Purpose of This Guide
This guide describes the CAPA module of QDMS Now — the nonconformity record, its lifecycle, root cause analysis, and the actions raised to close it.
It is written for the people who work the records: the person who detects a problem, the team leader who runs it, the performers who carry out actions, and the manager who decides whether it can be closed.
Who this guide is for
| Role | What to read first |
|---|---|
| Anyone who detects a problem | Nonconformity Records — how to open one properly. |
| Team leader | Lifecycle — the stages you drive and the reports you have to produce. |
| Analyst | Root Cause Analysis — the three methods and when each one is appropriate. |
| Action performer | Actions — your task, and what "performed" means. |
| Quality administrator | The Definitions pages — categories, sources and root cause catalogue. |
How the guide is organized
- Getting Started — what CAPA is and what has to exist before the first record.
- Nonconformity Records — the record itself, its fields, team and attachments.
- Lifecycle — the stages, what each one gates, and how records move between them.
- Root Cause Analysis — standard, 5 Why and fishbone.
- Actions — planning, performing and the automatic advance to closure.
- Definitions — categories, sources and root causes.
A note on discipline
The CAPA module can only be as useful as the records put into it. Two habits make the difference:
- Describe what was observed, not what you assume caused it. The cause is what the analysis stage is for; putting a guess in the description narrows the investigation before it starts.
- Write actions that can be verified. "Improve training" cannot be closed honestly. "Retrain the three operators on Line 2 against work instruction WI-114 and record the assessment" can.
note
Screens are configurable through Function Design. Field labels, hidden fields and custom fields may differ from what is shown here — the workflow and the stage gating do not.