Tag Archives: equipment

Lessons Learned from Intentional Adulteration Vulnerability Assessments (Part II)

By Frank Pisciotta, Spence Lane
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Food defense is the effort to protect food from intentional acts of adulteration where there is an intent to cause harm. Like counterterrorism laws for many industries, the IA rule, which established a compliance framework for regulated facilities, requires that these facilities prepare a security plan—in this case, a food defense plan—and conduct a vulnerability assessment (VA) to identify significant vulnerabilities that, if exploited, might cause widescale harm to public health, as defined by the FDA. Lessons learned during the conduct of food defense vulnerability and risk assessments and the preparation of the required food defense plan are detailed throughout this three-part series of articles. Part I of this series addressed the importance of a physical security expert, insider threat detection programs, actionable process steps (APS) and varying approaches to a VA. To further assist facilities with reviewing old or conducting new VAs, Part II will touch on access, subject matter experts, mitigation strategies and community drinking water through more lessons learned from assessments conducted for the largest and most complex global food and beverage facilities.

Lesson 6: Utilization of Card Access. The FDA costs of implementing electronic access control, as reported in the Regulatory Impact Analysis document (page 25) are shown in Table 1.

Average Cost Per Covered Facility Initial Recurring Total Annualized
Prohibit after hours key drop deliveries of raw materials $ $1070 $1070
Electronic access controls for employees $1122 $82 $242
Secured storage of finished products $1999 $– $285
Secured storage of raw materials $3571 $– $508
Cameras with video recording in storage rooms $3144 $– $448
Peer monitoring of access to exposed product (not used) $47 $1122 $1129
Physical inspection of cleaned equipment $– $303 $22
Prohibit staff from bringing personal equipment $157 $– $22
Total $9993 $1455 $2878
Table I. Costs of Mitigation

In our opinion, these costs may be underreported by a factor of five or more. A more realistic number for implementing access control at an opening is $5,000 or more depending on whether the wire needs to be run in conduit, which it typically would. While there are wireless devices available, food and beverage organizations should be mindful that the use of wireless devices may in some cases result in the loss of up to 50% of electronic access control benefits. This happens because doors using this approach may not result in monitored-for-alarm conditions, such as when doors are held open too long or are forced open. Some wireless devices may be able to report these conditions, but not always as reliable as hardwired solutions. Using electronic access control without the door position monitoring capability is a mistake. From a cost standpoint, even a wireless access control device would likely be upwards of $2,000 per opening.

Lesson 7: In the interest of time, and in facilities with more complex processes (which increases the work associated with the VA), plan to have quality, food safety and physical security personnel present for the duration of the VA. But also bring in operational specialists to assess each point, step or procedure for the respective operational areas. You may wish to have a quick high-level briefing for each operational group when it’s their turn to deliberate on their portion of the manufacturing operation. Proper planning can get a hybrid style VA done in one-and-a-half to three days maximum for the most complex of operations.

Lesson 8: Conduct a thorough site tour during the assessment process; do not limit your vulnerability activity to a conference room. Both internal and external tours are important in the assessment process by all members of the team. The external tour is needed to evaluate existing measures and identify vulnerabilities by answering questions such as:

  • Is the perimeter maintained?
  • Are cameras pointed correctly?
  • Are doors secure?
  • Are vehicles screened?
  • Are guards and guard tours effective?
  • Internal tours are important to validate documented HACCP points, steps or procedures.A tour also helps to validate process steps that are in multiple parts and may need to be further assessed as a KAT, for public health impact, accessibility and feasibility or to identify issues that have become “invisible” to site employees which might serve a security purpose.
  • Properly conducted tours measure the effectiveness of a variety of potential internal controls such as:
    • Access control
    • Visitor controls
    • Use of identification measures
    • Use of GMP as a security measure (different colors, access to GMP equipment and clean rooms)
    • Effectiveness of buddy systems
    • Employee presence

Lesson 9: Do not forget the use of community drinking water in your processes. This is an easy way to introduce a variety of contaminants either in areas where water is being treated on site (even boiler rooms) or where water may sit in a bulk liquid tank with accessibility through ladders and ports. In our experience, water is listed on about half of the HACCP flow charts we assessed in the VA process.

