Quality and compliance in USDA regulated industries

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Issues faced by Industry
Global foodservice operators have multiple strategies that have contributed to the complexity of their organization. Most operators have realized the need for a single unified enterprise-class system to address all their quality, performance and regulatory compliance needs, due to the different business solutions and quality systems, which have been implemented to manage various departmental processes. Due to the disparate way in which most operators have been functioning with different distribution arrangements spread across the country, the task of coordinating these becoming highly cumbersome and complex. With each operation using its own system (financial, manufacturing, ERP or getting/planning) and with no clear visibility into all operations, it is nearly impossible to track quality or compliance issues.

Integration is the key to success. A unified system solution could manage complex business processes, the existing systems, manufacturing processes and facilitate integration for effective quality control and compliance. The industry also requires a system that reflected the business processes in critical areas of food quality and safety, inventory control, distribution, channel complexity, business modeling, streamlined manufacturing, change management and cost containment. These flexible and scalable business solutions help manufacturers to continuously improve their operations while managing the complexities of global foodservice production.

Challenges to Industry
Food manufacturers focus most on microbiological quality, since microorganisms pose a challenge to the food industry with most food processes designed to reflect microbial quality. Although, the US food supply is considered safe, food borne illness has always been of serious concern, since there is no way to keep track of its frequency and a majority of the cases go unreported. Six agencies in the federal government have primary responsibility for food safety - two agencies under the Department of Health and Human Services (HHS)--the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC); three agencies under the Department of Agriculture (USDA)--the Food Safety and Inspection Service (FSIS), the Agricultural Research Service (ARS), and the Cooperative State Research, Education, and Extension Service (CSREES); and the Environmental Protection Agency (EPA).

Testing foods before consumption for the presence of pathogenic microorganisms is critical, and can be deemed "safe" through proper audit of the food supply. Quality Assurance personnel (QA) need to continually monitor incoming raw products and finished ones to insure compliance with compositional standards, microbiological standards, and various government regulations. Most QA specialists halt production and refuse acceptance of raw material, or stop shipments if specifications for a product or process are not met. The QA Departments have required facilities like analytical testing lab, an inspection lab for raw materials, a sensory lab and a microbiology lab to assure that food supplied is of the highest quality. QA teams need to keep complete track of compliance issues that could vary from legal requirements, industry standards, internal company standards, shelf-life tests and customer specifications. They should follow through on all test procedures from testing of raw materials, in process tests to finished products. It is essential that all QA records are maintained so that customer complaints, problems due to poor quality of raw materials, erratic supplies and malfunctioning of process equipment are registered in the system. This helps in further investigation and initiation of remedial measures to avoid recurrence of such problems.

Quality engineers must have access to systems that extract daily complaint records from corporate warehouses and correlate that data with manufacturing and process quality records. It must be robust and proactive to inform the users about product quality levels, with alerts to plant supervisors on possible concerns in the manufacturing process. These systems should provide quality managers with visibility into quality information all of their products including complaints categorized by criticality. This data can then be further used to determine the root cause of the complaint. The system should have an inbuilt powerful and flexible reporting capability that helps the users to view predefined standard reports or generate custom reports with little effort, thereby getting critical data to the right people at the right time

Product Recall
Total product recalls are getting expensive and generate a lot of bad media publicity. Products get recalled due to problems with a particular food product, food batch or lot. Total product recalls can severely damage a supplier or brand in terms of reputation and consumer confidence, apart from leaving manufacturers in huge debts and possible litigation. Therefore, it is critical to implement the right solution that can help mitigate risk associated with poor quality and help maintain quality records to trace the source of problem for meat products, dairy food batches or food lots.

The U.S. Department of Agriculture (USDA) and the U.S. Department of Health and Human Services (DHHS) have developed the "Dietary Guidelines for Americans". The Food and Nutrition Board of the National Academy of Sciences National Research Council have developed recommendations for nutrient intakes. The U.S. Food and Drug Administration (FDA), operating under the Federal Food, Drug and Cosmetic Act, regulates the labeling for all foods other than meat and poultry. The U.S. Department of Agriculture (USDA) under the Federal Meat Inspection Act regulates meat and poultry products.

