ParanoiaIQ — CAPA Investigation Tool Preview

Overview

Seven tools. One nonconformance. 30 seconds.

The CAPA Investigation Tool runs a structured opening analysis on any nonconformance, complaint, or audit finding. It produces a formal problem statement, sets the priority tier, defines scope, identifies containment actions, assesses field action risk, calculates regulatory deadlines, and generates a step-by-step investigation agenda — all before the CAPA owner touches the form.

Problem Statement

Generates a formal IS / IS NOT analysis and a structured problem statement from raw inputs. Prevents vague CAPA scope that fails inspection.

IS / IS NOT Method

Priority & Classification

Classifies the CAPA as CRITICAL / MAJOR / MINOR / OBSERVATION with regulatory basis. Determines routing — internal CAPA, external CAPA, or evaluate first.

ISO 13485:2016 §8.5.2

Scope Boundary

Defines what is in scope and what is explicitly out of scope. Open questions that require investigation before scope can be confirmed are surfaced and assigned.

ISO 13485:2016 §8.5.2(a)

Containment Plan

Identifies immediate containment actions with urgency flags. Distinguishes actions required today from those required before root cause completion.

ISO 13485 §8.5.3

Field Action Risk

Evaluates whether in-field units pose patient safety risk. Risk levels: HIGH (recall/notice likely required), MEDIUM (evaluate further), LOW (no action indicated).

21 CFR Part 806 / ISO 14971

Deadline Calculation

Calculates containment, root cause, corrective action, and closure deadlines based on priority tier and date opened. Flags overdue and urgent milestones.

ISO 13485:2016 §8.5.2

Investigation Agenda

Generates a prioritized, role-assigned investigation agenda with specific tasks, owners, and regulatory references for each step.

CAPA SOP / ISO 13485

Step 1 (alternate) — AI-assisted entry

Paste a raw problem description — the AI fills the form

Paste any CAPA input text — an NCR narrative, audit finding write-up, complaint description, or meeting notes. The AI extracts all structured fields with confidence ratings. Reviewer confirms before running the analysis.

ParanoiaIQ — CAPA Investigation · AI Extract

Tool UI — AI Extraction Results

ParanoiaIQ

CAPA Investigation

AI Extract

Manual Entry

History

API Key

••••••••••••••••

Paste Problem Description

NCR-2026-041: During final QC of LOT-2026-0041 (23 units, FMP-300 infusion pump), flow rate testing at 125 mL/hr revealed delivery error of +14.8%. Specification tolerance is ±5%. Life-sustaining device...

Extract Fields with AI

Extracted — Review Before Running

Product

FMP-300 Infusion Pump

✓

Failure Mode

Flow rate over-delivery

✓

Detection

Final Inspection

✓

Units Affected

✓

Life-Sustaining

Yes

✓

Patient Outcome

No involvement

→ Use These Fields

What Gets Extracted

Claude reads the raw problem description and extracts every field needed for the CAPA analysis — product name, component, failure mode, detection point, units affected, lot number, risk flags, and patient outcome.

Source types it handles well

• Internal NCR write-ups
• Audit finding descriptions (FDA 483, notified body)
• Complaint summaries and MDR narratives
• Management review action items
• Supplier corrective action requests (SCARs)

Risk flags (life-sustaining, sterile product, vulnerable population) are confidence-rated separately. They drive the priority tier directly.

Paste any CAPA input — NCR narrative, audit finding, complaint. AI extracts structured fields and confidence-rates each one. Life-sustaining and sterility flags are detected from text and explicitly surfaced for reviewer confirmation.

ParanoiaIQ

CAPA Opening Report — CAPA-2026-0089 · FlowMaster IV Infusion Pump

ISO 13485 · ISO 14971 · 21 CFR 806

⚠ Do These Today — Immediate Containment Required

Quarantine all 23 units from LOT-2026-0041 — hold for inspection and disposition. No shipment until root cause is understood and lot is cleared or rejected.

Check adjacent lots (LOT-2026-0039, LOT-2026-0040) for same flow sensor configuration — same supplier calibration batch may be implicated.

