CAPA Effectiveness & Corrective Action Velocity

PharmaFill Contract Manufacturer – FDA Regulated QMS

Open Backlog
142
+8 vs last month
Mean Cycle Time
47d
vs 28d target
Effectiveness Pass Rate
78%
vs 95% target
Recurrence Rate
14%
vs 8% target
Overdue CAPAs
23%
33 items overdue

CAPA Open Backlog by Age Bucket

Mean Closure Cycle Time Trend (Days)

Recurrence Rate by Root Cause Category

Open CAPA Status (Top 22 Items)

CAPA ID Title Source Owner Days Open Due Date Status
CAPA-2024-089 Vial Seal Integrity Failure Audit S. Chen 62 2024-11-15 Overdue
CAPA-2024-112 Out-of-Spec Particulate Count Customer M. Rivera 48 2024-12-03 On Track
CAPA-2024-076 Temperature Deviation in Storage Internal J. Park 81 2024-10-28 Overdue
CAPA-2024-134 Label Misprinting Batch B-7712 Supplier L. Thompson 29 2024-12-18 On Track
CAPA-2024-098 Aseptic Fill Process Drift Audit R. Johnson 55 2024-11-22 Overdue
CAPA-2024-145 Calibration Overdue Equipment Internal A. Kim 19 2024-12-20 On Track
CAPA-2024-067 Environmental Monitoring Alert Customer P. Martinez 94 2024-10-15 Overdue
CAPA-2024-128 Autoclave Cycle Validation Gap Audit N. Singh 36 2024-12-10 On Track

Root Cause Category Distribution (Pareto)

CAPA Source Mix

Verification Audit Fail Rate
22%
14 of 64 closed CAPAs
Quality Engineer CAPA Load
18/FTE
142 open / 8 engineers
Regulatory Observation Repeat Index
0.34
Same findings in follow-up

Overdue CAPA Alert

33 CAPAs past target close date

CAPA-2024-067
Environmental Monitoring Alert
94 days
Due: Oct 15
CAPA-2024-076
Temperature Deviation
81 days
Due: Oct 28
CAPA-2024-089
Vial Seal Integrity Failure
62 days
Due: Nov 15

Effectiveness Verification Pass Rate Trend

QMS Sync: 2024-12-01 08:15 UTC | Root Cause Taxonomy: v3.2 (ISO 9001:2015)
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