Information & Training. | Quality Assurance. Quality Management.
Document Control
Document Control allows an organization to distribute information, instructions, records to those who require the necessary documents, when they require the documents.An effective document control system facilitates:
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▪ Ease of access to required information.
▪ Ensures instructions are clearly defined and distributed.
▪ Defines a process for creating, approving and distributing documents.
▪ Identifies the functions necessary to approve documents.
▪ Ensures un-authorized changes are not made to documents.
▪ Ensures only the correct revisions of documents are in use.
▪ Facilitates communication with suppliers to ensure that current documented demands are clearly defined.
▪ Improves customer satisfaction by allowing customers to clearly understand the specification and capabilities of products and processes to be provided.
▪ Provides an assurance to management that change requirements will be effectively communicated to stakeholders (employees, suppliers, customers, shareholders, regulators, the community, etc.).
Document Control is essential in the assurance of product and process quality. As organizations grow is size and complexity the necessity for an effective and efficient document control process increases.
Definition:
A document is an organized form of information that can serve as evidence or proof.
Regulatory agencies and auditing bodies see document control as critical to product and process quality assurance. For example the following is an excerpt from a US FDA (Food & Drug Administration) warning letter related to document control and records management.“Complete, true and accurate records are the foundation for good manufacturing practices. Reliable documentation is a control, which raises assurance of the quality of the product manufactured. Violations concerning inadequate documentation are serious and should be handled as such.”
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. …
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