Five Types of GMPs for Food Processing

Assuring quality of a manufactured product requires certain procedures and standards. In many industries, these procedures and standards are often referred to as Good Manufacturing Practices, or GMPs. The Food and Drug Administration (FDA) outlines Current food Good Manufacturing Practices, or CGMPs, in Title 21 of the Code of Federal Regulations, Part 110 (21 CFR 110).

The FDA provides CGMPs to assure that food processors maintain sanitary conditions that minimize the risk of contamination by “hazardous” materials. We’ll cover what the FDA considers hazards in a future blog entry. But for now, we’ll focus on CGMPs.

So what aspects of a food processing operation should be controlled and monitored to assure they conform to CGMPs? Through working with food processors, we’ve found that just about every aspect of a food processing operation might come under scrutiny during an inspection — from the personal hygiene of the workers in the plant, to the equipment used to make the food products, to the processing facility itself.

The FDA outlines CGMPs in five subparts:

1. General Provisions

— Do you know the terminology that should be used in describing CGMPs? This first section provides guidelines. It also explains when to use “shall” versus “should” in differentiating between when compliance is necessary (“shall”) and when procedures and practices are directly related to unsanitary conditions as specified in Section 402(4)(a) (“should”). It also delineates plant and employee responsibilities with regard to personal hygiene. Food safety education is addressed as well as the need for supervisory personnel to ensure compliance.

2. Building and Facilities

— How should a facility be designed and maintained to help assure food safety? In this section, CGMPs are outlined for the maintenance of the grounds, including litter control, waste removal and treatment, and grounds maintenance and drainage. Plants should be designed and built to reduce the potential for contamination. Sanitary operations, facilities, and controls are also outlined.

3. Equipment

— This section provides requirements and expectations for the design, construction, and maintenance of equipment and utensils to ensure sanitary conditions. But did you know it also includes an automatic control for regulating temperature or an alarm system to alert employees to significant change in temperature? Other requirements are general and intended to prevent contamination from any source.

4. Process and Controls

— How should a food processing facility keep sanitary conditions in check? This section of CGMPs addresses general sanitation and controls necessary to ensure that food is suitable for human consumption. It addresses the monitoring of physical factors (critical control points or CCPs), such as time, temperature, humidity, pH, flow rate, and acidification. Warehouse and distribution requirements are also included, requiring finished foods to be stored and distributed under conditions that protect against physical, chemical and microbial contamination. The container must also be protected from deterioration. This section also outlines very general requirements for warehousing and distribution.

5. Defect Action Levels

— There may be unsanitary circumstances that are simply inescapable. So how does the FDA address this? This last part allows the FDA to define maximum defect action levels (DALs) for a defect that is natural or unavoidable even when foods are produced under CGMPs (as covered in the sections above). These defects are not hazardous to health at low levels and include rodent filth, insects or mold. Those exceeding maximum DALs will be considered in violation.

We continue to appreciate the diligence our food processing customers demonstrate in following CGMPs to assure high-quality food products. What are your facility’s CGMPs, and how do you verify that your operation is in compliance? As you have gained experience in the industry, are there any types of required controls that surprised you? What other aspects of food processing do you think should be controlled that aren’t currently covered in regulations? We’d love to hear more about the policies and procedures that have been successful for you. And to learn more about food safety practices and CGMPs for food processing, check out our white paper, Understanding GMPs in Food Processing.

10 Things To Know About Color-Coding: Communication is Key

Essential to an effective color-coding system is a well thought-through communication plan. With the proper communication channels in place, your color-coding system has the best chance for successful adoption—in turn helping you to mitigate the risk of cross-contamination. Communication should start at the top of the company, and go down to each and every employee. When all employees are knowledgeable about the new or changed program, the chances of success are even higher.

HACCP Plan for food safetyThe initial employee training communications must be clear and concise to ensure everyone is on the same page. When starting, or even revising, a color-coding system, employees must understand the reason for the change. Dealing with the threat of cross-contamination is serious, and the need to establish barriers to those threats is critical. The better every employee understands this, the more effective the color-coding system will be when put into practice.

Communicating with employees on how color-coding can help with tool storage is also very important. Establishing procedures for storage can help with tool inventory management. If employees are taught the proper procedures for tool storage right out of the gate, this will go a long way in preventing any loss of tools or time. One particular way to help encourage proper storage is to use custom shadow boards that integrate outlines of the tools so that there is no question where tools belong. Some facilities might use the 5S system to maximize organization. The use of color-coding is a great way to enhance the 5S philosophy. 5S is a Japanese workplace organizational system which uses five phases: sort, set in order, systematic cleaning (or shine), standardize and sustain. Along with using shadow boards, 5S helps encourage employees to properly store tools, maximizing their usable life.

