SIEMENS

Active Workspace 4.2

Managing CAPA
AW032 • 4.2
Contents

Introduction to CAPA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Overview of CAPA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Components of Managing CAPA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

CAPA business process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Create a CAPA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Assign the CAPA Owner, CAPA Approver, and other team members . . . . . . . . . . . . . . . . 4-1

Describe the CAPA problem in detail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

Define the CAPA containment actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

Perform a root cause analysis of the CAPA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

How to perform a root cause analysis of a CAPA . . . . . . . . . . . . . . . .............. . . . . 7-1
Add the defects that define the caused-by analysis of the CAPA . . . . .............. . . . . 7-2
Link a defect to a failure code from the failure catalog . . . . . . . . . . . .............. . . . . 7-5
Add the required 5 Whys to defects . . . . . . . . . . . . . . . . . . . . . . . . .............. . . . . 7-6
Edit the 5 Whys and their Why questions based on your findings and attach the required
documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .............. . . . 7-10
Delete a 5 Why or a Why question based on your analysis . . . . . . . . .............. . . . 7-12
Mark a defect as a root cause and add the failure code for the defect . .............. . . . 7-12

Create a corrective action plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

Define the preventive actions that stop recurrence of the CAPA problem . . . . . . . . . . . . . 9-1

Generate the CAPA 8D report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1

AW032 4.2 Managing CAPA 3

Chapter 1: Introduction to CAPA

Overview of CAPA
Teamcenter Issue Management and Corrective Action Preventive Action (CAPA) allows you to
capture various forms of complaints, defects, and nonconformances, called issues, in a central
location. It provides tools to find the root cause of the issue and its resolution (corrective action) and
prevent their recurrence in future (preventive action).
It allows you to:
• Document the issue using a simple web-based user interface in Active Workspace. In Active
Workspace, you can describe the issue and add details about it.

• Document the resolution of the issues, and create reports summarizing the problem resolutions.

• Automate your company’s business processing using a workflow through which an issue is
tracked from its submission to completion.
Siemens PLM Software provides templates you can use to get started and also lets you define
your own.

• Manage the action plans (also referred to schedules) for resolving the issue, such as revising a
product’s deliverables. These are done through the second stage of investigation, a CAPA.

• Derive enterprise change requests (CRs), implementing any product structure changes.
When CAPA activities result in engineering or manufacturing change requests, each change
maintains it association with the entire CAPA investigation.

Components of Managing CAPA

Identifying an issue is the first step in the evaluation of a problem that can lead to a corrective action
preventive action (CAPA) investigation and requests to change the deliverables. These change
requests are implemented through a managed process, such as Teamcenter Change Manager.
• Issue
An issue identifies a problem. The issue can be a complaint from a customer, a nonconformance,
or other general problems.
The issue is tracked through an automated process, or workflow, where it is reviewed and
investigated.

• CAPA
A CAPA manages the resolution of one or more issues. It is usually derived from an issue, but it
can be created directly. During a CAPA process, you investigate the potential causes, identify

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 Chapter
Chapter 1: 1: Introduction
Introduction to CAPA
to CAPA

root causes, and define the containment, corrective, and preventive actions for resolving and
preventing the issue from occurring again.

• Engineering change request

If the CAPA investigation determines that a product structure change is required, an engineering
change request (CR) is created and implemented through a managed process, such as
Teamcenter Change Manager.

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Chapter 2: CAPA business process

The following graphic shows the sequence of tasks required to create and process a CAPA:

