The Grand Avenue Software CAPA module is based around a seven-step process for managing CAPA Requests.
%%{init: {"flowchart": { 'padding':'5', 'curve': 'basis', "htmlLabels": false }} }%%
flowchart LR
Submit["`**Submit New Request**`"];
Classify["`**Classify, Prioritize, and Assign**`"];
Hold["`**Request Placed On Hold**`"]
Investigate["`**Investigate and Plan**`"];
Approve["`**Approve Plan**`"];
Implement["`**Implement and Verify**`"]
Effectiveness["`**CAPA Effectiveness Verification**`"]
Closed["`**Closed**`"]
Submit --> Classify & Hold --> Investigate --> Approve --> Implement --> Effectiveness --> Closed;
click Submit "#CapaSubmitNewRequestForAction" "Submit New Request for Action"
click Classify "#CapaApprovePrioritizeAndAssignRequest" "Approve, Classify, Prioritize and Assign Request"
click Hold "#CapaPlaceCapaRequestOnHold" "Request Placed On Hold"
click Investigate "#CapaInvestigateAndPlan" "Investigate and Plan"
click Approve "#CapaApprovalOfSolutionPlan" "Approval of Solution Plan"
click Implement "#CapaImplementationAndVerificationOfSolutionPlan" "Implementation and Verification of Solution Plan"
click Effectiveness "#CapaVerificationOfCapaEffectiveness" "Verification of CAPA Effectiveness"
click Closed "#CapaReviewAndClosureOfRequest" "Review and Closure of Request"
The first step in a corrective and preventive action process is a request for action. Based on identification of a problem, concern, idea or opportunity, someone must communicate the background of the situation and request approval and resources to address it. A new CAPA Request can be initiated by clicking the Submit New Request link in the navigation menu.
To initiate a new CAPA Request, click the "Submit New Request" link in the navigation menu. The software will automatically take you to the Add New CAPA Request page, where you will be assisted in describing the background of the situation. After describing the situation and how it affects the organization, you will submit the new request into the CAPA process, where it will be approved and prioritized by a CAPA Module Coordinator (see the Approve, Prioritize and Assign Request step).
The CAPA Module Coordinator may return the CAPA Request to you if additional information is required. In that case, you will receive a new Submit New Request task. The task will contain the feedback entered by the CAPA Module Coordinator, and you will be responsible for addressing those concerns before resubmitting the CAPA Request.
The Add/Edit CAPA Request page begins with a section to document as much background detail as possible about the situation. This section allows you to:
NOTE: see Process Impacts Overview
Review each potential impact in the Process Impacts table and specify whether it applies to the CAPA Request. If the impact is not applicable to the CAPA Request, you may be required to enter a justification of why it does not apply (see Edit Process Impact). The "Description Required" column indicates whether you must provide a description or justification for an impact.
Process Impacts identified as applicable for a CAPA Request may require the CAPA Module Coordinator to assign a follow-up Impact Implementation task during the implementation of the CAPA. The "Requires Task" column indicates whether a follow-up task will be assigned during the implementation of the Request.
If no Process Impacts have been configured by the CAPA Module Coordinator, this section will not be displayed.
Once you have finished entering all of the background information about this CAPA Request, you can submit it to the CAPA process by clicking the "Save and Proceed to Signoff" button (see Sign Off Submit New Request). If you need to save your work and return to it later, click the "Save for Later" button. You will receive a Submit New Request task as a reminder to finish the work later. The task will have a default Due Date, but you will be able to modify it using the Change Due Date button on the "My Tasks" page.
Clicking the "Cancel" button will discard your changes and return to the "My Tasks" page.
If at some point prior to submitting you decide that the CAPA Request is no longer valid, clicking the "Withdraw Request" button will take you to the Withdraw CAPA Request page.
Once you have finished updating any necessary background information about this CAPA Request, click the "Save Changes" button to save your changes and return to the previous page.
Clicking the "Cancel" button will discard any changes and return you to the previous page.
You can also modify the classification and prioritization of CAPA Requests that are either On Hold or in the Preliminary Review step. See the section on classifying and prioritizing CAPA Requests in the Prioritize and Assign section of the online help.
To upload a file containing background information about a CAPA Request, enter a brief description of the file and then click the "Browse" or "Choose File" button to find and select the file from your local machine. Once you have selected the file, click the "Save" button to upload the file and return to the Add/Edit CAPA Request page.
If you choose to make changes to a previously uploaded file, the page will display a link to the current version. You can replace the current version by selecting another file to upload.
Click the "Cancel" button to discard any changes and return to the Add/Edit CAPA Request page.
An "affected article" is a tangible business item that is related to the CAPA Request. Some examples are:
It is your responsibility as the Originator to identify these articles so that the CAPA Module Coordinators and the assigned Investigator will later have the necessary background information to perform a root cause analysis, and identify the necessary actions to address the CAPA Request.
The Add/Edit Affected Article page provides fields for identifying:
NOTE: The "UDI Number(s)", "Serial Number(s)" and "Lot Number(s)" fields are only displayed if they have been configured for use in your system by a CAPA Module Administrator (see Configure CAPA Process Options).
Once you have completed all the required information, click the "Save Article and Close" button to save your results and return to the Add/Edit CAPA Request page. If you want to enter more than one article at a time, click the "Save Article and Add Another" button. If, while entering information about an article, you decide that it is not relevant to this CAPA Request, you can click the "Cancel" button to discard the information you've entered and return to the Add/Edit CAPA Request page.
Document the activities performed to contain/eliminate a detected nonconformity. Corrections may be added or edited from the time CAPA Requests are initiated until they are submitted for Formal Review.
To upload a file containing additional information about the correction, click the "Add Correction Attachment" button (see Add Correction Attachment). To edit or delete an attachment, click the corresponding button in the table.
To upload a file containing information about a Correction, enter a brief description of the file and then click the "Browse" or "Choose File" button to find and select the file from your local machine. Once you have selected the file, click the "Save" button to upload the file and return to the Add/Edit CAPA Request page.
If you choose to make changes to a previously uploaded file, the page will display a link to the current version. You can replace the current version by selecting another file to upload.
Click the "Cancel" button to discard any changes and return to the Add/Edit CAPA Request page.
Use the Comments field to record any additional comments with your signature. Then enter your signoff key and click the "Sign Off" button. Your task will be closed, and an Approve New Request task will be assigned to the CAPA Module Coordinators. If you are submitting this CAPA Request for the first time, it will be assigned an automatically generated ID (e.g. CAPA-00001).
Click the "Cancel" button to return to the previous page without submitting the CAPA Request.
Withdrawing a CAPA Request removes it from the CAPA process. Enter comments describing why you are withdrawing this CAPA Request, and then click the "Withdraw Request" button to sign off on your task assignment and return to your task list. The CAPA Request will be withdrawn from the process.
In many cases a withdrawn CAPA Request will simply be deleted from the system. However, in the following cases it will instead be given a Status of "Withdrawn" and retained for historical purposes:
Click the "Cancel" button to return to the previous page without withdrawing the CAPA Request.
