A batch record documents what happened during the production of a batch. Creating batch records is a necessary part of a batch manufacturing ecosystem. Batch records can be useful for process improvement instead of just stored for use during an FDA audit or product recall. Data from a complete and accurate batch record can be extracted and analyzed to understand what made a “better” or scrap batch. Batch management tools produce a rudimentary batch record. ECS is experienced with augmenting a batch record with details that support better analytics.
A minimally acceptable batch record accurately records supplier batch identification for each batch component or ingredient, allowing a manufacturer to assist the FDA in tracing a product problem to the root cause. Material traceability can be useful for process improvement. For example, because natural ingredients vary in makeup, ECS has found it valuable, when such data can be made available, to record supplier batch parameters that may affect finished goods quality. Recipes can be written to vary the quantity of a natural ingredient to provide a consistent effect. The precise inventory consumption records that are part of material traceability can be used to discover and eliminate waste.