Tag Archives: audits

Zia Siddiqi, Orkin
Bug Bytes

Get Your Food Manufacturing Facility Audit-Ready

By Zia Siddiqi, Ph.D.
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Zia Siddiqi, Orkin

Being audit-ready at any moment can be a daunting task, but pest management is one aspect of your audit that you can ace if you’re doing the right things. Pest control can account for up to 20% of your score, so taking it seriously can give you a huge boost the next time an auditor comes to your facility.

There are two components needed to help ease the stress of a third-party audit: An Integrated Pest Management (IPM) program and proper documentation.

IPM programs focus on incorporating green prevention and exclusion tactics into your facility’s ongoing sanitation and facility maintenance strategies, only using chemical solutions as a last resort. FSMA established that these tactics should be used when dealing with food safety issues and that thorough records should be kept to document the risk-based prevention efforts. This gives food manufacturing facilities even more of a reason to employ an IPM program.

A strong IPM program already has documentation built into it, as tracking pest activity and monitoring results over time are crucial steps to implementing the most effective pest prevention techniques for your business. Every IPM plan is tailored to your facility’s needs, so it needs to be dynamic and adaptable over time as new technologies emerge and your business needs change. Having the ability to show documentation of these changes and their positive effects will get you off to a great start on your next audit in showing your risk-based prevention food safety plan. If you do not already have an IPM program in place, speak with your pest management provider about establishing one.

Auditors like to see IPM programs in place because it means your business is taking a proactive approach and keeping detailed records.

Think about it like this: If the auditor is the judge and there’s no jury, would you ever walk into a court case without any evidence to prove your innocence? Of course not! So you wouldn’t want to walk into an audit without any documentation either.

In other words, document everything. Facilities must prepare and implement written food safety plans that identify potential risks to food safety, enumerate the steps and processes that will be executed to minimize or prevent those dangers, identify and implement monitoring procedures, keep detailed records of the food safety program, and list actions that will be taken to correct problems that do arise. If you’re doing all of this, you’ll make an auditor’s life that much simpler and improve the chances of receiving a high score.

When working to get audit-ready, you’ll want to have the following forms of documentation ready to go:

Proof of Training and Certification

Even though you know that your pest management professional is properly trained and certified, your auditor does not. Keep documentation on hand at your facility, as auditors may want to see one or more of the following documents:

  • A copy of the valid registration or certification document
  • hysical, written evidence that your pest management provider has been properly trained to use the materials necessary for your IPM program
  • Evidence of training on IPM and Good Manufacturing Practices (GMPs)

Proof of Service and Material Changes

A strong IPM program changes as new technologies emerge and your business’s needs shift over time, so be sure to have detailed documentation of these changes as they occur. It’s also important to note the reasons for making changes. Auditors will be looking for written documentation for even the smallest of changes to your IPM program, so take careful notes as your program adapts along with your business.

It can also help to assign specific roles to your employees. This not only will give employees clear direction on how they can contribute to your IPM program, but it can also help your case with an auditor by showing that your facility is maintained by an entire team rather than just a few people. Teamwork is a key part of any IPM program, so be prepared to show how your team runs effectively.

Pest Sighting Reports That Correspond with Corrective and Preventive Actions

When there is a pest sighting in your facility, record it immediately. Keeping records of sightings will help ensure that steps are taken to improve and show accountability to an auditor. Once action is taken, record exactly what was done and the results of the counteractive efforts. That way, you’ll have a paper trail that shows an auditor that for every pest problem, your pest management provider came up with a proactive pest solution that resolved—or is working to resolve—the issue.

After taking corrective action, continue monitoring the issue over time and note any developments in order to help prevent the issue from reoccurring. Creating a trend report that keeps track of which pests your facility is dealing with over time can help, too, as it will help you determine which pests are the most problematic. Your provider can help build such a report.

Records of Pest Monitoring Devices and Traps with Corrective Actions

Pest monitoring devices and traps are great for giving insight into areas around your facilities that are most susceptible to pests. Along with these devices, however, you’ll need to show the following information to an auditor:

  • When and how often the monitoring devices and traps were checked
  • The type and quantity of each pest found
  • Corrective actions taken to reduce pest activity and prevent further issues

Work with your pest management provider to gather all of this information, as it is usually the technician who works on these devices regularly. Being able to give an auditor the full picture can certainly help you on your inspection as it demonstrates attention to detail throughout your entire facility.

Annual Pest Management Assessments and Resulting Actions Taken

With most IPM programs, your pest management provider will thoroughly inspect your facility annually to identify areas that can be improved. Many auditors require these annual check-ups, and they will be looking for proof that these facility assessments occurred and that action was taken as a result that led to positive changes. Year-over-year improvement is important, so measure your success against the areas of improvement specified in these annual inspection reports. That way, you can meet the objectives prior to an audit.

These annual inspections give you a chance to look back and see the progression over the years. If there are any pest issues that pop up year after year, make them a priority in order to show that your program is trending in the right direction.

This proactive approach to pest management will help protect your business from pests and the inherent risks, as well as help give you a better chance of receiving an excellent score on your next audit.

So don’t be afraid of an audit the next time one comes around. With a strong IPM program in place and detailed documentation over the course of the year, there won’t be an exorbitant amount of preparation needed. Stay organized and keep all of the above-mentioned documents together and on-site to keep things simple for both you and your auditor. All of these elements will help your facility receive a strong score and be audit-ready at a moment’s notice.

