Investigating a CAPA

Displays the Investigate CAPA Task Owner and the Due Date. Click the Change Task Owner link to assign this task to another user. For additional information, see Changing the Task Owner.

Displays the basic detail information about the non conformance.

Specify if an existing NC or CAPA will be used for the non conformance investigation. If NC or CAPA is selected, then zoom to select the record and enter a rationale.

Click the Add Investigation Tool link and then enter the information in the following fields:

• Tool* - Select the tool(s) for the investigation of the CAPA. The following tools are available and modifiable:
• 5 Whys
• Brainstorming
• Cause and Effect Diagram
• Check Sheet
• Fall Tree
• Fishbone
• Flow Chart
• Histogram
• Pareto Chart
• Run/Control Chart
• Traditional Narrative
• Other

NOTE: For more information on configuration, see Investigation Tools.

• Comment - Enter any additional information regarding the tools used.

Enter the information in the following Result of Investigation section fields:

• Result* - Enter the investigation result summary.
• Performed By* - Zoom to select the actor who performed the investigation if this user is different than the user signing off the investigation step.
• Performed Date* - Enter the date the investigation step was performed.

Enter the information in the following Root Cause Analysis section fields:

• Root Cause Against - Specify whether the root cause is against a product or process.
• Product - This option makes the Product field required.
• Process - This option makes the Process field required.

NOTE: For information on configuration, see Root Cause Against.

• Product/Process* - Enter or zoom to select the product or process the root cause is against. This product/process information is populated by the information entered during CAPA creation.

NOTE: For information on configuration, see Product Setup and Process Setup.

• View Failure Mode Report - Click the View Failure Mode Report link to view more complete analysis of past causes found on the same failure mode.

NOTE: For more information on configuration, see SmartInsight Reports in the Reporting and Analytics Guide.

• Failure Mode* - Enter or zoom to select the failure mode.

NOTE: For information on configuration, see Failure Mode Setup.

• Failure Mode Description - Enter a description of the failure mode.
• Root Cause* - Enter or zoom to select the root cause for the selected failure mode. The drop down contains the following filtered options:
• Product Failure Cause - Displays all root causes found in past investigations for this product specific failure mode.
• All Product Failure Cause - Displays all root causes found in past investigations for all product failure modes.
• Standard Product Failure Cause - Displays all causes listed in the standard cause table.

• Root Cause Description - Enter a description of the root cause.
• Root Cause Percentage - Select the percentage for which this root cause is weighted on the failure, such as 50% Operator not Skilled, 50% Missing Procedure.
• Caused By - Enter or zoom to select the organization unit associated with the root cause.
• Organization Unit Type - Displays the organization unit type associated with the org unit selected in the Caused By field.

If the Perform Final Risk Assessment option in the Policy section is set to Yes, the fields in this section must be completed prior to signing off the CAPA investigation. If entered in Master Setup of the failure mode, the Severity Rating, Occurrence Rating, and Detection Rating will default from the failure mode selected in the first field of this section and populate the other fields in this section.

• Failure Mode - Select the failure mode associated with the risk assessment. This defaults from the root cause analysis performed previously in the investigation step.
• Severity Rating* - Select the severity rating for the risk assessment of the CAPA. The following severity ratings are available and modifiable:
• Negligible (1)
• Moderate (2)
• Minor (3)
• Fatal (4)
• Critical (5)

NOTE: For information on configuration, see RA Severity Rating.

• Occurrence Rating* - Select the occurrence rating for the risk assessment of the CAPA. The following occurrence ratings are available and modifiable:
• Remote (1)
• Low (2)
• Moderate (3)
• High (4)
• Very High (5)

NOTE: For information on configuration, see RA Occurrence Rating.

• Detection Rating* - Select the detection rating for the risk assessment of the CAPA. The following detection ratings are available and modifiable:
• Very Low
• Low
• Medium
• High
• Very High

NOTE: For information on configuration, see RA Detection Rating.

• Heat Map Values - The Severity Rating and Occurrence Rating are assigned values from 1-5 with 1 being the lowest risk and occurrence and 5 being the highest. The numbers represent heat map values. When the Severity Rating and Occurrence Rating are selected, a chart or heat map of the Risk Analysis is generated and can be viewed. A Risk Analysis Outcome is generated which can be any of the following: Low, Moderate, High. Click the View Heat Map link to display the chart.

NOTE: For information on the configuration of heat maps, see Heat Map Required Actions and Heat Map Solutions.

• Risk Priority Number - The risk priority number for the risk assessment of the CAPA is calculated based on the selected Severity Rating x Occurrence Rating x Detection Rating.
• Document Number - Enter or zoom to select a document number referenced for the risk assessment. This document list can be maintained using our Document Management solution or any other enterprise document Management system.
• Severity Rationale* - Enter the severity rationale for the risk assessment.
• Mitigation - Enter the mitigation for the risk assessment.

Enter the information in the following Proposed Action Plans section fields:

• Plan Type* - Select a Plan Type option. Default plan types include the following:
• Corrective - This option is typically used in a CAPA coming from a failure.
• Preventive - This option is typically used in a CAPA created to prevent a potential failure from happening.

NOTE: For information on configuration, see Plan Type.

• Plan No. - Enter the plan number of the action plan, such as 1, 2, or 3. This option does not have any business logic tied to it and is only used as a reference number.
• Action Plan* - Enter the action plan.
• Action Plan Detail* - Enter a description of the action plan.
• Justification - Enter the justification for the action plan.
• Assigned to Role* - Enter or zoom to select the user role for the user to be assigned to the action plan.

NOTE: For information on configuration, see Roles.

• Assigned to User* - Enter or zoom to select the user assigned to the action plan.

NOTE: For information on configuration, see Users.

• Due Date* - Enter the due date for the action plan.
• Checklist - Zoom to select a checklist to be used for this action plan. For information on configuration, see Checklists.
• Is Plan Complete - Select whether or not this action plan is complete.
• No - This will later require the action plan to be signed off by the assignee.
• Yes- The action plan is signed off. The user must specify whether or not there is confirmation and objective evidence that the specific requirements have been fulfilled. The user must also enter information in the Completed By, Completed Date, and Comment fields.
• Skipped - The action plan is skipped and will not need to be signed off once the investigation has been approved. A comment must be entered.

Enter any other sites impacted by this CAPA.

If needed, the CAPA Coordinator can add attachments prior to signing off the investigation.