The Grand Avenue Software NCM module provides a five-step process for the standard reporting and dispositioning of nonconforming materials:
%%{init: {"flowchart": { 'padding':'5', 'curve': 'basis', "htmlLabels": false }} }%% flowchart LR Submit["`**Submit NCM Report**`"]; Propose["`**Propose Disposition Plan**`"] Approve["`**Approve Disposition Plan**`"] Implement["`**Implement Disposition**`"] Close["`**Closed**`"] Submit --> Propose --> Approve --> Implement --> Close; click Submit "#NcmSubmitNcmReport" "Submit NCM Report" click Propose "#NcmProposeDispositionPlan" "Propose Disposition Plan" click Approve "#NcmApproveDisposition" "Approve Disposition Plan" click Implement "#NcmImplementDisposition" "Implement Disposition" click Close "#NcmTaskCloseNcmReport" "Review and Closure of NCM Report"
Nonconforming materials are typically discovered during inspection of newly received shipments, or during manufacturing and testing activities. The process of recording this discovery and dispositioning the nonconforming materials begins with preparing and submitting a detailed NCM Report. NCM Reports can specify details about
In the Grand Avenue Software Nonconforming Materials system, any user that discovers nonconforming material is capable of initiating an NCM Report and printing nonconforming material "tags" to identify quarantined materials (see the Submit NCM Report task).
To begin the process of submitting an NCM Report, click "Submit an NCM Report" on the navigation menu to proceed to the Add NCM Report page, where you will fill out the information about the nonconforming material.
While you are entering an NCM Report, the system will assign you a Submit NCM Report task, which authorizes you to continue making changes to the Report up until the time that you sign off the report. Later, if the Report is returned to you for additional changes, the system will assign you another Submit NCM Report task to perform those changes.
Once you have provided all necessary information about the Report, it will proceed on to the Propose Disposition Plan step, where the NCM Module Coordinator will finish proposing disposition activities for the nonconforming material.
NOTE: If the NCM Process has been configured to streamline the process for NCM Module Coordinators and there is only one NCM Module Coordinator defined, an NCM Report created by the NCM Module Coordinator will automatically advance to the Propose Disposition task.
Each NCM Report starts with a brief description of the potential nonconformance.
The user must then identify the Part associated with the potentially nonconforming material. To fill in the Part Number for the NCM Report, click the "Select..." button after Part Number field. Fill in any applicable search criteria and click the "Search" button to look for the part. Then, click the corresponding "Select" button to fill in the Part Number and Part Name fields.
Once you have started an NCM Report for a specific part, you will only be allowed to change the selected part to other parts that have the same Unit of Measure. You can only change the part during the development of the initial disposition plan.
Once you have selected the part, you must also fill out the following information:
List the actions that need to be taken to locate and contain the Nonconforming Material.
Select values for each of the custom fields configured by your organization. Fields will only be displayed if they have been configured (see Configure NCM Report Fields).
Click the "Add NCM Background File" button to add an NCM Background File. This will take you to the Add NCM Background File page.
Click the "Edit" button to change a particular background file. This will take you to the Edit NCM Background File page.
Click the "Delete" button to remove a particular background file.
The Activity Log section contains a list of activities performed during the investigation of the reported nonconformance.
Click the "Add Entry" button to add a row to the Disposition Plan. This will take you to the Add NCM Report Entry page.
Click the "Edit" button to edit a particular row. This will take you to the Edit NCM Report Entry page.
Click the "Delete" button to remove a particular row.
You can print an information sheet to accompany the nonconforming materials.
NOTE: Your organization may have configured the text displayed for this button to match the terminology used by your company's policy. See the Configure NCM Process Options page for more information.
Review and edit each potential impact in the Process Impacts table to specify how it applies to the NCM Report's disposition plan. If the impact is not applicable to the disposition plan, you may be required to enter a justification of why it does not apply (see Edit Process Impact). The "Description Required" column indicates whether or not you must provide a description or justification for an impact.
Process Impacts identified as applicable for a disposition plan may require the NCM Module Coordinator to assign a follow-up Impact Implementation task during the implementation of the disposition plan. The "Requires Task" column indicates whether or not a follow-up task will be assigned during the implementation.
If no Process Impacts have been configured by NCM Module Coordinators, this section will not be displayed.
You can request input from an NCM Review Board to help determine the appropriate disposition for the nonconforming materials identified in the Disposition Plan.
Click the "Request Disposition Input" button to initiate this request, and you will be taken to the Request Input for Disposition Plan page, where you will select the appropriate NCM Review Board reviewers to provide feedback. If NCM Module Administrators have defined more than one NCM Review Board, you will first be taken to the Select NCM Review Board page, to select the appropriate NCM Review Board for this NCM Report.
When you request input from an NCM Review Board, each of the assignees will receive a Provide Disposition Input task. You can see the status and any comments for these tasks in the Disposition Plan Input Tasks list.
You can request assistance from other users in completing the Disposition Plan, and any missing information on the NCM Report.
Click the "Assign Collaboration Task" button to initiate this request and you will be taken to the Assign Disposition Collaboration Task page.
When you request assistance from another user, they will receive a Disposition Collaboration task. You can see all the status and any comments for these tasks in the Disposition Plan Collaboration Tasks list.
At any point you may click the "Save for Later" button. This will save any changes you have made to the Report and take you to your Task List. If this is the first time the Report has been saved, a Submit NCM Report task will be created, to allow you to complete the submission of the Report. 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 "Cancel" at any point will discard any changes made since the last save and take you to your Task List.
When you are finished entering information about the NCM you may click the "Proceed to Signoff" button. If you are the originator you will be taken to the Sign Off Submit NCM Report page.
If you are an NCM Module Coordinator signing off on the Propose Disposition task, you will be required to fill in all blank fields before proceeding to the signoff page. This is also the final point at which the Nonconforming Material Tag can be printed. If all information is complete, you will be taken to the Sign Off Propose Disposition page to select the NCM Review Board approvers that will be assigned Approve Disposition tasks. If NCM Module Administrators have defined more than one NCM Review Board, you will first be taken to the Select NCM Review Board page to select the appropriate NCM Review Board for this NCM Report.
