Tag Archives: audit

What Matters When Considering a Food Safety Audit?

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Food companies need to get audited and their personnel need to get trained frequently, and this is a growing trend in the evolving regulatory landscape and a highly competitive and global supply chain. However, what matters the most to food companies when getting audited? How significant is auditor competence as an attribute? How about the time that the audit takes, and the time to get the report? Or for training, what role does technology play?

To understand this, Eurofins conducted a blind survey of industry participants – nearly 600 respondents answered questions related to Certification and food safety Training.

Some of the highlights included:

EurofinsSurveyMarch2015_1EurofinsSurveyMarch2015_2EurofinsSurveyMarch2015_3 Ultimately, the following factors influenced food companies’ decision to go through food safety certification:

  1. Customer Requirements/Requests Relationships;
  2. Industry Standard; and
  3. Value Proposition. 

When it came to training, the top three influencers to go through Food Safety Training were identified as:

  • Developing Competence (Gaining, Improving, Growing)
  • Relevance and Subject of Training Cost and Time

EurofinsSurveyMarch2015_4

Paul Dewsbury, B.Sc.

Honey Laundering: Food Fraud That’s Not So Sweet

By Paul Dewsbury
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Paul Dewsbury, B.Sc.

ThermoFisherpodcastAs a result of my research, I found two fantastic resources describing the background of food fraud, the first is an excellent 3-minute podcast on our website, titled, Food Fraud by Dr. Jennifer McEntire, who at the time was VP and Chief Science Officer at The Acheson Group and is now the newly appointed VP of Science Operations at the GMA. Dr. McEntire succinctly gets to the crux of the reasons pertaining to food fraud and it is well worth a listen.

The second is a 3-minute slide deck narrated by renowned food safety expert Professor Chris Elliot, Director of the Institute of Global Food Safety at Queens University Belfast. Professor Elliot highlights the impact of various food frauds including melamine adulteration in milk, spices, meat and he specifically expands on the topic of honey laundering.

There are too many honey adulteration frauds to list here and while some have resulted in huge fines and criminal charges, there is one that will not go away is the mislabeling of Manuka honey. This premium product (and premium price) is a rare honey from New Zealand produced by bees that pollinate the manuka bush and has numerous claimed medicinal properties that can be extremely profitable for the fraudsters through substitution with a basic product. As food fraud is an international issue, various organizations likeInterpol and Europol have food fraud units and here in the UK the government has committed to, and is setting up a dedicated Food Crime Unit.

Moving into the science, one of the best literature resources I would like to share is the Food Fraud Resources website which has some highly cited articles including reviews, thought leadership and analytical methods that are available for download. There are various techniques for honey analysis in the journals and I want to briefly focus on one of the most powerful for authentication, the use of isotope analysis. In our Application Note 30177, Detection of Honey Adulteration with FlashEA Elemental Analyzer and DELTA V Isotope Ratio Mass Spectrometer, we describe a fully automated system for the detection of honey adulteration with C4-syrups according to the AOAC 998.12 guidelines and is routinely used in many laboratories.

Is honey analysis or food fraud of interest to your laboratory? If so, share your thoughts and experiences in the comments below. 

Check out Thermo Fisher’s Food Community page for more resources, on-demand webinars, videos, and application notes.

 

Thermometer, Thermostat, or Smart Thermostat? Supply Chain Quality Approaches

By John McGlinn
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What can the seemingly straight-forward tools we use to regulate temperature tell us about our approaches to supply chain quality?

The seasons bring with them our sensitivity to weather conditions, and especially to how hot or cold it is, inside or out. We measure those conditions, and we try to regulate them so that we can stay within a safe and comfortable range. In many ways, the processes we use to do these things have analogies in the world of Quality Assurance. What can the seemingly straight-forward tools we use to regulate temperature tell us about our approaches to supply chain quality?

Thermometer

The definition of a thermometer is “a device that measures temperature or a temperature gradient, using a variety of different principles.” Two components are required: it must be able to sense the temperature and any change in it, but then it must also convert that information into some kind of scale using numbers. A key property is standardization, especially when regulating production processes. There should be nothing subjective about a temperature reading. Without standardization and agreement on the scale to be used, the readings are meaningless.

While a thermometer is critical to many production processes (not to mention in medicine, weather and scientific research) it has, by design, some limitations. 1. A thermometer does not initiate a reading. Someone decides to use a thermometer at a certain time to get a reading. In this way, a thermometer is a highly effective, yet passive instrument. 2. It shows a snapshot of what is happening at the moment of the reading. 3. It does not show any comparisons to what happened before, or what comes after, unless it is integrated into a system that goes beyond being the technology of the thermometer, i.e., beyond the” bulb” and the “mercury” it contains.