When a CAPA Request is submitted to the CAPA process, a CAPA Module Coordinator will be assigned the task of reviewing the Request and documenting whether it will be approved (see the Approve New Request task).
If the CAPA Request is approved, CAPA Module Coordinators are responsible for documenting its priority (see the Prioritize and Assign task). When a CAPA Request is prioritized, the CAPA Module Coordinator can either initiate an investigation (see Investigate and Plan) or temporarily place it on hold (see Place CAPA Request On Hold).
As a CAPA Module Coordinator you will receive an Approve New Request task assignment whenever a new CAPA Request is submitted into the CAPA process. Open the task to go to the Review New Request page, where you will review the CAPA Request and indicate whether it should be accepted into the CAPA process.
The Review New Request page displays the background information for the new CAPA Request. Before approving a new CAPA Request for action, you should review the background information for correctness/completeness. To make any necessary changes, click the "Edit Request Information" button. You will be taken to a page where you are allowed to modify any of the background information (see Add/Edit CAPA Request).
After you have finished reviewing the CAPA Request and making any necessary modifications, you must specify whether the Request is valid. A configurable user assistance link is provided to display your organization's criteria for valid CAPA Requests.
If the CAPA Request has been initiated because of another Grand Avenue Software process, an additional "Withdraw as Duplicate" button is available to allow you to withdraw the Request as a duplicate of an existing CAPA Request. If you believe the CAPA Request is a duplicate of another CAPA Request, click the button to proceed to the Select Existing Request page, where you will be able to search for and select the existing CAPA Request.
Clicking the "Finish Later" button will return you to the "My Tasks" page, leaving the CAPA Request to be reviewed at a later date.
Enter any additional comments and your account signoff key, and click the "Sign Off" button to finish approving the CAPA Request. The CAPA Request will be automatically assigned a CAPA ID, its Status will be set to "New Request", its Accepted Date will be set to the current date, and you will receive a Prioritize and Assign task assignment in your "My Tasks" page.
If you wish to approve the CAPA Request and go directly to the Prioritize and Assign page, click the "Sign Off and Prioritize" button.
If you are not ready to approve the CAPA Request, click the "Cancel" button. The information you have entered will be discarded, and you will be returned to the Review New Request page.
To find existing CAPA Requests similar to the new CAPA Request, fill in the appropriate search criteria and click the "Search" button. Use the "Info" links next to each of the CAPA Requests in the search results to determine whether it addresses the issue described by the new CAPA Request.
Once you have identified the duplicate CAPA Request, click the "Select" button to proceed to the Withdraw New Request as Duplicate page.
You can only select CAPA Requests that:
If you do not find an existing CAPA Request that adequately addresses the issue described by the new CAPA Request, click the "Cancel" button to return to the Review New Request page.
Use the Comments field to explain why the existing CAPA Request already addresses the issue described in the new CAPA Request, then enter your signoff key and click the "Withdraw as Duplicate" button. The new CAPA Request will be deleted from the system, and the source of the CAPA Request will be added to the existing CAPA Request as an additional Related Source.
Clicking the "Cancel" button will return you to the Review New Request page without withdrawing the new CAPA Request.
Enter detailed instructions about the additional information required for this CAPA Request. If necessary, you can also choose to select a different Assignee for the Submit New Request task than the one that originally performed the task.
Enter any additional comments and your signoff key, and then click the Return for More Information button to sign off your task and initiate a Submit New Request task with the specified instructions, assignee and due date.
Clicking the "Cancel" button will return you to the Review New Request page without sending the CAPA Request back for more information.
Indicate the reason why the CAPA Request is not appropriate for the CAPA process in the Task Comments field. Then, enter your signoff key and click the "Sign Off" button to permanently close the CAPA Request.
If the system has been configured to delete rejected CAPA Requests (see Configure CAPA Process Options) the Request will be deleted from the system. Otherwise its status is set to "Withdrawn", and the CAPA Request is permanently retained in the system for future reference.
Clicking the "Cancel" button will return you to the Review New Request page without rejecting the CAPA Request.
After a CAPA Request has been approved a CAPA Module Coordinator must determine its priority and when to begin its investigation. The CAPA Module Coordinator can either immediately initiate an investigation (see Investigate and Plan), or temporarily place the CAPA Request on hold (see Place CAPA Request On Hold).
This task can be launched either from the "My Tasks" page or, because it follows immediately after approving the CAPA Request, from the Approve New Request page (see the "Signoff and Prioritize" button).
The Prioritize and Assign page allows you to prioritize and route newly approved CAPA Requests.
Click the "Initiate Investigation" button to proceed to the Initiate Investigation page, where you will prioritize the CAPA Request and assign a lead Investigator to respond back with a root cause analysis and solution proposal.
Click the "Place Request on Hold" button to proceed to the Place CAPA Request On Hold page, where you will be required to prioritize the CAPA Request before moving it to the pool of CAPA Requests that are temporarily on hold.
If any of the background information needs to be updated, click the "Edit Request Information" button (see Edit CAPA Request).
Click the "Finish Later" button to return to the "My Tasks" page. The Prioritize and Assign task will remain open so that you can return to it later.
Before initiating an investigation or placing a CAPA Request on hold, you will be required to specify a priority for investigating the Request.
The following additional fields may be enabled for your site by CAPA Module Administrators (see Configure CAPA Fields).
Before initiating an investigation for a CAPA Request you must prioritize it for investigation. For information about filling out these fields, review the detailed description about Prioritizing a CAPA Request in the Prioritize and Assign section of the online help.
After you have classified and prioritized the CAPA Request, you must assign an Investigator. This individual will be primarily responsible for performing and documenting the results of the root cause analysis and developing a proposed solution plan.
Once you have selected an Investigator, indicate the date by which the Investigator must submit the results of the root cause analysis and a corresponding solution plan.
Enter any additional information into the Comments field, then sign off the task by entering your account signoff key into the Signoff Key field and clicking the "Sign Off" button.
The system will initiate the investigation phase by creating an Investigate task assignment for the specified Investigator.
Clicking the "Cancel" button will discard all of the information you have entered and return you to the previous page without initiating an investigation.
Before placing the CAPA Request on hold you must classify and prioritize it. For information about filling out these fields, review the detailed description about Classifying and Prioritizing a CAPA Request in the Prioritize and Assign section of the online help. You will be able to update any of this information later using the Manage On Hold CAPA Requests link on the Manage CAPA Requests page.
After you have classified and prioritized the CAPA Request, enter any additional information into the Comments field, then sign off the task by entering your signoff key and clicking the "Sign Off" button.
CAPA Requests placed on hold in this manner should be regularly reviewed to determine when they are ready to have an investigation initiated. You will use the Manage On Hold CAPA Requests link on the Manage CAPA Requests page to review/update these CAPA Requests, and initiate an investigation for them when they are ready.
Clicking the "Cancel" button will discard all of the information you have entered and return you to the Prioritize and Assign page without placing the CAPA Request on hold.
The next step of the CAPA process involves an analysis of the problem/opportunity and the development of a solution plan to address any identified root causes. The Investigator takes the lead in this part of the process, performing a root cause analysis and documenting the findings as part of the Investigate task.
