INTEGRATED CAPA WORKFLOW
Problem → Root Cause → Action → Effectiveness → Closure
Every analysis and action below is linked to this CAPA record.4/11workflow steps
CONTROLLED APPROVAL WORKFLOW
Electronic Approval & Rework
Segregation of duties is enforced: a CAPA owner or creator cannot approve the same CAPA.
Action Not Submitted
No approval request has been submitted.Submit the CAPA when the problem definition and ownership are ready for independent quality review.
CAPA Details
Problem definition and evidence baseProblem Statement
Seal strength failures were observed during final inspection on the packaging line.
Containment
Quarantined the affected production window and increased seal-strength sampling to every 30 minutes.
Root Cause
Not documented
Corrective Action
Cleaned the sealing jaws, standardized temperature settings and replaced a worn thermocouple.
Preventive Action
Introduced preventive cleaning frequency, thermocouple verification and SPC monitoring of seal temperature.
Effectiveness Check
Not documented
Root Cause
Corrective & Preventive Action Plan
Actions feed the operational side of the CAPA workflow.| Type | Description | Owner | Due | Status | Update |
|---|---|---|---|---|---|
| No actions added. | |||||
Linked Analyses
One-click access to every analytical layerFishbone / Root Cause1 linked analysisOpen latest →
Pareto Analysis1 linked analysisOpen latest →
Markov Lifecycle ForecastNot startedGenerate lifecycle →
CAPA Summary
SourceInspection
OwnerProcess Engineer
Detected2026-08-05
Target2026-08-25
Verification-
Submitted-
Final Approval-
Closed-
Workflow Timeline
Traceability of the CAPA improvement cycleFishbone cause removed21 Aug 2026 09:56
Operator did not identify early seal degradationSystemFishbone cause removed21 Aug 2026 09:54
Film surface contaminationSystemFishbone cause removed21 Aug 2026 09:23
High humidity near packing lineSystemFishbone cause removed21 Aug 2026 09:23
Airflow from nearby door affected coolingSystemFishbone cause removed21 Aug 2026 09:22
Temperature sensor verification overdueSystemFishbone cause removed21 Aug 2026 09:21
Seal strength test interval too longSystemFishbone cause removed21 Aug 2026 09:20
Cleaning interval not defined by production hoursSystemFishbone cause removed21 Aug 2026 09:20
Temperature setting changed without documented verificationSystemFishbone cause removed21 Aug 2026 09:20
Film thickness variationSystemFishbone cause removed21 Aug 2026 09:19
Shift handover did not highlight temperature driftSystemFishbone cause removed21 Aug 2026 09:19
Worn thermocoupleSystemFishbone cause removed21 Aug 2026 09:19
Sealing jaw contaminationSystem