assessment of the performance of the Quality System. Ensure that performance measures are established so that feedback on performance occurs and that corrective measures are taken in a timely manner.

      • For the Technical Manager: Ensure that all organizational levels are aware of Quality System responsibilities. Ensure that all management and technical staff have performance standards that hold them accountable for implementation of the Quality System. Ensure that customers and measurements of customer quality are identified for all products, services, and activities within your areas of responsibility. Ensure that a system is in place for communication with customers and suppliers. Establish a process for ensuring that customer needs are agreed to and met. Establish a process for taking corrective action when customer needs are not met.

   6. Describe the roles and responsibilities of government contractors as well as holders of Federal Government-funded assistance agreements (e.g., States, universities, and nonprofit institutions operating through interagency agreements, grants, or other agreements) in implementing and overseeing government Quality Systems. Identify and describe the quality oversight functions for government contracts that are inherently governmental and must be performed by government personnel, as well as those that can be delegated to contractor personnel. Identify the quality oversight functions that are inherent to the Federal Government in the oversight of its assistance agreements, and those that can be delegated to other governmental entities and assistance agreement holders.

      Inherently Governmental Functions:

      An “inherently governmental function” is defined in the Federal Acquisition Regulations (FAR Part 07, Subpart 7.5, 7501), as well as in the Office of Management and Budget (OMB) circular A-76 and supplemental guidance. The OMB A-76 definition notes that “an inherently governmental function is a function which is so intimately related to the public interest as to mandate performance by Government employees. ... These functions include those activities which require either the exercise of discretion in applying Government authority or the use of value judgement in making decisions for the Government.” The OMB circular and supplementary guidance provides numerous examples of functions that are and are not inherently governmental. According to the FAR, the definition of inherently governmental function is “a policy determination, not a legal determination.”

1.3 Resources to Support the Quality System

1. Describe the process used by senior management to provide resources (e.g., staff, travel, training, contractor support, equipment, and supplies) to plan, implement, assess, and improve the Quality System.

   1. Resource Planning: For each organization and program covered by this QMP, identify the responsibilities and procedures for annual estimation of resources required for managing quality. Identify priority funding areas.

   2. Evaluation of Expenditures: Describe an annual process for estimating expenditures and evaluating the adequacy of these resources to address potential weaknesses in the management of quality.

2. Resource planning and expenditure estimates must address: Government personnel, support to Government personnel (e.g., training, travel), and costs associated with contractor responsibilities where applicable.

Understanding What’s Required for Estimating Resources:

In this section, you are asked to develop a process for planning adequate resources and evaluating whether the budgeted resources sufficiently met targeted quality goals. Key elements of this requirement include:

• Deliberate use of the term “estimates” for both planning and evaluation so that significant levels of detail are not added to the planning, budgeting, and program evaluation process;

• Recognition that you may not receive all the resources you request and that you will have to target expenditures to the most critical areas; and

• An annual evaluation of estimated expenditures tied to the assessment of quality required in other sections of this document.

1.4 Quality System Customers and Suppliers

A Word About Customers and Suppliers:

Each product, service, or activity of environmental data collection or environmental technology programs involves both customers and suppliers. These relationships are often complex, and customers can sometimes be suppliers and vice versa. Customers and suppliers may be both internal and external to the organization.

• Customers: For a Federal facility collecting environmental data for a CERCLA cleanup, for example, the customer(s) may include members of the public, the regulators, or even the facility Remedial Project Manager. When a Federal facility is collecting discharge information to support its compliance with a State NPDES permit, the customer will be the State agency that will review the compliance information.

• Suppliers: Contractors, subcontractors, private and public laboratories, and many other providers of equipment, supplies, and services are the typical suppliers of environmental data and technology programs. It is important to recognize, however, that they may also be customers seeking guidance and direction from contract management personnel and technical staff.

  
  
  

  1. Quality System Customers: This section is designed to ensure that the Quality System includes a thoughtful process for identifying the customer for environmental data collection and use and environmental technology programs. Identify customers and their specifications, and describe the process by which those specifications are built into the systematic planning for and evaluation of environmental data collection and use and environmental technology development and implementation.

A Word About Customer Needs, Expectations, and Specifications:

ANSI/ASQC E4 uses the terms “needs and expectations” when referring to the constellation of specifications that are identified by customers. These specifications can be assigned different levels of priority depending upon whether they are “legal requirements” or customer expectations or preferences separate from legal requirements. For example, it will be an absolute requirement that a treatment facility meet legally mandated effluent discharge limits. A number of choices exist for how the treatment facility is built and designed to meet these requirements. While the customers (owner of the constructed treatment facility) may expect or prefer certain design and operation features, the ability to deliver these features may be dependent on a variety of resource (financial, schedule, and personnel) and contractual constraints.

Identification of customer specifications will often require distinction between requirements, expectations, and preferences, and will involve setting priorities in accordance with constraints to achieving customer demands. These constraints may be financial, contractual, and technical. Obviously more flexibility will exist in negotiating changes to customer expectations and preferences than in negotiating requirements. Although this document uses the shorthand term “specifications” when describing customer requirements, expectations, and preferences, that term is meant to reference the full range of customer demands.

1. Identification of Quality System Customers and Their Specifications: Identify the customers for each product, service, and activity that are the principal concern of the Quality System. Describe how customers’ requirements, expectations, and preferences (also called customer specifications) are identified by senior management. Specify senior management responsibilities in defining the work objectives to satisfy the customer specifications.

