Ask the Experts – Automation Pathogen Detection

No Comments

An ideal pathogen detection solution should provide increased confidence in results, high reproducibility and robustness to routine testing labs, fit seamlessly in laboratory workflow without disrupting it, and work well for medium-to high-throughput testing laboratories. This Q&A provides some insights.

Q: How can an automation system help safeguard against false negative pathogen results?

Pathogen testing can typically be broken up into three categories:

  1. Raw material testing;
  2. Finished product testing; and
  3. Environmental monitoring.

Regardless of the type of testing that is done, it is clear that pathogen detection is an important component of any hazard analysis and risk-based preventative control program. Verification of results is crucial, particularly negative results. When performing pathogen testing with a real-time PCR based assay, the presence of an internal amplification control is critical. When present for each individual sample, the internal control monitors for inhibition, which can be common with matrices such as spices and chocolate. When a negative result is obtained, it is important to know if that sample is truly negative because the pathogen of interest is not present or if the reaction was inhibited.

Another potential for false negative results can come from technician error. If a sample is not actually added to the reaction block, tube or strip for testing, the result will be negative. Therein lies the power of an automation system. The iQ-Check Prep automation system employs a liquid level sensing volume verification step at the beginning of the run. Utilizing monitored air displacement technology and conductive pipette tips, users are alerted if a sample was missed in the setup. The user then has the option to add the sample or skip it and continue the run. If the sample is not added, the result is flagged as invalid. Combining the internal control of iQ-Check real-time PCR detection kits with the verification of the iQ-Check Prep automation system, users can be confident in their results and safeguard against false negatives.

Q: How can an automation system be incorporated into a laboratory without disrupting existing workflow?

Incorporating an automation system into a laboratory can greatly increase efficiency, traceability and throughput…if it is the right solution for the lab. Many factors need to be taken into consideration, for example batch processing. Examining time intervals at which samples finish incubation can determine how batch processing fits into the lab workflow. Technician responsibilities also play a part. Does the system require monitoring and continuous feeding of samples or is it a walk away system that frees technicians up to perform other lab duties? Another important consideration is maintenance. The scheduled upkeep of the system needs to be evaluated not only for the amount of time required but for the cost associated with the maintenance.

The iQ-Check Prep system was designed with efficiency in mind. Samples are processed in batches (plates of 94 samples at a time) for a throughout of >500 samples per instrument per eight hour shift. The system is a true walk away system that does not require constant monitoring or continuous feeding. The maintenance is self-contained and completed by the instrument in 5 minutes. These are just a few questions to ask when considering an automation system for the laboratory. The chosen system should fit effortlessly into the laboratory workflow and increase throughput and efficiency without causing major disruptions.

For more information, visit Bio-rad.com. 

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

Final FSMA Rules – How to Prepare?

By Sangita Viswanathan
No Comments
Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

In a recent FSMA Fridays event, three experts from The Acheson Group – Jennifer Cleveland McEntire, Ph.D., Vice President and Chief Science Officer; <strong”>Anne Sherod, Director of Food Safety; and Valerie Scheidt, Director of Food Safety – talked about preparing for final FSMA rules. Food Safety Tech presents some excerpts:

FSMATo-DoListHow close are we to the final rules in terms of how much can things still change, and are we more confident about some rules than others in terms of how much change we might still see?

We anticipate some changes with the proposed Third Party Certification rules especially around the responsibility of auditors to have mandatory reporting to FDA if they find any signification non-conformances. And this covers findings from consultative audits as well, so we feel it may be counterintuitive to do this as companies are aiming for continuous improvement.

We also think they may be some changes with the Food Defense rule. The agency may consider how GFSI views food defense and some of the mitigation strategies that are being proposed.

But for the most part, we think the other proposed rules will pretty much be as is.

What are Top 3 things that companies should be doing NOW to prepare?

First, companies need to figure out who that qualified individual will be especially in manufacturing facilities that have to comply with the preventive controls or foreign supplier verification rule. It’s important that this qualified individual is adequate informed and understands their responsibilities and what they need to do.