Supply chain quality tools: Audits and self audits

The analogue to the thermometer in the world of Quality Assurance is an audit. An audit is initiated by some agent (management, legislative enforcement, voluntary compliance with industry standards). Someone or something then takes the “temperature” of a process at some moment in time. It shows just that – what is happening at the moment. It makes the assumption that the next moments in time, until the next audit, will be just as “healthy.”

Thermostat

Rather than a self-contained tool (like a thermometer), a thermostat is a part of a control system. The system has the capacity to sense the temperature of a system, and respond in such a way that the system returns to a certain level, a “set point.” When it senses an anomaly, it responds by switching on either the heating or cooling components, or by regulating the flow of heat transfer materials.

Supply chain quality tools: Reports

The analogue to a simple thermostat in the supply chain quality world is an assortment of reports. They include information that is collected, such as:

  • Certificates of Analysis (COA)
  • Certificates of Compliance (COC)
  • Dynamic questionnaires
  • PDF Forms
  • Certifications

When the reports show that, at that moment, things are “too hot” or “too cold” (in other words, out of specification), then the system responds to what is collected with:

  • Corrective action plan
  • Material specifications, whether new or adjusted
  • Purchase order information
  • Supplier nonconformances
  • Supplier scorecards
  • Supplier rankings
  • Supplier processes (to be used)
  • Supplier procedures (to be used or changed.)

It’s clear that the system is set up to respond. However, it also means that the system may swing between various points of being outside the range of necessary specifications, just as a simple home thermostat may be constantly adjusting to return to a desired temperature, although much of the time it is in a condition of “returning to” rather than “at” a specified temperature. Once it reaches that temperature, it immediately begins to destabilize. Once it reaches a certain boundary, the thermostat kicks in to move back toward the “ideal.”

In the supply chain quality management context, this may allow for material variability that is constantly trying to return to a condition of compliance with specifications.

Smart Thermostat

No modern building is without a “smart” thermostat. What makes smart thermostats truly smart is that they reduce the amount of variability. They are so sensitive to changes that the response is quick and decisive. The variability is broken up into very small stages, and even a small increment triggers a quick correction, making the system much more consistent and stable.

Supply chain quality tools: Material variability management and Statistical process control

Just as a thermostat is really a component of a system, Material Variability Management (MVM) is a “smart thermostat” in the domain of supply chain quality management. Electronic documents flowing at a constant rate through a system, powered by Statistical Process Control (SPC), can spot trends and anomalies much more quickly than the large increments that cause a system to constantly react, getting too hot and too cold, while assuming that averaging the two makes the environment pleasantly warm.

Material Variability Management is based on the physical inspection and/or testing of all critical inputs and sub-assemblies in real time, along with specification verification, as well as approval to ship so that no material that doesn’t meet specifications moves through the supply chain. It is a system that integrates an array of tools such as:

  • Specification collaboration/distribution/sign-off
  • Supplier COA test data capture (manual and computer-to-computer)
  • Production batch tests data capture
  • Outbound COA generation from batch test data capture
  • SPC Analyses including individual test trending of out-of-spec conditions and into problem zone (beyond 3 sigma and approaching spec limits)
  • Ship-to-Control visualizations and range setting
  • Alerts for material problem performance
  • ANSI Z1.4 Sampling data capture and analysis
  • Lab test analysis data capture and comparisons
  • Advanced-BI for user-definable reports and dashboards
  • Material and location QA audits

MVM powered by SPC turns a supply chain quality management system into a truly SMART thermostat. Instead of taking a snapshot of reality and reacting to it, it can sense trends and send early warning signals that prevent the entire system from becoming unstable. Your enterprise deserves state-of-the-art support, especially when the technology is affordable, reliable, will save you money, and will secure your reputation for high quality.

Top 5 Reasons Organizations Fail Audits and How to Not Be One of Them

By Chelsey Davis
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When it comes to audits, there are plenty of reasons for failing, especially in the food and beverage industry. To help shed light on some of the reasons companies fail audits and to help prevent future failure, here’s our top 5 reasons to why organizations fail.