After identifying one or more root causes, the Investigator then determines the appropriate set of actions for each. The Investigator is responsible for describing how each Implementor will verify that the assigned action was completed, along with a planned date for the completion of the implementation and verification.
The Investigator may also be responsible for determining how to verify that the actions implemented by this CAPA Request eliminated the root causes of the existing or potential nonconformities (see Verification of CAPA Effectiveness).
Finally, the Investigator is also responsible for identifying the impacts of the proposed set of actions, including documents and/or production processes that will be affected.
The Investigator can request assistance with any aspect of the root cause analysis or solution plan development by assigning Investigation Collaboration tasks.
After the Investigator has completed the Investigate task a CAPA Module Coordinator must perform a Preliminary Review, in which all of the root causes and actions will be reviewed for accuracy and completeness. The CAPA Module Coordinator will have the ability to add, modify or delete any solution information during this phase, and may potentially return the solution back to the most recent Investigator for additional development or substantive changes to the plan. If appropriate, the CAPA Module Coordinator can also place the CAPA Request On Hold.
Once the CAPA Module Coordinator and the Investigator have a proposed solution plan, the CAPA Module Coordinator will be responsible for determining the necessary set of approvers to approve the plan (see Approval of Solution Plan).
Once an investigation has been initiated for a CAPA Request, the assigned Investigator will receive an "Investigate" task assignment. This assignment gives you the ability to document the results of the root cause analysis, describe a set of proposed actions to address those root causes, and identify the potential impacts to the organization.
Launching the Investigate task will take you to the Describe Root Cause and Solution Plan page, where you can see an overview of the problem/opportunity and launch the necessary pages to document potential root causes and corresponding actions.
This page provides an overview of the problem/opportunity, the proposed solution, and a set of controls necessary to add to or modify the solution proposal prior to submitting it for approval.
NOTE: see Process Impacts Overview
Review and edit each potential impact in the Process Impacts table and specify whether it applies to the CAPA Request. If an impact is not applicable to the CAPA Request, you may be required to enter a justification for why it does not apply (see Edit Process Impact). The "Description Required" column indicates whether you must provide a description or justification for an impact.
Process Impacts identified as applicable for a CAPA Request may require the CAPA Module Coordinator to assign a follow-up Impact Implementation task during the implementation of the CAPA. The "Requires Task" column indicates whether a follow-up task will be assigned during the implementation of the Request.
If no Process Impacts have been configured by the CAPA Module Coordinator, this section will not be displayed.
The Investigation Activity Log section contains a list of activities performed during the investigation of a CAPA Request (for example, the documentation from the root cause analysis could be uploaded as an entry in the activity log).
The Solution Plan section contains the content of the root cause analysis and proposed action plan. The section for each root cause and action can be expanded to show more details. The "Show All" toggle will expand the detail section for each root cause and action.
At the bottom of the page are a set of buttons that allow you to perform additional tasks for documenting the root cause analysis and proposed solution plan:
During the Investigate task, the Investigator will be able to perform the following additional actions:
During the Investigation Collaboration task, the user will be able to perform the following additional actions:
During the Preliminary Review task, a CAPA Module Coordinator can perform the following additional actions:
The Add/Edit Root Cause page is used to document information about each of the root causes identified during analysis. The following information can be recorded for each root cause:
After any changes to the information about the root cause, select from the set of options at the bottom of the page:
To upload a file containing analysis results for a specific root cause, enter a brief description of the file and then click the "Browse" or "Choose File" button to find and select the file from your local machine. Once you have identified the file, click the "Save" button to upload the file and return to the Add/Edit Root Cause page.
If you have chosen to make changes to a previously uploaded file, the page will display a link to the current version. You can replace the current version by selecting another file.
Click the "Cancel" button to discard any changes and return to the Add/Edit Root Cause page.
The Add/Edit Action page is used to document information about each action proposed to address a root cause. For each action, you must provide the following information:
NOTE: During Preliminary Review a CAPA Module Coordinator must specify an Implementor and a Planned Action Completion Due Date.
After any changes to the information about the root cause, select from the set of options at the bottom of the page:
To identify a document that will be impacted by a proposed action, enter a descriptive summary of the document, including the document name/number and revision (if applicable). If an electronic markup of the proposed changes to the document is available, click the "Browse" or "Choose File" button to find and select the file from your local computer. Once you have identified the file, click the "Save" button to upload the file and return to the Add/Edit Action page.
If you have chosen to make changes to a previously uploaded file, the page will display a link to the current version. You can replace the current version by uploading another file.
Click the "Cancel" button to discard any changes and return to the Add/Edit Action page.
This page is used to define a plan for measuring the effectiveness of a CAPA Solution.
Use the "Will this CAPA Request have CAPA Effectiveness Verification?" field to indicate whether verification of effectiveness will be required to establish that the CAPA Actions implemented by this CAPA Request eliminated the root causes of the existing or potential nonconformities.
Click the "Save" button to save your changes and return to the previous page.
Click the "Cancel" button to discard any changes and return to the previous page.
Use the following fields to identify the potential impacts a solution may have on the organization:
Click the "Save" button to save your answers and return to the Describe Root Cause and Solution Plan page.
Click the "Cancel" button to discard any changes to your answers and return to the Describe Root Cause and Solution Plan page.
When assigning collaboration tasks to request assistance with the development of a solution plan, you should give detailed instructions to the assignee. The assignee will have the ability to edit any portion of the solution plan, so your instructions should be specific enough to guide the assignee to enter the appropriate information.
After entering the instructions for the task, select the assignee and a due date, and then click the "Assign Task and Close" button to assign the task and return to the Describe Root Cause and Solution Plan page.
Click the "Assign Task" button to assign the task and remain on this page to assign another task.
Clicking the "Cancel" button will return you to the Describe Root Cause and Solution Plan page without assigning a task.
To sign off your Investigate task, enter any additional comments about the task, enter your signoff key and then click the "Submit" button to sign off the task. A CAPA Module Coordinator will be assigned a Preliminary Review task for the CAPA Request.
Click the "Cancel" button to return to the previous page.
The Investigation Collaboration task allows you to assist in the development of the root cause analysis and/or solution plan for a CAPA Request. The assigned task has a set of specific instructions and a due date by when the task should be completed. Any activities you perform to complete this task can be documented in the Investigation Activity Log.
When you launch an Investigation Collaboration task, you will be taken to the Describe Root Cause and Solution Plan page to perform the requested work.
When you have completed the assigned task, click the "Proceed to Signoff" button (see the Sign Off Investigation Collaboration page).
To sign off your Investigation Collaboration task, enter any additional comments about the task, and then enter your signoff key. Then click the "Sign Off" button to sign off the task. The Investigator will receive an email notification that you have completed the task.
Clicking the "Cancel" button will return you to the Describe Root Cause and Solution Plan page without signing off the task.
