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QUALITY MANAGEMENT PLAN FOR THE NATIONAL CHILDREN'S STUDY
Citation:
KANTOR, E. J., J. J. QUACKENBOSS, W. GALKE, AND D. MICHAEL. QUALITY MANAGEMENT PLAN FOR THE NATIONAL CHILDREN'S STUDY. Presented at National Children's Study Assembly Meeting, Washington, DC, November 29 - 30, 2005.
Impact/Purpose:
The objective of this task is to provide the National Children's Study Program Office with a quality management plan that will delineate a systematic planning process for the implementation of the National Children's Study. The QMP is to state the goals and objectives of the NCS, the management structure, project schedules, resources, milestones, and requirements. The QMP is to identify the type of data and information the study requires, how and where this information will be obtained, the study's design, boundaries and constraints. The QMP is to describe the multidisciplinary effort for the NCS and identify all QA documents needed for its implementation. The QMP will identify the organizations and persons responsible for the development, implementation, oversight, and monitoring of the NCS quality assurance requirements.
Description:
EPA has taken the lead, in consort with NIH, in developing the Quality Management Plan (QMP) for the National Children's Study (NCS); the QMP will delineate a systematic planning process for the implementation of the NCS. The QMP will state the goals and objectives of the NCS, the management structure, project schedules, resources, milestones, and requirements. The QMP will identify the type of data and information the study requires, how and where this information will be obtained, the study's design, boundaries and constraints. The QMP will describe the multidisciplinary effort for the NCS and identify all QA documents needed for its implementation. The QMP will identify the organizations and persons responsible for the development, implementation, oversight, and monitoring of the NCS quality assurance requirements. The Quality Management Plan for the NCS, which will serve as the "umbrella" quality assurance document under which individual project or institutional specific Quality Management Plans, Quality Assurance Project Plans (QAPP) and Standard Operating Procedures (SOP) will be developed and implemented. The NCS QMP will address how specific quality assurance (QA) and quality control (QC) activities will be coordinated, integrated, and monitored over the course of the 21+ year study. The QMP will cite and explain all individual QA documentation that is expected to be developed over the course of the NCS study, the timeline for its development, who is responsible for what, who reports to whom and what procedures will be in place to assure the successful implementation of the QAM and it subsequent component QMPs, QAPPs and SOPs. The specific roles, authorities, and responsibilities of the various Agencies and Offices involved with the NCS will be clearly delineated. This QMP will be based on EPA's Requirements for Quality Management Plans (QA/R-2) which can be found on the web at http://www.epa.gov/quality/qs-docs/r2-final.pdf.
The QMP will document the NCS Management and Organization, addressing NCS quality systems overall policy, scope, applicability, and management responsibilities. The Quality System Components will be discussed on how the NCS will manages its quality system and define the primary responsibilities for managing and implementing each component of the system. Personnel Qualification and Training will be reviewed to document the procedures for assuring that all personnel performing work for the NCS have the necessary skills to effectively accomplish their work. Procedures for Procurement of Items and Services that directly affect the quality of NCS activities will be documented. Appropriate controls for quality-related Documents and Records determined to be important to the mission of the NCS will be discussed. The QMP will document how the NCS will ensure that Computer Hardware and Software will satisfy its requirements. The QMP will document the Planning of individual data collection activities within the NCS to ensure that data or information collected are of the needed and expected quality for their desired use. And finally the QMP will describe or reference the process(es), including the roles, responsibilities, and authorities of management and staff for Assessment and Response. The QMP will Document how the NCS will determine the suitability and effectiveness of the implemented quality system.
Although this work was reviewed by EPA and approved for publication, it may not necessarily reflect official Agency policy.