Legend

Newly related
Data-Only Object
Object

Child references Removed relationship

Parent via Lookup

Workflow Object Workflow Object

New relationship Parent references Children reference

Children via Related List Parent via Lookup

Newly related One-to-Many (parent : children)

Junction Object * Children appear in Related List on Parent
Object
* Parent appears in Lookup field on Children
Relationship is identical, regardless where it initiated

Public Group – unchanged Additional/background

information
Workflow Status
Public Group - original
Public Group - renamed Workflow-triggered
notification
Opened Status
Public Group - original
Public Group – new
Data-triggered notification
Time-triggered notification Closed Status

Workflow Action

Location Highlighter
(for Demos)

Parallel Workflow Actions

Electronic Signature required

Approval 1 Approval 2 Optional Approval

Comment required

Record locked
Child Parent Child
Record Record Added

Separators between
Workflow Permission Groups

Updating Workflow Legend

Notes for config addition
Status/Action/Step to be Status/Action/Step to be Status/Action/Step to be
ADDED to the WF CHANGED in the WF REMOVED from to the WF Notes for config removal

Workflow Status Workflow Status Workflow Status New/updated automation

(triggered here)

New/updated automation
Workflow Step Workflow Step Workflow Step
(triggered elsewhere)

Workflow Action Workflow Action • Task/Info or developers

Workflow Action

OOB = already part of

out-of-the-box QPA
 Quality Event
Top-Level Design

Quality Event
(DEV-)

Nonconformance Investigation Action Escalated Action

CAPA SCAR OOS
(NC-) (INV-) (ACT-) (EA-)

Investigation Impacted Lot Action Escalated Action

CAPA SCAR
(INV-) (IL-) (ACT-) (EA-)

Nonconformance Quality Event

CAPA
(NC-) (DEV-)
Containment
Phase 1A
Investigation
Scrap

Phase 1B
Investigation
Return

Phase 2
Mfg Investigation
Rework
Phase 1A
Phase 2 Investigation
Lab Investigation
Escalated Action
Phase 1B
Investigation

CAPA

Stand Alone CAPA

(sCAPA-)
Action Effectiveness Check
(ACT-) (EC-)

Action Investigation Effectiveness Check

Stand Alone CAPA
(ACT-) (INV-) (EC-)
(sCAPA-)

-CONFIDENTIAL-
 Quality Event

Quality Event - Owner (group)

Open Cancel Canceled

BR: Manager
BR: Analyst
1

Submit
Notify Owner?

More Information Quality Event - Quality (group)

Required
In Review Cancel

BR: Manager
2

Auto-perform if Auto-perform if Complete

[Type] = ‘Nonconformance’ [Type] = ‘OOS’

Auto-perform if
[Type] <> ‘OOS’ and

Automation
Check Type [Type] <> ‘Nonconformance’
3
Convert to
Convert to OOS Continue as Quality Event
Nonconformance

Quality Event - Owner (group)

Investigation, RCA and
Action Planning

BR: Manager
BR: Analyst
Closed – Converted to
Closed – Converted to OOS Must be cl osed:
Nonconformance INV Investigatio Escalated
CAPA Action
n Action

Submit for Approval

NC OOS Notify Approver(s)

Quality Event - Quality (group)

Auto-create Auto-create Reject

Nonconformance Pending Final

Canceled Approval
4

BR: Manager
OOS Canceled Notify CAPA Initiator?

FYI: Auto-performed if
child NC is canceled Approve

FYI: Auto-performed if Must be cl osed:

child OOS is canceled Al l child records

Closed Reopen
5
All ERs must be closed before
entering locked states
Notification – coming due New ERs should not be
Notification – past due created in locked states
Extension
OOB: Can be created in Request
any non-terminal state

-CONFIDENTIAL-
 Standalone CAPA

CAPA Initiator (group)

Effectiveness
Check CAPA - Initiator (group)

BR: Manager
BR: Analyst
Open Cancel Canceled
1
Extension
Must be cl osed:
Request ER
Submit
Notify Approver(s)

Request Additional
Pending Request Approval Cancel

BR: Manager
Information
2
CAPA Quality (group)
Extension CAPA - Quality (group)
Notify CAPA Initiator? Request
Submit for investigation

CAPA Owner (group)

Investigation and Action CAPA - Owner (group)

BR: Manager
Planning

BR: Analyst
3
Notify Approver(s) Extension
Request Action Investigation

Must be cl osed: Complete

ER, INV

CAPA Quality (group)

Reject Pending Approval CAPA - Quality (group)

BR: Manager
4

Notify CAPA Owner? Auto-approve child Actions

QA Initial Approval

CAPA Owner (group)

Pending Implementation CAPA - Owner (group)

BR: Manager
BR: Analyst
5
Notify Approver(s)
Extension Eff. Check
Request
Complete Notification – coming due
Must be cl osed: Notification – past due
ER, ACT

Notify CAPA Owner?

CAPA Quality (group)
CAPA - Quality (group)
Reject Final Approval Pending Final Approval
6
BR: Manager

QA Final Approval
Notify CAPA Owner?

Reopen Closed
7

-CONFIDENTIAL-
Must be child of QE -- Do not allow
stand-alone record. Nonconformance

1
Nonconformance
Identification & Cancel Canceled

BR: Analyst
Documentation

Submit

Cancel
More Information
Evaluation 2
Required

Impacted
Inve stigation
Lot
Complete

Disposition Planning

SCAR CAPA

BR: Manager
Submit for Approval

3
Return to Disposition Pending Disposition
Planning Approval

Return to Disposition
Planning
Managerial Approver (field) Managerial Approval
Disposition Accepted
2 (optional)
Managerial Approver (field)

Disposition Execution 2

Disposition Confirmed

3
Return to Identification
Closed
and Documentation

Exte nsion The following child records are

Reque st not state specific and can be
created in any non-terminal
unlocked state.

