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How Root Cause Analysis Strengthens Your Production

Root Cause Analysis

Root Cause Analysis is a method used to find the source of a problem once a problem has already occurred. By identifying the underlying cause of any incident, you can further prevent future incidents from happening. Within Root Cause Analysis, two of the more common methods are the “5 Whys” method and the Ishikawa, or fishbone, Diagram. We’ll explore both of these methods and show how each method has its merits to food manufacturing and production facilities.

In order to perform a root cause analysis, you need to gather the facts and evidence for the issue that’s occurring.

  • What is the nonconformity? —Consider what is going on in your facility that needs to be addressed.

  • When did the nonconformity occur, and when was it discovered? —Identify the time period when the issue happened and take into consideration how much time passed between when it happened and when you realized it happened.

  • Are there any products or processes that may have been implicated? —Follow the incident to any later processes to discover what products may have been impacted as a result.

  • Has the immediate correction or corrective action been completed? —Even though you realized what happened, make sure that the immediate cause has been identified and corrected to prevent additional incidents or nonconformities.

Once you identify the root cause, it’s time to implement a proposed action plan. Outline who needs to do what in order to fix the nonconformity. There is no set way to discover the root cause, but let’s explore two of the more common, simple methods.

5 Whys

The 5 Whys is the method commonly used by facilities who are certified by GFSI standards. The 5 Whys method is more or less like a toddler—just keep asking, “Why?” until you get to your true “because.” The true definition is a bit less straightforward. It is “an iterative, interrogative technique used to explore the cause-and-effect relationships underlying a particular problem.” The 5 Whys method benefits companies because it encourages deeper probing. The whole point of this method is to keep asking why to find the source of the issue. By repeating this question, you go past the superficial answer. Unfortunately, the results of this method are not always repeatable. Depending on who is asking the question, you may get different causes. Also, this method relies on experienced staff to know which questions to ask.  

Ishikawa Method

When the “5 Whys” method is too basic, the Ishikawa method may be more appropriate. The Ishikawa method divides various root causes into categories (which are not predefined). From there, arrows indicate where causes can cascade into a nonconformance during the audit process. These diagrams were first used in 1968 by Kaoru Ishikawa. Causes act as a source of variation, which is then grouped into categories to identify and classify the sources.

In manufacturing, the Ishikawa method is also called the 5M Model:

  • Machine
  • Method
  • Material
  • Man
  • Measurement

For food, these have been transitioned to:

  • Equipment
  • Process
  • People
  • Materials
  • Environment
  • Management

The Ishikawa Diagram considers many factors that may have caused the initial problem by dividing the causes into finite categories within production.

Both the 5 Whys and Ishikawa methods are considered two of the more basic methods of root cause analysis. Even though they are considered basic, they still encourage you to keep searching for the initial cause of the incident or nonconformity that occurred. Alchemy Academy offers an online solution to your root cause analysis learning. Explore additional methods and find your answer to root cause analysis today.

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Addressing the 5 Dimensions of Food Safety Culture


Safety culture, more specifically food safety culture, has been a focus more and more in the workplace as a key factor in providing the best possible product for your consumers. The Global Food Safety Initiative, GFSI, wanted to develop a concrete definition for this term so they could have a clearer outline of what to address:

“A company’s food safety culture is the shared values, norms, and beliefs that affect mindsets and behaviors toward food safety in, across, and throughout the company.”

As with any process, there are different stages to make sure that you attain this concept. With food safety culture, GFSI expects that to fully internalize the concepts and have a solid grasp, it could take up to eight years depending on the size of the facility.

For a better understanding of what safety culture really is, Cultivate Food Safety worked with GFSI and companies across a variety of industries to divide it into five dimensions for a full picture.

#1 Vision & Mission

What message is leadership consistently sharing with employees in the organization?

Vision & Mission really amounts to the fact that positive practices start at the top and work their way down. Managers and others in leadership positions can affect a positive culture by setting expectations and priorities for food safety in the business strategy. Additionally, you can emphasize its importance by dedicating resources to help the food safety culture cause.

#2 People

What is the reward or recognition for exhibiting positive food safety culture attributes?

Where ‘Vision & Mission’ focuses on the top of your organization, ‘People’ focuses on the people behind the product. What management does to motivate those who implement daily processes can have an impact on how engrained food safety culture is within the organization.

  • Offer training to let employees know what to do.
  • Give incentives, rewards, or recognition for people who show these traits.
  • Establish an infrastructure of people at all levels who are passionate about food safety culture to act as influencers in your facility.

While this dimension stresses the positive, there should also be consequences for those who don’t follow best practices. Ideally, the rewards should outweigh the consequences, but you need both to make sure the culture sticks.

#3 Consistency

How do you document and hold people accountable for food safety measures?

To be truly effective with food safety culture, you need to be consistent with the rhythm you have for communicating results. Keep track of the consequences, both positive and negative, for every process you have in place. Hold workers accountable for their actions but remember that people respond better to positive reinforcement than negative.

#4 Hazards & Risk Awareness

What do you do to make sure that everyone is engaged, regardless of business size?

At times the food industry might face more challenges than other industries, in particular the issue of turnover. Having a successful food safety culture means that everyone is involved, despite a number of factors. There needs to be an awareness of the hazards and risks that are involved within specific roles and particular to the facility or product. In addition to the initial training, you need to make sure that employees retain the information.

#5 Adaptability

How do you respond in times of crisis and are you able to respond quickly?

There are many change-management tools to help businesses of all sizes to be agile in dealing with crises. Additionally, we have to consider expectations and regulations and fit the culture to these ideals. Cultural implications might also come up in this dimension. Importing and exporting can change the lens with which we need to view our product and the safety culture behind it.