AW032 4.2 Managing CAPA 2-1

Chapter 3: Create a CAPA

Once you, as a Quality Management Representative (QMR), have identified a problem as an issue
and investigated it, you can derive a CAPA from it to investigate potential causes and resolutions.
Using this, you can create an action plan for resolving the issue and ensuring that it does not occur
again. You can also create a CAPA directly and bypass the issue investigation stage if you are certain
that a problem must be investigated with a CAPA. After you specify the CAPA details, you can save it
to edit it at a later stage. Alternatively, you can submit it to a workflow process that automatically
routes the CAPA through a company's business process to resolve the issue.
You can attach many types of files to an issue or CAPA to aid in its investigation. You can also attach
any type of Teamcenter object that is in the Teamcenter database. For example, you can attach an
item revision of a part or a drawing. You can choose how to relate it, including adding it as the item
that contains the problem being investigated or as the solution.
If you are a QMR and have created the CAPA or you are assigned as the CAPA Owner or CAPA
Approver, you can modify it. You cannot modify the CAPA if it is closed. As you modify the CAPA, the
CAPA is checked out, so that other users cannot access the CAPA while you are editing it.
1. On the home page, click the CHANGES tile.

2. To derive a CAPA from an issue, do the following:

a. In Active Workspace, from the CHANGES folder, select and open the required issue that is
the source of the CAPA.

b. From the Primary toolbar, click New > Derive Change.

c. In the Derive Change panel, select CAPA.

3. To create a new CAPA, do the following:

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 Chapter
Chapter 3: 3: Create
Create a CAPA
a CAPA

a. From the Primary toolbar, click New > Create Change.

b. In the Create Change panel, select CAPA.

4. In the Synopsis box, summarize the CAPA.

5. In the Description box, describe the CAPA.

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 Create a CAPA

6. From the CAPA Category list, select the appropriate category.

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 Chapter
Chapter 3: 3: Create
Create a CAPA
a CAPA

7. From the CAPA Sub-Category list, select the appropriate subcategory.

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 Create a CAPA

8. Specify a proposed due date.

9. (Optional) Add supporting objects and reference documents to the CAPA.

For example, to add a supporting object to the CAPA, to the right of Attachments, click .

10. Do one of the following:

• To continue editing later, click Create.
The CAPA is created and displayed in edit mode. You can send it for resolution later.

• To send it for resolution immediately, click Submit.

The CAPA is sent through the default workflow for resolution. Reviewers and approvers for
the CAPA may be automatically assigned depending on how your organization’s CAPA
workflow is configured.

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Chapter 4: Assign the CAPA Owner, CAPA Approver,
and other team members

After creating a CAPA, you must assign the users who are designated as CAPA Owner, CAPA
Approver, and CAPA Supplier. You must also assign roles to the other CAPA team members and
specify the team member roles in resolving the CAPA.
The CAPA Owner updates the CAPA at each stage and submits the CAPA for approval depending on
the workflow used by your organization. For example, the CAPA Owner adds the containment actions
and submits the CAPA for approval.
The CAPA Approver reviews the work of the CAPA Owner and provides feedback if further changes
are required. If no changes are required, the CAPA Approver approves the work at that stage of
the CAPA resolution. The CAPA is the reassigned to the CAPA Owner to continue work on it. For
example, the CAPA Approver reviews the containment actions entered by the CAPA Owner and
then approves the CAPA. The CAPA is reassigned to the CAPA Owner to work on the next stage:
adding the root cause analysis of the CAPA.
Some additional roles could be:
• Team Lead: Leads the team by assigning tasks, tracking the CAPA progress, and ensuring that
the team meets the proposed due dates of resolving the CAPA.

• CAPA Champion: Interacts with the customers and is a point of contact for the customer.

1. In Active Workspace, from the CHANGES folder, select and open the CAPA that you want to edit.

2. From the Primary toolbar, click Edit > Start Edit.

3. In the Status section of the Overview tab, do the following:

a. From the Process Type list, select the type of resolution you want to use for the CAPA. You
can choose to use 8D for the steps in the full Eight Disciplines (8D) problem solving model or
4D for a compact resolution. You can also use 1D as a complaint notice.

b. From the Actual Step list, select the current step applicable to the CAPA.
If you are using a workflow to process the CAPA, the workflow updates this field when a
discipline step is completed.

4. From the Primary toolbar, click Edit > Save Edits.

5. In the Related Issues and CAPAs section, you can add the issues and CAPAs that are either
implemented by this CAPA or are similar to this CAPA.

