ORA Laboratory Policies
Food and Drug Administration
The document control and management procedure in each laboratory describes the process for controlling quality documents that form part of its management system. The quality documents include those required for the generation of laboratory data. These documents include those published by the laboratory and those published externally. Documents of external origin include regulations, standards, test methods, instructions and manuals.
4.3.2 Document Approval and Issue
Documents issued to personnel in the laboratory as part of the management system are reviewed and approved for use prior to issue in accordance with the laboratory’s document control and management procedure. The laboratory’s master list identifies the current revision status and distribution of documents in the management system. Through the use of the master list, quality documents are posted to personnel to preclude the use of invalid or obsolete documents.
220.127.116.11 Procedure Content
The laboratory’s master list and document control and record management procedure provide for the following:
- Authorized management system documents and external documents are at locations where operations essential to the effective functioning of the laboratory are performed.
- Documents are reviewed according to a schedule and revised to ensure continuing suitability and conformance with the management system and ISO/IEC 17025 requirements.
- Invalid or obsolete documents are promptly removed from all points of issue or use, or marked as Uncontrolled to assure against unintended use.
- Obsolete documents retained for either legal or knowledge preservation purposes are suitably marked such as Archived or Obsolete.
18.104.22.168 Document Identification
A document control header as described in the laboratory’s document control and management procedure uniquely identifies management system documents generated by the laboratory. Such identification includes the identification number and inclusive pagination. The issuing authority is indicated by the name of the approving official for each document.
4.3.3 Document Changes
Changes to documents are reviewed and approved in accordance with the laboratory’s document control and management procedure. Unless designated otherwise, this procedure is followed by the same personnel or function as in the original review or approval. The use of reference documents and information is required upon which to base the review and approval.
The altered or new text is identified either in the document, document change history section, on a cover page, redline file, or in attachments. Changes can be described in general terms since the details can be demonstrated in the archived document.
The laboratory’s document control and management procedure addresses the handling of document amendments by hand pending reissue.
22.214.171.124 Computerized Systems
The laboratory’s document control and management procedure addresses the control of electronic management system documents.
- Each ORA laboratory has its own document control and management procedure. A template is provided in Volume II, Section 1, ORA-LAB.4.3, Document Control and Management
- ORA-QMS.001, Document Control and Management