Incidents

1. Select the Main Menu icon.
2. Select My Networks or Partner Networks depending on the desired network.
3. Select a Network in the header.
4. Select a Partner or Location (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
5. Select the Go button.
6. Click Add in the Do menu.
7. Fill in the following fields in the General section:
   1. Summary field – Required. A brief description of the incident (255 characters maximum).
   2. Description field – A detailed description of the incident (5000 characters maximum).
   3. Priority drop-down – Required. The urgency with which the issue must be resolved:
      • Low – The incident is low priority.
      • Medium – The incident is medium priority.
      • High – The incident is high priority.
      • Critical – The incident is critical.
   4.  Incident Category drop-down – The primary cause of the incident:
      Incident options

      • Aggregation Error – An aggregation or disaggregation error occurred.
      • Damage from Packing, Transport, or Filling – The product was damaged during the packing, transportation, or filling process. This includes breakage, scratches, or particles resulting from damage.
      • Cannot Reconcile Serial Number with ERP or WMS – The product's serial number could not be reconciled against the appropriate ERP or WMS system.
      • cGMP SOP Not Followed – Good manufacturing practices documented in the current standard operating procedure (SOP) were not followed.
      • Closure Issue with Lid or Cap – A problem occurred with the product's lid or cap.
      • Commissioned Product Not Shipped – The commissioned product was not included in the shipment.
      • Contamination from Foreign Particle or Particulate – The product was contaminated with an undesired particulate.
      • Damaged Product – Product was damaged at an undetermined time.
      • Handling or Storage Deviation – An unplanned deviation from current best practices related to product handling or storage occurred.
      • Improper Artwork Inspection – An error occurred during artwork inspection.
      • Incorrect Label Information – The product's label includes incorrect information, such as dosage or usage information.
      • Label Quality Inconsistency – The product's label (e.g. graphics, colors, or fonts) does not meet quality requirements.
      • Label Compliance Error – The product's label is not in compliance with necessary regulations.
      • Lot and Expiration Print Issue – An issue occurred related to lot and expiration information.
      • Material Shortage – A material shortage occurred.
      • Market Language Translation Error – An error occurred when translating product information for the target market.
      • Manufacturing Facility Exception – The issue is related to an exception raised by the manufacturing facility.
      • Missing or Incorrect Documentation – Required product documentation is missing or incorrect.
      • Missing Product or Partial Lot – Not all expected product is included in the lot.
      • Not On-Time or In-Full – The shipment was late or missing product.
      • Out of Specification – The product is not compliant with required specifications.
      • Partial Serial Number Legible – The serial number is not legible.
      • pH Shift Due to Glass Dissolution – The product's pH has changed.
      • Poor Label Adhesion – An issue occurred with the product's label.
      • Poor Chemical Durability – An issue occurred with the product's durability, such as weathering, pitted surfaces, or delamination.
      • Product Shipped but Not Commissioned – The product is not in the required state of Commissioned.
      • Printed Serial Number Does Not Match Data – The product serial number does not have the expected value.
      • Product Shipped but Not QA Released – The product is not in the required state of QA Released.
      • Potential Leaching or Interaction with Product – The product has possibly interacted with an undesired contaminant.
      • Printing Materials Issue – A printing error occurred.
      • Quality Issue During Incoming Inspection – An issue was discovered during product inspection.
      • Raw Material Quality – The product does not meet quality requirements.
      • Reduced Performance in Glass Prefilled Syringe – The product's quality has been affected by interaction with glass.
      • Reduced Potency from Adsorption of Product onto Glass Surface – The product's potency has been affected by interaction with glass.
      • Serial Number Commission Output Change – A commissioning error occurred.
      • Shipment Damage – The shipment was damaged at an undetermined time.
      • Short Shipment or Production Run – The shipment or production run does not include all expected contents.
      • Short Shipment Received – The received shipment does not include all expected contents.
      • Silicone Lubricants Impacted Product Quality – The product's quality has been affected by interaction with silicone lubricants.
      • Temperature Excursion During Shipment or Storage – The product did not stay within the required temperature range.
      • Variability in Particle Size, Hardness, Disintegration, and Compressibility – The product does not meet consistency requirements.
   5. Incident Due Date field – Required for Owners to submit the incident to the Partner or for Partners to add an incident. The date that the incident must be closed by.

