Quality & Compliance
Quality (NCR & CAPA)
Register a defect. Find the cause. Fix it for good.
Hans Westbeek / Unsplash
This is the plant's defect book and its improvement book. An NCR, a nonconformance report, is one record of one thing that went wrong: a bad batch, a mislabeled pallet. A CAPA, the corrective and preventive action, is the investigation that stops it coming back. The NCR asks what to do with the bad material. The CAPA asks why it happened at all.
An operator opens the NCR the moment they see the defect and names the item, the machine or the work order. A quality engineer assigns an investigator and records the first containment step, for example that the lot is quarantined. The engineer submits a decision on the material and a second person approves it. The system refuses to let the investigator approve their own conclusion. On the improvement side the root cause goes through five rounds of why, each action carries one owner and one date, and the plan waits for proof that the defect stayed away before it closes. If the defect returns, the plan reopens.
Findings from In-Process & SPC, statistical process control, arrive here as an NCR or a CAPA. A CAPA action can become a maintenance job, so the fix lands on the machine and not only in the report.
Who uses it
| Person | What they do here |
|---|---|
| Operator | Opens an NCR the moment they see a defect. |
| Quality Inspector | Opens NCRs and records the first containment step. |
| Quality Engineer | Investigates, decides what happens to the material, and starts the CAPA. |
| Quality Manager | Owns the CAPA, checks that the fix held, and closes it. |
| Plant Manager | Approves the decision on the material. This is the second signature. |
| Action owner | Closes one action in the plan. |
Today vs Phasis
What you get
- When something is wrong, someone writes it down in one place.
- A second person must approve what happens to the bad material.
- The first person cannot approve their own work.
- Each action in the plan has an owner and a date, and the plan closes only on proof the fix held.
- An auditor can see who reported, who checked, who signed, and why the material was released or thrown away.
- The extra-strict steps are a switch, so the same module serves a food plant and a pharma plant.
See it on your own plant.
Thirty minutes with an engineer. We walk the modules you care about against your own lines and shifts.