Date the hour someone first knew, link the duplicates without burying the one that names an injury, and leave the reportability call to the qualified person who signs it.
A report arrives, and the hour an employee first held it is stamped beside it.
02
A clock is already running, because 21 CFR 803.3 dates awareness to any employee.
Reason
03
A duplicate is linked and not merged, so the one line naming harm survives the cluster.
04
A cluster is a trend analysis, and 21 CFR 803.53 runs five work days from one.
05
A severity band is set, and it is kept apart from the reportability question.
Decide
06
A consumer hazard surfaces, and 16 CFR 1115.14 allows ten days to investigate.
07
A not-reportable view is drafted, and 21 CFR 803.20(c)(2) leaves that call to a qualified person.
Out
08
One defect meets two regimes, and CRA Article 14 adds a third from 11 September 2026.
09
Execute write actions only inside the approval boundaries agreed during implementation.
→Product statement
Intake, dating, linking and routing belong to the agent. The reportability decision, and the name that stands under it, belong to a qualified person the rule itself describes.
Example workflow
One report, arrival to decision
AgentHuman
1Report receivedA complaint, a field report, a support thread, a returned unit or a failed test
2Awareness dated and recordedWho first held the information, the hour it reached them, the product and what it describes
3Duplicates linked, not mergedThe cluster, each member left whole, the outlier lines and confidence
4Controls appliedHarm-language checks, clock checks, regime checks and triage confidence
No human action required
Stages 1 to 4 run unaided, and no report is closed at any of them — the agent is preparing, and the reviewer lane opens at the reportability gate.
5DecisionSplits at the reportability gate
No harm language present
Goes to the qualified reviewer to decide.
Anything naming injury
Adds a regulatory-affairs read first.
Reviewer decision
The report is held with its arrival hour, the cluster it joined and the clocks it sits under.
Decide · Attach evidence · Send to regulatory review
Decided — by the qualified reviewer▼
6Complaint and event-file records updatedOnly where write access and event-file policy allow it
7Outcome evaluatedDecision accuracy, reopened duplicates, reviewer corrections and what the later audit turned up
Corrections
Each correction the reviewer makes counts in the evaluation.
What should not run autonomously
Human approval stays in control
Outside the boundary — human approval required8 items
Concluding that an event is not reportable.
Signing the written report that goes to the Commission.
Closing a report whose text names an injury.
Deciding a quarterly summary form is enough.
Automation boundaryAgent acts unaided
✓Date the hour the first employee became aware.
✓Link duplicate reports and preserve each reportability determination.
✓Record the deliberation a reviewer relied on, dated and sourced.
✓Hold the report for the reviewer who decides it.
No report closes as not reportable except by a qualified person, inside agreed boundaries.
Judging whether a device may have contributed.
Telling a regulator the review is complete.
Setting which day a statutory clock is counted from.
Changes to the triage rules or the reportability gate.
Example output
One defect report, annotated
An engineering agent keeps the cause and a warranty agent keeps the unit; this one keeps whether a report must be told to a regulator. Below is one report exactly as the agent leaves it.
Triage record · single reportIllustrative example
Report
Recorded as
Awareness
Evidence of record
Confidence
Held for
Customer report, one product line
Unexpected speed change, injury named
Linked, not merged
Support thread, 3 August 2026
Held undecided
The qualified reviewer, by name
As receivedDrawn from the support thread and the complaint file, and it concludes nothing those two do not carry.
What the record holdsSupport thread linesComplaint file entryLinked duplicate set
Why no decision hereCalling a report not reportable is an act a qualified reviewer owns.
ActionDecideAttach evidenceSend to regulatory review
What the score decidesBelow the configured threshold a report gets a regulatory read before the reviewer sees it.
Value
Where AI adds value
The same four claims, placed at the point in the workflow where each one applies.
Where the value landsValue 01 – 04
Each reportFrom the hour it was first held
03Report
Where the report is used
The best published duplicate detectors put the true match in a top-ten shortlist about three times in five, so a linked cluster is a shortlist for a reader and not a closure.
01Approved path
The clock started already
A treadmill importer settled with the Commission this August over a hazard known from March 2018 and reported in October 2022; those reports were triaged, not missed.
02Human review
What was checked, and not found
No live standard defines defect-report severity: IEEE 1044-2009 has been Inactive-Reserved since 5 March 2020, and the classes in IEC 62304 and ISO 26262 attach to a software item or a hazard, never to a report. Corrective action moved to ISO 13485 clause 8.5 via § 820.10(c) on 2 February 2026.
04Build an evidence trail
The report, the hour it arrived and the person who judged it stay together.
Integrations
Typical integrations
Five system groups connect to the same agent. Which of them are in scope is decided in discovery.
Defect and complaint trackingJira · Bugzilla · complaint logs Field and test defect records
Support and field intakeHelpdesk · CRM · field reports First-contact report lines
A class-level triage figure can read clean while injury-adjacent complaints carry most of the reviewer corrections. Nestack reports the correction rate by defect class, not only in total.