   6. Current Assignees at [Owner Name] field – Required. The users from the Owner assigned to take action on the incident (defaults to Unassigned if not entered).

   7. Responsible Party at [Owner Name] field – Required. The user from the Owner that is responsible for the incident's resolution (defaults to Unassigned if not entered).

8. Fill in the following fields in the Issue Details section:

   1. ID Type drop-down – The type of shipping document that is associated with a delivery involved with the incident:
      • Bill of Lading – The transaction is identified by a Bill of Lading number.
      • Destruction Order – The transaction is identified by a destruction order number.
      • Invoice Number – The transaction is identified by an invoice number.
      • Nota Fiscal – The transaction is identified by a Brazil nota fiscal document number.
      • Packing Slip Number – The transaction is identified by a packing slip number.
      • PO Number – The transaction is identified by a purchase order (PO) number.
      • PRO Number – The transaction is identified by a PRO freight number.
      • Return – The transaction is identified by a return authorization number.
      • Sales Order Number – The transaction is identified by a sales order number.
      • Shipment Number – The transaction is identified by a shipment notification number.
      • Transfer Number – The transaction is identified by a transfer order number.
      • Other – The transaction is identified by another type of identification number.
   2. Value field – Conditionally required if an ID Type is entered. The value of the selected ID Type (72 characters maximum).
   Select the Add icon to add another ID Type and Value.

   3. Product Name field – The name and Item or Packaging Code of the product affected by the incident, which must exist in the Owner's instance of Master Data Exchange.

   4. Lot Number field – The lot number of the product affected by the incident.

   5. Product Details field – Read-only. High level product information (e.g. strength, dosage form, item code). This is field is present but does not display any values in this release.

      Select the Add icon to add another impacted Product Name.

9. Fill in the following fields in the Responsible Entity section:

   1. Responsible Entity field – Read-only for Partners. The name and identifier of the Partner company or location that the incident is being submitted to. If a user at the Owner is adding the incident, the Partner must exist in Master Data Exchange and be linked to the current network. If a Partner user is adding the incident, this field displays the Partner company name.

   2. Responsible Party field – The user from the responsible entity that is responsible for the incident's resolution (defaults to Unassigned if not entered).

   3. Current Assignees field – Required. The users from the responsible entity that are assigned to take an action on the incident (defaults to Unassigned if not entered).

   4. Entity Address field – Read-only. The address of the entity involved in the incident, which must exist in Master Data Exchange. This field is present but does not display any values in this release.

10. Fill in the following fields in the Linked Processes section:

    1. Relationship field – The type of relationship the linked process has to the current incident:

       • Blocks – The linked process prevents the current incident’s resolution.
       • Blocked By – The current incident prevents the linked process's resolution.
       • Contains – The linked process is the parent of the current incident.
       • Contained By – The current incident is the parent of the linked process.
       • Dependent On – The linked process affects the current incident's resolution.
       • Dependency For – The current incident affects the linked process's resolution.
       • Relates To – The linked process is related to the current incident.
    2. ID or Summary field – The identifier or summary of another process related to the incident.
    Select the Add icon to add another linked process's Relationship and ID or Summary.

11. Fill in the following fields in the Responses section:

    1. Internal Only switch – Required. Indicates whether team members from the Partner company associated with the incident can view the comments and attachments:
       • Yes – Only team members from the Owner can view the comments and attachments.
       • No – (default) Team members from the Partner associated with the incident can view the comments and attachments.
    2. Comments field – Additional comments about the incident or explanations for the attachments (5000 characters maximum).
    3. Attachments field – Drag and drop a file to attach or select the browse link to search for the file. The file name must not exceed 250 characters. For a list of supported file types, see What file types can I include in an attachment
    Select the Add icon to add another row with the Internal Only, Comments, and Attachments fields displayed.

12. Select Save (displays only if the user adding the incident is from the Owner and has permission to submit incidents to Partners).

    The incident is saved.

1. Select the Main Menu icon.
2. Select My Networks or Partner Networks depending on the desired network.
3. Select a Network in the header.
4. Select a Partner or Location (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
5. Select the Go button.
6. Click Search in the Do menu.
7. Filter to find the incident.
8. Select the Action icon in the row for the incident.
9. Select Copy.
10. Fill in the following fields in the Copy Incident [Incident ID] panel:
    1. New Incident Summary field – Required. A brief description of the incident (255 characters maximum).

