Document Revision Control Guidelines

A Document Revision Control system is the spine of your Quality Assurance Program. It is critical for ISO 9001 implementation. This system documents the methods that your organization uses to control, review and approve its documentation. Below is a list of items to consider and document when creating your Document Revision Control System. Your numbering scheme The process on creating new documentation The process on updating the current documentation Who is required to review, approve and sign off the documentation The difference between master, control and non control copies Identification of the Master List The method for tracking the location of all documents Who is responsible for conducting the document control tasks The method for obsoleting unwanted documents A mandatory / automatic document review process The method used to prevent the unintended use of non control documents or old documents. The policy on document readability The documentation storage methods. Any information that is used for Product Quality or the Quality Management System must be incorporated into the Document Control system. This includes: Quality Management Systems Process Procedures Employee Work Instructions Specifications Software Machine Operation Manuals CAD Drawings Blue Prints Process Change Notification Quality Record Formats Flowcharts Numbering Scheme Within your Document Control Revision system, outline your numbering scheme for the documentation. Make the scheme appropriate to your organization. Consider these factors: Process step Department numbers Type of Document Document Revision Document Locations Ease of Identification Document Format Sequential ID number Origin Date

Master Vs. Control Documents The document control system should have a master document in which there is only one copy of this document. Specify the location of the master document. Ensure that no one can tamper with the master copy. The master may be digital, hardcopy or a combination of both. Keep the masters in the same location. If the master copy is digital, you could store the files in a directory titled Master Documentation. If the master is a hard copy, you could stamp the document with Master. The master copy must be readily identifiable as the master. Maintain a master document list which can be easily accessed as necessary. This list must show the document number, document name, latest revision letter, and origin date of the document. A control document is normally a copy of the master document. A control copy is usually placed at the point of use. These documents should also be readily recognized as controlled. You want to be sure employees are not using uncontrolled documents. The location of these controlled document needs to be tracked. When you permanently update the master document, the document control function updates the control documents too. Reviewal / Approval Document Review / Approval depends on the nature of the document and the organization's management structure. We recommend a mandatory minimum of two people review the document. For small businesses it could be the writer and the primary user of the document. For a process procedure of a larger business it could be the writer, process owner, engineering, quality and production control. When a document is reviewed and approved, a signature should be used. This could be handwritten or digital. During an audit you must prove that the document was reviewed and approved. Document Revision Control Function The document revision control system must specify who is responsible for maintaining the document control system. Document who completes these tasks: Designates the master document Tracks the locations of control documents Distributes the documents Assures the documents are reviewed Ensures they are legible Ensures they are available at all points of use Maintains the master list Document Revision Control Changes When changes occur to a document, the document control system should specify these items: How to make a change The method that the writer uses to document the changes Who is responsible for reviewing and approving the changes The process on how the old document is removed from the system and all points of use. There are nine Procedures or documents that are mandatory. These are 1. Quality policy 2. Quality objectives 3. Quality Manual 4. Control of Documents 5. Control of Records 6. Nonconforming control 7. Corrective Action 8. Preventive Action 9. Internal Audit

The standard also requires procedures to ensure effective planning, operation and control of processes. Procedures Why do you need procedures? Because They prevent loss of specific details. They control sequence of steps. They provide consistency of results. They promote uniformity and reduce variation between employees. They are a necessary training tool. They are your internal standards. They are audit references. Changes can be easily tracked as improvements are made. Cover the 6 Ws in your procedures 1. Why must the procedure be followed? 2. How is the activity performed? 3. What is covered within the procedure? 4. When is the procedure applicable? 5. Where does the activity take place ? 6. Who is responsible for following the procedure? Make the procedure readable. Make it easy to find the information. Make it logical. Keep is simple. How do you know which details to include and which details not to include in a procedure? Ask this question about the details. If I leave a specific detail out of the procedure does it affect product quality? If it doesnt affect product quality then you can leave those details out. Flowchart Samples These flowchart samples can apply to your business or your processes. Every organizations process can be flowcharted. Flowcharts are a visual presentation of your process steps. A flowchart is a step by step picture of your process. Use flowcharts to Visualize your processes Show step by step details of your current process Overview detail procedures Study processes Provide common reference talking points during a meeting Illustrate a desired flow of a new improved system. Easily identify non value added steps. Quickly train your employees Visualize Your Process Flowchart samples allows you to picture your process on a piece of paper or on your computer monitor. Flowcharts lets you experience and feel the process without you actually conducting the work. Flowcharts shapes show others details about your process. Step by Step Details A flowchart documents added value steps, non added value steps, decision steps, documentation steps, information flow and many other critical stages necessary to conduct your process. Overview of Detailed Procedures A top down flow chart outlines the critical steps involved in complicated procedures. The reader can then easily recognize the significant steps. The flowchart directs the reader where to find more details.