GFSI Basics: Is FSSC 22000 Right For Your Company?

By Maria Fontanazza
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Food Safety Tech recently sat down with experts from Eurofins to discuss FSSC 22000. According to Kristopher Middleton, technical manager at Eurofins, and Kim Knoll, food safety systems national sales manager at the company, there are still quite a few companies (especially in North America) that are unfamiliar with the ins and outs of the certification scheme. In a Q&A with FST, Middletown and Knoll break down the basics of FSSC 2000, along with explaining some of its benefits.

Kristopher Middleton
Kristopher Middleton, technical manager, Eurofins

Food Safety Tech: How is the trend with FSSC 22000 evolving?

Kristopher Middleton: The scheme started in 2009 based on a demand for people wanting to have an ISO-based certification within the GFSI benchmarking process. When the program came out, it trended toward larger companies that already had ISO-based certifications, mainly ISO 22000 and ISO 9001. The FSSC 22000 scheme is the fastest growing GFSI benchmarking scheme currently. It’s not just for large multinational companies; a lot of smaller suppliers are seeking certification to this scheme. The foundation continues to expand its scopes to become a true farm-to-fork certification program.

FST: Is FSSC 22000 also appropriate for a single site or for a company with fewer than 50 employees?

Middleton: The certification doesn’t discriminate based on facility size—nor footprint or number of employees. It’s ideal for any company that has a robust food safety management system and manufacture products that fall within the FSSC 22000 scope of certification. This currently includes manufacturers of perishable animal products (feed and food), perishable vegetable products, products with a long shelf life, biochemical products (i.e., food ingredients, vitamins, biocultures, etc.), manufacturers of food packaging, and primary production of animal products.

The key thing about FSSC 22000 certification is that it is not a terribly prescriptive food safety scheme, when compared to others that are available. You will be successful with FSSC 22000 certification if you are confident and knowledgeable about your own food safety management system, and you have appropriate justification or validation for the method in which your programs have been implemented, as well as validation for the controls of your food safety hazards.

FST: Are there quite a few companies that have not heard of FSSC 22000 or are not aware that it is a GFSI-recognized scheme?

Middleton: Since ISO 22000 was not terribly popular here in North America, it didn’t catch on right away. It was more so overseas that it caught on. However, within the past two years the scheme has become increasingly popular here, especially among companies that have other ISO standards already implemented (i.e. ISO 9001, 14001, 18001,etc), where it relates to occupational health and safety, environmental, and quality. The reason for that is the FSSC can easily intertwine with that entire management system program so that it all works together versus having separate programs in place.

Kim Knoll
Kim Knoll, food safety systems national manager, Eurofins

Kim Knoll: I’m having a lot of conversations with smaller manufacturers who are brand new to GFSI. Many of them are being asked by their customers to achieve a GFSI benchmarked certification and are in the early stages of researching scheme options.  Some of these companies are surprised to learn that FSSC 22000 is a viable option.  Like other certification schemes, Eurofins lends support to companies planning to pursue FSSC 22000 through training courses, consulting services, pre-assessments and ultimately certification services. Even though FSSC 22000 is a newer scheme, auditor availability is not an issue.

FST: What are the key differences between FSSC 22000 and the other GFSI schemes?

Middleton: Probably the most apparent difference with FSSC compared to other GFSI benchmark schemes is the fact that your certification lasts for three years, not one year. The reason for that is that it’s not a product-based certification like the others, it is a process-based certification and it uses the accreditation standard of ISO 17021 not ISO 17065. It also uses ISO 22003 for direction to the certification body for the conducting of the audit. That doesn’t mean that sites won’t be audited annually; it just means that once the certificate is granted, it’s good for three years.

Another key difference is that there is no true pass or fail within the audit. It’s a conform or not-conform audit. The decision to certify is based off the findings from the auditor and their recommendations, as well as the decision from a technical review meeting at the certification body. It requires the effective closure of a particular non-conformance or satisfactory plan being submitted for the closure of those non-conformances before the actual certificate can be granted. So that’s a bit different, because you can just submit plans for your non-conformances [instead of] actually showing that everything has been completely resolved. That being said, if a facility isn’t able to hold or get a certificate, if there’s an imminent food safety threat noted during an audit—if there’s an issue, such as a potential recall or contaminated goods, the ability to be granted that certificate is not feasible.

FST: Can you walk us through the auditing and certification process under FSSC 22000?

Middleton: Like any of the standards out there, you can get a pre-assessment, which is not necessarily part of the certification activity. The certification activity starts at a Stage 1 audit within this scheme (also known as a document audit within other schemes). It’s an evaluation of a facility’s food safety management system document to determine if they’re valid. The process does not include an entire evaluation of the implementation of the program, just simply that the programs are adequately designed and meet the requirements that are in place.

Next there’s a Stage 2 audit (sometimes referred to a facility audit) that is conducted no more than six months after the Stage 1 audit. The Stage 1 audit will identify the areas of concern—programs that might not meet exactly what the specifications required within the standard, which would become non-conformances in a Stage 2 audit (also called a facility audit or certification audit).

The Stage 2 audit is the full evaluation of the implementation of the program that was reviewed in the Stage 1 audit. Following completion of the audit, effective closure of non-conformances is required. This closure can either be [related to] major non-conformances, CAPA or root cause analysis. You have to supply evidence that the non-conformance is properly eliminated and will not recur, and this evidence must be supplied to the certification body and the auditor for review.