When it comes to audits, there are plenty of reasons for failing, especially in the food and beverage industry. Whether it’s an audit for GFSI, FDA or an audit required by any of your customers, the consequences of failing can be very costly. And while the whole team receives praise when an audit is successfully completed, there are a select few that bear the burden of audit failure (QA professionals). To help shed light on some of the reasons companies fail audits and to help prevent future failure, we’ve listed our top 5 reasons to why organizations fail.

1. Human Error

It doesn’t matter what industry you’re in, human error is bound to occur. The key here is to be able to minimize the chances of human error as much as possible. As a quality assurance manager, it’s important to make sure all employees are well-trained and fully understand the reasoning for performing certain functions of the job in a particular way. When employees understand the why regarding processes, it will be easier to remember going forward. Additionally, you should have systems and internal audits in place to ensure that what is supposed to happen is happening.

2. Compliance vs. Business as Usual

During audit time, there is often a conflict of interest when it comes to quality assurance managers and making sure the business is still operating as usual. As part of the process to prepping for an audit, management needs to ensure everything is up to standards, and this can possibly include stopping production lines, which interferes with the operation manger’s strict schedules. The important thing to convey here is the fact that compliance should come before anything else. The consequences of failing to meet compliance requirements will surely cost more than a delay in product delivery.

3. HACCP Failure

Hazard Analysis and Critical Control Points (HACCP) is a management system that helps prevent foodborne diseases and essentially operates to protect consumer safety. When it comes to audits, HACCP documentation is incredibly important, which is why it’s crucial to have it complete and comprehensive. Not doing so can be enough to cause your organization to fail. (Download this HACCP checklist as a guide to help you get started).

4. Lack of Supplier Control

All the guidelines and processes in the world you use to keep your organization compliant wouldn’t help much if your suppliers weren’t in sync. And with today’s global food supply chain, it is becoming increasingly difficult to manage risks of food fraud and contamination. One way to help tackle this issue is supplier scorecarding. Automated scorecarding helps both parties examine data and results based on the same information, fostering closer collaboration, information exchange, review of standard and best practices, as well as the occasional review of ingredient specifications, so that all stakeholders involved can work toward the same goals.

5. Lack of Documentation and Organization

“The best part about prepping for an audit is gathering all the required documents,” said no one ever. Not being organized can definitely hinder your chances of successfully completing an audit. And with multiple suppliers providing multiple different documents, staying organized can be a challenge. A filing cabinet just won’t cut it anymore. As a quality assurance manager, you were not hired to be a paper clerk, but agile document management is critical to the success of your business. This is where automation comes into the picture. Are you getting the data and information out of your documents that you need to improve your business? Can you satisfy an auditor with just a few mouse clicks? Automating this process not only helps your organization overall, but also helps you—the quality assurance hero—save time and energy.

Check out our chat with John Paul Williams, Director, Enterprise Solutions and Market Development, Americas, at Polycom, to learn more about why automation is so important for evolving businesses.

Which GFSI Standard is Right for Me, and How Do I Prepare For The Audit?

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So your company has decided to pursue certification against a GFSI benchmarked standard. How do you go about choosing the right standard for you, and how can you prepare for your first audit? This article offers some advice.

One of the most important questions to ask before researching and deciding upon a standard for GFSI certification is, “Do any of my company’s current or prospective customers require GFSI certification to a particular standard?

Some customers do require their suppliers to achieve certification to a particular GFSI benchmarked standard and it is worth investigating customer requirements upfront before investing time and resources in the development of a standard specific food safety management system, which is not recognized by a particular customer.

While GFSI benchmarked standards are similar to each other in the core criteria of a supplier’s food safety management system, there are subtle differences with respect to the level of prescriptiveness and certification cycles required by each standard. While GFSI’s motto is “One Certified, Accepted Everywhere,” the reality is that retailers and manufacturers have unique requirements for their suppliers to support organizational initiatives and it is in the best interest of suppliers to understand such requirements for increased market access of their company’s food products.

Identify your company’s preparation profile

Once customer requirements for GFSI certification are evaluated, the next step is to assess management objectives for GFSI certification as commitment and resource requirements maybe different depending on which standard is adopted for certification.

At their most basic level, all GFSI benchmarked standards require the development and implementation of a food safety management system (FSMS) for certification. However, some schemes extend the scope of certification beyond food safety requirements and offer certification of both a food safety and quality management system (FSQMS) such as BRC Global Standard for Food Safety or SQF Code Level 3.

Distinguishing between implementation of these two types of management systems is critical for determining management commitment, resource requirements, implementation of timelines, and maintenance (certification) of the system.

