Tag Archives: software

Ryan Mead, Focus-Works
FST Soapbox

8 Reasons to Go Digital 2016

By Ryan Mead
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Ryan Mead, Focus-Works

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

1.     Overwhelming Amount of Paperwork

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

2.     Constant Change in Food Safety Standards

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

3.     Consumer Confidence

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

4.     Economics

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

5.     Operator Error and Omission

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

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

6.     Monitoring and Notification

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

7.     Audits: Go from Stressful to Easy

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

8.     The Technology Is Available

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

Jim Hammel, vice president, customer success at Sample6
In the Food Lab

Using Software for Environmental Tracking and Data Visibility

By Jim Hammel
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Jim Hammel, vice president, customer success at Sample6

There is growing evidence that a strong environmental program is critical to identifying potential issues before they threaten product. This data must be captured regularly based on a robust environmental sampling plan and then analyzed in order to take advantage of the results. However, without the proper tools, this is challenging, time consuming and ineffective.

How Software Strengthens a Sampling Program

The most critical component of an environmental sampling plan is zone coverage. Many sampling plans exclude zone 1, direct food contact, because this implicates the finished product and may lead to a test-and-hold situation. However, at minimum, zones 2-4 should be covered in a sampling plan. In addition, it is important to randomize test points and schedules. Sanitation crews are held to rigorous standards, but it is human nature to complete repetitive tasks in the same manner. By randomizing which test points are tested—by day, time and operator—quality teams are more likely to identify potential areas of concern. Randomization is a challenging task to complete manually but a routine task for software.

Using Software for Environmental Tracking and Data Visibility
Using software enables environmental tracking and provides and data visibility. Image courtesy of Dietz & Watson

In addition, ensuring test-point coverage is a key component to sampling plans. An interval for test-point coverage is typically included in environmental sampling plans. It is up to quality teams to ensure that their sampling programs are consistent with these business rules. When this is tracked in an Excel spreadsheet, randomization is typically sacrificed to ensure test-point coverage. This is tracked in a large table with dates on one axis and test points on the other. The challenges to this approach include randomization, analysis and management of more than one test-point coverage interval. Business rules of this nature can be easily managed through software algorithms. In fact, the task of creating a schedule according to a series of business rules is not unlike a macro.

Lastly, robust sampling programs include detailed remediation and response plans in the event of a positive or presumed positive test result. The details on these plans are reviewed internally to ensure that the issues have been adequately addressed. Documentation that each step has been completed in a timely manner is absolutely essential in today’s regulated food production environment. Remediation records may be requested in a government or supplier food safety audit. Emails, meeting notes, pictures and cleaning records can certainly be kept in file drawers, but the more accessible this information is, the more likely it will be used. Approval processes and business workflows have been automated in a variety of software tools. Everything from sales to expense reports has sought support from software to ensure that their workflows are executed consistently and with traceability. Software can support food safety efforts in this way as well.

Dos and Don’ts of Data Analysis

The next challenge in environmental monitoring is the volume of data generated and the tools required for effective analysis. A robust environmental sampling program for Listeria can range from 10 to 15 samples per week per line—often much more. Each test result includes metadata such as sample location, day and time, sample collector and result. In a plant with 10 lines, there are 150 test results per week, or 7,800 test results per year. When compiling results for the past three years, the numbers reach nearly a quarter of million just for pathogen testing. Routine testing such as yeast, mold and Enterobacteriaceae should also be considered in the analysis. The sheer volume of the data can be challenging in a spreadsheet but routine in a database.

Don’t rely on unmanageable spreadsheets. Analysis should look for trends in the data as well as compliance to the program. Completing this task in spreadsheets requires that the data be properly formatted. Further, the database-like structure that would enable analysis is often inconsistent with the table format used for sample schedule generation. In addition, this task is time consuming, manual and error prone; therefore, the frequency of analysis may be reduced.

Don’t take an analog approach to floor plans and risk it being outdated. Particularly for environmental data, it is important to understand the proximity of test points and their results. This allows managers to look for patterns or workflow trends that may be impacting results. This task typically requires mapping the test points and their results to a floor plan. Many plants keep a copy of the floor plan and recent findings posted on the wall.

Do use the tools available. In today’s data-rich food production environment, successful data analysis must be automated.