Clicking the "Withdraw" button will allow you to permanently withdraw the NCM Report from the process (see the Withdraw NCM Report page). The report status will be changed to withdrawn and all open task assignments will be canceled.
You can return the Report to the originator or someone who can act for the originator for more information or clarification.
Clicking the "Return for Information" button will take you to the Return for Information page. NOTE: You cannot return an NCM Report to the Originator when working on a follow-up disposition plan.
Enter a brief description of the manner in which the materials are potentially nonconforming.
Next, record the Quantity of affected material, including the specific UDI Numbers and/or Serial Numbers.
Finally, indicate where the nonconforming materials were found (Location Found and Process / Operation Found if applicable), and record where materials have been quarantined. If Defect Codes have been configured, select the code that most closely matches the type of nonconformance found.
Once you have finished recording the information about the nonconforming materials, you can select a Disposition Code to recommend, along with any necessary instructions and/or justification. If the disposition instructions require additional detail, you can upload files with the information into the Disposition Instruction Files table (see Add/Edit Disposition Instruction File).
Click the "Save" button to save your changes and return to the Edit NCM Report page.
Click the "Save and Add Another" button to save your changes, clear the fields, and enter another NCM Report Entry.
Click the "Cancel" button to discard your changes and return to the Edit NCM Report page.
Enter a short description of the file to be uploaded.
Click the "Browse" or "Choose File" button to find and select a file from your local machine.
Click the "Save" button to save your changes. You will be taken back to the previous page.
Clicking the "Cancel" button will return you to the previous page without saving your changes.
To upload a file containing background information about the nonconformance, 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 Edit NCM Report page.
If you have chosen to make change 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 Edit NCM Report page.
Enter any additional comments and your signoff key, and then click the "Sign Off" button to sign off the task and submit the report into the NCM process. You will be taken to the "My Tasks" page.
Clicking the "Cancel" button will return you to the Edit NCM Report page without submitting the report.
Withdrawing an NCM Report removes it from the NCM process. Your task assignment for completing this report will be closed and the report marked as "Withdrawn" and removed from the process.
To withdraw the NCM Report, enter the reason you are removing the report into the comments field and then enter your signoff key and click the "Withdraw Report" button.
Clicking the "Cancel" button will return you to the Edit NCM Report page without withdrawing the report.
The Propose Disposition Plan step allows the NCM Module Coordinator to propose dispositions for the identified nonconforming material and then send the proposal to the appropriate NCM Review Board for approval. (See Approve Disposition Plan.)
When an NCM Report is submitted, the NCM Module Coordinator is responsible for reviewing the report for completeness and making any necessary corrections (see Edit NCM Report). If necessary, the NCM Module Coordinator can return the report to the Originator for additional information, or withdraw the report altogether. The NCM Module Coordinator is also responsible for proposing a disposition plan, comprised of recommended disposition codes and instructions for each NCM Report Entry.
The NCM Module Coordinator will also be assigned the Propose Disposition task when the disposition implementation fails for an NCM Report Entry (see Cancel Failed Implementation). In that case the NCM Module Coordinator is responsible for proposing a new disposition plan for the entry that failed.
Once the disposition plan has been completed the NCM Module Coordinator is responsible for sending it to the appropriate NCM Review Board for approval see (Sign Off Propose Disposition).
This page allows you to return an NCM Report to someone (typically the Originator) who can fix incomplete or incorrect information on the report. You should provide a detailed description of the necessary changes in the Comments field.
After entering your signoff key, click the "Sign Off" button to return the NCM Report to the assigned user. Once the assigned user has completed the requested changes, the NCM Report will be sent to you again to continue the process.
Clicking the "Cancel" button will return you to the Edit NCM Report page without returning the NCM Report to the assigned user.
This page displays the list of NCM Review Boards that have been configured for your organization. When you have determined the appropriate NCM Review Board for this NCM Report, click its corresponding "Select" button.
If you are distributing the NCM Report to the NCM Review Board for input about the correct disposition, you will be taken to the Request Input for Disposition Plan page.
If you are distributing the NCM Report to the NCM Review Board for final approval of the proposed dispositions, you will be taken to the Sign Off Propose Disposition page.
Click the "Cancel" button to return to the Edit NCM Report page without selecting an NCM Review Board.
Enter a detailed description of the feedback you need to propose disposition codes and instructions. This will be sent to each person assigned a Provide Disposition Input task.
The departments defined for the selected NCM Review board will be displayed with the default approvers listed. You can change an approver by selecting a different user or remove the department from the disposition input request by clearing the field. You can also select additional people to provide input.
Select a date by which the input is required.
Depending on how the system has been configured, you may receive email notifications when users complete their assigned Provide Disposition Input tasks. See the "Notify the Coordinator upon Disposition Input Task completion?" option on the Configure NCM Process Options page, for more information about how NCM Module Administrators may configure these notifications.
Click the "Request Disposition Input" button to assign the tasks and return to the Edit NCM Report page.
Click the "Cancel" button to return to the Edit NCM Report page without assigning any Provide Disposition Input tasks.
When assigning collaboration tasks to request assistance with the development of a disposition plan, you should give detailed instructions to the assignee. The assignee will have the ability to edit any portion of the disposition plan, along with any fields on the NCM Report, 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 Edit NCM Report 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 Edit NCM Report page without assigning a task.
This page allows the NCM Module Coordinator to optionally bypass the NCM Review Board approval for a disposition plan and proceed directly to implementation. This is only an option if the "Allow NCM Report with Disposition Input to bypass review board approval?" setting on the Configure NCM Process Options page has been set to "Yes".
Signs off the task and sends the disposition plan to an NCM Review Board for approval before it is implemented.
Clicking this button will take you to the Sign Off Propose Disposition page to select the NCM Review Board approvers that will be assigned Approve Disposition tasks. If NCM Module Administrators have defined more than one NCM Review Board, you will first be taken to the Select NCM Review Board page to select the appropriate NCM Review Board for this NCM Report.