Once the Investigation has been completed, it is the responsibility of the CAPA Module Coordinators to review the investigation activities, results of the analysis and the proposed solution plan (see Review Root Cause and Solution Plan). During this task, an assigned CAPA Module Coordinator can review and modify any part of the Investigator's work to make simple changes or finish aspects of the solution that the Investigator left for the CAPA Module Coordinator to complete. If there are significant changes required in the solution, the CAPA Module Coordinator can also send it back to the Investigator with instructions. The CAPA Module Coordinator may also place a CAPA Request back on hold if the Investigation has uncovered new information regarding the priority of the Request.
During the Preliminary Review, the CAPA Module Coordinator uses the same pages as the Investigator used during the Investigate task, and the directions on how to use the tools are similar. There are a few minor differences during Preliminary Review, which are covered below.
After reviewing and making any necessary changes to the solution, if a Formal Review is required the CAPA Module Coordinator will also be responsible for identifying the list of approvers. The potential list of approvers will either be created from the roles defined for the CAPA Review Board, or from the list of departments if no review board has been defined. The CAPA Module Coordinator may also assign additional approvers if necessary.
Note that the system can be configured to allow a CAPA Module Coordinator to optionally bypass the Formal Review process for simple CAPA Requests. See Configure CAPA Process Options for more information.
Select the individuals that will be assigned to review and approve the solution plan. You can select an approver from each area of responsibility that needs to be included in the approval process, and optionally assign additional approvers as needed.
Use the "Approval Due Date" field to specify the date by when all approvals must be completed.
Enter any additional feedback into the Comments field, enter your signoff key, and then click the "Submit" button. Your task assignment will be closed and each of the assigned approvers will receive a Formal Review task.
Click the "Cancel" button to return to the Review Root Cause and Solution Plan page without submitting the solution for approval.
Enter any additional feedback into the Comments field, enter your signoff key, and then click the "Submit for Implementation" button. Your task assignment will be closed, and an Implement and Verify task assignment will be created for each proposed action and assigned to the designated Implementor with the planned date for completion. If any applicable process impacts require an implementation task, you will be assigned a task to select assignees and due dates for those tasks (see Assign Impact Implementation Tasks).
Click the "Cancel" button to return to the Review Root Cause and Solution Plan page without submitting the solution for implementation.
During Preliminary Review, if you determine that the Investigator's analysis is incomplete or significant changes to the proposed solution plan are required, this page allows you to send the plan back to the Investigator with detailed instructions and a due date for changing the proposed solution plan.
After entering the instructions into the Comments field, enter your account signoff key and click the "Reject Solution Plan" button. Rejecting the solution plan returns it to the Investigator as an Investigate task assignment.
Click the "Cancel" button to return to the Review Root Cause and Solution Plan page without rejecting the solution.
The next step of the CAPA process requires the review and approval of the solution plan's proposed impacts on the organization. During the Investigate and Plan step, the Investigator and CAPA Module Coordinator documented the list of impacts to documentation and processes. This information is provided to each Formal Review approver to allow them to accurately assess the resource impact on their organization. Approval must be unanimous before a solution will move on to implementation (see the Implementation and Verification of Solution Plan step).
Note that the system can be configured to allow a CAPA Module Coordinator to optionally bypass the Formal Review process for simple CAPA Requests. See Configure CAPA Process Options for more information.
The CAPA Module Coordinator has the option to cancel a Formal Review that is in progress. Any remaining open Formal Review assignments will be canceled, and the request will return to the Preliminary Review step.
Once a solution plan is approved, an Implement and Verify task assignment will be created for each proposed action and assigned to the designated Implementor with a planned date for completion. If any applicable process impacts require an implementation task, the CAPA Module Coordinator will be assigned a task to select assignees and due dates for those tasks (see Assign Impact Implementation Tasks).
If any of the approvers rejects the proposed solution plan, it will return to Preliminary Review for a CAPA Module Coordinator to determine how to address the concerns indicated in the rejection comments.
During the Formal Review task, approvers will be required to look at the proposed solution plan and its impact to their organization. Performing this task takes you to the Approve Solution page, which displays the solution plan and allows you to record your approval or disapproval along with comments about your decision.
The Approve Solution page allows you to review the proposed solution plan and then record a decision to approve or reject it. Information about the potential impacts of the solution plan is provided in the following fields:
In addition to information about the solution and its potential impact on the organization, the Approve Solution page also displays the decisions and comments of other approvers in the "Approvers" table.
Once you have finished reviewing the information provided, you can indicate your approval or rejection of the solution in the "Approve Solution?" field. If you choose to reject the solution, you will be required to provide feedback in the Comments field.
Once you have recorded your decision and any necessary feedback, complete the task by entering your signoff key and selecting the "Sign Off" button.
Click the "Cancel" button to discard any changes and return to the "My Tasks" page.
The next step of the CAPA process consists of the implementation of the CAPA Actions and verification that the actions were completed. The assigned Implementor for each action will receive an Implement and Verify task. Implementors should submit their assigned actions for final approval and closure only after completing both the implementation and the verification. As each action is signed off and submitted for approval, the CAPA Module Coordinator will receive a Review Action Implementation task to review the evidence and verify that the Implementor completed the assigned work for the action.
If any applicable process impacts require an implementation task, the CAPA Module Coordinator will be assigned a task to select assignees and due dates for those tasks (see Assign Impact Implementation Tasks).
Once the CAPA Module Coordinator has reviewed and signed off all Review Action Implementation tasks, and all users assigned Impact Implementation tasks have completed their work, the CAPA Request will proceed to the Review and Closure of Request step, where the CAPA Module Coordinator will initiate any required verification of effectiveness and/or follow-on CAPA Requests.
When a solution plan is approved, the users assigned to complete the implementation and verification of each action will receive "Implement and Verify" tasks. Clicking on the task assignment will take you to the Verify Action Implementation page, where you will be presented with instructions on how to verify that the action was completed. After the verification has been documented, you can sign off the task and the CAPA Module Coordinator will be assigned a Review Action Implementation task to review your results.
This page displays the instructions for implementing an action and verifying its completion, and allows you to document the results of the verification. If this action was previously submitted for approval and returned by the CAPA Module Coordinator, this page will also include instructions from the CAPA Module Coordinator about what additional information must be provided.
Verification results can be entered both as textual feedback using the Action Verification Results field and by uploading files containing evidence generated during the verification process. For example, if a spreadsheet is used to track the quality checks for a series of lots, that spreadsheet could be uploaded into the CAPA system. To upload one of these files, click the "Add Action Verification File" button (see Add Action Verification File). To edit or delete a verification file, click the corresponding button in the table.
During the implementation of an action you can enter intermediate results and save them without closing the action by clicking the "Save for Later" button.
When you have finished documenting the completion and verification of the action, click the "Save and Proceed to Signoff" button to proceed to the Sign Off Action Implementation page.
Clicking the "Cancel" button while making changes to the Action Verification Results will discard any unsaved changes and return you to the "My Tasks" page.
To upload a file containing objective evidence generated during the verification of an action, enter a brief description of the file and then click the "Browse" or "Choose File" button to find and select the file from your local computer.
If you have chosen to make changes to a previously uploaded file, the page will display a link to the current version. You can replace the current version by selecting another file.
Click the "Save" button to upload the file and return to the previous page.