Answering the Call for Communication

Lastly, for an environmental monitoring program to be effective, communication is critical. The members of the quality team need to know what specific tasks are expected of each of them and when. Sanitation workers need to know what areas require their timely response. Executives need visibility into the results and actions underway so that they can support their teams and make critical food safety decisions. While these tasks can be completed manually, it is ripe for automation and new tools are streamlining the communication process.

Food safety managers and quality teams are working diligently with their sanitation teams to keep their plants and product safe.  However, they need to leverage the available tools needed to do their jobs efficiently and effectively. New software tools designed for the food safety industry are changing the way the industry handles safety initiatives. In particular, sampling program, data analysis and communication tools are ripe for automation. Take advantage of technologies and tools already in use in business today so you are prepared to manage the food safety challenges of tomorrow.

FST Soapbox

HACCP, HARPC, and How Using Software Helps

By Steven Burton
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With nearly one in every six Americans falling prey to foodborne illnesses each year, food safety is a major public health issue. For several decades, current Good Manufacturing Practices (cGMPs) provided the basic food safety framework for manufacturers. However, these guidelines were not sufficient to cover all potential food safety hazards. In the 1960s, NASA asked Pillsbury to manufacture the first foods for space flights, and so the Hazard Analysis & Critical Control Point (HACCP) system was born. HACCP was later endorsed by the Codex Alimentarius Commission, which was formed by the Food and Agriculture Organization of the United Nations and the World Health Organization in 1963.

HACCP is a global standard and its principles are the defining elements of ISO 22000, BRC and SQF, all premiere global food safety standards. In 1996, an E. coli outbreak in Scotland claimed 10 lives. The Pennington report in the aftermath of this tragedy recommended use of HACCP by all food manufacturers to ensure food safety. While HACCP is mandatorily used for seafood, juice and USDA-regulated meat processing, it could not win universal acceptance across the food industry; most of the food industry sectors rely on cGMP for providing a food safety framework.

The number of people affected by foodborne illnesses can be attributed to a flawed food safety system. Thinking caps were put on and President Obama’s administration rigorously pursued what it hoped would be an effective food safety paradigm. On July 4, 2012 Hazard Analysis and Risk Based Prevention Control (HARPC) was introduced under FSMA section 103. Although the system is still a work in progress and FDA has yet not disclosed the regulations that will determine the functionality of HARPC, the agency is bound to issue the regulations by August 30, 2015. HARPC will become effective 60 days following this date, and companies will be required to enforce HARPC within a period of 12 to 36 months, depending on the size of a facility.

HARPC is designed along the lines of HACCP but is meant to be more comprehensive. For a “Simple Simon” it would be tough to differentiate between the two, but HARPC provides an all-encompassing food safety structure by focusing on preventive controls to make food safety more iron clad. With the exception of exempted facilities, HARPC will apply to all facilities subjected to FDA’s Bioterrorism Facility Establishment registration. All such facilities will be expected to enforce a functioning and adequate HARPC plan. Failure to do so and FDA would be authorized to take legal actions such as issuing a public warning letter or an import alert (in case of a foreign supplier), initiating criminal proceedings against a non-compliant facility, or suspending food facility registration of a facility until requirements are met. By doing so, FDA has put the onus squarely on the shoulders of respective facilities. Companies will be required to do a lot more and should expect deeper FDA involvement. Expert help to enforce a rather complex HARPC protocol seems unavoidable; there is a fair chance that users could find themselves lost in the translation and may end up facing FDA’s wrath if their plan is inadequate. Let me break it down a bit more and distinguish the main differences between HARPC and HACCP.

Qualified Food Safety Experience. HARPC requires one member of a company to be the qualified individual to complete an entire food safety plan. This means that said individual has undertaken education from a credible institution and gained experience by completing it. HACCP requires at least one person to be HACCP certified, but the plan must be constructed by a team of people.

Process Flow Diagram. Under the HACCP standard, food safety plans must include a clear flow diagram outlining the process, from start to finish, that the ingredients will take throughout your facility. HARPC has no regulations regarding this.

Hazard Variables. Traditionally, hazards were limited to biological, chemical and physical hazards under the HACCP paradigm. Yet, under HARPC, you must also outline Radiological and Terrorism hazards.

