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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.