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PURPOSE This procedure establishes a consistent approach for managing controlled and uncontrolled documents. This procedure interprets the requirements of Oak Ridge National Laboratory (ORNL) Procedure IO- 201, "Document Control" and replaces the ORNL Quality Assurance Procedure QA-L-6-100, "Document Control." Until revision, ORNL IO-201 will be a supplement to this procedure. APPLIES TO This procedure applies to documents created, maintained, released, received, and distributed by ORNL organizations, guest researchers, and ORNL subcontractors. Vendor documentation that is substituted for controlled procedures and used directly to perform work is managed according to requirements of this procedure. OTHER ORNL Records Management procedures may be supplemented DOCUMENTS by division, program, or operating document management NEEDED procedures when necessary. Supplementary procedures reflect ORNL requirements. Copies of supplementary procedures will be sent to the ORNL Records manager during first review. WHAT TO DO A. Categorization Originating Categorizes documents as controlled or uncontrolled. Organization Documents that must be controlled include, but are not limited to: o Documents that define technical requirements of safety or safety-related systems, structures, and components o Documents that provide instruction for operation and/or maintenance of safety or safety-related systems or equipment (e.g., procedural documents) o Baseline documents associated with configuration management facilities, systems, or activities o Other documents based on the complexity, importance, and risk associated with their related activities, including drawings and instructions; licensing requirements; manufacturing instructions; QA and quality control manuals and plans; specifications; and documents related to environment, safety, and health B. Management NOTE: Line managers determine which alternatives apply to uncontrolled documents. Manages both categories of documents in accordance with guidance provided in Appendix A, "Document Management Matrix." C. Documentation Documents categorization and management decisions from Subsections A and B. RECORDS o Controlled Document List o Controlled Document Transmittal/Receipt o Distribution Lists for controlled documents o Document control procedures or operating instructions REFERENCES o IO-201, "Document Control" Approved by: [R. I. Van Hook] Executive Vice President Lockheed Martin Energy Research Corporation
APPENDIX A Document management matrix ___________________________________________________________________________ Activity/responsible Controlled Uncontrolled person documents documents ___________________________________________________________________________ Creation/ Ensure that document has Ensure that document creator and sponsor unique identification, can be linked to revision levels, and activity page numbers including total number of pages Ensure that document is Ensure that document is complete, legible, complete, legible, accurate, technically accurate, technically adequate, reproducible/ adequate, reproducible/ translatable (i.e., translatable (i.e., language and format), language and format), and useable and useable Review/ line manager Identifies reviewers Determines if review is necessary Creator and Ensure that document is Ensure that document is sponsor reviewed by reviewers reviewed by reviewers Ensure that review is Resolve comments documented and that comments are resolved Approval/ line manager Identifies appropriate approvals for documents under his or her control Creator and Obtain appropriate approval Obtain approvals as sponsor necessary Distribution/ Identifies document Identifies document line manager recipients recipients Releases document for distribution Distributor Distributes documents in Transmits documents to accordance with Appendix B, listed recipients "Distribution of Controlled Documents" Document holder Maintains documents in accordance with Appendix B of this procedure Revision or change/ line manager With the exception of minor With the exception of or editorial changes, minor or editorial ensures that document changes, ensures that revisions/changes are revisions/changes are identified and have the identified and have same review and approval the same review and as the original document approval as the original document Distributor Distributes revised Distributes copies of documents to original revised documents to listed recipients in original listed accordance with Appendix recipients B of this procedure Recall or cancellation/ line manager Identifies individuals authorized to recall or cancel documents Creator and Obtain approval for Obtain approval for sponsor cancellation or recall cancellation or recall (if needed) Distributor Ensures that distributed Notifies distribution copies of recalled or list of recalled or canceled documents are canceled documents (if returned or destroyed needed) Ensures that record copy Ensures that record is retained in accordance is retained in with approved requirement accordance with information documents approved requirement information documents ********** APPENDIX B DISTRIBUTION OF CONTROLLED DOCUMENTS WHAT TO DO A. Receiving Controlled Copies for Distribution Distributor 1. Establishes a receipt review process to (Distribution verify that controlled documents are: Control Point) o At the correct distribution control point o Correspond to those listed on the transmittal o Legible or have been accepted for legibility by the releasing creator or sponsor 2. Resolves noted document deficiencies with the releasing creator or sponsor before distribution. B. Distributing Controlled Copies Distributor 1. Updates master copy, or equivalent, upon (Distribution acceptance of document. Control Point) 2. Maintains distribution lists with current holder assignment and location. NOTE: Documents without proper identification are "uncontrolled" or "information only" copies. 