6. Click the Team tab.

7. In the Team tab, do the following:

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 Chapter
Chapter 4: 4: Assign
Assign the CAPA
the CAPA Owner,
Owner, CAPACAPA Approver,
Approver, and other
and other teamteam members
members

a. In the D1- Establish The Team section, click Add .

b. In the Add panel, search for and select the team members in the Users tab, and click Add.

c. To specify the role of the team member in resolving the CAPA, from the Primary toolbar,
click Edit > Start Edit.

d. In the 8D Role column, type the role of the team member.

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 Assign the CAPA Owner, CAPA Approver, and other team members

e. From the Primary toolbar, click Edit > Save Edits.

f. In the Team Leader (CAPA Owner) section, click Add .

g. In the Add panel, search for and select the user to be assigned as the CAPA Owner in the
Users tab, and click Add.

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 Chapter
Chapter 4: 4: Assign
Assign the CAPA
the CAPA Owner,
Owner, CAPACAPA Approver,
Approver, and other
and other teamteam members
members

h. If the team leader changes, you can replace the existing team leader:
The CAPA must always have a team leader assigned to it.

A. Select the existing team leader In the Team Leader (CAPA Owner) section, and click
Replace .

B. In the Replace panel, search for and select the required user, and click Add.

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 Assign the CAPA Owner, CAPA Approver, and other team members

i. In the Champion (CAPA Approver) section, click Add .

j. In the Add panel, search for and select the user to be assigned as the CAPA Approver
in the Users tab and click Add.

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 Chapter
Chapter 4: 4: Assign
Assign the CAPA
the CAPA Owner,
Owner, CAPACAPA Approver,
Approver, and other
and other teamteam members
members

k. (Optional) In the CAPA Supplier section, click Add .

l. In the Add panel, search for and select the user to be assigned as the CAPA Supplier in the
Users tab and click Add.

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Chapter 5: Describe the CAPA problem in detail

After the Quality Management Representative (QMR) assigns the CAPA Owner, CAPA Approver,
and optionally, a CAPA Supplier and other CAPA team members, the CAPA Owner opens the CAPA
and adds the following CAPA details:
• Add additional information that describes the CAPA problem, category, subcategory, and
proposed due date.

• Add the defect that has resulted in the CAPA.

• Add the problem items that have resulted in the CAPA.

• Add the files that provide supporting information to resolve the CAPA.

• Add the internal and external links that provide supporting information to resolve the CAPA.

1. In Active Workspace, from the CHANGES folder, select and open the CAPA that you want to edit.

2. Click the Problem Description tab.

3. In the Problem Description tab, do the following:

a. From the Primary toolbar, click Edit > Start Edit.

b. In the Describe The Problem section, you can edit the Description, Priority, CAPA
Category, CAPA Sub-Category, and Proposed Due Date of the CAPA.

c. From the Primary toolbar, click Edit > Save Edits.

d. In the Defect From Catalog section, click Add to to add the appropriate defect that
resulted in the CAPA.

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 Chapter
Chapter 5: 5: Describe
Describe the CAPA
the CAPA problem
problem in detail
in detail

e. Go to the Palette tab to choose a defect from the Clipboard, Favorites, or Recent sections.

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 Describe the CAPA problem in detail

f. You can also go to the Search tab to search for the required defect and add it to the CAPA.

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 Chapter
Chapter 5: 5: Describe
Describe the CAPA
the CAPA problem
problem in detail
in detail

g. In the New tab, you can create a new defect by specifying a name and description.

h. (Optional) Select the Recurring check box if the defect is a recurring defect.

i. (Optional) Specify the Category of the defect and click Add.

The added defects automatically appear in the Root Cause Analysis tab. You can add more
defects as defect causes in this tab and mark a defect as the root cause of the CAPA.

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 Describe the CAPA problem in detail

j. In the Problem Items section, click Add to to add the problem items that are causing
the CAPA.

k. In the Add panel, select the type of item and specify the required option to create the
problem item.
You can also use the Palette tab or the Search tab to locate the required problem items.

