This Help Center is a preview of a future release. The final Help Center will be available on the Validation date.

Direct supplier incidents

Direct supplier incidents allow users at companies that own or link to APT (e.g. supplier relationship managers, quality compliance managers, manufacturing plant managers) to collaborate with their internal locations and external Partners to investigate and resolve problems, as well as update processes to ensure an incident does not happen again. For example, a Supplier might need to report a shortage in raw materials to a Manufacturer, or a CMO might need to report a late or missing shipment from the Supplier to the Manufacturer.

Add an 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 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. Business 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. Deviation Type drop-down – The way in which the incident varies from standard operating procedure:
      • Planned – The deviation that caused the incident was intentional.
      • Unplanned – The deviation that caused the incident was not intentional.
      • Other Deviation Type – If selected, fill in the text field that displays with the deviation type that caused the incident.
    5. Resolution 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. 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).
    7. Responsible Department at [Owner Name] field – The business area of the Owner company responsible for the incident's resolution (defaults to the job function of the user adding the incident, if available):
      • Business Development – The user responsible for resolving the incident is part of a Business Development team.
      • Clinical Research – The user responsible for resolving the incident is part of a Clinical Research team.
      • Contract Management – The user responsible for resolving the incident is part of a Contract Management team.
      • Corporate Management – The user responsible for resolving the incident is part of a Corporate Management team.
      • Customer Service – The user responsible for resolving the incident is part of a Customer Service team.
      • Engineering – The user responsible for resolving the incident is part of an Engineering team.
      • Information Technology – The user responsible for resolving the incident is part of an Information Technology (IT) team.
      • Operations – The user responsible for resolving the incident is part of an Operations team.
      • Packaging – The user responsible for resolving the incident is part of a Packaging team.
      • Production or Manufacturing – The user responsible for resolving the incident is part of a Production team or Manufacturing team.
      • Project Management –The user responsible for resolving the incident is part of a Project Management team.
      • Purchasing – The user responsible for resolving the incident is part of a Purchasing team.
      • Quality Assurance, Control, or Validation – The user responsible for resolving the incident is part of a Quality Assurance (QA) team, Control team, or Validation team.
      • Research, Development, or Formulation – The user responsible for resolving the incident is part of a Research team, Development team, or Formulation team.
      • Sales or Marketing – The user responsible for resolving the incident is part of a Sales team or Marketing team.
      • Supply Chain – The user responsible for resolving the incident is part of a Supply Chain team.

    8. 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).

    9. Material Type field – The type of the material associated with the incident:

      • API – The incident is associated with an active pharmaceutical ingredient (API).
      • Finished Good – The incident is associated with a finished good.
      • Serialized Product – The incident is associated with a serialized product.
      • Secondary Packaging – The incident is associated with packaging that is not in direct contact with the product.
      • Excipient – The incident is associated with an excipient or inactive substance.
      • Finished Good - Sample – The incident is associated with a sample of a finished good.
      • Primary Packaging – The incident is associated with packaging that is in direct contact with the product.
      • Delivery Mechanism – The incident is associated with the method used to administer a product.
      • Label and Artwork – The incident is associated with the product label or artwork.
      • Contact Material or Equipment – The incident is associated with materials or equipment intended to come in direct contact with a product.
      • Shipping Material – The incident is associated with materials used in product shipping.
      • Blood Product – The incident is associated with a substance prepared from human blood.
      • Other Material Type – If selected, fill in the text field that displays with the type of the material associated with the incident.

    10. Material Subtype field – Enabled if a Material Type is selected. The subtype of the material associated with the incident. The Material Subtypes available depend on which Material Type is selected:

      • Biological API – The incident is associated with a biological API.
      • Chemical API – The incident is associated with a chemical API.
      • Released – The incident is associated with a finished product that has been released.
      • Shipped – The incident is associated with a finished product that has been shipped.
      • Each – The incident is associated with a serialized each.
      • Inner Pack/Bundle – The incident is associated with a serialized inner pack.
      • Case/Shipper – The incident is associated with a serialized case.
      • Pallet – The incident is associated with a serialized pallet.
      • Carton – The incident is associated with a carton.
      • Tray – The incident is associated with a tray.
      • Inner Pack/Bundle – The incident is associated with an inner pack or bundle.
      • Shelf Pack – The incident is associated with a shelf pack.
      • Anti-Adherent – The incident is associated with an anti-adherent.
      • Binder – The incident is associated with a binder.
      • Coating – The incident is associated with a coating product.
      • Disintegrant – The incident is associated with a disintegrant.
      • Filler – The incident is associated with filler.
      • Flavor – The incident is associated with a flavoring product.
      • Color – The incident is associated with a coloring product.
      • Lubricant – The incident is associated with a lubricant.
      • Glidant – The incident is associated with a lubricant glidant.
      • Sorbent – The incident is associated with a sorbent.
      • Sweetener – The incident is associated with a sweetener.
      • Preservative – The incident is associated with a preservative.
      • Sample – The incident is associated with a sample of a finished good.
      • Ampoule and Closure – The incident is associated with a sealed ampoule.
      • Vial and Closure – The incident is associated with a sealed vial.
      • Blister Pack and Foil – The incident is associated with a blister pack.
      • Bottle and Lid or Cap – The incident is associated with a bottle.
      • Sachet or Pouch – The incident is associated with a sachet or pouch.
      • Strip Package – The incident is associated with a strip.
      • Bulk Packaging – The incident is associated with bulk packaging for multiple items.
      • Oral – The incident is associated with a product administered orally.
      • Transdermal – The incident is associated with a product administered transdermally.
      • Injectable – The incident is associated with an injectable product.
      • Pulmonary Inhaler – The incident is associated with a product administered through a pulmonary inhaler.
      • Implant – The incident is associated with an implanted medical device.
      • Ophthalmic – The incident is associated with a product administered to the eye.
      • Primary Label – The incident is associated with a product's primary label.
      • Secondary Label – The incident is associated with a product's secondary label.
      • Leaflet or Insert – The incident is associated with the contents of a leaflet or insert accompanying a product.
      • Carton Artwork – The incident is associated with artwork on a product carton.
      • Formulation Equipment – The incident is associated with equipment used in product formulation.
      • Filling Equipment – The incident is associated with equipment used in filling packages.
      • Bulk Storage Equipment – The incident is associated with equipment used in product storage.
      • Transfer Equipment – The incident is associated with equipment used in product transfer.
      • Pallet – The incident is associated with a pallet used for shipping.
      • Pallet Label – The incident is associated with a label for a pallet used for shipping.
      • Case Label – The incident is associated with a label for a case used for shipping.
      • Stretch Wrap – The incident is associated with stretch wrap packaging.
      • Fresh Frozen Plasma – The incident is associated with fresh frozen plasma.
      • Platelets – The incident is associated with blood platelets.
      • Albumin – The incident is associated with medicinal albumin.
      • Cryoprecipitate – The incident is associated with cryoprecipitate, which is a concentrated frozen blood product.
      • Packed Red Blood Cells – The incident is associated with packed cells used for blood transfusions.
      • Other Material Subtype – The incident is associated with a user-defined material subtype.

    11. Material Problem drop-down – Enabled if a Material Subtype is selected. The problem with the material that contributed to the incident. The Material Problems available depend on the Material Subtype selected:

