On Jan. 4, President Barack Obama signed the Food Safety Modernization Act into law, requiring all facilities registered with the FDA under the Bioterrorism Act to develop a written food/feed safety plan that evaluates hazards and details procedures to control those hazards so they do not cause adulteration or misbranding of product.
The regulation applies to all commercial grain elevators, feed mills, feed ingredient manufacturers, grain processors, millers and exporters, as well as foreign facilities that ship agricultural products, feed and feed ingredients intended for consumption in the United States.
One way to ensure compliance with the law’s written food/feed safety plan requirement is to implement a HACCP (Hazard Analysis and Critical Control Point) plan. While the FSMA does not mandate facilities use HACCP, David Fairfield, director of feed services for the National Grain and Feed Association, says applying HACCP principles within a feed manufacturing setting provides an excellent opportunity to evaluate operations, identify potential hazards and eliminate or minimize those hazards.
HACCP was originally designed to replace finished product testing by entities such as Pillsbury Co. and the U.S. Government. The program was even put into place at NASA to ensure the safety of food for astronauts.
Developing a HACCP plan takes time, dedication from management and staff, and an acute understanding of all the raw materials and processes used at the facility. Breaking HACCP into “Preparation”, “The Seven Principles” and “Implementation” is an effective way to learn about the plan and determine how best to utilize the information in your facility.
As is the case with any new program launched in the workplace, there is preliminary work required before it can be implemented. Before starting a HACCP plan, these steps must be completed:
1. Choose a HACCP coordinator and team
In some cases, the best candidate for this important position is clear. A company may select a quality control manager, corporate food safety director or operations manager. But if a company determines its staff doesn’t have enough expertise, management can seek an outside specialist or consultants for additional help.
2. Provide HACCP team with education and training
If a company chooses to train its own employees rather than hire a consultant or other outside help, education is necessary.
“There are a variety of resources available,” says Keith Epperson, vice president of manufacturing and training, American Feed Industry Association. “There is a short course offered each Spring and Fall at Kansas State University that is co-sponsored by AFIA and NGFA, and the Northern Crop Institute holds its own HACCP training courses.”
NGFA also organizes a HACCP for the feed industry distance learning program, which is available to members at any time through its website.
3. Create and use process flow diagrams
A process flow diagram is a basic diagram that serves as a visual of how a product or a process flows from start to finish (Figure 1).
Fairfield, the instructor of the NGFA’s Model Feed Quality Assurance distance learning program, including its HACCP elements, says viewing a verbal picture of how a process flows, or how material flows through equipment, aids in identifying where potential hazards might be introduced.
Creating these documents is an integral step if utilizing HACCP is a company objective.
“Process flow diagrams are a fundamental HACCP requirement,” says Fairfield. “If you want to meet the criteria, you’ve got to create these process flow diagrams. They may, in some cases, be very specific, and very general in other cases. But it will help during the risk assessment step to identify where potential hazards may enter the scene.”
4. Develop prerequisite programs
According to Fairfield, this area can be a source of confusion for students in his HACCP training course. He clarifies that prerequisite programs are simply the written procedures and policies a firm has in place to meet regulatory requirements and ensure either the quality or the safety of the products they produce.
“If you’re a medicated feed mill and you handle animal drugs and produce medicated feed, there is a set of good manufacturing practices with which you comply. So, an example of a prerequisite program would be the SOPs (standard operating procedures) the facility has in place to enable compliance with those current good manufacturing practices.”
Necessary prerequisite programs may include Ingredient Specifications/Standards, Approved Ingredient Supplier Processes, Ingredient and Finished Product Testing or Feed Quality Audit Processes.
5. Describe and write out the raw materials, feed products and processing and distribution methods used within the facility
Records must be kept of all the incoming materials, as well as the processes they undergo before exiting the facility. Examples of raw materials include grains, processed ingredients, liquids, minerals, vitamins and even packaging supplies.
