Revision Level: / NC
Standard Operating Procedure / Page: / 1 of 3
DCN Number: / DCN-001
CONTROL OF DOCUMENTS
1.0ME4.9(D)11/27/96002MFG ENGPLANT PROCESS CHANGEPURPOSE
1.1To ensure that all controlled documents are reviewed, revised, and approved before use.
1.2To ensure that all obsolete documents are removed from theirpoint of use and identified as historical information that may be filed for legal or knowledge preservation.
2.0SCOPE
2.1This procedure applies to Controlled Documentswithin the EON INSTRUMENTATION, INC. Quality Management System.
3.0RESPONSIBILITY
3.1The President has assigned the General Manager as theDocument Control Coordinator to maintain the document control activity.
3.2The Document Control Coordinator shall maintain controlled documents in accordance to this procedure and Document Control Master List, F-001.
4.0DEFINITIONS
Documents - Any paper or electronic files (media) that contains information, which defines the EON INSTRUMENTATION, INC. Quality Management System.
Document Control -Activities to ensure that the review, approval, issuance, retrieval, storage, and disposal of documentation are performed to provide approved documents of the most current issue and revision at all applicable locations.
DocumentControlCenter- The location within organization where controlled documents reside.
Controlled Documents – Those documents that have been “Reviewed and Approved” with a DCN and recorded on the Document Master List.
Note: DCN’s are not required on External Documents or Forms.
DCN – Document Change Notice – A form which indicates “Review and Approval” of documents before being recorded onto the Document Master List. Note: DCN’s are not required on External Documents or Forms.
External Documents - Written, printed, or published material (including electronic media) external to the organization but, determined to be necessary for the planning, and operation of the Quality Management System.
5.0PROCEDURE
General Requirements
Documentation in support of the Quality Management System will comply with sections 5.1. – 5.16 of this procedure.
Document Change Notice (DCN)Originators
5.1When creating a new procedure or work instruction use following templates:
- F-021, Blank Work Instruction Format
- F-021A, Blank Work Instruction Process
- F-022, Blank Procedure Format
- When submitting new or revised documents for review and approval complete the Document Change Notice (DCN), F-003 and submit to the Document Control Coordinator. Refer to DCN for specific instructions.
Review and Approval of DCNDocument Control Coordinator
5.3Assign DCN # to Document Change Notice (DCN). Refer DCN Number List (F-001).
5.4Identify applicable DCN approvals within Section B.
5.5Submit DCN for review and approval.
5.6If, approval continue to step. 5.8
5.7If, rejected notify Originator.
Document Control Master ListDocument Control Coordinator
5.8Record all information related to the approved document and DCN onto the Document Control Master List, F-001.
5.9File either / both the electronic or hard copy of document.
5.10File the Document Change Notice (DCN), F-003 by numerical order.
5.11Ensure that when distributing REVISED documents to point of use, that OBSOLETE documents are removed.
5.12OBSOLETE documents not retained for historical or knowledge purposes shall be destroyed. Those documents retained for knowledge purposes shall be marked in ANY manner as deemed acceptable by Document Control Coordinator.
Control of External DocumentsDocument Control Coordinator
5.13General:
Only those external documents “Determined” by the organization to be used for “Planning or Operation” of the Quality Management System are required to be controlled.
Note: Not all external documents are required to be controlled. Only those determined as such.
5.14External documentation determined for use in the Quality Management System shall be placed onto the Document Control Master List, F-001and DO NOT require a Document Change Notice (DCN), F-003.
5.15Distribution of external documents shall be recorded within the Controlled Distribution Point section of the Document Control Master List, F-001.
5.16If, no document number exist on an external document use only unique name.
6.0REFERENCES
Procedures / Policies:
- Quality System Manual, QSM-001
Instructions:
- None
Forms:
- F-001, Document Control Master List (including DCN List, Document Numbering Scheme)
- F-003, Document Change Notice (DCN)
- F-021, Blank Work Instruction Format
- F-021A, Blank Work Instruction Process
- F-022, Blank Procedure Format