document control for quality management

Document Creation and Approval

Identify the need for a new document or a revision

Determine the document type (e.g., policy, procedure, work instruction)

Assign a document owner and responsible parties for creation and approval

Develop the document content

Review and revise the document as necessary

Obtain approval from relevant stakeholders

Ensure proper version control and document numbering

Archive previous versions of the document if applicable

Document Distribution and Access

Determine the appropriate distribution method (e.g., hard copy, electronic)

Identify the intended recipients and ensure they have access to the document

Communicate the availability and location of the document

Establish controls to prevent unauthorized access or distribution

Update distribution lists as needed

Document Retrieval and Revision Control

Establish a centralized document repository or database

Develop a robust search and retrieval system

Clearly label and organize documents for easy identification

Implement a revision control process

Track and document all document revisions

Ensure proper approval for document revisions

Communicate and distribute revised documents to relevant parties

Archive superseded or obsolete documents

Document Review and Change Management

Schedule periodic document reviews to ensure accuracy and relevance

Identify the frequency and criteria for document reviews

Assign responsible parties for conducting document reviews

Document and track all review activities and findings

Implement a change management process for document updates

Assess the impact of proposed changes on other related documents

Obtain necessary approvals for document changes

Communicate and implement approved changes

Document Training and Awareness

Identify the individuals or groups requiring training on document usage

Develop training materials and resources

Schedule and conduct training sessions

Document attendance and completion of training

Assess the effectiveness of the training program

Provide ongoing support and guidance on document usage

Promote awareness of document control procedures within the organization

Document Retention and Disposal

Define the document retention period based on legal and regulatory requirements

Establish a clear retention policy for different types of documents

Implement controls to ensure proper document storage and preservation

Regularly review and update the document retention schedule

Develop a secure disposal process for expired or irrelevant documents

Document and track the disposal of documents in accordance with the policy

Document Auditing and Compliance

Conduct regular internal audits to assess compliance with document control procedures

Document audit findings and recommendations for improvement

Develop corrective and preventive actions to address any non-compliance

Verify the effectiveness of implemented actions through follow-up audits

Communicate audit results and promote accountability for document control

Continuously monitor and improve the document control system