Appendix B

Requirements for Quality Management Plans (QMPs)

This quality management plan (QMP) requirements list is applicable to multi-year, multi-project efforts and is based on EPA guidance (PDF) (30 pp, 87 KB, About PDF). A QMP defines an organization's quality system and documents policies and procedures that will be used to meet customer's quality needs.

Note (1): If a requirement is not applicable, state "not applicable" and provide an explanation regarding why. Note (2): To eliminate redundancy, reference to other sections of the QMP is permissible. Note (3): Ensure that the QMP clearly designates the personnel responsible for performing each procedure described in the QMP.

Section 0.0: QMP Approval

An approval page for the signatures of the senior accountable manager, senior line management (as appropriate) and the QA manager of the organization(s) that are part of this program level quality system needs to be provided. Signatures must be obtained prior to submitting the QMP for Agency review.

Section 1.0: Project Objectives and Responsibilities

1.1		Program Quality Policy. State the "quality policy" established and implemented by program management which ensures that this environmental program produces the type and quality of results needed and expected.

1.2		Program Organizational Structure and Communication. Describe functional responsibilities (including QA personnel), levels of accountability, authority, and communication for each organization that is part of this program level quality system. Demonstrate that the QA Manager(s) is/are independent of groups generating, compiling, and evaluating environmental data. Include a discussion of how disputes regarding quality system requirements, QA/QC procedures, assessments, or corrective actions are resolved. Note: It may be helpful to include organizational charts in addition to a narrative discussion.

1.3		Technical Activities. Briefly describe all technical activities (e.g., basic research, technology evaluation, modeling, technology construction, etc.) that are supported by the quality system.

1.4		Communicating the Program's Quality System. Describe how program management ensures that the quality management plan is communicated to and understood by those who are required to follow it (e.g., training, meetings, etc.).

1.5		Resources. Describe program management procedures for allocating resources (human and financial) to implement the quality system (including, but not limited to, personnel training, quality system audits).

1.6		Authority to Stop Work for Safety and Quality Considerations. Define who has the authority to stop unsafe work, or work of inadequate quality.

1.7		Management Assessment of Quality System Adequacy. Describe how program management assesses and documents quality system adequacy. Include frequency of assessment, description of assessment (purpose, types of activities reviewed), and possible response actions.

Section 2.0: Quality System and Description

2.1		Quality System Elements. Generally describe the principal components (or "tools") comprising the quality system and how they are used to implement the quality system. This includes (but is not limited to): QMPs; QA project plans, standard operating procedures; and audits/assessments. Include how and when each component is applied to individual projects and tasks.

2.2		Quality Management Plan Reviews and Revisions. Describe procedures for updating quality system documentation.

Section 3.0: Personnel Qualification and Training

3.1		Personnel Training and Qualification Procedures. Describe how program management ensures that all personnel performing work (including subcontractors, if applicable) are trained and qualified to perform work prior to initiating work. In addition to formal education, include specific on-the-job training for technical and management personnel (e.g., lab, field, health and safety, management, QA).

3.2		Formal Qualifications and Certifications for Specialized Activities. Identify when formal qualification or certification is required.

3.3		Training Documentation. Describe how program management ensures that required training is performed and documented.

3.4		Evidence of Personnel Job Proficiency. Describe how objective evidence of personnel job proficiency is documented and maintained.

3.5		Re-Training. Describe how the need for re-training is evaluated.

Section 4.0: Procurement of Items and Services Related to Technical Activities

4.1		Procurement Planning and Control. Describe procedures for planning and controlling the procurement of items and services (e.g., subcontractor who provides analytical support, subcontractor who provides drilling support, calibrated sampling equipment, etc.).

4.2		Procurement Technical and Quality Requirements. Describe procedures for ensuring that procurement documents (e.g., formal contract with subcontractor, purchase order for equipment, etc.) clearly describe the item or service needed and the associated technical and quality requirements (including a quality system consistent with EPA requirements when applicable). Include a discussion of when procurement documents will require the supplier to furnish a demonstrated capability to furnish items and services that meet all requirements and specifications.

4.3		Procurement Document Specification of Verifying Supplier's Conformance. Describe procedures for ensuring that procurement documents specify how the supplier's conformance to customer's requirements will be verified.

4.4		Procurement Document Review. Describe procedures for the internal review of procurement documents to ensure accuracy and completeness.

4.5		Review of Changed Procurement Documents. Describe procedures for ensuring that changed procurement documents receive the same level of internal review and approval as the original documents.

4.6		Review of Procured Items and Services. Describe how procured items and services are reviewed to ensure compliance with requirements and specifications.

Section 5.0: Documents and Records

5.1		Records Management Procedures. Describe records management procedures from preparation to disposal, including maintenance (protection from damage and deterioration), storage (including accessibility), and retention (including disposition in accordance with statutory or contractual requirements). Describe how these records management procedures are controlled and maintained. Include printed and electronic records. Identify which documents/electronic records are included under these record management procedures (e.g., QAPP, data package, electronic data, laboratory notebooks, chain-of-custody forms, etc.).

5.2		Document Control. Identify which documents require control (e.g., technical manuals, operating procedures, QAPPs, SOPs, final reports, etc.). Describe procedures for document review and approval (internal to the organization and external, e.g., client), and revision (before and after submission to client). Include procedures for distribution, replacement of previous document versions, and for ensuring that obsolete documents are no longer used.

