A QA Project Plan (QAPP) describes the necessary QA procedures, quality control (QC) activities, and other technical activities that will be implemented for a specific project or program.
A Project Quality Management Plan describes an organization's quality system,
i.e., its systematic approach to quality
assurance. The Quality Management Plan is also know as the Quality Management System, (QMS). ISO 9001 provides guidelines for one type of QMS.
A QAPP describes the activities of the data operations project involved with the acquisition of QA information whether generated from direct measurements activities, collected from other sources, or compiled from computerized databases and information systems.
The QAPP documents the results of a project's technical planning process, providing in one place a clear, concise, and complete plan for the QA data operation and its quality objectives and identifying key project personnel.
Yes. With permission of the QA Manager of the organization sponsoring the work, these two documents may be combined into a single document for small programs, grants, and contracts. The combined document should address satisfactorily all the elements of both documents.
The QAPP communicate, to all parties, the specifications for implementation of the project design and to ensure that the quality objectives are achieved for the project.
It does not guarantee success every time, but the prospects are much higher with a QA Project Plan than without one. Up-front planning eliminates approaches that do not work well (or not at all), which potentially reduces the cost of lost time and rework.
Implementation as prescribed, with appropriate QC practices employed, increases efficiency and provides for early detection of problems, either in the field or in the laboratory. This again saves time and money from the rework and enables the ability to make decisions more expeditiously. For example, following calibration procedures help assures the credibility and usability of data generated by laboratory instruments.
Prepare a QAPP is prepared either part of or after the project planning process. But in all cases, the QAPP should be completed and approved before the starting the project.
The following is a brief summary of the process:
Yes. Complete all work involving the collection or use of data with an approved QAPP. A QA Project Plan should generally be approved before any data collection operation starts.
Advance approval ensures that the team completed all the planning steps, including connecting actions with needs. Clear documentation increases the likelihood that the project achieves its intended results. If the plan is not approved before work begins, a stop-work order may be issued.
When changes affect the scope, implementation, or assessment of the outcome, revise the plan to keep project information current. The Project Manager, with the assistance of the QA Manager, determines the impact of any changes on the technical and quality objectives of the project.
For long-term projects, such as multi-year monitoring programs, review the QA Project Plan annually by the Project Manager to determine the need for revision.
When a substantive change warrants, the originator of the QAPP revises the plan to document the change, and then submits the revised plan to the approving authority. Implement the change only after approval of the revision. Send the revised plan to all the individuals cited in the distribution list.
Document retention should comply with the approving organization's specifications first, and the specifications of the organization performing the work second.
Divide the QAPP into four basic element groups:
A QAPP that addresses the basic elements defines and describes the following:
What if some of the elements do not apply? Plans vary in their level of complexity, based both on the nature of the work being performed (such as the collection of new data or the use of previously collected information), available resources, and the intended use of the data.
The organization sponsoring or overseeing the work may specify additional information to clarify project-specific information.
Referring to existing documents can reduce the plan preparation and review time and length. Any documents prepared before the QAPP, such as standard operating procedures (SOPs), sampling and analysis plans (SAPs), work plans, assessments, literature files, and data sets from other projects, may be appended. Alternatively, they may be incorporated by reference, if those sources are readily available to both reviewers and project personnel who implement the QAPP.
A Plan should have enough information to describe project objectives and details. The number of pages needed to address this information varies with the complexity of the project and intended use of the information.
A plan for some QA data operations may involve a qualitative discussion of the experimental process and its objectives, while a plan that describes a complex project may involve extensive documentation to adequately describe activities.
Multi-year projects, and projects conducted at multiple sites, containing the same project objectives and sampling and analytical processes, may be described in a generic QAPP. You may describe site specific activities in supplements, for example, separate field sampling plans. Review generic plans annually to determine if any changes are necessary.
is a process in which you identify the problem to be investigated or the
decision to be made, and
then define the project's objectives, the type, quantity and quality of
information needed, the technical
and quality control activities, and the level of oversight to ensure
satisfaction of project criteria.
Project planning necessitates the coordinated efforts of many individuals, such as those who generates information and those who uses the information or make decisions based on that information. These individuals include:
and technical staff (for example, hydrologists, chemists, data validators, samplers, and statisticians).
In addition, include peer reviewers and individuals with varied expertise to ensure it sufficiently addresses technical areas, thus helping to minimize problems during implementation.
Those who are both involved in planning the project and experienced in the operations, prepare and/or assist in the preparation of the QA Project Plan. For internal projects, the Project Manager or Principal Investigator is generally responsible for overseeing plan preparation. For externally funded projects, the recipient of the funds is usually responsible for project plan development.
This varies with each organization. Reviewers with expertise in the project specific areas, such as
These reviewers may also use tools, such as a checklist, in their review.
The approving authority will vary with the individual organization. The organization's Project Quality Management Plan establishes how, when, and by whom development, review, approval, and effective oversight of QA Project Plans should occur. This includes processes for extramural organizations that prepare QA Project Plans.
The Project Manager or Project Officer, and the QA Manager usually approves the QA Project Plan. For extramural projects, the responsible organization's Project Manager, or Principal Investigator, and QA Manager may review and approve the QA Project Plan, and then submit it for customer approval. It is also beneficial if other key staff, such as the laboratory directors and prime contractors and subcontractors, sign the plan to indicate their review and approval
In situations where only non-critical deficiencies in a QAPP have not been resolved (such as a final organizational chart or a data analysis procedure that will not be followed for weeks), conditional approval may be given to allow the project to start while these deficiencies are being resolved. The plan is then resubmitted for approval when the information is finalized. The concept of conditional approval, however, varies with individual organizations; some organizations may not permit conditional approval of a QA Project Plan.
All personnel involved in the project should retain or have access to the current version of the QAPP. This may include the Project Manager, laboratory manager, field team leader, modeler, QA Manager, data reviewers, and any essential contractor and subcontractor personnel involved with the project.
The organization performing the work is responsible for ensuring that the QAPP is implemented as written and approved, whether this work is conducted by contract personnel or in-house personnel. Ultimately the Project Manager is responsible for project activities. A clearly written QA Project Plan will help the Project Manager implement the plan, because all project personnel will understand the specifications before the start of data generation activities.
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