Lesson 10: Some mitigation strategies may exist but may not be worth taking credit for in your food defense plan. Due to the record keeping requirements being modeled after HACCP, monitoring, corrective action and verification records are required for each mitigation strategy associated with an APS. This can often create more work than it is worth or result in a requirement to create a new form or record. Appropriate mitigation strategies should always be included in your food defense plan, but sometimes it produces diminishing returns if VA facilitators try to get too creative with mitigation strategies. Also, it is usually better to be able to modify an existing process or form than having to create a new one.

Lesson 11: In cases of multi-site assessments, teams at one plant may reach a different conclusion than another plant on whether an identical point, set or procedure is an APS. This is not necessarily a problem, as there may be different inherent conditions from one site to the next. However, we strongly suggest that there be a final overall review from a quality control standpoint to analyze such inconsistencies adjudicate accordingly where there is no basis for varying conclusions.

Lesson 12: If there is no person formally responsible for physical security at your site, you may have a potential gap in a critical subject matter area. Physical security measures will make at least a partial contribution to food defense. Over 30 years, we have seen many organizations deploy electronic access control, video surveillance and lock and key control systems ineffectively, which provides a false sense of security and results in unidentified vulnerability. It is as important to select the right physical security measures to deploy, but also critical to administer them in a manner that meets the intended outcome. Most companies do not have the luxury of a full-time security professional, but someone at the plant needs to be provided with a basic level of competency in physical security to optimize your food defense posture. We have developed several online training modules that can help someone who is new to security on key food defense processes and security system administration.

Lesson 13: As companies move into ongoing implementation and execution of the mitigation strategies, it is important to check that your mitigation strategies are working correctly. You will be required to have a monitoring component, correction action and verification intended for compliance assurance. However, one of the most effective programs we recommend for our clients’ food defense and physical security programs is the penetration test. The penetration test is intended to achieve continuous improvement when the program is regularly challenged. The Safe Quality Food (SQF) Institute may agree with this and now requires facilities that are SQF certified to challenge their food defense plan at least once annually. We believe that frequency should be higher. Simple challenge tests can be conducted in 10 minutes or less and provide substantial insight into whether your mitigation strategies are properly working or whether they represent food defense theater. For instance, if a stranger were sent through the plant, how long would it take for employees to recognize and either challenge or report the condition? Another test might include placing a sanitation chemical in the production area at the wrong time. Would employees recognize, remove and investigate that situation? Challenge tests are easy high impact activities; and regardless of the outcome, can be used to raise awareness and reinforce positive behaviors.

Whether training a new security officer, reviewing existing security plans or preparing for an upcoming vulnerability assessment (due July 26, 2020), these lessons learned from experienced security consultants should help to focus efforts and eliminate unnecessary steps at your facility. The final installment in this series will address broad mitigation strategies, the “Three Element” approach and food defense plan unification.

Challenge

Three of the Most Common Maintenance Challenges In the Food And Beverage Industry

By Bryan Christiansen
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Challenge

Food and beverage professionals will agree that food manufacturing is a sector with conditions like no other. The industry is highly regulated because its products are for human consumption. Any deviation from strict control can lead to contaminated products with the possibility of outbreaks, illnesses and lawsuits.

Thus, maintenance managers in food manufacturing must contend with several unique challenges that come with multiple regulatory bodies, keeping highly automated and complex equipment running, and ensuring workers’ safety, all while producing hygienic goods.

This article will review three of the most common maintenance challenges being experienced in the food and beverage industry and some recommendations on how to deal with them.

1. Maintaining Complex Equipment

A typical food and drink processing plant today would be fitted with an array of complicated and highly sensitive equipment. From peeling machines to refrigeration plants and very complex packing machinery, every component demands constant attention.

