Regulatory Compliance for Food Safety
Different types of software, used separately or in an integrated fashion, can be leveraged to meet the requirements of Hazard Analysis and Critical Control Points (HACCP) compliance.
Rory Granros, Infor
Product recalls have dominated food headlines recently. It only takes one contaminated product slipping past inspectors for the consequences to be devastating. In one case from 2008, Peanut Corporation of America was forced into bankruptcy after it was determined to be mainly responsible for a salmonella outbreak that killed nine people and sickened more than 600. In another example, Topps Meat closed its doors in 2007 after recalling 21.7 million pounds of frozen meat (an entire year’s production) contaminated with E. coli.
These kinds of nightmare scenarios are exactly why the Hazard Analysis and Critical Control Points (HACCP) process was created. HACCP emphasizes prevention over finished product inspection as a means of ensuring food safety. A well-designed and enforced HACCP policy can prevent physical, chemical, and biological toxins from infiltrating food products during the manufacturing process, making the products safer and reducing the number of recalls.
HACCP is based on seven principles and requires coordination of technologies from enterprise software down to the instrumentation level:
Conduct a hazard analysis. Hazards are conditions that may pose an unacceptable health risk to consumers. To conduct a hazard analysis, identify the significant hazards associated with each step of the manufacturing process, as well as the measures (such as temperature, pH, and moisture level) that can prevent them.
Determine the critical control points (CCPs). CCPs are steps at which to apply control to prevent, eliminate, or reduce a food safety hazard to acceptable levels (such as cooking, acidification, and drying steps).
Establish critical limits. Critical limits are the operational boundaries of CCPs that control food safety hazards. If critical limit criteria go unmet, HACCP is not preventing, eliminating or reducing food safety hazards.
Establish monitoring procedures. Ensuring that critical limits are being met allows food manufacturers to assess trends before a loss of control occurs, and to make adjustments while continuing the process.
Establish corrective actions. Should loss of control occur, manufacturers must have written plans in place for disposition of the product and correction of the process.
Establish record-keeping and documentation procedures. The HACCP system requires the preparation and maintenance of a written HACCP plan together with other documentation. This must include all records generated during the monitoring of each CCP and notations of corrective actions taken.
Establish verification procedures. Document the scientific or technical validity of the hazard analysis and the adequacy of the CCPs. The system should also be subject to periodic revalidation using independent audits or other verification procedures.
Despite most process manufacturers having some degree of HACCP guidelines in place, the number of product recalls for the industry increased in 2008. Part of this challenge is ensuring compliance with HACCP principles across all manufacturing operations. In addition, public concern over several recent high-profile recalls mean process manufacturers may face stricter government oversight—including regulations requiring companies to report possible contamination within 24 hours to state agricultural authorities.
Different approaches to compliance
Expansive supply chains and complex products only complicate the issue of product safety. As food manufacturers create more and fresher products, outsourcing increases and supply chains are stretched to meet consumer demands. This intensifies the chances of product safety issues from cross-contamination or a safety breach as well as the risk of more complex product claims.
After taking these variables into account, reliance on manual inspection processes and human intervention is a risk most companies cannot afford to take. However, manufacturers can leverage existing technology to automate and ensure the effectiveness of their HACCP programs. By integrating automated HACCP throughout the supply chain, companies can prevent food contamination and avoid costly recalls.
Product lifecycle management (PLM) software is one step that can be taken toward a fully automated HACCP. The best PLM software will support five of the seven HACCP principles (hazard analysis, identification of CCPs, establishing critical limits, record-keeping, and verification) and provide design and simulation from sub-raw materials to finished goods. Any PLM solution being considered should also support definition and verification, and manage the definition and setup of HACCP in downstream data and processes.
A PLM solution should also be capable of instantly alerting plant operators of any HACCP or claim substantiation risks, allowing them to mitigate issues and ensure that proper HACCP controls are developed and integrated into all appropriate downstream processes and systems.
Enterprise asset management
Another piece of the HACCP enforcement puzzle often employed is enterprise asset management (EAM). EAM solutions track maintenance requirements for plant assets. Many of these technologies also comply with the HACCP principles of hazard analysis and record-keeping.
Maintenance capabilities offered by EAM solutions not only reduce safety risks and improve product quality, but also increase asset availability and extend asset lifecycles. Effective preventive maintenance puts an end to “out of tolerance” conditions, which improves product safety, supports audits, minimizes write-offs, and improves customer service. Since some recent recalls began with leaky pipes, leaky roofs, inadequate sanitation procedures, and improperly maintained filling equipment. Integrating HACCP practices into preventive maintenance programs protects brand equity of products, and reduces record-keeping costs.
Event management software can be used to help manufacturers respond to food safety concerns by providing proactive, real-time exception management to detect conditional change anywhere in the supply chain and communicate it instantly to those who need to take action—both inside and outside the organization. Comprehensive event management can monitor CCPs as well as establish corrective actions across departments, plants, and even into the executive level. Some event management solutions even support HACCP’s record-keeping and verification principles.
Enterprise resource planning (ERP) with integrated quality control is one of the more common software components of an HACCP program. Starting with full lot control to the sublot level from tracking of container temperature and conditions through delivery at the customer, ERP systems can be used to manage inverted, convergent, and package bills of material and process conditions with integrated HACCP data. With every movement of materials and production step, processing conditions and lot quality data is captured. Integrated quality control manages testing, quarantine, disposal or release of lot and sublots. Any failed tests or tests that are trending negatively can allow active management of lot and sublots. Timely issue identification can minimize the time to mitigate an issue and limit a company’s exposure.
What’s it worth?
Although an effective recall process reduces costs and disruptions, just one product recall can ruin a hard-won reputation, and force companies to close their doors forever. Even the most effective recall only slightly reduces the negative impact on businesses and brand. Proactively developing and certifying products and materials, preventing equipment safety risks and planning with compliance restraints can help the process manufacturing industry improve product safety and reduce non-value-added costs, as well as increase consumer confidence, create more competitive products and expand profitability.
All of the above-mentioned types of software — PLM, EAM, and event management — can be integrated into an existing ERP system, allowing process manufacturers to form a holistic and proactive food safety strategy. Such a strategy can be used to identify contamination at its earliest stages, contain it, and protect manufacturers from the risk of meeting a similar fate as Peanut Corporation or Topps Meat.
Rory Granros is the director of process industry solution marketing for Infor, a global provider of enterprise software. For more information, contact firstname.lastname@example.org .
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