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From: Food Quality & Safety magazine, December/January 2010

Automated HACCP Can Improve Safety

It can also improve performance and profitability

by Nikki Willett

The food processing industry has done an incredible job of building new industrial automation systems to improve overall production processes, reduce time and cost of production, and increase overall throughput, product yields, and efficiency. In the past 18 months, however, the industry has seen an unprecedented number of supply chain safety and quality failures.

In 2008, annual nationwide estimates held steady at 87 million cases of food-related illnesses, with 371,000 hospitalizations and 5,700 deaths, according to the Centers for Disease Control and Prevention (CDC). These statistics have fueled a reduction in overall consumer confidence and increased scrutiny by Senate committees and a number of domestic and international government agencies and groups.

Food processing companies also face the continuing challenge of maximizing food safety while complying with a growing number of regulations: ISO 22000, FDA 21 CFR Part 110, the FDA Bioterrorism Act of 2002, hazard analysis and critical control points (HACCP), safe quality foods (SQF), and others. Timely information about supplier controls and the production process is needed to adequately analyze and detect problematic processing trends and take immediate corrective action when needed.

Because the food processing industry is dependent on extended supply chains with multiple vendors, several variables can have a negative impact on the process, including increasing prices, diverse standards among suppliers, geographic distance, and tight timelines. Even though risk and quality management are critical, most organizations still use a paper-based approach for their food safety and quality management system. They generate and track myriad paper-based documents within a process that leads to resource overload, untimely data, and inefficiencies. The long-term effects of such a system range from enormous costs for failures due to recalls and suspensions to loss of retail and consumer confidence.

The food industry must improve its safety record to maintain the good faith of consumers. Yet even with more focus on quality, problems continue, including:

  • contamination of raw materials prior to or during processing;
  • unclean equipment and lack of preventive maintenance;
  • insufficient employee training; and
  • incorrect labeling or packaging.


Fragmented Processes and Systemic Problems

These problems persist for several reasons: Processes are fragmented and disconnected, procedures may not be well documented, the required steps in the process are not always completed, and employees don’t know or understand their responsibility or authority. Points of potential noncompliance are often not identified, and suppliers are not closely monitored or compelled to enforce their own quality process improvements. Companies may neglect to do a comprehensive review of the processes and procedures within their food safety and quality systems. Their focus is on the food product rather than on efforts to resolve systemic issues. If a problem occurs, these companies react quickly to find a solution but neglect to identify the root cause of the problem.

These operational deficiencies are key contributors to recent events. Last spring, headlines about food contamination focused the spotlight on weaknesses within supply chain management and the food processing industry itself.

“We recognize that we have reached a plateau in the prevention of foodborne disease,” said Robert Tauxe, MD, MPH, deputy director of the CDC’s Division of Foodborne, Bacterial, and Mycotic Diseases. During a briefing in April, Dr. Tauxe called for new farm-to-fork efforts to evaluate food safety, including improved methods to quickly trace the source of contaminated produce.

Several months later, too many food processing companies are not yet following and enforcing standard and consistent procedures, and they have not implemented organization-wide trending data to predict quality and safety across all food products and processes. Without good reporting and trending capabilities, top management at these companies cannot make accurate assessments about the issues, risks, and costs facing the organization.

Good quality planning, independent 3rd party gap-assessment audits, and automated systems can address these deficiencies. The same principles of industrial automation should be applied to best practices in quality and safety management automation with a system-wide program that trains employees, implements well-documented standard operating procedures (SOPs), and properly utilizes technology to put global practices and procedures in place.

Many companies within the pharmaceutical industry, which parallels the food processing industry in several ways, have recognized the benefits of an integrated and automated quality and safety platform.

Steps in the Process

Table 1. Applying Hazard Analysis and Critical Control Points (HACCP) to Process Automation </div
click for large version
Table 1. Applying Hazard Analysis and Critical Control Points (HACCP) to Process Automation

Planning and Documentation: The foundation of a successful quality and safety management system is adequate planning and setup. Define code rules and ownership, and determine the rules and the variances to those rules. Determine the processes and the owners of those processes. Decide how severity levels for issues will be defined, as well as who will enter the information.

The new system must be scalable, simple, risk-based, and easily integrated throughout the organization. Ensure that sufficient mechanisms are in place so that all steps are completed for each event. Determine the right people to involve in the quality and safety process and when to involve them. Determine how procedure revisions will be handled and how these rules and procedures should be enforced on a global level.

With good documentation standards and practices, fully automated document management and SOP training, and an effective enforcement system, companies can demonstrate a commitment to food and consumer safety that will be an asset in any future liability litigation.