Because of evolving science and industry, we need to be able to problem-solve and update our internal culture to match external expectations. Using managers to support their team members can help affect change quickly. In a recent survey, 43.2% of supervisors reported that they rarely or never receive coaching from managers. Keeping your managers as a resource trickles down and impacts workers at all levels.

These five cultural dimensions work together to form a mindset of food safety culture. Driving these behaviors can be a lengthy process, but it really is important to your facility’s success. You might hit roadblocks along the way because people’s individual experiences can create challenges with truly internalizing this mindset. By keeping a consistent commitment to it throughout the organization, you can help you bring the importance of food safety culture to life. Reinforce your commitment by using tools to increase worker confidence in your food safety’s daily implementation. By using your resources to support your employees, recognizing their success, and keeping a consistent message of food safety culture’s importance, you drastically improve your chances for long-term success.

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The 5 Essential Steps to Creating Your EMP


You don’t have to be in the food industry to be aware of recalls that happen, seemingly more and more. Every day people are aware of listeria and E. coli that might have never heard of it forty years ago. How do we protect our products and keep from having to recall? Environmental monitoring (EM) is an important way to identify things that might harm your consumers. It’s a part of many different regulatory requirements, but it’s also the best manner of checking that your cleaning has been effective and keeping disease out. The food industry considers Environmental Monitoring Programs (EMPs) as a control in your facility, but there’s a clear outline of how to best set them up.

Step 1: Conduct a risk assessment

Get a group of employees together to do a risk assessment that are subject matter experts in different areas in your facility—managers or scientific experts who know different sides of production. There are different ways to do a risk assessment and gather information. If you’re not comfortable with doing this on your own, consultants can be helpful.

Risk assessments have to be unique to each facility and make sure to consider the following:

  • the types of products produced

  • regulatory requirements

  • known hazards

Step 2: Identify your sanitary zones

Different regulations require various sanitary zones to be tested for EMPs. For example, USDA requires that you test zone one (it’s also recommended by some customers). Zone one is anything that is a product contact surface– filler nozzle, tanks, conveyor belts, employee hands, product contact utensils, and worktables. FDA facilities focus on zone two and three, which are non-food contact surfaces close to food and non-food contact surfaces. Zone three is more remote non-food contact surfaces. Outline these zones so you can tell where you need to focus your sampling program.

3: Decide on sampling sites in your sanitary zones

Make a spreadsheet to keep track of where the sampling sites are. Keep separate sheets for the different zones so you do the appropriate number of tests for the correct zones. As a general guideline, the FDA recommends 10 to 15 sites for zones two and three with tests completed weekly. Depending on the risk and your trend analysis of results, you might want to adjust how frequently you test and how many sites you test.

Step 4: Determine which bacteria to test for

Different tests offer information on a broad spectrum of pathogens. You can use recall data to find which bacteria might typically be present in similar requirements. Testing requirements vary from zone to zone. Even if it’s not a requirement, it’s usually a good idea to test for general cleanliness in zone 1. Testing for APC (aerobic plate count) or ATP (adenosine triphosphate) will check the microbial load in these areas. Zones 2 to 4 run a risk for listeria or salmonella species, which will use different tests than zone 1. Additionally, consider which ingredients you use when determining the tests to run. Eggs, for example, might have a higher likelihood of salmonella, but their risk might vary depending on pasteurization.

Step 5: Set your testing frequency

Once you establish the zones, sampling sites, and bacteria you want to test for, you need to determine how frequently you will run the tests. Depending on need, you should run tests anywhere from weekly to monthly. If a ready-to-eat food doesn’t support Listeria monocytogenes growth, then you would usually test this monthly. FDA guidelines outline the testing schedule in a straightforward way:

Zone 1: If needed, then weekly Zone 2: Every week
Zone 3: Every 2 weeks
Zone 4: Monthly

USDA uses a prescriptive formula to determine how often sites should be tested which can be found in their resources. No matter your guidelines, make sure you record all of your processes to complete your Environmental Monitoring Program. As you gather more information, if you notice increased positives then you might need to adjust your frequency.

You also have to determine the number of sites to be tested at the specified time intervals. The quantity should be at least consistent with regulatory guidance documents. It may also be determined by risk assessment after determining the total number of sites to be sampled in each zone. For example, if you identified 20 potential sampling sites in a zone, you want to consider taking 5 samples per week to assure all sites area sampled within a one month period.


Environmental Monitoring and Environmental Monitoring Programs can seem intimidating if you’re just beginning the process. Making sure you follow all the rules and adhere to USDA, FDA, GFSI, and customer requirements is an ongoing process. With training and other resources, you can establish an EMP and set your facility up for success. Documenting your process and keeping track of your results can prevent incidents in your company that might lead to recalls or foodborne illness outbreaks.

Alchemy Academy’s Solution

To get more information about EMPs, Alchemy Academy has a fully online course that helps you set up your facility for success. Learn how to set up your program, perform risk assessments and test, and manage your results. We also review software options that are available to help make running your EMP easier. Our EMP template package gives you additional resources to get you on the right track.

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Your 5 Workers’ Rights Through OSHA


Even though worker injuries and fatalities have decreased, the food industry is statistically more likely to experience either of these. As a leader in your company, you can directly affect the safety of everyone in your facility. Keeping your employees safe and helping them be aware of their rights can help you build a stronger relationship with them, too. The Occupational Safety and Health Act of 1970 started a movement to protect workers when they’re at work. We spend so much time there, so it’s important that everyone feels safe. This law makes sure that companies think of how they can keep their workers well and out of harm’s way.

What is OSHA?

Signed into law in December of 1970, the Occupational Safety and Health Administration (OSHA) is a part of the U.S. Department of Labor. It’s a continuous work-in-progress meant to keep workers safe while at work. OSHA works to make sure that workplaces have and enforce standards, plus give enough training and education to people at work.