Attributes to consider and evaluate against the different GFSI benchmarked standards when deciding which GFSI standard to implement may include consideration of the following:

  • Type of operation
  • Number of locations
  • Physical size of the facility
  • Number of employees
  • High or low-risk product
  • Number of HACCPs
  • Product category(ies) to be included in scope of certification
  • Ability of management and staff to submit to required unannounced audit during certification cycles.

Developing, implementing, and maintaining a food safety management system is a financial commitment on the part of the company seeking certification with immediate and long term benefits as previously discussed. As such, budgeting for the initial development and implementation as well as continued maintenance of the system is necessary. Consideration should be given to the need for initial training of key management and staff to the selected standard, consultancy, allocation of management and staff time, and initial audit costs. Maintenance of the system should consider continued training needs as new editions of the standards are issued, annual review, revision, and verification of the system, and annual recertification costs.

How to prepare for the audit

In preparation of the audit, it’s helpful to prepare an Internal Preparing Checklist, covering the following aspects:

  • GFSI Standard: Have you determined which GFSI standard best fits your company culture and acquired the current version of the standard?
  • Commitment: Is senior management fully committed to implementation and maintenance of the selected standard’s requirements?
  • Food Safety Management Team: Do you have a qualified HACCP team leader, inter-departmental HACCP team, and designated individual(s) to lead the development and implementation of the food safety management system?
  • Training: Are the company’s designated HACCP and food safety management leads trained in the requirements of the current version of the standard?
  • Readiness: Does the company have a well developed, implemented, and documented HACCP system with core prerequisite programs included allergen management, internal audit, GMPs, process and product segregation, SSOPs, specification approval, supplier approval, recall plan, traceability and training?
  • Timeline: Has senior management set a target date for certification?
  • Consultancy: Do company resources lend itself to successful development of a documented food safety management system, which meets all requirements of the standard, or is there a need for a standard specific consultancy?
  • Internal Audit (Gap Assessment): Has the food safety management team conducted an internal audit of its system against the requirements of the standard? Are “Gaps” or a reason of non-conformance to standard requirements identified with a correction action plan?
  • Third Party Assessment: Is there a need for a third-party (certification body) to conduct a pre-assessment audit of the company’s system against standard requirements? Third party pre-assessments provide objective and competent evaluation of the system by a trained auditor in preparation for the planned certification audit.

The above article has been adapted from a white paper published by CERT-ID, which has over 15 years’ experience in providing certification services globally. For more information, visit www.cert-id.com.

How to Run an Audit-Ready Co-Pack Operation

By James Houghton
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If an auditor were to walk through your site today, would you be proud of its set-up and its ability to uphold quality and regulatory standards for yourself and your client?

I think many of us have once been – or are still – in a state of scurrying around right before an auditor knocks on our front doors. When you’re small and growing quickly, it’s hard not to be reactive for things like regulatory audits. But at some point, you have to proactively build out repeatable processes to drive long-term growth, and start really taking control of your own operation.

Here’s the ideal:

You want your co-pack operation to be in a state of audit-readiness. That is, if an auditor were to walk through your site today, you’d be proud of its set-up and its ability to uphold quality and regulatory standards for yourself and your client.

Earlier in October, I presented a webinar on “How to Run an Audit-Ready Co-Pack Operation,” i.e., how to get your house in order. Here are the five pillars of maintaining a state of audit-readiness for your co-pack operation:

Culture

In the same way that you have built a culture of collaboration and client satisfaction you’ll also need to build one for Quality. The way you prioritize and permeate Quality initiatives throughout the organization, from your senior team to your shop floor staff, will show when the auditor walks through the doors.

Paperwork

It’s vitally important that your paperwork is in order, including your SOPs, transactional items like RFQs, POs, and SOWs, and most importantly, the batch record. The auditor will be looking for two things amongst all of your documentation: content and consistency. The content needs to meet regulatory requirements, and there needs to be consistency between what you say you do and what you actually do.

It’s not rocket science: you need to write out what you do, and then you have to do the activities that reflect what you’ve written down. This is often the one thing that won’t be maintained properly, unless it’s given attention.

Physical Space

Your physical space will be audited to ensure it’s set up with the correct flow, that it is kept clean, and there is documentation to that effect.

To make sure your physical space is up to par for an audit, imagine that you yourself are the product… go back to your receiving doors and physically walk through your facility, as a “day in the life” of your product. You’ll be able to see where you go, how you are handled, and where each step is documented. Along the way, anything that’s not delineated, not treated or identified properly, or does not follow a logical flow, are the areas you need to lock down before an audit.

