📊 Management Review
Your command center — three views of the same quality data for different audiences and purposes.
Quality Report
Auto-generated management review document pulling live data from every module. Enter the review period and meeting chair, then click Refresh. Export to PDF or print for board/leadership meetings.
Dashboard
Real-time KPI tiles, open item counts, overdue CAPAs, and pending approvals. Use this for daily or weekly operational oversight. Red items need immediate attention.
Analytics
Historical trend charts and KPIs across all modules. Select a date range to see how quality performance has changed over time. Export a summary for regulatory submissions.
Approvals
Admins see a CAPAs awaiting approval queue on the Dashboard. Review and approve or reject submitted CAPAs before they enter the active workflow.
✅ CAPAs — Corrective & Preventive Actions
The backbone of your quality system. CAPAs are formal records that document a problem, its root cause, and the actions taken to prevent recurrence.
Creating a CAPA
Click + New CAPA or use the Escalate to CAPA link on any Failure, Complaint, Audit finding, or Risk. Fill in title, source, owner, priority, and due date.
Phases
CAPAs move through: Identification → Root Cause Analysis → Action Plan → Implementation → Verification → Closed. Click the phase buttons inside each CAPA to advance it.
Root Cause Analysis
Document the 5-Why or fishbone analysis in the RCA field. A CAPA cannot be effective unless the true root cause is identified — not just the symptom.
Approval Workflow
New CAPAs start as Pending Approval until an admin approves them. This ensures management visibility before resources are committed. Rejected CAPAs are returned with comments.
Verification & Closure
After implementation, document the effectiveness check — evidence that the action actually fixed the problem. A CAPA is only closed once verification is recorded.
Overdue CAPAs
CAPAs past their due date turn red on the Dashboard. Filter by All statuses to find them here. Contact the owner or extend the due date with justification.
| CAPA ID | Title | Source | Priority | Owner | Phase | Status | Due |
|---|
🔧 Failure / Repair Log
Record every product failure, field return, warranty claim, and assembly defect. This log feeds quality metrics and provides the data needed to identify systemic issues.
Logging a Failure
Click Log failure. Choose the type (Field Return, Warranty, Assembly Defect, etc.), describe what happened, enter the serial number if known, and rate severity.
Serial Numbers
Always record the serial number when known — it links the failure to the Device History Record (DHR), giving you a complete unit-level service history.
Escalating to CAPA
If you see the same failure more than once, or if the failure is safety-related, use Escalate to CAPA to launch a formal corrective action. One-off failures can remain as log entries.
Failure Analysis
The Analytics section shows a failure breakdown chart by type. Regular review helps spot trends — e.g. if one component is failing across multiple units.
Log field returns, vendor non-conformances, and assembly defects. Escalate to CAPA if systemic action is needed.
| ID | Date | Type | Description | Serial # | Failure reason | Sev. | Status | CAPA |
|---|
📋 Audit Findings
Record non-conformities and observations from internal quality audits, external audits, and regulatory inspections. Every finding must be tracked to closure.
Logging a Finding
Click Log finding. Reference the relevant QMS clause or standard (e.g. ISO 13485 §7.5.1). Classify as Major (immediate CAPA required), Minor (corrective action needed), or Observation (no immediate action).
Major vs Minor
A Major finding means a complete absence of a required process or a systemic breakdown — it blocks certification. A Minor is a single lapse or isolated gap. Both require documented corrective action.
Linking to CAPAs
Major findings must be linked to a CAPA. Use the CAPA column to reference the CAPA ID once created. Auditors will check that the CAPA was implemented and effective.
Closure Deadlines
Set realistic closure dates based on finding severity. Minor findings are typically closed within 30–90 days. Track closure in the Status column and document objective evidence of correction.
Record non-conformities from internal audits. Major findings should drive a CAPA.
| ID | Date | Clause | Finding | Class | Status | CAPA |
|---|
💻 Software Incidents
Track software bugs, system outages, and data integrity issues that cause downtime, financial loss, or customer disruption. Maintains an audit trail for 21 CFR Part 11 and software validation requirements.
