I’m an engineer by degree and my approach to solving problems. When posed with a project, issue, etc., I typically try to utilize “the process approach” to tackle the task. ISO 9001:2000 and 13485:2003 speak a great deal to this approach:
The cycle above is often referred to as “the Deming Cycle” and is better defined here. Other tools such as Design For Six Sigma (DFSS), DMAIC, and SIPOC use different terminology but very similar approaches. The point is that all these tools and approaches are useful for nearly any type of problem, issue, or project.
The November 2006 issue of MD&DI has an article that suggests using a design process approach to developing Design Control procedures. As the article suggests and based on my own experience, regulations for design controls are vague. Also, companies struggle a great deal with Design Control procedures usually because these processes are developed by individuals and updated on an ad hoc basis.
The next time you or your organization is challenged with creating or updating Design Control and other procedures, try some of techniques referenced above.
