11. Assessments
Effective Date: 07/2008
Point of Contact: Quality Engineer for Regulatory Programs
Several systems are used to monitor or assess the ability to conform to the requirements of this plan. The following monitoring systems are tools that are used to measure the degree of conformance with this plan, to determine the effectiveness of the plan, and to continually improve the quality of products and services provided. The Project Manager is responsible for initiating, tracking, following up, and documenting in a timely manner all corrective actions that are required as a result of assessments in accordance with Section 13, Corrective Action and Quality Improvement.
Management System Assessments
The project manager or personnel responsible for overseeing and/or performing the work direct an annual management system assessment (MSA). Management system assessments determine both noteworthy accomplishments and significant QA issues and identify opportunities for improvement.
The purpose of this assessment is to evaluate the following:
- Effectiveness of the management control systems that are established to achieve and assure quality
- Adequacy of resources and personnel available to achieve quality objectives to which the quality systems apply
- Effectiveness of training and assessment
- Applicability of data quality requirements
- Client complaints.
The results of the MSA are documented in a report that is distributed to appropriate project staff. The Self-Assessment Report exhibit may be used to document the assessment, or the report generated must contain the following information as a minimum:
- name of participant(s)
- date of assessment
- location of assessment
- date of report
- itemized account of all documents/procedures reviewed with a summary of deficiencies and/or conclusions
- time frame for correction of deficiencies
- name of action owner(s)
- follow-up report with all updates and/or corrective actions attached
- actual date corrective actions/updates were implemented, including approvals.
The distribution of the report is determined based on the assessment outcome.
Assessments shall be maintained in the project records.
Technical System Assessments
The project manager or laboratory or QA personnel direct technical system assessments (TSAs) periodically throughout the duration of a project. The goal is to cover critical practices over the project's life cycle.
The TSA is performed by personnel independent of those having direct responsibility for the activity being evaluated.
The results of the TSA are documented in a report that is distributed to appropriate project staff. The Self-Assessment Report exhibit may be used to document the assessment, or the report generated must contain the following information as a minimum:
- name of participant(s)
- date of assessment
- date of report
- itemized account of all documents/procedures reviewed with a summary of deficiencies and or conclusions
- time frame for correction of deficiencies
- name of action owner(s)
- follow-up report with all updates and/or corrective actions attached
- actual date corrective actions/updates were implemented, including approvals.
The distribution of the report is determined based on the assessment outcome.
Assessments shall be maintained in the project records.
Performance Evaluation Assessments
Staff supporting the project demonstrate that they can meet the client data quality requirements by participating in an external blind, annually at a minimum, if such a program is available for the analyte(s) of interest. For assistance in identifying performance evaluation programs contact the PE Coordinator. Document the identified performance evaluation program(s) on the Project Planning Checklist.
Analytical results are submitted to the originating agency and the staff receive a summary of performance back. Results from the external blind shall be distributed to all participating staff and shall be made available to regulators and clients upon request. Any deficiencies noted require timely corrective action.
The analytical results, summary of performance, and any corrective actions are maintained as records.
Quality System Assessments
The adequacy of the quality system and its implementation shall be assessed annually as an independent assessment. An external assessment may be used to fulfill this requirement.