What is the General Duty Clause?

The General Duty Clause is brief but has several parts. Part (a) has to do with the employer and part (b) has to do with employees. Each part basically says that both employers and employees will do what the OSH Act outlines to keep everyone safe from recognized hazards at work.

Who does OSHA protect?

OSHA was made to protect people at work. Workers’ rights are outlined in the OSHA documentation as five separate items. OSHA protects workers by giving them the right to the following:

  1. A safe and healthful workplace
    At your workplace, employees shouldn’t have to work around serious hazards. Having a pivotal role in your workers’ welfare, you should do whatever you can to keep risks at a minimum. If there is any way to do work-related tasks in a less hazardous way, that should be the usual way, even if it’s less efficient. You should also be sure to notify employees if they’ve been exposed to hazardous chemicals. If there’s any chance that they may develop an illness due to being exposed to these chemicals, they have a right to know. If you can’t offer a safer solution to a risky task, providing Personal Protective Equipment is helpful, but not the first choice for keeping your employees safe.
  2. Complain or request corrections
    If an employee sees something that could be unsafe or unhealthful, they have the right to say something about it. OSHA works to make sure that employees don’t have to be scared of a company getting back at them if they report dangerous conditions. They should feel comfortable saying what could be done better to make work safer, plus be able to find out what is done about it. Complaints can also be anonymous, making reporting less intimidating.
  3. Information on injuries and illnesses.
    The OSHA 300 log goes hand in hand with this right. It’s an annually posted summary of any injuries or illnesses related to a facility. The recordkeeping rule is for employers with more than ten workers but is really recommended for all employers. This rule gives everyone a clear idea of how safe their workplace is. Keeping written logs of any related illness or injury helps you create a more open dialog with your employees.
  4. Receive training from employers
    When you work somewhere, you have the right to learn how you can keep yourself safe. As a leader in your facility, you should offer enough training to let workers do their job in the safest way possible. All of the training should also be easy enough to understand and in different languages, so no one misses out in the translation.
  5. Participate in OSHA inspections
    If there are any concerns, employees can also walk along during the inspection and point any concerns out. Inspectors might not have a full grasp of where things might go wrong, and this right just means that they can show where it did (or even almost did.) Their perspective might give the inspector an insight to point out how the facility can be safer for everyone.

While this is just a brief summary of what OSHA does, its purpose is driven by getting people home safe from work. Safety training, including OSHA training, is just one way to improve the workplace. Giving people a secure environment to work in makes it easier to have satisfaction at their job.

Workplace Safety Culture

Every company has a Workplace Safety Culture, whether it be good or bad. A good culture results when a company demonstrates its commitment to provide a safe workplace for employees and when employees demonstrate their commitment to practice safe work habits. The company should have well defined and implemented safety programs, accident and near-miss investigation processes, adequate machine guarding and effective training programs. Employees should take personal responsibility for their safety and those around them.

What’s your food safety culture like? Alchemy EHS Consultants can help you comply and improve to keep your employees safe, reduce potential OSHA fines and reduce workers’ compensation costs

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Your Defense Against Intentional Adulteration


The idea of contaminated food brings up images of court jesters doing taste tests to make sure that kings and queens aren’t poisoned. Stories of intentional adulteration go back hundreds of years. People have to eat, and some people have hateful intentions. So, what can we do to keep these people from succeeding? It’s no longer just people in positions of power who need to be concerned with food fraud. Using strong food defense methods helps you back your brand and comply with FSMA’s Intentional Adulteration (IA) Rule. Some IA deadlines have already passed, and enforcement inspections start as soon as March 2020.

What is the Intentional Adulteration (IA) Rule?

Intentional Adulteration was the last of the seven foundational rules that came from the Food Safety Modernization Act. The IA Rule was proposed in late December of 2013 but was finalized on May 27, 2016. This rule created requirements to prevent (or at least minimize) acts meant to cause broad public health harm. Congress and the FDA scoped the rule so that it affects the weakest points of the food supply chain.

Who does it cover?

Facilities that manufacture, process, pack, or hold human food are covered by the IA rule—so if you have to register with the FDA under section 415 of the Food, Drug, and Cosmetic Act, the IA Rule applies to you. Intentional Adulteration applies to both domestic and imported food. Retail food and farms aren’t covered, and there are exemptions for very small businesses and some others as well.

What does it mean to me?

Food defense plans and training are both required for the Intentional Adulteration. Food defense plans are made up of six parts:

  1. Vulnerability assessment—used to find the points with the highest risk for intentional adulteration
  2. Mitigation strategies—measures to minimize or prevent vulnerabilities at each actionable process step
  3. Procedures for food defense monitoring—documented steps and frequency to monitor mitigation strategies
  4. Food defense corrective action procedures—written outline for steps to take when mitigation strategies aren’t put in place properly
  5. Food defense verification procedures—what is done to make sure that monitoring, corrective actions, and mitigation strategies are done properly
  6. Records—documentation to show that all of the procedures from the other parts of the food defense plan were fully and accurately completed

Food Defense Dynamics

Food defense threats have three different factors: motivation, capability, and vulnerability. Motivation accounts for the reason someone would purposely tamper with food. Capability is someone’s power to commit the crime. That includes what was used and how they did it. Vulnerability is how likely is someone to be successful at corrupting the food. What all has been put in place to prevent outside influence? Successful food defense plans consider in what areas are vulnerabilities likely to exist and how can people take advantage of these.