      • Material Shortage – A material shortage occurred.
      • Not On-Time or In-Full – The shipment was late or missing product.
      • Damaged Product – Product was damaged at an undetermined time.
      • Missing or Incorrect Documentation – Required product documentation is missing or incorrect.
      • Temperature Excursion During Shipment or Storage – The product did not stay within the required temperature range.
      • Contamination from Foreign Particle or Particulate – The product was contaminated with an undesired particulate.
      • Manufacturing Facility Exception – The issue is related to an exception raised by the manufacturing facility.
      • Raw Material Quality – The product does not meet quality requirements.
      • Impurities Present – One or more impurities were found in the product.
      • Handling or Storage Deviation – An unplanned deviation from current best practices related to product handling or storage occurred.
      • cGMP SOP Not Followed – Good manufacturing practices documented in the current standard operating procedure (SOP) were not followed.
      • Short Shipment Received – The received shipment does not include all expected contents.
      • Missing or Incorrect Documentation – Required product documentation is missing or incorrect.
      • Product Shipped but Not Commissioned – The product is not in the required state of Commissioned.
      • Missing Product or Partial Lot – Not all expected product is included in the lot.
      • Printed Serial Number Does Not Match Data – The product serial number does not have the expected value.
      • Commissioned Product Not Shipped – The commissioned product was not included in the shipment.
      • Product Shipped but Not QA Released – The product is not in the required state of QA Released.
      • Cannot Reconcile Serial Number with ERP or WMS – The product's serial number could not be reconciled against the appropriate ERP or WMS system.
      • Aggregation Error – An aggregation or disaggregation error occurred.
      • Partial Serial Number Legible – The serial number is not legible.
      • Serial Number Commission Output Change – A commissioning error occurred.
      • Variability in Particle Size, Hardness, Disintegration, and Compressibility – The product does not meet consistency requirements.
      • Poor Chemical Durability – An issue occurred with the product's durability, such as weathering, pitted surfaces, or delamination.
      • Silicone Lubricants Impacted Product Quality – The product's quality has been affected by interaction with silicone lubricants.
      • Potential Leaching or Interaction with Product – The product has possibly interacted with an undesired contaminant.
      • Closure Issue with Lid or Cap – A problem occurred with the product's lid or cap.
      • pH Shift Due to Glass Dissolution – The product's pH has changed.
      • 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.
      • 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.
      • Label Compliance Error – The product's label is not in compliance with necessary regulations.
      • 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.
      • Market Language Translation Error – An error occurred when translating product information for the target market.
      • Improper Artwork Inspection – An error occurred during artwork inspection.
      • Damaged Product – Product was damaged at an undetermined time.
      • Lot and Expiration Print Issue – An issue occurred related to lot and expiration information.
      • Poor Label Adhesion – An issue occurred with the product's label.
      • Short Shipment or Production Run – The shipment or production run does not include all expected contents.
      • Other Material Problem – The problem with the material is user-defined.

    12. Escalated checkbox – Select this checkbox to indicate that the location affected needs the incident to be escalated.

    13. Originating Location field – The name and identifier of the internal or external location where the cause of the incident originated, which must exist in Master Data Exchange.

  8. Fill in the following fields in the Transaction IDs 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.
  9. Fill in the following fields in the Partner section:

    1. Partner Company field – Read-only for Partners. 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. Current Assignees at Partner field – Required. The users from the Partner that are assigned to take an action on the incident (defaults to Unassigned if not entered).

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

    4. Responsible Department at Partner field – The business area of the Partner company responsible for the incident's resolution (defaults to the job function of the Responsible Party at Partner, if available):

      • Business Development – The user responsible for resolving the incident is part of a Business Development team.
      • Clinical Research – The user responsible for resolving the incident is part of a Clinical Research team.
      • Contract Management – The user responsible for resolving the incident is part of a Contract Management team.
      • Corporate Management – The user responsible for resolving the incident is part of a Corporate Management team.
      • Customer Service – The user responsible for resolving the incident is part of a Customer Service team.
      • Engineering – The user responsible for resolving the incident is part of an Engineering team.
      • Information Technology – The user responsible for resolving the incident is part of an Information Technology (IT) team.
      • Operations – The user responsible for resolving the incident is part of an Operations team.
      • Packaging – The user responsible for resolving the incident is part of a Packaging team.
      • Production or Manufacturing – The user responsible for resolving the incident is part of a Production team or Manufacturing team.
      • Project Management –The user responsible for resolving the incident is part of a Project Management team.
      • Purchasing – The user responsible for resolving the incident is part of a Purchasing team.
      • Quality Assurance, Control, or Validation – The user responsible for resolving the incident is part of a Quality Assurance (QA) team, Control team, or Validation team.
      • Research, Development, or Formulation – The user responsible for resolving the incident is part of a Research team, Development team, or Formulation team.
      • Sales or Marketing – The user responsible for resolving the incident is part of a Sales team or Marketing team.
      • Supply Chain – The user responsible for resolving the incident is part of a Supply Chain team.

