Change can bring either an opportunity or a setback, depending on how you handle it. This is applicable to all aspects of your life. But in business, the ability to adapt to change is critical to your success. If your company is regulated by the FDA, or certified through ISO, being able to control changes is critical to maintaining compliance with these regulations. Failure to have a robust change control system not only exposes the company to compliance risks, it also presents the opportunity for a waste of resources and increases the cost of doing business due to this waste. The expectation is that all changes have been thoroughly reviewed by the appropriate experts to identify any potential impact of the change. Also, there must be a way to ensure the change did not have any negative impact on the product or its users. A key step to take, prior to making any changes, is to document the rationale for making the identified adjustments.
The principle of “change control” is addressed in ISO standards and GMP regulations. From the viewpoint of these regulations, change management is meant to help manufacturers ensure production of safe and high-quality products in spite of any changes in the design of the product, equipment, manufacturing materials, processes, computer systems and all associated documentation. In 21 CFR Part 820, the FDA has identified a number of areas that are encompassed in change management: design changes, document changes, production and process changes, process validation changes or process deviations, and non-conforming product.
The hope is that all potential impact is recognized and addressed prior to making the identified changes. The easiest way to make sure all aspects are considered is to have appropriate procedures in place to guide the process. The fundamentals of your change management system should be spelled out in your quality manual. From there, it is suggested to have a “master change control” system and a number of subsystems to address the various types of changes. The master SOP will typically define the overall responsibility and authority for reporting, investigating and decision-making for critical changes. For each of the change management subsystems, an SOP should be in place, defining a given change and how to manage it. You will also need to make sure there is an effective audit trail in place to provide confidence that the desired changes are implemented in a controlled environment with documentation and proof of training (when necessary).
Change can originate from numerous sources, such as customer complaints, returns, non-conformances, etc. There may also be various people, facilities and/or departments involved in the change management process. Any given change can effect materials, facilities, utilities, product design, formulations, processes, packaging, labeling, equipment, computer systems, and documentation.
Let’s talk biological indicators!
Talk with one of our experts to get your questions answered and see how we can help you solve your BI pain points.