Problem Statement

IS / IS NOT

"The FlowMaster IV Infusion Pump (FMP-300), LOT-2026-0041, is delivering flow rates 14.8% above setpoint at the 125 mL/hr setting — exceeding the ±5% specification tolerance — as identified during final QC inspection on April 15, 2026."

FMP-300 model, LOT-2026-0041 (23 units)

125 mL/hr flow rate setting

Final QC inspection — in-house, pre-shipment

+14.8% over-delivery (spec: ±5%)

IS NOT

Not detected in released or distributed units

Not confirmed across all flow rate settings

Not yet linked to specific sub-component root cause

Not observed in adjacent lots (pending verification)

Priority & Classification

ISO 13485:2016 §8.5.2

CRITICAL Internal CAPA

Corrective action · NCR source

Life-sustaining device — flow rate error can cause patient harm
23 units affected — lot-level failure, not isolated unit
Failure mode directly affects device primary function
Out-of-specification at 2.96× tolerance limit

Scope Boundary

ISO 13485:2016 §8.5.2(a)

In Scope

Flow sensor calibration process for FMP-300

LOT-2026-0041 disposition decision

Adjacent lot verification (0039, 0040)

Sensor supplier qualification review

Out of Scope

Other FMP models (FMP-200, FMP-400)

Other flow rate settings until verified

Design changes — corrective action first

Open Questions

? Is calibration error consistent across all 23 units or random?
? Same sensor batch used in adjacent lots?
? Supplier calibration certificate for this lot — obtained?

Containment Plan

ISO 13485:2016 §8.5.3

TODAY

Quarantine LOT-2026-0041 — all 23 units. Physical hold tag. Block from shipment in ERP/WMS.

TODAY

Pull and inspect 5 units from adjacent lots (0039, 0040) at 125 mL/hr — document results.

48 HRS

Pull supplier calibration certificates for sensor batch — compare to accepted specification.

48 HRS

Review final QC test records for this lot — determine when and how deviation first appeared.

Field Action Risk

21 CFR Part 806 · ISO 14971

HIGH RISK

Life-sustaining device — flow rate error directly affects drug delivery
If any affected units were distributed, patient harm is possible
15% over-delivery of certain medications (e.g. vasopressors, anticoagulants) is clinically significant

⚑ If any LOT-2026-0041 units have been shipped, evaluate for field safety corrective action under 21 CFR Part 806. Confirm full lot disposition before closing containment.

CAPA Deadlines

ISO 13485:2016 §8.5.2

Containment

Apr 22, 2026

⚑ Urgent — 5 days

Root Cause

May 15, 2026

30 days

Actions Complete

Jun 14, 2026

60 days

Closure Target

Jul 14, 2026

90 days

Generated Investigation Agenda

100% flow rate verification of all 23 LOT-2026-0041 units at 125 mL/hr — document individual results

Owner: QC Engineering ISO 13485 §8.2.4

Retrieve and review flow sensor calibration records and supplier CoC for this lot — compare to acceptance criteria

Owner: Supplier Quality / Incoming Inspection ISO 13485 §7.4

Run 5-factor fishbone (6M) — Machine, Method, Material (sensor), Measurement, Man — identify most likely root cause category

Owner: CAPA Owner / QA Engineer ISO 13485 §8.5.2(b)

Verify adjacent lots LOT-2026-0039 and LOT-2026-0040 — same sensor batch, same calibration procedure

Owner: QC / Manufacturing Engineering ISO 13485 §8.5.3

Review manufacturing batch records for LOT-2026-0041 — process parameters, in-process checks, operator sign-offs

Owner: Manufacturing QA ISO 13485 §7.5.1

Confirm lot distribution status — verify no units shipped. If any distributed, initiate field action risk assessment under 21 CFR Part 806

Owner: Regulatory Affairs / QA Management 21 CFR Part 806

Define corrective action — address root cause. Define effectiveness check criteria before closure

Owner: CAPA Owner ISO 13485 §8.5.2(c)(d)

CAPA Opening Summary

This CAPA addresses a flow rate over-delivery failure identified during final QC inspection of the FlowMaster IV Infusion Pump (FMP-300), LOT-2026-0041. Testing at the 125 mL/hr setting revealed flow rates 14.8% above setpoint — 2.96× the ±5% specification tolerance. 23 units from this lot are affected. No patient involvement has been confirmed; all units were intercepted pre-shipment.