Signs off the task and sends the disposition plan directly to implementation.
Clicking this button will take you to the Sign Off Propose Disposition page to sign off the NCM Report as approved. From there you will proceed directly to the Assign Disposition Tasks page.
Clicking the "Cancel" button will return you to the Edit NCM Report page without signing off on the task.
Select the users from the selected NCM Review Board that will be assigned to review and approve the proposed disposition plan. Each department has a default approver, according to the procedure set on the Configure NCM Review Boards page. If no default approver is identified for a department, the corresponding department manager is used. You can also assign additional approvers, to include people that are not normally on the NCM Review Board.
If the NCM process has been configured to "Require All Review Board Members during Review" (see Configure NCM Process Options) you must select a user for every department listed. Otherwise you can remove specific departments from the review by clearing the default user assigned for that department.
After you have identified all necessary approvers, indicate whether or not a CAPA should be initiated by selecting Yes or No for the "Should a CAPA be initiated?" field. If you select No, you must enter a justification for why this NCM Report does not require a CAPA to determine and address the root causes of the problem.
Enter your signoff key and optional comments, and then click "Sign Off". The NCM Report will proceed to the Approve Disposition Plan step, where each approver you have identified will receive an Approve Disposition task. Any Provide Disposition Input tasks that are still In Progress will be automatically canceled.
If you indicated that a CAPA request should be initiated, you will be taken to a page to assist in submitting the request (see Integration with CAPA Process).
Clicking the "Cancel" button will return you to the Edit NCM Report page without distributing it for approval.
The NCM Module Coordinator can request input to aid in determining the disposition of the Nonconforming Materials (See Request Input for Disposition Plan). Normally the request will be sent to an NCM Review Board; however the NCM Module may choose anyone that they need feedback from. See the Provide Disposition Input page for detail on how to complete this assignment.
The Additional Instructions field will contain specific instructions from the NCM Module Coordinator for the input desired about the proposed disposition plan for this NCM Report. Use the Comments field for any feedback you wish to provide about the appropriate disposition for the nonconforming materials described in the disposition plan.
Click the "Sign Off" button to save your comments and close this assignment.
Click the "Cancel" button to return to your task list without saving any changes.
The Disposition Collaboration task allows you to assist in the development of a disposition plan for an NCM Report. The assigned task has a set of specific instructions and a due date by when the task should be completed. When you receive a Disposition Collaboration task, you will be able to contribute to the assigned disposition plan and any of the fields on the NCM Report (see the Edit NCM Report page).
When you have completed the assigned task, click the "Save and Proceed to Signoff" button (see the Sign Off Disposition Collaboration page).
To sign off your Disposition 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 collaboration task. The NCM Module Coordinator will receive an email notification that you have completed the task.
Clicking the "Cancel" button will return you to the Edit NCM Report page without signing off on the task.
Before the disposition plan for an NCM Report can proceed to implementation, it must be approved by representatives of departments on the NCM Review Board. Each approver identified by the NCM Module Coordinator during the Propose Disposition Plan step will receive an Approve Disposition task. If all approvers approve the proposed disposition plan, the NCM Report will proceed on to the Implement Disposition step.
If any of the approvers reject the NCM Report, it will return to the Propose Disposition Plan step.
Each user receiving an Approve Disposition Task for an NCM Report is responsible for reviewing and either approving or rejecting the proposed disposition plan. Clicking on an Approve Disposition assignment on the "My Tasks" page will take the approver to the Sign Off Approve Disposition Plan page.
The Sign Off Approve Disposition page displays the NCM Report and the disposition plan to be reviewed. After reviewing the disposition plan, you can either approve or reject it. If you choose to reject the disposition plan, you must provide feedback in the "Comments" field.
You may receive multiple Approve Disposition assignments for a given disposition plan. Each of these assignments will be on behalf of a particular department. The department for which the assignment is on behalf of will appear in the task instructions above the Approve / Reject field.
After you have recorded your decision and any necessary comments, enter your signoff key and click the "Sign Off" button.
Clicking the "Cancel" button will return you to the "My Tasks" page without signing off on the assignment.
Once the proposed disposition plan has been approved by the assigned members of the NCM Review Board, the NCM Module Coordinator assigns individuals to execute the actions for each of the NCM Report Entries in the disposition plan (see Assign Disposition Tasks). The assigned individuals will receive an Implement Disposition task describing the disposition actions they must complete for each NCM Report Entry they are responsible for. The NCM Module Coordinator may also indicate the need for the Device History Record to be updated.
As each Implement Disposition task is completed, the NCM Module Coordinator will be assigned to review the disposition results (see Review Disposition Results task).
When the NCM Module Coordinator approves disposition results that require an update to the Device History Record, a user will be assigned to make the necessary changes (see Update DHR task).
The NCM Module Coordinator is also responsible for assigning Impact Implementation tasks for any applicable Process Impacts that are configured to require follow-up tasks.
The NCM Module Coordinator can also assign users to perform any additional administrative actions that need to be completed as a result of the disposition actions (see Assign Rollout Task for Disposition Plan).
After all Review Disposition Results, Disposition Rollout and Update DHR tasks for the original and all follow-up disposition plans have been completed, the NCM Report will proceed on to the NCM Module Coordinator to be closed (see Close NCM Report).
Once a disposition plan has been approved, the NCM Module Coordinator must assign appropriate users to implement the disposition actions for each NCM Report Entry. Assigned users will receive Implement Disposition tasks, and be responsible for completing the disposition work before the specified due dates. Tasks to update the Device History Record (DHR) can also be assigned as necessary for any disposition actions that should be recorded.
If any of the applicable Process Impacts requires a corresponding Impact Implementation task, the NCM Module Coordinator is also responsible for assigning someone to ensure that each task is completed.
The NCM Module Coordinator can also assign ad hoc Disposition Rollout tasks for additional work that needs to be taken to communicate the results of the disposition actions (for example, assigning a user to update the corresponding records in an ERP system).
