Inspections (Inspection Shield)
Inspection Shield is ProBeya's pre-inspection simulation and readiness module. It enables teams to create versioned inspection checklists (GMP, FDA, ISO, or custom), run simulated inspection sessions against those checklists, capture per-checkpoint findings, and compute readiness scores — all before the actual regulatory inspector arrives.
The best way to pass an inspection is to inspect yourself first. Inspection Shield makes that practice systematic and measurable.
Overview
Regulatory inspections are high-stakes events in pharma and manufacturing. Organizations that prepare with mock inspections consistently perform better. However, managing checklist templates, tracking findings, and measuring readiness across multiple inspection types is complex without a dedicated tool. Inspection Shield fills this gap.
Getting Started
- Navigate to the Inspections section from the main menu.
- Click New Checklist to create an inspection template.
- Define sections and checkpoint items with guidance text, weights, and criticality levels.
- Set the checklist type (e.g., "gmp", "fda", "iso", "custom") and version.
- Activate the checklist when it is ready for use.
- Click Start Session to begin a simulated inspection against a checklist.
- Walk through each checkpoint, recording pass/fail/NA results with comments and photo evidence.
- Complete the session to compute the readiness score.
How It Works
Checklist Templates
Checklists are versioned templates that define what to inspect:
| Field | Description |
|---|---|
| Name | Display name (e.g., "EU GMP Annex 11 Readiness Check") |
| Type | Inspection framework identifier (gmp, fda, iso, custom) |
| Sections | Array of section objects, each containing checkpoint items |
| Version | Integer version number for template revision tracking |
| Status | Lifecycle: draft, active, or archived |
Checkpoint Items
Each section contains one or more checkpoint items:
| Field | Description |
|---|---|
| Question | The inspection question or requirement to verify |
| Guidance | Optional helper text explaining what the inspector looks for |
| Weight | Numeric weight for score calculation (higher = more important) |
| Criticality | Classification: critical, major, minor, or info |
Inspection Sessions
A session represents one execution of a checklist. When you start a session, you walk through each checkpoint and record findings:
| Finding Field | Description |
|---|---|
| Result | Pass, fail, or not applicable (NA) |
| Comment | Detailed observation or evidence description |
| Photo Key | Reference to an uploaded photo (via S3 storage) |
| Severity | Optional severity override for this specific finding |
Readiness Scoring
When a session is completed, the system computes a readiness score based on:
- Pass/fail ratios across all checkpoint items
- Weighted scoring (critical items count more than minor ones)
- Criticality level of failed items
The score provides a numeric indicator (0-100) of inspection readiness.
Session Tracking
Sessions are linked to their parent checklist and include metadata about who conducted the session, when it was started and completed, and the computed readiness score. The getChecklist procedure returns a session count, enabling "template usage" tracking.
Configuration
Checklists and sessions are scoped to the organization. Listing supports filtering by type, status, and name search, with pagination (default 20, max 100).
Playbooks, findings, and readiness scores are stored in dedicated tables for advanced analytics.
Permissions
| Action | Required Role |
|---|---|
| Create/edit checklists | Quality manager or admin |
| Start inspection sessions | Any organization member |
| Record findings | Session conductor |
| Complete sessions | Session conductor |
| View checklists and sessions | Any organization member |
| Archive checklists | Quality manager or admin |
All mutations are logged to the audit trail.
Tips & Best Practices
When regulations change or internal standards evolve, create a new version of the checklist rather than editing the active one. This preserves historical session data tied to the original version.
If your readiness score is low, prioritize remediating critical and major findings. Minor and info items can be addressed later — inspectors focus on critical controls first.
Schedule pre-inspection simulations at least 4-6 weeks before a planned regulatory visit. This gives enough time to address findings and re-verify.
Use the photo key feature to capture evidence of compliance (or non-compliance) during the walk-through. Visual evidence is powerful for both internal tracking and auditor presentations.
Related Features
- Compliance Radar — track compliance requirements that inspections verify
- Five-S Audit — 5S audits share the same checklist-and-score pattern
- Gemba Walks — on-the-floor observations complement inspection findings
- Action Log — create action items from inspection findings