What QMS manages
QMS manages quality processes between your organization and external partners. Each core process is its own object and its own lifecycle. They are not folded into one quality-event object and distinguished only by type.
QualityDocs change control revises or obsoletes a controlled document. Change control here covers a product, process, equipment, system, or supplier. The two processes may reference each other. They do not share one control record.
Common processes
| Process | What it is for |
|---|---|
| Quality incident | Report first, then triage. A process record is created only after you decide to open a case |
| Deviation | Something that already departed from the expected process. It can lead to an investigation and actions |
| Nonconformance | A material, product, or process that does not meet a stated requirement |
| Lab investigation | An investigation opened from a laboratory result, including out-of-specification results |
| Complaint intake | Receipt and triage before a complaint is opened |
| Complaint | A product complaint that has been accepted into the complaint process |
| Change control | A controlled change to a product, process, equipment, system, or supplier |
| CAPA action | A corrective or preventive action hanging off a process |
| Continuous improvement | A proactive improvement, or a CAPA that must continue after the original process is closed |
| Audit | One internal audit, external audit, or inspection |
| Finding | A nonconformity or observation recorded during an audit or other inspection |
On the drug side, CAPA is not a process sitting beside deviation. Actions hang off a deviation, complaint, nonconformance, finding, or change. When the original process is already closed and the work must continue, open a standalone CAPA under continuous improvement. Do not reopen the closed record.
Quality incidents and complaint intakes stay in triage. They are not counted as deviations, complaints, or the other process records.
Quality incidents
Anyone can report a quality incident and attach a description and files. Quality staff triage it: close it, or move it into a state that creates a process record. Targets include deviation, nonconformance, lab investigation, complaint, continuous improvement, change control, and medical-device CAPA. Fields and attachments are copied onto the new record.
A QR code opens the same intake page. The person scanning it needs a QMS license. If the device has no session, they sign in first.
Complaint intake and Promote to Complaint
A complaint can be created directly. Intake is for receiving and triaging before you decide to open a case. One intake can list several reported products, and each product can list several batches.
Promote to Complaint runs once. Running it again does not create a second set of complaints. Before it runs, required fields on the complaint must already be filled on the intake and the reported products.
Without a per-batch split, each reported product becomes one complaint and all of that product's batches are written on it. With a per-batch split, each batch of each product becomes its own complaint.
A quality user who cannot create complaints opens the case with Promote. The system creates the complaint. The person who clicked remains the initiating user.
Investigation, root cause, and actions
An investigation hangs off a deviation, complaint, nonconformance, lab investigation, finding, or standalone CAPA. A root-cause analysis can start from the investigation or directly from a standalone CAPA. A 5 Why is recorded on that analysis. It is not its own process.
A CAPA action is a child record. Finishing the action does not close the parent. The parent moves on only when its own lifecycle allows it.
Approval
Send for Approval chooses participants. Approve and reject are verdicts on the task. The in-approval state menu does not offer a direct state change for approve or reject. A rejection reason is written when the task is completed. An object that requires an electronic signature must have e-signatures enabled first.
Where to start
| Goal | Article |
|---|---|
| Report then decide | Quality incident triage |
| Complaint intake and Promote | Complaint intake and Promote |
| Send for approval and tasks | Workflow approval tasks |
| Controlled document revision | QualityDocs change control |
Quality navigation lists process types; Reports includes open deviation/complaint views when seeded.
Typical deviation path
- Create deviation or spawn from incident triage.
- Attach investigation, root cause, CAPA actions (children).
- Send for Approval — approvers work in My Tasks.
- Close parent when lifecycle allows; post-close CAPA uses continuous improvement.
FAQ
| Symptom | What to check |
|---|---|
| Cannot create complaint | Use intake Promote to Complaint |
| Menu approve disabled | Use workflow tasks |
| Parent open after CAPA done | Expected — advance parent separately |