The recent announcement of the final two safety regulations required by the Public Health Security and Bio-terrorism Preparedness and Response Act of 2002 gives the FDA new authority to protect the nation's food supply. Four proposed rules to implement the Bioterrorism Act have already been announced, and FDA expects to issue final rules in October, with rules going into effect on December 12, 2003. FDA's final rules of critical importance to the food processing and manufacturing sectors are around - Registration of food facilities, Notice prior to import of food shipments, Maintenance and inspection of records and Administrative detention.

Hazard Analysis Critical Control Point (HACCP)
Developed by NASA and Pillsbury Corporation to ensure food safety for the first manned space missions in the 60's, HACCP is a universal method for conducting food safety hazard analysis. Its focus on a preventative approach towards controlling food safety, rather then end product testing makes it a widely used system, and currently a regulatory requirement.

The Codex Alimentarius Commission created in 1963 by FAO and WHO to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Program, specifies a standard approach to HACCP and follows 7 basic principles - Conduct a hazard analysis, Determine the CCPs, Establish critical limit(s), Establish a monitoring system, Establish corrective actions, Establish verification procedures and Establish documentation.

The benefits associated with HACCP are numerous as can be seen here -

• Ensures a preventive approach
• Identifies process improvements
• Drastic reduction in end product testing
• Complementary to quality management systems - ISO 9000
• Provides evidence of due diligence
• Drastically reduce product recalls
• Enhanced customer satisfaction
• Compliance with standards and regulations
• Consistency across the enterprise

The many challenges that organizations face as they attempt to implement powerful quality and compliance management systems - primary among them being the ones listed below -

Assembling your team
Top management must have an expanded role and demonstrate leadership in directing and supporting the quality management initiative through a variety of methods from establishing and monitoring achievement of measurable quality objectives to communicating customer requirements to the work force. Top management must be involved during the development, as well as the implementation and maintenance of the quality management system. Driving from the top and at the same time empowering a multidisciplinary team of individuals from within the organization who understand the critical processes involved, and take ownership of solutions, controls and procedures.

Training your team
To ensure effective implementation of the system, it is essential that employees understand the basic principles of the quality and compliance system and their role within it. They must be trained to identify potential problems and initiate appropriate countermeasures.

Process Documentation
Organizations have a considerable task cut out for them in process documentation, since understanding and documenting its processes is going to be the most critical aspect. It is important for organizations to realize the significance of a process approach and that it clearly applies to all activities that influence quality in their enterprise. Defining the process inputs, outputs, flows, measurement points and boundaries and understanding the aspects of each process to help identify which process parameters affect product conformity.

Organizations need to establish the process parameters that can be monitored and measured to ensure conformity of product and suggest plans for actions to be taken when out-of-control signals are detected. It covers all products manufactured at the factory, and also the production processes from raw material sourcing to delivery of finished products to the customer. For each process step all potential hazards to consumer safety and product integrity should be identified and appropriate control measures established to minimize risk. Foreign objects, chemical, microbiological and packaging defects critical to consumer safety are documented with the teams involved and this is reviewed annually. Describe the product and product composition as well as product usage and final users.

Hazard Analysis & Control Measures
List all potential hazards associated with each process step and conduct the hazard analysis for each of the identified hazards, following general principles for quantitative risk assessment. They also need to consider what control measures, if any, exist which can be applied for each hazard, since more than one control measure may be required to control a specific hazard(s) and more than one hazard may be controlled by a specific control measure.

Critical Control Points & HACCP Review
The following range of measures can be established for the CCP such as - critical limits, monitoring system, corrective action, documentation and record keeping, verification procedures and regular routine audits of completed checklists. It is essential that all controls required by the hazard analysis should be regularly reviewed, verified and validated to ensure that they are functioning effectively and that they are still up to date and reflect current knowledge. This can be done through internal auditing, and also by the HACCP Team - who must additionally carry out a review of the HACCP Study annually and follow any significant changes in the process.

