22Managing Corrective and Preventative Actions

Managing Corrective and Preventative Actions

This chapter covers the following topics:

• About Managing Corrective and Preventative Actions

• Scenario for Managing Corrective and Preventive Actions

• Process of Managing Corrective and Preventive Actions

About Managing Corrective and Preventative Actions

This chapter describes recording and managing corrective actions and preventive actions (CAPAs) for Siebel Adverse Events and Complaints Management (Siebel AECM).The following table defines and distinguishes these two terms. But generally, corrective and preventive actions are called CAPAs; this is how they will be referred to generically in this chapter.

Table Terms Defined with Examples

Term	Definition from ISO 8402	Example
Corrective Action	Action taken to eliminate the causes of an existing non-conformity, defect, or other undesirable situation in order to prevent recurrence.	When devices were returned because of damage caused by electrostatic discharge (ESD) during assembly, the corrective actions were (i) implementation of ESD controls and (ii) ESD control training for operators.
Preventative Action	Action taken to eliminate the cause of a potential non-conformity, defect, or other undesirable situation in order to prevent occurrence.	When control charts indicated the diameter of a molded part was drifting towards the upper limit, the preventive action was to replace the mold and validate that the new parts met the specifications.

The CAPA record in Siebel AECM is designed to contain all information about a corrective or preventive action: from its creation through planning and implementation through authentication, closure and beyond.

Related Topics

Capturing Adverse Events and Complaints

Investigating Adverse Events and Complaints

Recording Product Analysis for Adverse Events and Complaints Management

Regulatory Reporting

Communicating with Customers for Adverse Events and Complaints Management

Closing Adverse Events and Complaints

Scenario for Managing Corrective and Preventive Actions

This scenario is an example process performed by the Siebel administrator, and the corrective and preventive action team. Your company might follow a different process according to its business requirements.

This process is designed to illustrate the functionality of Siebel AECM.

The Siebel Administrator

The administrator sets up the activity templates that the corrective and preventive action team members use in the course of planning, implementing, and verifying corrective and preventive actions.

Before creating these templates, the administrator consults with the corrective and preventive action team. It is very important that the activities defined by the template accurately and completely reflect the company’s policies and procedures for the handling of corrective and preventive actions.

The administrator also checks the necessary codes for CAPA have been set up as appropriate for the company’s business needs.

The Corrective and Preventive Action Team Members

The product analysis team has alerted the CAPA team that some of the cartridges used in the new blood analyzer are out of tolerance and that this is causing them to jam in the analyzer. The CAPA team is responsible for correcting this problem.

The CAPA manager creates a corrective action record. He fills in all the information known about the problem and its root cause, including the associated product analysis and product issue records. The CAPA team use this record as the project file, referring and adding to it throughout the life cycle of the CAPA.

All information associated with the CAPA is stored and accessible from this record. The information takes a variety of forms, from short comments where employees share information about recent actions and findings, to longer notes (both public and private), and large documents such a reports and specs that are saved as file attachments.

The CAPA manager uses the activity template to generate a standard set of activities that outline the team’s standard operating procedure for implementing corrective and preventive actions. He assigns the activities to members of his team. The manager uses the list of activities to monitor the progress of the CAPA; noting the start and end dates and which activities have been completed and which are still to be done.

CAPA team members are assigned activities, with start and due dates. They carry out their assigned activities, recording the tools and parts used, how long each activity takes to complete, and the results and measurements obtained.

Major milestone dates, both target and actual, are recorded on the main form of the CAPA record. Also the approval history of the CAPA record is tracked as changes in the CAPA’s status are made, from Open, through Approved, to Verification.

Process of Managing Corrective and Preventive Actions

This example process represents the tasks that are carried out in the Scenario for Managing Corrective and Preventive Actions.

Administrator Procedures

• Creating Corrective Action Activity Templates

• Setting Up Codes for Corrective and Preventive Actions

End-User Procedures

• Creating a CAPA Record

• Managing Corrective and Preventive Actions

• Tracking Approvals and Other Changes to Corrective and Preventive Actions

Creating Corrective Action Activity Templates

Corrective action activity templates are used to create a standard sets of activities that the CAPA team follow as they plan, implement, and verify a CAPA.

This task is a step in Process of Managing Corrective and Preventive Actions.

To create a corrective action activity template

1. Navigate to the Administration - Data screen, then the Activity Templates view.

2. In the Activity Templates list, create a new record and complete the necessary fields.

   1. Set the Type field to Corrective Action.

   2. Set start and end dates for the activities by specifying Lead Times and Durations.

   3. Leave these fields blank: Sales Stage and Sales Method; they do not apply to product issue activities.

3. Associate individual activities with the template, as described in Siebel Applications Administration Guide.

Setting Up Codes for Corrective and Preventive Actions

The administrator defines the codes that are used to categorize corrective and preventive actions and their root causes.

This task is a step in Process of Managing Corrective and Preventive Actions.

To set up codes for corrective and preventive actions

• See Setting Up Codes.

Note: Typically, you create codes of type Corrective Action for use with CAPA records. However, all types of codes can be associated with CAPA records.

