13. Corrective Action and Quality Improvement

Effective Date: 07/2008
Point of Contact: Quality Engineer for Regulatory Programs

The corrective action process consists of identification, evaluation, determination of corrective action, timely implementation of corrective action(s), and documentation. The corrective action process provides a basis for continuous improvement of project activities and services.

In addition to other sections of this Plan, Project staff comply with the following subject areas:

Documentation in the Assessment Tracking System (ATS) is required when a PNNL item or associated PNNL documentation does not meet one or more specified requirements, when samples are mishandled or misidentified by project staff, and when the quality of reportable data is inadequate or indeterminate (i.e., no objective evidence is available to substantiate data quality or to indicate that established procedures were met). The events leading to the problem shall be determined and documented, as well as the extent and impact of the problem on previous work and other work activities. Independent verification of corrective action is required. In cases where the client has misidentified or mishandled samples, actions stated in Section 3, Receiving and Handling Samples, shall be followed.

Nonconforming items must be clearly marked, easily recognizable, and segregated to prevent use (a yellow hold tag may be used for this purpose).

Project staff forward any issues or complaints from clients to the project manager for action. Issues and complaints can be received via written communications, conversations, telephone messages, and e-mail messages, etc. A copy is maintained in the project records as well as any subsequent actions.

The Project Manager or laboratory management is responsible for initiating, tracking, following up, and documenting in a timely manner all corrective actions in ATS that are required as a result of assessments.

The Quality Representative monitors results from internal and external assessments, quality problems, client complaints, and applicable performance indicators (e.g., failure rates) for trends. Analysis of this information will include, where possible, identifying common work processes for item quality problems, conducting cause-and-effect analysis, and determining effective corrective and preventive actions from external sources. Such results are reported to the Project Manager and/or laboratory management according to Section 14, Quality Assurance Reporting.

To support continuous improvement, lessons learned and operating experiences are communicated with staff through the PNNL Lessons Learned/Operating Experience website.

References

Assessment Management subject area
Issue Management subject area
Stopping and Restarting Work (Safety Rights and Responsibilities) subject area