Event

Ext Req CC
CAPA
Process Process 1
Initiator
Opened

Assigned To

Scheduled Schedule Reviewers

Reviewer
(Assigned To
Send For Approval
Schedules Approval)
ES
Locked
Reject Awaiting Event Review

Summary Req’d

ES
Event Review - Approve

Assigned To
ES
Awaiting Event
Reject
Approval
Alternate Approver
Summary Req’d
Summary Req’d

TWC ES
AT01
Approve ES
Awaiting Alternate
Reject
Event Approval
Scheduled Summary Req’d
Quality Approver
(TWC Schedules Approval)
ES Scheduled
Event Disposition
Approve Quality Approver
(System Action) (Assigned To
Schedules Approval)

TWC 1 – Event – Perform

AT02 TWC - Close Move to NC

Addendum
Closed

TWC Activities:
AT01 – Schedule Quality Approver to perform the “Approve” activity.
AT02 – Perform “TWC - Close” activity when Prod Impact is No Product Impact. Open new NC when Prod Impact is Potential Product Impact.
Non-Conformance Event

TWC 1 – Event – Perform

AT02
Move to NC

Event Disposition
(System Action)

TWC To Investigation
AT04
Planning

Investigation Planning

Assigned To
Execute Investigation

Ext Req
Process
Executing Investigation Modify Plan

Summary Req’d
CAPA
Schedule Reviewers

ES
Locked
Reject Awaiting NC Review

Summary Req’d
Assigned To
ES
Scheduled
Reviewer Review - Approve

(Assigned To
Schedules Approval) Summary Req’d

Awaiting NC Approval Alternate Approver

ES
Scheduled ES
TWC Awaiting Alternate NC
Quality Approver Reject Approve - Close AT05
Approval
(Assigned To
Schedules Approval) Summary Req’d

AT06
ES
Addendum
Closed Approve - Close

TWC Activities:
AT04 – Perform “To Investigation Planning” activity
AT05 – Schedule Quality Approver to perform the “Approve - Close” activity.
AT06 – Close Children records when Parent closes.
 Lab Event
CC Ext Req
CAPA
Process 1 Process

Initiator Opened

Assigned To

Scheduled Schedule Reviewers

Reviewer
(Assigned To
Send For Approval
Schedules Approval)
ES
Locked
Reject Awaiting Event Review

Summary Req’d

ES
Event Review –
Approve
Assigned To

ES
Awaiting Event
Reject
Approval
Alternate Approver
Summary Req’d
Summary Req’d

TWC ES ES
AT01
Approve Awaiting Alternate
Reject
Event Approval

Summary Req’d

ES
Scheduled Event Disposition
Approve Scheduled
(System Action)
Quality Approver Quality Approver
(TWC Schedules Approval) (Assigned To
Schedules Approval)

TWC 2 – Lab Event – Perform

AT03 TWC - Close Move to Lab NC

Addendum
Closed

TWC Activities:
AT01 – Schedule Quality Approver to perform the “Approve” activity.
AT03 – Perform “TWC - Close” activity when Prod Impact is No Product Impact. Open new Lab NC when Prod Impact is Potential Product Impact.
 Lab
Lab Non-Conformance Event

TWC 2 – Lab Event – Perform

AT03
Move to Lab NC

Event Disposition
(System Action)

TWC To Investigation
AT04
Planning

Ext Req
Process
(Exec) Investigation Planning

Assigned To

Execute Investigation
Confirmatory Lab
CAPA Test Invest

Modify Plan
Executing Investigation
Summary Req’d
Ext Req
Process
Schedule Reviewers

ES
Locked
Awaiting NC Review Reject Scheduled
Summary Req’d Reviewer
(Assigned To
Schedules Approval)
Review - Approve

ES Summary Req’d

Reject Awaiting NC Approval Alternate Approver

Summary
Req’d

ES
TWC Awaiting Alternate NC
Scheduled Approve - Close AT05
Approval
Quality Approver
(Assigned To
Schedules Approval) AT06
ES
Addendum
Closed Approve - Close

TWC Activities:
AT04 – Perform “To Investigation Planning” activity
AT05 – Schedule Quality Approver to perform the “Approve - Close” activity.
AT06 – Close Children records when Parent closes.
 Confirmatory Test
Lab NC
Opened
Initiator

TWC
AT07 To Test Planning

Test Planning

Assigned To CC
Process 1
Schedule Reviewers

ES
Awaiting Test
Reject
Scheduled Plan Review

Reviewers Summary Req’d

(Assigned To ES
Schedules Approval)
Quality Plan Approval
Approval - Plan
(Req’d)