Each one of these assets is part of a fast-moving production line that require specialized skills to monitor and keep in peak operating condition. In addition, this industry is under constant pressure to both improve and modify existing machinery, while also adopting new technology (especially automation).

Many food processors need to run their production 24/7 to stay competitive. It is apparent that the maintenance team has a lot to handle under such conditions,

To maintain the highly automated systems and keep equipment running optimally, food production and maintenance managers must stay on top of new techniques. They need to research, provide ideas and adopt newer and better maintenance strategies. Although it’s expected that there would already be some maintenance schedule in place, just any old routine will not work.

Imagine trying to run such a sensitive system on reactive maintenance alone where components are left to fail before repairs are carried out. Downtime would be disproportionately high and the enterprise runs the risk of shortening the lifespan of their assets. Instead, it is advisable to switch from reactive to preventive maintenance or look to implement any of the other proactive maintenance strategies like predictive maintenance or reliability-centered maintenance.

A proactive maintenance strategy is the most straightforward way to improve overall maintenance operations that will keep downtime and the associated stress of loss of revenue to the minimum.

2. Extremely Hygienic Workplace

Because they make products for human consumption, food and beverage manufacturers must enforce hygienic practices and maintain their equipment under the highest standards of food safety.

Failure to do this can lead to many serious problems like producing contaminated food, product recalls, foreign material complaints, lawsuits, outbreaks and infections (botulism, E. coli, Listeria, etc.).

To avoid the above, food and beverage manufacturers should pay attention to the following:

  • Pest control. Adopt pest detection, monitoring and control with or without the use of chemicals. Where chemicals are used, there should be extra care to avoid food and drink contamination.
  • Cleaning. Constant cleaning and disinfection is necessary to maintain high hygiene standards and reduce any risks of foreign materials complaints and foodborne illnesses outbreak. Cleaning also helps prevent injuries to workers particularly in the processing and packing areas where the risk of slips, trips and falls increases due to wet floors. Wet floors alone account for the second highest cause of injuries in the food industry, according to Health and Safety Executive.
  • Personal hygiene. Establish written and strict protocols for personal cleanliness of staff that include the use of Personal Protective Equipment (PPE).
  • Waste management. Prompt removal of waste materials to control odor and deter pests and rodents.
  • Overall maintenance. Adopt proactive maintenance schedules for the entire plant and all food processing machinery.
  • Staff training. Employees should be educated and trained for their own safety and to preserve the integrity of the plant and its products. This is vital for success because procedures will only be as good as the team that will implement them.

3. Compliance With Regulatory Standard

Manufacturers of edible products are subject to the regulations imposed by the relevant authorities in every country in which they operate. This means food and beverage manufacturers must:

  • Deal with a wide range of regulations regarding food safety.
  • Ensure strict enforcement with policies and procedures that could vary from country to country.

For example, manufacturers in the United States are subject to USDA Food Safety and Inspection Service (FSIS) regulations and those of the FDA. Food and drink processors in the UK are regulated by the Food Standards Agency.

Officials from these agencies are authorized to carry out unannounced routine inspections or complaints-based inspections. There are some critical food safety non-compliance issues they typically look out for. Maintenance managers must be aware of them and they include:

  • General cleaning. To minimize the risk of food contamination.
  • Machine safety. Machinery must be safe to use, all electrical faults should be corrected quickly, and any safety guards must be in place. Safety breaches in this regard can lead to serious injuries. An example is this 2014 case involving food giant Henz and a maintenance engineer where the employee lost an arm in an unguarded potato peeling machine.
    Food Safety. Machinery must run efficiently, be clean, keep food and drinks at the right temperature, be free of rust, etc.
    Pest Control.

To thrive in this industry, organizations need to be fully aware of the regulations appropriate to their kind of business and the risks under which they operate. The risk of contamination is ever-present but unfortunately, the nature of the business means this risk can not be completely eliminated.