Why CRITICAL

The CRITICAL classification is driven by three factors acting together: this is a life-sustaining device (infusion pump), the failure mode directly affects primary device function (drug delivery accuracy), and the magnitude of the deviation (14.8% vs. ±5% tolerance) is substantial. Sterility or life-sustaining device failures are never classified Minor under ISO 13485 §8.5.2 regardless of detection point or patient involvement. The CRITICAL tier carries a 30-day root cause requirement and 90-day closure target.

Field Action Risk

Field action risk is assessed as HIGH. While all known affected units were intercepted in-house, the first step in the investigation must confirm that no units from this lot or adjacent lots were distributed. If distribution is confirmed, the flow rate error profile of this device class — used for IV medication delivery including drugs with narrow therapeutic windows — creates potential for patient harm. A field safety evaluation under 21 CFR Part 806 would be required in that scenario.

Scope and Root Cause Direction

Root cause analysis should focus on the flow sensor calibration chain: sensor supplier calibration certificate, incoming inspection acceptance criteria, and in-process calibration verification during assembly. The IS / IS NOT analysis constrains scope to this lot and this failure mode — expanding scope prematurely to other models or settings before root cause is established is a common CAPA failure pattern that extends timelines without improving outcomes.

ParanoiaIQ — What This Means

This CAPA is CRITICAL. That classification has specific consequences.

A CRITICAL CAPA on a life-sustaining device with a lot-level failure mode is not a routine quality event. FDA's QMSR expectation — and ISO 13485 §8.5.2 requirement — is that the root cause is identified, the corrective action is validated, and effectiveness is confirmed before closure. Most Warning Letters citing CAPA deficiencies are not about companies that skipped CAPA. They are about companies that closed CAPA without confirmed root cause or without validated effectiveness checks.

If FDA reviews this CAPA later, the expectation existed at the time of this decision — not after more data was gathered. The investigation standard is set at opening, not at closure.

Option 1 — Handle Internally

Proceed with internal QA team. Requires: CAPA SOP aligned to ISO 13485 §8.5.2, engineering resources for root cause analysis, validated effectiveness check protocol, and QA management bandwidth to hold the timeline. Realistic at well-resourced companies.

Option 2 — CAPA Reset Sprint

Engage ParanoiaIQ for a focused sprint: investigation structure, root cause facilitation, corrective action design, and effectiveness check criteria. Typical engagement: 3–5 days of structured work over 2–3 weeks. CRITICAL tier — 30-day root cause clock is already running.

→ Engage on This CAPA

mcollins@paranoiaiq.com · Response within 24 hours

Tool	Regulation / Standard	Decision Logic	Output Type
Problem Statement	IS / IS NOT Method	Formal statement + IS / IS NOT matrix from raw inputs — prevents vague scope at opening	Generated
Priority & Classification	ISO 13485:2016 §8.5.2	CRITICAL / MAJOR / MINOR / OBSERVATION; life-sustaining and sterility flags override to CRITICAL/MAJOR	Automated
Scope Boundary	ISO 13485:2016 §8.5.2(a)	In scope / out of scope / open questions; limits scope creep while ensuring full coverage	Generated
Containment Plan	ISO 13485:2016 §8.5.3	Immediate actions (today) vs. short-term (48 hrs) — urgency-flagged and role-assigned	Generated
Field Action Risk	21 CFR Part 806 · ISO 14971	HIGH / MEDIUM / LOW based on patient exposure, device class, and failure mode severity	Automated
Deadline Calculation	ISO 13485:2016 §8.5.2	Containment, root cause, actions, closure — calculated from date opened and priority tier	Calculated
Investigation Agenda	CAPA SOP / ISO 13485	Prioritized steps with task description, owner, and specific regulatory reference for each action	Generated