Any other non-conformances (also known as minor non-conformances) must have corrective action plans. Companies need to state how they plan on resolving the issue. They will be “closed” but left open for the next audit, which has to occur within one calendar year (known as a surveillance audit). The term “surveillance audit” within this standard is different from some of the other standards. Within some of the other standards, a surveillance audit is not a yearly activity—it is done within the year of certification. The surveillance audit within this standard is a yearly audit that is required to meet the requirements of GFSI. It’s also a requirement within [ISO] 17021 and [ISO] 22003 that surveillance audits are conducted. The GFSI requirement changed the surveillance audit within the ISO world because they used to do a sampling audit, which progressed to a full-blown audit. Your whole food safety management system will be evaluated, which is slightly different from ISO 22000 surveillance audits.

After that audit is conducted, you have another surveillance audit in the following calendar year. Within those surveillance audits, if any minor non-conformances or non-conformances from the previous audit are still present, they are upgraded to major non-conformances and [companies] would have to implement a full corrective action plan, root cause analysis, etc. and then determine the solution.

Once the second surveillance audit is conducted, the following year will be your recertification audit, which is simply another facility audit. It’s not a document audit—you don’t have to do Stage 1 audits after that initial one. This recertification audit occurs prior to your certificate expiring.

FST Soapbox

Inquiries, Responses and Audits: The Chipotle Effect

By Dan Bernkopf
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In an age where news is reported instantly, those outside the food industry have a heightened awareness and concern over their favorite brands’ commitment to food safety. Conversely, every food industry’s safety and quality operations teams are more than likely putting measures in place to tighten up their supply chain controls and re-evaluate their own food safety programs to ensure that their companies don’t become the next headline.

You better believe suppliers and their customers alike are also re-evaluating their ability to quickly, and effectively, respond to such an incident with the data and records needed to determine root causes—and with good merit, especially if you take a step back and really think about what is needed when a response or inquiry comes in surrounding a Chipotle-type food safety incident. Responses to such incidents typically fall along the lines of: 

  • Evidence of current food safety plan, including comprehensive risk analysis, HACCP/HARPC plan, validation studies or documents
  • Inspection data and documents on your suppliers, including onsite inspection, transportation and product receiving inspections, complete with non-compliance reports and CAPAs for the last six months
  • All data records relative to your internal processing CCP(s) or equivalent, including monitoring frequencies and all non-compliance reports, complete with their CAPAs for the last six months
  • All regulatory and non-regulatory audit reports or actions, including non-compliance reports and their CAPAs
  • Additional available internal or external laboratory evidence that demonstrates environmental monitoring of your facilities and resulting continuous improvement and sanitation validation for the last two years
  • Additional internal or external laboratory pathogen monitoring programs for field, transportation, raw material supply and finished products, etc. as evidence to support your food safety program

The sheer volume of records, data and information needed in such an on-demand short timeframe can be extremely overwhelming. Without quick access to the critical records needed to determine root cause or, more importantly, thwart an incident from expanding, food safety and quality operations should be taking a close look at how they are managing their food safety data records and reports.

Are binders full of documents, or a combination of paper/silo data records going to suffice when it comes to inquiries, responses (and audits)? Or, is there a better way to manage food safety and quality data to ensure not only data is accessible, but also that food safety programs are working?

One sure bet is that there will be a higher number of audits and inquiries. Is your team and/or supplier prepared for the increase of these types of activities?

  • Inquiry: A request for a single or series of data and or documents usually related to a specific FSQA event or question
  • Response: The collected data, data reports, document or document reports related to a specific audit or inquiry
  • Audit: An activity that reviews one or many elements of a food safety plan to assure that the plan is complete, performed as described and meets the food safety design as intended. Audits are known and expected activities to review such safety plan elements even though the actual audit date and time may be known or unknown

We all know that audits are often lengthy exercises, yet they are still predictable. On the other hand, inquiries can be more difficult in that information requests may involve a very deep dive into a very specific area of inquiry.

In all honesty, if inquiries or responses or audits have to be planned for in advance, then you are not prepared. In order to always be prepared, it’s imperative to have better systems in place to manage any type of internal or external examination of your food safety and quality information. Regardless of whether it is an audit, response or inquiry, it is important to have easy access to records, verify that your programs are working, have corrective actions in place, and show visibility (and transparency) in your operation.

Thus it all comes back to how you or your suppliers are managing food safety records day in, day out. If FSQA operations are still relying on manual-based food safety and quality management processes versus food safety and quality management technologies, then chances are that you’re reacting to latent results, and you’re not able to identify trends and opportunities for improvement. The burden to manage inquires, responses or audits—as they continue to grow in cadence—will become overwhelming.

Without a doubt, the Chipotle effect is being felt throughout the industry. There will be increased accountability to ensure an adequate food safety program is in place and verification that the program is working. It will become even more imperative—and expected—that data and records are readily available to efficiently respond to inquiries, responses and audits.

Specific Training Required Under FSMA: A Look at Each Rule

By James Cook
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All seven core rules of FSMA require general training of individuals or employees and qualified individuals requiring education, training or experience to perform specific tasks. By including training in these regulations, the FDA has made specific training mandatory.