The three most common motivators are economically motivated adulteration, also known as “EMA”, terrorism, and sabotage. Economically Motivated Adulteration is sometimes called food fraud. EMA is something done to have a monetary gain or economic upper hand or get around trade policies. Terrorism involves people who target the food system to either cause fear, public health harm or social and economic disruption. The target of sabotage is the company more than the public. Sabotage would be when a disgruntled employee, consumer, or competitor wants to damage the brand. This can be a bit more difficult to pinpoint since a lot of times it’s done by someone who knows the business well.

Protecting your food from intentional adulteration is important to your business’s success, even if you don’t produce high-risk foods. Whether or not you fall into the IA Rule category, keep in mind how you can avoid incidents and save yourself money and hassle, plus protect your most valuable asset—your customers. Learn how you can protect your facility with Alchemy Academy. Our Food Defense Supervisor Awareness course is fully online and helps you get a better understanding of what to think about when securing your products.

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7 Steps to Effective Sanitation


As human beings, we all feel a need for cleanliness, hygiene, and sanitation when it comes to our food preparation. That’s all sanitation is, right? Just a large-scale version of what we do to keep a tidy kitchen. In fact, sanitation is much more involved than scrubbing dishes in the sink or wiping down a counter. While the desired end result is essentially the same, there are additional factors involved in food sanitation on a production and manufacturing level. The principles involved and the fundamentals at play form a base to outlining effective sanitation in your facility.

Seven Steps to Effective Sanitation

1. Dry Pickup

The first step to effective food safety and sanitation is removing excess soils with dry pickup. In areas near the production floor, like dry goods warehouses or employee welfare areas, dry pickup might be the only cleaning method you need. As the name “dry” implies, this step is cleaning without water–maybe scraping or using a brush or tools to remove any dirt. In production areas, dry pickup might go a bit further. These areas might also need vacuuming, which not only removes or loosens dry material, it also collects what it removes so it can be taken away from the production area.

2. Pre-Rinse Program

Following dry pickup, begin your pre-rinse program. This eliminates more dirt and grime before you apply compounds or scrub equipment. Use a top-down approach and rinse with hot water and high pressure to fully loosen anything that might be on your equipment or food contact surfaces. Some pre-rinse might contain detergents in low concentrations to make the process easier. It’s always best to complete this step soon after production ends to reduce residual buildup on equipment.

3. Cleaning Agent or Detergent Application

After the initial two steps of removing any dirt or grime, start applying detergents and/or cleaners. Be sure to consider that water characteristics can have an impact on detergents. Some chemicals might interact with elements of the water and make it less effective. Choose your cleaning agent or compound based on what kind of soil is there. Heavy organic residue oil (fats, meat residues, etc.) need more alkaline cleaners to successfully remove them.

4. Post-Rinse Procedure

Post-Rinse keeps cleaning agents and detergents from transferring to food. You don’t want possibly abrasive or harmful cleaners in your product. Post-rinse is just one more rinsing step to remove cleaners from equipment and places that might come in contact with food.

5. Preliminary Inspection

A preliminary inspection typically involves segmented inspections. They might involve several groups or departments as well as multiple layers of staff, inspecting areas fully or in a randomly sampled inspection process, including equipment or hygienic zones. People who work in a particular area might be more familiar with spots where there’s more likely to be buildup. By breaking this step down into separate areas and groups of people, you divide the work to make sure it’s well done.

6. Pre-Op Inspection

Your last visual review is the pre-op, or pre-operative, inspection. This checks how clean your facilities and equipment are. Pre-op inspections are very detail-oriented and require highly trained personnel. These specialists inspect areas, lines, or pieces of equipment using a random generator program. If anything is found during the pre-op inspection, you have to start taking (and documenting) corrective actions to keep the entire sanitation program from breaking down.

7. Sanitizer Application

The last step for sanitation is applying sanitizers. After the pre-op inspection is complete, apply sanitizers to food contact surfaces and nearby zones, according to your SSOPs. Sanitizers don’t work on areas that haven’t already been cleaned—they sanitize at the microbiological level. This one step doesn’t replace the rest of the cleaning and sanitation process.

Why is sanitation important? Food sanitation is more than just rules and regulations. Food safety and sanitation are incredibly important pieces of your business. They make your products safe for your customers, keep recalls down, and increase your revenue. Keeping these steps in mind helps you know that your production is done in a clean, sanitary environment. This good food hygiene helps you have a positive contribution to food supply on a global scale.

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The 5 Factors That Guide Effective Internal and External Audits

effective internal audits

Using Internal Audits for External Audit Excellence

Audits play an integral role in the successful production or manufacturing of food and beverages at a fundamental level. Both internal and external audits serve as documented evidence that companies are performing due diligence to adequately protect their food from unsafe or unsecured practices, thereby safeguarding their consumers from potentially unsafe products.

ISO 19011 defines audits as “[the] systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are filled.” If we deconstruct this statement, we can infer several factors that governing bodies deem central to audit success for food safety standards:

1. Ethical Conduct
2. Systematic
3. Independent
4. Evidence-Based
5. Objectively Evaluated

In exploring these principles, we can further outline the dynamic relationship between internal and external audits.

Ethical Conduct

The first principle from the ISO audit definition speaks to integrity more than anything else. Ethical conduct refers to reporting findings from your audit in an open and honest manner. When documenting findings from your internal audits, be sure to reflect any non-conformances that you may come across. Try to view your facility and processes as if it were from an outside perspective, removing as much bias as possible. By recording non-conformances and the corrective actions you take when you do find them, you provide external auditors with a more accurate baseline to compare against and demonstrate that you have made attempts to improve based on your findings. While performing an SQF audit or GMP audit, for example, a food auditor will review your documentation in addition to asking verbally. Maintaining ethical conduct and accurately representing your facility gives validation to what you say and reinforces trust with your food auditor and furthermore your consumers.


