Document Control Policy - ASQ



PurposeThe purpose of this document is to establish the Ticalion Quality Management Services, LLC (TQMS) document control process. ScopeThe document control process applies to Policies, Manuals, Standard Operating Procedures, Job Aids, Templates and Supporting Documents (e.g. quality system controlled documents) that are governed by the TQMS quality management system (QMS). Roles and ResponsibilitiesDocument ManagerOversee the daily operations of the Document Control ProcessUpdate the document control process and procedural documents to maintain currency with best practices and requirementsManage controlled documents in accordance with approved procedures for document controlEmployees and ContractorsFollow approved procedures for creating, revising, reviewing, approving, controlling, and accessing controlled documentsParticipate in the controlled document review and approval processQuality Assurance Establish and operate the Document Control SystemFunction as the document owner for the Document Control policies, processes and proceduresParticipate in the controlled document review and approval processEstablish and manage a system and procedures for managing controlled documents throughout the document lifecycleMaintain the quality record for the document control system in accordance with SOP Record Management Related DocumentsDocument NumberDocument TitleWI-DOC-01-01Controlled Document Content, Format and Style RequirementsWI-DOC-01-02Controlled Document Collaboration, Review and ApprovalWI-DOC-01-03Controlled Document NumberingWI-DOC-01-04Creating Tests of UnderstandingWI-DOC-01-05Controlled Document Periodic ReviewWI-DOC-01-06Controlled Document Retirement and ArchivalWI-DOC-01-07Controlled Document Release, Access and AvailabilitySOP-EDM-01Electronic Document Management System General UseWI-EDM-01-09Electronic Document Management System Route Setup and InitiationWI-EDM-01-01Managing EDMS User AccountsSOP-REC-01Record ManagementSupporting DocumentsDocument NumberDocument TitleFLW-DOC-01-01-01Document Control Process FlowchartTMP-DOC-01-01-01Policy (POL) TemplateTMP-DOC-01-01-02Manual (MAN) TemplateTMP-DOC-01-01-03Standard Operating Procedure (SOP) TemplateTMP-DOC-01-01-04Work Instruction (WI) TemplateTMP-DOC-01-01-05Supporting Document (FRM) TemplateDefinitions and AcronymsAcronym/TermDefinitionApprovedThe status of an item (e.g., controlled document, controlled record) that has been reviewed, found acceptable and documented as acceptable by all approvers.Archive:1.) A collection, usually of records, that is stored and maintained for historic reference. 2.) A lasting collection of system data or other records that are in long term storage.Change ControlThe process of identifying, documenting, verifying, reviewing and approving changes before their implementation.Controlled DocumentA document that is reviewed and approved prior to use, version controlled, and has a life cycle.Document Control SystemThe processes that govern the controlled document lifecycle.Quality System Controlled Document (aka Quality System Document)Controlled documents whose existence is mandated by the quality management system requirements. Typically, quality system controlled documents consist of policies, manuals, plans, standard operating procedures, work instructions, forms, and templates. Record (aka Quality Record)Any written or electronic documentation providing evidence that activities were performed and their results. Records include original documents, accurate reproductions of original documents, electronic data and files. Records do not exist until the activity has been performed.Record ManagementThe policies and procedures that govern systematic control of all records from their creation, or receipt, through their processing, distribution, organization, storage, retrieval, retention and ultimate disposition.Uncontrolled DocumentAny copy of a controlled document that exists outside of the EDMS. Examples include desk copies and copies that are transported away from the controlled source in any manner to any location.ProcessControlled Document HierarchyThe Quality Management System (QMS) is documented through a hierarchical structure of controlled documents. The levels of controlled documents used and the types of documents within each level are: Level 1 – Top-Level policy documentsPolicy (POL)Level 2 - High-Level plan documentsManual (MAN)Plan (PLN)Level 3 – Mid-Level process documentsStandard Operating Procedure (SOP)Level 4 – Low-Level detailed instructional documentsWork Instruction (WI)Level 5 –Support documentsFlowchart (FLW)Form (FRM)Protocol (PCL)Template (TMP)Test of Understanding (TOU)Controlled Document Lifecycle Controlled documents exist within a defined controlled document lifecycle. The following are the primary steps in the controlled document lifecycle.Writing documentsReview of draft documentsApproval of draft documents resulting in controlled documentsAccess and use of controlled documents Periodic review of controlled documentsRevision of controlled documents, if necessaryRetirement of controlled documentsArchival of controlled documentsRefer to Figure 2: Controlled Document Lifecycle, for a general schematic of the controlled document lifecycle. Figure 2: Controlled Document LifecycleControlled Document Lifecycle for Level 5 Support DocumentsLevel 5 support documents exist within a unique lifecycle that differs from the lifecycle of Level 1 through Level 4 controlled documents. Level 5 support documents do not require a periodic review because one or more of