Also it’s really important to understand thoroughly the preventive controls rule and how it applies to your facility for instance, to your pre-requisite programs, GMP etc. Analyze how the preventive control rule will go beyond process control, and CCPs.

Another aspect that companies are really struggling with is document management, and realizing how they will be used by FDA.

Adding a fourth to do, companies need to be thorough with Supplier Controls – understand who is in the supply chain, and how they have been approved. FDA will be interested to know if you know their risks and how you are managing them.

In the area of supplier control, FDA made some significant changes in this last round of revisions. Will these hold? If so, what should companies be doing now to prepare?

You will need to have strong supplier controls. Although it looks like a new component, it was always expected. While regulatory compliance is the baseline, what we are seeking in brand protection as an end result. There are two things to get started – get a supplier approval process in place, after assessing supplier risk and making decisions on what can control that risk. You will also need to have monitoring and verification programs, and corrective actions in place.

Step two will be managing all this information. Documentation needs to fully support this system. Companies can do this either manually, or leverage technology that they currently are using, or can look for new technology opportunities. Whatever option they choose, companies must have everything in writing, especially a list of non-negotiable items that they can provide to their suppliers to see what they can do to meet your requirements.

From a scientific standpoint, it looks like companies will need to validate safety processes. Will FDA will be flexible in accepting tried and true operations, or will new studies need to be conducted?

FDA will accept tried and true operations, e.g. if you are doing a cook process, and you are monitoring for end point internal temp of 160 degrees, or if you have pH control of less than 4.6, and if these help in eliminating pathogens, then you have scientific validation for what you are doing. However, if you are doing a new process or a novel product, and have no process that’s scientifically supported, such as cook process, temperature or pH control, you need to have supporting data. In such cases, you will need to reach out to a Qualified Individual, and possibility have to do those studies to to make sure you have scientific justification for validation of your food safety plan.

What are requirements for a qualified individual?

A qualified individual is someone who has the required education, training, and experience to make decisions that are needed. However, that FD training that is required, doesn’t exist yet. So there’s a little bit of ambiguity here. But you look at types of responsibilities and information they need to know, the individual primarily has to be knowledgeable and confident about food safety. Just because that training and curriculum aren’t out yet, it doesn’t mean that you cannot look intuitively, and tell and this is the appropriate person and identify any training they may need.

Click here to listen to this webinar, and get more of your questions answered.

Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC

Top 10 Elements of a Successfully Certified GFSI Program

By Bill Bremer
No Comments
Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC

GFSIstandardsDec2014The Global Food Safety Initiative (GFSI) relies on a number of benchmarked schemes to establish food safety requirements, all are designed to ensure the quality and safety of a company’s products.

In order to become certified to one of these GFSI-recognized schemes, a company must undergo a third-party audit by a certified auditor. Kestrel’s experience conducting these audits has revealed that companies who successfully achieve certification demonstrate a number of common attributes—regardless of their chosen scheme:

  1. Corrective and preventive actions are up-to-date and current.
  2. Continuous improvement/root cause analysis process is in place to make ongoing improvements and to ensure final resolutions to all out-of-control issues or non-conformances to the Food Safety Program.
  3. Premises, facility, and building programs are established and operating, including controls, signage, direction, job training, and physical evidence of a fully implemented Food Safety Program.
  4. Preventive maintenance system links scheduled maintenance to Hazard Analysis & Critical Control Points (HACCP) critical equipment monitoring requirements.
  5. Approved materials and process specifications are managed and controlled.
  6. Product identification and traceability processes are in place, including complete records detailing all activities for the production of food product.
  7. Document management and control program is updated, validated, and maintained. Developing program management systems helps ensure compliance with document management and control.
  8. Food safety program updates and management are completed through annual and multi-year planning for maintaining the Food Safety Program, including management of change, management review, approvals, and internal audit.
  9. Records and verification management systems provide access to supporting data, as determined by FDA/FSMA and company programs.
  10. Data management of food safety records outlines processes for assuring prompt or immediate access to critical records, as needed, for audit, compliance, or regulatory purposes.

 

John Kukoly of BRC Global Standards

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

By Sangita Viswanathan
No Comments
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
1 Comment
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.

