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.
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.
FSMA Preventive Controls: Tips for Compliance
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.
Some good ideas for moving the needle forward include benchmarking with other retailers or businesses that are facing the same
changes. Don’t underestimate the change management that will
be necessary. The retail industry is very
complex, as is the supply chain, and
new regulatory requirements add
esponsibility and can cause undue
pressure. Take this into consideration and plan, plan, plan. Always
hink about unintended consequences. Be sure to utilize the
expertise of frontline workers.
They do the jobs every day and
know the most about potential
ssues or roadblocks that could
Where Do We Go from Here?
Develop metrics to gauge the success of your work
and program implementation. It is important for leadership to easily visualize how your work and changes have
impacted the business as well as the compliance status. Conduct mock audits and other activities where employees can
be a part of the learning process and better understand how to
integrate the new requirements into their jobs. Be sure to have
at least a 3-year communication plan for continued reinforcement of the rules, the requirements and the whys. This is no
longer just a “special project” but a new way of being that will
need to be continually executed.