9. Records Management
Effective Date: 07/2008
Point of Contact: Quality Engineer for Regulatory Programs
Staff shall comply with the Records Management and Laboratory Record Books subject area.
Analytical laboratory staff members shall treat the following, as a minimum, as records:
- record books and equivalent records that document laboratory activities and data
- sample log-in and tracking records
- project documentation (e.g., analytical services request, Statement of Work, work order, client agreement)
- sample data
- standards data (including preparations and calibrations)
- QC data, including control charts when generated
- operating logs
- results of reviews
- assessments
- training documentation
- procedures.
Electronic data and other project information used as final record material must be stored in PNNL's Total Records Information Management (TRIM) storage system.
The project manager and project staff will determine which records will be located directly in the project records and which records will be referenced therein.
Client confidentiality, proprietary rights, and other related issues are discussed comprehensively in the SBMS subject area, Sensitive Unclassified Information.
Specifically, staff will not:
- Share or release specific data to parties other than the client, unless specifically requested by the client in writing. In general, this means that client information will not be divulged to individuals other than the client or their designees. On occasion, staff may utilize generalized results; however, client details will not be released.
- Divulge client information, as included in audits or review of records, to auditing personnel of other clients. Client auditors may review data and reports produced for their organization only. The only auditing groups that may be granted access to multiple client reports and data are accreditation on-site assessors, the Department of Energy (DOE), and PNNL's quality assurance personnel.
- Divulge client information to persons within DOE or PNNL without the need to know for business purposes.
Computer systems containing confidential or proprietary information shall be password protected with access limited to persons with a need to know for business reasons. The SBMS subject area, Unclassified Cyber Security, shall be followed.
References
Records Management subject area
Laboratory Record Books subject area
Sensitive Unclassified Information subject area
Unclassified Cyber Security subject area