Nonconformity Records
The nonconformity is the central record of the CAPA module. It carries the problem from the moment it is detected to the moment it is formally closed, and everything else in the module β root causes, actions, progress reports β hangs off it.
The record's code is generated automatically and becomes read-only once the record exists. Refer to a nonconformity by its code in every other system; it is the stable identifier.
Core fieldsβ
- Code β auto-generated. Read-only after creation.
- Name β a short title for the problem.
- Type β Corrective, Preventive or Improvement. See What Is CAPA?.
- Source β where the record came from. Selected from the nonconformity source list.
- Categories β one or more categories classifying the record. Multi-select.
- Detection organization unit β where the problem was found.
- Responsible organization unit β who owns fixing it.
- Team leader β the person accountable for driving the record through its lifecycle.
The teamβ
| Field | Purpose |
|---|---|
| Team leader | Drives the record. Receives the stage tasks. |
| Team members | The people who work the record with the leader. Can save progress reports. |
| Informers | Notification targets. They are kept aware but have no task. |
Changing a record's category cancels the existing stage tasks and reassigns new ones to the team leader and team members. This is deliberate β a recategorized record may belong to a different team β but it means an in-flight record briefly loses its open tasks.
Child recordsβ
A nonconformity carries several collections that appear as their own tabs:
| Collection | Description |
|---|---|
| Progress reports | One per cycle. Records what is known so far and decides whether root cause analysis and a close report are required. |
| Root causes | The findings of the analysis. See Root Cause Analysis. |
| Actions | The corrective/preventive work itself, each with its own state machine. See Actions. |
| Close progress reports | One per cycle. Records what was actually done and the result. |
| Attachments | Evidence β photographs, measurements, correspondence. |
Progress reports and close progress reports are multi-cycle: each time the record re-enters that stage, a new cycle is opened with an incremented cycle number, and the previous cycles remain visible as history.
Cross-module linksβ
A nonconformity can be linked to records in other modules β most commonly a customer complaint. The link is stored on the CAPA side and is visible from both records.
The relationship also drives behaviour: when a nonconformity linked to a complaint is closed, the complaint is notified and can advance its own close stage automatically.
Creating a nonconformityβ
- Open CAPA β Nonconformities and choose New.
- Select the type and the source.
- Write the name and the description of what was observed.
- Select the categories, the detection and responsible organization units.
- Assign a team leader, team members and informers.
- Attach evidence.
- Save as draft, then submit it for open approval.
Fill in the detection and responsible organization units accurately even when they are the same. They are what makes the module's reporting able to distinguish "where problems are found" from "where problems originate" β two very different management questions.