2. Development of Quality Measures of Customer Specifications: Describe the process for developing quality measurements associated with customer specifications for the products, services, and activities identified for each organizational unit covered by this QMP. Briefly describe the quality controls established to evaluate the conformance of specific products, services, and activities to customers’ specifications.

3. Negotiation of Changes to Customer Specifications and/or Quality Measurement: Describe the process for negotiating changes in customer specifications based on resource limitations or other constraints (e.g., technical, political). Describe a process for negotiating acceptable quality measures with customers when feedback from suppliers identifies resource or other constraints that prevent achieving the customers’ desired objectives. Outline appropriate dispute resolution procedures for disagreements over quality measures. Existing dispute resolution mechanisms can be cited (e.g., Federal facility agreements that govern CERCLA cleanups often have well-defined dispute resolution procedures that meet this requirement).

4. Accessibility to Information and Complaint Management: Describe how senior management provides customers with access to customer service personnel or the equivalent to enable them to seek assistance, conduct business, or voice complaints. Describe the organization’s complaint management process, including the chain of command for management of complaint resolution. Describe a management process and roles and responsibilities that ensure that complaints are resolved promptly and effectively and that complaints are compiled and analyzed for improving performance at all organizational levels.

5. Determining Customer Satisfaction: Briefly describe the process and information used to determine customer satisfaction or dissatisfaction with products and services. Describe the process that the organization uses to follow up with customers to ensure prompt corrective action and feedback to customers on performance issues.

Establishing Quality Measurements:

The products, services, and activities of environmental programs are quite varied. The challenge for each organizational unit is to identify the specific product, service, or activity associated with environmental data collection and use and environmental technology development and implementation, and to develop a measurable standard of quality.

For example, if an organization’s environmental data collection product is compliance monitoring to compare the effluent concentrations discharged against NPDES permit requirements, the customer for this activity may be the State regulatory agency. In this case, a customer quality measurement imposed on the supplier may be the percentage of samples analyzed by a contractor laboratory over a 1-month period that meet data validation and verification requirements.

1. Quality System Suppliers: Communication to and feedback from suppliers are critical elements of the Quality System’s ability to meet customer specifications. This section is designed to ensure that suppliers are identified and that a process for communication to and feedback from suppliers in meeting customer needs is put in place. (Section 4.0 contains more-detailed requirements related to procurement.)

   1. Identification of Suppliers: Identify the suppliers and backup suppliers of the products, services, and activities for which the organization documenting the Quality System is responsible.

      Identification of Suppliers:

      This refers to suppliers whose products, services, and activities directly affect the quality of the organization’s products, services, and activities. As many of these specific suppliers are project-dependent and may not be known in advance, the identification of generic types of suppliers may be appropriate.

   2. Communication with Suppliers: Describe how customers’ specifications are communicated to suppliers to ensure that the product, service, or activity meets these specifications. (See Section 1.5 below.)

   3. Feedback from Suppliers: Describe how feedback is obtained from suppliers on constraints (e.g., resources, technology) that affect their ability to meet specifications established for the products, services, and activities for which they are responsible.

1.5 Communication of the Quality System

1. Describe how the Quality System is communicated to personnel at all organizational levels by both management (senior and line) and QA personnel.

2. Describe how key decisions, directions, and specifications are effectively communicated to all customers and suppliers, both internal and external.

About Communication:

Importance: The most well-thought-out policies, procedures, and technical guidance to manage quality are only effective if communicated to all those who supply the organization’s needs. Communication of these policies to customers prior to their adoption is essential to ensure that the policies, procedures, and guidance are aligned with customer needs. If policies and procedures are not communicated to customers until after adoption, the organization and its customers may not have the same expectations as to how the Quality System is maintained and how customer needs will be met. Differing expectations are a frequent source of conflict in the implementation of environmental programs.

Who? As described in this section, customers and suppliers incorporate the universe of external and internal interests who are responsible for and are users of environmental data collection and environmental technology programs. Sometimes these individuals are also described as “stakeholders” and include: employees of the organizational units; support contractors, subcontractors, and their field personnel; State and Federal regulatory agencies; local government personnel; Indian Tribes; environmental organizations; reuse committees; Restoration Advisory Boards; and many others.

How? Effective communication requires a thoughtful commitment to thinking through the nature of the audiences and their needs for information. A communication strategy can be used to outline communication of different information to different audiences.

1.6 Management Assessment of the Quality System

1. Describe the Regular Management Assessment Process: For each organizational unit covered by the organization’s QMP, describe how the implementation and effectiveness of the Quality System are regularly assessed and documented. Such assessment will take place at least annually.

   • To evaluate whether the system produces environmental data and technologies of a quality adequate to support the organization’s mission;

   • To evaluate the adequacy of resources available to support the Quality System; and

   • To identify corrective actions that can improve, modify, and/or better implement the Quality System.

2. Identify Quality Measurements for the Quality System: Describe the process for assessing successful implementation of the Quality System.

   Management Quality System Measurements:

   Assessments of management Quality System performance and effectiveness are different but directly related to measurements of customer satisfaction. While customer Quality System measurements relate directly to customer specifications, management Quality System assessments will measure:

   • The frequency with which customer satisfaction measurements are achieved,

   • Staff knowledge of the customers and their quality requirements, and

   • The existence of a feedback system that systematically conveys customer requirements to suppliers.

3. Describe the management responsibilities for the assessment of the Quality System. Each organizational unit must be assessed.

4. Describe the processes used to report the results of assessments to senior management, determine appropriate corrective actions, and evaluate the effectiveness of the corrective actions.

Other elements of assessment procedures and requirements are contained in Section 9.0 of this document.

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