Chapter 8

Implementation of Work Processes

Once proper planning has been performed (as described in Chapter 7), it is important that the implementation of the required procedures be done. It is the responsibility of the EPA TLP to ensure that the required procedures are properly implemented.

8.1 QAPP Development, Review, and Approval

The EPA TLP develops a QAPP based on NRMRL guidance (see Chapter 2 and Appendix B). The QAPP must be reviewed and approved by the Division QA Manager with concurrence by the Branch Chief before the project begins. A research project begins as soon as TLP is prepared to collect data/information to support Agency decisions or for inclusion in research products (e.g., reports [both paper and electronic], journal articles, symposium/conference papers, extended abstracts, computer products/software/models/databases, or scientific data). QA comments are documented in a memo or a review form to the TLP, with a copy forwarded to the TLP's first line supervisor. The format of this memo or review form may be Division-specific.

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8.2 SOP Development

In some instances, procedures for sampling, analysis, or other quality activity (e.g., standards preparation) are routine and are used for more than one project. Oftentimes, it is necessary that more than one person perform a procedure. In these cases, an SOP should be written. SOPs are also recommended for special or critical operations. SOPs can make the development of QAPPs more efficient, since they can be attached or referenced. The need for the development of an SOP is determined by the TLP, QAM, or line management. SOPs must be reviewed and approved as described previously in Section 2.3.4.4.

1. Scope and Application
2. Method Summary
3. Sample Preservation, Containers, Handling, and Storage
4. Reagents
5. Equipment/Apparatus
6. Procedure
7. Calculations
8. Quality Assurance/Quality Control
9. References

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8.3 QAPP/SOP Implementation

It is the responsibility of the Branch Chief to ensure that the general procedures utilized throughout the Branch are implemented during data collection activities (e.g., ORD Policy 13.4). This is a significant part of ensuring that the requirements of the Laboratory Competency Policy (PDF) (4 pp, 183 KB) are met. It is the responsibility of the EPA TLP to ensure that the required procedures specified during the planning process for a specific project are implemented during data collection activities. This is done by the TLP personally observing the procedures being performed or by requesting that the Division QA Manager perform an audit of the project activities outlined in a QAPP and/or SOP. In either case, deviations from project requirements must be documented, along with the corrective action performed. Corrective action must be performed as soon as possible to minimize any effect on data quality. If data quality is affected by any deviations, this must be discussed in any project report/paper.

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8.4 QAPP/SOP Revisions

During the course of a project, it may be necessary to revise QAPPs and/or SOPs. Revisions are required whenever a significant change in the plan or procedure occurs. Over time, it may also be necessary to revise QAPPs and/or SOPs to ensure they are still applicable for the work being performed. QAPPs and project-related SOPs need to be reviewed on a yearly basis for long-term projects. This review should be documented in a memo (or e-mail) from the TLP to the QAM stating either that no revision is required or providing a tentative date for the submission for approval of a revised QAPP and/or project-related SOP.

Branch/Division SOPs that are not project-specific need to be reviewed every 2 years. This review can be documented by e-mail or a dated note on the cover page indicating either that no revision is necessary or a tentative date for submission for approval of a revised SOP. Revisions (as necessary) in the form of an addendum or fully revised document must be made as soon as a significant change is identified. Significant revisions to a QAPP/SOP must go through the same review and approval process as new documents as presented in Section 8.1 above for QAPPs and Section 2.3.4.4 for SOPs. It must then be verified that the revised procedures are being implemented properly, as discussed in Section 8.3. Copies of the most current document must be made available to the appropriate project/branch/division personnel. All previous document versions must be archived.

Responsibilities for revisions to, distribution of, and archival of QAPPs/SOPs are as follows:

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