According to the Centers for Disease Control and Prevention (CDC), approximately one in six Americans fall ill annually due to consuming contaminated food, resulting in an estimated 3,000 fatalities. In addition to the devastating human toll, the Grocery Manufacturers Association estimates that the average cost of a food recall for a company is around $10 million in direct expenses, not to mention the subsequent damage to brand reputation and lost sales.
In light of these rising public health concerns and the financial strain caused by foodborne illnesses, the 2011 Food Safety Modernization Act (FSMA) shifted the FDA's focus from merely reacting to food safety issues to proactively preventing them. Under FSMA, food facilities are now required to conduct a thorough hazard analysis and implement risk-based preventive controls. For many facilities, color-coding has emerged as one of the key preventive controls to safeguard food from direct contamination, cross-contact, and cross-contamination incidents.
Defining Preventive Controls
Preventive controls, as outlined in 21 CFR 117 Subpart C, refer to risk-based measures ensuring that relevant food safety hazards are significantly reduced or eliminated when these controls are applied. These regulations also stipulate that food manufactured, packaged, or stored in a facility must not be adulterated or misbranded in any way.
As illustrated in the diagram to the right, Preventive Controls differ from the modified Current Good Manufacturing Practices (CGMPs), which are the legally mandated minimum standards for sanitary and processing practices detailing the methods, equipment, facilities, and controls for producing safe and wholesome food.
Color-coding, as an industry best practice, can certainly qualify as a valid preventive control.
Benefits of Color-Coding as a Preventive Control
Color-coding provides a quick and efficient means of communicating crucial food safety information, irrespective of language barriers. This simplicity makes color-coding an effective preventive control.
Colors can indicate the progress of a process—think of traffic lights and what each color communicates to drivers. The same principle can be applied to Material handling across process flows, signaling whether a product should proceed to the next stage or not.
Moreover, colors serve as visual cues to identify personnel, equipment, or tools within an area. If blue-bristled pipe brushes are used for cleaning food conveyance pipes and black-bristled tube brushes are used for clearing drains, there’s a clear distinction between food-contact and non-food contact tools, preventing accidental misuse.
Additionally, color-coding can separate zones and products based on risk. Something as simple as red and blue storage tubs can easily differentiate low-risk raw meat from high-risk processed product, thus preventing cross-contamination. It can also be used to separate allergen zones.
Color-Coding as a Preventative Strategy
There are three primary ways a color-coding plan can integrate into a food safety management system:
1. **As Part of Standard Operating Procedures (SOPs):** A color-coding plan can specify colors for scoops used in handling different products within an allergen SOP or for cleaning brushes used on various surfaces within a Sanitation Standard Operating Procedure (SSOP).
2. **As a Preventive Control Within a Food Safety Plan:** For this, the plan must be validated or justified, monitored, verified, and reviewed as a food safety control.
3. **As a Standalone Color-Coding Plan:** This might reference other procedures and can also follow the same format as the food safety plan.
The facility may choose to incorporate color-coding into their Current Good Manufacturing Practices (CGMPs), Preventive Controls, or Best Practices framework as long as there’s consistency and a clear process of justifying, verifying, and reviewing the program.
Developing a Color-Coding Plan
The steps to establishing any preventive controls are as follows:
1. **Conduct a Comprehensive Hazard Analysis:** Identify areas where there’s a possibility of allergen cross-contact or cross-contamination. These could be ideal places to establish color-coding zones or use color-coded implements.
2. **Evaluate the Applicability of Color-Coding:** Determine if color-coding will prevent issues. If scoops need to be separated because they're hard to distinguish, color-coding would be an appropriate preventive control. However, if raw product is touching finished product due to insufficient workspace, color-coding might not be helpful.
3. **Establish Control Measures, Preventive Controls, and Practices:** Color-coding may be employed as part of the current Good Manufacturing Practices, as a risk-based Preventive Control, or as an industry best practice.
4. **Set the Monitoring, Corrective Action, Verification, and Review Criteria:** For monitoring, process leaders and managers can effectively observe whether colored tools are being used in the correct zones. Corrective actions might include placing affected products on hold or retraining specific employees. Verification comes through pre-operational inspections and observing on the floor that the right tools are being used in the right zones. Review the criteria for the plan to ensure it’s functioning correctly and still meets the needs of that area.
5. **Educate, Train, and Refresh Employees on the Plan:** Workers should be reminded of color-coding procedures through ongoing education. They should be retrained on color-coding at least annually or whenever there are changes to the plan.
Evaluating Risks with the Hazard Analysis Cube
The Hazard Analysis Cube is a method for visually identifying the three key variables necessary for a comprehensive hazard evaluation:
1. **The Food Safety Hazard** refers to the type of contaminant—biological, chemical, or physical—that might negatively impact food. Although stating the hazard remains crucial, FSMA goes beyond this basic level.
2. **The Mode of Hazard Introduction** explains how the hazard was introduced—whether accidentally, naturally occurring in the product, or deliberately added by malicious agents.
