1. From Home Screen Click on "New" button.  
2. This button is also available when you are in the CAPA Module section of Action Items.

Clicking on "New" button in both of the sections mentioned above will get you to the same screen of choices.

1. Make sure you have the correct Organization selected.  This should match the organization your are currently logged in under.
2. Select "Action Item Requests" in the "Select Document Class" drop down box.
3. Select "Early Alert Request" in the "Select Document Type" drop down box.
4. There is only one option for "Select Document Layout" drop down box and it should be shown "Early Alert Request Layout"
5. Press on Chevron to continue

This section is very important because it allows easy navigation and searching of Early Alerts.  This section will also enable users to pull out data for various reports.

1. Follow the proper Title format when opening an early alert.  This will allow easy sorting in the future.  
2. Control number is automatically assigned and will start with letters "EA" followed by an auto incremental value.
3. Status and Creation Date are automatically assigned.  Status will be updated accordingly based on what part of the Early Alert Process you are in.   NOTE: Creation Date field is included in the customer initial and final communication response.
4. Effectiveness Review can be selected depending on how you want to track your customer response.  If an Early Alert is kept in-house, there might not be a need for an Effectiveness Review.  If an Effectiveness Review is checked off, make sure to specify proper time period, the default is 90 days but can be modified as needed.
5. Allowances will dictate the list of candidates available for Approval and Escalation flow.  You can select all of them by holding control key and clicking/highlighting all options, or if you anticipate for example that an Early Alert will only need TKAMs as part of the approval flow, then just select a single option.
6. Selecting the expediter will route the Early Alert to the proper TKAM for investigation and communication with customer.  Click on the Chevron to open the list of available expediters (NOTE: this list will vary based on the allowances you selected in Step 5).  Click on person's name and button "Add Selected", if the person's name is not listed try to increase number of Entries form default of 6 to 10 or more.
7. Select an additional expediter if necessary. Click on the chevron, select from list of names and click on "Add Selected"
8. Selecting a manufacturing department will allow data reporting in the future.  Click on Blue text "Early Alert Manufacturing Department" to see a list of department options.  Select the radio button next to the appropriate manufacturing department or the product and click on the chevron to select.  
9. Selecting a product from the Early Alert Product list will allow data reporting in the future.  This product list is limited to the products listed in the SOP-01551 which require engineering review.  To add additional products to the drop down list please contact the system administrator.  To select a product click on the blue text "Early Alert Product List" which will show a drop down list, in the list select your product and click on the chevron to add.  NOTE: This field is included in the customer initial and final communication response.
10. Selecting a parameter will allow reporting in the future.  This parameter list is limited based on non-raw material parameters measured on the list of products form the step above.  To add additional parameter to the selection list contact the system administrator.  To select a parameter click on the blue text "Early Alert Parameter List" which will show the applicable list form which you can click in the check box to select a parameter and then on chevron to add.  Multiple parameters can be selected only if the analytical method is the same for each parameter for example: Particle Counts.  NOTE: This field is included in the customer initial and final communication response.
11. This screen shot shows a properly populated "Action Request Identity" Section.
12. Save your record by pressing the "Save" button form the top menu

A due date is automatically configured to be 30 days after an Early Alert is created.  You are able to change the due date if necessary by clicking on the calender icon next to the due date and selecting the correct due date.  The due date can be revised for the record in the future as well.

1. Select the source of Early Alert Request by clicking on the drop down box arrow and clicking on an item form the list. This field will allow reporting on sources of EA's in the future.
2. Select the violation of Early Alert by clicking on the drop down box arrow and clicking on an item form the list. This field will allow reporting on violations of EA's in the future.
3. Type in the Lot Number of the product associated with this Early Alert.  NOTE: This field is included in the customer initial and final communication response.
4. Select the incident date associated with the violation by clicking on the calender icon next to incident date text box.  Select necessary date from the calender.  This could be the date of the QC test or In-Process check which resulted in the violation.
5. Type in Early Alert Description NOTE: This field is included in the customer initial and final communication.
6. Type in the Control Limit of Violating Parameter.  This could be either our internal dynamic limit, internal fixed limits, or customer's control limits.  Beside the values type in which control limits are violated.  Internal Fixed, Internal Dynamic, Customer Fixed.  NOTE: This field is included in the customer initial and final communication.
7. Type in the value of Violating Parameter. NOTE: This field is included in the customer initial and final communication.
8. This screen shot shows a properly populated "Early Alert Description" Section.
9. Save your record by pressing the "Save" button form the top menu

1. Image can be added using snag-it and your computers copy and paste function into this section.

NOTE: Best browser to use for this feature is firefox.  Adding images to this section is not the same as having them display on the initial and final reports.  In order to show images on the report they have to also be attached in the section below in either .png or .jpeg format.

1. Minitab file from engineering review can be attached in this section by clicking on the "Attach File" button
2. Browse for the file on your computer to define file path
3. Type in description of attached file for example "Minitab File"
4. Click "Confirm" to Attach
5. Click Icon to add multiple attachments

To add image fields into Initial and Final reports, they must be attached either in png or jpeg format in this section.  If multiple file types are attached for example pdf and png, only the png file types will show the image on the report, so don't worry about pdf attachments showing on the reports.

This section can be used if there are any Associated Items with this product in C-Pro.  For example any procedure, customer complaint, NCMR, or control plan.

1. Click on "Manage Associated Items" and follow steps on the screen to add "Associated Items".

NOTE: Associated Items must already be in C-Pro in order to be associated with an Early Alert.

This section allows you to associate a customer profile with the Early Alert. This field is included in the customer initial and final communication response.

1. Click on "Manage Hosted Date" button
2. Click on "Customer Profile - Americas"
3. Search for customer profile by typing the name into search box
4. Select Customer Profile to Add
5. Click on Add Selected
6. Click chevron to return back to the Early Alert Request Page

Add names of notification recipients in this section.  Do not add the expediter to avoid multiple emails being sent to them.  Notification Recipients can be added later as well by the expediter.

1. Click on Chevron to add recipients

1. Save Changes
2. Submit to Expediter

NOTE: If the same person is the initiator and an expediter of the early alert.  Then the acceptable will be automatic.  If a different person is doing an engineering review and then assigning the EA to a TKAM, then the expediter (TKAM) will have to accept this Early Alert.