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 Chapter
Chapter 5: 5: Describe
Describe the CAPA
the CAPA problem
problem in detail
in detail

l. In the Files section, click Add to to add the attachments that provide more information
about the problem to the CAPA Owner.

m. Click Choose File to select the required file and click the Add button.

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 Describe the CAPA problem in detail

n. In the Web Links section, click Add to to add links to information available on an external
site.

o. Specify the required URL in the URL box and the name of the link in the Name box, and
then click the Add button.

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 Chapter
Chapter 5: 5: Describe
Describe the CAPA
the CAPA problem
problem in detail
in detail

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Chapter 6: Define the CAPA containment actions

After defining the CAPA problem in detail, the CAPA Owner must define the interim containment
actions that must be performed to stop the current problems. A combination of these containment
actions comprises the containment action plan of the CAPA. For example, consider the following
problem: The Nanobox cannot dissipate the heat load due to a faulty cooling body. The containment
action to stop this problem is to stop production of the product where the old cooling body is in use
and restart production only when the new cooling body is available.
1. In Active Workspace, from the CHANGES folder, select and open the CAPA that you want to edit.

2. Click the Containment Action tab.

3. In the Containment Action tab, do the following:

a. In the Containment Action Plan section, click Add to .

b. Specify a name for the containment action and optionally enter a description.

c. (Optional) Specify a due date and select other options as appropriate.

d. (Optional) Select Confirmation Required to make the responsible user confirm the action.

e. (Optional) Select Feedback At Completion to collate feedback from the responsible user
after implementing the containment action.

f. Select the Autocomplete By Dependent check box if dependent quality actions can close
the parent quality action.
Selecting this check box allows you to avoid performing the manual step of closing the
parent quality action.

g. (Optional) From the Quality Action Status menu, select a status. By default, it is Draft.

h. To create the containment action, click Add.

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Chapter 7: Perform a root cause analysis of the CAPA

How to perform a root cause analysis of a CAPA

After defining the containment actions to be performed, the CAPA Owner must add the defects that
define the caused-by analysis of the defect that you have added in the Problem Description tab.
This analysis defines the defects that have caused the problem at its source. The defect from the
Problem Description tab automatically appears in this tab as a starting point for the analysis.
To this, you must add the various defects that in turn caused this defect. For the problem description
defect and each defect, you can use the methodology of 5 Whys to perform a root cause analysis of
the specific defect. Using this, you can identify the root cause of the problem, and you can develop
the corrective actions and preventive actions.
The 5 Whys is a methodology that consists of continuously asking why a problem occurred till you
find the root cause of the problem. In some cases, you can find the root cause before reaching the
fifth (Why) question. In other cases, you might have to ask more than five Why questions to find
the root cause. When you identify the root cause, you can find a solution for it to ensure that it
does not occur again.
You can add the following types of 5 Whys:
• Specific: In this type of Why, you can add the questions that define why the problem occurred.

• Detection: In this type of Why, you can add the questions that define why the problem was
not detected earlier.

• System: In this type of Why, you can add the questions that define why the system allowed
the problem to occur.

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Perform
a roota cause
root cause analysis
analysis of theofCAPA
the CAPA

After performing the root cause analysis, you can mark which defect is the root cause.

Add the defects that define the caused-by analysis of the CAPA
You must add the defects that define why the problem occurred. For each defect, you can create a
chain of defects that describe why the earlier defect occurred. For example, if the CAPA is created
to resolve the problem of the engine not starting, you must add the defects that describe why the
engine was not starting. The following might be possible reasons:
• Battery is disconnected

• Engine Starter is faulty

• Vehicle key is defective

• Fuel supply line is disconnected

• Battery is discharged

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 Perform a root cause analysis of the CAPA

You add the primary defects for each reason. Then, you must add secondary and tertiary defects
that describe why the primary defects are caused. For example, if the battery is discharged because
of an alternator failure, add a defect for alternator failure. If the alternator failure occurred because
the alternator coil is burnt, add a defect for a burnt alternator coil.
In this manner, continue adding the required defects. Subsequently, you can link a defect to a failure
code from the failure catalog, and use the 5 Whys to determine which defect is the root cause of
the problem.
1. In Active Workspace, from the CHANGES folder, select and open the CAPA that you want to edit.

