Assessing Effectiveness of CAPA

Purpose

Learn how to:

• Locate and view the periodic tasks for assessing effectiveness of CAPA
• 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 are equipped to handle assessment of CAPA effectiveness in SimplerQMS
• Periodic tasks ensure that CAPAs are assessed for effectiveness
• CAPAs with a conclusion are set to close and the status should be “CAPA closed”
• All decisions are captures including electronic signature
• Ineffective CAPA actions trigger further processing
• 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 2.8 version
• 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 roles in the CAPA
  • CAPA Responsible Person
• All persons in the QA Responsible user group will automatically be assigned to the Effectiveness Assessment Task

Section 1: Workflow overview

A CAPA Effectiveness Assessment is a periodic task that is automatically generated after a CAPA has been approved and released. The purpose of the assessment 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.

While section 4 indicates the last actions or steps to be performed to close an effective CAPA, choosing 5 and 6 will result in a new Effectiveness Assessment task to be generated that needs to be assessed again.

An example of a path could therefore be 3 -> 5 -> 3 -> 4

Illustrative timeline

Below is an illustration of the timeline for a Recorded Issue, CAPA and the Effectiveness Assessment. The objective is to provide the user with an idea of how the flows and processes are interlinked. In addition, a visualisation of how the Scheduling values works for the effectiveness task. Please note below is only illustrative and simplified i.e., CAPA Attachments and Change Requests are not covered, reviews are not reflected, documents may be sent back for drafting or go into overdue states etc.

Section 2: Finding and Viewing Effectiveness Assessment task

When a CAPA has been approved, it generates an effective version (in PDF format) of the CAPA, which contains a periodic task for assessing the CAPA effectiveness.

Step 2.1 – Find the Effectiveness Assessment

The quickest way to find the task is to locate it in the Assessments tab in Detail Listings or search for the document number or per option I and II below:

I. From Detail Listings: From the CAPA view in the Task Area, select the CAPA document, and select Detail Listings under View Extensions

ii. This will show related items below, click on Assessment tab to view the periodic task.
II. Via Search for the document number and unfold the Periodic Task group if needed

Alternatively, you can find it via the Effectiveness Assessments view or in the Assigned to Me window per option III and IV.

III. From Effectiveness Assessment view: From the Home screen, go to Main views -> Tasks & Assignments -> Effectiveness Assessments view and locate the task

IV. The periodic task will automatically assign to the CAPA responsible person when it reaches the activation date. A notification will be sent via email, and the periodic task can be found in the Assigned to Me box.

The status of the Effectiveness Assessment can be found on a CAPA’s metadata card under the field CAPA Effectiveness Assessment. In addition, most CAPA views will have visible column that provides you the same information. This indicates to the user what actions needs to be taken on the CAPA if it is not already closed.

Step 2.2 – View the CAPA Effectiveness Metadata

Once you have located the periodic task for the CAPA effectiveness, the metadata contains information about the CAPA and the assessment of effectiveness.

Scheduling values are system generated but can be changed if you reschedule the task. The due date (Period End Date) for the assessment is calculated at 45 days from the effective date of the released CAPA (the PDF version). The Activation Date is set to 14 days before the due date and on the Activation Day, a notification email is sent to the assigned responsible person and an assignment is generated in SimplerQMS.

If you need to change the scheduling values to reschedule the task, go to Step 3.1 –  the assessment – Responsible Person

Section 3: Rescheduling or Starting CAPA assessment

When the assessment is on the state Scheduled, no changes can be made in the metadata.

If the periodic task needs to be rescheduled, the CAPA responsible person can make this adjustment.

Step 3.1 – Reschedule the assessment – Responsible Person

I. Select the periodic task, under State Transition, click on Reschedule

The scheduling values and the responsible person field in the metadata becomes editable and can be changed only by the responsible person (and process manager). The other fields remain as read-only.

II. Assign the values based on your company’s preference of scheduling the assessment

III. Click on Save

IV. Under State Transition, click on Schedule. The dates should be calculated based on the values you set

Step 3.2 – Start the CAPA Assessment – Responsible Person

Once the CAPA is back on Scheduled, the CAPA responsible person can get started with the assessment of the effectiveness.

There are 2 ways to start the assessment:

Option 1: Manually assess the CAPA

When the CAPA is still on scheduled, the CAPA responsible person can trigger the assessment manually at any time before the activation date.

The period end date of the assessment will remain the same even if the assessment was started manually.

I. Select the periodic task

II. Under State Transition click on Assess Effectiveness Now

a. The state will become Pending Assessment, and a task will be assigned to the responsible person and the metadata becomes editable.