Training Required by FSMA Final Rules

In the current Good Manufacturing Practices (cGMP) and preventive control rules, as per 21 CFR 117.4 and 507.4, all individuals engaged in the manufacturing, processing, packing and holding of food must have the education, training or experience to perform assigned duties and must be trained in the principles of food hygiene and food safety. However, the preventive controls qualified individual (PCQI) and qualified auditor, to rules 21 CFR 117.180 and 507.53, can be an individual who has successfully completed a class equivalent in curriculum to that recognized by the FDA, or have the necessary job experience. In both cases, the training must be documented, including the date of training, type of training and those personnel trained.

This means that all employees are to be trained in food hygiene and food safety to at least the standard presented in the regulations and more specifically as per the cGMP requirements. Additionally, individuals who are responsible for a specific critical control point will still need to be trained in HACCP. However, this will probably not be sufficient for an employee responsible for preventive control, as he or she may require training in Hazard Analysis Risk-Based Preventive Control (HARPC), or training specific to the area in which the employee is involved (e.g., allergens, sanitation, supply chain or recall programs, or preventive controls).

For the preventive control qualified individual and qualified auditor, the training needed may be that of the approved FDA curriculum, as developed by the Food Safety Preventive Control Alliance (FSPCA). Although this training course is not a regulatory requirement, FDA inspectors and other regulatory personnel who are auditing facilities will have completed this training, meaning qualified auditors will be expected to have this training, and eventually preventive controls qualified individuals (PCQIs) will be expected to do so too. The qualified auditor and a PCQI will still require the education, experience and other training to perform the specific job duties as listed in the regulations. Unfortunately, it is likely that neither the industry nor the government will have enough lead instructors ready to train everyone who would want or need to be trained before the compliance dates become effective. Additionally, this training course is not yet available for animal food, and the industry has been informed by FSPCA that a Foreign Supplier Verification Program (FSVP) training module will be added to the training course. The FSVP is discussed in the Supply-Chain Preventive Control module, and the fact that there are some similarities between these regulations helps individuals involved in the FSVP program, or in auditing it.

In the produce safety rule, training requirements are listed in subpart C 21 CFR 112.21, 112.22, 112.23 and 112.30. Personnel who require training are those handling covered produce and their supervisors. As with the cGMP and preventive control rules, the principles of food hygiene and food safety must be taught to these personnel. More specifically they must learn how to identify an ill or infected person, and be taught about microorganisms of public health significance, such as Salmonella, Listeria and E. coli O157 on food contact surfaces. Additionally, personnel who harvest covered produce must be trained in recognizing produce that is contaminated with known or reasonably foreseeable hazards to ensure it isn’t harvested. These personnel must be trained in the use of harvest containers and equipment to ensure that they are functioning properly, clean and maintained, and to identify when they are not. At the same time, employees must be trained in correcting any issues or in reporting them to a supervisor in order to have them corrected. All this training must be documented in the same way as the cGMP and preventive control programs.

Unlike the cGMP and preventive control rules, the produce safety rule’s requirement to have a qualified individual, supervisor or responsible party on each farm that has completed a recognized FDA course, or equivalent, is not optional. This course will be available through the Produce Safety Alliance and is anticipated to start in September 2016. The grower food safety course required for supervisors will include an introduction to produce safety, worker health and hygiene training, soil amendments, wildlife, domestic animals and land use, agricultural water, post-harvest handling and sanitation, as well as how to develop a food safety plan.

The training for produce, conducted by the Produce Safety Alliance and/or trained trainers, does not cover training for sprouts; training for sprouts is being developed by the Sprout Safety Alliance and will include topics specifically for sprouts, such as antimicrobial treatment of sprouting seeds.

In the FSVP, the qualified individuals must have the education, training or experience necessary to perform activities as per 21 CFR 1.503. These qualified individuals will develop the FSVP and those activities such as hazard analysis, supplier approval, determining verification activities and frequency, corrective actions and other activities for the FSVP. These personnel must be able to read and understand the records to be reviewed for this program. This means they must know English and may also need to know the local language at point of product manufacture or farming. 

At this time there is no structured training program for these individuals, but the FSPCA training program, alongside education and experience can provide the training necessary for these people to perform the job activities. A PCQI would be qualified for the role of a FSVP qualified individual, but the FSVP probably would not be qualified for the PCQI role. This is because the activities in the FSVP are not as complicated as those required by the cGMP and preventive controls rules, and therefore the FSVP qualifications would not need to be as stringent.

Training Under Proposed Rules

In the proposal for Sanitary Transportation of Human and Animal Foods, 21 CFR 1.910, the FDA requires carriers of these products to train personnel who are engaged in transportation operations. This should include awareness of potential food safety problems that may occur to food during transport, basic sanitary practices that would address those problems and the responsibilities of the carriers in the regulation. As with all training in these regulations, the type of training, who was trained and when they were trained must be documented.

Since this is a proposal, the training for teaching the carrier’s responsibility is not yet finalized but will require nothing more than explaining that section of the regulation. The training of potential food safety issues and the problems that might occur during transport are handled during standard cGMP and food safety training.

For the proposed Intentional Adulteration rule, per 21 CFR 121.160, the personnel and supervisors assigned to the actionable process steps must receive training in food defense awareness and their responsibilities in implementing the migration strategies. Also, as per 21 CFR 121.130, the vulnerability assessment is to be performed by a qualified individual, and this individual is to be qualified through experience and/or appropriate training.

For basic food defense, the FDA offers various courses and information, such as Food Defense 101, on their food defense webpage. An online course is offered in English and Spanish and covers the awareness training and the regulations for employees. Upon course completion, a certificate is provided. The agency also has a downloadable food defense plan builder that can be used to develop a food defense program. The agency also provides vulnerability assessment software, but additional training in PAS 96 or ISO/TS 22000 food defense would aid qualified personnel in making sure that this vulnerability assessment is correct and that the strategies to reduce risks are appropriate and not excessive.

