qms-complaint

Complaint Handling

Capture. Triage. Resolve.

The five-day clock started Monday. By Thursday you realized it was reportable. One day left. Intake triage that identifies critical complaints immediately, not after the queue.

Complaint Handling

The five-day clock.

A surgeon reports that a device shut off during a procedure. Monday morning. The person who took the call is on vacation Tuesday. Nobody reviews it until Wednesday. Thursday, someone reads the notes and realizes: this might be reportable.

The clock started Monday. You have five days. It's now Thursday. You've used four days to figure out that you have a reporting window.

Complaint Lifecycle

Finding the signal

Most complaints are routine—dented packaging, usage questions. One in a hundred might indicate a serious safety issue. If your system treats them all first-in-first-out, that serious complaint waits behind ninety-nine minor ones.

Complaint Triage

Seal triages at intake. "Death or serious injury?" "Device malfunction during use?" The answers determine classification. Critical complaints don't wait in queues. They escalate immediately.

The pattern nobody saw

One battery complaint is an anomaly. Three is a cluster. Eight across three lot numbers is systemic.

The person handling complaint eight doesn't know about complaints one through seven. They're in different files, assigned to different investigators.

Seal analyzes complaints across products, lots, symptoms, and time. When complaints cluster, the system alerts quality leadership.

Regulatory reporting

MDR: 5 days for death or serious injury, 30 days for malfunctions that could cause harm. When an event is reportable, Seal calculates the deadline based on when you became aware. The countdown is visible on dashboards. As the deadline approaches, escalation intensifies.

Global vigilance

Complaint from Germany. Same day, another from Brazil. A week later, Japan and Australia. Four regulatory systems, four different reporting requirements, four different deadlines.

When a complaint is classified, the system shows which regulatory reports are required based on where the event occurred and where the product is marketed.

Capabilities

01Multi-Channel Intake
Capture complaints from calls, emails, sales reports, social media. All channels feed the same workflow.
02Severity Classification
Consistent triage with decision trees. Serious events escalate immediately. Regulatory deadlines tracked automatically.
03Product Evaluation
Manage return requests, track receipt, assign evaluation, document findings with photos and analysis.
04Regulatory Reporting
Generate MDR, MedWatch, CIOMS forms. Track deadlines and submission status. Never miss a reporting window.
05Trend Analysis
Pattern detection across products, lots, and time. Alert on clusters before signals become crises.
06CAPA Integration
Complaints triggering systemic issues link to corrective actions. Verify that fixes resolve complaint patterns.
07Global Vigilance
Track different regulatory requirements by geography. Same investigation data feeds MDR, EU vigilance, and other jurisdictional reports.
08Customer Communication
Track acknowledgments, updates, and response letters. When customers call back, their history is instant.
01 / 08
Multi-Channel Intake
Multi-Channel Intake

Entities

Entity
Description
Kind
Complaint
Customer or patient report. One in a hundred might be serious—triage finds it before the clock expires.
type
Serious Complaint
Death, serious injury, or malfunction that could cause harm. Clock starts now.
template
CMP-2024-001
Monday: device shut off during procedure. Thursday: someone realizes it's reportable. One day left.
instance
Minor Complaint
Dented packaging, usage questions. Handle appropriately, but not urgent.
template
Triage
Decision tree at intake. 'Death or serious injury?' 'Malfunction during use?' Critical complaints don't wait in queues.
type
MDR Report
The five-day clock. Miss the deadline, face enforcement. Countdown visible on dashboards.
type
5-Day MDR
Death or serious injury. Five calendar days. Monday call, Friday deadline.
template
30-Day MDR
Malfunction that could cause harm. 30 days from awareness.
template
Investigation
What happened? Product defect, use error, environmental factor? You need the device to know.
type
Product Evaluation
Physical examination of returned product. Photos, measurements, findings. Sometimes you can't get it back—document why.
type
Trend Analysis
One complaint is an anomaly. Three is a cluster. Eight across three lots is systemic. See the pattern before it becomes a crisis.
type
TREND-2024-Q3
Eight battery complaints across three lots. Pattern detected. Investigation initiated before #9 arrives.
instance
Customer Response
When the surgeon calls back: 'What happened with my report?' Their history is instant.
type

FAQ

The system guides classification based on event type, injury severity, and product involvement. Investigation findings feed a decision tree that identifies whether MDR, MedWatch, or other reporting is required. The system tracks reporting deadlines from the moment an event is classified as reportable.