White Paper: Color-Coding as a Preventive Control

According to the CDC, 1 in 6 Americans become sick by eating contaminated food every year, resulting in an estimated 3,000 deaths. As if the human cost isn’t sobering enough, the Grocery Manufacturers Association also estimates the average cost of a recall to a food company is $10 million in direct costs in addition to brand damage and lost sales.

Considering growing public health concerns and the economic burden of foodborne illnesses, the 2011 Food Safety Modernization Act shifted the FDA’s focus from simply responding to food safety problems to trying to prevent them. FSMA now requires food facilities to conduct a comprehensive hazard analysis and then establish risk-based preventive controls. For a number of facilities, color-coding has become one of the preventive controls to protect food against direct contamination, cross-contact, and cross-contamination incidences.

Defining Preventive Controls

According to 21 CFR 117 Subpart C, preventive controls are risk-based assurances that relevant food safety hazards are significantly minimized or prevented upon application of that control. The same regulations also stipulate that food manufactured, packed, or held by a facility will not be adulterated or misbranded in any way.

As illustrated in the diagram to the right, Preventive Controls are distinguished from the modified Current Good Manufacturing Practices (or CGMPs, which are the minimum, legally required sanitary and processing practices describing the methods, equipment, facilities, and controls for producing safe and wholesome food).

Color-coding as an industry best practice can definitely qualify as a valid preventive control.

Benefits of Color-Coding as a Preventive Control

Color-coding quickly communicates essential information for food safety, regardless of language barriers. It’s this simplicity that makes color-coding an effective preventive control.

Colors can signal the process status – visualize the traffic lights and what each color communicates to a driver. The same concept could apply to material handling across process flows and act as a signal for whether the product should move to the next process level or not.

More importantly, colors act as visual cues to identify the 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 is a clear identifier between food-contact and non-food contact tools to prevent accidental misuse.

The other function of color-coding is that colors can separate zones and products based on risk. Something as simple as red and blue storage tubs could easily separate low-risk raw meat from high-risk processed product to prevent cross-contamination. It can also be used to separate allergen zones.

 Color-Coding as a Preventative Strategy

There are three main ways a color-coding plan can fit into a food safety management system:

1. As part of the Standard Operating Procedures: A color-coding plan can specify the colors used for scoops for handling different products within an allergen SOP, or cleaning brushes to be used for different 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 could reference other procedures and can also follow the same format as the food safety plan.

The facility may decide to reference color-coding within 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. m.

 Developing a Color-Coding Plan

The steps to establishing any preventive controls are as follows:

1. Conduct a Comprehensive Hazard Analysis: Do you have areas where there’s a chance of allergen cross-contact or cross-contamination? These could be the right place to establish color-coding zones or use color-coded implements.
2. Evaluate the Applicability of Color-Coding: Will color-coding prevent issues? If you need to keep scoops separated because they’re not easily identifiable, it would be an appropriate use of color-coding as a preventive control. If raw product is touching finished product because there isn’t enough workspace, color-coding may not help.
3. Establish Control Measures, Preventive Controls, and Practices: Color-coding may be employed as part of the current Good Manufacturing Practices, or 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 watch out for colored-tools being used in the wrong zones. Corrective actions vary from putting affected products on-hold to retraining specific employees. Verification comes through pre-operational inspection and being on the floor to see that the right tools are being used in the right zones. Review the criteria for the plan to ensure it’s working and still fits the need in that area.
5. Education, Train, and Refresh the Employees on the Plan: Workers should be reminded of color-coding procedures through continuous education. They should be retrained on color-coding at least yearly, or whenever there are changes to the plan.

 Evaluating Risks with the Hazard Analysis Cube

The Hazard Analysis Cube is one way of visually identifying the three key variables essential for a comprehensive hazard evaluation:

 The Food Safety Hazard refers to the type of contaminant i.e. biological, chemical or physical, that may adversely affect food. Though stating the hazard is still key to the process, FSMA moves hazard analysis beyond this fundamental.

