Compliance

Create an Early Alert Response

Updated on

This help tutorial goes into detail on how to make an Early Alert Response.  

NOTE: Only the expediters can create a response after an Early Alert has been entered and routed to them by the requester.

1.0  Navigate to Early Alert Request

1.0  Navigate to Early Alert Request

From C-Pro Home Screen

  1. Display Main Menu
  2. Click on "CAPA" Module
  3. Click on "Action Items" Section of the Module
  4. Click "By Document Type" to filter out early alert action only
  5. Click on "Early Alert Requests"
  6. Open the necessary early alert request form the list

You must create the response form correct Early Alert Request in order to have records correctly linked.

2.0  Various Response Options

2.0  Various Response Options

Two types of responses are available for this module: Communication Response and Investigation Response.  Each of the two responses is further broken down as such:

Communication:

  • Initial Early Alert Communication
  • Final Early Alert Communication

To determine which communication response is needed, analyze all the information provided on the early alert request.  If this Early Alert will require communication to the customer, determine if it's a quick solution.  When a solution/recommendation is found quickly there is no need for an initial response.  You can just create a Final Communication as a response.  When a solution/recommendation can take days and weeks, you should create both an initial response and a final response.  Initial response will warn the customer about issue and communicate to them that investigation is on-going.  The final response will be sent to the customer upon completion of the investigation, it will include information on actions taken and final recommendation

Investigation:

  • TKAM Investigation
  • Quality Control Investigation
  • Engineering / Operations Investigation

To determine which investigation response is needed, analyze all the information provided on the early alert request.  Determine based on the information give if the investigation can be completed by the TKAM.  If QC and/or Engineering investigation is required all three response types can be created.

3.0  Creating a Communication Response

3.0  Creating a Communication Response
  1. When only single communication response is needed click on "Create Communication Response"
  2. When both the Initial and Final Communication response is needed click on "Create Multiple Responses"

3.1 Single Communication Response Option

3.1 Single Communication Response Option
  1. Select response type form the drop down list by clicking on the arrow down and then on the item in the list.
  2. Click on Chevron to Continue

3.2 Multiple Communication Response Options

3.2 Multiple Communication Response Options
  1. Select multiple responses by holding the control key and clicking on the response type to highlight them
  2. Click on Chevron to Continue

4.0  Creating an Investigation Response

4.0  Creating an Investigation Response
  1. When only single investigation response is needed click on "Create Investigation Response"
  2. When multiple investigation responses are needed click on "Create Multiple Responses"

4.1  Single Investigation Response

4.1  Single Investigation Response
  1. Select response type form the drop down list by clicking on the arrow down and then on the item in the list.
  2. Click on Chevron to Continue

4.2 Multiple Investigation Responses

4.2 Multiple Investigation Responses
  1. Select multiple responses by holding the control key and clicking on the response type to highlight them
  2. Click on Chevron to Continue

5.0  Assigning Responses

5.0  Assigning Responses

By default the responses will be assigned to the expediter of the early alert and must be re-assigned appropriately.  It's likely that communication responses will stay assigned to the expediter by the investigation responses will be re-assigned.  

  1. Open the response needed to be re-assigned by clicking on the blue text "Early Alert Investigation Response EA-XXXXX: Name"\
  2. Click on "Request Reassignment" button
  3. Click on chevron to select the new "Assignee"
  4. Type in the name in the search box
  5. Click on the correct name
  6. Click on "Request Reassignment" button to continue
  7. Once the new Assignee accepts the response C-pro will automatically update the record.

 

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