Finished product descriptions would include the product name, characteristics, shelf life, distribution methods and labeling instructions. These descriptions are vital in identifying hazards in the facility and implementing the seven principles of HACCP.
The Seven Principles of HACCP:
The basis of any sound HACCP program is following the following seven principles:
- Conduct a hazard analysis
- Identify critical control points (CCPs)
- Establish critical limits
- Establish CCP monitoring requirements
- Establish corrective action procedures
- Establish verification procedures
- Establish recordkeeping procedures
The most crucial HACCP principle is performing an appropriate and comprehensive hazard analysis. Hazards are any significant risks that could have a severe adverse impact on the health of the animals that consume the product, or the humans that subsequently consume such hazards through animal-based foods. The rest of the HACCP plan hinges on the types of hazards identified in this first step.
“You first identify hazards that are significant and pose a risk to health,” says Fairfield. “And second, you identify specific steps in your manufacturing process — critical control points — where you can intervene and eliminate or minimize the hazard to acceptable levels. This would be depicted on the process flow diagrams.”
Establishing critical limits on hazards is not a specific requirement of the FSMA, but it could be required by FDA when implementing the law for identified hazards. It also would be required for facilities aiming to become HACCP certified by an accredited third-party auditor.
Conducting the first two steps must be done thoroughly, and may take up to a year to complete, depending on several factors.
“I am often asked ‘How long is it going to take to develop a whole HACCP plan and implement it?’ and I give a guarded answer,” says Fairfield. “To a large degree, the time it will take to design and implement a HACCP plan is dependent upon the level of documentation you already have with your prerequisite programs. If you already have a formal quality assurance program that’s comprehensive, well-documented and spells out employee operating procedures, it may progress relatively quickly.”
Epperson points out that even if a HACCP plan is turned around quickly — in less than 60 days, for example — HACCP auditors look for more than merely what the plan says, but also for documented history of the plan in action.
“You could put it together in a month, but when the auditor comes to the facility, they would truly only see a shell of a program,” says Epperson. “Once the plan is in practice, an integral part of HACCP is the organization’s ability to make changes and adjustments when it identifies an aspect of the plan that isn’t working. Documentation of these changes are considered correction procedures.”
Verification and documentation are the final pieces of the HACCP puzzle. Once the hazards are established and critical control points are identified in the manufacturing process, the final step is making sure the plan is followed through.
“Documentation is the key piece of evidence in showing an auditor that you know your hazards and critical control points, you check them on a regular basis and you make changes to the program as needed, “says Epperson.
Once each of the seven HACCP principles are addressed, the plan is ready to put into practice.
Implementation and certification:
There are a number of reasons why a facility would implement a HACCP plan, outside of the need to comply with the FSMA. For example, a customer may require their suppliers to be HACCP certified, or they may want to use a HACCP certification as a marketing tool — a seal of feed safety approval. If they choose to take that route, an accredited third-party HACCP auditing firm must audit the facility.
HACCP audits are used to verify the effectiveness of the overall HACCP system. As part of the audit, the third party will:
• Review records (SOPs, HACCP plan, etc.)
• Review adherence to manufacturing and housekeeping procedures
• Have discussions with employees to gauge their understanding of the HACCP program and their responsibilities
• Review equipment calibration records
• Review employee training records
After the initial comprehensive third-party audit, additional partial audits typically will be conducted over the next two years. On the fourth anniversary of the initial audit, the audit cycle starts over with another comprehensive audit.
A facility may also choose to implement HACCP, but forego a third-party audit. According to Epperson, many companies implement the seven principles of HACCP simply as a way to discover any weaknesses or potential hazards in the facility. But they may not need to, or be able to, produce the fees for the audit and certification process.
“They recognize the value of HACCP in regard to what it can do to improve the safety of their processes and their facility, but it may not be necessary to become certified if their customers are not asking them to become certified.”
Whether or not implementation ends in a third-party audit and certification, completing the seven principles of HACCP is worth the effort as an aid in complying with the Food Safety Modernization Act.