Risk Management
Risk Assessments · Mitigation Tracking · Risk Register · Trending
Identify risks before they become audit findings — and track mitigation before they become incidents. Replace static spreadsheets and point-in-time assessments with a living risk register that connects to every deviation, CAPA, and audit in your quality system.
A risk register that stays current
Every risk record is linked to the quality events that inform it — deviations, CAPAs, audit findings, supplier issues. When something changes in one area, the risk picture updates with it.
Structured assessments, not freeform documents
Severity, likelihood, detectability, and risk score calculated consistently across all assessors, all sites, and all risk categories — so your risk register holds up under regulatory scrutiny.
AI that flags what’s emerging
Kintavo AI monitors your risk records alongside deviation and CAPA trends to surface risks that are increasing in likelihood before they cross a threshold — giving your team time to act rather than react.
Risk is part of compliance — not separate from it.
A risk in Kintavo is connected to the CAPAs it generated, the deviations that revealed it, the changes it influenced, and the suppliers it involves. Risk management is not isolated.
Risk doesn't live alone.
Every risk connects to the deviations that revealed it, the CAPAs that addressed it, and the changes it influenced.
Find the risk before it becomes a finding.
Risk that's identified and mitigated never becomes an audit finding. Kintavo gives quality teams a structured, connected system to identify, assess, and mitigate risk before it surfaces somewhere worse.
From identification to verified mitigation.
Every risk follows the same structured workflow — identification, assessment, planning, mitigation, monitoring — with the audit trail built as the process runs.
Identify
Capture risks linked to processes, products, equipment, and quality events.
Assess
ISO 14971-aligned scoring with configurable risk matrices.
Plan
Mitigation actions assigned with deadlines and owners.
Mitigate
Actions tracked through completion. Residual risk verified.
Monitor
Periodic reassessment. Trending across products and processes.
Ready to see the full platform working for your organization?
Book a personalized demo. We'll show you Kintavo configured for your regulatory environment and your specific workflows — not a generic product tour.
FAQ Questions & Answers
Q: What kinds of risks can be managed in Kintavo?
Kintavo's Risk Management module is designed for any risk category relevant to a regulated quality organization — process risks, product risks, equipment risks, supplier risks, regulatory compliance risks, and organizational risks. Risk categories, scoring matrices, and assessment templates are all configurable by your QA team, so the system reflects how your organization actually thinks about risk rather than forcing a generic framework on your processes.
Q: What risk methodology does Kintavo support?
Kintavo supports FMEA-style risk assessments (severity × likelihood × detectability = RPN) as well as simpler 2-factor matrices (severity × likelihood) depending on your needs and regulatory context. ISO 14971, ICH Q9, and general GxP risk principles are all supported. Your team configures the scoring scales and risk thresholds; Kintavo calculates and enforces them consistently across every assessment.
Q: How does the risk register connect to other quality modules?
Every risk record in Kintavo can be linked to the deviations, CAPAs, audit findings, supplier records, or equipment events that inform it. When a linked deviation is opened or a CAPA closes ineffectively, the risk record is flagged for reassessment. This keeps your risk register from becoming a static document that drifts out of date between formal review cycles.
Q: Can we track mitigation actions and verify they were effective?
Yes. Each risk record supports one or more mitigation actions with owners, due dates, and completion requirements. Once a mitigation is marked complete, the risk record can be reassessed to calculate the residual risk score. If the residual score still exceeds your threshold, the record stays open. Effectiveness verification is part of the workflow, not an afterthought.
Q: How does periodic risk review work?
Kintavo can be configured to trigger periodic review reminders on risk records — quarterly, semi-annually, or on whatever cycle your SOPs require. Owners receive notifications when a review is due, and a no-change attestation or updated assessment is required to reset the review clock. All review activity is captured in the audit trail.
Q: Who can initiate and update risk records?
Risk record initiation can be open to any qualified user or restricted to QA and management roles depending on your configuration. Most organizations allow risk identification to come from anywhere — production, lab, quality, clinical — and restrict assessment and scoring to trained QA staff. Kintavo's role-based permissions support whatever model your organization uses.
Q: Does Kintavo support risk-based decision making for CAPAs and audits?
Yes. Risk scores from Kintavo's risk register can inform prioritization in both CAPA and Audit Management. High-risk areas can be flagged for more frequent internal audits, and CAPA records can reference the risk records they're intended to mitigate. This creates a defensible, traceable link between your risk management program and your corrective action activity — exactly what regulators look for in a mature quality system.
Q: Is the risk register compliant with ISO 14971 and ICH Q9?
Kintavo's risk module is designed to support the documentation and process requirements of both ISO 14971 (medical devices) and ICH Q9 (pharmaceuticals). This includes structured hazard identification, risk estimation, risk evaluation, risk control, and residual risk documentation. The specific implementation is configured by your team to match your regulatory context and applicable standards.
Q: Can we run risk assessments on suppliers and equipment, not just processes?
Yes. Risk assessments in Kintavo can be scoped to any object in the system — a specific supplier, a piece of equipment, a process step, a product type, or a site. Supplier risk scores feed into Supplier Quality monitoring frequency. Equipment risk scores can inform calibration and maintenance intervals. The risk module is not siloed from the rest of the platform.
Q: What does implementation look like for Risk Management?
Your dedicated implementation lead works with your QA team to configure risk categories, scoring matrices, assessment templates, thresholds, and review cycles — typically within the first two to three weeks of onboarding. Existing risk registers can be migrated from spreadsheets or prior systems. Most customers have their risk register live and actively maintained within 30 days of kickoff.
Your risk register is a document. It shouldn't be.
A spreadsheet captures risk at a point in time — but your quality system generates new information every day. Deviations open. CAPAs close ineffectively. Suppliers miss qualifications. Equipment trends toward failure. None of that automatically updates a static risk register, which means the document your leadership reviews and your auditors inspect is always a version behind reality.
Kintavo Risk Management gives you a living risk register that stays current because it's connected to everything else. Assessments that calculate consistently across every assessor and every site. Mitigation tracking with owners, due dates, and effectiveness verification. And AI that monitors your deviation and CAPA activity to surface emerging risks before they cross a threshold — giving your team time to act rather than react.