Green color-coded wall bracket with rubber clips for sanitation Red color-coded wall bracket with rubber clips for sanitation Blue color-coded wall bracket with rubber clips for sanitation
Zone 1 Zone 2 Zone 3

Daily communication to employees is essential to the longevity of the program. Daily communication starts with good signage. Clearly written instructions, bilingual if necessary, are essential to providing employees with instructions on the color-coding program. It may even help to include visual or graphic representations on the signage for each zone; for example, a picture of a peanut on the sign designating the color of tools intended for use with peanuts. In addition to written instructions, daily verbal communication is also vital. Any changes or revisions to the color-coding plan must be clearly communicated to all employees, from the top down.

It is a best practice to include your color-coding program in your official regulatory documentation. Many regulatory bodies require documentation of certain procedures, and color-coding can become a great advantage for your operation. While color-coding is not required for compliance with any food safety regulations, it is looked upon with favor by auditors. Including your color-coding plan in the facility’s Preventive Control or Prerequisite Procedures, which includes GMPs, SOPs, CCPs, and Non-CCPs, will go a long way in ensuring company-wide adoption, consistency, and compliance of the program. For facilities that must comply with HACCP or HARPC regulations, including color-coding on those plans is, again, not required but, a best practice. HACCP, or Hazard Analysis & Critical Control Points, is a food safety management system which helps to identify and control cross-contamination threats. Similarly, HARPC, also known as Hazard Analysis and Risk-Based Preventive Controls, also requires identification and control of risks in food processing facilities.

Here are some important things to remember:

  • Start at the top and go down
    • Communicate with all levels of employees to ensure complete implementation
  • Have good signage
    • Signs should have written and visual cues to identify the zone and where the tools are approved for use
    • Include a printout that gives details for reordering of tools, such as vendor, item number, manufacturer, etc.
  • Keep up with training
    • Consistent training programs for all employees will improve adoption and ongoing use of the program
  • Include color-coding on regulatory plans
    • Color-coding is looked upon favorably by regulatory bodies

10 Things To Know About Color-Coding: Keep it Simple

The core piece of advice that Remco communicates to food facilities implementing a color-coding program is to keep it simple. A common paraphrase of Occam’s Razor, originally written in Latin, is “All things being equal, the simplest solution tends to be the best one.” A color-coding program that is overly complex could become problematic for your facility and end up requiring more time and effort than it should, as well as involving more risk for cross-contamination. Determining what works and what doesn’t is easier with a simple color-coding plan.

Red Vikan Brush Cleaning MachineryFood safety is a challenging endeavor in an industry with complex regulations, and color-coding is intended to simplify an element of it. Completely simplifying food safety is impossible, but color-coding can help, while supporting the overall goal of food safety regulations. Color-coding offers a method to intuitively keep tools organized and clearly communicate which tools belong in certain areas. Visual identification of equipment is quick when tools are color-coded.

The foremost principle to remember regarding the simplicity of a color-coding system is to limit the number of colors used to what is absolutely necessary. For example, many food production operations have determined that only two colors are necessary: one for “food contact” and another for “non-food contact.” A plan like this would ensure that tools used on the floor are easily identified as being different than those intended to be used on food and food contact surfaces. This type of simplistic plan is very easy to explain to employees and communicate throughout the facility.

In cases when more than two colors are necessary, it is advisable to choose colors based on functionality. For example, some food production facilities employ processes that involve cooking raw meat. The potential for cross-contamination between raw and processed zones is a hazard that absolutely must be managed. Typically, two different colors are designated for raw and processed zones, and a third color is chosen to identify equipment designated for non-food contact areas. This type of a plan integrates more colors, but remains intuitive and should only require basic training for employee adoption.

Color-coding can become a method to standardize processes within a plant or a group of plants. Some businesses choose to standardize processes in order to reduce waste and variation in the end product result. This type of standardization can be applied to cleaning tools and sanitation processes, and color-coding is a suitable fit for this type of model. An example of this is to apply the same color-coding model across all production lines that run the same process within a plant. It can be taken a step further and applied across all plants that run the same processes so that only one training program needs to be developed and administered.

Using a color-coding model that is not straightforward can create more of a need for specialized training. For example, a total color-coded red broom and handle is easier to identify than a specialized broom that mixes a green broom head with a red handle. A plan with combo color equipment will require more time and resources to train staff, especially if either color is used elsewhere in the plant. The whole premise of color-coding is to make tools easy to visually identify without the need for in-depth training. Using combo color tools robs a color-coding program of that intuitive simplicity, and in turn, requires more resources than necessary for your operation to implement and adopt. It also increases the risk of cross-contamination if employees do not understand the program.

When designing a color-coding program for your operation, remember that the ultimate end goal is to ensure the safety of the food produced in the facility. For each color that you integrate into your plan, ask yourself if it is a necessary step in the process in order to effectively mitigate risk. If a color designation does not serve the purpose of managing a significant food safety risk, it is always the best practice to opt for simplicity. A plan that is overly complex is difficult to communicate and understand. A simple plan is easily adopted and becomes an intuitive method for managing food safety risks.

