Review plan details
Add the record and review-team details first. Then customize the review checkpoints to match your product, process, approved procedures, and quality-system requirements.
Information entered here remains in the current browser page; this tool does not upload it to a server.
1. Review checklist and assignments
The initial checklist is an editable starting point. Remove irrelevant items and add product- or process-specific checkpoints required by your procedures.
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Important: “Reviewed - acceptable” is a checklist status, not an independent release authorization. Follow your approved quality procedures and required approval workflow for final disposition.
2. Batch Record Review Plan
Planning note: this summary reflects the checklist information entered by the user. It does not independently determine product conformity, regulatory compliance, or authorization to release a batch.
Review checkpoints
| ID | Category | Checkpoint | Risk | Evidence reference | Reviewer | Status | Finding / notes | Planner flag |
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Outstanding review items
Suggested follow-up actions
What is a batch record review plan?
A batch record review plan is a structured way to organize the checks required before a manufacturing record can be considered complete under the organization's procedures. For medical-device manufacturers, a Device History Record (DHR) documents the production history and relevant evidence for a device or batch, as applicable to the manufacturer's quality system and regulatory obligations.
Why plan batch record reviews?
- Consistency: use a repeatable checklist instead of relying on memory alone.
- Accountability: assign review checkpoints to appropriate roles.
- Risk focus: make higher-risk process steps, acceptance results, and record controls visible.
- Finding follow-up: document issues and make unresolved items easier to track.
- Traceability: reference the underlying records, evidence, and applicable procedures.
Common batch record review areas
Depending on the device and manufacturing process, a review may include record completeness, component and material traceability, equipment identification, process parameters, inspection results, operator records, deviations, nonconformances, rework, electronic record history, required approvals, yield calculations, and final disposition. The applicable review scope should be established by your procedures and risk assessment.
How to use this planner
- Enter the product, batch, record, site, and planned review details.
- Customize the example checkpoints to match your approved review procedure.
- Assign a qualified reviewer and link the relevant evidence for each checkpoint.
- Record the status and document findings or references to the relevant quality record.
- Generate the plan, review the outstanding items, and export the results.
- Transfer the reviewed output into your controlled document process when required.