Consultant & Speaker, Lean Quality Systems, Design Control, Process Validation, and Lean Manufacturing at Atzari
The Copy-Paste Trap: Why ‘More Traceability’ Sometimes Means Less Control In many quality systems, traceability is built by duplicating the same requirement or risk note into multiple places: • Into the protocol header. • Into the work instruction step. • Into the training module. • Into the batch record template. On paper, it looks like “more traceability.” In reality, each copy is now a forked truth—a parallel line of evidence that can drift out of sync the next time something changes upstream. A hypothetical scenario: An engineer updates a risk control limit in the design spec. But one test protocol still has the old number. The training slide deck is never updated. A year later, an audit flags an inconsistency—yet all the downstream documents had been “approved” at the time. This isn’t a failure of the people—it’s a failure of structure. The more we copy, the more entropy we create. Lean Documents & Lean Configuration fix this by: • Storing the limit in a single authoritative node. • Letting all downstream artifacts reference that node’s field rather than embedding the value. • Making the audit trail show where-used relationships instead of redundant text blocks. • Reducing review fatigue by ensuring approvers only sign for the parameter once. True traceability means a single chain of evidence, not a scrapbook of copies. LDLC’s biggest win here is often invisible: less paperwork drift, fewer hidden discrepancies, and stronger audit readiness. #LeanDocuments #LeanConfiguration #LDLC #Traceability #SingleSourceOfTruth #ChangeControl #AuditReady #RiskManagement #ProcessIntegrity #OperationalExcellence #ContinuousImprovement #QualityByDesign #RegulatoryCompliance #SystemsThinking #ThroughputOverCost