    2. Sections to Copy section – Required. When selected, the new incident uses the values entered for that section:

       • Linked Processes checkbox – When selected, the Linked Processes are copied to the new incident.

11. Select Add in the Copy Incident [Incident ID] panel.

    TraceLink saves the new incident with all of the copied values, with the following exceptions:

    • A new Incident ID is generated for the incident.
    • The Date Reported becomes the date the incident is copied.
    • The Added By User becomes the user who created the copy of the incident.
    • The Responsible Party at [Owner Name] is set to Unassigned.
    • The Current Assignees at [Owner Name] is set to Unassigned.

When a user assigned as the Responsible Party or a Current Assignee is ready to submit the incident for investigation, that user submits the incident to the Responsible Entity so that the Partner is alerted to the incident and can begin reviewing and investigating it.

1. Select the Main Menu icon.
2. Select My Networks or Partner Networks depending on the desired network.
3. Select a Network in the header.
4. Select a Partner or Location (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
5. Select the Go button.
6. Click Search in the Do menu.
7. Filter to find the incident.
8. Select the Action icon in the row for the incident.
9. Select View Incident.

10. Select the Edit icon in the General section to fill in the following fields:

    1. Resolution Due Date field – Required. The date that the incident must be closed by.
    2. Select Save.

11. Select the Edit icon in the Partner section to fill in the following fields:

    1. Responsible Entity field – Required. The name and identifier of the Partner company that the incident is being submitted to. If a user at the Owner is adding the incident, the Partner must exist in Master Data Exchange and be linked to the current network. If a Partner user is adding the incident, this field displays the Partner company name.
    2. Select Save.

12. Select Submit to Partner.

    The incident is saved and submitted to the Responsible Entity specified for review, and the incident Status is updated to Under Investigation.

When the incident's investigation is complete and an acceptable final response has been provided, any user with the Close permission can close the incident so that other users know the investigation is complete and the incident is resolved.

1. Select the Main Menu icon.
2. Select My Networks or Partner Networks depending on the desired network.
3. Select a Network in the header.
4. Select a Partner or Location (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
5. Select the Go button.
6. Click Search in the Do menu.
7. Filter to find the incident.
8. Select the Action icon in the row for the incident.
9. Select View Incident.
10. Select Closed from the Status drop-down in the top right of the screen.
11. Fill in the following fields in the Close Incident [Incident ID] panel:

    1. Resolution Type drop-down – Required. The reason why the incident is being closed:

       • Resolved – The problem that caused the incident is resolved. This resolution type cannot be selected if the incident Status was changed from To Do to Closed.
       • Duplicate – An incident for the problem already exists.
       • Not an Issue – The incident was created in error and the investigation determined there was not actually a problem.
       • Other Resolution Type – If selected, fill in the text field that displays with the final outcome of the incident.
    2. Reoccurring Incident checkbox – Select this checkbox to indicate that the incident has previously occurred one or more times.

    3. Final Root Cause field – Required. The main issue that directly caused the incident to occur:

       • Documentation – The incident occurred due to a documentation issue.
       • Equipment – The incident occurred due to an equipment issue.
       • Material – The incident occurred due to a material issue.
       • Procedure – The incident occurred due to a procedural issue.
       • Process – The incident occurred due to a process issue.
       • Root Cause Not Attributed to Partner – The root cause of the incident cannot be attributed to the Partner.
       • Other Final Root Cause – If selected, fill in the text field that displays with the main issue that directly caused the incident to occur.
    4. Closing Statement field – Additional comments about the incident's closure (500 characters maximum).
    5. Attachments field – Drag and drop a file to attach or select the browse link to search for the file. The file name must not exceed 250 characters. For a list of supported file types, see What file types can I include in an attachment
12. Select Close in the Close Incident [Incident ID] panel.
13. Select Close in the confirmation dialog.

    The incident is closed by changing the Status to Closed.

If an incident is closed accidentally or the incident needs additional work after closing, a user can reopen the incident.

1. Select the Main Menu icon.
2. Select My Networks or Partner Networks depending on the desired network.
3. Select a Network in the header.
4. Select a Partner or Location (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
5. Select the Go button.
6. Click Search in the Do menu.
7. Filter to find the incident.
8. Select the Action icon in the row for the incident.
9. Select View Incident.
10. Select Under Investigation from the Status drop-down in the top right of the screen.
11. Fill in the following fields in the Reopen Incident [Incident ID] panel:
    • Comments field – Captures any comments about reopening the incident (5000 characters maximum).
    • Attachments field – Drag and drop a file to attach or select the browse link to search for the file. The file name must not exceed 250 characters. For a list of supported file types, see What file types can I include in an attachment
12. Select Reopen in the Reopen Incident [Incident ID] panel.

