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- Pharmaceuticals QMS
- Features
- Corrective Actions
Corrective Actions
Assign correction, retain its root cause and have an independent reviewer verify effectiveness.
OverviewEffectiveness review×
Pharmaceuticals QMS · Corrective Actions
New
Effectiveness review
Corrective actions
| Nonconformance | Owner | Action | Completed at | Status | |
|---|---|---|---|---|---|
| NNC-2782 | ACT-441 | Effectiveness review | |||
| NNC-9626 | ACT-278 | Effectiveness review | |||
| NNC-9151 | ACT-728 | Effectiveness review | |||
| NNC-9351 | ACT-261 | Effectiveness review | |||
| NNC-1117 | ACT-811 | Effectiveness review |
6 of 6 records
ACT-441Corrective actions · CA-51678
Effectiveness reviewNonconformanceNNC-2782
What you can do
Make correction a reviewable piece of work
Each Corrective Action belongs to a Nonconformance and has an Owner from People. The action record carries root cause, the planned action, due date, completion date and status. The owner has one place to explain the remedy and submit completion evidence. The parent issue remains the context for judging whether that remedy addresses the original problem.
The action moves through planned, approved, implementing, effectiveness review and closed states. During implementation, the Corrective Action Owner submits completion against their People identity and the linked source. An independent reviewer tests effectiveness. If verification fails, implementing work resumes. Closing the parent nonconformance waits until every linked corrective action has passed effectiveness review. This keeps partial completion from being mistaken for complete issue resolution.
How the work is organized
- Cause and plan. Record the root cause and action against a named nonconformance before work begins.
- Ownership. Give the action to a person with a due date and preserve who submitted completion.
- Effectiveness. Have a reviewer other than the Owner test the result against the original inspection evidence.
What to agree during setup
Define what counts as an adequate root cause for each class of problem. Decide what completion evidence the Owner will present and how it will be checked against the source inspection. The Corrective Action record has a completion date; its action and root-cause text should be specific enough for a reviewer to understand the submitted work. Name who approves an action before implementation and who conducts effectiveness review. Those people must be resolvable through People and the inspection assignment.
Agree how failed verification returns to the owner. The reviewer should explain what did not work, and the owner should update the same linked action rather than creating a disconnected second remedy. For an issue with several actions, review the complete set before changing the parent to closed.
Check the handoff on an actual case
Start with a nonconformance linked to a failed inspection check. Create a corrective action with a concrete root cause, assigned Owner and due date. Move it into implementation after review of the plan. The Owner records completion; a separate Quality Reviewer examines the result in the context of the inspection. First rehearse an ineffective result: the work should return to implementation and the parent issue should stay open. Then rehearse an effective result and inspect whether any other linked action still awaits review. Close the parent only when that set is complete.
What your team sees
- Corrective action work — Owned actions with due dates and current implementation state.
- My corrective actions — The Owner’s assigned root causes, plans and deadlines.
- Effectiveness review — Completed actions awaiting an independent decision.
Follow the work through
Use corrective action to rehearse owner submission, failed verification and closure.
What it keeps track of
Data model- Corrective actions
- Corrective Actions records for Quality & Compliance (Source).
- Nonconformances
- Nonconformances records for Quality & Compliance (Source).
- Inspections
- Inspections records for Quality & Compliance (Source).
- Inspection checks
- Inspection Checks records for Quality & Compliance (Source).
- People
- People records for Quality & Compliance (Source).
Who uses it
Permissions- Corrective Action Owner
- Documents and completes the remedy.
- Quality Reviewer
- Approves the plan and checks effectiveness independently.
- Inspector
- Provides the source inspection record.
Set up Pharmaceuticals QMS your way.
Start free, then use Proto to change fields, steps and approvals before your team goes live.