    5. Partner Location field – The name and identifier of the Partner location involved in the incident, which must exist in Master Data Exchange.

  10. Fill in the following fields in the Impact section:
    1. Business Impact field – How the Owner's business is impacted by the incident (500 characters maximum).
    2. Financial Impact field – The monetary impact that the incident has on the Owner (12 numbers maximum).
    3. Date Supply Impacted field – The date that the Owner's production supply is affected by the incident.
    4. Date Resources Deployed field – The date that resources (e.g. employees, money) are deployed to deal with the incident.
    5. Originating Location Investigation Due Date field – The date that the investigation of the incident by the Originating Location is due to the Owner (defaults to a future date based on the network configuration set by an Administrator).
    6. Date Escalation Report Requested field – Displays only if the Escalated checkbox is selected. The date the request for an escalation report is requested.
    7. Escalation Report field – Displays only if the Escalated checkbox is selected. The file containing the escalation report. Drag and drop the escalation report file for the incident or select the browse link to search for the file. The file name must not exceed 250 characters, and only .doc, .txt, .csv, .jpeg, .png, and .pdf are supported.
    8. Impacted Departments section – The different departments at the Owner affected by the incident:

      1. Department drop-down – Required. The department at the Owner affected by the incident:

        • Business Development – The Business Development team is affected by the incident.
        • Clinical Research – The Clinical Research team is affected by the incident.
        • Contract Management – The Contract Management team is affected by the incident.
        • Corporate Management – The Corporate Management team is affected by the incident.
        • Customer Service – The Customer Service team is affected by the incident.
        • Engineering – The Engineering team is affected by the incident.
        • Information Technology – The Information Technology (IT) team is affected by the incident.
        • Operations – The Operations team is affected by the incident.
        • Packaging – The Packaging team is affected by the incident.
        • Production or Manufacturing – The Production team or Manufacturing team is affected by the incident.
        • Project Management – The Project Management team is affected by the incident.
        • Purchasing – The Purchasing team is affected by the incident.
        • Quality Assurance, Control, or Validation – The Quality Assurance (QA) team, Control team, or Validation team is affected by the incident.
        • Research, Development, or Formulation – The Research team, Development team, or Formulation team is affected by the incident.
        • Sales or Marketing – The Sales team or Marketing team is affected by the incident.
        • Supply Chain – The Supply Chain team is affected by the incident.
      Select the Add icon to add another impacted Department.
    9. Impacted Products section – The products affected by the incident:
      1. Item or Packaging Code field – The item code or packaging code of the product affected by the incident, which must exist in the Owner's instance of Master Data Exchange.
      Select the Add icon to add another impacted Item or Packaging Code.
    10. Potentially Impacted Products section – The products that might be affected by the incident:
      1. Item or Packaging Code field – The item code or packaging code of the product affected by the incident, which must exist in the Owner's instance of Master Data Exchange.
      Select the Add icon to add another potentially impacted Product.
    11. Impacted Locations section – The locations affected by the incident:
      1. Location Type drop-down – Indicates whether the impacted location is internal or external:
        • Internal – The location belongs to the Owner company.
        • External – The location belongs to the Partner company.
      2. Name or ID field – The name or identifier of the location affected by the incident, which must exist in Master Data Exchange and be linked to the current network.
      3. Contact field – The user that is the regulatory contact for the location (defaults to the Regulatory Contact entered in Master Data Exchange for the location, if available).
      Select the Add icon to add another row with the Location Type, Name or ID, and Contact fields displayed.
    12. Potentially Impacted Locations section – The locations that might be affected by the incident:
      1. Location Type drop-down – Indicates whether the impacted location is internal or external:
        • Internal – The location belongs to the Owner company.
        • External – The location belongs to the Partner company.
      2. Name or ID field – The name or identifier of the location potentially affected by the incident, which must exist in Master Data Exchange and be linked to the current network.
      3. Contact field – The user that is the regulatory contact for the location (defaults to the Regulatory Contact entered in Master Data Exchange for the location, if available).
      Select the Add icon to add another row with the Location Type, Name or ID, and Contact fields displayed.
    13. High Priority Reasons section – The reasons that resolving the incident must be a high priority:

      1. Reason drop-down – Required. The reason that resolving the incident is a high priority:

        • Disruption or Customer Back Order – The incident disrupts the customer's ability to fill orders.
        • Extended Time to Resolve – The incident cannot be resolved in a timely manner.
        • Field Action Required – The incident requires additional action to be taken in the field.
        • Top Product Impacted – The incident negatively affects an important product.
        • New Product Launch Impacted – The incident interferes with the launch of a new product.
        • Manufacturing Disruption – The incident disrupts manufacturing operations.
        • Manufacturing Downtime – The incident results in manufacturing downtime.
        • Market Supply Impacted – The incident negatively impacts market supply.
        • Medically Significant – The incident is medically significant.
        • Patient Safety Impacted – The incident negatively affects patient safety.
        • Revenue Impacted – The incident negatively affects revenue.
        • Unavailable to Customers – The incident results in product being unavailable to customers.
        • Other High Priority Reasons – If selected, fill in the field that displays with reason that resolving the incident is a high priority.
      Select the Add icon to add another high priority Reason.
  11. Fill in the following fields in the Material section:

    1. [Owner Name] Internal Material Number field – The Internal Material Number the Owner uses to identify the product affected by the incident (255 characters maximum).

    2. Partner Internal Material Number field – The Internal Material Number the Partner uses to identify the product affected by the incident (255 characters maximum).

    3. Material Name field – The name of the product affected by the incident (255 characters maximum).

    4. Material Description field – A description of the product affected by the incident (500 characters maximum).

    5. [Owner Name] Lot Number field – The identifier used by the Owner for the lot affected by the incident (255 characters maximum).

    6. Partner Lot Number field – The identifier used by the Partner for the lot affected by the incident (255 characters maximum).

    7. Defective Quantity field – The amount of product affected by the incident that is no longer saleable (72 characters maximum).

    8. Defective Unit of Measure drop-down – The unit of measure associated with the defective product.
      • Ampoule – The product is measured in ampoules.
      • Bundle – The product is measured in bundles.
      • Bag – The product is measured in bags.
      • Bottle – The product is measured in bottles.
      • Box – The product is measured in boxes.
      • Bulk Box – The product is measured in bulk boxes.
      • Card or Blister – The product is measured in cards or blisters.
      • Centiliter – The product is measured in centiliters.
      • Capsule – The product is measured in capsules.
      • Case – The product is measured in cases.
      • Cubic Centimeter – The product is measured in cubic centimeters.
      • Cubic Feet – The product is measured in cubic feet.
      • Cubic Inch – The product is measured in cubic inches.
      • Cylinder – The product is measured in cylinders.
      • Centimeter – The product is measured in centimeters.
      • Can – The product is measured in cans.
      • Crate – The product is measured in crates.
      • Cartridge – The product is measured in cartridges.
      • Cubic Meter – The product is measured in cubic meters.
      • Carton – The product is measured in cartons.
      • Kilometer – The product is measured in kilometers.
      • Deciliter – The product is measured in deciliters.
      • Dispenser – The product is measured in dispensers.
      • Decimeter – The product is measured in decimeters.
      • Drum – The product is measured in drums.
      • Display – The product is measured in displays.
      • Dozen – The product is measured in dozens.
      • Each – The product is measured in eaches.
      • Fluid Ounce (US) – The product is measured in US fluid ounces.
      • Gallon (US) – The product is measured in US gallons.
      • Gaylord Box – The product is measured in gaylord boxes.
      • Gram – The product is measured in grams.
      • Gram or Liter – The product is measured in grams or liters.
      • Gross – The product is measured in grosses of product.
      • Hectoliter – The product is measured in hectoliters.
      • Kiloliter – The product is measured in kiloliters.
      • Kilogram – The product is measured in kilograms.
      • Kit – The product is measured in kits.
      • Pound (US) – The product is measured in US pounds.
      • Lot – The product is measured in lots.
      • Liter – The product is measured in liters.
      • Meter – The product is measured in meters.
      • Microgram – The product is measured in micrograms.
      • Microliter – The product is measured in microliters.
      • Milligram – The product is measured in milligrams.
      • Milliliter – The product is measured in milliliters.
      • Millimeter – The product is measured in millimeters.
      • Million – The product is measured in millions.
      • Ounce – The product is measured in ounces.
      • Pack – The product is measured in packs.
      • Package – The product is measured in packages.
      • Pair – The product is measured in pairs.
      • Pallet – The product is measured in pallets.
      • Piece – The product is measured in pieces.
      • Pint – The product is measured in pints.
      • Pouch – The product is measured in pouches.
      • Quart – The product is measured in quarts.
      • Roll – The product is measured in rolls.
      • Set – The product is measured in sets.
      • Sheet – The product is measured in sheets.
      • Square Centimeter – The product is measured in square centimeters.
      • Square Foot – The product is measured in square feet.
      • Square Inch – The product is measured in square inches.
      • Square Meter – The product is measured in square meters.
      • Tablet – The product is measured in tablets.
      • Thousand Piece – The product is measured in thousand pieces.
      • Thousand – The product is measured in thousands.
      • Tote – The product is measured in totes.
      • Tray – The product is measured in trays.
      • Tube – The product is measured in tubes.
      • Unit – The product is measured in units.
      • Vial – The product is measured in vials.