2. Click the Root Cause Analysis tab.

3. In the left pane of the Root Cause Analysis tab, select the defect where you want to add the
new defect, and do the following:
a. From the Primary toolbar, click New > Defect.

b. Specify a name for the defect and optionally, enter a description.

c. (Optional) Select the Recurring check box if the defect is a recurring defect.

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Perform
a roota cause
root cause analysis
analysis of theofCAPA
the CAPA

d. (Optional) Specify the Category of the defect and click Add.

The defect is added under the defect that you had selected in the left pane.

e. Repeat the above steps until you complete adding all the required defects.

4. To add attachments to the defect, do the following:

a. In the left pane, select the defect where you want to add an attachment.

b. In the right pane, click the Attachments tab.

c. In the Files section, click Add to .

d. In the Add panel, click Choose File to select the required file and click the Add button.

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 Perform a root cause analysis of the CAPA

Link a defect to a failure code from the failure catalog

After you add all the required defects, you can link a defect to a failure code from the failure catalog.
You can link only one failure to a defect.

Note
You can link only one failure to a defect.

1. In Active Workspace, from the CHANGES folder, select and open the CAPA that you want to edit.

2. Click the Root Cause Analysis tab.

3. In the left pane of the Root Cause Analysis tab, select the defect that you want to link to
a failure code.

4. In the Failure Code From Catalog section in the right pane, click Add .

5. In the Add panel, search for and select the required failure, and click Add.

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root cause analysis
analysis of theofCAPA
the CAPA

6. If you want to change the linked failure, you must replace the existing failure with another failure
from the catalog. Do the following:

a. Select the existing failure and click Replace .

b. In the Add panel, search for and select the required failure, and click Add.

Add the required 5 Whys to defects

For the problem description defect and each defect, you can implement the 5 Whys by adding the
required 5 Whys and the Why questions to determine which defect is the root cause of the CAPA.

1. In Active Workspace, from the CHANGES folder, select and open the CAPA that you want to edit.

2. Click the Root Cause Analysis tab.

3. In the left pane of the Root Cause Analysis tab, select the defect where you want to add the 5
Why, and do the following:

a. From the Primary toolbar, click New > 5 Why.

b. Specify a description and select the type of 5 Why from the 5 Why Type list.

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 Perform a root cause analysis of the CAPA

c. Click Add.
The 5 Why appears under the defect.

4. To add a Why question to the 5 Why, select the 5 Why and do the following:
a. From the Primary toolbar, click New > Why.

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Chapter 7: 7: Perform
Perform
a roota cause
root cause analysis
analysis of theofCAPA
the CAPA

b. Specify a description and click Add.

5. Repeat the above steps till you complete adding the required 5 Whys and their Why questions.

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 Perform a root cause analysis of the CAPA

6. To view a hierarchical view of the Why questions that you added to the 5 Why, select a 5 Why in
the left pane, and click the Methodology tab in the right pane.

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a roota cause
root cause analysis
analysis of theofCAPA
the CAPA

Edit the 5 Whys and their Why questions based on your findings and
attach the required documents
After adding the required 5 Whys and their Why questions, you can edit them to reflect your finding
and attach the required documents to support your findings.
1. In Active Workspace, from the CHANGES folder, select and open the CAPA that you want to edit.

2. Click the Root Cause Analysis tab.

3. In the left pane of the Root Cause Analysis tab, select and expand the required defect that
contains the 5 Whys and their Why questions to be edited.

4. Select a 5 Why and do the following:

a. From the Primary toolbar, click Edit > Summary.

b. In the Overview tab in the left pane, make the required updates.

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 Perform a root cause analysis of the CAPA

c. From the Primary toolbar, click Edit > Save Edits.