Modify Plan
Assigned To Executing Test Plan
Summary Req’d

CC
Process 2
Schedule Reviewers

ES
Awaiting Results
Reject
Approval

Summary Req’d
ES
Scheduled
Approvers Approve
Quality Approval
(Req’d)
(Assigned To
Schedules Approval)

Locked
Complete

TWC
AT06 TWC - Close Addendum

TWC Activities:
Closed
AT07 – Perform “To Test Planning” activity
AT06 – Perform “TWC – Close” Activity when Parent Closes
 Invalid Assay

Initiator Opened

CC
Send For Approval Process 1

Assigned To

ES
Summary Req’d
Awaiting Invalid Assay
Reject
Approval
Alternate Approver
Summary Req’d

CAPA

ES
Awaiting Alternate
Reject
Closure Approval
TWC ES
AT05 Summary Req’d
Approve - Close
Scheduled
Quality Approver
(TWC Schedules Approval)
ES Scheduled
Approve - Close Quality Approver
(Assigned To
Schedules Approval)

Closed

Addendum

TWC Activities:

AT05 – Schedule Quality Approver to perform the “Approve - Close” activity.

 Lab Investigation
Lab NC
Opened
Initiator

TWC To Investigation
AT04
Planning

Investigation Planning

Assigned To CC
Process 1
Schedule Reviewers

ES
Locked
Awaiting Investigation
Reject
Scheduled Plan Review
Reviewers Summary Req’d
(Assigned To
Schedules Approval) ES

Quality Plan Approval

Approval - Plan
(Req’d)

Assigned To Executing Investigation Modify Plan

CC
Summary Req’d
Process 2

Schedule Reviewers

ES

Reject Awaiting Review

Summary Req’d
ES
Scheduled
Approvers Approve
Quality Approval
(Req’d)
(Assigned To
Schedules Approval)

Locked
Complete

TWC
TWC - Close AT06 Addendum

TWC Activities:
Closed
AT04 – Perform “To Investigation Planning” activity
AT06 – Perform “TWC – Close” Activity when Parent Closes
 Addendum
Parent

CC
Process 1
Initiator
Opened

Scheduled Send for Closure

Send for Closure
Review
Reviewers Approval
(Assigned To
Schedules Approval) Assigned To
ES
Locked CC
Awaiting Closure Process 2
Reject
Review

Summary Req’d

ES
Accept – Send for
Review Approval

ES
Awaiting Closure
Reject
Approval
Alternate Approver
Summary Req’d
Summary Req’d

ES
Awaiting Alternate
Reject
TWC ES Closure Approval
AT05 Approve - Close
Summary Req’d
Scheduled
Scheduled
Quality Approvers
(TWC Schedules Approval)
ES Quality Approver
Approve - Close (Assigned To
Schedules Approval)

Closed

TWC Activities:

AT05 – Schedule Quality Approver to perform the “Approve - Close” activity.

 CAPA
Page 1 Parent
Opened

Initiator TWC
AT08
Submit

Planning

Assigned To CC
Process 1 CAPA
page 2

Schedule Reviewers

Task
Action

ES
Locked
Reject Awaiting Plan Review

Summary Req’d

ES
Scheduled
Review - Approve
Reviewers
(Assigned To
Schedules Approval)

ES
Locked
Reject Awaiting Plan Approval

Summary Req’d Summary Req’d

Alternate Approver

Scheduled ES
Quality Approver Awaiting Alternate Plan
(TWC Schedules Approval) Reject
TWC Approval
ES
AT09
Approval - Plan Summary Req’d

ES
Approval - Plan
AT11
Scheduled
CAPA
Quality Approver
Page 2 Work in Progress (Assigned To
Schedules Approval)

TWC Activities:
CC Ext Req
AT08 – Perform “Submit” activity Process 2 Process Assigned To
AT09 – Schedule Quality Approver to perform the “Approval - Plan” activity. (Exec)
AT11 – Perform “Approval Received” on the child when Parent enters “Work in
Progress” state.
 CAPA CAPA
Page 1
Page 2
Task
Action

Work in Progress

CAPA TWC Task Complete

AT10
pg 1 Modify Plan Task(s) Completed (No Child)

Summary Req’d

Pending Closure

Assigned To
Send for Approval Eff Check

Assigned To
Quality Approver

ES
Awaiting Closure
Reject
Approval
Summary Req’d
Summary Req’d
Alternate Approver

Scheduled
Quality Approver ES
(TWC Schedules Approval) Awaiting Alternate
Reject
TWC Closure Approval
ES
AT05
Approve - Close Summary Req’d

ES
Scheduled
Approve - Close
Quality Approver
AT12
(Assigned To
Schedules Approval)
Closed