    9. Defective Item IDs field – The identifiers (e.g. container IDs, bag IDs, serial numbers) associated with the individual items of defective product (1000 characters maximum).

    10. Samples Available checkbox – Select this checkbox to indicate that samples of the defective product are available.

  12. Fill in the following fields in the Response section:

    1. Initial Response Due Date field – Read-only for Partners. The date that an initial response from the Partner or internal location is required by (defaults to a future date based on the network configuration set by an Administrator).

    2. Final Response Due Date field – Read-only for Partners. The date that the final response from the Partner or internal location is required by (defaults to a future date based on the network configuration set by an Administrator).

  13. 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.
    1. 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.
  14. Fill in the following fields in the Comments and Attachments 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.

  15. 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.

    or

    Select Add (displays only if the user adding the incident is from the Owner and does not have 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:
      • General checkbox – When selected, the values for the General section are copied to the new incident.
      • Transaction IDs checkbox – When selected, the values for the Transaction IDs section are copied to the new incident.
      • Partner checkbox – When selected, the values for the Partner section are copied to the new incident.
      • Material checkbox – When selected, the values for the Material section are copied to the new incident.
      • Impact checkbox – When selected, the values for the Impact section are copied to the new incident.
      • 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.
    • The Responsible Party at Partner is set to Unassigned.
    • The Current Assignees at Partner is set to Unassigned.

Modify an incident

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 Partner Company 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. Partner Company 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 the Edit icon in the Response section to fill in the following fields:

    1. Final Response Due Date field – Required. The date that the final response from the Partner or internal location is required by (defaults to a future date based on the network configuration set by an Administrator).
    2. Select Save.

  13. Select Submit to Partner.

    The incident is saved and submitted to the Partner Company specifed for review, the incident Status is updated to Under Investigation.

When a user who is assigned as the Responsible Party or a Current Assignee is ready to provide an early assessment of the incident before a full investigation is completed, that user enters an Initial Response so that other users know the incident investigation is in progress.

  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 Response section to fill in the following fields:
    1. Submit Initial Response switch – Required. When selected, indicates that the early assessment of incident is complete.
    2. Initial Response field – Required. The initial response to the incident, which contains the results of the initial investigation by the Partner or internal location (5000 characters maximum).
  11. Select Save in the Response section.

    12. The initial response to the incident is submitted.

When the user who is assigned as the Responsible Party or a Current Assignee is ready to provide a final assessment of the incident containing the results of the investigation and the proposed solution, that user enters a Final Response so that other users know the incident investigation is complete.

