On September 21, 2020, the Food and Drug Administration announced the release of a draft rule for the food industry, “Requirements for Additional Traceability Records for Certain Foods” (also referred to as the Food Traceability Proposed Rule). This is one of the last remaining elements of the FDA’s Food Safety Modernization Act (FSMA), assigned to the FDA by congressional mandate. This draft rule requires that the FDA implement additional traceability expectations for the food industry based on risk. This new rule is being billed by the FDA as part of its overall “Blueprint for the New Era of Smarter Food Safety”, which outlines several key elements, including enhanced traceability.
Our overall impression is that our customers, such as yourself, are already largely in compliance with the requirements as they’re currently written, perhaps with just a few minor gaps. The FDA has provided more information about the rule on their website.
7 Key Takeaways Regarding This Rule:
This is a draft rule. Now is the time to submit any feedback or concerns.
Its scope is limited. It pertains specifically to those who manufacture, process, pack, or hold specific types of foods on the FDA’s “Food Traceability List” (FTL).
It requires tracking specific activities. The FDA refers to these as “Critical Tracking Events” (CTEs), and they include: growing, receiving, transforming, creating, and shipping.
It requires tracking specific data. The FDA calls these “Key Data Elements” (KDEs), and they must be tracked for each Critical Tracking Event. They include information such as grower location identifier; lot numbers and other traceability identifiers; business names, numbers, and points of contact; quantities and units of measure; and other key elements.
It requires farms to communicate some basic information to customers. This includes location identifiers for the growing area and each location the product was processed or stored at, including business names and key contacts.
The record format is flexible. Under the rule, the FDA allows either paper or electronic records. However, it’s worth noting that, especially for finished companies who produce ready-to-eat foods, the FDA has made it clear that there is a preference for electronic records, where necessary to facilitate traceability (see the next requirement).
Records must be readily available. The FDA requires that companies be able to provide a sortable electronic spreadsheet to the FDA containing any affected products, within 24 hours of any FDA request, to assist in the investigation of any outbreak or recall.
If you’d like a member of our team to help you conduct an assessment of your company’s traceability programs, we’re ready to assist you, virtually or on-site! Reach out to us at firstname.lastname@example.org.
In today’s food manufacturing environment, basic food safety principles are no longer enough to meet customer and regulatory requirements. The rules have changed, in large part due to the Food Safety Modernization Act (FSMA). In addition to new laws from legislators, the standards and demands of customers now far surpass regulatory requirements. What this means is there is now an expectation to not only master Hazard Analysis Critical Control Points (HACCP) but to go one step further and become Global Food Safety Initiative (GFSI) certified. To gain certification with any of these programs, you need to start in the same place. You start with a HACCP plan.
12 Steps to a Good HACCP Plan
When building out your HACCP plan, follow this specific methodology involving 12 steps. If you are having trouble, just reach out to your friendly neighborhood Safe Food Alliance team.
One thing to remember as you build out your plan – a HACCP Plan is a living document, and as such, should be revisited often as your processes change, your company grows, and you discover better ways to produce your product. Now that we have that covered, let’s begin.
1. Assemble the HACCP Team
Your plan will typically include a table where all the names of the HACCP Team members are written and signed, and the team leader is clearly designated. The team functions best when it’s highly cross-functional and includes members of various departments such as sanitation, maintenance, production, and quality. It’s essential to have these varied perspectives and background knowledge.
In this section, you should include a brief description of each member’s current position, background, and experience. You’ll also need to have a copy of a HACCP formal training certificate for the HACCP coordinator, from an accredited two-day HACCP course. There should be some sort of documented HACCP training for the rest of the team as well, whether conducted internally or by someone like us. The more knowledgeable the team, the better the plan will be.
2. Describe the Product
This section should include a full description of each product or family of products within the scope of the plan. Product descriptions should consist of details that impact the food safety of the product, including (as applicable):
the recipe or formulation
the packing materials and any other information such as the modified atmosphere
the conditions in which the product is to be stored (e.g., temperature, light, humidity)
the shelf life
any potential for abuse in the distribution chain or by consumers, which may put the product at risk.
The better you define the product before starting the hazard analysis, the more thorough the review will be.
3. Identify the Intended Use
The intended use is based on the usual consumption of the commodity by the final consumer or user. Again, defining intended use helps ensure a more thorough hazard analysis later. This section includes both your company’s intended purpose based on product design, as well as potential other applications. The more you know your consumers, the better you can take care of them. A classic example, in this case, is cookie dough: it’s a product you typically cook before consumption, but in some cases, it’s eaten raw. For this reason, several companies have had recalls on their cookie dough due to consumer illness.
