CAPA Closure Rate
84%
▲ 6% vs last quarter
Overdue CAPAs
7
▲ +2 this week
Training Compliance
91%
▲ 3% vs Q4 2024
Deviation Rate
1.2%
▼ −0.4% improvement
Repeat Deviations
4
→ Stable vs prior
Active CAPA Register
Open · In-Progress · Overdue
| CAPA ID | Description | Owner | Due | Status | Sev. |
|---|---|---|---|---|---|
| CAPA-0241 | Batch record error — Mfg Fill Line Vials | J. Pinkk | Mar 15 | Overdue | Crit |
| CAPA-0238 | Sterility test OOS result | M. Red | Mar 28 | In Progress | Crit |
| CAPA-0236 | Environmental monitoring exceedance | S. Cyan | Apr 5 | In Progress | Major |
| CAPA-0233 | SOP deviation –> cleaning validation | A. White | Apr 12 | Open | Major |
| CAPA-0229 | Label reconciliation discrepancy | T. Blue | Apr 18 | Open | Minor |
| CAPA-0225 | Compressed air specification failure | L. Yellow | Apr 22 | Open | Major |
| CAPA-0218 | HVAC calibration out-of-tolerance | R. Brown | May 1 | Open | Minor |
CAPA Status
Distribution · Q1 2025
Closed 52%
In Progress 26%
Open 14%
Overdue 8%
Quality Insights
Automated Quality Forecast
CAPA-0241 escalation risk. 7 days overdue. Batch record errors on Fill Line Vials show a recurring pattern —> 3rd occurrence in 6 months.
2h ago
Mfg Fill Line Vials operators have the lowest SOP retraining completion rate (61%). Correlated with 4 of 7 open CAPAs.
5h ago
QC Lab deviation rate dropped 42% following April competency reassessment. Model attributes to HPLC retraining.
1d ago
Predicted: Environmental monitoring CAPAs likely to increase in Q2 if HVAC validation SOP is not reissued before End of March.
1d ago
14 employees are overdue for annual GMP refresher. Two are assigned to sterility testing —> critical risk.
2d ago
Retraining Completion Heatmap
By department × month · 2024–2025
Low
High
A
M
J
J
A
S
O
N
D
J
F
M
Mfg
78
Manufacturing · Apr: 78%
82
Manufacturing · May: 82%
65
Manufacturing · Jun: 65%
91
Manufacturing · Jul: 91%
94
Manufacturing · Aug: 94%
80
Manufacturing · Sep: 80%
76
Manufacturing · Oct: 76%
58
Manufacturing · Nov: 58%
72
Manufacturing · Dec: 72%
45
Manufacturing · Jan: 45%
61
Manufacturing · Feb: 61%
61
Manufacturing · Mar: 61% ← Low Risk
QC Lab
93
QC Lab · Apr: 93%
96
QC Lab · May: 96%
90
QC Lab · Jun: 90%
95
QC Lab · Jul: 95%
88
QC Lab · Aug: 88%
97
QC Lab · Sep: 97%
99
QC Lab · Oct: 99%
85
QC Lab · Nov: 85%
92
QC Lab · Dec: 92%
95
QC Lab · Jan: 95%
97
QC Lab · Feb: 97%
98
QC Lab · Mar: 98%
Supply
66
Supply Chain · Apr: 66%
74
Supply Chain · May: 74%
79
Supply Chain · Jun: 79%
83
Supply Chain · Jul: 83%
77
Supply Chain · Aug: 77%
68
Supply Chain · Sep: 68%
75
Supply Chain · Oct: 75%
81
Supply Chain · Nov: 81%
64
Supply Chain · Dec: 64%
78
Supply Chain · Jan: 78%
84
Supply Chain · Feb: 84%
89
Supply Chain · Mar: 89%
Reg.
98
Regulatory · Apr: 98%
100
Regulatory · May: 100%
97
Regulatory · Jun: 97%
99
Regulatory · Jul: 99%
100
Regulatory · Aug: 100%
98
Regulatory · Sep: 98%
95
Regulatory · Oct: 95%
97
Regulatory · Nov: 97%
99
Regulatory · Dec: 99%
100
Regulatory · Jan: 100%
100
Regulatory · Feb: 100%
100
Regulatory · Mar: 100%
Eng.
62
Engineering · Apr: 62%
48
Engineering · May: 48%
77
Engineering · Jun: 77%
80
Engineering · Jul: 80%
65
Engineering · Aug: 65%
74
Engineering · Sep: 74%
59
Engineering · Oct: 59%
71
Engineering · Nov: 71%
78
Engineering · Dec: 78%
63
Engineering · Jan: 63%
75
Engineering · Feb: 75%
79
Engineering · Mar: 79%
KPI Trend Lines
12-Month Rolling · Key Quality Metrics
CAPA Closure %
84%
Deviation Rate %
1.2%
Training Compliance
91%
Repeat Deviations
4
OOS Events
3
Right First Time
96%
SOP Compliance by Category
GMP
General
General
Sterile
Technique
Technique
Clean
Room
Room
Data
Integrity
Integrity
Root Cause Analysis : CAPA Source Distribution
Pareto · Q1 2025 · 41 total events
32%
Human
Error
Error
24%
Procedure
Gap
Gap
18%
Equipment
Failure
Failure
12%
Material
Quality
Quality
7%
System/
IT
IT
5%
Enviromental.
Control
Control
2%
Other
🔑 Root cause insight: 56% of CAPAs trace to human error and/or procedure gaps —> the primary retraining opportunity.
Top 2 causes → 80% volume