  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 Response section to fill in the following fields:

    1. Submit Final Response switch – Required. When selected, indicates that the final assessment of the incident is complete.
    2. Final Response field – Required. The final response to the incident, which contains the results of the investigation and the solution proposed by the Partner or internal location (5000 characters maximum).
    3. Date Samples Sent to [Owner Name] field – The date that samples of the affected product are sent to the Owner.
    4. Date Samples Received by [Owner Name] field – The date that samples of the affected product are received by the Owner.
    5. Date Samples Sent to Partner field – The date that samples of the affected product are sent to the Partner company.
    6. Date Samples Received by Partner field – The date that samples of the affected product are received by the Partner company.
    7. Inventory Impact field – A description of the extent to which the impacted product is affected (5000 characters maximum).
    8. Inventory Analysis Method field – A description of the method used to determine the extent to which the impacted product is affected (5000 characters maximum).

    9. Initial Containment Actions field – A description of the first steps to prevent the incident from affecting more product (5000 characters maximum).

    10. Recommendation from Originating Company field – A description of what the company that the incident originated from suggests to prevent the issue from occurring again in the future (5000 characters maximum).
    11. Immediate Corrective Actions field – A description of the first corrective actions taken by the Partner to fix the issue that caused the incident to occur (5000 characters maximum).

    12. Available Replacement Materials section – The products that can replace the product affected by the incident:

      1. Item or Packaging Code field – The item code or packaging code of the product that can replace the product affected by the incident, which must exist in the Owner's instance of Master Data Exchange.
      2. Availability Date field – The date that the substitute product is available to replace the affected product.

      3. Transaction 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.
      4. Transaction ID Value field – Conditionally required if an Transaction ID Type is entered. The value of the selected Transaction ID Type (72 characters maximum).
      Select the Add icon to add another replacement material.

    13. Potential Root Causes section – The possible root causes of the incident:

      1. 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 Potential Root Cause – If selected, fill in the text field that displays with the main issue that directly caused the incident to occur.

      2. Potential Root Cause Notes field – A description explaining how the potential root cause is determined (e.g. which root causes were considered) and what the root cause of the issue is believed to be (5000 character maximum).

      3. Final Preventative Actions field – A description of the final corrective actions taken by the Partner to prevent the incident from occurring again after they have performed a root cause analysis (5000 character maximum).

      4. Methods to Prove Preventative Actions Taken field – A description of the measures implemented to prove that the corrective actions (e.g. testing, audits) have been successfully implemented (5000 character maximum).

      Select the Add icon to add another potential root cause.
  11. Select Save in the Response section.

    12. The final response to the incident is submitted.

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 the Edit icon in the General section to fill in the following fields:

    1. Originating Location field – Required. The name and identifier of the internal or external location where the cause of the incident originated, which must exist in Master Data Exchange. Read-only until the Edit icon is selected.
  11. Select the Edit icon in the Impact section to fill in the following fields: 
    1. Impacted Products section – The products affected by the incident:
      1. Item or Packaging Code field – The item code or packaging code of the product affected by the incident, which must exist in the Owner's instance of Master Data Exchange.
      Select the Add icon to add another impacted Item or Packaging Code.
    2. Impacted Locations section – The locations affected by the incident:
      1. Location Type drop-down – Indicates whether the impacted location is internal or external:
        • Internal – The location belongs to the Owner company.
        • External – The location belongs to the Partner company.
      2. Name or ID field – The name or identifier of the location affected by the incident, which must exist in Master Data Exchange and be linked to the current network.
      3. Contact field – The user that is the regulatory contact for the location (defaults to the Regulatory Contact entered in Master Data Exchange for the location, if available).
      Select the Add icon to add another row with the Location Type, Name or ID, and Contact fields displayed.
  12. Select Save.
  13. Select Closed from the Status drop-down in the top right of the screen.
  14. 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
  15. Select Close in the Close Incident [Incident ID] panel.
  16. 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.

Monitor ongoing incidents

Monitor incidents at a high level to understand the state of all incidents that you have access to. For example, manufacturing plant managers might need to follow up with the incidents assigned to them regarding supply shortages.

  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:

  • Total Open Incidents – The number of incidents with a Status of To Do or Under Investigation.
  • Critical Incidents – The number of incidents with a Priority of Critical.
  • No Activity This Week – The number of incidents that have not been updated in the last 7 days.
  • Closed This Week – The number of incidents that have been closed in the last 7 days.
  • Total Assigned To Me – The number of incidents that are currently assigned to the user.
  • Critical Incidents – The number of incidents with a Priority of Critical.
  • No Activity This Week – The number of incidents that have not been updated in the last 7 days.
  • Closed This Week – The number of incidents that have been closed in the last 7 days.