When the NCM Module Coordinator launches this task, they will be taken to the Assign Implementation and Rollout Tasks for Disposition Plan page.
This page displays a summary of the disposition plan that was approved by the NCM Review Board.
To complete this task, you must assign users to implement each of the actions for that disposition plan. Click the "Assign Implement Disposition Tasks" button to proceed to the Assign Implement Disposition Tasks for Disposition Plan page.
If any of the applicable Process Impacts requires a corresponding Impact Implementation task, you can click the "Assign Impact Implementation Tasks" button to proceed to the Assign Impact Implementation Tasks page. These tasks must be assigned before you can click the "Proceed to Signoff" button.
If there are any additional administrative actions that need to be completed, you can click the "Assign Rollout Task" button to assign users to perform the necessary work (see Assign Rollout Task for Disposition Plan).
Once you have assigned all necessary tasks, you can click the "Proceed to Signoff" button (see Sign Off Assign Disposition Tasks). If you sign off on this task, the system will automatically notify you when all tasks have been completed by assigning you a Close NCM Report task.
If you want to keep this task open to monitor the progress of existing tasks or assign additional tasks as necessary, click the "Finish Later" button.
For each NCM Report Entry in the disposition plan, select the appropriate individual to implement the associated disposition actions and assign a due date for the required work. Each individual will be responsible for carrying out the disposition work based on the instructions associated with their assigned NCM Report Entry.
After selecting users and due dates for all NCM Report Entries in the disposition plan click the "Assign Tasks" button to proceed with assigning the Implement Disposition tasks. Any indicated Update DHR tasks will automatically be assigned after their corresponding Implement Disposition and Review Disposition Results tasks have been completed.
Clicking the "Cancel" button will return you to the Assign Implementation and Rollout Tasks for Disposition Plan page without assigning any of the disposition tasks.
For each of the applicable Process Impacts that requires a corresponding Impact Implementation task, you must select an assignee and a due date for the completion of the task. You should also review the default instructions for each implementation task and add any details that should be communicated to the assignee.
Clicking the "Cancel" button will return you to the Assign Implementation and Rollout Tasks for Disposition Plan page without assigning any of the required Impact Implementation tasks.
Enter detailed instructions to the assignee of this Disposition Rollout task. Then, select an assignee and a due date for the task.
Click the "Assign Task and Close" button to assign the task and return to the Assign Implementation and Rollout Tasks for Disposition 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 Assign Implementation and Rollout Tasks for Disposition Plan page without assigning a task.
Enter any additional comments that you want to include in the NCM Report's task history, then enter your signoff key and click the "Sign Off" button to complete this task.
When all disposition tasks have been completed for the original and all follow-up disposition plans, you will automatically receive a Close NCM Report assignment.
Clicking the "Cancel" button will return you to the Assign Implementation and Rollout Tasks for Disposition Plan page without signing off on this task.
Users receiving Implement Disposition tasks are responsible for completing all disposition work for the associated NCM Report Entry before the assigned due date. Detailed instructions about the approved disposition actions are provided for each entry. As the user makes progress on the disposition actions, they can record the results of their work and optionally upload files containing additional information about the results. When all disposition work for an entry has been completed, the user can sign off their task.
As each Implement Disposition task is completed, the NCM Module Coordinator will be assigned to review the disposition results (see Review Disposition Results task).
NOTE: If the NCM Process has been configured to streamline the process for NCM Module Coordinators, an NCM Report Entry assigned to be implemented by an NCM Module Coordinator will automatically advance to the Review Disposition Results task.
The disposition actions for this NCM Report Entry are described in the Disposition Code and Disposition Instructions fields.
Use the Disposition Results field to describe the outcome of the disposition work. As you make progress on this work, you can save your changes and return to the "My Tasks" page by clicking the "Save for Later" button.
You may be required to enter the quantities of material that were Accepted and Rejected as a result of your work. If the resulting quantities do not add up to the original quantity reported for this NCM Report Entry, you should select "Yes" for the "Is there a Quantity Discrepancy?" field, and describe the reason for the discrepancy in the Disposition Results field.
You can also upload any files generated as a result of this work (e.g. test results, summary tables) by clicking the "Add Disposition Results Files" button (see the Add Disposition Results File page).
Clicking the "Cancel" button will return you to the "My Tasks" page without updating the Disposition Results.
When you have completed the assigned disposition actions for this NCM Report Entry, click the "Save and Proceed to Signoff" button (see Sign Off Implement Disposition).
When you have verified that the disposition results for this NCM Report Entry are accurate and complete, click the "Save and Proceed to Signoff" button (see Sign Off Review Disposition Results).
You can request additional information about or corrections to the results of the disposition work, by clicking the "Return for More Information" button (see Return Disposition Results for More Information).
If you determine that the disposition actions for this NCM Report Entry cannot be successfully completed, click the "Cancel Failed Implementation" button to begin the process of proposing a new disposition plan for this entry (see Cancel Failed Implementation).
Enter a short description of the results file to be uploaded.
Click the "Browse" or "Choose File" button to find and select a file from your local machine.
Click the "Save" button to save your changes. You will be taken back to the Edit Disposition Results page.
Clicking the "Cancel" button will return you to the Edit Disposition Results page without saving your changes.
Enter any additional comments and your signoff key, and then click the "Sign Off" button to sign off the task as completed.
Clicking the "Cancel" button will return you to the Edit Disposition Results page.
After each Implement Disposition task is completed, the NCM Module Coordinator is assigned to review the accuracy and completeness of the disposition results. If any of the information is incomplete or incorrect, the NCM Module Coordinator can either make any necessary changes to the results (see Edit Disposition Results) or send it back for additional work (see Return Disposition Results for More Information).
If the NCM Module Coordinator determines that the disposition actions for this NCM Report Entry cannot be successfully completed, they can cancel the disposition implementation for this NCM Report Entry and begin the process of proposing a new disposition plan for it (see Cancel Failed Implementation).
