Exception Root Causes
A misalignment exception occurs when there is a misalignment between the physical supply chain and virtual supply chain. More specifically, a misalignment exception causes the product identifier on a physical package of product to be inconsistent with the associated transaction information (TI) (the virtual information that is often provided using an EPCIS file). While significant work among trading partners has sought to define processes for resolving such misalignment exceptions, but there remains a great need for understanding the root causes of such exceptions and preventing future exceptions before they occur.
Below is a repository of root causes of misalignment exceptions that have been identified by trading partners and the preventive actions that can be taken to prevent those root causes. These are provided to enable other trading partners to learn from these experiences and identify preventive actions that they may take. We encourage trading partners to review these experiences before the regulations take effect on November 27th 2023 and consider how they might incorporate the identified preventive actions.
Please note, our emphasis here is not on tracking and reporting the exceptions themselves. Rather, our focus is on identifying the root causes of exceptions and the preventive actions that can prevent future exceptions. To make this a valuable resource, we encourage you to share your own experiences with the industry through the form linked here!
Exception Root Causes Submissions
| # | Process Impacted | Root Cause of Exception - Type | Root Cause of Exception - Description | Resulting Exception Type | Resulting Exception Detail | Expected Frequency of Root Cause | Expected Breadth of Root Cause | Potential Preventive Actions | |
| 1 | Manufacturer - Warehouse Processes | Human Error | Operator picked the correct quantity for the order but scanned and capture the serialization barcode for additional products that are not picked for the order. | Data, No Product | This results in having the right product with the right quantity shipped but with additional serialization data for products that were never shipped. This will create problems later on when those products are scanned again to pick for a different order down the road. | Infrequently (e.g., 1 to 2 times per year or less) | Moderately Broad (e.g., likely to cause an exception for a case or tote) | Add a system control at the manufacturer/3PL shipping process to automatically compare the total number of serial numbers scanned for the order to the total quantity of the order and make sure they match. And if there is a mismatch, throw an error message and stop the transaction in the system. The same kind of process need to be established at the wholesaler receiving process where there should be an automatic check to see if the number of serial numbers received in the TI matches with the total physical quantity received. |  |
| 2 | Manufacturer - Warehouse Processes | Human Error | Operator picked the product but didn’t scan and capture the serialization barcode. | Product, No Data | This results in having the right product with the right quantity shipped but with serialization data missing for some of the product packages where the supplying site missed to scan. If the packages with the missing serial numbers are at the saleable unit level that is inside a case, then wholesaler’s system may not catch this until at the time of their downstream pick/pack process. | Moderately Frequent (one or a few times per year) | Moderately Broad (e.g., likely to cause an exception for a case or tote) | Add a system control at the manufacturer/3PL shipping process to automatically compare the total number of serial numbers scanned for the order to the total quantity of the order and make sure they match. And if there is a mismatch, throw an error message and stop the transaction in the system. The same kind of process need to be established at the wholesaler receiving process where there should be an automatic check to see if the number of serial numbers received in the TI matches with the total physical quantity received. | |
| 3 | Manufacturer - Data Systems | Other Data Systems | Systems take long time to process incoming shipment data queue and hence TI/TS data trigger is delayed. | Product, No Data | Incoming shipment data are processed first in first serve basis and processing errors or delays cause delays in triggering the DSCSA TI/TS data to customers | Frequently (daily, weekly, monthly) | Very Broad (e.g., likely to cause exceptions for entire lot or shipment) | Expedite shipment data processing by speeding up data processing, automatic error management, continuous monitoring of pending data queues. | |
| 4 | Manufacturer - 3PL activities | Other Process/Engineering | Orders closed by 3PL at the end of the day instead of when the product physically leaves the facility. | Product, No Data | Product will reach the customer frequently before the data is triggered to them especially when the customers are within few ours of warehouse location and physical product arrives at customer facility on the same day | Frequently (daily, weekly, monthly) | Very Broad (e.g., likely to cause exceptions for entire lot or shipment) | 3PL should close the order and send shipment confirmation as the physical shipment leave the 3PL facility | |
| 5 | Manufacturer - Warehouse Processes | Human Error | Warehouse scanning the incorrect barcode on pallet | Product, No Data | Due to incorrect pallet label scanned, incorrect data flows through the system that eventually fails in the interface. Due to this failure the file never makes it to the customer | Frequently (daily, weekly, monthly) | Very Broad (e.g., likely to cause exceptions for entire lot or shipment) | Train warehouse operator to identify and scan the correct label on the pallet. Adhere to a common label standard as much as possible | |
| 6 | Manufacturer - Data Systems | Master Data | GLN/sGLN of a customer location was not communicated or was changed | Product, No Data | Due to the GLN/sGLN having changed, the file errors out when being sent to the customer | Frequently (daily, weekly, monthly) | Very Broad (e.g., likely to cause exceptions for entire lot or shipment) | Define a process to communicate any new locations and/or changes to locations. This needs to be both internal between teams in a company and externally between trading partners. | |
The experiences and information provided through this tool are strictly anonymous and are provided “as is” by the submitting individual. This information is purely educational and should not be construed as regulatory advice. While the tool provides valuable ideas and insights, each company must make its own determinations with regard to the preventive actions that are appropriate for their business.