Document Control Checklist

FREE document control checklist. Ensure proper document management, version control & approval workflows. ISO 9001 compliant.

Industry: Manufacturing
Frequency: Monthly/Quarterly
Estimated Time: 30-45 minutes
Role: Operations Manager
Total Items: 38
Compliance: ISO 9001:2015, ISO 14001, FDA 21 CFR Part 11

Document Creation & Approval

Verify proper document creation and approval processes.

Written procedure for document creation exists?
Standard templates used for documents?
Document authors clearly identified?
Formal review process in place?
Approval authority defined and documented?
Documents signed and dated upon approval?
Photo evidence of approval signatures

Version Control & Revision History

Ensure proper version control practices.

Consistent version numbering system used?
Revision history maintained for all documents?
Changes between versions clearly described?
Effective dates clearly marked?
Superseded documents clearly marked?
Only current versions accessible to users?

Distribution & Access Control

Verify document distribution and access controls.

Document distribution lists maintained?
Access controls based on roles/responsibilities?
Controlled copy system in place?
External document distribution tracked?
Read/acknowledgment confirmations obtained?
Training on new documents tracked?

Storage & Retention

Verify proper document storage and retention.

Documents stored securely (physical/electronic)?
Backup system in place for electronic documents?
Document retention schedule established?
Archive procedure documented?
Secure disposal method for obsolete documents?
Document retrieval process effective?
Physical storage conditions adequate?

Document Change Control

Verify document change management process.

Formal change request process exists?
Impact assessment conducted for changes?
Changes approved by appropriate authority?
Changes communicated to affected parties?
Change implementation verified?
Emergency change procedure defined?

Periodic Review & Audit

Verify ongoing document management effectiveness.

Documents reviewed at defined intervals?
Review schedule documented and followed?
Obsolete documents identified and removed?
Master document list maintained?
Regulatory compliance verified?
Document control system audited regularly?

Related Manufacturing Checklists

Why Use This Document Control Checklist?

This document control checklist helps manufacturing teams maintain compliance and operational excellence. Designed for operations manager professionals, this checklist covers 38 critical inspection points across 6 sections. Recommended frequency: monthly/quarterly.

Ensures compliance with ISO 9001:2015, ISO 14001, FDA 21 CFR Part 11. Regulatory-aligned for audit readiness and inspection documentation.

Frequently Asked Questions

What does the Document Control Checklist cover?

This checklist covers 38 inspection items across 6 sections: Document Creation & Approval, Version Control & Revision History, Distribution & Access Control, Storage & Retention, Document Change Control, Periodic Review & Audit. It is designed for manufacturing operations and compliance.

How often should this checklist be completed?

This checklist should be completed monthly/quarterly. Each completion takes approximately 30-45 minutes.

Who should use this Document Control Checklist?

This checklist is designed for Operations Manager professionals in the manufacturing industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.

Can I download this checklist as a PDF?

Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.