Contents

10. Document Control

Effective Date: 11/01
Point of Contact: Quality Engineer for Regulatory Programs

Documents that specify quality requirements or prescribe activities affecting quality, e.g., procedures and instructions and changes to these, are controlled in order to ensure that the versions used are complete, correct, and current. Controls include review, approval, and distribution control.

Project staff control test plans, technical and operating procedures and Interim Change Notices (ICNs) in accordance with Document Control subject area. Note: These are the minimum documents that must be controlled.

Project staff use the Interim Change Notice (ICN) form for the purpose of making a correction or simple modification to a document. The ICN provides for identifying, approving, and issuing the change within a short period of time. The ICN receives the same level of review and approval as the original document if the process is changed or the change is technical in nature. Since multiple ICNs can make a document difficult to implement, it is policy that a document be revised when a change is extensive or there are already three ICNs applied to the document.

The procedure owner ensures a current controlled version of all applicable procedures is readily accessible at each place where work covered by the procedure is performed. The use of uncontrolled copies of procedures in laboratories is prohibited.

Project staff use only the most recent versions of procedures for performing work. Older copies may be retained for reference purposes provided they are clearly marked as "obsolete" or "superseded" otherwise they are discarded.

Explanatory notes not changing the procedure may be made on controlled copies of procedures.

References

Document Control subject area