Logging an Incident
Click Log incident. Identify the affected system, describe the impact and root cause, and record total downtime hours. Rate severity from Low (minor disruption) to Critical (data loss or patient risk).
Downtime Tracking
Record start and end times to calculate total downtime. This feeds into the Analytics section and Management Review as a KPI for system reliability and availability.
Escalating to CAPA
Recurring incidents or those with significant customer impact should be escalated to a CAPA. Document the software change control process used to resolve the issue.
Validation Records
For regulated software (21 CFR Part 11, IEC 62304), attach validation test results in the record. The incident log provides the traceability required during FDA inspections.
Track software incidents causing lost time, financial impact, or customer disruption.
| ID | Date | System | Impact | Down (h) | Sev. | Status | CAPA |
|---|
💬 Customer Complaints
Every complaint from a customer, distributor, or end user must be documented, evaluated for reportability, and tracked to resolution. This log is required for MDR / vigilance reporting.
Logging a Complaint
Click Log complaint as soon as a complaint is received — even verbal ones. Record customer name, complaint description, product / serial number, and initial severity assessment.
Severity Assessment
Critical = patient injury or device failure in use. High = product unusable, significant impact. Medium = workaround exists. Low = cosmetic or minor inconvenience. Critical complaints require MDR evaluation within 5 business days.
MDR / Vigilance
For medical devices: assess every complaint for reportability to FDA (21 CFR Part 803) or EU MDR. Document your reportability decision and rationale in the complaint record, whether or not you file a report.
Escalating to CAPA
Any complaint involving a safety issue, or any category of complaint occurring more than once, must be linked to a CAPA. Trend data in Analytics helps identify when a CAPA threshold is reached.
Track voice-of-customer complaints. Recurring or safety-related complaints should drive a CAPA.
| ID | Date | Customer | Description | Category | Sev. | Status | CAPA |
|---|
🚚 SCARs — Supplier Corrective Action Requests
Issue formal written requests to suppliers when their product or service causes a quality failure. Tracks the supplier's investigation and corrective action response.
Issuing a SCAR
Click Issue SCAR. Select the supplier, describe the nonconformance with specific part numbers and quantities affected. Set a response deadline — typically 15–30 days for initial response.
Supplier Response
When the supplier responds, update the record with their root cause analysis and proposed corrective actions. Evaluate whether their response is adequate before accepting it.
Linking to MRB
SCARs often originate from MRB actions — when you disposition nonconforming material as Return to Vendor in the MRB, issue a SCAR to document the formal corrective action request.
Supplier Scorecard
SCAR history by supplier feeds into your supplier qualification process. Suppliers with multiple open or overdue SCARs should be placed on approved supplier review or disqualified.
Supplier Corrective Action Requests — issue formal SCARs to vendors and track responses.
| SCAR ID | Issued | Supplier | Issue | Sev. | Response due | Status | CAPA |
|---|
📦 MRB — Material Review Board
Formally review and disposition nonconforming material — whether received from a supplier, returned from a customer, or identified during in-process inspection. Every piece of nonconforming product must have a documented disposition decision.
Creating an MRB Record
Click New MRB record when nonconforming material is identified. Record the part number, vendor (if applicable), quantity affected, and a clear description of the nonconformance.
Disposition Options
Accept As-Is — use with documented justification. Rework — repair to conformance then re-inspect. Scrap — destroy and replace. Return to Vendor — send back with a SCAR. Each option has different documentation requirements.
SCAR & CAPA Links
For Return to Vendor dispositions, issue a SCAR and record the SCAR ID here. If the same nonconformance recurs, escalate to a CAPA to address the systemic root cause.
Quarantine Control
Nonconforming material must be physically quarantined and labeled until disposition is decided. Use the MRB ID as a quarantine tag reference to maintain traceability in your warehouse.