5. To edit a Why question, select it and do the following:

a. From the Primary toolbar, click Edit > Summary.

b. In the Overview tab in the left pane, make the required updates.

c. From the Primary toolbar, click Edit > Save Edits.

d. In the right pane, click the Attachments tab.

e. In the Files section, click Add to .

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a roota cause
root cause analysis
analysis of theofCAPA
the CAPA

f. In the Add panel, click Choose File to select the required file and click the Add button.

6. Repeat the above steps till you complete editing the required 5 Whys and their Why questions.

Delete a 5 Why or a Why question based on your analysis

While performing your analysis, you might find that a 5 Why or a Why question is not relevant to the
CAPA. In such a case, you can delete the 5 Why or Why question from the CAPA.
1. In Active Workspace, from the CHANGES folder, select and open the CAPA that you want to edit.

2. Click the Root Cause Analysis tab.

3. In the left pane of the Root Cause Analysis tab, select and expand the required defect that
contains the 5 Why and Why questions to be deleted.

4. To delete a Why question, select the Why question, and do the following:
a. From the Primary toolbar, click Edit > Delete.

b. In the confirmation message, click Delete.

The existing Why questions are automatically rearranged. For example, if you have four
Why questions and you delete the third Why question, the existing fourth Why question
becomes the third Why question.

5. To delete a 5 Why, select the 5 Why, and do the following:

a. From the Primary toolbar, click Edit > Delete.

b. In the confirmation message, click Delete.

The 5 Why and its associated Why questions are deleted.

6. Repeat the above steps till you complete deleting the required 5 Whys and their Why questions.

Mark a defect as a root cause and add the failure code for the defect
1. In Active Workspace, from the CHANGES folder, select and open the CAPA that you want to edit.

2. Click the Root Cause Analysis tab.

3. After you complete the root cause analysis, select the defect that is the root cause of the CAPA,
and, from the Primary toolbar, click Manage > Mark as Root Cause.
You can mark only one defect as the root cause. In the Overview tab in the right pane, the Root
Cause property is set to True. If you decide to mark a different defect as the root cause, the
Root Cause property of the existing defect is set to False, and the new defect's Root Cause
property is set to True.
You can also right-click on a defect, and choose Mark as Root Cause.

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 Perform a root cause analysis of the CAPA

Note
The root cause appears in the 8D report.

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Chapter 8: Create a corrective action plan

After performing a root cause analysis of the CAPA, the CAPA Owner must add the different
corrective actions that can be performed to resolve the CAPA, implement these corrective actions
to confirm their effectiveness, and then specify the best corrective action to be implemented. The
corrective action to be implemented might be a combination of the effective corrective actions that will
completely resolve the CAPA.
1. In Active Workspace, from the CHANGES folder, select and open the CAPA that you want to edit.

2. Click the Corrective Action tab.

3. To create the corrective actions to be planned for the CAPA, do the following:
a. In the Plan Permanent Corrective Action and Confirm Effectiveness section, click Add
to .

b. Specify a name for the corrective action and optionally, enter a description.

c. (Optional) Specify a due date and select other options as appropriate.

d. (Optional) Select Confirmation Required to make the responsible user confirm the
corrective action.

e. (Optional) Select Feedback At Completion to collate feedback from the responsible user
after implementing the corrective action.

f. Select the Autocomplete By Dependent check box if dependent quality actions can close
the parent quality action.
Selecting this check box allows you to avoid performing the manual step of closing the
parent quality action.

g. (Optional) From the Quality Action Status menu, select a status. By default, it is Draft.

h. To create the corrective action, click Add.

4. To define the quality actions that confirm the effectiveness of the corrective action, do the
following:
a. In the Plan Permanent Corrective Action and Confirm Effectiveness section, select
a corrective action.
The Quality Action section appears to the right of the Plan Permanent Corrective Action
and Confirm Effectiveness section.

b. In the Quality Action section, click Add to .

