![[logo] US EPA](https://webarchive.library.unt.edu/eot2008/20090507204843im_/http://www.epa.gov/epafiles/images/logo_epaseal.gif){kind=logo}
Frequent Questions - General Quality System Questions
- What is a quality system?
- Does a quality system ensure that data collected
are 'good' data?
- What is the difference between quality assurance
and a quality system?
- What is the difference between quality assurance
and quality control?
- What is the difference between a Quality Management
Plan and a Quality Assurance Project Plan?
- Which EPA documents do I use to implement
and manage my quality system?
- Must a Quality Management Plan be called a Quality Management Plan, and similarly, must a Quality Assurance Project Plan be called a Quality Assurance Project Plan?
What is a quality system? A quality system is the means by which an organization manages its quality aspects in a systematic, organized manner and provides a framework for planning, implementing, and assessing work performed by an organization and for carrying out required quality assurance and quality control activities. It encompasses a variety of technical and administrative elements, including:
- policies and objectives,
- organizational authority,
- responsibilities,
- accountability, and
- procedures and practices.
Does a quality system ensure that data collected are 'good' data? No. Data are neither 'good' or 'bad' but rather data are either useful for their intended purpose or not useful for their intended purpose. One must know in what context data are to be used to judge whether or not the data are adequate.
What is the difference between quality assurance and a quality system? Quality assurance is a system of management activities to ensure that a process, item, or service is of the type and quality needed by the user. Thus, quality assurance is just one part of a quality system. A quality system provides the framework for developing quality assurance policy and management controls.
What is the difference between quality assurance and quality control? Quality assurance is a management or oversight function; it deals with setting policy and running an administrative system of management controls that cover planning, implementation, and review of data collection activities and the use of data in decision making. Quality control is a technical function that includes all the scientific precautions, such as calibrations and duplications, that are needed to acquire data of known and adequate quality.
What is the difference between a Quality Management Plan and a Quality Assurance Project Plan? A Quality Management Plan is a document that describes a quality system in terms of the organizational structure, policy and procedures, functional responsibilities of management and staff, lines of authority, and required interfaces for those planning, implementing, documenting, and assessing all activities conducted. A Quality Assurance Project Plan is a document that describes the necessary quality assurance, quality control, and other technical activities that must be implemented to ensure that the results of the work performed will satisfy the stated performance criteria. A Quality Management Plan documents the overall organization/program whereas a Quality Assurance Project Plan documents project-specific information. Usually you document your quality system once (and update it on a regular basis) but need to document the quality assurance activities for each project.
Which EPA documents do I use to implement and manage my quality system? If you are not an EPA employee, use:
- EPA Requirements for Quality Management Plans (QA/R-2),
- EPA Requirements for Quality Assurance Project Plans (QA/R-5) and
- any applicable guidance including that produced by the EPA Quality Staff or the EPA organization sponsoring the work.
If you are an EPA employee, use:
- EPA Order CIO 2105.0 (PDF 12pp, 94K About PDF),
- EPA Quality Manual for Environmental Programs, CIO 2105-P-01-0 (PDF 62pp, 169K About PDF), and
- any applicable guidance including that produced by the EPA Quality Staff or the EPA organization sponsoring the work.
Note: EPA may also use EPA Requirements for Quality Management Plans (QA/R-2) and EPA Requirements for Quality Assurance Project Plans (QA/R-5) since these documents contain the equivalent specifications as Chapters 3 and 5 of EPA Manual 2105-P-1-0, respectively.
For directions on accessing the files listed above, see Information About Downloadable Files. For copies of guidance produced by the EPA Quality Staff see Agency-wide Quality System Documents.
Must a Quality Management Plan be called a Quality Management Plan, and similarly, must a Quality Assurance Project Plan be called a Quality Assurance Project Plan? No. As long as all the required information is provided, the title of the documentation does not matter.