Material Review Board — track nonconforming product returned from the field and record disposition decisions.
| MRB ID | Date | Part / Product | Vendor | Qty | Nonconformance | Disposition | Status | SCAR | CAPA |
|---|
👁 Near Miss Reports
A near miss is any event that could have caused injury, product failure, or a quality escape — but didn't. Capturing near misses is one of the highest-value quality activities because it lets you fix problems before they cause real harm.
Reporting a Near Miss
Click Report near miss. Describe what happened, what could have happened, and where it occurred. Anonymous reporting is encouraged — the goal is learning, not blame.
Categories
Choose the appropriate category: Safety (potential injury), Quality (potential nonconformance), Process (breakdown in procedure), Environmental, or Equipment. Categories drive the right investigation approach.
Investigation
Every near miss should be investigated, even if briefly. Identify the immediate cause and any contributing factors. High-severity near misses should result in a CAPA to prevent the event from becoming an actual incident.
Culture Indicator
Near miss reporting rate is a measure of psychological safety. More reports = healthier culture. A sudden drop in reports often means staff are afraid to report, not that incidents have stopped occurring.
Report near misses — events that could have caused harm but didn't. Anonymous reporting is encouraged. All reports help prevent future incidents.
| ID | Date | Category | Description | Potential severity | Reported by | Status | CAPA |
|---|
🛡 Risk Register
Proactively identify, score, and manage quality and business risks before they become problems. The risk register is a living document — review it at every management review meeting.
Adding a Risk
Click Add risk. Describe the risk event, choose a category (Quality, Safety, Supply Chain, Regulatory, etc.), and score each dimension on a 1–10 scale.
Risk Scoring (L × I × D)
L = Likelihood of occurrence. I = Impact if it occurs. D = Detectability (1 = always detected, 10 = never detected). Score = L × I × D. Higher scores need more urgent action.
Risk Ratings
Critical (≥200) — immediate CAPA required, escalate to leadership. High (100–199) — action plan required. Medium (40–99) — monitor and mitigate. Low (<40) — accept and document.
Linking to CAPAs
Critical and High risks must be linked to a CAPA. When the CAPA is completed, re-score the risk — the residual risk score should be lower, confirming the mitigation was effective.
Review Cadence
Review the full risk register at least quarterly. New risks should be added as soon as they're identified — from customer feedback, supplier changes, regulatory updates, or near miss patterns.
Identify and score risks (Likelihood × Impact × Detection). Link CAPAs to high-rated risks.
| Risk ID | Description | Category | L | I | D | Score | Rating | Status | CAPA |
|---|
📜 Device History Record (DHR)
A unit-level view of every quality event linked to a specific serial number — failures, repairs, complaints, and MRB actions. Required by 21 CFR Part 820.184 for medical devices.
Looking Up a Unit
Enter or scan a serial number in the search box and click Look up. The DHR displays every quality record linked to that unit across all modules — failures, complaints, MRB actions.
How Records Link
Records automatically appear in the DHR when a serial number is entered in Failure, Complaint, or MRB records. Always record the serial number in those modules to maintain traceability.
Regulatory Use
The DHR proves traceability during FDA inspections, notified body audits, and litigation. You must be able to show the complete service history for any returned or field unit on demand.
All Units View
The All tracked serial numbers table at the bottom shows every unit with at least one quality event. Use this to identify units with repeat issues or to generate a field safety report.
Device History Record
Complete service and return history by serial number
All tracked serial numbers
📈 Analytics
Historical trend charts and KPI summaries across all quality modules. Use this to spot patterns, demonstrate continuous improvement, and prepare data for management reviews or regulatory submissions.
KPI Tiles
The top row shows snapshot counts for each module — total records, open items, and closed this period. Red tiles indicate items needing attention.
Trend Charts
Select a date range (4 weeks to 12 months) to see how event volumes have changed over time. A downward trend in complaints or failures indicates your quality improvements are working.
Breakdown Charts
CAPA-by-source and failure-by-type charts show where your quality problems originate. Use these to prioritize where to focus improvement efforts and resources.
Exporting
Click Export summary to download an analytics report as a CSV or formatted document. Use this for management review presentations, regulatory filings, or supplier quality reports.
Analytics
Historical trends and current quality standings