Document control procedure example free download as pdf file. A simple guide to document control what is document control and why do we need it. The document control representative shall maintain a master log of project or organization documents. The table below identifies the title of the heading, and a description. Standard operating procedure for document control and storage. However, a written procedure detailing your approach to document control is not enough. The document control process applies to policies, manuals, standard operating procedures, job aids, templates and supporting documents e. The qmsp for the control of documents relates to clause 4. Document control procedures set the framework for how documents are approved, updated or amended, how changes are tracked, how documents are published internally or externally, and how documents are made obsolete a document management system helps automate the control and tracking of documents that are managed according to document control procedures. Standard operating procedure for document control and. Nov 03, 2010 to request changes, submit a document change request to the document control representative. Writing down how you control documents will make it much easier to train staff and to audit the process, so even though its no longer a required procedure in iso 9001.
These items should be handled as projectrelated documents or evidence according to the sesd operating procedure for sample and evidence management. A document control system provides a method for formatting documents so that they are. Sops must use the standard format template and include a standard header on each page. In this document, records of functional characteristics of quality control are stated in making sure that products and services does not only meet standard but can also reach beyond that. The external document control list, qms f 24 is able to store a link to the online location of the. Documents, such as quality manual, security manual and. These documents have been developed specifically for our institutions and may not be appropriate for implementation in other settings.
February 4, 2015 revision history the top row of this table shows the most recent changes to this controlled document. Document control is not a set it and forget it thing processes change, documents change. This procedure applies to all documents required by the iso 9001. All creativity inc qms documents, where practicable, should use a standard format, specific for the document type. The standard doesnt set out how you should identify your documents but an example format.
To request changes, submit a document change request to the document control representative. When practical, external documents that are readily available on the internet should not be maintained at qnp. The next step is to start your sop format with an sop control block, a header as well as a footer. The purpose of this procedure is to document the aforementioned activities, herein after. What is document control and a document control system. If you are a procedure document control manager who is looking for templates and examples that you can use for procedure documentation, you are on the right page.
Although the concepts of dmr and qsr are defined in cfr 820. The web version of all qms documents and key business processes is the latest version. All hods shall be responsible to follow this sop for maintaining control on all. The body of each operating procedure should address these main topics, as applicable. A control plan is a type of document containing control procedures that are needed to be implemented so that quality plan products or services are met. Project managers or operations department is responsible for working with document control quality assurance for. Purpose to establish a consistent process for controlling the documented information required to maintain qnps quality management system. Documented information control procedure iso 9001 2015. Creating procedures for engineering document control. Engineering document control egp0101 document format this document is uncontrolled when printed. A document control plan is an essential component of the project plan that guides the project team regarding the control of documents, including their creation, version control, retention, and other important issued related to documentation. Document control is all to do with transferring information between relevant parties. For example if the doc ref no of a process is 12, reference numbers of its. To lay down a procedure for control of documents and documented data.
Record management references further assistance purpose the purpose of this procedure is to outline the process. Equipment manuals regarding the operation, safety, repair or maintenance of equipment used by qnp in the processing of customer orders. Document control systems, procedures, forms and templates. The documented information control procedure defines the methods and responsibilities for controlling documents used to provide work direction or set policy and defines methods for document revision, approval, and distribution this procedure applies to all documents required by the iso 9001. Sep 19, 2014 the document control management representative shall be responsible for coordinating, developing, issuing and controlling project or organization documents. Moreover, a standard operating procedure document prevents employers from repeating instructions to employees. If the master document file is managed by software there should be no need for control copies because the software will take care of only displaying the authorized master copy if control copies are required, procedures should include instructions for updating and retiring them to keep them in sync with the master. The document control management representative shall be responsible for coordinating, developing, issuing and controlling project or organization documents.
Include this information either in the header top of the page, footer bottom of the page or in a combination of the two. Feb 29, 2020 how to write a standard operating procedure. A document management system helps automate the control and tracking of documents that are managed according to document control procedures. Dec 23, 2018 international quality standards, example.
A control plan is a document containing the procedure or the methods to control quality of products and services of a business to meet standards. Get free templates and learn from industry practitioners and experts how standard operating procedure sop is used as a compliance tool. The template is fully editable and you can make changes based on your better judgment and needs of the project. Documentation systems document control, including procedures, forms, and templates. External documents are maintained as digital files whenever possible.
The format contains all the fields necessary in a document of this nature. The standard specifies that 7 controls should be defined within the procedure. Documentation control process office of the president page 2 rev. The appropriate document control procedure should be applied to. Documentation control process office of the president page 1 rev. Controlled documentation also ensures that when the system is revised. The person responsible for carrying out this procedure will document it and seek approval from the unit headmanager. The official controlled copy of this quality manual is the digitally signed pdf document held within our network server and visible to all authorised users. The document management process consists of document creation. Where a form is able to be filled in this should be done so in a pdf rewritable template format.
