Control of Documents
The purpose of documents’ control is to ensure that necessary, accurate and up-to-date documents are available to the personnel using them, including personnel of external organizations conducting audits.
- approval by the General Manager of documents for adequacy prior to issue;
- reviewing and updating as necessary and re-approving documents;
- ensuring that changes and current revision status of documents are identified;
- ensuring that relevant versions of applicable documents are available at points of use;
- ensuring that documents of external origin are identified and their distribution is controlled;
- preventing the unintended use of obsolete documents and applying suitable identification if retained for any purpose;
- obtaining customer or regulatory agency approvals when required by contract or regulatory requirements;
- coordinating document changes with customer or regulatory authorities, in accordance with contracts or regulatory requirements.
This process is designed to keep all internal and external documents (see General Documentation Requirements), including all specifications and regulations, within the company’s management system, to ensure the distribution to all concerned parties and the use of the last and valid edition.
Electronic System of Documents
If the company utilizes an electronic system for the control of documentation and data it has to ensure the system provides for a scheduled generation of backup files for such documentation.
When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.
Confirmation of the ability of the computer software to satisfy the intended application would typically include the verification and configuration management to maintain its suitability for use.
To preclude the loss of documents due to hardware or software failures, an electronic system is programmed to create backup files on a schedule that ensures records are never lost. Typically, an electronic system provides for file backup on a daily basis.
The retention period for electronic documents is typically in accordance with requirements defined by applicable regulations and the provider.
Within such a system, document files are typically created, maintained, identified, revised, distributed, accessed, presented, retained and/or deleted using computer systems (e.g. a web-based system). Some systems specify immediate obsolescence for any information or data that is downloaded or otherwise extracted (e.g. printed on paper) from the electronic files.
To ensure retrieval of archived documents, applicable hardware and/or software is normally retained after it has been replaced.
Control of Document Procedure
The control of document procedure shall include following items:
- Retention of a master copy – usually it is kept by the Quality Department;
- Examination by the Department Manager and approval from the General Manager prior to issue on a title page;
- Review and update, to include an approval process by the General Manager;
- Version control (for the electronic documents);
- Identification of revision status on a table of contents that identifies parts and sub-parts with a list of effective pages within the manual;
- Inclusion preface or introduction outlining the general contents of the manual and reference numbers for the content of the manual;
- Revisions are identified and retained as history for a specified period under a record of revisions, both temporary and permanent. Also it has to be marked identification of revised content;
- Background or source references are identified and retained as history;
- Distribution by the Quality Manager to ensure appropriate availability at points of use with a defined distribution method and identification of recipients;
- Documents are checked by the Quality Manager to verify they remain legible and readily identifiable;
- Documents of external origin are identified, updated, distributed and retained by the Quality Manager;
- Obsolete documents are identified and retained as specified;
- Documents are disposed of as specified.
Additionally each documented procedure that is not held within a manual typically includes:
- A title page that identifies the operational applicability and functionality;
- Identification of the date(s) of issue and date of effectiveness;
- Reference numbers for the content;
- A distribution list;
- Identification of responsibility for authorizing the document.
Do not forget, you must have a system which is proved in practice and shall be continuously updated according the company’s needs and customer’s requirements.
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