Section 6.0: Computer Hardware and Software

This section applies to computer hardware and software operations that directly impact the quality of the results of environmental programs (both developed and purchased) including: design, design analysis, data handling, data analysis, modeling of environmental processes and conditions, operations or process control, and data bases.

6.1		Conformance to User and EPA Requirements. Describe procedures for ensuring computer software and computer hardware/software configurations meet user's requirements and conform to applicable EPA requirements (e.g., Y2K compliance, security [protection from physical loss of data], and privacy [protection from unauthorized use of data]).

6.2		Configuration Testing. Describe procedures for testing computer hardware/software configurations prior to use to ensure technical requirements and quality expectations are met; include how the results of configuration tests are documented and maintained.

6.3		Configuration Change Assessment. Describe procedures for assessing changes to hardware/software configurations; include how changes are evaluated based on the impact on technical and quality objectives of the program.

6.4		Re-Testing and Re-Documentation. Describe procedures for re-testing and re-documentation when components are changed (creating a new configuration) or when program requirements change (bringing capability of the configuration into question).

In addition to environmental data collection activities, Sections 7-10 must also be addressed for the design, construction, and operation of environmental technologies; use of secondary data (i.e., use of environmental data); and development/modification of mathematical models (i.e., use and/or generation of environmental data), when applicable.

Section 7.0: Project Planning

7.1		Planning and Documenting the Generation, Acquisition, and Use of Environmental Data. Describe procedures for planning and documenting all work involving the generation, acquisition, and use of environmental data (and the design, construction, and operation of environmental technologies as applicable). Identify types of planning documents generated (e.g., work plans, QAPPs, etc.) and summarize their purpose.

7.2		Identifying and Documenting Type and Quality of Environmental Data Needed. Describe how the type and quality of environmental data needed (including secondary data, mathematical models, and the quality of technology design) are identified. Describe how this information is documented (e.g., DQO Process, QAPP, etc.).

7.3		Including Key Users, Customers, and Technical Staff in Planning. For each applicable technical activity, describe procedures for involving the key users and customers of the data (and technology or model), in addition to the technical staff, during project-specific planning.

7.4		Reviewing and Approving Planning Documents. Describe procedures used for review and approval (internal to organization and external, e.g., client) of planning documents prior to initiation of work. Reference to Section 5.0 may be applicable.

Section 8.0: Implementation of Work Processes

8.1		Implementation of Work According to Planning Documents. Describe procedures (e.g., meetings, documentation) for ensuring that all work is performed according to approved planning and technical documents.

8.2		Standard Operating Procedures Documentation. Describe the process for documenting standard operating procedures. Describe how standard operating procedures should be written so that they are easily understood by the user and contain sufficient detail and clarity.

Section 9.0: Project Assessment and Response

For the purposes of this section, audits and assessments are synonymous.

9.1		Planning Project Assessments. Describe how, in the planning stage, management determines the appropriate type of assessment activity (e.g., technical systems audit, performance evaluation audit, etc.) for a particular project.

9.2		Assessment Planning and Procedures. Describe the process used to ensure assessments are performed according to approved written procedures.

9.3		Assessment Personnel Qualifications. Describe procedures for ensuring that assessments are performed by qualified personnel. Assessors shall be capable of assessing technical requirements and other procedures specified in the planning document.

9.4		Assessor Responsibility and Authority to Stop Work. Describe the assessor's responsibility and authority to stop work. Describe conditions under which a stop work order may be needed.

9.5		Assessment Documentation, Reporting, and Review. Describe assessment documentation, reporting, and review procedures. Include procedures for documenting and reporting assessment results to management. Include a discussion of how the assessor reports the impact of a negative assessment result on planned operations. For each procedure, include a time line for completion.

9.6		Assessment Responses and Follow-up Action. Describe procedures for documenting assessment responses and how corrective action occurs. Include how follow-up is performed to ensure action was taken. For each procedure, include a time line for completion.

Section 10.0: Assessment and Verification of Data Usability

10.1		Assessing, Verifying, and Qualifying Data. Describe procedures for assessing, verifying/validating, and qualifying data obtained from environmental data operations according to their planned intended use, including secondary data and mathematical modeling. (Describe procedures for assessing and verifying the performance of environmental technology for its intended use.).

10.2		Expressing and Documenting Limitations on Data. Describe procedures for expressing and documenting (in print, or electronically) any limitations on this intended data use (and/or technology performance).

10.3		Providing Independent Review of Data-Containing Project Reports. Describe procedures for the independent review of project reports containing data, or reports containing the results of environmental data operations (and/or technology performance), to confirm that the data or results are presented correctly. Reference to Section 5.0 may be applicable.

10.4		Management Approval of Reports. Describe procedures for obtaining management approval of these reports prior to release, publication, or distribution. Reference to Section 5.0 may be applicable.

Section 11.0: Quality System Improvement

11.1		Quality Improvement Process. Describe the quality improvement process used to continuously develop and improve the quality system. Include procedures such as communication with and among customers and suppliers; staff identification of problems and solutions, etc.

11.2		Preventing, Detecting and Correcting Quality System Problems. Describe procedures used to prevent, detect and correct quality system problems.

11.3		Response Actions. Describe procedures for planning, documenting, and implementing response actions to quality system problems.