Is Your Design on the Road to Success (Part 4 of 4)

Do your processes enable you?

In our previous article, we asked the following four questions to help our readers determine whether their design is on the road to success:

  1. Before you begin formal development, do you know exactly what your product will look like, how it will function, and how it will handle fault conditions?
  2. Do the tools your company uses for development, documentation, configuration management, verification, and complaint-handling work well with your processes?
  3. Does your company have a partner that can help you anywhere in your development cycle, from concept through design transfer, from usability to risk management, from process development and improvement to test lab preparation?
  4. Do your processes allow you to efficiently make changes to designs while meeting FDA and international regulations?

This article will focus on the last question, “Do your processes allow you to efficiently make changes to designs while meeting FDA and international regulations?”

This series is medical device-centric (FDA, ISO 14971, and so forth), but the recommendations apply to any regulated space.  The standard numbers and regulatory organizations (FAA instead of FDA, for example) may change, but good design is good design.

We’ve seen customers on both ends of this spectrum.  While some customers’ processes are so burdensome that a small design change can take a month to get approved, other customers have practically no formal processes in place, which makes it very difficult when it comes time to submit to regulatory bodies for marketing approval.  Let’s consider each case.

An overly burdensome process is characterized by:

  • Having too many reviews,
  • Having too many reviewers,
  • Review cycles that drag on for weeks or months, and/or
  • Reviewers who are unavailable when a release needs to be performed.
  • Having too many approvers
  • Enables re-hashing of questions that have been previously resolved
  • Is so rigid that projects have to stop for extended periods

On the other hand, a process that is too light may lack documented processes that describe (not a comprehensive list):

Like good requirements, the ideal process:

  • Clearly defines how the company operates,
  • Addresses all of the applicable standards and statutory requirements (risk management, design controls, etc.),
  • Is well-structured and easy to follow and understand,
  • Avoids dictating specifics at the Standard Operating Procedure level, focusing on the what rather than the how (leave the how to lower-level work instructions that are carefully tailored for efficiency),
  • Minimizes blocking points (e.g., reviews where a required attendee is not present), and
  • Provides contingency flexibility when a blocking point cannot be avoided.

Call The Realtime Group today at 972 985-9100 and let our quality experts help you!  If you don’t have any processes in place, ask us about providing your company with a lightweight Quality Management System framework, readily tailorable to your company’s needs and culture that gives you everything you need to be compliant without bogging your company down with excess process.  On the other hand, if you’re mired in bureaucratic processes, Realtime can help you lean out your processes to give you the flexibility you need while still maintaining compliance.