Navigating Changing Quality Requirements in a Regulated Industry
Quality standards from all institutions are periodically updated. A system that was designed to meet the quality requirements of yesterday, may not meet the requirements of tomorrow. How will you respond when an agency asks your firm if you have complied with the updates? There are many factors in determining the best course of action, but one thing is certain, the regulatory agencies will not accept doing nothing. Action doesn’t necessarily mean upgrading legacy manufacturing and computer systems throughout an entire organization to meet the new requirements. Realization of the cost of such an effort quickly jumps to the forethought. So what do you do? Well, a plan for action is a good place to start, and in most cases, is welcomed and appreciated from the agencies. So it’s simple, how do you get from here to there? Bring forth the “Transition Plan”.
The transition plan is the road map of how to get from there to here. Specifically speaking in terms of quality requirements, it should cover some key concepts:
- What is the current state? The current state should be an accurate depiction of all things associated with the changing requirements. It seems helpful to start with a list of the systems affected by the change. What are the current requirements?
- What is driving the change? Why do you need to change? What regulations from what agencies?
- What does the future state look like?
- How much work will need to be done to complete the transition? Should there be a method to determine prioritization. Does the work need to be prioritized in parts to focus on the more important parts?
- What are the risks? How will you deal with the risks? If you try to test a legacy system with requirements it was never designed to meet, it could fail. What will that failure implicate? Will historical produced lots need assessment? You did, after all, just fail to meet a quality requirement.
- Be prepared in advance to deal with potential failures. A good way to mitigate the impact of failures is to apply a prospective risk assessment. Think about what the potential failure modes would be then the impact that those failure modes
would have on the process and product. If this is navigated well, you’ll probably find that only a specific failure in a very specific way actually has real product impact.
- Write reports that demonstrate progress. Depending on how extensive the plan is, it may be necessary to show incremental improvement. Often you’ll find that the scope and method evolve over time and the reports are a good mechanism to capture those changes.
The general outline here has been generated and applied for some of the ICQ clients. They have undergone regulatory scrutiny with great success. The concept has been proven in application to satisfy agencies where gaps may exist.
Written By: George Jehourian, Consultant III
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