This tutorial will describe in detail the steps required to complete an Early Alert Response
Navigate to the response by following tutorial "Navigating, Opening, Editing and Saving an Existing Early Alert" Steps 1-3.
1.0 Completing Communication Response
Once you have the communication response open you can see that a lot of information has been copied over to it form the request.
- Various menu items and actions that can be done on an early alert response.
- Link to the Request
- Information on whom requested this, whom the expediter is, and whom it's assigned to.
- Categorization information which is copied from the request
- Description of the Early Alert which is copied from the request
- The section that will need to be completed in order to complete this response
- Customer profile information which is copied form request
The only section that will need to be completed on this response is Section 6 (Step 6). Into this section you will need to upload a snap shot of the final communication response going out to the customer. Attach the communication response in PDF format. Make a Recommendation for Material Disposition.
1.1 Editing Communication Response
The initial communication response contains one less step where you do not need to fill in "Recommendation for Material Disposition" Section. When completing an initial response you will omit steps 2 and 3.
- Click on the Edit button
- Select the category for Recommendation for Material Disposition. NOTE: This response will appear on the Final Communication Response Report to the Customer
- Press Save to make sure that recommendation for Material Disposition is save to the database.
- Navigate to Sharepoint to run the communication response report. (Follow steps listed in tutorial "Early Alert Reporting") Take a screen shot of the PDF of the report and copy it into this section. NOTE: Best browser to copy and paste images is Firefox.
- Attach the PDF of the response into the Attachment section by clicking on the "Attach File" button. Browse to the file on your computer, which will fill in the file path. Type into the cell below file path a description for example: EA-XXXXX Initial or Final Communication Response. Click "Confirm" to attach
- Save Changes again.
- Press "Complete Response" when the above steps are all completed and the response is emailed to the customer. Responses do not require approvals.
IMPORTANT NOTE ON SEQUENCE: The Recommendation for Disposition must be selected and saved prior to running the "Final Communication Response" report because that information is needed for the report - Only applicable for Final Communication Response.
2.0 Completing an Investigation Response
Once you have the necessary response open you can see that a lot of information has been copied over to it form the request.
- Various menu items and actions that can be done on an early alert response.
- "Identity" section provides a lot of information from the Request as well as a link to the Request.
- Description of the Early Alert which is copied from the request
- Root Cause Analysis Section - will need to be completed in order to complete this response
- Solution Section - will need to be completed in order to complete this response
- Customer profile information which is copied form request
- Associated Items Section can be used if any new procedures were written as part of the solution or if a control plan was updated.
- Notification List can be used to add notification recipients.
2.1 Root Cause Analysis
- Click on "Edit" button to complete the "Root Cause Analysis" section.
- Select the "Root Cause" Category from the list. (If your root cause is not on the list, please contact system administrator)
- Select Contributing Factors - if necessary
- Describe in Detail the Root Cause Analysis that was done. (How the problem was created) NOTE: This section appears on the Final Customer Communication Report.
2.2 Solution
- What corrective action has been implemented as part of a solution for this Early Alert? NOTE: This section appears on the Final Customer Communication Report.
- Provide a responsible person for implementation and the date of completion of the implementation. NOTE: This section appears on the Final Customer Communication Report.
- What preventative Actions are being put into place to make sure this does not re-occur? NOTE: This section appears on the Final Customer Communication Report.
- List additional internally kept details if necessary.
- Provide information on Labor Time and Cost of Implementation if known.
2.3 Image and Attachment Section
Attachment section can be used to attach RFC file of the investigation, any other relevant documents that were used during the investigation. Image section can be used to display a screen shot of the documents being attached. Image section is not required, but allows users to see what the attachment look like without actually opening the file.
- Add image into this section by using computers ctrl+C and ctrl+V functions. Best browser to attach image is Firefox.
- Click "Attach File" button
- Click on "Browse" to find the file to be attached
- In the text box below type in attachment description such as RFC or Raw Material CoA
- Click "Confirm" button to add
- If more then one attachment is necessary press append row button to add another file







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