There is an abundance of training courses and materials available from the FDA, USDA FSIS, associations and industry. FSMA employee training requires having personnel with the proscribed education and experience to perform specific tasks, and that they be trained as soon as possible in order for them to develop the programs. Additionally, all personnel should be trained at least annually in food hygiene, food safety and food defense.

Gary Smith, Eurofins’ Food Safety Systems

FSMA Mandates Employee Training. Are You Prepared?

By Maria Fontanazza
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Gary Smith, Eurofins’ Food Safety Systems
Gary Smith, Eurofins’ Food Safety Systems
Gary Smith, director of food safety, Eurofins Scientific

Training plays a huge role in the effective implementation of FSMA. The preventive controls for human food final rule calls out areas in which training is now obligatory, namely ensuring that employees involved in the manufacturing, processing, packaging and holding of food are properly educated on food safety and food hygiene (mandated under Current Good Manufacturing Practices). FDA has initiated an extensive training strategy, part of which includes establishing a National Coordination Center (the agency awarded a $600,000 grant to the International Food Protection Training Institute in October), along with several collaborative efforts with other federal agencies and industry partners.

Although many food companies have been conducting training as part of their standard procedures, preparing employees for the implementation phase of FSMA may be more complicated than they anticipated. In a Q&A with Food Safety Tech, Gary Smith, director of food safety services at Eurofins Scientific, shares insights on some of the hurdles that industry is encountering (including manufacturers in the animal food arena) related to training and FSMA compliance.

Food Safety Tech: How has FSMA changed the landscape of employee training?

Gary Smith: There are a couple of updates that are very important to note for the industries as a whole. First, employee training is now mandatory for both human food facilities and, probably even more importantly, animal food facilities. Many of the human food folks may have been asked by customers or by other entities via corporate internal procedures to do training of employees and to have a training program in place. For a lot of the pet food and animal feed manufacturers, having a comprehensive training program for all employees is significantly different than what has been requested and expected of them in the past.

Second, the preventive controls rule for both human food and animal food specifically requires that animal food and human food manufacturers conduct training of all their employees on at least food safety and food hygiene topics. Now, what does that mean? We’re interpreting that to mean basic GMPs as well as common food safety hazards. Realistically, this will probably be a 30 to 60-minute training session in which everyone in the facility will have to attend, and FDA doesn’t state specifically that it has to be done more than at least once. There is no frequency for re-training. However, once the compliance dates are effective, it’s mandatory that the training has been completed. This is a new concept for the majority of industry who may have had corporate training programs or customer-driven training programs, but never a mandated regulatory requirement for training.

FST: What challenges do food companies face in ensuring that employees are prepared for the implementation phase?

Smith: There’s the challenge of putting together the training, which, in the big picture of FSMA, shouldn’t be that big of a deal.

Some of the biggest challenges companies face (especially in trying to get ahead of the game and be proactive) is the identification of the preventive controls qualified individual. Is it an internal person? Is it a consultant? Do they have to go through a specific training class? The answer is yes, they do. How do they deal with foreign suppliers? A lot of folks are really confused about the concept of the Foreign Supplier Verification Program rule and what it means. Do they need to audit [their suppliers]? Do they need to be GFSI certified? There are a lot of questions concerning the importation of ingredients from outside the United States—what’s the requirement? This is probably the biggest area in which people seek clarity.

Another [challenge] is internal supplier approval, because the new rule talks about supplier approval as one of the preventive controls that has to be in place. Again, who can do those audits? When do we have to conduct an audit? What does the audit have to cover? A lot of folks are struggling with this area as well.

The last challenge: A lot of folks have HACCP, whether they are human or animal food manufacturers, and this has been required or requested by customers for a while. But how do we transition from having a HACCP plan to a food safety plan that meets the preventive control requirements in addition to the HACCP requirements? How do I build in allergen management as a preventive control? How do I build in sanitation as a preventive control? How do I build in supplier approval as a preventive control? There are a lot of questions surrounding whether companies should scrap their HACCP plan and start over, or whether they have to add on to it.

FST: Eurofins offers an extensive training schedule for the first half of 2016. How do these offerings play into FSMA’s compliance requirements?

Smith: Eurofins is now offering the highly anticipated 2.5-day training created by the FDA’s Food Safety Preventive Controls Alliance (FSPCA). The standardized curriculum is designed to meet the training requirements under Title 21 Code of Federal Regulations Part 117.115 for the “preventive control qualified individual” who conducts certain Food Safety Plan activities. In addition, Eurofins offers core courses such as Environmental Monitoring, Internal Food Safety Auditing and HACCP to help support the development and implementation of a company’s food safety plan.

Ryan Mead, Focus-Works
FST Soapbox

8 Reasons to Go Digital 2016

By Ryan Mead
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Ryan Mead, Focus-Works

This year, more food manufacturing companies than ever are actively seeking software solutions for food safety and quality management. The majority of food businesses still collect food safety records using pen and paper, which is a time-consuming process and is far from reliable. Fortunately, food safety software is drastically changing the way HACCP and other QA/QC data becomes collected and stored. The following are some reasons food safety software is a must-have in 2016.