Creating a CAPA Record

Corrective actions can be created and viewed in these screens:

• Corrective Actions.When a CAPA record is created in this screen, no default type is associated with the CAPA.

• Product Issues. When a CAPA record is created in this screen, the default type is Product Issue.

• Repairs. When a CAPA record is created in this screen, the default type is Product Analysis.

When a CAPA is created from the Product Issues or the Repairs screen, a CAPA number is assigned automatically. You can configure the application to copy information from the Product Issue or the Product Analysis record to the CAPA record. Review the configuration of the Create Product Issue button (see About Configuring Adverse Events and Complaints Capture) for an example of a similar configuration.

This task is a step in Process of Managing Corrective and Preventive Actions.

To create a CAPA record in the Corrective Actions screen

1. Navigate to the Corrective Actions screen, then the Corrective Action List view.

2. In the Corrective Action List, create a new record and complete the necessary fields.

   Some fields are described in the following table. Note that some of these fields are filled in when the CAPA is first created, and other fields are filled in later in the CAPA investigation.

   Field	Comments
   Accounts	The accounts requiring the fix.
   Actual Fixed	The date when the fix was actually implemented.
   Area	Classification for the corrective action. The Type field constrains this drop-down list.
   Asset #	For example, the asset number of the first machine to which the fix is applied.
   CA #	Unique number to identify the CAPA. It is auto-generated when the CAPA record is created.
   Codes	Typically, select codes of type Corrective Action. Example uses: Use codes to indicate the root cause of the CAPA. Use codes to classify the CAPA.
   Comments	Use this field to record and share short notes during the life cycle of the CAPA.
   Corrective Action	Detailed description of the corrective action and its root cause.
   Fix Age	Number of days since the Actual Fixed date.
   Lot #	For example, the first lot number to which the fix is applied.
   Mfg Name	Typically this is the (internal) manufacturing site.
   Serial #	Serial number of the asset. This field is automatically populated if there is a serial number associated with the asset.
   Status	Changes to this field are tracked in the Approvals view.
   Sub Area	The Area field constrains this drop-down list.
   Sub Status	The Status field constrains this drop-down list.
   Target	The version of the product targeted to have the fix.
   Type	The type of corrective action: Product Analysis, Product Issue, Manufacturing, Preventive Action, Other.

3. Drill down on a record in the Corrective Action List.

4. Click the Related Products tab, create new records for the products related to the CAPA, and complete the necessary fields.

5. Click the Product Issues tab, create new records for any product issue related to the CAPA, and complete the necessary fields.

6. Click the Product Analysis tab, create new records for any product analyses related to the CAPA, and complete the necessary fields.

Managing Corrective and Preventive Actions

Use the views on the Corrective Actions screen to store, maintain, and share many types of information about a CAPA.

Typically several employees are assigned ownership of a CAPA record and are assigned activities related to the CAPA. All owners update the CAPA record during the course of the CAPA’s life cycle.

This task is a step in Process of Managing Corrective and Preventive Actions.

To add information to CAPA records

1. Navigate to the Corrective Actions screen, then the Corrective Action List view.

2. In the Corrective Action List, drill down on a CAPA record.

3. Modify the record by editing the Status, Comment, and Date fields.

4. Create activity plans for the CAPA record as follows:

   1. Click the Activity Plan tab.

   2. In the Activity Plans list, create a new record and complete the necessary fields.

      Some fields are described in the following table.

      Field	Comments
      Planned Start	Make sure that this date is correct before you choose a template. The due dates for the template-generated activities are based on this start date and on the lead time set in the template.
      Template	Only templates whose type is Corrective Action can be selected in this field.

   3. Modify the activities in the Activities list or create new activities as required.

5. Create private and public notes for the CAPA record using the Notes tab.

6. Associate files to the CAPA record using the Attachments tab.

For general information about activities, notes, and attachments, see Siebel Fundamentals.

Tracking Approvals and Other Changes to Corrective and Preventive Actions

Changes in the status of the CAPA record are tracked in the Approvals view. Changes to other fields in the CAPA record can be seen in the Audit Trail view. For information about enabling Audit Trail, see Siebel Applications Administration Guide.

Note: For information about configuring the Corrective Action screen to use buttons and workflows for changing the status of a CAPA record, see About Configuring CAPA Approvals.

This task is a step in Process of Managing Corrective and Preventive Actions.

To track approval history and other changes to CAPA records

1. Navigate to the Corrective Actions screen, then the Corrective Action List view.

2. In the Corrective Action List, drill down on a CAPA record.

3. Click the Approvals tab.

   Changes in the Status of the CAPA record is tracked in this view.

4. Click the Audit Trail tab.

   Changes made to fields in the CAPA record are tracked in this view.

About Configuring CAPA Approvals

There are no buttons or workflows associated with the Corrective Actions screen.

However, you can configure your application with Submit and Withdraw buttons and workflows similar to those used for approving product analysis records on the Repairs screen.

See:

• About Configuring Product Analysis Approvals for specific information on the product analysis approval workflows

• Configuring Siebel Business Applications for information about how to configure buttons

• Siebel Business Process Framework: Workflow Guide for information about how creating workflows