Click the "Cancel" button to discard any changes and return to the previous page.
After completing the implementation and verification steps for a CAPA Action, this page allows you to record additional feedback in the Comments field before entering your signoff key and clicking the "Sign Off" button to complete the task.
Click the "Cancel" button to return to the previous page without signing off on the task.
When the Implementor signs off the Implement and Verify task for an action, the CAPA Module Coordinator is assigned the Review Action Implementation task to review the documented results and determine whether all necessary work has been completed and verified. The CAPA Module Coordinator can make any necessary changes to the results, or return the action to the Implementor for additional information. Once all necessary information has been documented, the CAPA Module Coordinator will sign off on the action as completed. When all actions and Impact Implementation tasks have been signed off, the CAPA Module Coordinator will receive the Review for Closure task.
The Review Action Implementation page displays the results of the verification documented by the Implementor, along with the original instructions associated with the action. Use the instructions to assist in determining whether all the necessary work has been completed and verified.
As the CAPA Module Coordinator you are allowed to make any necessary changes to the Action Verification Results or any Action Verification Files that were uploaded by the Implementor (see Add/Edit Action Verification File).
During the review of an action implementation you can save your changes without closing the action by clicking the "Save for Later" button.
Clicking the "Cancel" button while making changes to the Verification Results will discard any unsaved changes and return you to the "My Tasks" page.
If you determine that all approved work for the action has been completed and properly verified, you can sign off on the action by clicking the "Save and Proceed to Signoff" button, which will take you to the Sign Off Review Action Implementation page.
If the Implementor did not complete and document all of the work or verification steps required for the action, you can request additional information by clicking the "Return for More Information" button, which will take you to the Return Action Implementation for More Information page.
Enter detailed instructions about the additional information that the Implementor must provide. If necessary, you can also choose to assign the task to a user other than the original Implementor.
By default, the due date for this additional information will be the original due date of the action. However, if that date has already passed, you will be required to select a new due date by which the information must be provided.
Enter any additional comments and your signoff key, and then click the Return for More Information button to sign off your task and send the action back to the assigned user with a new Implement and Verify task.
Click the "Cancel" button to return to the Review Action Implementation page without sending the action back to the assigned user.
Use the Comments field to enter any additional information about the implementation of the action. Then enter your signoff key and click the "Sign Off" button to close the action and sign off the work as completed.
If you need to return to the Review Action Implementation page to make any changes, click the "Cancel" button.
This task is assigned to CAPA Module Coordinators when one or more process impacts for a CAPA Request require implementation tasks. The CAPA Module Coordinator is responsible for assigning someone to complete each Impact Implementation task.
This page assists you with assigning required process impact implementation tasks.
The "Process Impacts" table displays the process impacts associated with this CAPA Request. The "Task Status" column indicates which impacts require an Impact Implementation task as follows:
When you are ready to assign one or more of the required tasks, click the "Assign Impact Implementation Tasks" button (see Select Process Impacts to Assign).
After you have started assigning tasks the process impacts, an "Impact Implementation Tasks" table will display the status of each assigned task. When a task has been completed, you can review the results and assign the task again if any follow-up work is required.
Once you have assigned all necessary Impact Implementation tasks, you can either sign off on your task or wait for them to be completed. To sign off your task, click the "Proceed to Signoff" button (see Sign Off Assign Impact Implementation Tasks).
Click the "Finish Later" button to return to the "My Tasks" page.
Enter any additional comments and your account signoff key, and then click the "Sign Off" button to sign off on this task.
Clicking the "Cancel" button will return you to your task list without assigning any tasks.
The next step in the CAPA process is for a CAPA Module Coordinator to initiate any necessary verification of effectiveness to establish that the implemented CAPA actions eliminated the root causes of the existing or potential nonconformities.
The CAPA process can be configured to require the determination of CAPA Effectiveness Verification Instructions during one of two possible phases:
A CAPA Module Coordinator initiates the verification of effectiveness process by assigning a CAPA Effectiveness Verification task to a user that will perform the verification. When this occurs, the CAPA Request's Status is set to "CAPA Effectiveness Verification" to reflect that the actions have been implemented but the CAPA Request cannot be closed until their effectiveness has been measured and verified.
Once the verification of effectiveness has been completed and signed off by the assignee, the CAPA Request will return to the Review for Closure task, where a CAPA Module Coordinator will review the results of the CAPA Effectiveness Verification to determine whether to close the Request or submit follow-on CAPA Requests to address new issues identified during the verification of effectiveness.
When you are assigned a CAPA Effectiveness Verification task, you will receive instructions for measuring and verifying the effectiveness of the implemented CAPA actions. These instructions will be displayed on the CAPA Effectiveness Verification task page.
This page contains an overview of the solution, and instructions for verifying the that the implemented CAPA actions eliminated the root causes of the existing or potential nonconformities.
Record verification results using the "CAPA Effectiveness Verification Results" field.
You can upload files containing objective evidence generated during the verification of effectiveness by clicking the "Add CAPA Effectiveness Verification File" button (see Add CAPA Effectiveness Verification File).
To edit or delete an uploaded file, click the corresponding button in the table.
Click the "Save for Later" button to save your results without signing off on the task.
Once you have completed all verification steps, you can click the "Proceed to Signoff" button to proceed to the Sign Off CAPA Effectiveness Verification page.
Click the "Cancel" button to return to the "My Tasks" page without saving changes to the CAPA Effectiveness Verification Results field.
To upload a file containing objective evidence generated during verification of effectiveness, enter a brief description of the file and then click the "click the "Browse" or "Choose File" button to find and select the file from your local machine. Once you have selected the file, click the "Save" button to upload the file and return to the previous page.
If you have chosen to make changes to a previously uploaded file, the page will display a link to the current version. You can replace the current version by selecting another file and then clicking the "Save" button.
Click the "Cancel" button to discard any changes and return to the previous page.
After you have completed the steps for measuring and verifying the effectiveness of the implemented CAPA actions, this page will allow you to provide additional feedback in the Comments field before entering your signoff key and clicking the "Sign Off" button to complete the task.
Click the "Cancel" button to discard your comments and return to the CAPA Effectiveness Verification page without signing off your task.
The final step of the CAPA process is for the CAPA Module Coordinator to review the complete record of the CAPA Request and determine the Request's disposition:
The system may be configured to require a final approval from a CAPA Review Board prior to closure (see Configure CAPA Process Options). If this setting is enabled, the CAPA Module Coordinator will submit the CAPA for approval, and it will only be closed if all assignees approve the closure.
Once all implementation tasks for a CAPA Request have been completed, verified and reviewed (see Implementation and Verification of Solution Plan) CAPA Module Coordinators receive a "Review for Closure" task assignment to review the results and determine the final disposition of the Request (see the Review for Closure page).
This page is used to review the CAPA Request and make decisions about its final disposition.
The first part of the page provides a complete report on the CAPA Request, including all information documented during investigation and implementation.
If the work for any of the actions or process impacts was incomplete or requires additional documentation, click the "Return to Implementation" button. You will be taken to the Return to Implementation page, where you will indicate what additional work is required and initiate any necessary implementation tasks.