1.     Overwhelming Amount of Paperwork

Many employees at food manufacturing facilities—whether meats, baked goods, or beverages—still rely on pen and paper forms, checklists, and log books to manage their food safety operations. This allows operator errors and omissions to happen far too easily. Even well managed systems that use paperwork can reach a tipping point. Quality managers already have a big enough workload, and piling on the job of verifying all paperwork only increases the chances of a failure.

2.     Constant Change in Food Safety Standards

FSMA, the most sweeping reform of food safety laws in more than 70 years, was signed into law in 2011. While most food manufacturers have only been mandated to register, the time of more strict enforcement is coming. Global standards for food safety such as, SQF and BRC, fall within this generation of compliance. The necessities of these programs are constantly changing, becoming stricter and introducing new categories of requirements. Food safety software offers an effective way to deal with the ever-shifting landscape by providing evolving solutions managed by a software provider.

3.     Consumer Confidence

Consumer expect a safe and healthy product, and as such, a company must instill a feeling of confidence. When a product is expected to provide nutrition, energy and enjoyment any incidence of foodborne illness will only prevent future confidence in the product. In addition, the consumer is likely to spread the news among peers about how he or she became sick. It is the duty of the food company to do everything in its power to process, store and prepare food in the safest way possible. That process starts with ensuring a higher level of reliability in a food safety program, which can be achieved by using food safety software.

4.     Economics

No food company wants to deal with the hassle of a lawsuit from an outbreak or recall. These events can cost thousands, if not millions, of dollars in damages and  cause serious loss to a company of any size. Although many companies carry insurance for these occurrences, there still is the loss of sale from consumer mistrust. Investing in software can help companies increase profits by improving efficiencies. For example, companies can measure these efficiencies not only from labor savings but also from significant savings in paper and toner (i.e., saving $2000–$5000 a year).

5.     Operator Error and Omission

In an age in which documentation is becoming digitalized, food safety requirements are becoming more tedious. Even the smallest employee error can have massive repercussions. The cost of added staff is one thing, but the reliability of the data and adherence to schedule is another. Relying on inaccurate data collection may result in a recall or damage to a company’s brand.

Pencil whipping (faking paperwork) occurs for a variety of reasons, from employees taking short cuts to avoidance of writing down out-of-spec data. Manual record keeping has proven over time to be prone to errors. Employees, bored with the distraction of measuring and writing down dough or batch temperatures, piece weights or metal detector tests, and fill out forms with moot numbers just to complete the form.

6.     Monitoring and Notification

Being aware of control points is another way in which companies can avoid disaster. Food safety software can give companies the ability to monitor oven and freezer temperatures, metal detectors, tests or any other control point in real time. This capability also alerts users when a control point is out of deviation (doing so at a glance), along with sending custom notifications, allowing a plant to quickly address problems while simultaneously properly documenting the issue.

7.     Audits: Go from Stressful to Easy

An upcoming audit can be stressful for any company, involving numerous people who are gathering an abundance of documentation. With food safety software there is no reason to scramble to get documentation together or waste precious time preparing it. Auditors can simply view a company’s software for any requested documentation. For example, a company can produce random temperature logs, metal detector times, SSOPs, customer complaints and a variety of other documentation in just a few clicks.

8.     The Technology Is Available

One of the reasons why so many companies continue to use paper and Excel-based systems today is because they are unaware of the abilities and functionality available to them. After completing the formidable task of attaining a new-found level of compliance, some companies may find it daunting to continue to go to the next step of converting to a computerized system. Finding user-friendly food safety software that has good customer support, as well as solutions that are customized to user needs, is not necessarily easy. The key is to find software and a supplier that can provide the right solution for your company and food safety program, whether it’s HACCP, BRC or SQF, and ensure that it fits within an acceptable budget. Consider not only the initial cost but also the cost of implementation. What resources will be required? How much can the supplier help with implementation? Having the right answers and the true costs will assist you in arriving at the correct solution.

FSMA

Are You Ready for the Produce Rule? You Just Might Be

By Marsha Madrigal
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FSMA

At last the new Produce Rule is out, issued on November 13, 2015.  For the first time in FDA history, the rule establishes a science-based minimum standard for growing, harvesting, packing and holding of fruits and vegetables grown for human consumption.  The rule can be found in Part 112 of the Code of Federal Regulations (CFR). It applies to both domestic and imported produce.

The new rule provides assurance that produce on the market is not adulterated under the Food, Drug, and Cosmetic Act.  It will accomplish this by establishing procedures, processes and practices that are known to minimize the risks of serious adverse health consequences or death to humans, and to prevent the introduction of known biological hazards into and or on produce.

The definition for a farm, covered under the rule, includes two kinds of farming operations, primary production farm and secondary activities farm. The primary production farm operates under one management, and the secondary activities farm is an operation. Where as the primary production farm owns, or jointly owns, a majority of interest in the secondary activities farm.

Food Safety Consortium
During the FDA Town Hall, an audience member asks about the Produce Rule and the work being done with Mexico. Watch the video

For the most part, the new mandated FDA Produce Rules, mirror what farmers, packers and others in the farm business have been doing all along.  For years now, produce buyers have required some kind of written guarantee from their suppliers such as a third-party audit certificate showing that the supplying farm or packing shed is complying with the farm food safety standards. Most farms and packing sheds have already undergone, if not one, but perhaps two or more third-party audits such as a Good Agricultural Practices (GAP) or, one of the Harmonized GAP audits, or a Good Manufacturing Practices (GMP) audit, or one of the Global Food Safety Initiative (GFSI) audits such as GlobalGAP, Safe Quality Foods (SQF) or BRC Global Standards (BRC).