If it was previously indicated that the results of the disposition actions must be recorded in the product's Device History Record, an Update DHR task will automatically be assigned after the NCM Module Coordinator signs off on the Review Disposition Results task (see Sign Off Review Disposition Results).
Enter any additional comments and your signoff key, and then click the "Sign Off" button to sign off the task and implementation as successfully completed. If it was previously indicated that the results of the disposition actions must be recorded in the product's Device History Record, an Update DHR task will automatically be assigned.
Clicking the "Cancel" button will return you to the Edit Disposition Results 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 Implement Disposition task. 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 Disposition task.
Clicking the "Cancel" button will return you to the Edit Disposition Results page without sending the task back to the Implementor.
Enter a detailed description of why the implementation of this NCM Report Entry is being canceled then click the "Cancel Failed Implementation" button to sign off this task.
You will be assigned the Propose Disposition task for the follow-up disposition plan and taken to the corresponding Edit NCM Report page.
Clicking the "Cancel" button will return you to the Edit Disposition Results page without canceling the implementation for this NCM Report Entry.
Users receiving Update DHR tasks are responsible for updating the Device History Record with the results of the disposition actions performed during the Implement Disposition task.
You are responsible for updating the product's Device History Record to include the Disposition Results for this NCM Report Entry.
Once you have updated the DHR, enter any additional comments and your signoff key, and then click the "Sign Off" button to sign off the task as completed.
Clicking the "Cancel" button will discard any comments you have entered without signing off on the task.
When the NCM Module Coordinator assigns one or more Disposition Rollout tasks for a disposition plan (see Assign Rollout Task for Disposition Plan), users receiving those tasks are responsible for performing the requested work.
The Rollout Task Instructions field contains specific instructions from the NCM Module Coordinator about the work you must complete before signing off on this task.
Once you have completed the requested work, use the Comments field to document the results of the work you performed. Then, enter your signoff key and click the "Sign Off" button to save your comments, and close this assignment. The NCM Module Coordinator will receive an email notification that you have completed the task.
Click the "Cancel" button to return to your task list without saving any changes.
The NCM Module Coordinator receives this task when all Review Disposition Results, Impact Implementation, Disposition Rollout and Update DHR tasks for the original and all follow-up disposition plans have been completed. The NCM Module Coordinator is responsible for signing off the NCM Report as closed.
Review the NCM Report to verify that all information is correct and complete.
If custom fields have been configured for NCM Reports, an "Edit NCM Report Information" button is displayed, which will allow you to make any necessary updates to those custom fields for the NCM Report (see Edit NCM Report Information).
Click the "Proceed to Signoff" button when you are ready to close the NCM Report (see Sign Off Close NCM Report).
Clicking the "Cancel" button will return you to your task list.
Make any necessary updates to the custom fields for this NCM Report and then click the "Save" button to record your changes and return to the previous page.
Clicking the "Cancel" button will discard any changes and return you to the previous page.
Enter any final comments about the resolution of this NCM Report, and then enter your signoff key and click the "Sign Off" button to close the report.
Clicking the "Cancel" button will discard any comments you have entered and return you to the previous page without signing off on the task.
The Manage NCM Reports page allows authorized users to perform administrative actions necessary to manage NCM Reports in the Grand Avenue system.
The page has links to the following actions:
This page displays a list of all NCM Reports that currently have disposition plans being approved.
Normally the Approve Disposition Plan step is only concluded once all approvers have signed off on their Approve Disposition tasks. The NCM Module Coordinator has the option to cancel an Approve Disposition Plan step that is in progress. Any remaining open Approve Disposition assignments will be canceled, and the request will return to the Propose Disposition Plan step.
To cancel the Approve Disposition Plan step for a disposition plan, click its corresponding "Cancel Approve Disposition" button (see the Cancel Approve Disposition page).
Click the "Close" button to return to the previous page.
Canceling an Approve Disposition Plan step that is in progress will immediately cancel any open Approve Disposition task assignments and return the disposition plan to the Propose Disposition Plan step, where you will be able to make any necessary changes to the NCM Report.
To proceed with canceling the Approve Disposition step for a disposition plan, enter a description of the reason for canceling, then enter your signoff key and click the "Cancel Approve Disposition" 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 Approve Disposition Plan step for this disposition plan.
Normally the implementation of an NCM Report Entry is reviewed and canceled if necessary during the Review Disposition Results task. If after closing an NCM Report it is determined that the implementation has failed, the NCM Module Coordinator can use this page to initiate the process to redisposition the associated nonconforming material.
To cancel a failed implementation for a closed NCM Report, fill in any applicable search criteria and click the "Search" button to find the desired NCM Report.
Click the corresponding "Cancel Failed Implementation" button for the NCM Report (this button is only displayed NCM Reports with implementations that can be canceled). This will take you to the Select Implementation to Cancel page where you will indicate which NCM Report Entry failed. The subsequent Cancel Failed Implementation page will allow you to record information about why the implementation failed, and then you will be taken to the Edit NCM Report page to begin work on the Propose Disposition Plan task for the new follow-up disposition plan.
This page displays a list of all of the disposition plans and their corresponding NCM Report Entries. A "Cancel Failed Implementation" button will be displayed for each NCM Report Entry that has a disposition status of "Complete".
To cancel a failed implementation for an NCM Report Entry, click its corresponding "Cancel Failed Implementation" button. This will take you to the Cancel Failed Implementation page, where you will record information about why the implementation failed.
Clicking the "Cancel" button will return you to the previous page.
Enter a detailed description of why the implementation of this NCM Report Entry is being canceled then click the "Cancel Failed Implementation" button to sign off this task. This description will be recorded in a Cancel Failed Implementation for Closed NCM Report assignment in the Task History. The status of the NCM Report will be changed back to "Redispositioning", and the original "Closed Date" will be cleared.
You will be assigned the Propose Disposition task for the follow-up disposition plan and taken to the corresponding Edit NCM Report page.