The word systematic can be used to imply “due professional care.” Your internal audit should be performed methodically, with a scope established beforehand. Complete each step of your audit thoroughly, respecting employees who are present while the audit is in process. Be intentional with how you record your findings and use templated documents to add to the consistency. If you do find any non-conformances, review the evidence to support it with employees who are present, making sure that everyone recognizes the reasoning. The “systematic” principle ties in with external audits in that professional auditors who evaluate BRC (or BRCGS), SQF, GMP, or GFSI audit standards are very practiced in how they audit facilities. In this instance, the internal audit function serves to mimic the external audit process and streamline audit completion.


The success of internal audits is dependent on the audit being facilitated by employees who work outside of the area being audited. Independence ensures that there is no conflict of interest, whether intentional or unintentional. Employees who work in the area regularly may not notice subtle deviations from established procedures or see visible evidence of non-conformances. GFSI standards dictate that internal audits must be done by employees outside of the audited department.

Evidence-Based Approach

Circling back to Ethical Conduct is the principle “Objectively Evaluated.” External food auditors may come to the same facility repeatedly but still must maintain that their audits are performed impartially and in a fair manner. Removing personal bias when inspecting conditions safeguards consumers, who essentially depend on this. Assessing conditions, and documenting them as they truly are, reflects a high standard and helps ensure food quality and safety. Use detailed templates and guidelines to perform your internal audits. Observe processes as they occur on a regular basis to have an accurate depiction of adherence to policies and standards. Stage internal audits to simulate external audits so employees are adequately prepared and can be more comfortable when external auditors do come in. Objectively assessing the state of your facility, documentation, and processes show integrity and reinforce the trust that backs your brand.

Following these principles helps you achieve “Excellent” marks on your external audits and minimize any incidents that could occur. BRC audits differ from SQF audits, but knowledge of the audit standards helps you adequately form your procedures and prepare for audit success. Learn more about internal audit best practices in our fully online courses Internal Auditing—Basics and Internal Auditing—Advanced. Gain valuable knowledge and resources to start your journey to audit success.

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Getting Guidance on the Produce Safety Rule

Produce Safety Rule

Adhering to Good Agricultural Practices has always been key to growing a successful agricultural business. In the past, voluntary FDA guidance documents provided a general idea of what to do in order to minimize risks throughout the production process. However, in 2011 the Food Safety Modernization Act (FSMA) brought about the most significant changes to U.S. food safety laws in more than 70 years. One of the seven major overarching rules under FSMA is the rule on Standards for the Growing Harvesting, Packing and Holding of Produce for Human Consumption, better known as the Produce Safety Rule. The Produce Rule applies to farms engaged in the growing, harvesting, packing, or holding of raw agricultural commodities (fruits, vegetables) for human consumption. This rule is the first mandatory federal law requiring growers to adhere to specific science-based standards to grow and pack products for human consumption.

While the law came into effect on January 26, 2016, the FDA understood there needed to be time allotted for the industry to comply. The Produce Safety Rule compliance dates vary on the size of the facility—very small farms were given four years to comply, small farms were given three, and larger companies were given two. Additionally, the Produce Safety Rule offered additional time for monitoring the agricultural water quality requirements as this is a complex area and one which FDA anticipated the need for training and education within the growing community. Commercial farms with average annual produce sales of at least $25,000 are covered under this rule. 

There are; however, qualified exemptions to the rule. Commodities, such as beans or potatoes, which are rarely consumed raw would not fall under the Produce Safety Rule, nor does produce that is grown either for personal consumption or consumption on the farm. The FDA has created a Produce Safety Rule decision tree that can help determine if your farm needs to be compliant or is eligible for a qualified exemption.

It is important to note that the Produce Safety Rule is derived from Good Agricultural Practices, or GAPs, and the principles that the FDA first laid out two decades ago. The Essentials of Produce Safety course is built for produce managers and supervisors across the supply chain. This online course reviews GAPs in detail and traces their evolution into what we recognize today as the Produce Safety Rule. One example of the approach FDA outlined might include worker health, hygiene, and training from subparts C and D in their Good Agricultural Practices guidance. Both of these subparts have a prominent role in the Produce Rule. They additionally impacted the revision of Good Manufacturing Practices (GMPs) from the Preventive Controls Rule, which covers manufactured products.

Focus on Training

You’re most likely familiar with FSMA’s requirement for specific training for designated employees in your facility—Preventive Controls Rule or Produce Safety Rule, depending on your operation type.  Best practices show that training affects employees at all levels in your facility:

  • Reinforce training regularly.—Train field or line workers when they are hired and in regular increments afterward.

  • Educate supervisors and managers.—Give employees in charge of supervising produce safety activities more background information so they understand what is done and why.

  • Offer training in language the employees speak.—Providing workers training and outlining learning outcomes in languages that they customarily speak adds to the value of the training you give.

  • Give real-world examples.—There are many companies that can attest that when employees understand why a task is important, they are more likely to own the responsibility for completing the task to the best of their ability.

  • Highlight the importance of good hygiene.—Illness might cause product contamination, so recognizing symptoms early is especially important in food production and manufacturing.

Learning is always essential to protecting your products and your company. Alchemy Academy offers exclusive content from the Produce Marketing Association that is complimentary to the FDA’s produce safety training curriculum and provides not only what needs to be done, but why it is important and offers insights on how best to not only be compliant with the FSMA rules but also best protect your company, your customers and your employees from the disruption of a produce safety illness outbreak. In Essentials of Produce Safety, individuals will learn how to better identify and manage produce safety risks within their operation and more. Get started with PMA’s exclusive online course today!

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What Kosher Means to Your Food Facility

Managing Kosher Production

While the word “kosher” has entered mainstream culture references, kosher food production demands strict adherence to a set of religious rules. You may have a general awareness of some of the requirements for what makes something kosher, but kosher certification requirements are rigorously detailed. Kosher manufacturing may seem intimidating, but this unique market has multiple rewards.