This means that those covered under the Produce Rule for growing, harvesting, packing and holding of fruits and vegetables grown for human consumption and have received a third-party audit should have no trouble achieving compliance with the new Produce Rule.

The above-mentioned third-party standards cover most aspects of the key requirements of the Produce Rule regarding agricultural water, biological soil amendments, domesticated and wild animals, worker training, health and hygiene, and equipment, tools, and buildings.

However, some key requirements of the new rule not noted in existing third-party standards include:

  • Water testing of untreated water, sample collection and survey creation for agricultural water.
  • Microbial standard limits for detectable amounts of microorganisms to include Listeria monocytogenes, Salmonella species, and E. coli 0157:H7 for the treatment process of soil amendments, including manure.
  • The final Produce Rule includes requirements to help prevent the contamination of sprouts. For example, requires testing of spent sprout irrigation water for pathogens and requires environmental monitoring for Listeria. Documentation or letters from seed and/or bean supplier for the prior treatment of seed and beans are acceptable.
  • The requirements of Domesticated and Wild Animals relies more on monitoring and assessing conditions during growing season. If you find evidence of potential contamination like animal excreta, you must take action and evaluate whether produce can be harvested or if there is a likelihood of contamination. The produce must not be harvested.

This rule does not apply to:

  • Farms that have an average annual value of produce sold during the previous three year period of $25,000/yea
  • Produce for personal or on-the farm consumption
  • If the produce is on the list of “rarely consumed raw commodities” such as sweet potatoes and
  • A food grain such as wheat or oats

The rule provides also for exemptions:

  • Produce that will receive commercial processing (kill-step) to reduce microorganisms of public health concerns.
  • Provides a qualified exemption and modification requirement for farms that meet certain requirements based on monetary value and direct sales to qualified end users such as consumers or restaurants. The farm must also meet associated modified requirements like establishing and maintaining certain documentation.

Under certain conditions the FDA may withdraw a farm’s qualified exemption.

The rule focuses on sources of produce contamination found in the past: Agricultural water, biological soil amendments, domesticated and wild animals, worker training, health and hygiene, and equipment, tools and buildings.

This rule and others under FSMA such as Preventive Controls for Human Food, Preventive Controls for Animal Food, and the Foreign Supplier Verification Program are a long overdue yet great achievement for FDA. The agency now shifts its gear into focusing on preventing food safety problems instead of reacting to food safety outbreaks.

FDA estimates that about 348,000 illnesses per year will be prevented by the implementation of this rule.

The compliance dates for the new rule are staggered and based on business size.

Resources

  1. Produce Rule: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
  2. FSMA Webinar Series: Final Rules for Produce Safety, Foreign Supplier Verification Program (FSVP), and Third Party Auditors
Timothy Ahn, LRQA

Beyond the Fluff: Leadership Must Demonstrate Food Safety Culture Through Actions

By Maria Fontanazza
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Timothy Ahn, LRQA

As the popular phrase goes, if you’re going to talk the talk, then you need to walk the walk. This expression really does ring true when discussing an effective food safety culture within an organization. Timothy Ahn, senior technical manager of food safety at LRQA sheds some light on the importance of management commitment as a foundation for success in implementing a food safety culture and how employee training fits into the picture.

Food Safety Tech: In your column on Food Safety Tech, “Tackling the ‘Why’ of Food Safety”, you touch on the point that food safety culture needs to start at the top. What are the issues in management today that prevents a food safety culture from flourishing within organizations?

Timothy Ahn: First, it’s important to define food safety culture. It can mean a lot of different things to people. The culture is the collective behavior from the organization around shared values and beliefs. From that perspective, it’s extremely important the leadership understands its beliefs and values. The collective behaviors of the leaders become really important, because we’re also talking about how the leadership sets management commitment and drives what’s important in the organization. The organization will follow whatever the leaders do and not necessarily what they say. That’s the issue—having the ability to get commitment from leadership that is demonstrated through their actions, which then transfers into rewards, objectives and consequences. What are the issues that are preventing the culture from embedding itself? Actions aren’t aligned with their words. You have a senior leadership group that will say one thing, but then their actions are different.

In addition, when cascading priorities are very different, food safety doesn’t get the right messages. It’s about growth, market share, profits—all of those financial measures are extremely important, because they have consequences and are also rewarded. Meanwhile, depending on the organization, the objectives around food safety culture may or may not be talked about, defined, or even rewarded. It’s really about making sure that the organization has cascading priorities.

FST: When taking a holistic approach to employee training, what are some of the challenges that companies can expect to encounter?

Ahn: I put food safety into three different buckets that build on top of each other.

  1. At the bottom is the foundation. It’s around good manufacturing practices and all the foundational activities that need to be in place for factory operations. How often you clean your equipment? What do you do around allergens? Can you trace your materials from one end to the other? Do you have a pest control program?
  2. Our food safety system: This includes things around HACCP: Do you have a HACCP plan in place? Do you understand what your hazards are? Have you defined your control measures?
  3. The last bucket is around the management system that drives food safety. Have you defined your objectives? Do you have a policy? Do you conduct a management review? Do you have an internal audit?

The issue with training is many operations only focus on the foundation. You need to have people who know how to clean equipment; you have to make sure that the pest control is done; you need to have good allergen management. Those are all pretty well done. Now you’re starting to get more traction in the second bucket, which is around HACCP, because with FSMA, HACCP is no longer an option; you need to be able to do it.