John A. Wadie, U.S. Marketing Development Manager, 3M

Interview: 30 Years of Petrifilm Technology

By Sangita Viswanathan
No Comments
John A. Wadie, U.S. Marketing Development Manager, 3M

3M Food Safety celebrated a milestone this past summer – the 30th anniversary of its PetrifilmTM Plates – currently the worldwide standard for fast, simple, easy-to-interpret indicator testing.

First introduced in 1984, the 3M Petrifilm Plate technology has long been the industry standard for efficient and reliable colony interpretation and enumeration for the F&B industry. In a chat with Food Safety Tech, John A. Wadie, U.S. Marketing Development Manager for 3M Food Safety Department, talked about the adoption of Petrifilm continuing to grow worldwide, which spoke to the product’s value and utility to the industry. We present below excerpts from a Q&A.

FST: How has the food safety environment changed in the last 30 years?

Wadie: The food industry has become increasingly global, with great awareness among consumers about food safety issues. The combination of these trends, combined with constant information dissemination on a variety of food safety issues, has placed enormous pressure on food companies to test more, do it faster and do it more efficiently. From a regulatory stand point also, there is much more pressure on food companies to proactively maintain and manage stringent food safety procedures, and testing plays a big role in managing this. The biggest change has occurred with the speed of testing. Alongside even faster testing, is the demand for accurate and consistent testing and results.  

FST: What attributes of Petrifilm Plates have made it so popular over the last 30 years?

Wadie: With more than 2 billion units sold and counting, 3M Petrifilm Plates are the world’s leading food indicator testing technology. They are currently in used by all kinds of food processors, universities, governments and third-party contract labs in no fewer than 65 countries.

3M-Petrifilm-July-2014The standout feature of the product, and probably the primary reason for its longevity, is its simplicity, due to the fact there is no need for customers to prepare, purchase or store agar dishes. The technology has also received numerous country-specific, as well as global, validations from multiple, rigorous sources. With Petrifilm Plates, you also ensure the consistency and accuracy of test results from technician to technician, and between plant locations, and these are very important attributes in the current multi-location setting of food companies.

FST: Against the backdrop of FSMA, how is food safety testing set to change in the near future?

Wadie: With new regulations, there’s even greater focus on food safety testing, and getting fast, consistent and accurate results. The regulations, and the standards benchmarked under GFSI, are also laying emphasis on how the testing is done, where it’s done, and who is doing it.

The next 30 years will continue to bring faster and more accurate methods of testing as well as improvements to the preparation process. With greater innovation and rapid detection technologies, it may soon be possible to do inline testing – to identify pathogens and bacteria within production lines as opposed to testing being a separate step.

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

What’s a Successful Food Safety Audit?

By Sangita Viswanathan
No Comments
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. 

What’s the Long-Term Value of Compliance Management Software?

By Brenda Percy
No Comments

When looking for an enterprise software solution, it is important to take into consideration its potential for long-term value. What exactly does this mean?

EtQComplianceManagementCost-Nov2014In a nutshell, long-term value is the amount of savings you can expect after using the software for a long period of time. Are you paying less in the long run or do you end up paying more? Keep in mind that lower upfront costs don’t always equate to lower long-term costs. It’s important to consider this when evaluating software vendors in order to choose the vendor that will provide more for your money…even years down the line.

To make the case for long-term value, EtQ commissioned Forrester Consulting to conduct a Total Economic Impact (TEI) study to examine the potential Return on Investment (ROI) enterprises may realize by deploying the EtQ Reliance platform. This TEI study provides readers with a framework to evaluate the potential financial impact of the EtQ Reliance platform within their organizations.

Forrester derived its conclusions in large part from information received in a series of in-depth interviews conducted with executives and personnel at four customers, each of which had been using EtQ’s Reliance platform between 1 and 9 years. Forrester’s findings break down the cost saving potential of EtQ Reliance. Through interviewing these customers, Forrester created a composite organization to describe the TEI of EtQ Reliance.

