1. Establish a document controller.
Who controls the documents your facility records? Your site should assign an individual or a team who is responsible for managing the documents and records that will be part of your quality system. This employee(s) should be experienced, organized, detail-oriented, and willing to tackle to task. In most cases, document control should be this person’s main responsibility because it is a very demanding job. Without this commitment, document and record control will be very difficult to manage.
2. Designate a document storage location.
Where do you store your documents and records? All documents and records that relate to the quality system should be in an electronic or paper form and be available to all employees. If a paper system is used, you will need to designate a location where all forms and manuals are stored. If an electronic system is used, some employees should have read access and some employees should have revision access. All documents and records should be accessible to all employees.
3. Develop standard forms.
What form or format should I use? If possible, the same format should be used for all documents and all records. There should be a register or a list of all documents and records in the quality system. This should be under a controlled environment to prevent anything from falling through the cracks. It is important to include only quality system documents and records, not all documents and records that are used to run the business.
4. Include important information.
What information is needed on documents and records? There are several pieces of information that are important to include on all documents.
- The name of the document
- Document reference number - Try to assign reference numbers that match the standard numbers you will be using.
- Who approves the document
- Date of the last approval
- Version number
- Revision history (typically listed at the end of the document)
- The procedure, which includes photographs, diagrams, and other instructions to help the reader understand the procedure.
Documents should include sufficient information to allow the reader to understand the procedure, but not become so packed with information that they are confusing.
5. Maintaining document review.
How do you control documents and records? Establish how often documents and records will be reviewed and who is responsible for the review process. Typically this will be the document controller or a member of the document control team. This review process should be part of the document and record register. A column that lists the review due date and when it was actually reviewed should be added to the register. This will help to ensure that all documents and records are reviewed on time and according to the established frequency.