Webinar: Next Gen QMS: Quality, Risk & Compliance Unified Through AI

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Webinar: Next Gen QMS: Quality, Risk & Compliance Unified Through AI

Yield (Theoretical vs. Actual)

Definition

Theoretical yield is the expected quantity of finished product a batch should produce, based on the formula and quantities defined in the Master Batch Record, assuming no losses. Actual yield is the quantity genuinely produced and confirmed at the end of the batch. The two are reconciled within the batch record, with significant variances typically triggering an investigation.

Benefits

Automating the yield reconciliation calculation within the EBR by comparing actual output against theoretical yield and flagging variances beyond an acceptable range removes reliance on manual calculation and ensures yield discrepancies are caught consistently rather than depending on a reviewer noticing a manual math error.

Use Case

At the end of a production run, an operator records the actual quantity produced. The EBR system automatically calculates the yield percentage against the theoretical yield defined in the MBR and flags the batch for investigation when the variance falls outside the pre-established acceptable range.

Frequently Asked Questions (FAQ)

  • Common causes include material losses during processing, equipment inefficiencies, sampling for testing, or genuine process issues. Investigation is needed to determine which applies in a given case.

  • Not necessarily. Some yield loss is expected and accounted for within a defined acceptable range; it becomes a quality concern specifically when the variance falls outside that established range, prompting investigation.

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