If the effectiveness of the implemented CAPA Actions must be verified, click the "Initiate CAPA Effectiveness Verification" button to assign someone a task to perform that verification (see the Initiate CAPA Effectiveness Verification page).
If there are any remaining or newly-identified issues from this CAPA Request that require additional work, click the "Initiate Follow-On Request" button to start the process of submitting a new CAPA Request to address them. You will be taken to the Initiate Follow-On Request page, where you will provide information about the scope of the follow-on CAPA Request.
If the CAPA Request requires no additional follow-on CAPA Requests or verification of effectiveness, you can proceed with closing it by clicking the "Close Request" button.
Click the "Finish Later" button to return to your task list without closing the CAPA Request.
Describe any remaining or newly identified issues not addressed by this CAPA Request and click the "Initiate Follow-On Request" button.
The original CAPA Request will remain open with a link to the newly created follow-on CAPA Request, and you will be taken to the Edit CAPA Request page to enter any additional information about the new CAPA Request before returning to the Review for Closure page.
Clicking the "Cancel" button will return you to the Review for Closure page without initiating a follow-on CAPA Request.
This page is used to assign a CAPA Effectiveness Verification task to verify the that the implemented CAPA actions eliminated the root causes of the existing or potential nonconformities. The assignee will receive instructions on what objective evidence will be required to verify that the actions were effective in eliminating the root causes.
The CAPA process can be configured to require these CAPA Effectiveness Verification Instructions to be defined either during investigation or after implementation.
See Configure CAPA Process Options for details on configuring when the CAPA Effectiveness Verification Plan is determined.
Select a user to perform the task and a due date for completion.
Enter any additional comments and your signoff key, and click the "Initiate CAPA Effectiveness Verification" button.
You will receive a new Review for Closure assignment when the CAPA Effectiveness Verification task is completed.
Clicking the "Cancel" button will return you to the Review for Closure page without initiating CAPA Effectiveness Verification.
If the CAPA Request had Impact Implementation tasks, a Process Impacts table will display the implementation results for each Process Impact. If any Process Impacts require additional work, select "Yes" to open a new Assign Impact Implementation Tasks task.
Select any CAPA Actions that require additional work to complete the original solution plan. A new Review Action Implementation task will be initiated for each selected CAPA Action.
Describe the additional work required and indicate a date by which the work should be completed.
Enter any additional comments and your signoff key, and click the "Return to Implementation" button.
You will receive a new Review for Closure assignment when all newly assigned implementation tasks have been completed. If a CAPA Effectiveness Verification task has already been performed prior to returning a CAPA Request to implementation, you will be required to assign another CAPA Effectiveness Verification task to ensure that verification is still applicable and complete.
Clicking the "Cancel" button will return you to the Review for Closure page without returning the CAPA Request to implementation.
If Verification of CAPA Effectiveness has not been performed, you may be asked to provide a justification before closing the CAPA Request.
Enter any comments and your signoff key, and then click the "Close Request" button to close this CAPA Request. The Status of the CAPA Request will be set to "Closed", and your task assignment will be completed.
Clicking the "Cancel" button will return you to the Review for Closure page without closing the CAPA Request.
If Verification of CAPA Effectiveness has not been performed, you may be asked to provide a justification before closing the CAPA Request.
Select the individuals that will be assigned to review and approve the closure of this CAPA Request. You can select an approver from each area of responsibility that needs to be included in the approval process, and optionally assign additional approvers as needed.
Use the "Approval Due Date" field to specify the date by when all approvals must be completed.
Enter any additional feedback into the Comments field, enter your signoff key, and then click the "Submit" button. Your task assignment will be closed and each of the assigned approvers will receive a Formal Review task.
Enter any additional information into the Comments field, enter your signoff key, and then click the "Submit for Closure Approval" button.
Clicking the "Cancel" button will return you to the Review for Closure page without submitting the CAPA Request for approval.
Users assigned an Approve Closure task are required to review the CAPA Request to determine if it is ready to be closed.
If all assignees approve the closure, the CAPA Request will be immediately closed. If any of the assignees rejects the closure, the Request will be sent back to the Review for Closure task once everyone has signed off.
CAPA Module Coordinators can cancel open Approve Closure tasks using the Manage Approve Closure page.
The Approve Closure page provides an interface for quickly reviewing CAPA Request's implementation, verification and follow-on CAPA Requests. The page also displays the status and comments of other approvers in the "Approvers" table.
Once you have finished reviewing the information provided, you can indicate your approval or rejection of the closure in the "Approve Closure?" field.
Once you have recorded your decision and any necessary feedback, complete the task by entering your signoff key and selecting the "Sign Off" button.
Click the "Cancel" button to discard any changes and return to the "My Tasks" page.
The Manage CAPA Requests page allows authorized users to perform administrative actions necessary to manage CAPA Requests in the Grand Avenue system.
The page has links to the following actions:
Manage On Hold CAPA Requests - used by CAPA Module Coordinators to perform administrative actions on CAPA Requests that have been placed on hold.
Manage Formal Review - used by CAPA Module Coordinators to cancel open Formal Review tasks for a CAPA Request and return it to the Preliminary Review task.
Manage Implementation - used by CAPA Module Coordinators to cancel open implementation tasks for a CAPA Request and return it to the Preliminary Review task.
Cancel Open CAPA Requests - used by CAPA Module Coordinators to cancel open CAPA Requests and permanently withdraw them from the CAPA process.
Manage Approve Closure - used by CAPA Module Coordinators to cancel open Approve Closure tasks for a CAPA Request and return it to the Review for Closure task.
Record Additional Information for Closed CAPA Requests - used by CAPA Module Coordinators to record additional information for CAPA Requests that have been closed or withdrawn. This link is only displayed if this option has been enabled (see Configure CAPA Process Options).
Export CAPA Requests - Used by CAPA Module Administrators to export the metadata and file content for a selected set of CAPA Requests to a directory on the web server.
Administrative Update for CAPA Request Field Values - used by CAPA Module Administrators to make administrative corrections to the values of the following fields for existing CAPA Requests:
Administrative Update for Root Cause Field Values - used by CAPA Module Administrators to make administrative corrections to the values of the following fields for existing CAPA Root Causes:
This page displays a list of CAPA Requests that currently have a Status of "On Hold".
When an investigation should be initiated for a CAPA Request, click its corresponding "Initiate Investigation" button. You will be taken to the Initiate Investigation page, where you will select an assignee for the Investigate task.
To modify any of the background information about a CAPA Request, click its corresponding "Edit" button (see Edit CAPA Request).
Click the "Close" button to return to the previous page.
This page displays a list of CAPA Requests that are undergoing a Formal Review.
Normally a Formal Review is only concluded once all approvers have signed off on their Formal Review tasks. The CAPA Module Coordinator has the option to cancel a Formal Review that is in progress. Any remaining open Formal Review assignments will be canceled, and the CAPA Request will return to the Preliminary Review step.
To cancel the Formal Review for a CAPA Request, click its corresponding "Cancel Formal Review" button (see Cancel Formal Review).
Click the "Close" button to return to the previous page.