-CONFIDENTIAL-
 Impacted Lot

Evaluator
Nonconfor
mance

BR: Manager
BR: Analyst
Open Cancel Canceled

Submit

Automation
Pending NC Disposition
Parent Rejected
Approval

Parent Approved

Automation
Action Execution

Nonconform
ance Actio n
Actions Complete

Quality

BR: Manager
Reopen Closed – Approved

-CONFIDENTIAL-
 Nonconformance Action
(Containment)

IL

Manufacturing

Containment in Progress Cancel Canceled

Contained

BR: Manager
BR: Analyst
Area Manager
Area Mgmt Approval

Area Mgmt Approval

Reopen Closed

Add WF Action

-CONFIDENTIAL-
 Nonconformance Action
(Scrap)

IL

Manufacturing

Scrap In Progress Cancel Canceled

Scrapped

BR: Manager
BR: Analyst
Area Manager

Reject Scrap Complete

Area Mgmt Approval

Reopen

Closed

Add WF Action

-CONFIDENTIAL-
 Nonconformance Action
(Action)

IL

Procurement

Initiate Return Cancel Canceled

Authorize

BR: Manager
BR: Analyst
Manufacturing

Unable to Ship Process Return

Shipped to Supplier

Reopen

Closed – Returned

Add WF Action

-CONFIDENTIAL-
 Nonconformance Action
(Rework)

IL

Evaluator

Open Cancel Canceled

Submit Rework Plan

Quality

Reject Plan Rework Plan Approval

Approve Rework

BR: Manager
BR: Analyst
Manufacturing

Rework in Progress

Rework Complete

Reject Inspection Rework Inspection Area Manager

Approve Inspection

Reopen
Closed

Add WF Action

-CONFIDENTIAL-
 Nonconformance Action
(Escalated Action)

Evaluator

Open Cancel Canceled

Submit

Manufacturing

Action Planning

Action Plan Complete

Pending Action Plan Area Mgmt

Reject Action Plan
Approval

Update this workflow to match Escalated Action (SQM)

Initial Approval

Reject Pending Parent Approval

Parent Approved

Manufacturing
Implement Action

Implementation Complete

Implementation Area Mgmt

Verification

Verification Complete

Reopen Closed

-CONFIDENTIAL-
 Must be child of QE -- Do not allow OOS
stand-alone record.
Page 1

Lab Analyst
Open Cancel Canceled

Submit

Lab Management
Request More Info Lab Mgmt Review

Supervisor Review
Complete

QA QA Awareness

QA Awareness

Phase 1A
Investigation
Lab Analyst Phase 1A Lab Investigation

Assignable cause not

System Automation Go to Page 2
determined in Phase 1A
Assignable cause
determined in Phase
1A

Lab Mgmt Reject Phase 1A Document and Correct Local

Lab Error

Submit for Phase 1A CAPA

Approval
Lab Management

QA
QA Reject Phase 1A Phase 1A QA Approval Phase 1A QA Approval

Extension
Request

Closed – Local Lab Error

Extension
Request child
av ailable at all
open states
except l ock ed
approv al states

-CONFIDENTIAL-
 OOS
Page 2

End of
Page 1

Lab Analyst Phase 1B

Phase 1B Lab Investigation
Investigation

System Assignable cause not

Automation determined in Phase 1B

Assignable cause Go to “Phase 2

determined in Phase 1B Investigation”

Lab Reject 1B Assignable Document and Correct

Cause Lab Error

Lab Management
CAPA

Submit for Assignable

Cause Approval

QA
QA Reject 1B Assignable 1B Assignable Cause QA
Cause Approval

1B Assignable Cause QA
Approval

Closed – Assignable Lab

Error

-CONFIDENTIAL-
 OOS
Page 3

End of
Page 2

QA Phase 2 Investigation

Phase 2 Lab Phase 2 Mfr

Investigation Investigation
System Automation Phase 2 Investigations
Complete

Lab Management Phase 2 Lab & Mfg

Investigation Complete

Quality
CAPA
Event

Report Phase 2 Findings

QA QA Approval – Phase 2 Reject Phase 2 QA

Findings Approval

QA Approval – Phase 2
Findings

Closed – Phase 2
Findings Complete

-CONFIDENTIAL-
 OOS Investigation
(Phase 1A, 1B, 2 Manufacturing)

OOS

Supervisor

Open Cancel Canceled

Submit

Investigator

Investigation in Progress

Assessment

Complete

Area Mgmt
Lab Management
Lab Management Review
Reject

Lab Management
Approval

Extension
Request
Closed

Extension
Request child
av ailable at all
open states
except l ock ed
approv al states

-CONFIDENTIAL-
 OOS Investigation
(Phase 2 Lab Investigation)
Lab Analyst
OOS

Open Cancel Canceled

Submit

Lab
Management Reject Phase 2
Review Investigation Plan
Investigation Plan

Submit Plan to QA

QA Reject Phase 2 QA Review Phase 2

QA Investigation Plan Investigation Plan

Approve Phase 2
Investigation Plan

Lab Analyst
Phase 2 Investigation in
Progress

Submit Phase 2 Findings

Lab Management
Reject Phase 2 Phase 2 Investigation
Investigation Review

Phase 2 Investigation
Approved

Reject Phase 2 QA Phase 2 Investigation QA

Approval Extension
QA Approval
Request

QA Approval Extension
Request child
av ailable at all
open states
except l ocked
Closed approv al states

-CONFIDENTIAL-