Purpose
Learn how to:
- Locate and view the periodic tasks for assessing effectiveness of CAPAs
- Assess the CAPA effectiveness with 3 options:
- Close ineffective CAPA and create a new CAPA for further processing
- Reopen ineffective CAPA
- Assess and close effective CAPA
- Reschedule assessments
- Trigger a manual or immediate effectiveness check
Expected Outcome
- Users can assess CAPA effectiveness in SimplerQMS
- Periodic tasks ensure that CAPAs are assessed for effectiveness
- CAPAs assessed as effective are closed, with the status “CAPA closed”
- All decisions are captured including electronic signature
- Ineffective CAPAs trigger further processing
- The related issue (complaint, NC, supplier issue, audit finding or continuous improvement) is set to “Final Closure of Recorded Issue” after CAPA assessed as effective
Prerequisites for all
- Must be logged in to SimplerQMS
- Must be a member of one of these ‘User Groups’ to view records:
- All internal and external users
- Must be a member of one of these ‘User Groups’ to create new records
- All Contributors
Prerequisites for Assessing CAPA effectiveness
- Must be assigned to the following role in the CAPA:
- CAPA Responsible Person
- All members of the QA Responsible User Group are automatically assigned to the Effectiveness Assessment Task
Section 1: Workflow overview
A CAPA Effectiveness Assessment is a periodic task that is generated automatically after a CAPA has been approved and released. Its purpose is to verify the effectiveness of the CAPA. The assessment should determine if the CAPA is effective or not. Based on the decision, follow section 4, 5 or 6.
Section 4 describes the final steps to close an effective CAPA. Section 5 and 6 result in a new Effectiveness Assessment task, which must be assessed again.
For example, a path could therefore be 3 -> 5 -> 3 -> 4
Illustrative timeline
Below is an illustration of the timeline for a Recorded Issue, a CAPA and the Effectiveness Assessment. It shows how the flows and processes are linked, and how the scheduling values work for the effectiveness task. Note that the illustration is simplified: for example, CAPA Attachments and Change Requests are not covered, reviews are not shown, and in practice documents may be sent back for drafting or become overdue.
Section 2: Finding and Viewing Effectiveness Assessment task
When a CAPA is approved, an effective PDF version of the CAPA is generated, together with a periodic task for assessing the effectiveness of the CAPA.
Step 2.1 – Find the Effectiveness Assessment
To find the task, locate it in the Periodic Tasks group of the CAPA’s related records, or search for the document number, as described in options I and II below:
I. Open Views > 2. Main views > 14. CAPAs > All CAPAs and select the CAPA document. Then show its related records in one of these ways:
a. Right-click and select Open Workspace. Click Periodic Tasks to view the Effectiveness Assessment of the selected CAPA.
b. Click the arrow beside the selected CAPA to expand its list of related records and click the arrow beside the Periodic Task to view the Effectiveness Assessment of the selected CAPA.
II. Via Search: Search for the document number and, if needed, click the Periodic Task tab.
Alternatively, you can find the task in the CAPA Effectiveness Assessments view or in Assigned to Me, as described in options III and IV.
III. Click Views > 2. Main views > Tasks & Actions > CAPA Effectiveness Assessments and locate the task.
IV. On the activation date, the periodic task is automatically assigned to the CAPA Responsible Person. An email notification is sent, and the periodic task appears in Assigned to Me.
The status of the Effectiveness Assessment is shown on the CAPA metadata card, in the CAPA Effectiveness Assessment field.
Most CAPA views also show this information in a column. This tells the user which actions need to be taken on the CAPA if it is not already closed.