Slice performance — reported separately, not only in aggregateIllustrative example
Slice
Failure rate
Lift
Lift vs. threshold
Status
Injury-adjacent complaints
13.6%
3.7×
Review
Cross-regime field reports
9.6%
2.6×
Review
Duplicate-cluster outliers
6.0%
1.6×
Watch
Routine cosmetic defects
2.7%
0.7×
Normal
Bar: correction-rate lift vs. routine-cosmetic baseline · scale 0–4.0× · tick marks the 2.0× review threshold2 of 4 slices over threshold
Evidence-linked improvement
What a low-filed report costs
A cycle ends when the report held below the bar nobody set is a standing case. That suite is what the next intake window is measured against.
Improvement cycle · five stagesSwitchback — the path turns at Improve and returns at Learn
01Detect
Correction rate rises on injury-adjacent reports.
02Diagnose
The corrective action opened on a low-filed report, which stopped no clock and discharged no reporting duty, is worked backwards until one cause is left standing.
03Improve
The queue goes out numbered, and the reports beneath it ride with it.
04Verify
One reportability case still failing is enough to hold the queue back.
05Learn
It is kept for good, and the triage rules are amended in the same commit.
Learn → DetectThe return edge. The next intake meets a suite one case longer.
Typical build scope
Twelve workstreams across six weeks
The build scope read against the delivery timeline. Week structure follows the six-week plan — discovery, sources, triage workflow, evaluation, integration, then production validation and handover.
WorkstreamWeek 1Week 2Week 3Week 4Week 5Week 6
01Reportability triage and automation-boundary scope.
02Complaint, tracker and event-file sources.
03Reportability-clock and qualified-reviewer mappings.
04Complaint and report intake.
05Report dating and cluster binding.
06Confidence scoring and regulatory routing.
07Qualified-reviewer decision workflow.
08Event-file system integration.
09Reportability and severity cases.
10Guardrails and routing controls.
11Report-trail instrumentation.
12Deployment, documentation and Agent Care handover.
12 workstreams · 6 weeks · bar shows the weeks a workstream is active — several run in parallelFinal scope and sequence confirmed in discovery
Engagement tiers
What each tier includes
Rows are the capabilities named in each tier's scope. Higher tiers include everything below them.
Capability✓ in scope · — not at this tierPilotOne defect class, one cycleProductionProduction triage workflowAdvancedMultiple regimes / product lines
Introduced at Pilot
Triage to your reporting rules✓✓✓
Qualified-reviewer decision✓✓✓
Complaint-intake baseline✓✓✓
Introduced at Production
Reporting by defect class—✓✓
Regulatory review workflow in your systems—✓✓
Approved event-file write-back—✓✓
Tracker-and-file integration—✓✓
Introduced at Advanced
Multi-regime triage rules——✓
Cross-regime report packs——✓
High report volume——✓
Multi-regime deadline controls——✓
Build priceFrom $5,000From $8,000Custom quote
Final build priceConfirmed after discovery based on integrations, workflow complexity, report volume, routing controls and deployment requirements.
Separate from buildBuild pricing is separate from recurring Agent Care, which covers managed monitoring, evaluations, incidents and verified improvements after launch.
What we need from you
What you bring, and what we build with it
Each input maps to a piece of build scope and a week in the delivery timeline.
You bringWe build with it
01Your live defect classes and the duty each one can trigger→Triage-rule capture and clock versioningWeek 1
02Representative reports, complaint sets and past decisions→Source binding, linking logic and the intake baselineWeek 2
03Your escalation path and the reviewers it names→Triage-rule mapping, clock binding and the automation boundaryWeek 1
04Access to relevant APIs, feeds or exports→Complaint, tracker and event-file source assessment, then integration setupWeek 2
05Reports you would not want dated→Reportability cases and the failure roundWeek 4
06What no triage may conclude→Confidence scoring, review routing, guardrails and hold controlsWeek 3
07A qualified person who decides reportability→Handover to the qualified reviewer, then pilot and production validationWeeks 5–6
Nothing else is requiredDeployment, documentation and Agent Care handover are ours.
Delivery timeline
Four phases across six weeks
Week five carries two bands because those two phases coincide, not because the column reads better.
PhaseW1W2W3W4W5W6
DiscoveryW1
BuildW2 – W3
EvaluateW4 – W5
Pilot & LaunchW5 – W6
Week focusW1Triage-rule discovery, clock versioning and the automation boundaryW2Complaint and tracker integration and the intake baselineW3Report dating, linking logic and hold controlsW4Evaluation suite, reportability cases and failure-mode testingW5Event-file integration, pilot reports and targeted correctionsW6One intake cycle run under the quality lead, then Agent Care handover
Reading the bandEach bar covers the weeks its own work is named for, and week five holds a pair.
At the end of W6When the intake record validates, Agent Care takes the agent on.
DurationSix-week plan shown · typical delivery 4–6 weeks depending on scope confirmed in discovery.
Next step · Quality assurance AI agent
Build a defect triage agent around the report your last cycle filed below the line.
Show us one report you closed as not reportable. Not how quickly it was triaged. The hour an employee first knew, what the file holds of the reasoning, and whose name stands under the call. A clock that ran while nobody counted comes back as a case.
