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Quality Management System Document and Record Control Argenis Osorio – Manager, Quality Assurance 13-11-2012 Facilities Management.

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Presentation on theme: "Quality Management System Document and Record Control Argenis Osorio – Manager, Quality Assurance 13-11-2012 Facilities Management."— Presentation transcript:

1 Quality Management System Document and Record Control Argenis Osorio – Manager, Quality Assurance Facilities Management

2 Document and Record Control Purpose and Scope This procedure defines the process steps, roles and responsibilities that apply to the control of documents and records in the Quality Management System (QMS). This document describes the control of documents needed to: Properly identify all QMS and SAM documents Properly review and approve new documents for adequacy prior to use Properly review, update and re-approve already released documents, when necessary Ensure that all changes and revision status of documents are identified Ensure that only the current and relevant version of documents are available at the point of use Ensure that all documents of external origin, determined to be necessary for the planning and operation of the QMS, are identified and their distribution for use is effectively controlled Prevent the unintended use of obsolete documents to include the application of suitable identification to the documents if they are retained for any purpose 2

3 Document and Record Control Responsibilities Document Author Creating a new document Updating or revising an existing document Involving the relevant stakeholders in the review and development of a document Refer to QA-FOR-0002 QMS Pre Document Release Checklist to ensure document requirements have been met Forwarding a draft copy of the document to the Quality Assurance and EH&S Departments for pre-screening (if determined to be necessary) Facilitating the creation of a deployment and training plan for new or updated document(s) – if required Identifying any external documents that can affect the quality system or its processes and referencing in the relevant processes including locations and retention period 3

4 Document and Record Control Responsibilities – Continued Document Approver (Process Owner) Approving new document releases, document revisions and document obsolescence Confirming that all references in the document are valid and available Reviewing and approving the development and training plan (if applicable) Ensuring that the requirements of this procedure are followed Ensuring that obsolete documents of external origin are not available for use by mistake, by replacing it with updated version of the documents stamping printed documents as CONTROLLED DOCUMENT and distributing them (if applicable) 4

5 Document and Record Control Responsibilities – Continued Managers/Directors Management of all QMS master index of documents coding and revision number within the department Notifying their staff or employees of any new, revised or obsolete documents Ensuring that their personnel are made aware of and are following the relevant requirements of the QMS controlled documents 5

6 Document and Record Control Types of Documents Procedures A Procedures template QA-TMP-0001 is used primarily for high level documents that do not involve a lot of detail. This template is generally used to document critical business procedures and/or processes that affect several departments. SOP or Guideline A Word SOP Template - Short QA-TMP-0002 and/or Word SOP Template - Detailed QA-TMP-0008 is used to document the details of a particular task or activity. It generally includes step-by-step instructions, work guidelines that aim to streamline a particular process, and other types of detailed information. It defines the who, what, when, where, why and how of processes, systems, activities and controls. 6

7 Document and Record Control Types of Documents Process Map A Process Map template QA-TMP-0007 is used to document the graphical details of a particular task, activity or process that might otherwise be documented using a procedure or SOP/Guideline template. Forms A form template is used when the author wishes to capture data in a consistent and routine format. The form template comes on a word version QA-TMP-0003, a single page Excel Landscape version QA-TMP-0004, a single page excel Portrait version QA-TMP-0005 and, a multi-tab Excel worksheet version QA-TMP

8 Document and Record Control Reasons of Failure of Procedures in QMS The common reason is the failure of up-to-date your procedures, Your procedures are long and desperately complicated with lots of jargon, Your procedures are not clear to people, intricate and not easy to convey, Your procedures are not easily available, Your procedures are not followed by people If you cant control your procedures, it will not work, Too generic procedures are also not acceptable in policy system, Poorly designed procedures, which are tough to navigate is another reason of failure, Procedures are wrong and factually incorrect, and Procedures do not follow consistency in formats. 8

9 Document and Record Control How we document our Quality Management System? FM has a documented QMS with a four tier document tree 9

10 Document and Record Control The documents approval matrix is as follow (QA-PRO-0002): 10 Document Type Process Owner Manager, Quality Assurance EH&S ConsultantArea ManagerArea DirectorsFMD & FM VPs Tier 1 initial release DevelopYes Review Yes Tier 1 revisionDevelopYes Review Yes Tire 2 initial release DevelopReview Yes Tire 2 revisionDevelopReview Yes Tire 3 initial release DevelopReview Yes Tire 3 revisionDevelopReview Yes Tire 4 initial release DevelopReview Tire 4 revisionDevelopReview

11 Quality Management System Overview Where is Facilities Managements QMS located? Our QMS documentation is located on the Facilities Management SharePoint Site and in the FM P://drive: P://FM/Public/Quality Management System Here is where to find your procedures, SOP/Guidelines, forms, templates, etc. in order to perform your work. 11

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