One route for managing these challenges is a proactive and well-implemented preventive maintenance strategy supported by a computerized maintenance management system (CMMS) and properly trained staff. CMMS is designed to help you schedule, monitor, and automate your proactive maintenance work which enables you to stay in complete control of your maintenance operations at all times.

Such a well-maintained plant will be cleaner, last longer, run smoothly and generally perform more efficiently.

Megan Nichols
FST Soapbox

Quick Guide to Keeping Your Food Processing Facility Clean

By Megan Ray Nichols
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Megan Nichols

Keeping your food processing facility clean is actually even more important than the food itself. What steps can you take to help keep your food processing facility clean?

1. Cultivate a Clean Culture

Keeping your facility clean is more than just your job. It’s the job of everyone who walks through your doors, whether they work on the factory floor or in the offices. Your first step should be to cultivate a clean culture. Get everyone involved, from the newest hire all the way up to the CEO. Everyone should have their assigned job, but they should also feel comfortable speaking to their supervisors or upper management to report spills, possible contamination and other cleanliness problems.

It’s not just better for your overall workplace cleanliness—keeping a clean workspace helps to improve employee safety, productivity and morale as well.

2. Reinforce the Necessity for Personal Hygiene

When you have human employees involved in the production process, there is always a chance the product can become contaminated. Personal hygiene can help to reduce the chances of contamination by keeping your employees clean and safe as well.

Hand washing, for example, is a step that is often neglected but can mean the difference between a clean batch of food and a contaminated one. Good hand washing procedures can also help reduce the spread of cold and flu germs inside the workplace.
Personal protective equipment also falls into this category—gloves, hair and beard nets, shoe booties and other coverings should all be worn to lessen the possibility of contamination.

3. Keep Up With Your Equipment

The exact equipment you need to complete your work will vary depending on the type of food you’re processing, but for most foods that start with raw ingredients, you will need some sort of sifting equipment. These are designed to remove under- and oddly-sized food items or to remove dirt, leaves or other debris that might have come in contact with the food from the field where it was harvested.

Most sifting equipment relies on vibrating or moving sifters that can throw small particles into the air. While necessary, this also creates a new potential source of contamination for your food items. Investing in sifting equipment with a dust hood can help solve this problem. Not only do dust hoods keep your product and facility cleaner, machines with dust hoods reduce air pollution too.

4. Food Storage and Temperature

Food production facilities are at the mercy of temperature. Food that is allowed to get too warm can grow bacteria, making it dangerous to consume. Food that is left for extended periods of time at temperatures between 41 and 135 degrees Fahrenheit are also at risk for bacterial and microorganism growth.

Be vigilant about the temperature at which your food is stored. Food that needs to stay hot is required to be kept at 140 degrees or above, and cold food needs to be kept below 41 degrees.

5. Clean, Clean and Clean Again

Keeping all of your equipment clean and sanitized is an essential step in the maintenance of your food processing facility, but many pieces of equipment are not designed to be disassembled and sanitized separately. This may be tricky when there are cracks and crevices where food particles can get stuck, encouraging bacteria growth. You have two options for cleaning your equipment—clean in place and clean out of place.

Cleaning in place, as its name suggests, involves cleaning your equipment without taking it apart. This includes running sanitizing chemicals through the equipment and cleaning all accessible surfaces.

Cleaning out of place requires shutting down the equipment and disassembling it, allowing you to clean and sanitize all of those hard-to-reach corners. Depending on the piece of equipment, this may require shutting down your entire production line, so be sure that cleaning out of place won’t impact your production deadlines.

6. Cut the Clutter

Clutter in a workspace, even if it’s just boxes of product waiting to be palletized, can contribute to an unclean and unsafe work environment. Clutter allows the collection of dust, which can make its way into both food and equipment.

Take the time to dedicate specific areas to storage, preferably away from the primary production line. Keep your main traffic routes clear to prevent on-the-job accidents and ensure that anything kept in overhead storage is stable with no risk of falling.