3. Identifies controlled documents clearly by one of these methods: o Colored stickers or stamps on the spine or elsewhere on the copy o Numbers on the spine or elsewhere on the copy o Means that do not conflict with existing security markings or colors that appear elsewhere on the copy or spine. 4. Submits the original of the controlled document to the designated approved storage location. 5. Distributes controlled documents according to the distribution list. 6. Uses a transmittal that requires receipt acknowledgement by the controlled document holder and where necessary provides clear instructions for the insertion and removal of transmitted material. 7. Follows up on receipt acknowledgement transmittals not returned within the required time. 8. If follow-ups with appropriate management do not result in proper maintenance of controlled documents, then decontrols documents by removing control identification from the document and document holder by (1) removing document holder from the distribution list, and (2) informing the document holder of the action taken. C. Maintaining Controlled Documents Controlled 1. Updates controlled document holdings in Document Holder accordance with directions from the distribution control point. 2. Removes and discards all superseded or voided documents as directed by the distribution control point. 3. Signs and returns receipt acknowledgement within the specified time. 4. Notifies the distribution control point of changes in the controlled document assignment or location. 5. Notifies the distribution control point of lost, damaged, or destroyed controlled documents. 6. Returns lost documents that reappear to the distribution control point. 7. Implements a system to account for and locate controlled documents removed from assigned location. 8. Maintains consistent, accurate indices to identify controlled documents, current revision level, and any related temporary change through a manual or automated system readily available to all users. 9. Maintains under access control master copies of controlled documents as a means to confirm content and revision level. D. Maintaining Controlled Documents on Electronic Media Creator 1. Generates, revises, and releases electronic and Sponsor controlled documents using the same control elements as the record copy of controlled documents. 2. Keeps electronic documents current. E. Maintaining Originals of Controlled Documents Used for Revisions Distributor 1. Control originals of paper or electronic (Distribution documents used for revisions of controlled Control Point) documents. 2. Establish access and administrative controls to protect documents from loss or unauthorized changes. 3. Maintain accountability for paper originals removed from the files (if applicable). 4. Establish time frames for checkouts (if applicable). 5. Follow up on originals not returned within the specified time (if applicable). *********** APPENDIX C DOCUMENT MANAGEMENT GLOSSARY Baseline Documents--information that depicts the status of a component, system, or structure including, but not limited to, drawings, procedures, and specifications. Controlled Document/Manual--any document for which distribution and status are to be kept current by the issuer to ensure that authorized holders or users have available the most up-to-date version. Distribution Control Point--the organization/individual designated by the line manager as responsible for the controlled distribution of particular documents. Distribution List--a list of recipients for documents. List includes names and addresses. Document Management--the application of systematic control for the creation, revision, release, distribution, and file maintenance of documents. Document Sponsor--the organization/individual assigned to be responsible for the development and continued maintenance of a document. Information Only Copy--a copy of a document. Master Copy--the latest revision of the document/manual used by the distribution control point for reproduction, distribution, and reference. Record Copy--see ORNL Procedure X-AD-7, "ORNL Records Management," Appendix A. Uncontrolled Copy/Document--a document managed in accordance with the value of the information. Vendor Documentation--technical information supplied by equipment manufacturers, covering installation, operation, and maintenance of the equipment. This information also includes drawings, parts lists, and other information in the manual.
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Updated: Tuesday, 11-Feb-97 15:59:48 EST(npn)