CQ Summer ’26 | CAPA Effectiveness Review Enhancements - Epic SQX‑48645

Page Overview

Purpose
This page documents the Documentation Outline for Epic SQX‑48645, which enhances how CAPA Effectiveness is planned, monitored, submitted, approved, and concluded before CAPA closure.

The epic introduces Effectiveness Checks as a first‑class, governed lifecycle phase, ensuring that CAPA closure decisions are explicit, auditable, and defensible.

🎯 Epic Objective

The objective of Epic SQX‑48645 is to ensure that CAPA Effectiveness:

• Is clearly defined and scoped across the CAPA lifecycle

• Applies to all relevant Actions, including ad‑hoc Actions and Action Plans

• Is visible and understandable during monitoring and review

• Is formally submitted and approved, not implicitly assumed

• Has derived, consistent status behavior

• Directly drives Closure Review conclusions

End Goal
CAPA closure decisions are made based on explicit effectiveness evidence, not assumptions, and are fully traceable for audit and compliance purposes.

🧭 Epic Intent

Problems Before

• “Verification Plan” terminology caused confusion with Action verification

• Effectiveness scope (CAPA vs Action vs Action Plan) was unclear

• Actions added during Implementation could bypass effectiveness planning

• Effectiveness outcomes were informal and not approval‑driven

• “Status” labeling implied workflow rather than effectiveness decisions

• Effectiveness status behavior was implicit and inconsistently interpreted

Outcomes After

• Effectiveness Checks are explicitly named and consistently used

• Effectiveness can be scoped to:

  • Action Plan

  • Action

  • Root Cause

  • CAPA

• No Action bypasses effectiveness evaluation

• Effectiveness outcomes are formally submitted and approved

• Effectiveness status is fully derived and consistently displayed

• Closure Review conclusions are evidence‑based and auditable

This epic elevates CAPA Effectiveness from an implicit step to a governed, decision‑driven lifecycle phase.

📋 Sub‑Tickets

🧩 Effectiveness Check Terminology Alignment

(Sub‑Ticket: 1)

Change Summary

All references to “Verification Plan” are relabeled to “Effectiveness Check” to improve clarity and align terminology with CAPA effectiveness evaluation.

Scope of Relabeling

This terminology change applies globally across all user interfaces where Verification Plan is used, including:

• Object label → Effectiveness Check

• Grid label → Effectiveness Checks

• Related List label → Effectiveness Checks

• Any UI where Verification Plan is displayed

Rationale

• “Verification Plan” implies action‑level verification

• “Effectiveness Check” accurately represents evaluation of CAPA effectiveness

• Aligns terminology with:

  • Effectiveness monitoring

  • Closure Review conclusions

  • CAPA lifecycle outcomes

What Does Not Change

• No workflow or lifecycle behavior changes

• No backend logic or data changes

• No status or value changes

This update is a label‑only terminology alignment.

🧩 Effectiveness Check Definition for Ad‑Hoc Actions

(Sub‑Ticket: 2)

Overview

Effectiveness Check Plans can be defined during the CAPA Implementation stage for ad‑hoc Actions added to resolve additional findings.

Applicability

• CAPA is in Implementation stage

• CAPA Action EC is enabled

• A new ad‑hoc Action is being created

Effectiveness Check Plan Definition

When creating an ad‑hoc Action, the user must define an Effectiveness Check Plan with the following required fields:

• Interval (e.g., 30 days, 90 days)

• Estimated Days from Implementation (Numeric, Required)

• Success Criteria (RTF, Required)

Editing Rules

• EC Plan can be added, edited, or deleted

• Allowed only while the Action is in Draft / New status

Approval Integration

• EC Plan approval occurs via Implementation Change Approval

• On approval:

  • EC Plan is transferred as EC for the Action

  • EC Approval Status = “Plan Approved”

Outcome

No ad‑hoc Action added during Implementation bypasses effectiveness evaluation.

🧩 Effectiveness Check Definition for Action Plans

(Sub‑Ticket: 3)

Overview

Effectiveness Check Plans can be defined during the CAPA Investigation stage for Actions created as part of an Action Plan. This ensures effectiveness planning is established before Implementation begins.

Applicability

• CAPA is in Investigation stage

• Action Plans exist

• Actions are created from Action Plans

Effectiveness Check Plan Definition

When creating or editing an Action Plan, the user can define an Effectiveness Check Plan with the following required fields:

• Interval (e.g., days, weeks, months)

• Estimated Days from Implementation (Numeric, Required)

• Success Criteria (RTF, Required)

Behavior

• Effectiveness Check Plan is displayed:

  • Below the Action Plan information

  • In the Effectiveness Check grid

• When record is saved:

  • EC Scope is set to “Action Plan”

• EC Plan is visible from:

  • Action Plan

  • Action record

  • Investigation context

Outcome

Effectiveness expectations are defined early, supporting consistent planning and downstream evaluation.

🧩 Effectiveness Check Visibility & Context

(Sub‑Ticket: 4)

Change Summary

The Effectiveness Check Details page is updated to clearly display the scope of the Effectiveness Check, allowing users to understand what the EC applies to.

