“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 HACCP.
Seven Principles of HACCP:
The basis of any sound HACCP program is the following 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 hazard analysis
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.
Don’t rush it
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.”
Importance of record keeping
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.