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 Partner card

Displays only for Expanded Access users from the Owner if the Process is Incidents - Direct Supplier. A view of all incidents for the Network and Team selected in the header based on the Partners 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 Partners that have the most open 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 Search in the Do menu.
  7. Fill in one or more of the following fields to filter the results:

    • Partner field – The name and identifier of the Partner company 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.

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

  8. Select Show Additional Filters and fill in one or more of the following fields to further filter the results:

    • Summary field – A brief description of the incident.

    • Priority drop-down – 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.
    • Resolution Due Date field – The date that the incident must be closed by.
    • Responsible Party field – The user from the Owner or Partner that is responsible for the incident's resolution.
    • Current Assignees field – The users from the Owner or Partner company that are assigned to take an action on the incident.
    • Transaction ID – The type of shipping document that is associated with a delivery involved with the incident.
    • Current Assignees at Owner – The users from the Owner company that are assigned to take an action on the incident.
    • Current Assignees at Partner – The users from the Partner company that are assigned to take an action on the incident.
    • Responsible Party at Owner – The user from the Owner company that is responsible for the incident's resolution.
    • Responsible Party at Partner – The user from the Partner company that is responsible for the incident's resolution.
    • Responsible Department drop-down – The business area of the Owner or Partner company that is responsible for the incident's resolution:
      • Business Development – The user responsible for resolving the incident is part of a Business Development team.
      • Clinical Research – The user responsible for resolving the incident is part of a Clinical Research team.
      • Contract Management – The user responsible for resolving the incident is part of a Contract Management team.
      • Corporate Management – The user responsible for resolving the incident is part of a Corporate Management team.
      • Customer Service – The user responsible for resolving the incident is part of a Customer Service team.
      • Engineering – The user responsible for resolving the incident is part of an Engineering team.
      • Information Technology – The user responsible for resolving the incident is part of an Information Technology (IT) team.
      • Operations – The user responsible for resolving the incident is part of an Operations team.
      • Packaging – The user responsible for resolving the incident is part of a Packaging team.
      • Production or Manufacturing – The user responsible for resolving the incident is part of a Production team or Manufacturing team.
      • Project Management –The user responsible for resolving the incident is part of a Project Management team.
      • Purchasing – The user responsible for resolving the incident is part of a Purchasing team.
      • Quality Assurance, Control, or Validation – The user responsible for resolving the incident is part of a Quality Assurance (QA) team, Control team, or Validation team.
      • Research, Development, or Formulation – The user responsible for resolving the incident is part of a Research team, Development team, or Formulation team.
      • Sales or Marketing – The user responsible for resolving the incident is part of a Sales team or Marketing team.
      • Supply Chain – The user responsible for resolving the incident is part of a Supply Chain team.
    • Location field – The name and identifier of a location that is associated with the incident (e.g. a Partner location, impacted location).
    • Product field – The item code or packaging code of a product associated with the incident (e.g. an impacted product, an available replacement material).

    • Material Type field – The type of the material associated with the incident:

      • API – The incident is associated with an active pharmaceutical ingredient (API).
      • Finished Good – The incident is associated with a finished good.
      • Serialized Product – The incident is associated with a serialized product.
      • Secondary Packaging – The incident is associated with packaging that is not in direct contact with the product.
      • Excipient – The incident is associated with an excipient or inactive substance.
      • Finished Good - Sample – The incident is associated with a sample of a finished good.
      • Primary Packaging – The incident is associated with packaging that is in direct contact with the product.
      • Delivery Mechanism – The incident is associated with the method used to administer a product.
      • Label and Artwork – The incident is associated with the product label or artwork.
      • Contact Material or Equipment – The incident is associated with materials or equipment intended to come in direct contact with a product.
      • Shipping Material – The incident is associated with materials used in product shipping.
      • Blood Product – The incident is associated with a substance prepared from human blood.
      • Other Material Type – If selected, fill in the text field that displays with the type of the material associated with the incident.
    • 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.