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Introducing Our First In A Series of New R&Q Case Studies: Design History File Remediation

[fa icon="clock-o"] 2/12/16 12:56 PM [fa icon="user"] Stephen Biernacki [fa icon="folder-open'] remediation, Case Studies, Design History File Remediation

About R&Q's Case Studies: Our goal in producing case studies is to succinctly demonstrate how R&Q applied our unique expertise to tackle a client's challenge, implement a competent solution, and demonstrate real results. We will post each case study to our blog and offer a downloadable PDF as well, perfect for printing and/or emailing to colleagues and industry peers.

Our first case study focuses on Design History File Remediation and we hope you enjoy it. The content of future case studies will be around the services R&Q offers, including areas of regulatory, quality systems, design assurance, product quality, and post-market surveillance - particularly remediation. Subscribing to our blog is the best way to know when future case studies are available. View all of our available Case Studies.

 



Design history file remediation: compliance focused, with an eye on business needs.

 

Challenge

Quickly fix a DHF to reflect regulatory expectations.

A client’s product has been marketed for years with insufficient attention to DHF maintenance. As a result, the file was incomplete and not in compliance with regulatory expectations. Requirements, risk management, traceability, verification, and validation all needed “tender loving care” to bring them in line with the client’s recently updated quality management system. This was one of many products on a list for remediation, and as such, had a demanding timeline.


Solution

Risk-based remediation to work quickly and effectively.

The R&Q team worked handinhand with the client’s engineering and quality teams to piece together the fragmented and missing components of the DHF. After understanding the landscape, the team first remediated system level requirements and risk management. This allowed the R&Q team to focus on the most safetycritical areas of the product’s DHF, with the understanding that they did not have the time or the resources to create a “gold medal” DHF from the onset. The R&Q team constructed requirements, risk management, and traceability from the ground up. R&Q also led the client’s team in the proper construction of verification and validation protocols and records, including human factors.

 

Results

Fast remediation and a successful FDA inspection.

The R&Q team - consisting of a mechanical, electrical, and software expert - remediated the DHF of a complex electromechanical device in less than four months, and developed a quality plan to remediate the DHF further. Deliverables included approximately 3000 requirements (user needs, system, and 12 subsystems including software), a full risk management package, and thousands of pages of robust verification and validation protocols. Two months later, FDA inspectors audited the DHF during a design control audit with no findings. The inspector noted that this was the model the company should follow for subsequent remediation efforts.


 

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Case Study DHF Remediation

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