The first deadline has passed for compliance with the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act. The Preventive Controls for Human Food rule is now final; for some, the compliance date began in September 2016. However, FDA issued guidance on September 6, 2016, for comment that has yet to be finalized, so there is still more to expect with regard to clarity and interpretation of the final rule. While there is still much to learn about how FDA will approach verification of compliance with this rule, there are key learnings that may help others who are in the process of meeting these requirements as well as developing a sustained compliance as we move into the future. Here are some tips to keep in mind as you work toward meeting the requirements of this new rule.

Scope Creep
Scope creep is a common issue and one that can significantly impede progress. Remember to keep the work focused on meeting the requirements of the rule. Both quality assurance (QA) and operations professionals have a tendency to want to address all potential issues or problems, even those outside the rule. This can add complexity, time and cost. Remain focused on the must-haves and remember that you can come back to the “parking lot items for improvement” later if justified.

Diverse groups work differently. A standardized approach to address the rule and its requirements is key. Even the most experienced employees may not recognize that other businesses work very differently, even in the same area. Some execute their work in silos and drive results. Much frustration and rework can be avoided if you take the time to include cross-functional stakeholders in the design of the work. This can also assist in the final alignment of the execution.

Don’t think you can do it in a silo! True leadership and commitment at the top are imperative. Communication is important, and getting the buy-in from senior leadership is a game changer. They need education and should be able to talk comfortably about the new requirements and justification for changes you may need to make in your day-to-day business.  

Success comes in many forms. While a QA professional writes policies and procedures, it is imperative that business experts review and provide feedback on all policies and procedures. This is important to ensure that the policy and processes are well aligned to how the business is run and that the employees can easily understand them for proper execution; it also allows the business to have ownership in the process and feel that it played a part in the creation and implementation of the new way of doing things.

Making Changes
Probably the most challenging part of making these changes is encountering leaders who verbalize how important the work is but do not back up their words with actions. The value of building the proper relationships and establishing trust can never be underestimated. Try to involve these leaders in facility walks, audit activities and actual implementation processes so that they get a chance to truly see the value of the changes and the importance of ownership.