Document control is the program that governs how controlled documents, procedures, instructions, drawings, specifications, and travellers, are created, reviewed, approved, issued, revised, and retired. NQA-1 Requirement 6 and 10 CFR 50 Appendix B Criterion VI establish the requirements. The underlying principle is simple but demanding: at any point in time, only the current approved revision of a document should be in use for quality-affecting work. The consequences of using a superseded procedure are treated as a procedural violation, and if quality-affecting work was performed using an incorrect revision, the work itself may need to be re-evaluated.
What document control covers
Any document that directs or records quality-affecting work must be controlled. This includes procedures, work instructions, inspection plans, engineering drawings, specifications, purchase orders with quality requirements, and completed travellers. The program must maintain a master list, or equivalent, identifying the current approved revision of every controlled document. Without a master list, there is no reliable way to determine whether the documents in circulation are current.
The distinction between controlled and uncontrolled copies is fundamental. A controlled copy is one that is updated whenever a revision is issued; its holder is on the distribution list and receives new revisions automatically. An uncontrolled copy (a reference print, a personal copy) is not updated and carries the risk that it will be used after it has been superseded. Nuclear QA programs typically stamp or watermark uncontrolled copies explicitly to prevent inadvertent use in quality work.
Controlled vs. uncontrolled: An uncontrolled copy, for example, a personal reference print, is not updated when a new revision is issued. Using it for quality-affecting work is a procedural violation. Nuclear organisations typically stamp or watermark uncontrolled copies to prevent inadvertent use. If a superseded document directed quality work, the work may need re-evaluation against the correct revision.
Document preparation, review, and approval
Controlled documents must be prepared by qualified individuals, reviewed for technical adequacy, and approved by authorised personnel before issue. The approval chain must be documented, identifying who reviewed, who approved, and when. Electronic signatures are acceptable provided the system provides equivalent control and auditability to handwritten signatures, and the system itself is under configuration control.
Changes to controlled documents require the same level of review and approval as the original document. This is a requirement that organisations sometimes interpret loosely, creating informal minor-change processes that bypass the normal approval chain. NQA-1 does allow for expedited minor-change processes, but the changes must still be documented, authorised at an appropriate level, and incorporated into the formal document at the next revision. Temporary changes, field mark-ups authorised for a specific use, require documented authorisation, a defined validity period, and must be incorporated into a formal revision within that period.
The technical review should verify not only that the document is internally consistent, but that it correctly reflects the applicable requirements, current procedures, and any interface dependencies. A document that correctly describes a process that is itself incorrect does not satisfy the intent of document control.
Distribution, access, and obsolescence
Issuing an approved document is only part of document control. Getting it to every point of use, and removing the superseded revision, is equally important. The distribution system must know who holds controlled copies of each document so that when a revision is issued, superseded copies can be recalled or invalidated. Master lists must record not just the current revision but also the distribution of that revision.
Obsolete documents must be promptly removed from points of use. Leaving a superseded procedure at a workstation, even if a new revision has been issued, is one of the most common document control findings during nuclear QA audits. In electronic document management systems, access controls typically enforce this by preventing retrieval of superseded documents in the work execution environment while retaining them in the records archive for historical reference.
Document control programs must also address externally generated documents: vendor manuals, applicable codes and standards, and regulatory guidance. These must be identified, controlled at the applicable revision, and reviewed when new editions are issued for impact on the organisation's procedures and technical basis.
Common findings and how regulators evaluate document control
NRC and CNSC inspection teams assess document control by examining whether the master list is current, whether personnel at points of use have current revisions, whether changes are processed through the formal system rather than through informal mark-ups, and whether temporary changes have proper authorisation and defined validity periods. Unauthorised mark-ups on in-use procedures are treated as document control violations, and depending on the nature of the mark-up, may be treated as potential wilful violations if the change was intentional and undocumented.
A common systemic finding is the gap between document control as described in the QA manual and document control as actually practiced. Organisations that maintain excellent formal procedures but allow informal practice to deviate from them, particularly in high-tempo production environments, accumulate risk that surfaces during inspections. The best document control programs are those where the controls are embedded in the work process itself, making it easier to use the controlled document than to work around it.
Forged Operations manages document control end-to-end, revision tracking, approval workflows, point-of-use distribution, and master list currency. AI flags superseded documents still referenced in active work packages and surfaces pending revision approvals before they become overdue findings.
References
- American Society of Mechanical Engineers. ASME NQA-1-2022: Quality Assurance Requirements for Nuclear Facility Applications, Requirement 6 — Document Control. New York: ASME, 2022.
- U.S. Nuclear Regulatory Commission. "Criterion VI — Document Control." Code of Federal Regulations, 10 CFR 50 Appendix B. Washington, D.C.: NRC.
- CSA Group. CSA N286:12(R2018): Management System Requirements for Nuclear Facilities, Clause 5 — Management System Documentation. Toronto: CSA Group, 2018.
- International Atomic Energy Agency. Safety Standards Series No. GS-G-3.1: Application of the Management System for Facilities and Activities. Vienna: IAEA, 2006.