JD Consulting helped to develop a design control system that not only helped the client with their product development process, but also passed FDA inspection.

Problem:

Audit corrective action commitment specified design control program upgrade to meet QSR design control requirements. The client company was a manufacturing location that had recently acquired development projects. JD Consulting was selected to develop a workable program specific to the client’s operation.  The client was under a Warning Letter from the FDA, so time was of the essence.

Investigation and Analysis:

JD Consulting began with a comprehensive study of client operations and inter-relationships focused on both established and informal (previously unspecified) requirements for product development. First, JD Consulting conducted interviews throughout the organization. Next, JDC identified the key operational resource centers for efficient technology transfer. During the process, JDC collected potential obstacles or impediments for consideration within the overall design control strategy.

Solution:

JDC developed a custom design control to follow the current FDA design control guidance document format and vocabulary.

The program included:

1. A modular program with essentially stand-alone procedures allowing flexibility in development project scope.
2. Design review and document control strategies that allow flexibility and gave operational freedom (and responsibility) within an approved project plan
3. Sample forms and checklists identifying regulatory, standards and directive requirements.

JDC also developed a specific training program for each functional group, documented the procedure and conducted the training sessions. At the completion of this project, a QSR-compliant design control program had been fully implemented.

Results:

The completed design control program passed FDA inspection.  FDA inspectors were impressed with the innovative ideas that made the program easy to implement.  The client decided to use the program in an overseas operation as well.  The client continues to successfully use the program.

Jack Dhuwalia
© 2011