3. **The Focus Point of Control** refers to where the control strategies to prevent the hazards are implemented. This could be at the lower tier for materials, ingredients, or product, at a higher level involving processes and personnel practices, or at a much higher, systematic and environmental level.
For each potential hazard, a risk analysis should be conducted based on Likelihood x Severity, as shown in the diagram. High-risk issues, which pose greater public health concerns, require immediate attention, followed by those with moderate-to-low risk, and then very low, negligible, or no-risk issues.
Consider wheat and soy cross-contact, a chemical hazard that could be accidentally introduced during processing by personnel. This hazard would be classified as high-risk, and the goal of the preventive control would be to reduce the risk to safe, low levels.
Elements of a Color-Coding Plan
The format of the color-coding plan can mirror a typical food safety plan, requiring the same standard steps to prove its effectiveness. For instance, consider a critical step within a typical food safety plan where soy and wheat are used together while preventing cross-contact in the main supply of each allergen product container:
- The Material or Step is adding soy lecithin to wheat flour.
- The Hazard is chemical, specifically allergen cross-contact between the wheat and soy supplies.
- The Control Type used is allergen control through product handling and personnel practices, and sanitation control by cleaning lines between changeovers. As a justification, color-coding can also be used due to its role in preventing cross-contact incidents.
- As a Monitoring Action to ensure the color-coding plan is followed, the supervisor may ensure trained operators use blue scoops for handling wheat and red scoops for handling soy.
- If the wheat and soy scoops were accidentally switched, the Corrective Action steps might involve:
I) Stopping production.
II) Separating affected product from good batches and safely disposing of it.
III) Thoroughly cleaning scoops and affected areas.
IV) Restarting production.
V) Documenting the action.
VI) Identifying the root cause and preventing further cross-contact between allergens through employee education, training, and process redesign.
- As part of the Verification Action, Quality Control can take sample allergen swabs before production begins to confirm surfaces are allergen clean. QC can also verify if operators are following proper allergen handling procedures.
- Some of the Records and Supporting Documents that might be used in the plan are:
- Color-Coding Maps
- Allergen Control Plan
- Sanitation Standard Operating Procedures (SSOPs)
- GMP Records
- Corrective Action Records
The color-coding plan is typically reviewed annually or whenever there are significant changes in allergen handling and processing activities.
Educating and Training Employees on Color-Coding
When fostering company-wide awareness about color-coding, simply showing employees how to perform a task is insufficient. They should also understand, in the simplest terms possible, why color-coding enhances food safety and makes their jobs easier. Trainers should clearly explain concepts such as how certain food allergens could severely harm or even kill vulnerable individuals, reinforcing why color-coding as a preventive control is vital. When employees feel invested in a program and understand its importance, they're more likely to adhere to it.
After six months or at most a year, refresh employees and assess their understanding of the process and its significance. It’s also essential to re-educate and re-train employees if there’s a breakdown or change in the color-coding program.
If an employee uses the wrong scoop to handle allergens, it’s crucial to re-educate and re-train them to do it correctly the first time and always. If there’s a change in the color-coding program—say, switching from red to yellow scoops for handling soy—the plan must be updated to reflect the change, and employees must be re-educated and re-trained accordingly.
Deciding Which Products to Color-Code
When using color-coding as a preventive control, the recently published FDA FSMA Final Rule for Preventive Controls for Human Food recommends the following best practices:
- Color-coded uniforms, smocks, and footwear to identify employees working in high-risk areas and minimize pathogen contamination spread.
- Color-coded containers to identify and separate waste from usable or edible products.
- Color-coded equipment in hygienic zones to prevent tools from spreading one type of contamination or allergen to other areas in the plant.
- Color-coded facility maps to differentiate hygienic zones.
Tips on Implementing Color-Coding
Keep the color-coding plan simple. Plans work best with 3-5 colors in most small-to-medium-sized plants. Secondary methods of color-coding, such as using a broom that’s one color with a different-colored handle, often confuse workers and aren’t nearly as effective as a total-color system.
Be consistent with colors. Major changes shouldn’t occur frequently and should be carefully evaluated for necessity. Each change may cause confusion among staff and increase the risk of cross-contamination or allergen cross-contact.
Communicate the plan effectively and often. Post signs, hold training meetings, and have managers emphasize the need for color-coding. These efforts can foster a strong food safety culture among employees.
Seek assistance if needed. Remco Products offers a vast Knowledge Center filled with articles and white papers providing tips on developing and maintaining a color-coding plan. Experienced representatives can also visit your facility to help create the best color-coding plan tailored to your needs. Reach out if you’d like assistance or have any questions.
Stainless Leveler Feet,Stainless Adjustable Feet,Stainless Leveling Feet,Stainless Steel Adjustable Leveling Feet
Cixi Ruixin Machine Components Co., Ltd , https://www.adjustlevelingfeet.com