Error Tracking: Many companies lack connected data sources, while others cross-reference by hand any errors, deviations, and events across files, dates, lots, and other criteria, a time-consuming process that often misses impacts and trends. It is an inefficient approach that allows for repeated mistakes.

The first step should be to identify, collect, and record information that can occur anywhere throughout the process, including potential problems in the supply chain, final processing, labeling, distribution life cycle, and any potential for customer complaints. Being able to identify the root cause of a problem and focus on prevention and corrective actions are key. The more information there is available, the faster the response to a problem will be. Tracking problems allows companies to develop best practices and verify effectiveness.

Without an integrated system, identifying root causes is little more than guesswork. Assumptions are made based on rumor and conjecture, not on accurate and reliable data. Islands of information created by multiple data streams lead to inconsistencies and waste. Genuine measuring tools enable managers to determine precisely where, when, and why mistakes are occurring.

Auditing: Food processing companies need to have transparency about their supplier performance across the entire organization and all products to ensure consistency, quality control, and compliance. This means that organizations need to start focusing on global audit programs and planning. With paper-based solutions, the approach to global planning becomes more resource and time intensive.

Ensuring the rollout of a good audit program requires appropriate schedules for pre-qualification as well as for ongoing performance. But with suppliers all over the world, limited resources for internal auditors or costly third-party auditors, and limited availability of supplier teams, both initial and follow-up scheduling can be a nightmare. Follow-up audits may not happen.

Automated central systems for supplier audits can provide a complete closed-loop mechanism with checklists, schedules, findings, actions, and follow-up, helping standardize and streamline audit processes and cycles and ensuring that the management and quality team are more productive and efficient. These systems mean no document overload, as well as simplified and consistent reporting with complete traceability.

Figure 1. Integrated Food Safety Management Computerized System
click for large version

Trending, Analysis, and Risk Management: Collected data should be used to help a company detect minor problems before they become major ones, by applying risk management techniques throughout the food safety and quality program, with assessment of failures considered part of the overall product processing and packaging cycle.

Many companies continue to place risk techniques at the front or back part of the process, so that each department must individually track, trend, or analyze data. Progressive companies, however, are proactive rather than reactive. They implement and integrate risk techniques as part of the overall process so that the focus is on identifying and establishing priorities about potential problems. Management becomes more aware of critical problems, and each department identifies key areas that can improve efficacy and food safety.

Trending is key within an organization, helping to monitor the overall health of a company’s safety and quality systems. Measurement, data analysis tools, and processes should be implemented at different levels of the organization, with linkages between processes and safety and quality systems, and across multiple locations. Data should be configured so that problems related to suppliers, processes, or the quality system can be identified and acted upon quickly. Leverage as much information as possible to draw targets and assess effectiveness. Harmonization of sources, failures, and their root causes is essential to drawing meaningful conclusions.

HACCP and Process Automation

Re-engineering processes allows a company to get rid of all the waste and inefficiency in its systems. Automated, simple, and intuitive procedures and robust process architecture can result in quick navigation with a focus on problem solving rather than navigating the maze of paper. With automated workflow (business rules engine), notifications, and record tracking, companies can eliminate lengthy manual steps, streamline collaboration across the food value chain, and refine their HACCP approach to reduce risk and improve overall food safety. There are numerous examples of how companies can take many of the key information system components from International Standards Organization 22000 and see key results for HACCP from their process automation (see Table 1).

In summary, an automated food safety management system has several benefits:

  • It achieves consistent yield and uniformity from product to product and batch to batch;
  • It increases traceability, data accessibility, transparency, and reporting accuracy;
  • It reduces supply chain risk and improves safety and quality;
  • It reduces the necessity of multiple audits;
  • It improves cycle time for key processes: SOP approvals, changes, corrective actions;
  • It reduces overhead, waste, and costs;
  • It ensures the food safety process is validated, verified, implemented, monitored, and managed;
  • It increases trust along the entire production process for complete sustainability; and
  • It increases awareness across the enterprise.


A great recipe is no longer enough. Today’s business climate requires continuous process improvement and implementation of an automated and integrated safety and quality system. A constant flow of information across the value chain can reduce the time required to diagnose and resolve problems, can prevent supplier failures, and will allow a company to meet consumer expectations. A well-designed and implemented safety and quality management system can reduce risk and improve performance and profitability. ■

Willett is vice president of marketing and regulatory affairs at Pilgrim Software Inc. Reach her at or (813) 915-1663.



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