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Interfacing Technologies Corporation
CAPA — #11
#11.1
#11
#10
Table of Contents
Interfacing Technologies Corporation
CAPA — #11
CAPA — #11.1
CAPA — #11
CAPA — #10
1.
User Manual for Corrective Action Preventive Action (CAPA) Application
2.
Technical Support
3.
Legal Notices
4.
Release Notes 11.0
4.1.
New Features
4.1.1.
CAPA Application – Layout and Composition
4.1.2.
New CAPA – New Fields
4.1.3.
Add Action Item to CAPA – New Fields
4.1.4.
CAPA List – Templates
4.1.5.
New Features in Admin Settings
4.2.
Feature Improvements
4.2.1.
New CAPA – CAPA ID Reformatted
4.2.2.
New CAPA – Event Type Options
4.2.3.
Add Action Item to CAPA – Task Type
4.2.4.
Improvements in Admin Settings
4.3.
Known Bugs and Limitations
4.3.1.
General – Dropdown – More Items
4.3.2.
General – Select All and Import All
4.3.3.
General – Import from Excel
4.3.4.
General – Rich Text Pop-Up Option
4.3.5.
New CAPA – Action Item ID
5.
General Application Functionalities
5.1.
Field Behavior
5.2.
Grid
5.2.1.
Browse Grids
5.2.2.
Update Grids
5.2.2.1.
Inline Add/Inline Edit
5.2.2.2.
Add/Edit
5.3.
Data Extraction/Integration
5.4.
File Attachment
5.5.
Delete
5.6.
Comment
5.7.
Rich Text Field
5.8.
Dropdown
5.8.1.
Single-Select Field with Modal Window
5.9.
Templates
6.
CAPA Application Overview
6.1.
Accessing the CAPA application
7.
Settings
7.1.
General Settings
7.1.1.
EPC Settings
7.1.2.
Compliance Types List
7.1.3.
Frequency
7.1.4.
Category
7.1.5.
Location
7.1.5.1.
Region
7.1.5.2.
Country
7.1.5.3.
Site
7.2.
Action Item Setting
7.3.
CAPA Setting
8.
CAPA Application Forms and Workflows
9.
New CAPA
9.1.
New CAPA Instance
9.1.1.
CAPA Details
9.1.1.1.
CAPA Triggered From Audit Application
9.1.2.
Actions
9.1.2.1.
Add Action Item to CAPA
9.1.2.1.1.
Add Budget Information
9.1.2.1.2.
Internal Action Type Options
9.1.2.1.2.1.
Is a Re-Training or New Training Required?
9.1.2.1.2.2.
Does EPC Documentation Need to be Updated
9.1.2.1.2.3.
Other
9.1.3.
Submit or Save
9.2.
Review CAPA
9.2.1.
CAPA Details
9.2.2.
Actions
9.2.3.
Comment
9.3.
Modify CAPA
9.4.
Execute the Root Cause Analysis
9.4.1.
CAPA Details
9.4.2.
Root Cause Analysis
9.4.2.1.
5W
9.4.2.2.
Comparative Analysis
9.4.2.3.
3×5 Why Analysis
9.4.3.
Actions
9.5.
Verify CAPA
9.6.
Modify CAPA
9.7.
Execute Action Items
9.7.1.
Execute the Action Items
9.7.1.1.
Is a Re-Training or New Training Required?
9.7.1.2.
Does EPC Documentation Need to be Updated?
9.7.1.2.1.
Close IR in EPC
9.7.1.3.
Other
9.7.1.4.
Request Extension for Action Item
9.7.1.4.1.
Approve or Reject Extension Request
9.8.
Create SCAR
9.8.1.
Create SCAR Instance
9.8.1.1.
SCAR Details
9.8.1.2.
Issue Assessment
9.9.
Check Effectiveness & Approve
9.9.1.
CAPA Details
9.9.2.
Root Cause Analysis
9.9.3.
Actions
9.9.4.
Comment
9.10.
Sign Off
10.
CAPA List
11.
New SCAR
11.1.
New SCAR Instance
11.1.1.
SCAR Details
11.1.2.
Issue Assessment
11.2.
Create SCAR
11.3.
Submit to Supplier
11.3.1.
SCAR Details
11.3.2.
Issue Assessment
11.3.3.
Root Cause
11.3.3.1.
Investigation
11.3.3.2.
Analysis
11.3.3.3.
Root Cause
11.3.3.4.
Review
11.4.
Review SCAR
12.
SCAR List
13.
Dashboard
9.1.
New CAPA Instance
9.
New CAPA
9.1.1.
CAPA Details
This form is composed of two tabs:
CAPA
Details
Actions
9.
New CAPA
9.1.1.
CAPA Details
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