7. Keep Covers and Guardrails In Place and Maintained

Open tanks or containers that process food are prone to contamination and are difficult to keep clean. Any tanks or containers that have covers on them should be covered at all times to ensure the product is kept clean.

For places where guardrails are necessary, such as above production lines or other elevated walkways, confirm that the rails provide coverage on all exposed sides. Make sure that there is also no risk of any dirt or other contaminants from shoes or the walkways falling into food or onto the production line.

A dirty production line can cost you thousands of dollars to correct, costing even more if the contaminated product has to be discarded. Take the time to maintain your cleanliness and keep your facility running smoothly.

Developing an Effective Environmental Monitoring, Sampling and Testing Program

By Food Safety Tech Staff
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As the food industry is moving toward a more preventive food safety strategy, environmental monitoring is playing an increasingly critical role in testing. Hazard analysis is shifting the focus from finished product testing to proactively testing the environment and the processing as critical control points to continuously monitor and reduce risk. Today many facilities are adding or strengthening their environmental monitoring programs to enhance their food safety risk reduction efforts.

In a recent webinar, Ann Draughon, Emeritus Professor of Food Microbiology and Toxicology, University of Tennessee spoke about Developing an Effective Environmental Monitoring, Sampling and Testing (EMS) Program. We present some excerpts from her presentation.

What do you need to get started with an EMS program?

“You need to first identify the right team; think about what kind of food you are processing (raw products or ready-to-eat products) and if it has had any food safety outbreak associated with it; determine critical or hygiene zones in your facility; determine sample locations; finalize which indicator tests will be done, and in which zones; determine which pathogens you will test for; choose the right test methods; set a baseline, and link that with your sampling plan, and establish testing frequency once you have finalized the number of samples and zones,” explains Draughon.

To establish critical hygiene zones, she advises to:

  • Survey entire facility and have a map of that facility;
  • Study that map and identify traffic patterns to divide the facility into critical hygiene zones, GMP zones, and non-processing zones;
  • Put in place barriers between these zones and dedicate equipment to the critical hygiene zone, and restrict access between zones; and
  • Establish strict cleaning, sanitation and monitoring plans for these diff zones.

Sampling of zones should be based on risk of contamination and/ or transmission of pathogens to food from environment, says Draughon. The sampling should also take into account potential sources of product contamination by whatever means during food processing (see image 1 for examples of 4 zone and 3-zone hygiene systems).

Selecting the right assays for your EMS program

There are many options, and it can be confusing to select the right assay for your needs. Draughon advises that companies need to look their monitoring needs and consider both indicator bacteria and pathogenic bacteria to select the right assay.

For monitoring with indicator bacteria, most companies look at ATP for environmental sanitation, often before start-up to make sure facility is clean before processing begins. Protein assays are also used to pick up any allergen on equipment.

APC or total viable count is a simple assay offering many choices, which tests for the number of live bacteria on your equipment or in your environment that can grow under air or oxygen at room temperature.

Yeast/ mold count assays are good for two purposes: 1. Mold frequently is the cause of spoilage in food, so it’s useful to understand if there are any present to determine shelf life, and 2. It also helps us understand the number of particulates in the air.

We can also select specific microbial groups as indicators, such as total Enterobacteriacae, fecal coliform or E.coli or Listeria species.

Sample collection and prep

When we collect a sample, we have to clearly document the sample including information such as when it was taken, from where, by whom, what happened to that sample etc. Use clean SOPs to reduce error. Use the assays previously selected and do it as quickly as feasible. If you are working with an outside company, decide how they are going to handle the sample. Finally, always keep in mind plant safety and leave nothing behind after sampling, and avoid cross-contamination.

For characterizing pathogens, you may want to genetically fingerprint any pathogenic isolates from your facilities. This will allow you to see if you have a constant harborage of a particular pathogen or if it changes. Draughon recommends using a contract lab for characterizing pathogens, as they would be better suited, and have better resources to do this. Destroy the isolates after characterization – you don’t want any chance of the pathogen spreading into the product or the environment.