Step 2.2 – View the CAPA Effectiveness Metadata
The metadata of the periodic task contains information about the CAPA and the effectiveness assessment.
| Field name | Description | Note |
| Version to Review* | The name of the effective PDF version of the CAPA to be assessed. | Read-only |
| Controlled Working Copy | The name of the working copy of the CAPA. | Read-only |
| Responsible Person | One or more persons responsible for assessing the effectiveness. Taken from the Responsible Person(s) of the CAPA. | All members of the QA Responsible User Group are assigned to the Effectiveness Assessment. Read-only |
| Signature | Filled in when the task has been approved. | Read-only |
| Field name | Description | Note |
| Activation Date | The date the Responsible Person is notified to assess the effectiveness. Calculation: Period End Date – Time to Complete = Activation Date Example: 2023-02-15 – 14 days = 2023-02-01 | Read-only |
| Period End Date | The due date for the assessment. If the assessment has not been done by this date, the state of the task changes to overdue. Calculation: Period Start Date + Interval = Period End Date Example: 2023-01-01 + 45 days = 2023-02-15 | Read-only |
| Date Approved | The date the task was signed and approved. | Read-only |
| Periodic Task Number | The number that identifies the periodic task. | Read-only |
Scheduling values are generated by the system, but can be changed by rescheduling the task. The due date (Period End Date) of the assessment is 45 days after the effective date of the released CAPA (the PDF version). The Activation Date is 14 days before the due date. On the Activation Date, an email notification is sent to the Responsible Person and an assignment is created in SimplerQMS.
To change the scheduling values, reschedule the task as described in Step 3.1.
| Field name | Description | Note |
| Interval* | The time from the Effective Date of the released CAPA to the due date (Period End Date) of the assessment task. The default is 45 days. Example: If the effective date of a released CAPA is 2023-01-01, the due date of the task is 2023-02-15. | Read only Reschedule to change. |
| Time Unit* | The unit of the Interval (for example, days). Together with the Interval, it sets the time the Responsible Person has to assess the effectiveness before the deadline (Period End Date). | Read only Reschedule to change. |
| Time to Complete | Determines the Activation Date: the time (for example, the number of days) before the deadline when the assignment is created and the email notification is sent. Example: The Responsible Person is notified 14 days before the Period End Date (on the Activation Date). | Read only Reschedule to change. |
| Activation Time Unit | The unit of the Time to Complete (for example, days). Together, they set when the assignment is created and the email notification is sent. | Read only Reschedule to change. |
| Period Start Date* | Equal to the Effective Date of the released CAPA. See the note in Step 2.2 for more information. |
NOTE:
The Effectiveness Assessment task will only be triggered and created when the released version of the CAPA moves into the “Effective” state.
The effective date of the released CAPA (also the Period Start Date of the task) determines what happens:
If the Effective Date on the working copy of the CAPA is:
- In the past or today
-> The released version of the CAPA becomes effective immediately when the CAPA is approved, and its effective date is the approval date (even if the effective date of the working copy is different). - In the future
-> The released version of the CAPA moves to the “For Learning” state when the CAPA is approved, and only becomes effective on the Effective Date (in this case, the working copy and the released CAPA have the same effective date).
To make the released CAPA effective straight away, select it and click “Make Effective Immediately”. This creates the task.
Section 3: Rescheduling or Starting CAPA assessment
When the assessment is in the Scheduled state, no changes can be made to the metadata.
If the periodic task needs to be rescheduled, the CAPA responsible person can do this. A justification for the rescheduling is required.
Step 3.1 – Reschedule the assessment – Responsible Person
I. Select the periodic task and, in the Workflow section, click on Reschedule.
The scheduling values and the Responsible Person field become editable. Only the Responsible Person (and the Process Manager) can change them. The other fields remain read-only.
| Field name | Description | Note |
| Interval* | The time from the Effective Date of the released CAPA to the due date (Period End Date) of the assessment task. The default is 45 days. Example: If the effective date of a released CAPA is 2023-01-01, the due date of the task is 2023-02-15. | |
| Time Unit* | The unit of the Interval (for example, days). Together with the Interval, it sets the time the Responsible Person has to assess the effectiveness before the deadline (Period End Date). | |
| Time to Complete | Determines the Activation Date: the time (for example, the number of days) before the deadline when the assignment is created and the email notification is sent. Example: The Responsible Person is notified 14 days before the Period End Date (on the Activation Date). | |
| Activation Time Unit | The unit of the Time to Complete (for example, days). Together, they set when the assignment is created and the email notification is sent. | |
| Period Start Date* | Equal to the Effective Date of the released CAPA. See the note in Step 2.2 for more information. |
II. Set the values according to how your company wants to schedule the assessment.
III. Enter the mandatory Justification of Decision in the Periodic Task Info section.
IV. Click Save.
V. In the Workflow section, click Schedule. The dates are recalculated based on the new values.
Step 3.2 – Start the CAPA Assessment – Responsible Person
When the task is in the Scheduled state, the CAPA Responsible Person can start the effectiveness assessment.