Forrester classified the organization as a North American-based F-1000 company that manufactures and sells a wide variety of products and associated services, and with overseas operations in EMEA and APAC. This study projects the costs and benefits received over the course of three years. The composite organization has been using EtQ Reliance for three years to manage and track compliance and to meet its strategic goals. The study measured the use of the organization’s Document Control, Nonconformance Management, Change Management, Audits, Corrective Action and Delegation and Escalation tools.

The TEI methodology consisted of four components to evaluate the investment value of EtQ—benefits, costs, flexibility and risks. So what was the outcome?

  • The research shows a three-year risk-adjusted ROI of 77 percent for organizations using the Reliance platform.
  • Net Present Value (NPV) of more than $1.6 million attributed to modules such as Document Control, Nonconformance Management, Corrective Action and others.
  • Savings of more than $3 million over the course of three years.
  • 30,000 manufacturing labor hours saved.

The organization had a goal of achieving the following benefits which it was able to do with EtQ:

  • Increased productivity through compliance tracking and reporting.
  • Reduced employee time and effort in managing and tracking compliance processes.
  • Reduced risk of nonconformance in safety and quality.
  • Grow revenue and profits.

EtQ has been proven to provide long-term value and we are pleased with the results. To see more highlights from this study, see the TEI infographic (click on it to enlarge).

*This is a commissioned study conducted by Forrester Consulting on behalf of EtQ. It is not meant to be used as a competitive analysis.

 

Roberta Wagner, Director, Office of Compliance, for the Center for Food Safety and Applied Nutrition at FDA

How is FDA Surveillance Keeping Pace with FSMA Changes?

By Sangita Viswanathan
No Comments
Roberta Wagner, Director, Office of Compliance, for the Center for Food Safety and Applied Nutrition at FDA

Proposed rules under the Food Safety Modernization Act will mandate more inspections, more testing, and better risk-based profiling of food products – both sourced domestically and imported. How is FDA planning to keep pace with these changes? Roberta Wagner, Director, Office of Compliance, for the Center for Food Safety and Applied Nutrition at FDA, provided some insights, while speaking at the recent Food Safety Consortium, organized by Food Safety Tech. 

Section 201 under the Food Safety Modernization Act requires the Food and Drug Administration to designate food facilities at high-risk and non high-risk facilities, and accordingly, establish minimum frequency of inspection of these facilities. While high-risk facilities will have to be inspected by FDA once every three years, facilities deemed non high-risk will be inspected once every five years. Wagner described that the following factors have been considered so far for determining if a domestic food manufacturing facility is determined to be high-risk or otherwise:

  • Whether the facility has been involved in a Class 1 outbreak or recall;
  • Whether the facility has a history of non-compliance (based on Official – Action Indicated (OAI) or Voluntary Action Indicated (VAI) data);
  • If the facility has had any significant violations;
  • Future data considerations (see below);
  • Type of activity the facility is involved in; and
  • Date of last inspection.

Future data for consideration of high-risk and non high-risk categorization will include:

  • Inherent risk factors at product level (for instance is the product bakery goods, or seafood/ fresh produce etc);
  • Has the facility been linked to an outbreak, recall or adverse event (if so the risk profile gets elevated);
  • If any sample testing (product or environmental) is positive;
  • If there’s a history of customer complaints;
  • Robustness of QA/QC programs and 3rd part audit reports;
  • Financial viability of the company; and
  • Food safety culture of the facility/ company.

Foreign facility inspections

Under FSMA, FDA has also been mandated to increase the number of inspections the agency does on foreign facilities, to ensure the safety of imported foods. Wagner explained that FDA currently conducts about 1200 foreign facility inspections a year to determine if those facilities meed FDA regulations. With FSMA rules, FDA will have increased authority to conduct such inspections of foreign faciligies, and look at Foreign Supplier Verification Programs, and Voluntary Qualified Importer Program records, adds Wagner.

Under the new regimen, FDA has been mandated to conduct at least 600 foreign inspections during the first year of FSMA rule implementation. And the target is to double this number every year, for the next five years, taking it to 19,200 inspections by Year 6. Wagner feels this is an impractical number as FDA does not have the resources to do so many foreign inspections. “If we get the Foreign Supplier Verification Program under FSMA rule right, we effectively place the responsibility for ensuring safety of imported foods on the food industry and importers. FDA cannot, and should not be doing this,” she explains.