What Is Kosher?

Kosher is a set of rules for food production with religious significance. There is a set list of foods that are considered kosher, or acceptable to eat. The laws behind kosher food are deeply rooted in the Bible and further outlined in the Talmud and other Jewish traditions. Those who keep kosher take this designation very seriously, so there are many expectations when a product does obtain that designation.

kosher annual sales

$12 billion

What the kosher food industry generates in annual sales

consumers purchase kosher


Percentage of consumers who purchase kosher food for religious reasons

Non-Jewish Consumers who Purchase Kosher

35 million

The approximate number of non-Jewish consumers who purchase kosher products

Why Should I Become Kosher?

Let’s begin with the most evident reason to start producing kosher products—the revenue. The areas that sell kosher products are densely populated with consumers who depend on the availability of kosher products, creating a regular income. Kosher is a multibillion-dollar industry in the United States alone. It was recently reported that the kosher food industry generated over $12 billion in annual sales. When considering the global marketplace, this increases even more. As of 2009, Mintel Press reported that a mere 14% of consumers purchase kosher food because they follow kosher rules. That means that 86% purchase kosher products for non-religious reasons. Given the trends in kosher sales, it’s likely only increased since then. Secondly, though most purchase kosher products because of non-religious reasons, there is a wide range of religious and cultural groups that follow kosher practices. Keeping to these strict standards creates a solid brand loyalty to Kosher-sanctioned products. Finally, there are some individuals with allergies whose needs coincide with established kosher standards. For example, an individual with severe shellfish allergies might not be able to consume anything that has come into contact with shellfish to any extent at all. As kosher does not include shellfish, this individual would be able to take comfort in the fact that foods with this designation would be safe for their consumption.

Who Supervises Kosher?

Kosher designation requires extreme diligence. By having a kosher supervisor, or mashgiach, you ensure that your production facility is fully aligned with kosher standards. A rabbinical coordinator can go through every aspect of your processes, equipment, and materials to ensure that every detail is considered. Kosher certification requirements are very exact and consultants who specialize in governmental standards are not necessarily versed in the requirements of what makes food kosher.

What Comes Next?

Interested in finding out how kosher can work for you? Alchemy Academy offers a unique opportunity to start your journey to kosher production. Our Kosher eLearning Course helps plant managers or those in senior management understand the significance of kosher within their plant. This curriculum helps outline the bearing of kosher on a grander scale, giving perspective on the communities you directly impact with proper kosher production. By signing up for Managing Kosher Production, you get one step closer to a lasting relationship with valuable and loyal communities of consumers.

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How to Avoid Top Audit Non-Conformances

In the food production industry, the Global Food Safety Initiative, or GFSI, performs audits that act as unbiased, independent evaluations of food safety and quality systems. This reassures the public that the source of their food is looking out for their best interests and trying to avoid product recalls. Audits provide brief snapshots in time that inform vital decisions in the food safety and quality of the business. A successful audit provides assurance that the company can sell the product to customers with minimized risk. An unsuccessful audit, however, identifies opportunities for improvement within the organization and shows where food safety might be lacking. By knowing the most common non-conformances, you can look at your own food safety program and see where you have room for growth.

Top Audit Non-Conformances

One of the top major non-conformances for SQF audits is related to a requirement for a food fraud program. Clause mandates that you have to assess both your site and your raw material’s vulnerability to food fraud. The primary reason for non-conformances in this area is typically related to the food fraud program inadequately addressing all that it needs to. To avoid non-conformances based on this clause, document and maintain your Mitigation Plan to reduce risks. Review your program at least annually and schedule updates as needed. There are several tools to ensure that your food fraud program is successful: PWC Vulnerability Assessment, Food Fraud Database, and Horizon Scan provide supporting documentation.

Every facility is now required to have a risk-based environmental monitoring program.

The second major non-conformance is a recent update to edition eight, with a requirement for environmental monitoring programs. Every facility is now required to have a risk-based environmental monitoring program. Make sure that you perform risk assessments and test adequately for environmental pathogens. When you have completed the risk assessment, you can evaluate the results to determine which hazards to monitor. Your written program also needs to specify the sampling and testing schedule, as well as the number of samples to be taken and the frequency of sampling. Survey the plant to find sampling sites and designate the frequency based on risk. You can further justify the sampling by following regulatory, trade association, or scientific guidelines. The USDA and FDA both provide supporting guidance documents to justify sampling frequency. Some trade associations, such as the American Frozen Food Institute, also provide helpful compliance guidelines. Maintain thorough records for sampling and corrective actions after adverse results. By keeping adequate records, you can study the results to find a trend analysis and address any findings to improve future audit results.

Cleaning and sanitation are a vital part to any audit’s success. To ensure that you perform well in this area, double-check your written Sanitation Standard Operating Procedure program, or SSOP. Every SSOP should address the appropriate cleaning procedures for all major pieces of equipment in your facility. Within this documentation, you should also address the verification procedure for sanitation effectiveness. Include a visual pre-op inspection, as well as different types of either ATP or total plate count testing to verify that you’ve removed the soil and microbial loads from the equipment.

Next, be sure to address the critical control point or preventive control monitoring procedures. Be sure to perform preventive control monitoring procedures at the frequency designated in the food safety plan, in the manner in which it is outlined. When documenting preventive control monitoring, include an explanation for why you chose the critical control points that you did, and the critical limits to demonstrate that they will effectively control the identified hazards. To further support this portion of the audit, prepare your CCP monitoring and verification personnel to adequately respond in interviews. Ensure that they can confidently explain their responsibilities and how they fulfill recordkeeping requirements. Perform annual reviews to verify your CCP records for completion and accuracy.

