Serialization: How Will You Track Every Item?
Over the past few years, the use of serial numbers has increased dramatically, driven by increased regulation and a desire to know exactly when and where units were produced. When serialization is required, production processes must be changed significantly to ensure the integrity of data for each component.
When serial numbers are used, basic quality inspection techniques are only part of the post-production checks. Real world unit counts must correspond precisely with stored database information.
“If you’ve got 20 pallets and your data shows you have 15, you definitely have a stop shipment situation. You are now faced with a costly and time consuming investigation to determine if this was accidental or criminal intent,” says Stephen R. Lisa, director of product marketing at Systech International.
Major process changes are needed when serialization is adopted. Traditionally, the packaging paradigm has been to produce large numbers of identical items to exacting standards. Uniqueness constitutes a deviation, which means it is a reject.
These traditional workflows do not require tracking of individual package items. Rework, samples, line stops, and machine jams resulting in the manual movement of product have no impact on the end results. It does not matter if the same bottle was inspected twice or was packed into one case, removed and packed into a different case. The focus is on quantity verification not individualized tracking.
The emphasis changes significantly when each unit that’s produced receives a specific serial number. Data integrity is needed to ensure that the unit number is linked to the corresponding unit each and every time.
On the packaging line, quality assurance sampling, machine jams, power failures, reject bins, manual rework and quality challenges can cause multiple products to deviate from the data representation. After packaging is complete, quality assurance sampling/inspection, damaged packages, shipping configurations and manual rework all have an impact on the ability to maintain the match between the data and physical world.
Maintaining data integrity is not just an aggregation issue. It also applies to single items. The level of reliance on the operators to maintain the data integrity is always present. Typically, facilities should have a solution that can reduce the dependence on trained operators as much as possible.
When no parent serial number is assigned, virtual packaging functions support aggregations. This allows a single-child serial number to be used to obtain all siblings’ numbers, using inference to facilitate higher levels of aggregation. Virtual packaging may also be used to provide some level of auto-decommissioning when necessary.
When a run is completed, end of lot reconciliation verifies that that the physical world matches the stored data. Systems should provide reconciliation reports prior to ending the packaging lot, giving operators visibility to the commissioned, decommissioned, packed and orphaned products.
This allows operators to verify the physical product against the recorded data, ensuring that what was produced was not inadvertently modified through manual intervention. While manual overrides aren’t desirable, they must be in place so packaging can continue if equipment goes down. Any time an operator has to manually pack and label a case, the system solution should have checks and balances so operations can be completed when there is a discrepancy.
Maintaining the data integrity for offline use cases is important. For both aggregation and unit level, there has to be processes to address physical changes in the packaged product. Removing additional samples, replacing damaged packaging, replacing damaged labels or changing shipping configuration all require an update of the data to match the physical world.
Reduced Deployment Risks
Buying commercial off the shelf products can simplify the tasks associated with serialization. Solution such as Systech Serialized Product Tracking (SPT) can be quickly installed, increasing efficiency. What’s more, productized solutions are replicable, making packaging lines consistent. As more countries globally implement serialization requirements, manufacturers benefit from investing in serialization solutions that can be easily replicated.
For instance, a manufacturer who installs a productized serialization solution to address regulations in France can use the same solution in a facility in Turkey to meet regulations there. This repeatability reduces design, deployment, maintenance, and associated training costs. Moreover, since no new code is needed, software can be deployed and upgraded more easily than custom software.
Comprehensive Productized Solutions
Serialization extends risk mitigation beyond the comfort zone of most packaging engineers. Touch points that did not exist in the traditional packaging paradigm extend beyond the packaging line, crossing over to other areas. Packaging engineers may not be aware of the added risks or may assume that they are someone else’s problem. IT and network groups most likely don’t realize the impact they are going to have if they impose IT policies and requirements down to the packaging line.
Corporate engineering and IT groups need to be confident that sites can be deployed quickly with minimal disruption so multiple lines can be upgraded without impacting production quotas. Managers need to be confident that new workflows will have minimal impact elsewhere.
To address corporate and site concerns, it is important to combine productized software, proven standards and a repeatable methodology to reduce deployment times and risk. By utilizing productized software, manufacturers eliminate the software development lifecycle for design, implementation, unit testing, formal testing and deployment packaging. Systech takes on the responsibility of this development lifecycle.
Flexibility is a necessity for any automation technology. When corporate initiatives require individual sites to add serialization, these sites must still have the autonomy to manage site-specific requirements.
Refinement of workflows and device selection allows sites to achieve their objectives while supporting the corporate goals. Sites can leverage design and validation documentation from other sites while maintaining the ability to modify where needed.
The introduction of serialization into any existing packaging workflow will result in new workflows and processes. Some processes will have to change; others will be eliminated or added. Software and tools should recognize this and provide functionality to help to minimize the impact to the packaging workflows.
Systech SPT supports a variety of online and offline use cases that allow customers to deploy different packaging line workflows using a common solution architecture. For example, if a product is run on a manual line and an automated line, only the workflow and the configuration change. The solution architecture, software and deployment strategy remain the same. The software also extends beyond the packaging line to address offline operations such as rework, sampling and pallet building.
The need for flexibility sometimes extends far beyond corporate boundaries. The numbering formats for the EPCGlobal and GS1 standards have changed four times in the past five years. Solutions that are tightly tied to a single number standard can’t handle change without development. SPT handles evolving standards and regional regulations because formatting is in the configuration, not hardcoded in the software.Have an Inquiry for Siemens about this article? Click Here >>