Clicking the "Cancel" button will return you to the Cancel Failed Implementations for Closed NCM Reports page without canceling the implementation for this NCM Report Entry.
This task is automatically recorded in the Task History for an NCM Report Entry when it is being canceled as a failed implementation after the NCM Report has been closed (see Cancel Failed Implementation for Closed NCM Report page)
By default, NCM Reports cannot be modified once they have been closed or withdrawn. However, NCM Module Administrators can set an option on the Configure NCM Process Options page that allows NCM Module Coordinators to record additional information for those NCM Reports.
To record additional information for a closed or withdrawn NCM Report, fill in any applicable search criteria and click the "Search" button to find the desired NCM Report.
Click the corresponding "Record Additional Information" button for an NCM Report to proceed to the Record Additional Information for Closed Item page.
Click the "Cancel" button to return to the previous page.
The Export NCM Reports feature allows NCM Module Administrators to export the metadata and file content for a selected set of NCM Reports to a directory on the web server.
The export will generate a separate directory structure for each selected NCM Report, which will contain two types of files for each related item:
Click the "Export NCM Reports" link on the Manage NCM Reports page. You will be taken to the Select NCM Reports to Export page, where you can use search criteria to specify the set of NCM Reports that will be included in the export.
This page allows you to select the set of NCM Reports to be included in the export.
Fill in any applicable search criteria and click the "Search" button to find matching NCM Reports.
When the search results display the desired set of NCM Reports, click the "Export Results to Server" link to proceed to the Export NCM Reports to Server page.
Clicking the "Cancel" button will return you to the Manage NCM Reports page.
This page will export the metadata and file content for each NCM Report 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 NCM Reports 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 NCM Reports page.
NCM Module Administrators can configure the list of Process Impacts that will be used by NCM Reports (see Configure Process Impacts for Module). NOTE: Process Impacts cannot be defined for Immediate Disposition reports. If process impacts should be considered for nonconforming materials, then the Immediate Disposition process should not be used.
When an NCM Report is first created, a process impact is created for each corresponding process impact definition. As users edit the NCM Report, they will be displayed the list of process impacts to be considered for applicability (see Process Impacts). When performing the Assign Disposition Tasks task, the NCM Module Coordinator will assign Impact Implementation tasks for each applicable impact which was defined to require an implementation task.
When an NCM Report has an entry canceled for a failed implementation (Cancel Failed Implementation) the follow-up disposition plan will have a new set of process impacts created for consideration.
The NCM module can also be configured to allow users to immediately disposition nonconforming materials without going through the standard NCM Review Board process (see Configuring Product Disposition Codes for information on how to activate the Immediate Disposition process).
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If NCM Module Administrators have activated the Immediate Disposition feature for one or more product disposition codes, users can use the "Record Immediate Disposition" link on the navigation menu to fill out an NCM Report for nonconforming materials that they have dispositioned without going through an NCM Review Board process (see the Add/Edit NCM Report for Immediate Disposition page).
Once a user has completed the Immediate Disposition report and signed off on the Record Immediate Disposition task, the NCM Module Coordinator will receive the Review and Close Immediate Disposition Report task, where they will be responsible for reviewing the report for accuracy and completeness, and determining whether or not a follow-up CAPA request is required to determine and address the root causes of the reported nonconformances.
NCM Module Administrators can also configure the Immediate Disposition process to require an additional review prior to the NCM Module Coordinator review. If this option has been enabled, incoming Immediate Disposition reports will first be sent to a configured Reviewer. The Reviewer is responsible for completing the Review Immediate Disposition Report task for each report before it proceeds on to the NCM Module Coordinator.
The NCM Report is closed as soon as the NCM Module Coordinator signs off on the Review and Close Immediate Disposition Report task.
The Record Immediate Disposition task allows a user to fill out an NCM Report for nonconforming materials that they have dispositioned without going through an NCM Review Board process. The user must select the Part that was dispositioned and fill out all information for the nonconforming material and how it was dispositioned (see the Add/Edit NCM Report for Immediate Disposition page). Once they have completed the NCM Report, it proceeds on to the NCM Module Coordinator for review.
NOTE: If the NCM Process has been configured to streamline the process for NCM Module Coordinators and there is only one NCM Module Coordinator defined and no additional review step has been configured for Immediate Disposition reports, then an Immediate Disposition report created by the NCM Module Coordinator will automatically advance to the Review and Close Immediate Disposition Report task.
If you are unsure whether or not materials can be immediately dispositioned, click the "When can materials be Immediately Dispositioned?" link to review your organization's policy.
Fill out all required identification information about the material that was found to be nonconforming.
Use the Containment Description field to list all actions that were taken to locate and contain the nonconforming materials.
Select values for each of the custom fields configured by your organization. Fields will only displayed if they have been configured (see Configure NCM Report Fields).
Describe the manner in which the materials were nonconforming (Nonconformance Description). If Defect Codes have been configured, select the code that most closely matches the type of nonconformance found.
Next, record the Quantity of affected material, including the specific UDI Numbers and/or Serial Numbers.
Indicate where the nonconforming materials were found (Location Found and Process / Operation Found if applicable) and where they were quarantined (Quarantine Location).
Select a Disposition Code to indicate how the materials were dispositioned, along with any necessary justification. You will only be able to select disposition codes that have been approved for Immediate Disposition by NCM Module Administrators.
Use the Disposition Results field to describe the outcome of the disposition work. If necessary, update the quantities of material that were Accepted and Rejected as a result of the disposition work. If the resulting quantities do not add up to the original quantity reported for this NCM Report Entry, you should select "Yes" for the "Is there a Quantity Discrepancy?" field, and describe the reason for the discrepancy in the Disposition Results.
Click the "Add NCM Background File" button to add an NCM Background File. This will take you to the Add NCM Background File page.
Click the "Edit" button to change a particular background file. This will take you to the Edit NCM Background File page.
Click the "Delete" button to remove a particular background file.
Once you have filled in the NCM Report, you can print an information sheet to accompany the nonconforming materials.
