This is a ready-to-use form. Replace every <<FILL: ...>> placeholder with your own specifics and route it through your change control and document control systems. A worked filled specimen follows the template. It is an educational aid to adapt and verify, not a compliance guarantee.
Form control
| Field | Format | Required | Completed by | When |
|---|---|---|---|---|
| Change request number | Text | Yes | Document control | On request |
| Document affected | Text | Yes | Requester | On request |
| Change control reference | Text | Yes | QA | At assessment |
Purpose
Capture a proposed change to a controlled document, decide whether it is major or minor by a defined rule rather than opinion, and set the training impact and effective date from that decision. Tying training impact to the change type removes the temptation to call a real change “minor” to skip re-training.
1. Request
| Field | Entry |
|---|---|
| Change request number | <<FILL>> |
| Document affected (number, title, current version) | <<FILL>> |
| Requester and date | <<FILL>> |
| Reason for change | <<FILL: what and why>> |
| Section(s) affected | <<FILL>> |
| Trigger | <<FILL: periodic review / deviation / CAPA / new equipment / spec change>> |
2. Major or minor assessment
Apply the defined rule. A change is major if it affects how the task is performed or its acceptance; minor if it is cosmetic with no change to instructions.
| Question | Answer |
|---|---|
| Does it add, remove, or change a process step? | Yes / No |
| Does it change an acceptance criterion, limit, or specification link? | Yes / No |
| Does it change a responsibility or a role? | Yes / No |
| Does it change safety, quality, or data integrity handling? | Yes / No |
| Is it purely a typo, formatting, cross-reference, or owner-name fix? | Yes / No |
| Field | Entry |
|---|---|
| Determination | Major / Minor |
| Basis | <<FILL: which answers drove it>> |
| New version identifier | <<FILL: e.g. Rev C to Rev D (major) or 2.1 to 2.2 (minor)>> |
3. Training impact
| Field | Entry |
|---|---|
| Re-training required | Yes (major) / Read-and-acknowledge or none (minor), per SOP |
| Affected roles | <<FILL: from the training matrix>> |
| Training to complete before effective date | Yes |
4. Effective date and control
| Field | Entry |
|---|---|
| Approval target date | <<FILL>> |
| Effective date (on or after approval, allows training) | <<FILL>> |
| Prior version retired on effective date | Yes |
| Revision history entry (section + reason) | <<FILL>> |
Acceptance criteria
- The major/minor determination follows the defined rule and its basis is recorded.
- A change that affects how the task is performed is classified major and triggers re-training.
- The effective date is on or after approval with time for training.
- The change is linked to a change control record and a revision history entry that names the section and reason.
References
21 CFR 211.100(b) (procedures followed and documented) and 211.22 (quality unit approval). EU GMP EudraLex Volume 4, Chapter 4, Documentation. ISO 13485:2016 clause 4.2.4 (review, approval, and re-approval of document changes), for operations following that standard.
Confirm the current version and clause numbers of each reference before issue.
Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL: date>> | <<FILL: author>> | Initial issue. |
Approvals
| Role | Name | Signature | Date |
|---|---|---|---|
| Requester | <<FILL>> | ||
| Reviewer (SME) | <<FILL>> | ||
| Approver (QA) | <<FILL>> |
Filled specimen
A change request worked:
| Field | Entry |
|---|---|
| Change request number | DCR-2026-0231 |
| Document affected | SOP-QC-058, 100% Visual Inspection and AQL Re-Inspection, Rev C |
| Requester and date | J. Alvarez, 04 Mar 2026 |
| Reason for change | Update the critical-defect AQL and add a container-format inspection step for prefilled syringes |
| Section(s) affected | 5.1, 5.4 |
| Trigger | Spec change SPEC-088 plus a new PFS format |
| Question | Answer |
|---|---|
| Adds, removes, or changes a step? | Yes (new PFS step) |
| Changes an acceptance criterion or spec link? | Yes (AQL and SPEC-088) |
| Changes a responsibility? | No |
| Changes quality or data integrity handling? | Yes |
| Purely cosmetic? | No |
| Field | Entry |
|---|---|
| Determination | Major |
| New version identifier | Rev C to Rev D |
| Re-training required | Yes, all qualified inspectors for the line |
| Effective date | 04 Apr 2026 (approved 21 Mar 2026, training window between) |
| Revision history entry | ”Rev C to Rev D: Section 5.4 critical AQL aligned to SPEC-088; Section 5.1 adds PFS inspection step. DCR-2026-0231.” |
Because the change touches a step, an acceptance criterion, and data-integrity handling, it is major and triggers re-training, which is scheduled to finish before the effective date. Calling this “minor” to skip training would be the exact abuse the rule exists to prevent.
Common inspection findings this form prevents
- A real change slipped in as minor to avoid re-training.
- A revision with no recorded reason or no link to change control.
- An effective date set before approval, or with no window for training.
- A revision history that says only “general updates,” hiding what changed.
How to adapt this form
- Set your major/minor rule questions and your version scheme.
- Draw the affected roles from your document-to-role training matrix.
- Link this form to your change control record so the two stay consistent.
- Confirm each reference against its current published version before issue.