Eff Check

TWC Activities:
AT10 – Perform “Task(s) Completed” activity, when ALL child Task records exist in the “Complete” state.
AT05 – Schedule Quality Approver to perform the “Approve - Close” activity.
AT12 – Perform “TWC - Close” on all child Task records when Parent CAPA is closed.
 Task Action CAPA
CC Ext Req
Process 1 Process

Originator
Opened
Assigned To

Quality
Approver TWC
AT11
Manual
Approval Received Approval Received

Work in Progress
Assigned To

CC
Process 2
Modify Task
Work Completed
Ext Req
Process
(Exec)
AT10

Locked
Complete

TWC ES
AT12
TWC - Close

Closed

Addendum

TWC Activities:
AT10 – Perform “Task(s) Completed” activity, when ALL child Task records exist in the “Complete” state.
AT11 – Perform “Approval Received” on the child when Parent enters “Work in Progress” state.
AT12 – Perform “TWC - Close” on all child Task records when Parent CAPA is closed.
Effectiveness Check
Page 1 CAPA CC

Originator
(QA from CAPA or
CO from CC)
Opened

TWC
AT10
Submit

Close
Cancel
Process Planning

From EC
Assigned To Schedule Reviewers Page 2

ES Send for Approval

Locked
Reject Awaiting Plan Review

Summary Req’d
ES
Scheduled
Review - Approve
Reviewers
(Assigned To
Schedules Approval)

ES
Locked
Awaiting EC Plan
Reject
Approval

Summary Req’d Summary Req’d

Alternate Approver
Assigned To

ES
Scheduled Awaiting Alternate Plan
Reject
TWC Approval
Quality Approver ES
AT09
(TWC Schedules Approval) Approval - Plan Summary Req’d

ES
Approval - Plan

Work in Progress Scheduled

Quality Approver
(Assigned To
Schedules Approval)

TWC Activities: To EC
Page 2
AT10 – Perform “Submit” activity.
AT09 – Schedule Quality Approver to perform the “Approval - Plan” activity.
Effectiveness Check
Page 2

From EC
Page 1

Work in Progress

Assigned To

Modify Plan

Summary Req’d
Send for Approval

To EC
Page 1

Awaiting Closure
Reject
Approval

Summary Req’d
Summary Req’d

Alternate Approver
Assigned To

Scheduled Awaiting Alternate

Quality Approver Reject
TWC Closure Approval
ES
(TWC Schedules Approval) AT05
Approve - Close Summary Req’d

ES Scheduled
Approve - Close Quality Approver
(Assigned To
Schedules Approval)
Closed

Addendum

TWC Activities:

AT05 – Schedule Quality Approver to perform the “Close - Approve” activity.

 Standard Extension Request

Event
Non-
Lab Event Lab NC Task
Conformance
Action

Initial State of Request

Assigned To

Request Due Date

Extension
TWC
AT13
Move
ES

Extension Requested Ext Approval

ES
Ext Rejected
Scheduled
Summary Req’d Quality Approver
(Assigned To
TWC Activities:
Schedules Approval)
AT13 – Perform the “Move” Activity when the Ext State Rejection
Toll Gate
Extension Request enters the Ext. State
Rejection Toll Gate state.

Standard Extension Request

(Exec State)
CAPA Lab NC Task
Required due to second opportunity for Action
Extension Request on the same workflow
(return to different states)

Initial State of Request

Assigned To

Request Due Date

Extension
TWC
AT13
Move
ES
Extension Requested
Ext Approval
(Exec)

ES

Ext Rejected
Scheduled
Summary Req’d Quality Approver
(Assigned To
TWC Activities:
Schedules Approval)
AT13 – Perform the “Move” Activity when the Ext State Rejection
Toll Gate (Exec)
Extension Request enters the Ext. State
Rejection Toll Gate (Exec) state.
Close Cancellation Request 1

Confirmatory Lab Invalid Task

Event Lab Event CAPA Addendum
Test Investigation Assay Action

Initial State of Request

Assigned To
Send for Cancel
Approval

Locked ES
Awaiting Cancel
Reject Cancellation
Approval
Scheduled
Quality Approver Summary Req’d
(TWC Schedules Approval)
TWC
AT33
ES
Close Cancel - Approve

TWC Activities:

Closed-Cancelled AT33 – Schedule Quality Approver to perform the

“Close Cancel - Approve” activity.

Close Cancellation Request 2

Lab Confirmatory Task

Investigation
CAPA Test Addendum Action

Initial State of Request

Assigned To

Send for Cancel

Approval

ES
Locked
Awaiting Cancellation
Scheduled Approval
Reject Cancellation
Quality Approver
(TWC Schedules Approval) Summary Req’d

TWC ES
AT33
Close Cancel - Approve

TWC Activities:

Closed-Cancelled AT33 – Schedule Quality Approver to perform the

“Close Cancel - Approve” activity.