A practical worksheet from PharmExcel Consulting | Updated October 14, 2026
Use this manufacturing readiness assessment worksheet before a startup, product transfer, capacity increase, or operational recovery. Review it with operations, engineering, quality, and supply chain. The aim is a clear action list supported by evidence.
How to use the worksheet
Record your project, scope, target date, review date, and review lead. Mark each area Ready, Action required, or Not applicable. Record evidence for every conclusion and explain any Not applicable decision. Use your browser’s Print command to print this page or save it as a PDF.
| Review area | Questions to resolve |
|---|---|
| Scope and target date | Define the product, process, planned activity, and target startup or improvement date. |
| Capacity and workflow | Map processing and waiting time. Identify the constraint across manufacturing, testing, review, and dispatch. |
| Equipment and utilities | Confirm intended use, qualification status, calibration, maintenance, and unresolved faults. |
| Materials and suppliers | Confirm approved materials, availability, receipt requirements, and contingency contacts. |
| People and coverage | Check task qualifications, shift coverage, training capacity, and backup for critical roles. |
| Procedures and records | Verify current instructions, usable records, handoff responsibilities, and record review arrangements. |
| Quality decisions | Define deviation escalation, open quality risks, required approvals, and release responsibilities. |
| Storage and distribution | Check required conditions, monitoring, alarm response, packaging, and delivery arrangements. |
| Interruptions and recovery | Walk through an equipment failure, late material, unavailable specialist, and utility interruption. |
| Readiness decision | Assign every gap an owner, due date, required evidence, and approval route. |
Turn findings into actions
For each gap, record: issue; potential impact; required action; owner; due date; evidence needed; and closure approval. Use site procedures to decide which issues must close before the planned activity can proceed. Do not average the results into a pass score that could hide a critical gap.
Illustrative example: Equipment is available, but qualified testing coverage is missing during the planned batch window. Assign a lead to confirm qualified coverage and the approved testing sequence before committing to that schedule.
Finish with a documented decision
- List unresolved issues and their impact on the planned activity.
- Confirm required evidence and responsible approvals.
- Record approved controls and the next review date.
- Reassess readiness when the scope, equipment, process, or schedule changes.
This worksheet is an operations planning aid. Adapt it to the product, process, and approved site procedures. It does not replace validation, regulatory assessment, or quality approval. For context, see FDA’s CGMP overview.
Need help turning gaps into a workable plan?
Work directly with Rob Braddock, former COO of Evergreen Theragnostics and former Executive Director of Manufacturing Operations at BioCentriq. PharmExcel supports workflow assessment, manufacturing systems, facility readiness, and team responsibilities.
Explore manufacturing operations consulting or discuss your readiness priorities. Bring your target date, process map, and main operational concerns.