NOTE: Your organization may have configured the text displayed for this button to match the terminology used by your company's policy. See the Configure NCM Process Options page for more information.
Clicking the "Save for Later" button will allow you to record your changes without signing off on your task.
Clicking the "Withdraw" button will allow you to permanently withdraw the NCM Report from the process (see the Withdraw NCM Report page). The report status will be changed to withdrawn and all open task assignments will be canceled.
Clicking the "Cancel" button will discard any changes you have made and return you to the "My Tasks" page.
If you are the Originator, filling out the NCM Report for the Record Immediate Disposition task, clicking the "Proceed to Signoff" button will take you to the Sign Off Record Immediate Disposition page, where you can sign off on the task and have the report submitted for review.
If you are a Reviewer reviewing the NCM Report for the Review Immediate Disposition Report task, clicking the "Proceed to Signoff" button will take you to the Sign Off Review Immediate Disposition Report page.
If you are an NCM Module Coordinator reviewing the NCM Report for the Review and Close Immediate Disposition Report task, clicking the "Proceed to Signoff" button will take you to the Sign Off Review and Close Immediate Disposition Report page, where you will determine the need for a follow-up CAPA request and then close the NCM Report.
Enter any additional comments and your signoff key, and then click the "Sign Off" button to sign off the task and submit the Immediate Disposition report to an NCM Module Coordinator for review. You will be taken to the "My Tasks" page.
Clicking the "Cancel" button will return you to the Add/Edit NCM Report for Immediate Disposition page without submitting the report.
Immediate Disposition reviewers are responsible for reviewing all Immediate Disposition NCM Reports for accuracy and completeness (see the Add/Edit NCM Report for Immediate Disposition page).
After making any necessary changes to the report, the Reviewer signs off on the assignment and the Immediate Disposition NCM Report is sent to the NCM Module Coordinator for final review and closure (see Review and Close Immediate Disposition Report).
If the Reviewer determines that the dispositioning of the nonconforming materials should have been approved by an NCM Review Board, they can withdraw the Immediate Disposition NCM Report and require the user to submit a standard NCM Report instead (see Withdraw NCM Report).
Enter your signoff key and optional comments, and then click "Sign Off" to complete the task.
Clicking the "Cancel" button will return you to the Add/Edit NCM Report for Immediate Disposition page without signing off on the task.
NCM Module Coordinators are responsible for reviewing all Immediate Disposition NCM Reports for accuracy and completeness (see the Add/Edit NCM Report for Immediate Disposition page).
After making any necessary changes to the report, the NCM Module Coordinator must indicate whether or not a CAPA request should be initiated to determine and address the root causes of the reported nonconformances. Once the NCM Module Coordinator signs off on the task, the NCM Report will be closed.
If the NCM Module Coordinator determines that the dispositioning of the nonconforming materials should have been approved by an NCM Review Board, they can withdraw the Immediate Disposition NCM Report and require the user to submit a standard NCM Report instead (see Withdraw NCM Report).
Indicate whether or not a CAPA should be initiated by selecting Yes or No for the "Should a CAPA be initiated?" field. If you select No, you must enter a justification for why this NCM Report does not require a CAPA to determine and the root causes of the problem.
After indicating the need for a CAPA request, enter your signoff key and optional comments, and then click "Sign Off" and the NCM Report will be closed.
If you indicated that a CAPA request should be initiated, you will be taken to a page to assist in submitting the request (see Integration with CAPA Process).
Clicking the "Cancel" button will return you to the Add/Edit NCM Report for Immediate Disposition page without initiating a CAPA or closing the NCM Report.
The Nonconforming Materials module provides a Searching capability that allows any user to find NCM Reports that match specified criteria. For example, a user can search for all NCM Reports currently in process.
To search for one or more NCM Reports, click the "Search for NCM Reports" link on the navigation menu (Search for NCM Reports).
The NCM module also provides a standard set of dashboard charts for monitoring the status of your Nonconforming Materials process. To view these charts, click the "Dashboard" link for the NCM module on the navigation menu (NCM Dashboard).
The Search for NCM Reports page allows authorized users to search for NCM Reports 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 particular group of NCM Reports.
The Status field allows you to restrict your search to NCM Reports that are in a particular stage of the process:
Selecting an Applicable Process Impact will only find NCM Reports that have a disposition plan with the selected process impact marked as "Applicable". For example, you can restrict your search to only find NCM Reports that resulted in a regulatory impact.
You can use the following date-based search fields to narrow your search to NCM Reports that have fields within a specified date range:
When a search is performed, summary information is displayed about each report found. You can click on the "Info" link corresponding to each NCM Report to see more detailed information.
NOTE: When selecting the "Generate Chart for Results" link to chart the search results by Disposition Code, NCM Reports will be included in the chart totals for disposition codes found on both their successful and failed NCM Report Entries (see the Select Chart for Search Results page).
The dashboard allows you to monitor pre-defined measurements about your NCM process. The following charts are displayed:
NOTE: NCM Module Administrators and Coordinators can find additional information about any overdue tasks using the Manage Task Assignments page. Department managers can also use the same page to find information about overdue tasks for users in their departments.
NOTE: The values for the last month in any "by Month" chart only represent data through the current date, not projections or estimates for the entire month.
When an organization installs and rolls out the Grand Avenue Software Nonconforming Materials module, there are a number of preliminary configuration and boot-strapping steps that should be performed. Each step has its own configuration screen to assist NCM Module Administrators in getting the system ready for production.
The NCM module allows you to define custom fields for recording and trending additional information about NCM Reports. Fields that have been configured to be "Conditionally Required" are optional in the early stages of the NCM Process. Those fields are optional until the signoff step for the Propose Disposition task.
This page guides you through the steps in configuring the Nonconforming Materials 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 NCM Module page has links to the following configuration tasks:
The Configure NCM Process Options page is used by NCM Module Administrators to tailor the Grand Avenue Software NCM process to align with the organization into which it is deployed.
The following process options can be configured:
Setting this option to "Yes" will allow NCM Module Coordinators to record additional information using "Closed" tab on the Manage NCM Reports page.
