CAPA Workflows

A route is the process a finding runs through. The route determines which tasks are created, who owns each one, in which order, and with which deadline.

Routes are maintained by Mobile2b and selected per grade. They are not edited in the interface.

Browsing the library

Workflows lists every route. Select one to see its details and a diagram of its steps.

The header states the number of steps, the number of gates, and whether the route compiles evidence at closure.

In the diagram, approval gates are drawn as rings. Approving advances the route; rejecting returns it to the highlighted step, which then runs again.

Steps

Step	Purpose
Containment	Immediate action to limit the effect.
Root-cause analysis	Determine the cause. The analysis and its method are recorded and copied onto the finding.
Define corrective action	Specify the corrective action.
Implement action	Carry out the corrective action.
Gate	An approval decision.

A gate's meaning depends on its position. A gate after Define reviews the plan. A gate after Implement verifies the result and records the finding's effectiveness verdict.

Owner roles

Role	Resolved to
Auditor	The auditor of the source audit.
Responsible owner	The Owner of the finding's org unit for its management system.
Quality	The Quality lead of the finding's org unit for its management system.
Auditor / approver	The auditor, acting as approver.

Owners are resolved through the responsibility matrix, with inheritance up the organization tree.

The routes

Listed from lightest to heaviest. Deadlines are in days from the step's start; steps without a stated deadline carry none.

Observation

The finding is logged and no corrective action is due. The route has no steps.

Auditor-defined correction

Order	Step	Owner	Deadline
1	Define corrective action	Auditor	none
2	Implement action	Responsible owner	by the finding's planned date
3	Gate (verify)	Auditor / approver	none

Simple correction

Order	Step	Owner	Deadline
1	Define corrective action	Responsible owner	14 days
2	Implement action	Responsible owner	by the finding's planned date
3	Gate (verify)	Responsible owner	none

Reviewed correction

Compiles evidence at closure.

Order	Step	Owner	Deadline
1	Define corrective action	Responsible owner	7 days
2	Gate (review plan)	Quality	none
3	Gate (review plan)	Auditor / approver	none
4	Implement action	Responsible owner	by the finding's planned date
5	Gate (verify)	Quality	none
6	Gate (verify)	Auditor / approver	none

Root cause + correction

Compiles evidence at closure.

Order	Step	Owner	Deadline
1	Root-cause analysis	Responsible owner	7 days
2	Define corrective action	Responsible owner	7 days
3	Implement action	Responsible owner	by the finding's planned date
4	Gate (verify)	Quality	none

8D with containment

Compiles evidence at closure.

Order	Step	Owner	Deadline
1	Containment	Responsible owner	1 day
2	Root-cause analysis	Responsible owner	10 days
3	Define corrective action	Responsible owner	7 days
4	Implement action	Responsible owner	by the finding's planned date
5	Gate (verify)	Quality	none

Full CAPA

Compiles evidence at closure.

Order	Step	Owner	Deadline
1	Root-cause analysis	Responsible owner	5 days
2	Define corrective action	Responsible owner	7 days
3	Gate (review plan)	Quality	none
4	Gate (review plan)	Auditor / approver	none
5	Implement action	Responsible owner	by the finding's planned date
6	Gate (verify)	Quality	none
7	Gate (verify)	Auditor / approver	none

How a route is selected

Case	Route
The grade is on a management system's own scale	The route selected on that grade.
The grade is on a standard's scale, requiring information only	Observation
The grade is on a standard's scale, requiring a corrective action	Simple correction
The grade is on a standard's scale, requiring root-cause analysis and a corrective action	Full CAPA
The grade selects no route	No workflow starts. The finding is recorded without corrective tasks.

See Management systems for selecting a route on your own grades.

Evidence compilation

Routes marked as compiling evidence assemble the record of the case at closure: the finding, the analysis, the actions, the approvals and their evidence.

Notes and limits

• Routes are selected, not edited. The seven above are the complete set, with fixed steps, owners and deadlines.
• No escalation. An overdue step shows as overdue in the task list and in the daily digest, but is not reassigned or escalated automatically.