To help plan out your color-coding system, check out our worksheet to help you get organized.

10 Things to Know About Color-Coding: Zones and Critical Control Points

Understanding Zones and Critical Control Points in Color-coding

Just about every food processor knows that complying with food safety regulations from the FDA and other regulatory bodies is a vital aspect to the success of their overall operation. Without achieving this compliance, it would be fairly difficult to run an effective food processing program. The list of recalled food products seems to grow every day, most being the result of some sort of cross-contamination, and those recalls can cost millions of dollars. The old adage, “better safe than sorry,” definitely comes into play when talking about protecting against recalls. Color-coding is one simple method to help keep your food processing operation as “safe” as possible.

One of the most important FDA-proposed rules is HACCP. Complying with HACCP regulations is an important part of any food processing operation, and knowing where the critical zones are and preventing cross-contamination from happening is an integral part of this compliance. Currently, there are HACCP procedures for dairy, juice, retail seafood, and retail and food service.

Let’s back up for a second, HACCP stands for Hazard Analysis and Critical Control Points. HACCP is a preventative approach to the identification, evaluation, and control of food safety hazards that may cause illness or injury when not properly controlled. Put simply, HACCP is designed to help control the threat of cross-contamination from biological, chemical, and physical agents. According to the FDA, “any action or activity that can be used to prevent, eliminate or reduce a significant hazard” is considered a control measure. Color-coding is an excellent example of a control measure.

Once potential food safety hazards are identified, critical control points can be documented. The FDA defines a critical control point in a food manufacturing process as “a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.” Knowing where the critical control points exist in a food production process is essential to designing an effective HACCP plan.

Included in the many HACCP compliance resources available from the FDA is an example of a decision tree to help a food processing operation identify critical control points, seen below. Using a decision tree like this is not a mandatory part of the process, but it is valuable as a tool to facilitate the development of a thorough food safety program.

FDA Example of Decision Tree

Since color-coding is a control measure, color-coding zones often coincide with critical control points or groups of critical control points. For instance, a color zone may be assigned to an area where raw meat exists in a facility, since raw meat poses increased risks of bacterial contamination. There may be several critical control points that require other control measures within that one color zone, such as testing for contaminants or refrigeration of the raw meat prior to processing. Once the meat has been cooked, a different color may be assigned to the zone following the raw meat area to prevent bacterial cross-contamination into the finished product. For this purpose, color-coding is an excellent and simple way to visually confirm that equipment is in the appropriate critical zone in a food processing facility.

When color-coding is implemented, it is easily apparent which zones are which, and what they represent. Because of this instant recognition, separating contaminated food before it goes out to the public becomes easier. And we all know that internal recalls (or no recalls!) are less costly than public recalls.

To find out if color-coding is appropriate for your food processing facility, download our worksheet below.

10 Things to Know About Color-Coding: Preventing Cross-Contamination

Color-coding helps prevent cross-contamination in food processing facilities

In this third part of our color-coding series, we discuss how color-coding can help prevent cross-contamination in food processing facilities. Facilities with cross-contamination concerns should particularly consider color-coding their food processing plants to lower that risk. The threat of recalls is always prevalent, and food processing facilities should do what they can to prevent this from happening.

Prevent cross-contamination from biological hazardsColor-coding can help decrease the risk of contamination that leads to recalls. Food processors are regulated by the FDA to ensure that cross-contamination is controlled to keep consumers safe. One of the FDA’s rules includes HACCP, or Hazard Analysis and Critical Control Points, which imposes guidelines to help keep cross-contamination at a minimum, such as having a written safety plan.

Cross-contamination is prevented by keeping foods that transfer bacteria separate, or by keeping allergens separate. For example, we all know raw meat should never come into contact with processed meat, so you keep them separate. The simplest way to do this is to color-code the food processing facility. When a facility has a color-coded program in place, it makes it that much easier to distinguish between sections. For example, raw meat zones can be color-coded red, and the processed area green.

Sample Color-Coding Systems:

Preventing Functional Cross-Contamination:

Red: Raw Meat

Green: Processed or Cooked Meat

Preventing Departmental Cross-Contamination:

Blue: Seafood

Yellow: Chicken

Preventing Allergen Cross-Contamination:

White: Milk

Green: Soy

Yellow: Wheat

Color-coding makes it immediately apparent if there is a tool or piece of equipment in an incorrect zone, and the necessary steps can be taken to contain any contaminated food. Keeping zones separate is an extremely important food safety measure for preventing cross-contamination, and color-coding helps to do that. The next part in our series is how color-coding can help distinguish between critical zones and control points. For more information on color-coding, download our white paper below.