Indicate whether or not the system allows Unique Device Identifier (UDI) numbers to be recorded and tracked for parts in disposition plans. If this option is set to "No", the "UDI Numbers" 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 or not the system allows serial numbers to be recorded and tracked for parts in disposition plans. If this option is set to "No", the "Serial Numbers" field will never be displayed, and any information previously entered in this field will no longer be available (except in the audit trail).
By default NCM Module Administrators must assign a Reviewer for every department listed in the NCM Review Board. If you change this option to "No", NCM Module Administrators will be allowed to determine which departments are required for each review, based on the defined company policy. In either case, the system will always require at least two reviewers for every NCM report.
When an NCM Module Coordinator is assigning approvers for an NCM Report, they can specify additional "ad-hoc" approvers beyond those required by the Review Board. This setting controls the maximum number of additional approvers that a Coordinator can assign. You can enter any value from 2 to 10.
By default, the NCM process requires that disposition plans be approved by an NCM Review Board. This configuration setting gives the NCM Module Coordinator the option to approve a disposition plan without further review, if they have already requested Disposition Input from an NCM Review Board and all of those assignments have been completed.
When this setting is turned on, the NCM Module Coordinator is prompted to determine whether a disposition plan should be submitted to an NCM Review Board for approval, or if signoff of the Propose Disposition task is sufficient for approval (see Select Type of Disposition Approval).
This configuration option indicates if and when the NCM Module Coordinator should be notified about the completion of Provide Disposition Input tasks that they have assigned to NCM Review Board members. There are three possible choices:
The Immediate Disposition process can be optionally configured to assign all incoming Immediate Disposition Reports to a specific reviewer before they proceed on to the NCM Module Coordinator. If this option is chosen, the assigned Reviewer will receive a "Review Immediate Disposition" task for each incoming Immediate Disposition report.
Select "Yes" to activate the additional review step for the Immediate Disposition process, and select the user that will be the assigned Reviewer.
See the Configure Product Disposition Codes section for information on how to enable the Immediate Disposition process.
For organizations where the NCM Module Coordinator is regularly the Originator and/or Implementor for NCM Reports, the NCM process can be streamlined to automatically advance to the subsequent review step for a task when the NCM Module Coordinator is assigned to perform it. When this feature is turned on, it applies to the following tasks:
Select "Yes" to activate streamlining for the NCM process. When an NCM Report is automatically advanced past a task, an entry for that task will still be displayed in the "Task History" for the NCM Report with the "Task Status / Results" field set to "Automatically Advanced".
When an Originator is filling out an NCM Report, they have the option to print out an information sheet to identify and accompany the samples of nonconforming material. By default, this sheet is referred to as a "Nonconforming Material Tag". NCM Module Administrators can change this term to match the company's documented policy, and users will see the new term when filling out NCM Reports (see Edit NCM Report).
If the CAPA module is activated, any CAPA Request initiated by the NCM process (see Sign Off Proposed Disposition) will be populated with information from the NCM Report (see Integration with CAPA Process). Use the "Source Type for CAPA Request Initiated by an NCM Report" field to indicate the value that will be used to set the "Source Type" field of the CAPA Request. The NCM Report will also be added as a "Related Source" for the CAPA Request.
Click the "Save Configuration" button to apply your changes and return to the Configure NCM page.
Clicking the "Cancel" button will return you to the Configure NCM page without saving your changes.
An NCM Review Board is responsible for reviewing and approving the proposed disposition plans for nonconforming materials. The Grand Avenue Software NCM module allows an organization to define multiple NCM Review Boards, each with its own area of responsibility and/or expertise. The NCM Module Coordinator will select one of these NCM Review Boards when distributing an NCM Report for feedback on or approval of the disposition decisions for an NCM Report. NOTE: At least one NCM Review Board must be configured before NCM Reports can be distributed for approval.
To add a new definition of an NCM Review Board to the system, click the "Add NCM Review Board" button (see Add NCM Review Board).
To change the name or members of an existing NCM Review Board, click its corresponding "Edit" button (see Edit NCM Review Board).
To remove an NCM Review Board from the system, click its corresponding "Delete" button.
Click the "Close" button to return to the Configure Nonconforming Materials page.
Each NCM Review Board is configured as a list of departments that are normally required to approve an NCM Report. The NCM Module Coordinator can also add additional approvers for a particular NCM Report, prior to sending it out for approval.
Enter a descriptive name for the NCM Review Board, to help indicate when it should be selected to approve an NCM Report.
The table displays the current list of departments included in this NCM Review Board. Each department can have a specific user configured as the default approver. If no user is listed, the department manager will be used as the default approver.
Click the "Add Member" button to add a new department to the list of members for this NCM Review Board (see Add NCM Review Board Member).
Click the "Edit" button next to a department to change the department name and/or the default approver for this NCM Review Board (see Edit NCM Review Board Member).
Click the "Delete" button for a department to remove it from the list for this NCM Review Board.
Click the "Save" button to save this NCM Review Board and return to the Configure NCM Review Boards page.
Click the "Cancel" button to return to the Configure NCM Review Boards page.
Select a Department from the list of available Departments. Each department may only be added once to the NCM Review Board. You may also select a default approver. If no default approver is selected, the Department Manager will be used as the default approver of NCM Reports.
Click the "Save" button to save this member and return to the Edit NCM Review Board page.
Click the "Cancel" button to return to the Edit NCM Review Board page without saving any changes.
The following roles can be assigned by NCM 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 submit and view information for the NCM Module.
You can control which users are authorized by configuring the NCM Module Access List.
If a user is restricted from accessing information by the NCM Module Access List, that user will only be able to view NCM Module information when they have an open task assignment. An open task assignment temporarily authorizes a restricted user to access information about the item associated with that assignment. For example, an external supplier might normally be restricted from viewing information about an NCM Report, but would be temporarily granted authorization to see the NCM Report by an Implement Disposition task.
See the Configure Access List section in the General help for additional information about configuring this access list.
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