Who is this for?
Quality Event Owner - creating a CAPA from a Quality Event
Users with access to the CAPA module - creating a standalone CAPA
How to do it
A CAPA is normally created from a Quality Event during its assessment. It can also be created as a standalone document by a user with access to the CAPA module.
From a Quality Event
Create the CAPA from the Quality Event using Create CAPA, as described in the Managing Observations and Quality Events articles. The CAPA opens in the Draft state of the Planning phase and records the source under Source Quality Events.
Creating a CAPA from a Quality Event.
As a standalone document
Go to Events → CAPAs from the sidebar and select + New CAPA.
Complete the Create CAPA dialog and select Create. The CAPA opens in the Draft state and is assigned to the Author.
The Create CAPA dialog.
Create CAPA
Field name | Description | Note |
Title* | A short title that identifies the CAPA. | Required. The CAPA cannot be created without a title. |
What kind of action are you taking? | The CAPA severity/type, for example Minor or Major. | The available options depend on the CAPA type configuration (for example Minor / Major or Severity Low / High). |
❗Not every Quality Event needs a CAPA, and not every CAPA has to originate from one. Whichever route you take, record the why. The decision to open (or not open) a CAPA, and its justification, belong in the record. SimplerQMS supports this by capturing the Source Quality Events link and the CAPA history; the decision itself remains a quality judgement under your procedure.
💡Tip: Set a clear, specific Title and the correct action type at creation — these drive the CAPA ID, the template and the available workflow steps, and are harder to change cleanly later.