AW032 4.2 Managing CAPA 8-1

 Chapter
Chapter 8: 8: Create
Create a corrective
a corrective action
action plan plan

c. Specify a name for the quality action to confirm the effectiveness and optionally, enter
a description.

d. (Optional) Specify a due date and select other options as appropriate.

e. (Optional) Select Confirmation Required to make the responsible user confirm the
effectiveness of the corrective action.

f. (Optional) Select Feedback At Completion to collate feedback from the responsible user
after implementing the confirmation of the corrective action.

g. Select the Autocomplete By Dependent check box if dependent quality actions can close
the parent quality action.
Selecting this check box allows you to avoid performing the manual step of closing the
parent quality action.

h. (Optional) From the Quality Action Status menu, select a status. By default, it is Draft.

i. To create the confirmation of the effectiveness of the corrective action, click Add.

5. To specify the best corrective action to be implemented, do the following:

a. In the Implement Corrective Actions section, click Add to .

b. Specify a name for the corrective action and optionally enter a description.

c. (Optional) Specify a due date and select other options as appropriate.

d. (Optional) Select Confirmation Required to make the responsible user confirm the
corrective action.

e. (Optional) Select Feedback At Completion to make the responsible user provide feedback
after implementing the corrective action.

f. Select the Autocomplete By Dependent check box if dependent quality actions can close
the parent quality action.
Selecting this check box allows you to avoid performing the manual step of closing the
parent quality action.

g. (Optional) From the Quality Action Status menu, select a status. By default, it is Draft.

h. To create the corrective action, click Add.

8-2 Managing CAPA AW032 4.2

 Create a corrective action plan

AW032 4.2 Managing CAPA 8-3

Chapter 9: Define the preventive actions that stop
recurrence of the CAPA problem

After the CAPA Owner creates the CAPA's corrective actions, the CAPA Owner must define the
CAPA's preventive actions. These actions are performed to prevent a future occurrence of the issue.
1. In Active Workspace, from the CHANGES folder, select and open the CAPA that you want to edit.

2. Click the Preventive Action tab.

3. In the Preventive Action tab, do the following:

a. In the Prevent Recurrence section, click Add to .

b. Specify a name for the preventive action and optionally, enter a description.

c. (Optional) Specify a due date and select other options as appropriate.

d. (Optional) Select Confirmation Required to make the responsible user confirm the
preventive action.

e. (Optional) Select Feedback At Completion to collate feedback from the responsible user
after implementing the preventive action.

f. Select the Autocomplete By Dependent check box if dependent quality actions can close
the parent quality action.
Selecting this check box allows you to avoid performing the manual step of closing the
parent quality action.

g. (Optional) From the Quality Action Status menu, select a status. By default, it is Draft.

h. To create the preventive action, click Add.

AW032 4.2 Managing CAPA 9-1

 Chapter
Chapter 9: 9: Define
Define the preventive
the preventive actions
actions that stop
that stop recurrence
recurrence of theofCAPA
the CAPA problem
problem

i. In the Implement by Change Request/Change Notice section, add the change request or
change notice that implements the preventive action.

9-2 Managing CAPA AW032 4.2

Chapter 10: Generate the CAPA 8D report

1. In Active Workspace, from the CHANGES folder, select and open the CAPA that you want to edit.

2. In the Overview tab, from the Primary toolbar, click New > Generate Report.

AW032 4.2 Managing CAPA 10-1

 Chapter
Chapter 10:10:Generate
Generate the CAPA
the CAPA 8D report
8D report

3. In the Generate Report panel, select AWC CAPA 8D Report.

10-2 Managing CAPA AW032 4.2

 Generate the CAPA 8D report

4. In the Format section, do the following:

a. From the Report Display Locale list, select the required locale.

AW032 4.2 Managing CAPA 10-3

 Chapter
Chapter 10:10:Generate
Generate the CAPA
the CAPA 8D report
8D report

5. (Optional) In the Save to FileName box, type the report file name.

6. Click Generate.

Browse to the Downloads folder of your browser and open the report.

10-4 Managing CAPA AW032 4.2

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