Canceling a Formal Review that is in progress will immediately cancel any open Formal Review task assignments and return the CAPA Request to Preliminary Review, where you will be able to make any necessary changes to the Request or return it to the Investigator for additional work.
To proceed with canceling the Formal Review, enter a description of the reason for canceling the review, then enter your signoff key and click the "Cancel Formal Review" button. Notifications will be sent to all approvers, informing them why the review was canceled.
Clicking the "Cancel" button will return you to the Manage Formal Review page without canceling the Formal Review for this CAPA Request.
This page displays a list of CAPA Requests that are currently have any of the following open implementation tasks:
Normally the implementation of a CAPA Request is only completed when all these implementation tasks have been signed off, and the CAPA Request proceeds to the Review for Closure task.
The CAPA Module Coordinator has the option to cancel an implementation that is currently in progress, in order to make necessary changes to the implementation plan, or potentially withdraw the CAPA permanently from the process (see Cancel Open CAPA Requests). Any remaining open implementation tasks will be canceled, and the CAPA Request will return to the Preliminary Review task, where the assigned CAPA Module Coordinator can change make changes to the original plan before re-submitting for approval.
To cancel the implementation for a CAPA Request, click its corresponding "Cancel Implementation" button (see Cancel Implementation).
Click the "Close" button to return to the previous page.
Canceling a CAPA Request implementation that is in progress will immediately cancel any open implementation task assignments and return the CAPA Request to Preliminary Review, where the assignee will be able to make any necessary changes to the Request or return it to the Investigator for additional work.
The "Open Task Assignments" table displays a list of all currently open implementation tasks that will be canceled.
To proceed with canceling the implementation, select the user that will be assigned a new Preliminary Review task, and the due date for completing the task. Use the "Additional Instructions" field to provide guidance on what needs to be done with the CAPA Request before re-submitting it for implementation (or withdrawing it permanently from the process).
Use the Comments field to record any additional comments that will be recorded on the canceled task assignments, then enter your signoff key and click the "Cancel Implementation" button. The new Preliminary Review task will be assigned, and notifications will be sent to the assignees of all open task assignments informing them why the implementation was canceled.
Clicking the "Cancel" button will return you to the Manage Implementation page without canceling the implementation for this CAPA Request.
This page displays a list of all CAPA Requests that are eligible to be canceled and permanently withdrawn from the CAPA process. A CAPA Request is eligible if it meets all of the following criteria:
To cancel a CAPA Request, click its corresponding "Cancel Request" button (see Cancel Open CAPA Request).
Click the "Close" button to return to the previous page.
Canceling an open CAPA Request will:
NOTE: This operation is permanent and cannot be undone.
To proceed with canceling the CAPA Request, enter the reason for canceling the Request, then enter your signoff key and click the "Cancel Open CAPA Request" button.
Clicking the "Cancel" button will return you to the previous page without canceling this CAPA Request.
This page displays the list of CAPA Requests that have open Approve Closure tasks.
Normally the approval of closure for a CAPA Request is only concluded once all approvers have signed off on their Approve Closure tasks. The CAPA Module Coordinator has the option to cancel an approval that is in progress. Any remaining open Approve Closure assignments will be canceled, and the CAPA Request will return to the Review for Closure task.
To cancel the open Approve Closure tasks for a CAPA Request, click its corresponding "Cancel Approve Closure" button (see Cancel Approve Closure).
Click the "Close" button to return to the previous page.
Canceling the closure approval for a CAPA Request will immediately cancel any open Approve Closure task assignments and return the Request to Review for Closure, where you will be able to make any necessary changes before submitting it for closure again.
To proceed with canceling the Approve Closure tasks for the selected CAPA Request, enter the reason for canceling the approval, then enter your signoff key and click the "Cancel Approve Closure" button. Notifications will be sent to all approvers, informing them why the approval was canceled.
Clicking the "Cancel" button will return you to the previous page without canceling the approval for this CAPA Request.
This page displays a list of all CAPA Requests that have been closed or withdrawn.
By default, CAPA Requests cannot be modified once they have been closed or withdrawn. However, CAPA Module Administrators can set an option on the Configure CAPA Process Options page that allows CAPA Module Coordinators to record additional information for closed or withdrawn CAPA Requests.
To record additional information for a CAPA Request, click the corresponding "Record Additional Information" button (see Record Additional Information for Closed Item).
Click the "Close" button to return to the previous page.
The Export CAPA Requests feature allows CAPA Module Administrators to export the metadata and file content for a selected set of CAPA Requests to a directory on the web server.
The export will generate a separate directory structure for each selected CAPA Request, which will contain two types of files for each related item:
Click the "Export CAPA Requests" link on the Manage CAPA Requests page. You will be taken to the Select CAPA Requests to Export page, where you can use search criteria to specify the set of CAPA Requests that will be included in the export.
This page allows you to select the set of CAPA Requests to be included in the export.
Fill in any applicable search criteria and click the "Search" button to find matching CAPA Requests.
When the search results display the desired set of CAPA Requests, click the "Export Results to Server" link to proceed to the Export CAPA Requests to Server page.
Clicking the "Cancel" button will return you to the Manage CAPA Requests page.
This page will export the metadata and file content for each CAPA Request that matches the values in the "Search Criteria for Export" table.
Use the "File Format" field to indicate the format for the delimited text files.
Use the "List Separator" field to specify the delimiter to be used when exporting the delimited text files using a CSV file format. By default, the delimiter is set to the list separator for your locale, so you should only need to change this setting when exporting a CSV file for a different locale.
Use the "Date Format" field to select the format to be used when exporting date values. By default, the format is set to match the configuration setting for entering and displaying dates in Grand Avenue (see Configure System Date and Time Settings). This feature allows you to specify a different format if exporting to an application like Excel that expects a different format for your region (e.g. en-GB (dd/mm/yyyy) instead of en-US (mm/dd/yyyy)). Using the recommended culture-independent format defined by ISO-8601 (yyyy-mm-dd) will ensure that dates will always be interpreted correctly.
Click the "Export CAPA Requests to Server" button to initiate the export process. A successful export will indicate the full path of the export directory created on the web server.
Clicking the "Close" button will return you to the Manage CAPA Requests page.
CAPA Module Administrators can configure the list of Process Impacts that will be used by CAPA Requests (see Configure Process Impacts for Module).
When a CAPA Request is first created, a process impact is created for each corresponding process impact definition. As users edit the CAPA Request, they will be able to review the list of process impacts to consider each for applicability (see Process Impacts). After the solution plan for a CAPA Request has been approved, a CAPA Module Coordinator will assign Impact Implementation tasks for each applicable impact that was defined to require an implementation task (see Assign Impact Implementation Tasks).
The CAPA module allows authorized users to search for information managed by the CAPA process. See Configure CAPA Module View Access List for information on configuring the access list that controls authorization for search.
To search for a particular group of CAPA Requests, click the "Search for CAPA Requests" link on the navigation menu (see the Search for CAPA Requests page).
The Search for CAPA Requests page allows authorized users to search for CAPA Requests managed by Grand Avenue. See the Searching and Reports section for additional information about searching in Grand Avenue.
