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Food & Bev

Managing Organizational Changes the FSMA Will Bring

Bill Bremer, Principal Food Safety Compliance, Kestrel Management

The Food Safety Modernization Act (FSMA) spreads responsibility for food safety to every worker in the organization, from equipment operators on the plant floor to executives in office suites. Compliance with the new law will require organizational change from the bottom up.

Ignorance is no excuse under the FSMA, which can impose criminal fines of up to $250,000 on individual workers for looking the other way when safety lapses occur. The law pushes accountability for contamination all the way up the chain of command. Managers and executives who fail to clamp down on unsafe practices could be held as liable as workers on the plant floor.

Compliance requires more than paperwork. Companies must adopt an organizational structure that empowers their food safety staff to enforce preventive controls, but the true measure of FSMA compliance will be the spread of a culture of safety throughout the organization. Every employee must take their new responsibilities to heart.

One Position, Many Roles

The FSMA creates the position of a “qualified individual” (QI), an employee who will be responsible for developing and implementing your facility’s food safety plan. Selecting a QI is a difficult task--the individual must have a broad skill set, possessing both extensive technical knowledge and the power of persuasion. As any manager can tell you, crafting a plan is one thing--implementing it is another.

First, the QI must have a comprehensive food safety background and a thorough understanding of your plant’s operations. They must be able to identify the points where contamination could originate, so they need to know the plant’s operations inside and out. Every step of food preparation, from the loading dock to the warehouse to the quality-assurance labs, should be covered by preventive controls.

But developing a comprehensive set of preventive controls is only the first step. The QI is also responsible for verifying and validating the plan. They must keep detailed records that not only prove that the safety plan has been implemented, but also that the controls are effectively eliminating contamination risks. Developing a food safety plan requires the mindset of a scientist; validation demands a detective.

Finally, the QI needs to be a skilled administrator, able to wield real power over the plant’s daily operations. By law, the QI has the ultimate authority to shut down the plant entirely, halting all production until it is in compliance with the food safety plan. In reality, an effective QI will never need to take that step--they will have intervened beforehand, rooting out problems before they threaten the plant’s ability to operate safely.

The company can help the QI succeed by carefully designing the position:

  • Build an Effective Team No individual worker can fulfill all the QI’s roles singlehandedly. Appoint a team that will help the lead QI by providing technical knowledge of the plant’s operations, as well as helping verify record keeping. A list of alternates should also be prepared to take over implementation of the food safety plan when the QI is off duty. A single individual may have to hold the ultimate responsibility for the safety plan, but they shouldn’t be left alone to carry it out.
  • Clear a Channel to Upper Management The QI needs to have access to managers with the authority to implement changes to processes and personnel. The QI position will have considerable power to oversee the plant’s daily operations, so the position should be able to report directly to the facility’s manager.
  • Prepare to Resolve Conflicts Anticipate conflicts when implementing a new food safety plan--some workers and supervisors may resent having to make changes to their routine or carry out new documentation requirements. When conflicts arise, management needs to have a plan that backs up the QI’s authority without devaluing its employees.
  • Create a Culture of Safety The QI may have the ultimate authority to implement the food safety plan, but the responsibility for carrying it out rests with every employee. Training across all levels of the organization should emphasize that the law will hold them liable in the event of contamination--every employee has a legal obligation to the food safety plan. It will take time to build an environment in which every worker holds himself and his co-workers accountable for food safety.

Who has your back?

The FSMA gives your QI great power and tremendous responsibility. Do not be afraid of making the organizational changes necessary to help the QI team succeed. Management can provide them with the authority to make changes, but to succeed, the QI team must earn the respect of every staff member. Managing this change will require delegating new oversight powers, as well as incubating a new attitude on the production floor. The QI will not succeed without cooperation from every level of your organization.  

Bill Bremer is a Principal with Kestrel Management’s Chicago area practice and heads Kestrel’s food safety consulting group. In his food compliance roles, he has led compliance and assurance activities to help many food industry companies meet FDA/FSMA, GFSI (i.e., BRC, IFS, FSSC22000, SQF), HACCP, EHS, and overall operations management requirements.


The information contained in this article is intended for general information purposes only and is based on information available as of the initial date of publication. No representation is made that the information or references are complete or remain current. This article is not a substitute for review of current applicable government regulations, industry standards, or other standards specific to your business and/or activities and should not be construed as legal advice or opinion. Readers with specific questions should refer to the applicable standards or consult with an attorney.


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