Inspector, food safety
Participating in a mock inspection can be an effective method to determine whether your team is prepared for an unannounced inspection.

MANHATTAN, KAS. — The Food Safety Modernization Act (FSMA) has forced baking facilities to be inspection-ready at all times. From maintaining records to training staff, there is a myriad of tasks that must be constantly performed, observed and documented. 

Although some processes may fall through the cracks, even the smallest oversights could lead to a quagmire. AIB International zones in on the most common slipups and more during its F.D.A. Preparedness Inspections.

In this program, the organization delivers a simulated FSMA inspection to ensure that an operation’s regulatory policy is in line with F.D.A. rules and requirements. AIB also helps employees understand plant policies for handling inspections and that food safety plans meet the F.D.A.'s newest requirements.

AIB recently released a list of the top nine FSMA violations it found during the inspections that span from training blunders to lack of policy knowledge. 

1. Incorrect or missing information in F.D.A. registration 

Under FSMA, F.D.A. food facility registration requires operations to include additional registration information to improve database accuracy for facilities both in the United States and internationally. In addition to an email address for registration, bakeries need to renew registration every two years and provide an assurance that the F.D.A. will be permitted to inspect the facility as permitted by the Federal Food, Drug and Cosmetic Act. Registrations also must contain the type of activity conducted at the facility for each food product category. These requirements help the F.D.A. act quickly in response to food-related emergencies and allow it to use inspectional resources more efficiently. 

2. “No photography” policy not mentioned in opening meeting
F.D.A. investigators will want to take photographs when they find a violation in the facility. Remind investigators that your plant does not allow visitors to take pictures. If the F.D.A. agents insist on taking photographs, make sure someone is assigned to take the same photos for recordkeeping purposes. Before investigators arrive, consult with legal counsel to discuss how you can respectfully avoid photographs being taken. 

3. FSMA training not documented for qualified individuals outside of the Preventive Controls Qualified Individual 
Under Current Good Manufacturing Practices (cGMP) regulations, employees performing manufacturing, processing or packaging duties must have the education, training or experience to perform assigned duties and be trained in the principles of food hygiene and food safety. The training should be documented, including the date of training, type of training and personnel trained, and needs to be easily accessible for the F.D.A. investigators during an inspection.

4. HACCP plan not modified to address all preventive controls criteria
Although baking organizations can use existing food safety programs as part of their preventive controls, plans need to be updated to reflect current hazards. As food safety issues arise or conditions change, controls set in place should be documented.

Employees, food safety
Employees must possess a clear understanding of your organization’s policies and processes.


5. Personnel unfamiliar with facility regulatory policy
Employees can be pulled aside by investigators at any moment to discuss procedures in detail or to pull records. It’s crucial that they have a clear understanding of your company’s policies and can explain how processes work and why they are performed. This may entail taking extra time to train employees on methodologies and educating them on the reasoning behind it.

6. Plants unsure about which records can be given to the F.D.A.
At the time of the records review, the F.D.A. will have wide access to most documents within the organization. However, the agency is not entitled to review or copy any recipes or data pertaining to finances, pricing, research, sales or personnel other than to ensure that the company’s employees have received training appropriate to their position and responsibilities. If the F.D.A. requests copies of any records the company deems confidential, be sure to mark those records accordingly. 

7. Additional preventive controls not identified from existing prerequisite programs (critical sanitation cleaning, allergen control, process steps)
Existing records do not need to be duplicated and can be supplemented as necessary if they contain all the required information and satisfy the requirements of the preventive controls rule. However, facilities should consistently revisit these documents and update them to avoid penalty and minimize risk.

8. Plants unfamiliar with Current Good Manufacturing Practices 
Under FSMA provisions, all registered facilities must comply with cGMPs. Some of the previously noncompulsory provisions, such as education and training, are now required. Familiarize yourself with cGMPs by reviewing the regulations, attending seminars and performing audits. 

9. Validation of preventive controls not always understood or applied

Operators should ensure their food safety plan clearly details how they will validate preventive controls and revisit the plan at on a consistent basis. Preventive controls must be validated with scientific evidence and capable of effectively controlling an identified hazard. Commercial bakers can use AIB’s Kill Step Calculators to evaluate the lethality of a baking process to destroy pathogens in their products and demonstrate the effectiveness of the process to comply with the preventive controls rule. According to AIB, the project is the only associated-sponsored and sector-wide approach that the F.D.A. has seen to date.