Details Page Enhancements

When a user navigates to the Effectiveness Check details page:

• EC Scope is displayed below the details section

• If EC Scope = Action, the related Action record is displayed below the details section

Scope Clarification

• This enhancement is read‑only

• No editing or workflow behavior is introduced

• Behavior is explicitly defined only for EC Scope = Action

• No assumptions are made for other scope types

Outcome

Users can easily and accurately understand the scope of the Effectiveness Check during monitoring, review, and closure activities.

🧩 Effectiveness Conclusion Terminology

(Sub‑Ticket: 5)

Change Summary

The field previously labeled “Status” in the Verification / Effectiveness Check context is relabeled to:

✅ Conclusion

Scope of Change

This relabeling applies globally across all user interfaces where Verification Plan / Effectiveness Check is used, including:

• Verification Plan Grid

• Verification Plan Related List

• Verification Plan Object detail page

• Any UI where Verification Plan / Effectiveness Check is displayed

Rationale

• “Status” implies workflow tracking or system state

• “Conclusion” reflects a decision outcome related to effectiveness

This terminology aligns with:

• Effectiveness Check outcomes

• Closure Review conclusions

• CAPA lifecycle decision‑making

What Does Not Change

• No change to underlying values

• No workflow or lifecycle logic changes

• No approval behavior changes

This is a label‑only clarification focused on improving user understanding.

🧩 Effectiveness Check Submission & Approval

(Sub‑Ticket: 6)

Overview

Effectiveness Check outcomes can be formally submitted for approval by a CAPA Team Member once monitoring is complete. This initiates the approval workflow and locks the Effectiveness Check from further edits.

Preconditions

All of the following must be true:

• User is a CAPA Team Member with edit access

• CAPA is in Implementation or Verification stage

• Effectiveness Check is in Monitoring status

Submission Flow

• User navigates to the Effectiveness Check record

• Submit EC and Submit quick actions are available

• Clicking Submit EC opens a full‑screen modal popup

Submission Popup Details

The popup includes:

• Verification Plan Success Criteria

  • Read‑only

  • RTFE enabled

  • Populated from Success Criteria

• Outcome (Required)

• Outcome Conclusion (Required)

• CAPA Approval Matrix

  • Displays Effectiveness Reviewers listed on the CAPA record

• Approver Selection

  • User can select one or more approvers

• Attachments

  • Can be added

  • Displayed under the Notes & Files section of the Activity panel

Popup Actions

• Cancel

  • Clears entered information

  • Closes the popup

• Submit

  • Saves entered data

  • Proceeds with submission

On Successful Submission

The system performs all of the following:

• A Response Record is created

  • Response Type: Effectiveness Check

• An Activity log entry is created

  • Purpose: Submitting Effectiveness Check

• Effectiveness Check submission instance is created with ECs and inclusion

• Effectiveness Check is submitted for approval to selected approvers

• EC Status moves to “In Approval”

• Effectiveness Check is locked for editing

Outcome

Effectiveness Check outcomes are now formally governed, auditable, and ready for Closure Review.

🧩 Effectiveness Check Status Derivation

(Sub‑Ticket: 7)

Core Principle

Effectiveness Check Status is fully derived and displayed in the Compact Layout.
It is never manually editable and is calculated based on association context and lifecycle events.

✅ EC Associated with an Action

✅ EC Associated with Root Cause

✅ EC Associated with CAPA

Status Behavior Summary

• Pending Action Implementation indicates actions are not yet executed

• Monitoring is the active effectiveness evaluation state

• In Approval represents approval workflow

• Complete / Cancelled are terminal states

• Rejection always returns the EC to Monitoring

🔁 CAPA Lifecycle Alignment

CAPA Investigation
   ↓
Investigation Completed
   ↓
CAPA Implementation (Status: Open Actions)
   ├─ Actions executed and completed
   ├─ Ad‑hoc Actions may be added (with Effectiveness Check Plans)
   ↓
CAPA Verification Stage
   ↓
Effectiveness Checks (Status: Monitoring)
   ├─ Effectiveness Check scope may be:
   │     • Action
   │     • Root Cause
   │     • CAPA
   ├─ Effectiveness Check status is derived
   ├─ Effectiveness outcomes are monitored
   ├─ User submits Effectiveness Check (Submit EC)
   ├─ Effectiveness Check moves to In Approval
   ├─ Approval Outcome:
   │     • Approved → Effectiveness Check Completed
   │     • Rejected → Returns to Monitoring
   ↓
All Effectiveness Checks Completed
   ↓
Closure Review Created (Status: Pending)
   ↓
Closure Review Ready
   ↓
User enters Closure information and submits for approval
   ↓
Closure Review Approval Decision
   ├─ Rejected
   │     → CAPA may move back to:
   │         • Implementation
   │         • Verification
   │         • Investigation
   ↓
   └─ Approved
         ↓
Closure Review Conclusion
   ├─ Close Effective
   │     → CAPA Closed
   ├─ Close Partially Effective
   │     → Create New CAPA Revision? (Yes / No)
   └─ Close Ineffective
         → Create New CAPA Revision? (Yes / No)