Statuses
These are the statuses of a CAPA, from Initiated to Closed. A status marked Optional is not used on every record.
| Status | Who acts | What happens | Signature | Article |
|---|---|---|---|---|
| 1Initiated | Initiators, Coordinators | The CAPA is saved here. Sign to send it on to Awaiting Approver sign-off. | Yes | Create a CAPA |
| 2Awaiting Preliminary Reviewer sign-offOptional | — | Not used on every CAPA. | — | How a CAPA moves from Initiated to Closed |
| 3Awaiting Approver sign-off | Approvers | Sign to move the CAPA to Authorise Actions Implementation, or send it back to Initiated with a reason. | Yes | Sign a CAPA as Approver or QA |
| 4 | QAs | Sign to authorise the actions: the CAPA moves to Implement Actions. Or send it back with a reason. | Yes | Sign a CAPA as Approver or QA |
| 5Implement Actions | Coordinators, QAs | Each action is carried out and closed by its own Coordinators and QAs, from the Escalate button on its row; an action whose Closure Dependencies are open waits in Awaiting Dependency. When the last action is Closed, the CAPA moves to Awaiting QA sign-off by itself (recorded as Status auto-advanced, not signed). | — | Close a CAPA action |
| 6Awaiting QA sign-off | QAs | Sign to move the CAPA to Awaiting Effectiveness Review; the QAs' panel also offers Escalate status to Closed. Or send it back to an earlier status with a reason. | Yes | Sign a CAPA as Approver or QA |
| 7Awaiting Effectiveness Review | Coordinators | Answer Was the action effective? on the Effectiveness tab and sign with Save And Escalate. Yes moves the CAPA to Awaiting Effectiveness Verification; No, with a rejection reason, sends it back to Awaiting QA sign-off. | Yes | Record the effectiveness review of a CAPA |
| 8Awaiting Effectiveness Verification | QAs | Sign to close the CAPA, or send it back to Awaiting Effectiveness Review with a reason. | Yes | Close a CAPA |
| 9Closed | — | The CAPA is complete; its status button is greyed. | No | How a CAPA moves from Initiated to Closed |
Each action of a CAPA has its own statuses while the CAPA is in Implement Actions: In Progress, Awaiting Dependency, Awaiting QA sign-off and Closed.
Roles
Two kinds of role decide what you can do with a CAPA: your system role, and the roles you are named in on the CAPA.
System roles — set for each user
- Administrator
- A system role. Changes CAPAs and adds actions in Initiated and Implement Actions; marks obsolete and deletes. Signs only when named in a role.
- Supervisor
- A system role. Creates CAPAs, updates their roles, and adds actions in Initiated and Implement Actions.
- Regular User
- A system role. Creates CAPAs and updates their roles. Downloads a CAPA once it is Closed.
- Read Only User
- A system role. Opens the CAPAs and downloads a closed CAPA; cannot create or sign.
CAPA roles — named on each CAPA
- Initiators
- Named on the CAPA: the person who created it. Can change it in Initiated and Implement Actions, and send it on from Initiated.
- Coordinators
- Named on the CAPA. Send it on from Initiated, and record the effectiveness review.
- Approvers
- Named on the CAPA. Sign in Awaiting Approver sign-off.
- QAs
- Named on the CAPA. Authorise the actions, sign QA sign-off and verify effectiveness.
Each action also names its own Coordinators and QAs. They move that action from the Escalate button on its row: the action's Coordinators send it on from In Progress (to Awaiting Dependency while the actions in its Closure Dependencies are still open) and from Awaiting Dependency once those are Closed; its QAs sign it off in Awaiting QA sign-off or send it back to In Progress. When the last action is Closed, the CAPA moves to Awaiting QA sign-off by itself.
Who can do what
These are the permissions the CAPA Permissions page shows (CAPAs › Settings & Master › Permissions). A status name in a cell means the action is allowed in that status only.
| Your system role | Named on the CAPA | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Action | Administrator | Supervisor | Regular User | Read Only User | Initiators | Preliminary Reviewers | Coordinators | Approvers | QAs |
| Create a CAPA How to: Create a CAPA | Yes | Yes | Yes | No | Not a role on the CAPA for this action | Not a role on the CAPA for this action | Not a role on the CAPA for this action | Not a role on the CAPA for this action | Not a role on the CAPA for this action |
| Change the CAPA's details | Initiated, Awaiting Preliminary Reviewer sign-off, Implement Actions | No | No | No | Initiated, Awaiting Preliminary Reviewer sign-off, Implement Actions | Initiated, Awaiting Preliminary Reviewer sign-off, Implement Actions | Initiated, Awaiting Preliminary Reviewer sign-off, Implement Actions | No | No |
| Sign to send on from Initiated Read: How a CAPA moves from Initiated to Closed | No | No | No | No | Initiated | No | Initiated | No | No |
| Sign the preliminary review Read: How a CAPA moves from Initiated to Closed | No | No | No | No | No | Awaiting Preliminary Reviewer sign-off | No | No | No |
| Sign to move the CAPA on How to: Sign a CAPA as Approver or QA | No | No | No | No | No | No | No | Awaiting Approver sign-off | , Awaiting QA sign-off, Awaiting Effectiveness Verification |
| Move on from Implement Actions How to: Close a CAPA action Every action must be Closed first; the CAPA then moves on by itself (Status auto-advanced, not signed). The Permissions page still lists this move for Coordinators and QAs. | No | No | No | No | No | No | Implement Actions | No | Implement Actions |
| Record the effectiveness review How to: Record the effectiveness review of a CAPA Signed. An answer of No sends the CAPA back to Awaiting QA sign-off. | No | No | No | No | No | No | Awaiting Effectiveness Review | No | No |
| Send back with a reason Read: How a CAPA moves from Initiated to Closed | No | No | No | No | No | No | Awaiting Effectiveness Review | Awaiting Approver sign-off | , Awaiting QA sign-off, Awaiting Effectiveness Verification |
| Add an action To a saved CAPA. Actions added while you create the CAPA are part of the form. | Initiated, Awaiting Preliminary Reviewer sign-off, Implement Actions | Initiated, Awaiting Preliminary Reviewer sign-off, Implement Actions | No | No | No | No | No | No | No |
| Update Roles | Initiated, Awaiting Preliminary Reviewer sign-off, Implement Actions | Yes | Yes | No | No | No | No | No | No |
| Mark obsolete | Yes | No | No | No | Yes | Yes | Yes | Yes | Yes |
| Download the CAPA The CAPA itself, not its report, as the Permissions page shows it. | Yes | Yes | Closed | Closed | Yes | Yes | Yes | Yes | Awaiting Preliminary Reviewer sign-off, , Implement Actions, Awaiting QA sign-off, Closed |
| Download report | Yes | No | No | No | Yes | Yes | Yes | Yes | Yes |
| Delete | Yes | Yes | No | No | Yes | No | Yes | No | No |
The Permissions page itself shows one column per status and, in each cell, a tick for every role that may take the action. It reads "Note:- Administrator, Supervisor, Regular User are eligible to create CAPAs." It has Filters (to show one action) and Export, and no way to change a cell. It also lists actions this page leaves out: Post Remarks, Add Files, Delete Files, Download Files, Restore, Reset from obsolete and Reopen.
If something is different
- You are an Administrator but have no button to sign. Signing is done by the people named on the CAPA. An Administrator signs only when named in a role.