Beyond critical control points, it is also crucial to address pest prevention. Two of the top ten major non-conformances are related to pest prevention programs and pest activity. By implementing an effective pest prevention program, you can limit the non-conformances for both clauses and Evidence of pest activity, whether rodents, roaches, ants, or any other type of pest, leads to major non-conformances on your audit. If you feel you are unable to manage pest control yourself, you may want to use an outside pest control organization. If you do choose to manage this externally, be sure to verify that they’re doing everything that you’ve outlined within your program.

Another major non-conformance is classified under clause for internal audits and inspections. For internal audits other than the SQF system audit, there are two different components: one for the SQF system, the other for plant inspections. To prevent this non-conformance, keep a checklist to show that you are auditing all elements of the code. Be sure to perform an annual review to maintain compliance with this clause, as well.

Validation and Effectiveness are other factors in major non-conformances. Clause speaks specifically to the validation of good manufacturing practices and critical limits associated with critical control points or preventive controls in the food safety plan. To avoid a non-conformance in this portion of the code, validate changes within the SQF system any time you have new products, changes in raw materials, or new equipment changes with a process that adequately demonstrates you’ve performed SQF system verification and validation.

During the Process

While you are being audited, if you identify a non-conformance, there are ways to address it. Communicate closely with the Auditor throughout the process. This helps you understand the nature of the non-conformance and dispute it if you do not agree after the Auditor explains the issue. Take before and after pictures of non-compliant areas so you can show further proof when taking corrective actions later. Be sure to correct non-conformances as soon as possible and point them out to the Auditor. By taking quick corrective action, you demonstrate your commitment and sponsorship. Ask the Auditor to review results each day in an exit meeting. Daily meetings during the audit ensure that you are in agreement with any nonconformances that have been identified. Assess your ratings in the final exit meeting.

After the Audit

Meet with your Food Safety Team and work directly with them to establish appropriate corrective actions for each non-conformance. Investigate each non-conformance and establish the root cause for its deviation from the standard regulation. Each non-conformance should have a Corrective Action and Preventive Action (CAPA) record that goes with it to support actions to be taken to correct the non-conformance, as well as future actions to prevent the irregularity from occurring again. Each certification body has Corrective Action Forms for submission on or before a date set by the Auditor. After you have completed all appropriate records, follow up with the Auditor to ensure that the non-conformances have been closed. While it is not recommended, you can file an appeal if you have a strong dispute with the type of non-conformance. Any appeals, however, will affect your overall audit score, so do this with extreme caution.

In Conclusion…

With regular monitoring of systems that you have in place, you can avoid many non-conformances and ensure that you perform well on any audit—announced or unannounced. Review procedures and meet with your food safety team and SQF practitioner regularly to make sure that all team members are ready, even at a moment’s notice. Regular training also improves performance by refreshing everyone’s memory and keep processes on track.

Alchemy Academy provides online training that lets your employees train at their own pace, on site. If you are at all able, use a third party for reassessment. By using external individuals, you can get impartial feedback on processes and get recommendations for any changes that might need to be made during the annual reassessment process. Know your team, processes, and facility so there aren’t any surprises when you are faced with an audit. Minimize unused equipment, and don’t allow contractors on days when you do have audits. By limiting external factors, you reduce the chance that a non-conformance will be identified. Alchemy Solutions offers personalized training and consulting to help you along every step of the audit process. Our online courses offer in-depth knowledge to help you succeed in every aspect of the audit process.

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Taking Control of Your HACCP System

Implementing a HACCP System requires that both Prerequisite Programs and HACCP Plans are implemented.  Prerequisite programs are programs that are put in place in the facility to control hazards in the environment, preventing contamination of the product.

Many factors are taken into account to successfully produce safe and wholesome food. Governmental regulations guide implementation of GMPs, which stands for Good Manufacturing Practices, and outline prerequisite programs and HACCP plans to ensure the safety of the consumer. A successful HACCP system requires both PRPs, or prerequisite programs, and HACCP Plans. These two facets combined are essential to the development and implementation of a full HACCP system. The stronger the prerequisite programs are, the stronger your food safety plan will be. PRPs and HACCP plans provide the basic environmental and operating conditions necessary for safe and wholesome food.

HACCP systems deal uniquely with food safety issues.

While prerequisite programs and HACCP plans work together, each type differs from the other. Prerequisite programs deal indirectly with food safety issues and are more general in nature. They may be applicable throughout the plant, crossing multiple product lines. If your facility fails to meet a prerequisite requirement, the result is seldom a food safety hazard or concern. HACCP systems, however, deal uniquely with food safety issues. They are scientifically based, originating from hazards analyses. They are product and line specific. In HACCP plans, deviations from a critical limit typically result in action against the product.

When developing your prerequisite programs, keep in mind that many PRPs are based on cGMPs, or current Good Manufacturing Practices, and sanitation regulations. Outline ingredient specifications, including any raw materials used to create your product packaging, and processing aids that might affect the output. Allergen management programs, both cleaning and labeling, are included in prerequisite programs. Facilities that manufacture ready-to-eat products must legally also include microbiological monitoring in their PRPs. Additionally, include traceability programs that outline sourcing from raw materials to final product. Supplier approval programs should also be included in prerequisite programs.

One of the most critical programs included in PRPs is employee training. By effectively training employees, you reduce risk in other aspects of your HACCP plans and prerequisite programs. Food safety and personal hygiene training are the minimal requirements from FSMA for essential employee training. Employees must be trained upon hiring, and there must be at least annual refreshers for all employees to remain in compliance. Reinforcing key concepts with training and other visual reminders encourages employees to follow food safety and HACCP plans. Additionally, individuals involved in activities related to a critical control point or having to do with preventive controls might need specialized training to ensure that all procedures are being executed correctly and to be in SSOP compliance.