4. Construct the Flow Diagram
The process flow diagram must be clear and detailed to describe all process steps. Use this diagram to help ensure the hazard analysis is thorough and as a visual reference as your team considers potential hazards to the consumer. The flow diagram must include every process step that occurs on-site, from the very beginning (e.g., receiving and preparing ingredients, storing packing materials, etc.) to the very end (shipping, warehousing, etc.) The clearer the diagram is to the viewer, the easier to understand the process. Others may also use the table during site visits (e.g., customers, auditors, consultants, regulatory officials). Hence, it’s wise to design it in a way that it’s relatively clear to others who don’t know the process as well as you do.
5. On-Site Verification of the Flow Diagram
On-site verification of the diagram helps ensure its accuracy. Again, the purpose of this is primarily to ensure a thorough hazard analysis. The site will need to provide proof that the HACCP Team has verified the flow diagram. Some companies like to keep the first version of the diagram with hand-written notes on it, indicating changes made and initialed and dated by the participants. Ultimately, however, proof of the verification is best done with a final, updated copy that is signed; or meeting minutes indicating approval of the final version and signatures of participants.
6. Conduct a Hazard Analysis
The hazard analysis is part of the plan that typically takes the most time to review and update. Here the team collects and examines all relevant data to the product’s safety, including process performance, product defects, customer complaints, results of internal and third-party audits, and various other relevant information. The team must take the proper time to conduct a thorough analysis.
A Hazard analysis can vary in format, but needs to include these common elements:
List of all process steps and ingredients
Identification of potential hazards
Assessment of each hazard, with consideration of both severity and likelihood
Identification of ‘significant’ hazards
Justification of the assessment (detailed explanation as to the team’s reasoning)
Identification of appropriate controls for each hazard
Now, under FSMA, the identification of any Preventive Controls as well. For more information on this subject, take a look at this article. For training, refer to the PCQI course.
7. Determine Critical Control Points (CCP’s)
This one is a simple concept. Based on the hazard analysis described above, you can quickly identify all significant hazards and CCPs. Critical Control Points are those essential steps designed to control a specific hazard so that the product will be safe to consume. The team should use a decision tree like this one when determining CCPs.
8. Establish Critical Limits for Each CCP
A critical limit is a critical control point’s “go/no go” or “acceptable/unacceptable” criteria. For some processes, such as metal detection, it is as simple as testing with certified metal test pieces to ensure proper function. For other types of CCPs, it can be much more complex and include parameters such as temperature, humidity, product viscosity, or chemical concentration. All these variables and values have to be clearly defined, including both lower and upper limits, as applicable.
Documents related to the process and relevant sources used to establish the critical limits must be available to support the limits. These documents could be regulatory standards, guidelines, internal or third-party validation, experimental results, literature surveys, and expert guidance. The stricter the validated limits, the higher the potential efficacy.
9. Establish a Monitoring System
This step is where we define the monitoring method for each CCP. Monitoring is how we ensure the process has met the critical limit, so the product is safe. The monitoring procedure should contain the following:
What will you monitor?
How often shall it be monitored?
Who is responsible for performing the task?
What instruments will you use?
How will you monitor? (method)
The clearer the instructions, the fewer chances of failure.
10. Establish Corrective Actions
Each CCP is required to have predetermined and documented corrective actions for deviations that may occur. The corrective actions plan should comprise at least the following elements: the responsibility for each action, disposition of the non-complying product, the correction of the cause of failure, and recording the event. Keep records of activities readily available. If you need help with conducting root cause analysis for your corrective actions, check out our quick root cause analysis course.
11. Establish Verification Procedures
Much of the discussion in our HACCP courses end up centering around how to conduct verification in the context of HACCP properly. Verification procedures should be activities designed to confirm that the plan is: 1) being followed; 2) effective for its intended use, and 3) adequately maintained. We are looking for defined procedures here, indicating how we conduct routine verification activities like the sign-off of the CCP monitoring records, as well as how you complete the less-frequent validation. The more exhaustive the verification is, the more confident we can be of the plan. For more on verification, take a look at our article “The 6th Principle of HACCP: Verification”.
12. Establish Documentation and Record-keeping
This final step includes establishing both record-keeping processes and the company’s documentation system (establishing defined procedures, the company’s methods of document control, etc.). Consider:
How will you document your system?
What should you include?
Who is responsible for doing it?
How long are you keeping records? Where are you saving them?
Who needs to have access to what documents and how are documents controlled?
A better-documented plan helps ensure better execution.
As you may realize by now, developing and documenting an effective HACCP plan is not an easy task. Training on the methodology, experience, and technical elements are essential aspects of effective HACCP Plan implementation. If you need guidance with training or consultation, Safe Food Alliance is here to help.