the following apply:they are reviewed and approved with their parent procedure (including periodic review)they are intended for one-time use and/or they are approved by qualified personnel prior to and/or in conjunction with their use The following are the primary steps in the Level 5 support document lifecycle.Writing support documentsReview of draft support documentsApproval of draft support documents resulting in controlled documentsEffective support documents are made accessible and available for useExecution of a support documentReview and approval of the completed support documentArchival of completed support documents as controlled records Refer to Figure 3, Controlled Document Lifecycle – Level 5 Support Documents, for a general schematic of the Level 5 support document lifecycle. Figure 3: Controlled Document Lifecycle – Level 5 Highly Specific Support DocumentsNote: Level 5 support document periodic reviews occur with the parent Level 3 or 4 controlled document periodic review.Creating Controlled DocumentsControlled documents are created in a consistent format and style according to the work instruction Controlled Document Content, Format and Style RequirementsThe document author is required to create all necessary Level 5 supporting documents. Submission of Level 5 supporting documents may be delayed until the parent controlled document is ready for approval review. At the approval review stage, Level 5 supporting documents must be submitted for review along with the parent controlled document.The document author is required to create a test of understanding for every SOP and WI that impacts safety to persons, critical to quality activities and critical to business activities for use in providing training on SOPs and WIs. Tests of understanding are created after collaborative reviews have completed and the document is ready for approval routing. Tests of Understanding are created according to the work instruction Creating Tests of Understanding.Controlled Document CollaborationAfter drafting a new controlled document, including supporting documents and tests of understanding, the document author will coordinate a collaborative peer review of the document set. The peer review will include review by technical content subject matter experts and stakeholders whose work areas will be impacted by the new document. Collaboration and review is performed according to the work instruction Controlled Document Review and Approval.Controlled Document Numbering and ApprovalWhen collaboration and review is complete, the document author makes the necessary edits to the document and submits the final document to the Quality Assurance Document Management department. A document manager assigns a unique identifying number and routes the document for final approval signatures according to the work instruction Controlled Document Numbering and work instruction Controlled Document Review and Approval.Controlled Document Release, Access and AvailabilityOnce all required approval signatures are obtained, the document manager makes any previous version of the document obsolete and releases the new document for use according to work instruction Controlled Document Release, Access and AvailabilityThe electronic document management system (EDMS) is the source for controlled documents. Any copy of a controlled document that exists outside of the EDMS is by definition an uncontrolled document. Controlled documents are accessed through the electronic document management system according to work instruction Managing EDMS User Accounts and Standard Operating Procedure General Use of the EDMS.Controlled Document Periodic ReviewControlled documents may be reviewed and revised at any time, however, controlled documents are subject to an automatic periodic review every two years from the effective date of the document. The Quality Assurance document management department initiates and manages periodic review according to the work instruction Controlled Document Periodic Review.Controlled Document RetirementThere are two pathways to controlled document retirement. Upon release of a new version of a controlled document, the previous version is retired. During periodic review or any interim review, a controlled document may be identified for retirement. In some circumstances, a controlled document may be retired with no replacement. The Quality Assurance document management department retires documents in accordance with work instruction Controlled Document Retirement and Archiving Controlled Document ArchivalRetired controlled documents are retained as part of the quality record. Retired controlled documents will be retained in accordance with the requirements and methods established in the record management process. ExceptionsDocuments that are not identified as controlled documents in the quality manual and which are not required to be managed under the document control system are exempt from the requirements of this SOP. Such documents frequently include but are not limited to documents and records that are created and pertain to company financial information, marketing activities, and business development activities inasmuch as they are not required to be maintained under the quality system for compliance to federal, state or local law.Quality RecordsThe Quality Record (e.g. historic records of the quality management system)Document review and approval records (including EDMS metadata)Document HistoryDateVersionDescription of Change00-00-001.0New SOP ................
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