Material Control

An auditor will want to see that you’re in control of your materials, and that you have track and traceability. Being able to track where you’re storing things in the site, where it’s moving, what your processes are for moving inventory, etc… all that demonstrates that you have the traceability controls to be able to handle mock and real recalls and maintain consumer safety.

Production

Ahh… the production line. It’s where the magic happens. When setting up your production line, you need to make sure you have appropriate line clearance, the lines are segregated, the correct staff are on the line to do the project, and that they have had the proper training for their particular activity in the line. In the co-pack world, where things are highly customized with low repeatability, it can be easy to overlook the extensive amount of training it takes to make sure each production line is in good hands. You need, however, to make sure you do your due diligence to maintain production accuracy, quality assurance, and regulatory standards.

In the webinar, I discuss each of these areas in greater detail. If maintaining a state of audit-readiness is an endeavor you’d like to pursue, watch the webinar for more details or access the slide deck by clicking here. 

Ask the Expert : Root Cause Analysis – Responding to Audit Non-Conformances

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A food manufacturer’s food safety program must encourage continual improvement to their existing program in order to be successful and to comply with their food safety standard. And root cause analysis is a great tool for problem solving when a site is found not to be in conformance.

The food industry has been introduced to the concept of third-party certification to help manage and control their food safety programs. Food manufacturers benefit from a food safety quality system that is based on Global Food Safety Initiative (GFSI) principles.

Business People with Puzzle Pieces and Teamwork Concept

A food manufacturer’s food safety program must encourage continual improvement to their existing program in order to be successful. Current GFSI benchmarking initiatives have introduced the concept of implementing root cause analysis as a tool for problem solving when a site is found not to be in conformance with their food safety standard.

A new white paper from CERT ID covers relevant information that can assist food companies understand how to implement their solution, review and evaluate the results, and reflect and act on what was learned. This Q&A with CERT ID’s Michael J. Pearsall, Vice President of Business Development, offers some insights.

Q: These RCA tools are nice but require large amounts of resources to solve problems. Is this really necessary?

A: The effort and resources utilized to solve a problem should reflect the scale of the issue with regard to the impact on the person or organization. The tools that are normally advertised are to be used for complex problems. What about the simple day-to-day problems we all face as managers? A human being solves problems without even realizing it. You have a built in mechanism that you have acquired through life experiences and this device should be called upon first. Develop a personal strategy as to how to approach a problem that starts with observation; defining the issue; prioritization; short term strategy and finally a long term strategy to prevent issues from reoccurring. Complexity of problems change but your strategy should not.

Q: We went through a complex root cause analysis and solved the problem but it keeps reoccurring. It is very frustrating so how do we prevent this?

A: I hate to tell you this but problems are only temporarily solved. Many very intelligent people forget, the most important part of problem solving, developing a strategy to maintain the gains you spent so much of your resources to obtain.

There is an overused Old Testament bible story about David and Goliath. Many think that David killed Goliath with a stone from his sling but this is not true. David had developed a strategy to maintain his gain. David had to immobilize the giant to gain access to him. He solved the problem by hitting him in the head with a stone, but the long term strategy was to grab his sword to cut his head off securing the gains to his problem solving effort. It is necessary to think about how you will maintain the gain once a problem is unraveled.

For more information, click here to download Responding to Audit Non-Conformances: Root Cause Analysis, a complimentary white paper from CERT ID. 

John Kukoly of BRC Global Standards

BRC in 2015: What’s Changing, and How to Get There?

By Sangita Viswanathan
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John Kukoly of BRC Global Standards

What’s new for BRC this year?

2014 has been an extremely busy year for BRC. We wanted to think of BRC standard as not just an audit or a standard for certification. We want to strengthen food safety and help grow respect for food safety around the world. So in that spirit, we have strengthened our program.

One of the new changes is auditor competency programs. Under this, auditors need to understand the standard, know the audit technique, have a strong grasp of the industry they are in, whether it be dairy or thermal processing etc. They need to truly understand the processes involved, and where the risks are. While there have been some challenges with the auditor competency program, we have identified some auditors that are clearly strong. We are also addressing the gaps.

With the horse meat scandal, we realized that there are some times gaps and barriers with distributors and agents. So we have developed a standard for brokers and distributors to strengthen the supplier approval program. This year, we have also worked on BRC Issue 6, and developed best practices from our experiences. The standard has been growing in the U.S., Canada, Mexico, and Italy, and we are also expanding into new areas both geographically and industry sectors such as packaging, storage and distribution etc.