Written SOPs for EMS programs

It’s critical to have clear written SOPs for EMS programs which include the following:

  • Frequency of sampling;
  • When, where , how and duration of sampling;
  • Procedure for recording data and coding;
  • Sample number, size or volume;
  • Specific sampling and analysis validated protocols;
  • Monitoring of incubators and use of equipment;
  • Handling and shipping of samples; and
  • Alert and action levels and appropriate response to deviations from alert or action levels.

It’s also important that we train and validate the personnel performing EMS. Each individual doing this needs to demonstrate proficiency of doing this. They need to understand proper recording of EMS program data, alert and action levels, and zero tolerance levels. The personnel should be comfortable and qualified for sampling protocol, and using all the equipment.

In summary, sampling plans should be adaptable, which highest risk sites being tested initially. Establish a baseline and modify sampling plan as needed. Establish your sampling and testing criteria and sample as needed with each zone to fully assess the environmental program.

Top 10 GFSI Non-conformances, and How to Avoid Them

By Michael Biros
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Are you ready for audit? Gary Smith, Director of training and improvement solutions at SAI Global, talks about the top 10 GFSI non-conformances for SQF & BRC audits.

1. Business Continuity Plan Components/Annual Testing and Review

Many companies do not know what a business continuity plan is. It is not a recall and performing a mock recall will not count as an annual test and review. It is the continuing of business with a disruption in the supply chain. What are your plans for a key supplier going out of business or being affected by a natural disaster? If there is a fire or accident at one of your facilities, how are you going to ensure that your customers will still get delivery of your product? 

2. Food Safety Plan

HACCP has been around for years, but this is still a major area of focus. HACCP must be implemented and individuals must be properly trained in HACCP. All Critical Control Points (CCPs) must be validated. Review supporting documents during annual check. Is the flow chart current? Is the hazard analysis still correct? Question your employees during your internal audit. Get your employees used to and comfortable with answering questions about the food safety plan. 

3. Equipment and Utensil Condition

Utensils (scoops, shovels, belts, etc), equipment, and all food contact surfaces must be designed and in good condition so as not to be a food safety risk. Implement a foreign material control plan. Have a preventative maintenance schedule. Focus the internal audit program on equipment, not just employees. Use a flashlight when conducting internal audits. Train, empower, and reward production employees to identify equipment defects. Do not have temporary repairs. 

4. Allergen Management

Allergens are the number one cause of recalls. You must have a good allergen control program and this program must be validated. Identify ingredients as allergens at receiving and have a label inspection program. Specific allergen proteins must be validated with surface testing and product testing. Allergens must be listed as hazards in hazard analysis with the control as the allergen management program. 

5. Internal Audit

Have a strong internal audit program that emphasizes proactive solutions to avoid non-conformances. Manage non-conformances with a corrective action program. Take photos of all findings during internal audits. Make the process as formal as possible. Dress like the auditor would and ask employees questions. 

6. Condition of Walls, Doors, Floors, and Ceilings

Tape, cardboard, and construction plastic sheeting must not be used as these surfaces cannot be cleaned. Doors and windows must be properly closed. 

7. Product Traceability and Mock Recalls

If an auditor asks you about a product, you must be able to list all the raw materials, where they came from, and how they were processed to create your product. Keep the recall team current. Have procedures for a mock recall and always perform it. Make the mock recall a real test. Include ingredients and packaging in all traceability programs. Perform product trace exercises during the internal audit. 

8. Records

Make sure that your records are legible, authorized, and that demonstrated activities are taken. 

9. Procedures for Product Disposition when Calibration is Out

This is a new standard. Companies are now required to have documented procedures in place for when calibration equipment is down. 

10. Stay Vigilant!

If you’ve achieved food safety certification, congratulations! However maintaining certification takes commitment and dedication. Be sure to maintain a strong food safety culture within your organization. Communicate well across all levels of the company. Have a strong internal audit program and don’t be afraid to identify issues and focus on corrective action management.