Batch Recall & Rework Costs - गुणवत्ता विफलता

Definition

Manual batch records create quality traceability gaps. When a batch fails quality post-release or during customer use, investigators must manually retrieve and correlate: production worksheets, lab results, operator notes, equipment logs, and raw material documentation. This 1-2 week reconstruction effort delays root cause analysis. Incomplete deviation documentation may require conservative recalls of all potentially affected batches (broad impact). Electronic systems provide real-time data correlation, enabling precise batch traceability and targeted holds. For a manufacturer with ₹100 crore revenue producing specialty chemicals, typical rework/recall cost = 1-2% of revenue (₹1-2 crore annually). Electronic systems reduce this 40-60% through early detection and precise traceability.

Why This Matters

The Pitch: Indian chemical manufacturers lose ₹50-200 lakh annually on preventable rework and recalls due to manual batch record traceability gaps. Electronic batch records enable rapid root cause analysis (reducing investigation time by 60%), precise batch traceability (enabling targeted holds instead of blanket recalls), and automated quality alerts (catching 80% of issues pre-release).

Affected Stakeholders

Quality Assurance, Production, Regulatory Affairs, Customer Service, Supply Chain

Related Business Risks