One major development in 2014 was growth in unannounced audit, in response to customer requests. Customers came to us and asked us for that option that if they really feel ready for unannounced audits, they should do it. BRC currently has over a 1000 sites that are getting audited unannounced. And while it hasn’t been simple or straightforward, this is great progress.

Where’s BRC going in 2015 and beyond?

2015 is going to be a big game changer for us. In January, BRC Issue 7 will be launched, and for the first time, you can download the entire standard from the BRC website free of charge. Audits using the new Issue 7 will begin July 1. It’s a nice clean standard with a handful of changes, and cleaned up from Issue 6. Things we have added are food fraud, based on industry demand, given what happened with horse meat, olive oil, rice etc. BRC auditors are not forensic auditors or food fraud investigators. They will, however, focus on food defense programs, to confirm that you have control mechanisms in place to prevent fraud.

The revised standard will also included Expanded High Care, in which we have identified certain products with certain characteristics for greater scrutiny, for instance RTE products susceptible to pathogen growth. You need to make sure there’s no process to reintroduce the pathogens in the final product. This change has been a huge shift for some industries. While all standards cover the basic GFSI requirements, we have noticed that when it comes to RTE products, BRC is much more rigorous.

Another focus area will be prevent labeling errors to avoid recall. Often, the number one or two cause for recall is mislabeling, where the product inside the packaging is not accurately specified on the label. Often this is around allergen control, but if it’s in the package, it has to be on the label, and this is a big focus for the new version.

We are also expanding our BRC Global markets program to align better with the GFSI global markets program. In this we have roughly split the standard into three schemes – beginning, intermediate and full certification. If companies don’t have the ability, knowledge, or processes in place to get fully certified, it’s a systemic approach to work themselves forward. It’s one thing to get the standard and set the bar, but another process to prepare these companies for certification. So it’s very exciting program to work with real small sites, in developing areas of the world, where the food industry is still growing.

How will companies be affected by these changes? And why is embracing these changes important?

Management commitment is always important. We have done a lot of audits: Over the world, we have over 17,000 sites that are BRC certified on the food side alone. Ones that have done best are those that have embraced food safety culture as an organization. It’s really about how as an organization, you take something on. The companies that have always struggled are those that say, ‘it’s the QA manager’s job, and let them take care of it.’ BRC is trying to see how to improve, engage and then measure the culture of an organization especially when it comes to food safety. And this starts with training and the commitment to training. Sites should increase and improve their training, and focus on continually evolving and getting better with their food safety, food quality and regulatory compliance programs.

It’s important to embrace these changes, because we need to move forward to continue to reduce risks. Knowing our suppliers is a big part of that, and the new standards enable enhanced supplier approval, and controls, and transfer of information. In BRC Issue 7, supplier controls will be a critical focus area.

We also do have to get the internal house in order, so we need to have strong internal controls in place, and quality internal audits. Companies need to understand how to do these internal audits very well, and have process controls and, verification and validation programs in place. People understand the importance of food safety. But they don’t often use all the tools they have in their tool box as well as they can. We can use internal audits, root cause analysis, risk assessment, etc. more effectively to get more insights in our internal FSQA progams.

Overall, we should enhance food safety. The bar should be constantly raise. We can never be in a position where we say it’s safe and good enough, and we don’t have to do any more. We constantly have to move forward to meet expectations of consumers and customers. We need to follow continuous improvement, and get our partners involved, whether they are raw material suppliers, packaging providers, or distributors. What do they need to do, and how do we expect them to be our partners? We are certified, that’s great, but how can we transfer that along the supply chain? All these questions need to be continually addressed.

Listen to John Kukoly address more questions on how BRC can help you better prepare for FSMA and take on questions for the participants. Click here to access the webinar.

Gary Smith, Eurofins’ Food Safety Systems

Moving from GMP to GFSI Audits

By Sangita Viswanathan
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Gary Smith, Eurofins’ Food Safety Systems

Ask any one in the food safety and quality sectors of the F&B industry and they all talk about one uniform concern: Audits. The sheer number of audits, supplier audits, GFSI audits, FDA audits, unannounced audits, the work involved in preparing for these, and the possibility of still things not working as planned on the actual day of the audit.

Dispelling some of these concerns, Gary Smith, who leads the strategic development and oversight of Eurofins’ Food Safety Systems division, including auditing, certification, and training programs, spoke to Food Safety Tech about how companies can be better prepared; challenges in moving from traditional GMP audits to GFSI recognized certification audits; role of management; and what do you if you disagree with the auditor.

