Information & Training. | Quality Assurance. Quality Management.
Document Revision.
A critical requirement in a document management process is the ability to effectively control the revisions of documents that are in use throughout an organization. All documents will need to go through a document revision control process. A document in draft, un-approved form will need to be identified as such. Then when approved for release and use will need to be identified as an “approved version” of the document, then as the document goes through various iterations, each revision will need to be identified via a letter, or number or some other identifier which shows the most up to date revision of the document.Within revision control is the requirement to be able to track all previous revisions, recall and destroy all older versions as new updates are released.
Documentation
CAPA – Corrective And Preventative Action
Calibration Certification
Change Management and Control
Quality Management Training
Product and Process Validation
Supplier Quality Assurance
Audits & Auditing
Ensuring the Quality Management System is Risk based
Etc. …. Etc. …. Etc. …
Information & Training presentation >>>
Requirements for effective document revision control.
▪ All documents will have unique identifiers. Every document should have an individual identification, for example a document title and document number.
▪ All documents will be clearly identified in terms of version, for example A,B,C,D, or number 01, 02, 03, …etc.
▪ All pages within a document will be identified. Each page should be positively identified via a header or a footer on each page, for example SOP 7689.2 page 5 of 7. Attachments such as flow charts or appendices should be included in the page count.
▪ There needs to be effective documentation distribution with accurate up to date records maintained of documentation location, detailing document version status. Documents need to be readily available at points of use, there must be no confusion over which documents are to be used.
▪ For electronic documents, security levels may be implemented, for example read-only access, password requirements, etc..
▪ For hard copy documentation, color coded “date of release stamps” should be used on all distributed hard copies, to prevent photocopying of approved documents, which would invalidate the official distribution lists.
▪ There needs to be defined processes in-place to control and permit document revision.
Benefits of document revision control.
▪ By effectively controlling the revision of documents, there is an assurance that only the correct, up to date documents will be in use across the organization.
▪ When looking back to understand how a product or process was developed, you can verify previous practice requirements.
▪ The version history creates an “audit trail” of how the document was developed up to the current version.
▪ Revision control allows document control to delete and destroy older no longer relevant documents.
Information & Training. | Quality Assurance. Quality Management.
- The Principles of Quality Management
- The Quality Manual
- Quality Standards and Specifications
- The Quality Management System
- Revised requirements of ISO 9001: 2015
- Design Quality – Products & Processes
- Good Manufacturing Practice (GMP)
- Documentation
- CAPA – Corrective And Preventative Action
- Calibration Certification
- Change Management and Control
- Quality Management Training
- Product and Process Validation
- Supplier Quality Assurance
- Audits & Auditing
- Ensuring the Quality Management System is Risk based
- Etc. …. Etc. …. Etc. …
- Information & Training presentation >>>