Do you know the difference between a HACCP Plan and a Food Safety Plan? Do you know if your facility requires a designated Preventive Controls Qualified Individual or HACCP Trained Individual? Jeff Chilton, VP of Professional Services at Alchemy Systems answers frequently asked questions and more.
1. Which food sectors are mandated by regulatory agencies to comply with HACCP regulations and which ones are mandated to comply with Preventive Control for Human Food regulations?
Under the USDA inspection, all meat and poultry companies are mandated to comply with the HACCP regulations.
Under FDA jurisdiction, juice products and seafood products are mandated to comply with the HACCP regulations.
All other food sectors that are required to register with the FDA, other than exempt sectors such as alcoholic beverages and dietary supplements, are mandated by regulatory agencies to comply with Preventive Control for Human Food regulations. This includes facilities located within and outside of USA.
2. What if my industry is not mandated to comply with a HACCP regulation such as alcoholic beverages or dietary supplements?
Exempt food sectors are recommended to have a food safety system based on HACCP principles. This may be a requirement for the company if they are audited by a third party.
3. Who should take PCQI training for the Preventive Controls for Human Food Course?
All facilities that must comply with the FSMA Preventive Controls for Human or Animal Food should have at least 1 designated PCQI. It is recommended that the facility have more than one individual receive PCQI training to ensure adequate coverage in the absence of key personnel, and also to ensure competency of food safety team members.
4. Who should take Basic HACCP training?
In USDA facilities, it is required that the person who writes or reassesses the HACCP Plan receive HACCP Training. For SQF facilities, the SQF Practitioner is required to have HACCP Training. Otherwise, HACCP training is recommended for all food safety professionals.
5. Who should take Advanced HACCP Training?
Individuals who have had prerequisite HACCP training and QA Management personnel responsible for food safety should take Advanced HACCP training. It is also recommended for individuals who haven’t had basic HACCP Training in many years. The Advanced HACCP Training focuses more on Verification and Validation, as well as auditing and continuously improving your HACCP System. The Basic HACCP Training focuses on the 5 Preliminary Steps & 7 Principles of HACCP, and includes a mock HACCP Plan to promote understanding.
6. Does the training expire or how often should it be refreshed?
The training doesn’t expire, however, based on some audit requirements this training should be refreshed at least every five years.
7. What are the differences between a HACCP Plan and a Food Safety Plan?
There are quite a few differences between a HACCP plan and a food safety plan. It starts with the difference in the type of hazards that you have to analyze. Under the basic HACCP systems, you have to consider physical, biological, and chemical hazards. Under the preventive control approach for your food safety plan, there are three additional types of hazards that you have to consider, and these include radiological hazards as a type of chemical hazard. It also includes economically-motivated adulterants, which are associated with food fraud and the potential for environmental contamination in those facilities that produce ready-to-eat food products.
Another difference in HACCP versus the food safety plan is that FSMA regulations require a risk-based approach that also includes assessing likelihood of occurrence as well as the severity of consumer impact, as part of the hazard assessment. One of the major difference between food safety plans and HACCP plans is the HACCP plan primarily focuses on the identification of critical control points as part of that process. Under a food safety plan, the focus is not only on CCPs, a type of process preventive controls, but also on identifying other applicable preventive controls for allergens, sanitation, and the supply chain.
8. Can I have one Food Safety Plan that incorporates all requirements to meet FDA, HACCP and GFSI requirements?
You can have one plan that meets both the HACCP and food safety plan requirements. The important thing to note is that this will require the inclusion of the 5 preliminary steps, identification of preventive controls, and identification of CCPs.
9. What are some of the greatest challenges companies have developing their written HACCP Plans or Food Safety Plans?
One of the biggest challenges is obtaining the scientific information for hazard determination. This information isn’t always included in the raw material specifications. Another big challenge companies have when they develop their food safety plan is finding validation references for critical limits and/or process preventive controls. Beyond getting the scientific information, another challenge for QA managers and directors is getting your food safety HACCP team to actually aid in developing and implementing part of the HACCP and food safety plan. It is imperative to have the entire HACCP/Food Safety Team participate in the development of the HACCP Plan and management support throughout the organization for successful implementation.
10. What are some of the greatest challenges companies have implementing their Food Safety Plans?
One of the greatest challenges is meeting all the record-keeping requirements, making sure that preventive controls are identified, and records document the monitoring and the verification of the assigned responsibilities. Make sure the individuals you assign are responsible enough to perform recordkeeping complete, accurate, and timely manner. Records are critical in demonstrating compliance of your food safety plan to FDA investigators and GFSI auditors.
11. How often do Food Safety Plans have to be reassessed?
For companies that must comply with the FSMA Preventive Controls for Human or Animal Food rule, at a minimum, Food Safety Plans must be reassessed every three years. Companies that participate in third party audits and USDA regulated establishments must perform a HACCP Plan reassessment at least annually. All companies will need to reassess their Food Safety Plan anytime change occurs that could impact the safety of the product (new product or raw material, new supplier, deviation trends).
12. What training must be provided for front line employees and supervisors?
Employees involved in the manufacturing, process, packing and holding of FDA Regulated food products must be trained as Qualified Individuals. This training must cover employee hygiene GMP’s, principles of food safety, and job specific food safety responsibilities. Supervisors must also receive training on managing Qualified Individuals. Since these individuals perform Verification tasks, they must be trained on their role in the food safety system.
13. What is the difference between validation of critical limits versus the food safety system?
Critical limit validation must be science-based to control identified hazards. Food Safety System validation is based on the successful results of the implementation of the overall plan which could include record reviews and microbiological test results review.