From a quality and supply chain perspective, the SAP batch release process is key to ensuring the timely and accurate release of raw materials, semi-finished products, and finished products. In the life sciences industry, incoming raw materials are sampled and tested according to predefined test processes, and their dispositions are recorded in SAP. Similarly, intermediates, semi-finished products, and finished products are also sampled, tested, and released in SAP. The use of quality inspection stock is key to controlling stock usage by the supply chain. This batch release process often includes much more than a simple pass / fail record in SAP, as many other data points may require review. In this piece, we’ll be diving into three capabilities of batch release functionality in SAP.
Batch Release Functionality in SAP
In the life sciences, nearly everything used in manufacturing is batch managed. When items are released from quality inspection stock to unrestricted stock, they become available for use by the supply chain, hopefully in time for their planned use. Using a manufacturing Bill of Materials (BOM) for manufacturing or subcontracting allows for the planned usage of materials and easy issuance or consumption of planned materials to an order. Other non-BOM items can also be added to the manufacturing order through the goods issuance process. When these components are batch managed, material tracing happens automatically. This goods issuance of materials builds up a batch genealogy, or Batch Where Used List (BWUL), and has been available in SAP since the inception of Inventory Management.
The Batch Where Used List
The BWUL is a powerful top-down analysis tool for the Quality Management group to review for the release of intermediates, semi-finished products, and finished products. It gives visibility to all lower-level materials issued to the order for making the higher-level material as well as the Purchase Orders, Stock Transport Orders, and Process orders to order, ship, or manufacture the item. Using click-through capabilities, the user can go directly to each component batch details and inspection lot results. Displayed in a table view, this is simple and straightforward. This BWUL is commonly compared against the batch records to ensure that all materials, batches, and quantities have been issued that were written into the records at the time of manufacture.
As an extension of the BWUL, other capabilities may also be used to support batch release using standard batch management functionality, such as batch derivation. Batch derivation utilizes derivation records, including sender and receiver rules, to send and receive certain values from predetermined materials for each batch and determine how multiple values can be handled. This process allows an automated population of values based on the values of the lower-level items. However, the condition records can easily transform into a tedious amount of data to maintain whenever a new item is created. Batch derivation is a handy tool to have on hand, but many companies choose not to use it due to the limitations to its effectiveness when unplanned material usage is a common occurrence.
Global Batch Traceability
SAP’s Global Batch Traceability (GBT) enhancement expands batch traceability and integration capabilities beyond standard SAP features. To start, whereas the BWUL can only trace one batch at a time, GBT can trace multiple batches simultaneously. In addition to BWUL’s standard table view, SAP created a graphic user interface that allows viewers to better visualize all supply chain nodes, particularly components like purchase orders and stock transport orders. This function is also available for both top-down and bottom-up analyses. Additionally, GBT allows the traceability of Handling Units (i.e., pallets) across warehouses and supply chains, and it tracks information across both SAP and non-SAP systems, helping identify root causes of product defects, linking defects, to vendor systems, and more. GBT can also help manage data retention efforts for batches and vendors based on information from life cycle management processes and company data retention policies. The functions mentioned above are only a few highlights of GBT’s many capabilities.
Batch Release Hub
In its latest effort to enhance the batch release process, SAP released the Batch Release Hub. The batch release process, especially for finished products, involves much more than checking the status of individual component batches and quality test results. Often, larger and more mature organizations may have a multitude of systems to review data on to get the overall release picture. In performing the batch release, the QA department will often have to review quality management system tools for handling CAPAs, Deviations, and Change Controls to ensure that any problems encountered along the way have been satisfactorily reviewed and closed out.
Additionally, Regulatory Filing Systems may need to be reviewed to determine which countries a particular batch or product may be sold in. LIMS may store the test results for the various components or products. Manufacturing Execution Systems (MES) may contain the critical process parameters from the manufacturing process. Batch Records (electronic or scanned) are reviewed during the batch release process. Additional Quality Operations Systems tools such as Veeva could also be linked here as well.
In some situations, it’s possible to link some of this information to an SAP batch characteristic where a record number or status may be recorded. For complex data, this new Batch Release Hub seems to be what people in QA have always wanted – the ability to have everything in one place to make a quality batch release decision. The Batch Release Hub can hold in-house data while also facilitating integration and collaboration with other business partners, suppliers, and contract laboratories.
The great thing about the SAP Batch Release Hub is that it is easily scalable. Simply start by integrating one tool or area at a time until it’s built out to the preferred specifications. Users can decide what information they want to include in the Batch Release Hub. Knowledge is power, and having this information readily available in one place for the Quality team adds immediate value by saving time otherwise spent jumping in and out of multiple different systems.