III. Refer to the assignment description as a guide

At this stage, the options to proceed with the assessment will be under State Transition.

Option 2: Assess CAPA based on schedule

The CAPA responsible person gets notified on the activation date. On this day, an assignment in SimplerQMS will be generated and an email will be sent to the Responsible Person. The assessment will start and follows dates based on the scheduling values.

I. CAPA responsible persons receives notification that the assessment has reached the activation date and the assessment gets assigned

II. The state will become Pending Assessment, and in the state transition, it will show the options to continue with the assessment.

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 verified and can be closed – Responsible Person

When the CAPA assessment task is moved into “CAPA Effective and Can Be Closed” and the task is signed electronically, the Responsible Person should go to the CAPA (which is now in a version 2 and in Awaits Updates state) and

I. Open (Double-click on CAPA) and complete the CAPA document by finalizing the “Result of Effectiveness Assessment” section in the bottom of the document (or similar based on your Company’s CAPA template)

II. Update the metadata field “Conclusion of Closure” and the “Effective Date” and press save

III. Route the CAPA for review and/or approval and sign it

The assessment is now finalised and the released CAPA (PDF version) will move into either “For Learning” or “Effective” state depending on the Effective Date set. The previous version will automatically be retired. An additional Effectiveness Assessment task will be created but will be marked as “Obsolete Task – Working Copy Closed” as this should not be used.

Section 5: CAPA is Not Effective – Reopen CAPA – Responsible Person

When the CAPA has been assessed as not effective and therefore reopened to ensure actions are taken to make the CAPA effective, please follow the workflow (see also Section 1: Workflow overview):

1. Select the task and press “CAPA is not effective – Reopen CAPA”
2. Update CAPA with new actions and approve it (covered in this Section 5)
3. Find and get started on New Effective Assessment (Section 2 and 3)
4. 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 on “CAPA is not effective – Reopen CAPA”

II. Enter electronic signature. After the approval has been captured, the state is “CAPA Is Not Effective – Reopen CAPA” and a version 2 of the CAPA will automatically be assigned to the author, ready 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. The CAPA can either be routed for review or approval, this follows the steps in Work Instruction: Managing Quality Documents

V. When all approvals have been captured, it will generate a new PDF version and will retire the previous version

When the new version of the CAPA is in the state “CAPA Pending Effectiveness”, a new periodic task will be generated automatically for the CAPA effectiveness assessment (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 in case it is assessed effective) per 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 is to be issued, please follow the workflow section 6 (see also Section 1: Workflow overview):

1. Select task and click on “CAPA is Not Effective – Close CAPA (I will issue a new CAPA)”
2. Update and close CAPA 1 (covered in this Section 5)
3. Create CAPA 2 by copying CAPA 1 and follow the CAPA workflow for CAPA 2
4. Find and get started on Effective Assessment for CAPA 2 (Section 2 and 3)
5. 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 on 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 as to why CAPA 1 will be closed and a new CAPA 2 will be created. Once completed, save, and check in

II. In the metadata card, update the Conclusion of Closure and set Effective Date field to today’s date.

III. Click on Save after filling out the Conclusion of Closure and Effective Date

IV. The CAPA can either be routed for review or approval, this follows the steps in Work Instruction: Managing Recorded Issues and CAPAs (Step 3.4)

V. When all approvals have been captured, CAPA 1 will change state to “CAPA Closed”, and a new released PDF version will be created, and the old version will become retired. An Effectiveness Assessment task will be created but will be marked as “Obsolete Task – Working Copy Closed” as this should not be used.

Step 6.3 – Create CAPA 2 by copying CAPA 1 and follow the standard CAPA workflow for CAPA 2

To quickly create a new CAPA 2 and ensure a relations reference is created between CAPA 1 and CAPA 2, then 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

In addition, a CAPA relation field is automatically added on the CAPA 2 metadata card referencing the name of CAPA 1:

Please process CAPA 2 by drafting, reviewing, and approving it.

For further instructions on drafting, reviewing, and approving a new CAPA (and CAPA Attachments if needed), please review Work Instruction – Managing Recorded Issues and CAPAs

When CAPA 2 has been approved and released, it is time to assess the effectiveness of CAPA 2.

Follow the workflow again via section 2 -> 3 -> 4 (assuming CAPA 2 is assessed effective) in this WI.

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

Go to Detail Listings -> Docs to find the CAPA here or expand the details on CAPA 1 and look for CAPA 2 under Documents