    The incident is reopened by changing the Status to Under Investigation.

1. Select the Main Menu icon.
2. Select My Networks or Partner Networks depending on the desired network.
3. Select a Network in the header.
4. Select a Partner or Location (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
5. Select the Go button.

   View the cards in the dashboard, which display pre-defined queries to demonstrate the state of all incidents at a high level. The labels on each card in the dashboard display a value as a link to the right. When selected, this link displays the table view of the incidents, filtered to the selected value. For example, if the value for Critical Incidents is selected, the table view displays with a filter applied to show only incidents with a Priority of Critical.

Summary card

A summary of all incidents for the Network and Team selected in the header. A horizontal bar chart displays on this card with the following values, based on whether the user is assigned a role with expanded or standard access:

By Priority card

A summary of all incidents for the Network and Team selected in the header based on their Priority. A list displays on this card with the following values:

• Critical – The number of incidents with a Priority of Critical.
• High – The number of incidents with a Priority of High.
• Medium – The number of incidents with a Priority of Medium.
• Low – The number of incidents with a Priority of Low.

By Due Date card

A summary of all incidents for the Network and Team selected in the header based on their Resolution Due Date. A horizontal bar chart displays on this card with the following values:

• Past Due – The number of incidents that have not yet been closed with a due date prior to the current date.
• This Week – The number of incidents that have not yet been closed and are due within the next 7 days.
• Next Week – The number of incidents that have not yet been closed and are due in the next 7 to 14 days.
• In 2 or More Weeks – The number of incidents that have not yet been closed and are due in more than 14 days.

By Status card

A summary of all incidents for the Network and Team selected in the header based on their Status. A horizontal bar chart displays on this card with the following values:

• To Do – The number of incidents with a Status of To Do.
• In Review – The number of incidents with a Status of Under Investigation.

By Responsible Entity card

Displays only for Full Access users from the Owner if the Process is Incidents. A view of all incidents for the Network and Team selected in the header based on the Partners or locations associated with the highest number of incidents with a Status of To Do or Under Investigation. A list displays on this card with the 5 entities that have the most open incidents.

Recent Updates card

A view of all incidents for the Network, Team, and Process selected in the header based on the last time they were updated. A list displays on this card with the following values:

• Yesterday – The number of incidents that have been updated in the last 24 hours.
• This Week – The number of incidents that have been updated in the last 7 days.
• Last Week – The number of incidents that have been updated in the last 7 to 14 days.
• More than 2 Weeks – The number of incidents been updated in more than 14 days ago.

1. Select the Main Menu icon.
2. Select My Networks or Partner Networks depending on the desired network.
3. Select a Network in the header.
4. Select a Partner or Location (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
5. Select the Go button.
6. Click Search in the Do menu.
7. Fill in one or more of the following fields to filter the results:

   • Incident ID field – The incident's unique identifier.

   • Responsible Entity field – The name and identifier of the Partner company or location associated with the incident.

   • Status drop-down – The status of the incident:
     • To Do – Indicates that the incident is ready for review.
     • Under Investigation – Indicates that the incident has been created, reviewed, and submitted for investigation.
     • Closed – Indicates that the incident is closed.

8. Select Apply.

   The filtered results display in the table.

1. Select the Main Menu icon.
2. Select My Networks or Partner Networks depending on the desired network.
3. Select a Network in the header.
4. Select a Partner or Location (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
5. Select the Go button.
6. Click Search in the Do menu.
7. Filter to find the incident.
8. Select the Action icon in the row for the incident.
9. Select Follow or Unfollow.

   If you are currently not  following the incident, you begin following the incident. If you are currently following the incident, you stop following the incident.

1. Select the Main Menu icon.
2. Select My Networks or Partner Networks depending on the desired network.
3. Select a Network in the header.
4. Select a Partner or Location (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
5. Select the Go button.
6. Click Search in the Do menu.
7. Filter to find the incident.
8. Select the Action icon in the row for the incident.
9. Select View Activity.

   View the previous actions taken on the incident, as well as who took the action and when.