Controlling Hazards. Here is largely where the main difference lies: How to control a hazard. HACCP requires companies to mention their critical control points as well as outline a prerequisite program (PRP), although this has no set requirements. HARPC requires you to apply a sanitation preventive control to the hazards, which looks at monitoring, confirmation, corrective action, reviewing records and re-analyzing.

Reviewing the Plan. HACCP requires the individual in charge to review all HACCP documentation every year. This is in comparison to HARPC, which requires a facility to reanalyze its plan every three years.

Recall Plans. Recalls, as required under HARPC, are a special type of incident, with all of the attributes necessary to create and manage a recall plan. HACCP does not have such a requirement.

Use Software to Implement HARPC Plan

Using software can make life easier when it becomes time to implement a HARPC plan. Documentation is an important part of the HARPC system, and software can help generate most of the documents used to establish the plan. Such a system can link regulatory requirements with procedures and customize several aspects of the system during run time.

A risk analysis component of software helps a user identify the likelihood and severity of a particular hazard (a HARPC requirement). HARPC also requires sanitation control procedures at food surface contact points; software features can support cross contamination points to which hazards are assigned and controlled. Software also allows users to define equipment, with a facility to schedule and record calibration, maintenance, and verification activities, including management task assignment to satisfy HARPCs provisions regarding sanitation of utensils and equipment. In addition, it has the provision to document procedures as required by HARPC and can also flag employees for refresher training if they are involved in a violation.

Software also enables users to electronically record inspections, which satisfies the obligation under HARPC to carry out an environmental monitoring program (for pathogen controls). Interestingly, sensors could also be integrated with logging facilities to automatically collect sensor data, which could then be used to send out alerts if there is an abnormality. Software systems can also accommodate coverage of allergen hazards and run a food allergen control plan, including documentation of the process.

An incident management plan can assign and track corrective actions, root causes, employee retraining tasks, and preventive measures to individuals, and recall plans can be created and managed using the system. As many inspectors prefer remote review of documentation, software can provide such remote access, allowing inspectors to conduct off-site document reviews. This process can reduce on-site inspection times from five to three days. A list of approved suppliers can be maintained as well, and these suppliers can be linked to receiving functions, enabling users to receive and maintain a detailed and comprehensive record of ingredients.

HARPC is a reality that will have to be embraced very soon. Using software is a simple solution for the tough times that lay ahead for the food industry. It can serve as an all-encompassing and one-stop-shop for businesses that need help enforcing HARPC plans.

PerkinElmer Launches New Software for Rapid Detection of Food Adulterants

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Adulterant Screen™ software pairs with PerkinElmer’s advanced FT-IR spectroscopy instruments for single-step screening and analysis of food authenticity and nutritional components.

PerkinElmerAdulterantScreenPerkinElmer Inc., a global leader focused on improving the health and safety of people and the environment, today announced the launch of its Adulterant Screen™ software. This automated solution can help food industry professionals evaluate the integrity of food ingredients to guard against existing and potential food adulteration threats.

Adulterant Screen software, when paired with PerkinElmer’s Fourier Transform Infrared (FT-IR) and Near Infrared (NIR) spectroscopy instruments, creates a unique, combined hardware and software system that can confirm authenticity and perform nutritional analysis in a single step.

“Food quality professionals face an increasing number of risks related to their ingredients which need to be continually screened for known contaminants as well as unknown contaminants that may be unsafe substitutions,” said Jon DiVincenzo, President, Environmental Health, PerkinElmer. “We are committed to delivering advanced detection solutions to help our global customers address increasingly complex industry regulations related to food quality control and safety in the supply chain.”

Adulterant Screen software performs rapid, targeted and non-targeted screening for several types of adulterants. Its customized set-up enables fast, effective implementation without lengthy calibrations. Its simple and intuitive green light/red light, “pass/fail” results system enables easy implementation, regardless of the knowledge level of its users. Click here for more information on the Adulterant Screen software.

PerkinElmer also offers the DairyGuard™ milk powder analyzer, a near infrared (NIR) spectrometer specifically developed for food suppliers and manufacturers. The DairyGuard analyzer is the only system available that tests for unknown adulterants as well as known compounds.

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

By Brenda Percy
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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.