Food Safety Tech: What is the biggest challenge for a company moving forward from traditional GMP audits to GFSI recognized food safety certification audits?

Smith: A good GMP audit program has probably got about 80 percent of the full GFSI scheme. It’s a great precursor. But there are some aspects that are not addressed in GMP audits which are facility-specific, such as would we know if the floor is in bad shape etc.? With GFSI you can’t have any non-conformance. Internal audit programs, corrective action management, root cause analysis, all of these are a must for GFSI. So it’s much more advanced than what’s required in GMP.

The audits are also difference from a validation stand point. For instance, with GMP audits, you need to have six elements of a Pest Control program and a facility can say, I have all six, so I am set. But with GFSI certification programs, you need to have these six elements, but you also have to prove that these are effective.

GMP audits provide a snapshot in time, a look behind the curtain to make sure you are following all the requirements. With certification, it’s a more consistent and continuous process – you are always looking for ways for improvement, and ensuring the standards and systems are working the way they are supposed to.

FST: What is the role of management in the audit process – whether GMP or GFSI?

Smith: There’s a big difference when it comes to management participation with both these sets of audits. Management needs to understand that with GFSI certification, management is required to have a culture of continuous improvement, where they are constantly looking for issues to manage and ways to get better. Leadership has to drive that change and a lot of folks struggle with this. QA managers should focus on training them to bring managers to embrace and communicate that culture.

FST: For companies first looking into certification services, what criteria should they be using while selecting a certification body?

Smith: The most basic requirement according to me is auditor availability. You need to identify a certification body that has more than one or two certified auditors. While price should be a consideration, it shouldn’t be the top priority.

As companies move to certification versus auditing, it is also important to look for a food safety partner, one who can service many of your foods safety needs such as testing, consulting, training etc., versus just auditing. For instance, can you call the Certified Body in case you have a recall or a food safety incident, and can the CB help you minimize the issue and solve the problem? Of course, customer service is an important consideration; the auditor and the team have to be responsive and polite.

FST: What steps can a company take prior to an audit to give themselves the best chance for success on the audit?

Smith: Training is critical. The facility and the personnel concerned with the audit process need to thoroughly understand the standard against which they are being audited, what will be asked and assessed for. Companies need to be harder on themselves than the auditor will be. Get others in maintenance and product involved in the facility and ask them questions that an auditor may ask. Train them to answer those questions.

Have strong internal auditing programs so you are prepared. You should know your issues and some auditor shouldn’t be telling you what the gaps are. All this is time and energy consuming, but it’s worth it.

Taking pictures both internal and external can also help, and can be a great training tool. When you have actual pictures from the facility and the processes, there can’t be too much room for debate.

FST: If the company disagrees with an auditor or the audit findings, what should they do?

Smith: The first thing I would say is don’t be afraid to ask the auditor questions. It is okay to say, ‘show me in the standard where it says this is a nonconformance.’ Remember to ask them before they leave. In most cases, asking such questions can help solve 75 percent of the issues.

Auditors can help describe why something is a nonconformance. If as a facility there’s still disagreement, you can go to the CB and provide a written description with as much information as you can, specific to the standard, about why you disagree with the audit. You can do an investigation and in many cases, probably 40 percent of the time, the auditor could have made an error, and gone beyond the standard. Remember that for the CB also, it’s important for them to get it right. So sites shouldn’t be worried about asking auditors questions, and CBs should respond to them – all in the process of continuous improvement.

Unfortunately, in some instances, it gets escalated beyond the CB to the standard owner. Though it’s a really drastic step, it has happened with SQF. As the final step, the site can still contact the Accreditation body, the American National Standards Institute.

FST: What are some other concerns regarding audits against the backdrop of FSMA proposed rules and GFSI?

Smith: As the industry is still waiting for final FSMA rules, one requirement that is causing some concern is auditors having to inform FDA when they see a nonconformance during a consultative audit. There is some concern that such a requirement would discourage people to try and get better. Industry is also waiting to see how FDA views certification audits. Can this be a process to ease imports, or, for domestic suppliers, be a risk-reduction tool? For instance, if there are two food facilities that make the same product, one that uses a GFSI scheme and one that doesn’t, can the one that uses be considered lower risk and not require as much resources to assess risk? Can inspections be done less frequently for such a facility? Will FDA accept such factors in the final requirements?

Ultimately, we need to remember that certification in the food industry in the U.S. is only about six years old. We all need to collectively continue to drive the process forward.