The page displays a set of criteria that can be used to narrow your search to a subset of CAPA Requests.
If you enter values for "Affected Article ID" or "Affected Article Supplier", your search will only find CAPA Requests that have Affected Articles matching all criteria.
The Status field allows you to restrict your search to CAPA Requests that are in a particular stage of the process:
NOTE: CAPA Requests do not have a Status until they have been submitted into the process by the Originator. Searches with a value specified for Status will not find these CAPA Requests.
Set the "Has Open Overdue Tasks" field to "Yes" to narrow your search to CAPA requests that have at least one open overdue task assignment associated with them. Set it to "No" to narrow your search to CAPA requests that have no open overdue task assignments associated with them.
Selecting an Applicable Process Impact will only find CAPA Requests that have the selected process impact marked as "Applicable". For example, you can restrict your search to only find CAPA Requests that resulted in a regulatory impact.
Use the following date-based search fields to narrow your search to CAPA Requests that have fields within a specified date range:
When a search is performed, summary information is displayed about each CAPA Request matching your search criteria. To show all fields for the CAPA Requests, change the "Result Fields to Display" to "Show All Fields", or click the "Info" link for a specific Request to see more complete information.
The dashboard allows you to monitor pre-defined measurements about your CAPA process.
When an organization installs and deploys the Grand Avenue Software CAPA module, there are configuration steps that should be performed to prepare the system for production. These steps are accessed by CAPA Module Administrators on the Configure CAPA Module page.
This page guides you through the steps in configuring the CAPA module, and can be used as part of your Operational Qualification (OQ) procedures, by printing the checklist/signature version of the page. Perform and initial each step, then sign the page when it is complete.
This page is also used to modify configuration settings as necessary.
The Configure CAPA Module page has links to the following configuration tasks:
The Configure CAPA Process Options page is used by CAPA Module Administrators to tailor the Grand Avenue Software CAPA module to align with the processes of the organization into which it is deployed.
The following process options can be configured:
Setting this option to "Yes" will allow CAPA Module Coordinators to record additional information using the Record Additional Information for Closed CAPA Requests link on the Manage CAPA Requests page.
By default, CAPA Requests rejected by the CAPA Module Coordinator during Approve New Request are marked as "Withdrawn", but retained in the system for future reference. You can modify this behavior to instead delete CAPA Requests rejected by the CAPA Module Coordinator.
NOTE: CAPA Requests initiated by other processes (e.g. Complaint, NCM) will never be deleted. They are always marked as "Withdrawn".
Indicate whether the system allows Unique Device Identifier (UDI) numbers to be recorded and tracked for product-related affected articles on CAPA Requests. If this option is set to "No", the "UDI Number(s)" field will never be displayed, and any information previously entered in this field will no longer be available (except in the audit trail).
Indicate whether the system allows serial numbers to be recorded and tracked for product-related affected articles on CAPA Requests.
If this option is set to "No", the "Serial Number(s)" field will never be displayed, and any information previously entered in this field will no longer be available (except in the audit trail).
Indicate whether the system allows lot numbers to be recorded and tracked for product-related affected articles on CAPA Requests.
If this option is set to "No", the "Lot Number(s)" field will never be displayed, and any information previously entered in this field will no longer be available (except in the audit trail).
Indicate whether the system allows users submitting or investigating CAPA Requests to record corrections performed to contain/eliminate a detected nonconformity.
If this option is set to "No", the Corrections table will not be displayed for CAPA Requests.
By default, users performing Investigate and Investigation Collaboration tasks are authorized to make changes to the background information about a CAPA Request (e.g. field values, affected articles, background files, etc.).
Setting this option to "No" will prevent those assignees from making changes to the background information for a CAPA.
Indicate whether users can select "Improvement Action" for the Action Type when adding or editing CAPA Actions.
If this option is set to "No", only "Corrective Action" and "Preventive Action" action types will be available.
When updating this option, have a System Administrator update the "Which Action Type should I select?" user assistance (see Configure User Assistance).
By default, proposed solutions for CAPA Requests must be formally reviewed and approved prior to implementation (see Formal Review). Setting this option to "Yes" will allow a CAPA Request to optionally bypass the Formal Review process if it meets the following criteria:
This option to bypass the Formal Review process can be selected by the Investigator on the Describe Solution Impact page. The CAPA Module Coordinator is responsible for reviewing and approving this decision during Preliminary Review.
By default, users can select "Don't Know" for some solution impact questions during the investigation of a CAPA Request (see Describe Solution Impact). Setting this option to "No" will remove "Don't Know" from the list of available values, forcing the user to answer all questions before submitting the solution for approval.
By default, CAPA Requests can be closed by CAPA Module Coordinators immediately upon the signoff of the Review for Closure task. Setting this option to "Yes" will require the CAPA Module Coordinator to send CAPA Requests for approval by a CAPA Review Board prior to closure (see Approve Closure).
Indicate when CAPA Effectiveness Verification Instructions will be determined in the CAPA process.
Indicates whether a justification is required or optional when a CAPA Request is determined to not require a verification of effectiveness.
Click the "Save Configuration" button to apply your changes and return to the Configure CAPA page.
Clicking the "Cancel" button will return you to the Configure CAPA page without saving your changes.
The CAPA Review Board is the list of roles that represent specific responsibilities during the approval processes for a CAPA Request. The CAPA Review Board is used by CAPA Module Coordinators to select the necessary list of approvers for each CAPA Request.
A specific user can be assigned as the default approver for a given role. If no user is specified for a role, a CAPA Module Coordinator will assign a person when sending a CAPA Request to Formal Review. A role may be added more than once if multiple approvers are often assigned to review for that role. A CAPA Module Coordinator can also change or remove approvers from the CAPA Review Board used for an individual CAPA Request.
If no CAPA Review Board roles are defined, then the list of Departments is used as the default list of roles for the CAPA Review Board.
Click the "Edit" button next to a role to change the role name and/or the default approver. (See Edit CAPA Review Board Member)
Click the "Delete" button for a role to remove it from the list.
Click the "Add CAPA Review Board Member" button to add a new role to the list of CAPA Review board members. (See Add CAPA Review Board Member.)
Click "Close" button to return to the Configure CAPA page.
Enter a name for this review board role. You may also select a default approver. If no default approver is selected, a CAPA Module Coordinator may select one when the CAPA Request is sent for approval.
Click the "Save" button to save this role as a member of the review board and return to the Configure CAPA Review Board page.
Click the "Cancel" button to return to the Configure CAPA Review Board page without saving any changes.
The following roles can be assigned by CAPA Module Administrators using the Manage Role Assignments page:
See the Manage Role Assignments section in the General help for additional information about assigning roles to users.
By default, all users are authorized to view information for the CAPA Module.
You can control which users are authorized by configuring the CAPA Module View Access List.
See the Configure Access List section in the General help for additional information about configuring this access list.
By default, all users are authorized to submit information for the CAPA Module.
You can control which users are authorized by configuring the CAPA Module Submit Access List.
See the Configure Access List section in the General help for additional information about configuring this access list.
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