Audit Readiness & Compliance Quality Scorecard

Company: BioSeal Diagnostics
Standards: ISO 13485, FDA QSR
Site:
Finding Type:
Closure Rate (SLA)
82%
-5% vs Target
Open Major Findings
3
-2 vs Last Month
Repeat Finding Rate
18%
Target: <10%
Doc Control Exceptions
47
Open Items
Training Compliance
94%
6 Overdue
Cert Expiry Countdown
127
Days (ISO 13485)

Finding Severity Trend — Last 4 Audits

Closure Burndown (90 Days)

Compliance Radar — 6 Dimensions

Open Findings (18)

ID Severity Clause Area Owner SLA Days Left Status
AF-2024-087 Major 7.3.4 Design Control J. Martinez -3 CAPA in progress
AF-2024-091 Major 7.3.2 Design Validation K. Chen 2 Evidence review
AF-2024-103 Major 7.5.1 Process Control A. Johnson 8 Document update
AF-2024-056 Minor 4.2.4 Doc Control L. Davis 12 Pending approval
AF-2024-063 Minor 6.4 Training M. Taylor 15 Training scheduled
AF-2024-072 Minor 8.2.4 Internal Audit R. Patel 18 Schedule revision
AF-2024-081 Minor 7.4.1 Purchasing S. Kim 21 Supplier audit
AF-2024-095 Obs 5.6.2 Mgmt Review T. Wilson 25 Action plan draft

Repeat Finding Heatmap by Area

Past 4 audits • Color = repeat count
Q1 2024
Q2 2024
Q3 2024
Q4 2024
Design Control
2
1
3
2
Doc Control
1
0
1
1
Training
0
1
0
0
Process Control
1
0
1
2
Purchasing
0
0
0
1
Internal Audit
0
0
0
0

Training Compliance by Role

CAPA Linkage Rate
76%
from Audit Findings
Target: ≥80%
Internal Audit Adherence
88%
Schedule Adherence
2 audits delayed
Customer Audit Pass Rate
91%
No Major Findings
11 of 12 audits

Major Finding Alert

3 Major Findings open on Design Control (Clause 7.3) — 2 are repeat observations from prior surveillance audit. Customer audit scheduled in 6 weeks.

Critical Actions:
  • AF-2024-087 overdue by 3 days — escalate CAPA
  • Complete 6 GMP refresher trainings before audit
  • Resolve 47 document control exceptions

Certification Expiry Timeline

ISO 13485:2016 127 days
Expires: Jun 15, 2025 • Surveillance due
FDA QSR 21 CFR 820 89 days
Next inspection window opens May 8, 2025
Customer Approval (MedTech Corp) 42 days
Audit scheduled: Mar 28, 2025

Applicable Standards

• ISO 13485:2016 Medical Devices QMS
• FDA 21 CFR Part 820 Quality System Regulation
• ISO 14971:2019 Risk Management
• IEC 62304 Medical Device Software

Last Mock Audit Score

78/100
Conducted: Jan 12, 2025
Auditor: External Consultant (TÜV SÜD)
22-point gap to target (≥90 for certification confidence)

Next Audit Readiness Review

Feb 28, 2025 @ 10:00 AM
Attendees: Quality Director, Compliance Lead, RA Manager