SCS Global's Sr. Technical Director and Auditor Heena Patel

What’s a Successful Food Safety Audit?

By Sangita Viswanathan
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SCS Global's Sr. Technical Director and Auditor Heena Patel

Audits and being prepared, and audit-ready are becoming increasingly important in the food safety world as the industry is moving to compliance with rules proposed under Food Safety Modernization Act. In this Q&A, from a webinar hosted bySafetyChain Software, and SCS Global Services, Heena Patel, SCS Global’s Senior Technical Director and Auditor answers some key questions about audits.

Q: What are the 5 top Best practices to follow for successful audits?

Heena Patel: As an auditor myself, I have conducted hundreds of audits. Auditors look for specific things and can make keen observations. They look for confidence, if the audit team on the site is well prepared for the audit or not. So be prepared for the audit. Be confident, follow the audit plan, have key staff present for the opening and closing meetings and for the facility walk through.

Don’t make the auditor wait for you to locate reports and records. Follow the audit plan; the plan is sent to the site ahead of time for a reason. It has details about the audit and what it would involve, and is a very good guideline that can be used to prepare for the audit by getting ready all the necessary reports and records.

Conduct mock internal audit to prepare for the final audit. Internal audits can help you prepare for any surprises. Use the information for the internal audit to answer questions during the actual audit.

Senior management must be prepared to show commitment and support for the food safety team. This matters a lot to the auditors.

And finally, feed your auditor well. It’s not a good idea to have a grumpy auditor.

Q: What are the biggest ‘No-Nos’ leading to deductions?

Patel: I would list the following items that lead to deductions:

  • Lack of management commitment and lack of team work;
  • Being unorganized and unprepared;
  • Not following and/ or not understanding code requirements; and
  • Not fully answering auditors’ questions.

Having incompetent team and incomplete documentation reveals the company not having the necessary training, or professionally trained personnel in-house. Having pre-requisite programs in place is huge in the audit checklist and this covers aspects such as sanitation practices, mock recalls, allergen management, training, testing, etc. We also look for business continuity plans, and management reviews. At SCS Global, we use a matrix with all this information to see what has been addressed well during the audit.

Q: What do auditors look for in demonstrating continuous improvement?

Patel: As an auditor, I love this aspect of an audit. Auditors don’t like to see that the program is not moving forward and is not getting the commitment and resources required from management. They must be focus on investing in employees with training and continuous education programs; and focus on upgrading structures and fixtures throughout the building as needed. Key performance indicators or KPIs must be developed that measure the performance of the food safety and quality program. These must be based on findings of the internal audit, external audit, or recalls etc. It’s also important to trend and evaluate this data during management meetings to see where the program stands and how it can be improved, as part of the continuous improvement program.

Q: How can companies best prepare for unannounced audits?

Patel: Unannounced audits are great from an auditor’s view point, as we can use this to see if the site is truly audit-ready at all times. Often with announced audits, we go in and notice that the floor has been swept well, there are no cobwebs anywhere, everything’s nicely arranged on the shelves etc. But you also realize that the mock recalls has been conducted the day before; the internal audit was conducted two days earlier. And this is not a good sign.

It’s important for food facilities to have a schedule in house in which records based on internal audits/ sanitation programs/ mock recalls etc. can be updated on a continuous basis. The actual audit should just be used to review and sign off on these records.

How can companies be audit ready at all times? By monitoring all programs continuously; keeping the facility clean at all times; and keeping the paperwork up to date at all times.

Q: How can automation/ technology facilitate audit readiness?

Patel: Many years ago when I used to audit food facilities, there were no automation systems in place. Auditors were using hard copies and paper checklists. Now, automation has made the entire process more efficient and communication friendly. Automation can help prepare audit plans, schedule tasks and assign food safety personnel to different parts of the program; have a centralized repository for records and data; work with Certified Bodies and suppliers who can all see information in one place; report non-conformances; put in place due dates for suppliers and auditors to either confirm or reject actions; have records on who conducted the audit, all non-conformances, all corrective actions etc. Having automation technology helps save on all the paper work involved in managing a food safety program and preparing for an audit.

To sum up, automation can:

  • Provide greater records efficacy;
  • Make it easier to communicate with your auditor when on-site and pre-/post audit;
  • Incorporate automated reminders to help food safety managers and auditors meet required deadlines; and
  • Save time preparing for your audit by automating record keeping.

Get more insights into the auditor’s point of view as Heena Patel answers more questions on this topic. Click here to access the recorded webinar.