Verifying CAPA Initiation

Displays the Verify CAPA Initiation 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.

Verify the information previously entered in the Initiate CAPA task and then enter the following information:

• Impacted Site - Zoom to select the code(s) of the site(s) impacted by the CAPA.
• Do Related CAPA's Exist? - Specify if related CAPAs exist. If Yes is selected, zoom to select a related CAPA number. For information on configuration, see Saved Searches in the SmartSolve Utilities and Settings Help System.

Policies control the optional steps that can be performed in your CAPA workflow. An administrator can set these controls and restrict your CAPA Coordinator from selecting or changing these options. Specify the following:

• Policy for new Failure Modes - Specify what the policy will be if a failure mode or root cause that does not exist in the system is entered in the investigation:
• Do nothing - The new failure mode or root cause will not be added to the master setup table.
• Auto add new FM to master setup - The new failure mode or root cause will be automatically added to the master setup table(s). Notification is sent to the CAPA Coordinator.
• Route task - When a new failure mode or root cause is entered, it must be approved. An evaluation email(s) is sent to the CAPA Coordinator.

• Perform Initial Risk Assessment? - Select Yes if you want to perform Initial Risk Assessment. The default setting is set to No for this policy. If No is selected, then the initial risk assessment will be skipped for this record.
• Perform Final Risk Assessment? - Select Yes if you want to perform Final Risk Assessment. The default setting is set to No for this policy. If No is selected, then the final risk assessment will be skipped for this record.
• Perform Action Plan Verification/Validation - Select Yes if you want to perform Action Plan Verification/Validation. The default setting is set to Yes for this policy. If No is selected, then the action plan verification/validation will be skipped for this record.
• Perform Investigation Approval? - Select Yes if you want to perform Investigation Approval. The default setting is set to Yes for this policy. If No is selected, then the approval will be skipped for this record.
• Perform Effectiveness Review Planning? - Select Yes if you want to perform Effectiveness Review Planning. The default setting is set to Yes for this policy. If No is selected, then the review planning will be skipped for this record.
• Perform Implementation Verification? - Select Yes if you want to perform Implementation Verification. The default setting is set to Yes for this policy. If No is selected, then the verification will be skipped for this record.

If the Perform Initial Risk Assessment option in the Policy section is set to Yes, the following fields must be completed prior to signing off the CAPA verification:

• 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 High (1)
• High (2)
• Medium (3)
• Low (4)
• Very Low (5)

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.
• Severity Rationale* - Enter the severity rationale for the risk assessment.
• Mitigation - Enter the mitigation for the risk assessment.
• 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.

The following tasks have been configured as defaults in the CAPA workflow. Customers must configure their own roles to be assigned to these tasks.

• Investigation* - Investigation is a required task in the CAPA Management record and is typically performed by the business unit responsible for the product or process for which the CAPA was initiated. CAPA Investigator is an example of a user role that may perform this task.

NOTE: If the CAPA Type is Supplier and the Client is a Quality Portal User, then this field will default to blank and the user must enter or zoom to select a Client Contact.

• Investigation Approval* - Investigation approval is an optional task and takes place after the investigation is signed off in the system. Investigation approval can consist of multiple users. CAPA Approver is an example of a user role that may perform this task.
• Effectiveness Review Plan* - The effectiveness review plan is an optional task in the CAPA Management record and is typically performed by the CAPA Coordinator who builds the plan based on the type of CAPA. CAPA Coordinator is an example of a user role that may perform this task.
• Implementation Verification* - Implementation Verification is an optional task in the CAPA Management record performed by the user who must verify that the plans were implemented.
• Completion Review* - Completion review is a required task in the CAPA Management record and is typically performed by the CAPA Coordinator who must verify that the CAPA record can be closed. CAPA Coordinator is an example of a user role that may perform this task.
• Effectiveness Review* - Effectiveness review is an optional task in the CAPA Management record and is typically performed by the CAPA Coordinator who must verify that the CAPA plan provided and implemented is an effective plan. CAPA Coordinator is an example of a user role that may perform this task.
• Due Date Extension Approval* - Due date extension approval is a required task only if the due date extension is requested in the CAPA Management record. Due date extensions can be requested for investigations, implementations, and completions of CAPAs. CAPA Coordinator is an example of a user role that may perform this task.
• Coordination* - Coordination is a required task in the CAPA Management record. The CAPA Coordinator is typically the user who completes tasks like closure in the CAPA.
• Ownership* - Ownership is a required task in the CAPA Management record. The owner of the CAPA record is not assigned any task other than ownership and is typically the business process owner. CAPA Owner is an example of a user role that may be assigned to this task.
• Action Plan Verification/Validation* - Verification/validation is an optional task in the CAPA Management record and is typically performed by the user who must verify/validate proposed action plans prior to investigation approval.

NOTE: A CAPA Team must be configured by an administrator in order for users to be able to create CAPAs. For information on configuration, see Groups.

Enter the information in the following Due Dates section fields:

• Investigation Due Date* - Enter a due date for the investigation. The default due date interval is set to 7 days from the CAPA initiation date. This interval can be changed by modifying the CAPA Initiation Verification form.
• Implementation Due Date* - Enter a due date for the implementation. The default due date interval is set to 30 days from the CAPA investigation date. This interval can be changed by modifying the CAPA Initiation Verification form.
• Completion Due Date* - Enter a completion date for the CAPA. The default due date interval is set to 5 days from the CAPA implementation date. This interval can be changed by modifying the CAPA Initiation Verification form.

NOTE: For more information on configuration, see Forms Designer in the Studio Designer Help System.

If needed, the user can add attachments prior to signing off the verification.