There are two ways to start the assessment:
Option 1: Manually assess the CAPA
While the task is in the Scheduled state, the CAPA Responsible Person can start the assessment manually at any time before the activation date. The Period End Date of the assessment stays the same, even if the assessment is started manually.
I. Select the periodic task
II. In the Workflow section, click on Assess Effectiveness Now
a. The state will become Pending Assessment, a task will be assigned to the responsible person and the metadata becomes editable.
III. Use the assignment description as a guide.
The options for continuing the assessment are now shown in the Workflow section.
To complete the assessment, you will need to add the effectiveness results on the metadata of the task.
Option 2: Assess CAPA based on schedule
On the activation date, an assignment is created in SimplerQMS and an email is sent to the CAPA Responsible Person. The assessment then follows the dates set by the scheduling values.
I. The CAPA Responsible Person receives a notification that the activation date has been reached, and the assessment is assigned to them.
II. The state will become Pending Assessment, and the options for continuing the assessment are shown in the Workflow section.
III. To complete the assessment, you will need to add the effectiveness results on the metadata of the task.
Based on the option you choose when assessing the CAPA, proceed to
- Section 4: CAPA Effective and Can Be Closed
- Section 5: CAPA is not effective – Reopen CAPA
- Section 6: CAPA is not effective – Close CAPA (I will issue a new CAPA)
Section 4 : CAPA Effective and Can Be Closed – Responsible Person
When the CAPA assessment task is moved to “CAPA Effective and Can Be Closed” and the task is signed electronically, the Responsible Person should go to the CAPA (which now has a new version in the Awaits Updates state) and:
I. Open the CAPA (double-click it) and complete the CAPA document by finalizing the “Result of Effectiveness Assessment” section at the end of the document (or the equivalent section in your company’s CAPA template).
a. Note that the results of the effectiveness assessment (the provided justification) is captured on the metadata card of the CAPA and cannot be edited.
II. Update the metadata fields “Conclusion of Closure” and “Effective Date” and click Save.
III. Route the CAPA for review and/or approval and sign it
The assessment is finalized, and the released CAPA (PDF version) moves to either the “For Learning” or the “Effective” state, depending on the Effective Date. The previous version is retired automatically. An additional Effectiveness Assessment task is created, but it is marked as “Obsolete Task – Working Copy Closed” and should not be used.
Section 5: CAPA is Not Effective – Reopen CAPA – Responsible Person
When the CAPA has been assessed as not effective and is reopened, so that actions can be taken to make it effective, follow this workflow (see also Section 1: Workflow overview):
- Select the task and click “CAPA is not effective – Reopen CAPA”.
- The CAPA moves to the Awaits Updates state. Click on CAPA and update with new actions and approve it (covered in this Section 5).
- Note that the results of the effectiveness assessment (the provided justification) is captured on the metadata card of the CAPA and cannot be edited.
- A new Effectiveness Assessment task is generated, based on the defined schedule.
- Find and get started on the new Effectiveness Assessment when the re-evaluation date is reached (Sections 2 and 3).
- Assess CAPA as effective and close it (Section 4).
Step 5.1 – Assess CAPA as not effective and Reopen CAPA
I. When the effectiveness task is in the state Pending Assessment, click “CAPA is not effective – Reopen CAPA”.
II. Enter your electronic signature. The state changes to “CAPA Is Not Effective – Reopen CAPA”, and a new version of the CAPA is automatically assigned to the author for editing.