Risk-based foreign facility site selection

FDA will also adopt a risk-based approach to select foreign facilities for further inspection. This approach will consider:

  • Food safety risk associated with the sector or commodity;
  • Risk associated with manufacturing process;
  • Compliance history of facilities associated with an industry sector commodity in a given country or region (for instance, look at refusal rates for products denied try into the U.S. by country);
  • Quantity or volume of imported product from country or region;
  • Robustness of food safety system in the country; and
  • Portion of resources retained by the facility for compliance, follow up inspections and emergency response situations.

Based on this FDA will continue to diversify the product that it considers high risk, for instance dairy, baby food, candy… Wagner added that economically motivated adulterated continues to be a concern and cause for focus on food products such as oils, honey and dietary supplements.

Wagner also talked about Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting or PREDICT, a risk management tool used by FDA to efficiently and effectively make entry admissibility, decisions that prevent entry of adulterated, mis-branded or otherwise violative imported goods into the U.S., while expediting the entry of non-violative goods. Based on risk scores allocated to different products, this computerized tool targets entries of highest risk for further scrutiny, including field reviews and sampling.

She explained that this dynamic tool, which constantly adapts to different risk situations and products, provides automatic data mining and pattern recognition, provides automated queries of FDA databases including facility registration information, and thus, allows for risk-based allocation of FDA resources.

Purnendu C. Vasavada, Ph.D., Professor Emeritus at University of Wisconsin

What Should You Know About Food Safety Testing?

By Sangita Viswanathan
No Comments
Purnendu C. Vasavada, Ph.D., Professor Emeritus at University of Wisconsin

Food safety is in the news. Recent food industry, regulatory and consumer trends stress proactive, systematic and preventive approach to food safety by managing food hazards and risks. Testing for food safety hazards, particularly microbial hazards and allergens throughout the food production and processing chain is becoming increasingly important in assuring food safety. Food testing is also becoming important for detection of adulteration.

In next week’s Food Safety Consortium to be held in Schaumburg, IL, Purnendu C. Vasavada, Ph.D., Professor Emeritus at University of Wisconsin, River Falls, and President of PCV & Associates, LLC, will discuss trends in the food safety testing market and approaches for testing of food and food plant environment, emphasizing microbial and other significant food hazards. In this article, PC, as he is popularly referred to, gives a sneak-peek into his presentation.

Food Safety Tech (FST): You will be speaking about the Food Testing Market – what are some broad trends that you are seeing?

PC: Food Microbiology testing is increasing worldwide but majority of testing is still dealing with food quality assurance and ingredient and product testing. Testing for pathogens seem to be driven by regulatory requirement. According to recent market reports, 76 percent of test volume in North America is for routine microbiology. In the EU and Asia, routine microbiology accounts for 81 percent and 72 percent of test volume, respectively.

Most pathogen testing is for Salmonella, E. Coli 057:H7 and Stex, Listeria and as L. monocytogenes. There is an increasing interest in testing for Campylobacter.

Testing of in-process and environmental samples is more common in NA and Europe. In Asia in-process/environmental testing only accounts for 9 percent of total test volume.

FST: In your presentation at the Consortium, what will you talk about FSMA and its impact on food safety testing?

PC: I plan to include a brief discussion on testing as related to monitoring and verification of Preventive Controls.

FST: Where is food safety testing headed, and what should food safety managers keep in mind?

PC: Given the emphasis on supply chain management and process control to manage identified hazards in preventive mode, food safety managers should understand testing internal and external testing requirements and complexity of sampling, testing tools and approaches not simply focus on cost aspects. Even if testing is outsourced, becoming familiar with various methods and testing tools will be necessary.

FST: Who should attend your presentation and why?

PC: Plant managers, quality assurance supervisors, marketing managers, food safety testing methods, equipment and service providers as well as anyone interested in food safety testing would find this presentation very useful and relevant to their day-to-day activities.

Are you registered for the Food Safety Consortium yet? Sign up now, and hear from over 70 experts in this area.