1. The Mode of Hazard Introduction clarifies how the hazard was introduced—whether it was accidental, naturally occurring in the product, or deliberately added by malicious agents.
2. The Focus Point of Control refers to where the control strategies to prevent the hazards are put into place. Is it at the lower tier for materials, ingredients, or product, or 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. Issues that are of a greater public health concern are a high-risk priority and require immediate attention, followed by those with moderate-to-low risk, and then the very low, negligible, or no-risk issues.

As an example, consider wheat and soy cross-contact, a chemical hazard that could be accidentally introduced during processing by personnel. The hazard would be a high-risk issue, and the objective of the preventive control would be to reduce the risk to safe, low levels. 

For each potential hazard, a risk analysis should be conducted based on Likelihood x Severity. Issues that are of a greater public health concern are a high-risk priority and require immediate attention, followed by those with moderate-to-low risk, and then the very low, negligible, or no-risk issues.

As an example, consider wheat and soy cross-contact, a chemical hazard that could be accidentally introduced during processing by personnel. The hazard would be a high-risk issue, and the objective 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 be similar to a typical food safety plan, so it requires the same standard steps to prove its efficacy. As an example, let’s 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, and more specifically, the 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 because of its role in preventing cross-contact incidences.

- As a Monitoring Action to ensure the color-coding plan is followed, the supervisor may ensure, say, trained operators use blue scoops for handling wheat and use red scoops for handling soy.

- Now if the wheat and soy scoops were accidentally switched, the Corrective Action steps would likely be:

I) Stop production.

II) Separate affected product from the good batches and safely dispose of it.

III) Thoroughly clean scoops and the affected areas.

IV) Start production.

V) Document the action.

VI) Find the root cause and prevent 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 check if surfaces are allergen clean. QC can also check if the operators are following appropriate allergen handling procedures.

- Some of the Records and Supporting Documents that may 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 generally reviewed annually, or whenever there are significant changes in allergen handling and processing activities.

Educating and Training Employees on Color-Coding

When it comes to creating companywide awareness on color-coding, it’s not enough to show employees how a task is done. They should also learn, in the best and simplest way, why color-coding will help improve food safety and make their jobs easier. Trainers should clearly lay out the concepts, such as how certain food allergens could make a vulnerable individual seriously ill or cause death, and reinforce why color-coding as a preventive control is so important. When employees are invested in a program and feel like they have a stake in it, even just by knowledge of why and how it works, they’re more likely to follow it.  

After six months or at most a year, refresh the employees and evaluate to see if they know how well and why they are doing the process. It’s also essential to re-educate and re-train employees if there’s a breakdown or a change in the color-coding program.

If an employee is using the wrong scoop to handle allergens, it’s important to re-educate and re-train them to do it right the first time and at all times. If there is a change in the color-coding program, where a yellow scoop instead of red will then be used to handle soy, the plan must be re-developed to reflect the change and employees must be re-educated and re-trained on it.

Deciding Which Products to Color-Code

When it comes to 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 to minimize pathogen contamination spreading.
• Color-coded containers to identify and separate waste from useable or edible products.
• Color-coded equipment in hygienic zones to keep 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 plants. Secondary methods of color-coding, such as using a broom that’s one color with a different colored handle, usually confuse workers and aren’t nearly as effective as a total-color system.

Be consistent with colors. Large changes shouldn’t happen frequently, and should be carefully evaluated for necessity. Each change may cause confusion among the staff and could increase chances of cross-contamination or allergen cross-contact.

Communicate the plan effectively and often. Post signs, hold training meetings, and have managers reinforce the need for color-coding. Such measures can enhance food safety culture among the employees.

Bring in help. Remco Products has a large Knowledge Center full of articles and white papers with tips on developing and maintaining a color-coding plan. We can also send experienced representatives out to your location to assist with creating the best color-coding plan for your facility. Contact cs@remcoproducts.com if you’d like assistance or simply have questions.