FSSC 22000 lays out additional prerequisite programs for food safety that are essential to GMPs. There are several key PRPs related to the physical layout of the facility and the facility itself. The construction and layout of the building itself play an important role in the prerequisite programs for ISO 22000, including the layout of the premises and workspace. Include additional programs for utilities, waste disposal, and cleaning and sanitizing. Both layout and cleaning and sanitizing act as measures for prevention of cross contamination. FSSC 22200 requires that Operational Prerequisite Programs (OPRPs) be identified within the food safety system, as well. OPRPs are used to control the likelihood of introducing food safety hazards or contamination of the product. They are primarily used to reduce food safety issues and should not be used for food quality parameters. OPRPs are almost equally important to CCPs in the food safety system, and thereby must be verified and validated. They are defined based on risk, so a detailed risk assessment is vital to establish them.

HACCP plans are complementary to other programs, including industry and inspection programs. They must coexist with adequately implemented PRPs. A HACCP system relies on SSOPs and SPS (Sanitation Performance Standards) to serve as a solid foundation to be fully functional. With strong PRPs for food safety, your facility can effectively implement a HACCP system and protect your customers. Industry standards are ever evolving, but with regular employee training, you can ensure that you stay up to date with regulations and ensure safe, quality food to your consumers. 

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Label Transparency: Protecting Your Consumers from Allergens

Governmental regulations, such as the Food Safety Modernization Act (FSMA), have drastically impacted how food producers perform allergen control. Activities that were formerly merely suggestions are now compulsory in order to minimize the risk of allergens in food products. Food allergen preventive controls are both essential and beneficial to your bottom line. With increased allergen awareness among consumers, restaurants and other food handlers should encourage employees to train to increase their food allergy awareness and reduce the possibility of incident in their facility.

The Big 8

The majority of food allergic reactions in the United States stem from 8 allergenic categories. While some of these categories need to be further specified, the inclusion of any of these allergens must be documented to comply with regulations.

  1. Milk
  2. Egg
  3. Peanut
  4. Tree Nuts (species specific)
  5. Fish (species specific)
  6. Crustacean Shellfish (species specific)
  7. Wheat
  8. Soy

If your facility uses any of these products in your manufacturing, you must be vigilant in how you handle and manage not only the allergens, but also any materials that might come in contact with them. In larger facilities, consider separating production lines in close proximity with walls, curtains, or partitions to minimize the risk of allergen cross-contact. Additionally, create a hygiene map to indicate where different allergens are stored or located. This also illustrates the flow of allergens throughout the facility, offering a visual representation of any places where cross-contact may occur.

Food safety allergen training can inform employees of best practices and also create protocols for your facility. To increase awareness, staff training can include allergen identification and assess the ability of employees to clearly segregate the allergens. Establish a consistent manner to identify allergens within your production. One possibility for allergen identification is using a color-coding system to designate which allergen is present. Alternatively, you can use icons as labels—this prevents risk of confusion for any employees that might be color-blind. Identify allergens on raw material labels using the common name. Some ingredient names do not adequately identify the allergenic material, for example lecithin, which may contain a soy allergen. By listing the common allergenic name, you reduce the chance of misperception for other employees in the facility. When cataloging allergens, also include any packaging, processing aids, colors, flavorings, or lubricants that may transfer to food products.

Allergen controls begin as soon as you receive any materials. Prerequisite programs can be put in place that outline how to treat these materials, including documented allergen checks as you receive them. If your facility takes test samples upon receipt, ensure that you do not use same knives to open bags or containers of unlike allergens. After you do take any samples, ensure proper closure of the bags. Use designated tools and equipment to handle any allergenic materials and prevent cross-contamination.

When considering product manufacture and storage, be sure to adequately clean any shared equipment. Equipment design can facilitate cleaning, simply by having a sanitary design. Scheduling and engineering controls can minimize the frequency of intensive cleaning. Schedule equipment use in an order that runs unique allergens toward the end to help minimize changeovers. Do keep in mind that robust sanitation protocols must be executed if an allergen is present in one product but is not present in the next product scheduled to run. Visible inspection is one way to verify that the equipment is clean, but some allergens require further testing. If any residue is present, including films or protein sheen, the equipment is not “visually clean.” Visible cleanliness is only used as a minimum standard. Validated allergen-specific test kits are available for some food allergens. They detect the presence of food allergens on food-contact surfaces using swabs and are sensitive enough to detect levels of allergens that could cause a reaction.

Storing product causes additional allergen concerns. Keep allergen-containing rework and work in progress in sturdy containers with secure covers and disposable interior liners where this is appropriate. If possible, use containers that do not require equipment to move them—this minimizes the risk of damage to the container, resulting in a possible incident of product mixing with an allergen-containing product. When you do reuse a container, be sure to thoroughly wash and sanitize the container before you reuse it. Any bins used for storage should be marked with information such as the name of the rework, the allergen included, and dates for manufacture, storage, and using the rework. Clearly labeling the allergen and material in the containers helps reduce the risk of accidental product mixing.

Ultimately, allergen control is in the hands of your personnel. Manage employees’ outer clothing, as it may accumulate residual allergen from the processing area. Control traffic patterns of both people and raw materials to further reduce risk. Most importantly, proper allergen control training is essential for food companies.  Providing food allergy awareness courses is beneficial but emphasizing the importance of food allergen preventive controls is vital to protecting your customers. The Food Safety Modernization Act (FSMA) includes allergen control practices that are necessary for consumer protection and serve your best interests as well. Alchemy Academy is an industry leader in online food safety training. Click here to take PCQI training at your own pace. Protect your customers and protect yourself with food allergen preventive controls.