QA and regulatory
What the QA / regulatory role does, sees and signs in Factory OS, and how a typical day runs.
Default demo person: Jason Wong, QA engineer. This page describes the default access of the QA / regulatory role. The Org admin can change it under Settings > Roles & permissions; see Roles at a glance.
What you do
You raise and close nonconformance reports and corrective actions, handle complaints and audit findings, trace lots, and own gauges and calibration. The QA manager (in the demo, Grace Ooi) signs the manager-level steps.
Where you start
Sign in, choose your workspace, and the apps launcher opens. It shows one tile for each module your role can open. My work carries a number when records are waiting for you.
Your apps launcher
The apps launcher with the tiles this role can open.
- My work: the number of records waiting on you.
- Module tiles. Only the modules your role can open appear.
- Settings, if your role has it.
Your queue on Home > Queue (My work): Nonconformance reports, and corrective actions in Open, Implementing and Verifying effectiveness.
Your work queue on a phone
My work on a phone, the records waiting for this role.
- Page title and your role.
- One card per record waiting. Live-order records come first.
- Bottom tabs to move between modules.
Your daily screens
| Screen | Where | What you do there |
|---|---|---|
| NCR | /quality/ncr | Record and disposition nonconformances. |
| CAPA | /quality/capa | Run corrective and preventive actions. |
| Trace | /quality/trace | Trace a shipment to its lots and back. |
| Release checks | /quality/lrel | See the checks behind a lot release. |
| Device history | /quality/dhr | Read device history records. |
| Complaints | /quality/cmp | Customer complaints. |
| Calibration | /quality/gcal | Gauge calibration records. |
| Matrix | /quality/tgap | Training gaps. |
The nonconformance list
NCR list.
- Filter the reports.
- Status of each report.
- Open a report to disposition it.
What you can do
You have full access to: Quality, EHS. You can create, edit and take steps there.
Steps you sign, with the button names on screen:
| Record | Steps |
|---|---|
| Corrective actions | Containment done · investigate, Approve action plan, Actions complete · verify, Close · effective |
| Audit findings | Raise CAPA, Verify CAPA · close |
| Gauges | Record calibration |
| Gauge R&R studies | Calculate · submit, Approve study |
| SPC reaction plans | Record containment, Close · verified |
| Process validation | Approve protocol, Approve · validated |
| Anything a QC inspector signs | You may sign it too |
A signed step needs your e-signature specimen and, where a requirement is set, current training.
What you can see but not change
View access: Sales, Purchasing, Inventory, Production, Engineering, Maintenance. You can open and read these. Their action buttons are disabled with Your role can view this but not change it.
What you cannot do and who does it
| You cannot | Who does it | What you see |
|---|---|---|
| Release a lot, approve a device history record, approve an engineering change | QA manager | This step needs a QA manager signature. You are signed in as Jason Wong (QA engineer). |
| Record training | QA manager or HR (Org admin) | Training records are recorded by the QA manager or HR (Org admin). |
| Open Settings | Org admin | Your role has no access to Settings. |
Hidden for your role: Settings. They do not appear on the launcher. If you open one by address you see You do not have access to this page and Back to apps.
A typical day
Open My work. Read the open nonconformances and corrective actions. Details: Find your way around.
Disposition each nonconformance and raise a corrective action where needed. Details: NCR and CAPA.
Investigate a customer complaint. Details: Complaints.
Trace a lot when a problem is reported. Details: From product to repeat order.
Keep gauges in calibration. Details: Gauges and calibration.