Step 5.2 – Drafting of the new version of CAPA
I. The author checks out the new version of CAPA and start drafting, once completed, save, and check in
II. In the metadata card, update the Conclusion of Closure and Effective Date field. The author can update the content according to the resolution of the CAPA. You will also notice that the Initial Conclusion is not editable
III. Click on Save after filling out the Conclusion of Closure and Effective Date
IV. Route the CAPA for review or approval, following the steps in Work Instruction: Managing Recorded Issues and CAPAs
V. When all approvals have been captured, a new PDF version is generated and the previous version is retired.
When the new version of the CAPA is in the “CAPA Pending Effectiveness” state, a new periodic task for the effectiveness assessment is generated automatically (on the day the CAPA becomes effective).
Now, go to the new assessment task (Section 2), start or reschedule it (Section 3) and assess it again (Section 4, if it is assessed as effective), as shown in Section 1: Workflow overview
Section 6: CAPA is Not Effective – Close CAPA and issue New CAPA – Responsible Person
In the following section, the current CAPA is referred to as CAPA 1 and the new CAPA based on a copy of CAPA 1 is referred to as CAPA 2.
When CAPA 1 has been assessed as not effective and a new CAPA 2 will be issued, follow this workflow (see also Section 1: Workflow overview):
- Select task and click “CAPA is Not Effective – Close CAPA (I will issue a new CAPA)”.
- Update and close CAPA 1 (covered in Step 6.2).
- Note that the results of the effectiveness assessment (the provided justification) is captured on the metadata card of the CAPA and cannot be edited.
- Create CAPA 2 by copying CAPA 1 and follow the CAPA workflow for CAPA 2 (Step 6.3).
- Find and get started on the Effectiveness Assessment for CAPA 2 (Sections 2 and 3).
- Assess CAPA 2 as effective and close it (Section 4).
Step 6.1 – Mark task as CAPA not effective
I. When the effectiveness task is in the state Pending Assessment, click “CAPA is not effective – Close CAPA (I will issue a new CAPA)” and sign it.
Step 6.2 – Update and close CAPA 1
I. The author selects CAPA 1, checks out the new version of CAPA 1 to provide input on why CAPA 1 is being closed and a new CAPA 2 is being created. When finished, the author must save and check in the document.
II. In the metadata card, update the Conclusion of Closure and set the Effective Date field to today’s date.
III. Click on Save after filling out the Conclusion of Closure and Effective Date
IV. Route the CAPA for review or approval, following the steps in Work Instruction: Managing Recorded Issues and CAPAs (Step 6.6)
V. When all approvals have been captured, CAPA 1 changes state to “CAPA Closed”, a new released PDF version is created, and the old version is retired. An Effectiveness Assessment task is created, but it is marked as “Obsolete Task – Working Copy Closed” and should not be used.
Step 6.3 – Create CAPA 2 by copying CAPA 1 and follow the standard CAPA workflow for CAPA 2
To create CAPA 2 with a relation to CAPA 1, select CAPA 1 and click “Make a Copy of CAPA (using an empty template)”.
This ensures the following information is copied from CAPA 1: Site, Department, Process, Related Recorded Issue (if any), Responsible Person, Author and all Reviewers and Approvers.
Process CAPA 2 by drafting, reviewing and approving it.
For instructions on drafting, reviewing and approving a new CAPA (and CAPA Attachments, if needed), refer to Work Instruction: Managing Recorded Issues and CAPAs.
When CAPA 2 has been approved and released, its effectiveness must be assessed.Follow the workflow in this WI again: Section 2 -> 3 -> 4 (assuming CAPA 2 is assessed as effective).
Step 6.4 – Finding related CAPAs
Find CAPA 1 while CAPA 2 is selected
Go to the Relations section on the CAPA 2 metadata card. Click on the small blue square with and arrow or search for the document ID.
Relations -> Metadata card
Find CAPA 2 while CAPA 1 is selected
Select CAPA 1, then right-click and select Open Workspace.
Under Documents, look for CAPA 2.