Procedure for control of documented information trace. However, the simple fact is that following basic document control principals can help make almost any business more efficient. Building effective document control in an iso 9001. The purpose of this procedure is to outline the process for. Document control the process established in this procedure to define controls needed for the management of work health and safety documentation. It must not be reproduced in whole or in part or otherwise disclosed without prior written consent. Document control procedure example specification technical. Before using a printed copy, verify that it is the current version. This standard operating procedure is applicable for the control of documents and documented data at the formulation plant of pharmaceuticals company name with location. An existing sop may need to just be modified and updated, or you may be in a. Explore the mastercontrol product life cycle management platform. This procedure applies to all ems controlled documents throughout auburn university. All applicable documents shall be identified and controlled in such a manner.
When implementing a new document control system, the following steps will be needed. The overall goal for any policy or procedure document is for the design to be simple, consistent, and easy to use. Quality management system document and records control 2017. Qms quick learning activity abbreviations, terms, and acronyms. The author may be the original author, or the person revising the document. The purpose of this procedure is to outline the process for work health and safety whs document control. Quality management system document and records control. Analysis sop standard operating procedure for document control and storage for the pm. When the frame cannot be put on the document, for instance when the document is a pdf file, then, as far as possible, the name of the file shall give an indication of how it is intended to use the document. Document control and records management process description.
Document control maintains an electronic record of change incorporation and, when required, coordinates these incorporations with the. This will be used to house the document control information required for one to configure management and compliance standards. In the office of the president all internally controlled qms documentation is maintained in electronic format. A nonexistence, unrealized or improper document control plan, will create disorderliness in the project team that may seriously affect the business. The documented information control procedure defines the methods and responsibilities for controlling documents used to provide work direction or set policy and defines methods for document revision, approval, and distribution.
Just go over the list below for you to try and download the ones that you need. Procedures shall be in a format that is consistent with other controlled documents. Establishing which file or print is the master document is essential. An existing sop may need to just be modified and updated, or you may be in a scenario where you have. The documentation controller publishes the document on the web retaining the same filename and communicates the update to relevant staff. Standard operating procedure for document control and storage for the pm. All documents are available to staff in pdf format. The appropriate document control procedure should be applied to all documents produced by the ctu. Haas sop standard operating procedure for corrective action for the pm. Controlling documents is a key requirement of iso 9001. This is a standard operating procedure template with a clean and clever design.
An introduction to document control trust in quality. The document control policy also defines methods for document revision, approval, and distribution. Standard operating procedure sop o a set of written instructions that document a food manufacturers routine or repetitive activity. This document is a generic change control procedure document for use by ida projects. So for every training and orientation made, the sops we offer in this article serve as your bases. Everything from the document control procedures manual itself, to all the documents and files governed by the document control program, are managed within the centralized system. It provides guidance and template material which is intended to assist the relevant management or technical staff, whether client or supplier, in producing a project specific change control procedure document. These procedure templates communicate what needs to be done on a routine basis. A lot of people find document control to be exceptionally tedious. A standard operating procedure sop is a document consisting of stepbystep information on how to execute a task. Document control form the form used to create or change a document. This is the one that is kept up to date and is the one that is officially authorized if the master document file is managed by software there should be no need for control copies because the software will take care of only displaying the authorized master copy. Document control procedure purpose and application 1. In order to ensure a consistent format between documents, the campus has developed a number of microsoft word templates to help the writers of policies and procedures get started.
We dont want to waste time repeatedly orienting new and old employees now, do we. The control block could just be a simple table such as 3 by 4 table. For the purpose of this procedure, document refers to a controlled document unless otherwise stated. Everything from the document control procedures manual itself, to all the documents and files governed by the document control program, are managed within. Participant information sheet it is essential that only the current approved version is used, otherwise key information may not be communicated. Examples of documents are listed in appendix f, documents in document management system. The document control procedure document control quality. Microsoft excel, microsoft word, or pdf format for access by all rtipm. Policies, procedures and document control policy attachment 1 electronic version is the controlled version. Placing controls on a document means that we ensure that the. Establish and maintain procedure to control all documents that form qms. It is controlled according to the procedure for control of records tkqp102.
407 1129 197 773 39 1198 200 1468 1379 661 897 826 1 511 239 1404 155 403 514 692 1410 1144 685 1030 778 1570 20 144 234 778 1318 766 89 157 1076 210 119 851 225 264