But the missing piece in many organizations is at the top—the management systems. This is important, because when you talk about culture, that’s where it gets embedded within an organization—through implementation of the management system.

If you look at this holistically, you need to train across all of those areas, not just in the foundation. You can differentiate yourself from organizations that have effective food safety management systems (not just food safety systems) because they’re training across all those buckets.

The other part of training is management systems. Who do you train? Besides targeting first line employees and operators, you also need to train senior managers because these managers, along with leadership, need to better define the objectives and policies. What does it mean to conduct an effective management review? What does it mean to do an internal audit? What’s a good corrective action process? The training often falls apart because organizations haven’t embedded that very well.

FST: Do you see differences between implementing these practices in small versus large organizations?

Ahn: There are differences, but it’s not necessarily a function of the size of the company. It’s more around how they’ve approached developing and organizing their management system and in particular, their food safety management system.

FST: In reality, how long does it take a typical company to create an effective food safety culture?

Ahn: There are two parts to that question.

My belief is that if you want to implement a food safety culture, you need to create a food safety management system, otherwise it is just all words and talk. It’s what you do, not what you say. The way to do that is to embed a food safety management system within your organization.

The two questions are: How do you get to initiate it? And, how long does it take to execute once you decide to initiate?

To address the first question: How do you initiate it?

There are a couple of ways that it can happen. There’s nothing like a crisis to get the fire under somebody’s feet, whether it’s a recall or an incident, it will draw attention to the fact that there’s a problem and something needs to happen. But, that’s reactive and detrimental.

The other way to initiate is that if you have enlightened leadership—an owner or group of owners who understand where they want to go, where they need to go, what needs to be avoided and understands the importance of the organization’s culture in getting to the right place, etc.

Secondly, once you start this process, how long does it take to get this type of system running?

Based on my experience in implementing food safety management systems like FSSC 22000, it takes anywhere from 18 months to 2 years to get it established, and then probably another 18 months or so to actually fully implement. So it’s not something that happens in a couple of months. It takes some time to really get it implemented and embedded, because these are foundational elements you  must put into place. There’s a lot of momentum involved, and it has to move throughout the organization.

The term food safety culture has gotten a lot of attention—it’s a buzzword. But what does it really mean and how do you make it come to life? That’s really where people need to start looking. You make it come to life through implementation of structured food safety management systems—ones that are verified, and independently verified. Put substance and real work around your food safety culture instead of using a lot of fluffy words to describe it.

FDA

FDA Releases Voluntary Retail Program Standards

By Food Safety Tech Staff
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FDA

After receiving input from federal, state, and local regulatory officials, along with industry and trade associations, academia, and consumers, FDA issued its Voluntary National Retail Food Regulatory Program Standards last week. The standards address “what constitutes a highly effective and responsive retail food regulatory program,” according to the document.

The Retail Program Standards include:

  • Promoting the adoption of science-based guidelines from the FDA Food Code
  • Promoting improvement of training programs to ensure local, state, tribal, and territorial staff have the necessary skills, knowledge and abilities
  • Implementing risk-based inspection programs
  • Developing outbreak and food defense surveillance plans to enable systematic detection and response to foodborne illness or food contamination

The 2015 edition contains new worksheets that are intended to assist regulatory programs in looking at how their programs line up with the 2013 Food Code. This includes helping them assess the consistency and effectiveness of their enforcement activities, and a verification tool to help independent auditors with these self-assessments. Although jurisdictions can use the worksheets and other materials without enrolling in the Retail Program Standards, FDA encourages them to do so, as enrollment allows them to apply for FDA funding. The agency also lists the jurisdictions enrolled in the program here.

FSMA Final Rules Almost Here, Guide to GFSI

By Food Safety Tech Staff
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With a host of mandatory requirements under FSMA means, businesses may want to consider GFSI certification.

The first FSMA deadlines are now two months away, and manufacturers may wonder how and where GFSI certification ties into increased regulation. First, what are some of the main differences between GFSI and FSMA? GFSI is seen as more global, while FSMA is more US-focused. Of course, the final FSMA rules will require mandatory compliance, and GFSI is voluntary. However, GFSI certification is recognized among major domestic and international retailers, so compliance with a GFSI-recognized scheme is an important part of a company’s food safety program.

The Food Safety Consortium Conference features a GFSI Services & Compliance track. With increased regulatory demands under FSMA, speakers will discuss the role of food safety certification systems. A GFSI-certified facility is one step closer to compliance with FSMA and may be held in higher regard by FDA from an auditing and inspection standpoint versus a business that has not opted to obtain certification.

Obtaining GFSI certification provides several benefits to the food industry, according to a recent TraceGains blog about the GFSI journey, including:

  • Reducing duplication of audits
  • Creating a comparable audit approach and outcomes
  • Enabling continuous improvement and customer opportunity for GFSI-benchmarked companies
  • Enhancing trade opportunities
  • Gaining cost efficiencies throughout the supply chain
  • Increasing competitiveness in the global market

Several food safety management schemes are recognized by GFSI. Among them is FSSC 22000, which touts the certification of more than 10,000 businesses worldwide. This year’s Food Safety Consortium also includes the first FSSC 22000 North American Harmonization Day on Tuesday, November 18. The meeting will provide a technical update of FSSC 22000, along with current scheme and future plans for expanding scopes and preparing for GFSI benchmarking.