Our Work: Mitigating Field Issues
Multinational Medical Device Company Addresses Field Product Issues Through Audit
Background
A large medical device business faced a significant challenge with a newly launched product experiencing a high volume of product quality issues including complaints, reportable events, and even recalls.
Despite internal assessments indicating that their quality system was performing adequately, the persistent quality issues with the software prompted a need for an external evaluation.
Customer Challenge
The primary challenge was the high volume of product quality issues with the newly launched product's embedded software. These persistent issues were increasing system downtime and customer dissatisfaction.
The company’s internal assessments concluding their quality system was functioning properly, and no fundamental root cause could be determined with their design and development practices.
The discrepancy between perceived and actual performance highlighted the need for a thorough external assessment to identify potential risks and weaknesses in their processes.
Business leadership also worried about what a potential regulatory inspection might uncover, and what that impact might have on the business overall.
TRCG Approach
Engagement Objectives:
TRCG was engaged to perform an in-depth assessment focusing on three key areas:
Risk of Reactive Inspection: Evaluate the risk of a reactive inspection from externally visible signals.
Audit Risk: Assess the audit risk associated with the product quality situation.
Quality System Capability: Determine the Quality System's ability to manage product quality issues effectively.
Assessment Process:
Signals Assessment: TRCG associates began an analysis of externally visible signals for the client and similar products to determine the likelihood these signals might trigger a reactive FDA inspection.
Mock Audit: A thorough mock audit was designed to mimic an FDA reactive inspection, evaluating the business risk if such an inspection were initiated.
Quality Management System Analysis: Special care was taken to analyze the Quality Management System (QMS) and the artifacts it produces to determine the adequacy of the generated objective evidence for issue resolution.
Conducting the Audit
Signals Assessment:
Using both MDR and Recall data, we evaluated the post-market performance of the new product relative to other products the client manufactured, as well that of similar competitors. Leveraging this multi-perspective analysis provided our client a broader assurance.
Mock Audit:
Our audit team took two routes to mimic a reactive inspection, starting with both a sample of MDRs, as well as Recalls. Our team evaluated the links between the events and recalls, as well non-reportable events with the product; tracing backward from incidents into the design activities generating them; ultimately stressing investigation, design technical, and risk files, as well as the Subject Matter Experts (SMEs) participating in the audit.
QMS Assessment:
In the context of the post market issues sampled, our team assessed the adequacy of the QMS to support our backwards trace. We requested specific information, reviewed the defined root cause analysis process and associated tools, catalogued the required design artifacts, and identified opportunities for improvement in the execution of each area.
Results
Risk of Reactive Inspection:
The Desk Assessment confirmed that the client had a disproportionate volume of triggers in a number of indices, highlighting an elevated risk for a reactive inspection, as well as potential topics of concern.
Audit Risk
The mock audit highlighted a number of deficiencies with an overall assessment that the organization was not sufficiently prepared for a reactive inspection, and that such an inspection was a significant business risk.
Our team concluded:
The organization could not effectively correct or prevent safety issues.
Key SMEs were not effectively perform their duties.
Quality System Capability
While the QMS generated necessary objective evidence for issue resolution, Our team concluded:
Corrective & Preventive (CAPA) processes could be augmented with software specific Root Cause Analysis (RCA) guidance.
Personnel involved in Investigation and RCA activities had not utilized relevant design artifacts during the course of their investigation.
General Result
Following TRCG’s assessment, the organization took remediation steps and was ultimately better prepared for regulatory scrutiny. The insight provided also mitigated the risk of further quality issues and enhanced the organization's ability to manage product safety effectively.
Months later, the business did become the target of a reactive inspection, but having gone through similar lines of questioning during our mock audit, and the preparation and support provided by TRCG; the business successfully navigated the inspection without significant issue.
Timeline
TRCG understands that while compliance may be our business, it’s not yours. Keeping that top of mind, our teams seek to minimize disruption to business operations.
We were able to execute this entire engagement, from request and planning through reporting and advisement on remediations within three months — a single quarter. Keeping as many activities as possible remote, this swift and efficient timeline ensured that the client could quickly address and rectify the identified issues, minimizing disruption and risk.
Why TRCG
TRCG's associates have decades of Quality Management and Audit experience with some of the worlds largest and most successful organizations, as well as some of its smallest and most nimble. We’ve defended quality systems with regulatory authorities, and designed and maintained highly effective quality systems. Our comprehensive and focused approach provide you with not just compliance assurance, but strategies for building a more value-add quality system — driving better product and customer satisfaction.
We will provide you with the necessary insights to address your product quality issues and prepare for regulatory inspections. Our expertise in assessing risk and quality system capabilities will ensure your organization can identify and correct underlying problems promptly.