Lane performance can be added in any stage of the workflow even Reviewed. The number of shipments during the period should be indicated. Incidents are differentiated into two types of incidents:
Temperature-Generic - filling in only one number, the total of temperature incidents.
Non-Temperature - The user gets a list with generic categories
Note: On the forwarder side, lane performance can be edited by all users with Administrator access, as well as by the responsible and contributor roles involved in the lane workflow, regardless of user access level. On the manufacturer side, Tenant Administrator, along with the contributor, approver, and QA approver roles involved in the lane workflow, can edit lane performance. Tenant Administrators can perform these actions when a lane is in any workflow status except for no workflow. This enhancement allows pharma manufacturers to document and maintain performance data of lanes they own as well as lanes shared by forwarders.
Under the assessment, a user sees a Lane Performance tab. This will be included in the PDF export. When a lane with added Lane Performance is being shared with a customer, under the “Assessment tab” the customer can see Lane Performance. Lane Performance will now have an impact on the calculation of the Pharma Index.
Temperature Incidents
Temperature incidents are shipment incident categories that involve deviations from the desired temperature range during the transportation of healthcare shipments. These incidents are of critical importance in maintaining the quality, safety, and efficacy of temperature-sensitive healthcare products.
High Excursion: High excursion refers to a shipment incident where the temperature or environmental conditions have exceeded the acceptable range during transportation or storage. This can lead to potential damage or degradation of sensitive healthcare products.
Low Excursion: Low excursion is a shipment incident category where the temperature or environmental conditions have fallen below the acceptable range during transportation or storage. Similar to high excursions, low excursions can also impact the quality and effectiveness of healthcare products.
Low and High Excursion: This shipment incident category encompasses both high and low excursions in healthcare shipments. It indicates that the temperature or environmental conditions have deviated from the acceptable range in both directions at different points during transportation or storage.
Missing Logger: Missing logger refers to a shipment incident category where the temperature or environmental data logging device (logger) that is typically used to monitor and record conditions during shipment is not present or has been lost. This can hinder the assessment of whether the shipment has experienced any excursions.
Missing Logger Data: Missing logger data refers to a shipment incident category where the temperature or environmental data recorded by the logger during transportation is not available or has been lost. This can make it difficult to evaluate the conditions experienced by the healthcare products during the shipment.
Logger Not Activated: The logger not activated is a shipment incident category indicating that the temperature or environmental data logging device was not properly activated or turned on during the shipment. This results in a lack of recorded data, making it challenging to assess the conditions experienced by healthcare products.
Missing/Illegible Truck Print-out: Missing or illegible truck print-out refers to a shipment incident category where the documentation or records related to the truck used for transportation are either missing or cannot be read or understood. This can pose difficulties in determining the conditions and timeline of the shipment.
Box Qualification Time: Box qualification time refers to the duration for which a specific packaging box or container used for healthcare shipments has been qualified to maintain the required temperature or environmental conditions. It ensures that the box is suitable for maintaining product integrity during a defined period of time.
Non-Temperature Incidents
Non-temperature shipment performance categories assess the reliability and efficiency of transporting healthcare products on different aspects related to on-time delivery, transit time variability, delivery accuracy, shipment damage/loss, tracking/visibility, and compliance/regulatory adherence" or something along those lines.
Shipment Damages: Shipment damages refer to incidents where healthcare shipments sustain physical damage during transportation or handling. This can include issues such as broken containers, crushed boxes, or leaking packages. Shipment damages can compromise the integrity of healthcare products and potentially lead to contamination, spoilage, or loss of effectiveness.
Security Incidents: Security incidents involve unauthorized access, tampering, or theft of healthcare shipments. These incidents can pose significant risks to the safety and integrity of the products. Security incidents require immediate attention and investigation to ensure that the products have not been compromised and to prevent potential harm to patients or users.
Delays and Split Shipments: Delays and split shipments occur when the scheduled delivery of healthcare shipments is delayed or the shipment is divided into multiple parts. These incidents can result in potential storage or temperature control issues, as well as logistical challenges for inventory management and timely product availability.
Documentation: Documentation incidents involve errors, omissions, or inaccuracies in the required paperwork accompanying healthcare shipments. This can include issues with shipping labels, invoices, certificates, or customs documentation. Documentation incidents can cause delays, customs clearance problems, or regulatory non-compliance, potentially impacting the timely delivery and proper handling of healthcare products.
Wrong Quantity: Wrong quantity incidents occur when the actual quantity of healthcare products received does not match the quantity specified in the shipping documentation. This can result in inventory discrepancies, delays in treatment, or inadequate supply for patients or healthcare providers.
Wrong Item/Lot/Batch: Wrong item/lot/batch incidents refer to situations where the received healthcare products do not match the specified item, lot, or batch number mentioned in the shipping documentation. This can lead to incorrect medication or treatment, potential safety risks, or issues with traceability and product recalls.
Packaging Contamination: Packaging contamination incidents involve situations where the packaging materials of healthcare shipments are contaminated with foreign substances or pathogens. Contamination can occur during transportation or handling, potentially compromising the sterility or safety of healthcare products.
Classification of Incidents
For each category for which a value is defined, Validaide determines the frequency of incidents based on the number of incidents and the total number of shipments as follows:
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