Root Cause Investigation Support

When quality issues arise, identifying the true cause — not just the symptom — is critical to protecting patient safety, product integrity, and regulatory compliance. At Heurnova Consulting, we provide structured, data-driven root cause investigation support to help your organization resolve deviations, complaints, and nonconformances efficiently and effectively.

Our approach blends engineering expertise with regulatory insight to uncover systemic contributors across design, manufacturing, and supplier processes. Using methodologies such as 5 Whys, Ishikawa (Fishbone) Diagrams, Fault Tree Analysis (FTA), and Failure Mode and Effects Analysis (FMEA), we guide teams through a defensible, evidence-based investigation process that satisfies both internal quality requirements and external auditor expectations.

We go beyond identifying causes — we help you implement sustainable corrective and preventive actions (CAPA) that address process weaknesses and prevent recurrence. From data gathering and cross-functional facilitation to verification of effectiveness and documentation alignment, our team ensures that every step stands up to scrutiny.

Whether you’re responding to a regulatory audit, addressing recurring failures, or improving overall process resilience, Heurnova Consulting provides the clarity, tools, and technical depth needed to turn investigations into lasting improvement.

Problem Definition & Containment

Are you experiencing product failures, complaints, or nonconformances and need to quickly stabilize the situation while determining what went wrong? We help clearly define the issue, scope its impact, and implement containment actions to prevent further occurrence while the investigation proceeds.

This includes isolating affected batches, placing controls on ongoing production, and establishing interim safeguards. The result is a controlled environment that prevents escalation, protects customers, and sets a clean foundation for accurate root cause analysis.

Deliverables we can provide include, but are not limited to:

Clearly describe the nonconformance or complaint with factual data.
Verify scope (isolated incident vs. systemic issue).
Implement containment measures to stop further occurrence.
Document affected lots, devices, or processes.
Maintain communication logs with stakeholders and regulators if applicable.

Data Collection & Evidence Review

Do you need clarity on what data is relevant to the investigation — and how to evaluate it objectively? We structure the evidence-gathering process, reviewing production records, test data, deviations, field feedback, supplier documentation, and environmental or operator factors. We separate signal from noise, ensuring only meaningful data informs conclusions. This evidence-based approach supports unbiased decision-making and increases investigation accuracy and credibility.

Deliverables we can provide include, but are not limited to:

Gather test data, device history records (DHR), maintenance logs, and calibration certificates.
Review batch records and prior CAPAs for patterns.
Verify completeness and integrity of electronic data (ALCOA+ principles).
Record all observations and witness statements contemporaneously.
Maintain chain-of-custody documentation for samples or materials.

Root Cause Analysis (RCA) Techniques

Not sure which analysis method is most appropriate for your situation? We apply the appropriate RCA framework — such as 5 Whys, Fishbone/Ishikawa, Fault Tree Analysis, or DOE-based confirmation — depending on the nature of the failure. Our method ensures exploration of mechanical, process, human, environmental, and systemic contributors. This produces a defensible and well-supported root cause determination rather than guesswork or assumption-driven conclusions.

Deliverables we can provide include, but are not limited to:

Select the most appropriate tool: 5 Whys, Fishbone Diagram (Ishikawa), Fault Tree Analysis, or Kepner-Tregoe.
Include both technical and human factors.
Validate findings against process maps and specifications.
Correlate with risk management files (ISO 14971).
Ensure cross-functional participation for unbiased conclusions.

Verification of Root Cause & Corrective Action

How can you be confident that the proposed fix truly addresses the problem — and will not recur? We design and oversee verification activities that demonstrate the corrective action effectively resolves the identified root cause.

This includes test plans, data review, performance evaluation, and confirmation runs where necessary. You’ll receive clear, objective evidence that the issue has been resolved and will not repeat under normal use conditions.

Deliverables we can provide include, but are not limited to:

Test hypotheses by simulating or reproducing failure modes.
Link proposed corrections to measurable verification criteria.
Review potential unintended consequences of the fix.
Define success metrics and timelines for CAPA closure.
Confirm implementation effectiveness before closure.

Documentation & Regulatory Alignment

Do you need your investigation and corrective action to be documented in a clear, audit-ready, and regulatorily aligned format? We develop structured investigation reports, CAPA documentation, and supporting evidence packages aligned to ISO 13485, 21 CFR 820, and global regulatory expectations.

This ensures full traceability from issue identification through resolution, providing documentation that withstands internal, customer, and regulatory audits.

Deliverables we can provide include, but are not limited to:

Maintain investigation reports with clear problem statements, findings, and corrective/preventive actions.
Ensure linkage between complaint records, NCRs, CAPAs, and risk management documentation.
Retain all supporting evidence in the QMS under document control.
Include lessons learned in management review and training updates.
Prepare audit-ready summaries showing objective evidence and decision logic.

Continuous Improvement & Trending

Would you like to prevent future issues by identifying systemic contributors and improvement opportunities? We analyze recurring patterns, process interactions, and system vulnerabilities to identify areas for long-term improvement.

We help establish trending dashboards, monitoring criteria, and preventive action triggers. This shifts quality management from reactive to proactive — reinforcing product reliability, operational stability, and customer trust.

Deliverables we can provide include, but are not limited to:

Track CAPA effectiveness metrics and failure rates over time.
Analyze trends across similar products, processes, or suppliers.
Integrate findings into FMEA and design updates.
Use investigation outcomes to refine training and preventive controls.
Communicate results to leadership and quality teams for proactive action.

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