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Failure Analysis & CAPA

Driving Continuous Improvement through Systematic Problem Solving
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Failure Analysis & CAPA
Medical Devices
Combination Products
Drug Products
Personal Care Products
Our Failure Analysis & CAPA (Corrective and Preventive Action) services are designed to systematically identify, investigate, and resolve quality issues, thereby preventing recurrence and ensuring compliance with regulatory standards.​

About 40% of reported failures in MedTech can be attributed to materials, ranging from materials quality and appropriate selection to withstanding demanding performance requirements. When a sponsor notices a reported failure or complaint is associated with a device material, Chemva supports them by:​

- Employing structured methodologies to uncover the underlying causes of product or process failures.​

- Developing and evaluating effective corrective measures to address identified issues.​

- Establishing and executing a structured plan to correct and prevent quality problems, ensuring alignment with regulatory requirements.

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Medical Devices
Combination Products
Drug Products
Personal Care Products
Solutions
End-to-End Support for Safer, Smarter Medical Devices
Root Cause Analysis (RCA)

In the medical device and drug packaging, ensuring product quality and patient safety is paramount.

Root Cause Analysis (RCA) is a systematic process employed to identify the fundamental causes of defects or problems, rather than merely addressing their symptoms.

By uncovering these underlying issues, manufacturers can implement effective corrective and preventive actions, thereby enhancing product reliability and ensuring compliance with regulatory standards.​

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Root Cause Analysis (RCA)
Root Cause Analysis (RCA)

Our Approach

Our RCA service serves as a critical component of a robust Quality Management System (QMS), aligning with international standards such as ISO 13485 and regulatory requirements like FDA's 21 CFR Part 820.

  • Problem Definition and Scoping: Helping clients clarify the problem, define the affected systems or materials, and establish the scope of the investigation.
  • Failure Mode Investigation: Supporting technical evaluation of issues such as unexpected biological responses, chemical outliers, or test result variability.
  • Data Collection and Review: Guiding the collection and interpretation of analytical, historical, and manufacturing data including supplier assessments, test results, and material traceability.
  • Corrective/Preventive Action (CAPA) Strategy: Providing input on risk-based CAPA plans that are defensible in audits and inspections, from containment to long-term risk mitigation.
  • Regulatory-Ready Documentation: Drafting or reviewing RCA reports suitable for inclusion in regulatory submissions, internal audits, or responses to 483 observations and warning letters.

Common RCA Uses

  • Material Breakage or Brittle Failure: Device component fractures under expected loading due to formulation changes or process stress
  • Polymer Degradation or Instability: Unexpected degradation products observed in E/L studies or ISO 10993-13/14/15 testing
  • Discoloration, Delamination, or Cracking: Surface changes from sterilization, cleaning agents, or migration of additives
  • Unexpected Bioreactivity in Biocompatibility Testing: cytotoxicity or sensitization tied to leachable constituents or process residues
  • Out-of-Spec E/L Profiles or Analytical Failures: Unidentified peaks, contaminant carryover, or packaging interaction
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Solution Investigation/CAPA

 At Chemva, we help clients move from root cause understanding to effective resolution.

Once the underlying issue is identified through Root Cause Analysis (RCA), our Solution Investigation service supports the development of targeted, risk-based corrective actions that are scientifically and regulatorily sound, effective in preventing recurrence.

This service is an essential part of a robust CAPA process, aligned with FDA 21 CFR 820.100, ISO 13485, and risk management principles in ISO 14971.Purpose and Importance

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Solution Investigation/CAPA
Solution Investigation/CAPA

Our Approach

  • Feasibility & Impact Assessment of Solutions: Evaluating the practical and technical viability of proposed corrective actions, considering product design, manufacturing constraints, and regulatory risk.
  • Scientific & Technical Justification: Supporting evidence-based decision-making by assessing how each potential solution addresses the root cause, especially for materials, chemical interactions, or process conditions.
  •  Alternatives Evaluation & Trade-Off Analysis: Helping sponsors compare solutions (e.g., reformulation vs. supplier change vs. process revalidation) using risk/benefit and regulatory impact frameworks.
  • Verification & Effectiveness Planning: Advising on how to verify implemented actions resolve the issue, with clear criteria, timelines, and validation/verification study design.
  • CAPA Documentation for Regulatory Audits: Assisting in compiling documentation that demonstrates a clear trace from RCA → solution → verification → closure — aligned with FDA and ISO auditor expectations.
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Trust Figures
Transforming Material Challenges into Insights
23
+
Root cause investigations completed, identifying material related issues behind product failures
4
End-to-end CAPA delivered, from investigation to corrective action implementation
99.5
%
Product performance restored by finding the root case and resolving the issue with an alternative adhesive for a critical device joint
CHEMVA
Proven Results
Real-World Insights From Complex Projects
Learn about our scientific approach that helps clients.
Biocompatibility
Biological Evaluation Plan (BEP) for a Next-Generation Implantable Device
Developed a risk-based BEP to meet FDA and ISO 10993-1 standards, helping the client avoid delays and save $300K through targeted testing.
Biocompatibility
Medical Devices; Combination Products; Drug Products
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Details
Biocompatibility
Connectors Cracking: A Root Cause Analysis and Material Selection Effort
Chemva’s systematic approach not only resolved the cracking issue but also enhanced the product’s long-term reliability and manufacturability.
Materials, Failure Analysis & CAPA
Medical Devices; Combination Products; Drug Products, Personal Care Products
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Details
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