Quality and Compliance Management
Quality and compliance management are central to the way enterprises in the food industry operate, and effectively managing these key processes, can help them drive their industry towards growth and consumer loyalty. Food manufacturers need to minimize risk by implementing systems that are FDA compliant and ensure that stringent safety measures are taken - from sourcing of raw materials to the final finished products arriving at consumer homes. With the industry under pressure from tight margins, and varying cost implications, they require systems that can easily automate complex and dynamic business processes and give manufacturers high performance visibility into critical processes.

The enterprise system they select must support functionalities and metrics that identify key business goals essential to performance, compliance and growth. Robust applications offer speed and automation to provide effective and precise traceability of either meat or non-meat food products. In addition, they seamlessly integrate to allow producers to tap into information that can aid in managing product planning, procurement, financials and business intelligence. Advanced enterprise quality management systems offer extensive query and reporting capabilities, data acquisition, are fully Web-based and are designed to connect to the processes that the lab supports, particularly manufacturing, processing and R&D. Data acquired include information about material origin, in-process steps, final products, QA samples and much more. These systems provide flexible and scalable process manufacturing quality control for the dairy, food and beverage, pharmaceutical and health care industries. Enterprise quality and compliance management systems provide QC/QA information, plus full traceability from raw material intake, through in-process control to finished goods, storage and dispatch to the customer. They can be particularly valuable in allowing companies to comply with stringent customer specifications, as well as increasingly demanding government regulations. They use real-time validation to ensure compliance with quality procedures, manage customer relationships, and link customer complaint information with manufacturing data for better quality assurance.

The MetricStream Solution – Power Your Enterprise
Designed specifically to manage the complex approval process requirements of USDA regulated industries, keeping track of quality standards and regulations for multiple vendors, distributor networks and locations.

The FDA and USDA closely scrutinize and regulate foods under the various laws that have been passed by Congress. The recent announcement of the final two safety regulations required by the Public Health Security and Bio-terrorism Preparedness and Response Act of 2002 gives the FDA new authority to protect the nation's food supply. With HACCP (Hazard Analysis and Critical Control Point) studies and GMP strongly linked to Quality Assurance and regulatory compliance in the food industry, it is important that manufacturers follow these processes closely to produce safe and wholesome food through well-controlled operations that avoid waste and any type of contamination.

MetricStream's enterprise-class quality and compliance management solutions (QMS) provide solutions that are relevant to the foodservices industry -

Corrective and Preventive Action (CAPA) - Real-time reporting of problems combined with flexible workflows to ensure quick time to resolution. Corrective measures are applied whenever product or process nonconformance, supply-chain failures or customer complaints are detected

Audits and Inspections - Conducting internal audits or 3rd party supplier audits, analysis of samples from production trials and review of quality records. Includes trend analyses on audit histories and inspection findings

Complaints and Returns - The infrastructure to report and manage customer complaints such as defective food products, and also ensure root cause identification with measurable ex-post metrics

Metrics - The ability to measure costs of quality, and parameters that relate to supplier and distributor responsiveness and rate of problem resolution

Document Management - The infrastructure to store, manage and retrieve documents pertaining to complaints, production processes, supplier qualification and training material, with appropriate levels of access security

Supplier & Distributor Management - The ability to track supplier/distributor performance parameters including number of complaints, inspection histories, corrective and preventive action reviews

MetricStream's seamlessly integrated suite of web-based products, facilitate enterprise-wide deployment and assist customers throughout all phases of installation and deployment.

Technical Details

• Fully web-based with an intuitive, easy-to-use user interface.
• J2EE and XML compliant, n-tier architecture
• Runs on Windows NT, Solaris and Linux
• Tightly integrates with Oracle Manufacturing, Financials, HR and other third party applications.

MetricStream’s quality and performance management solutions help Foodservices Operators benefit significantly through the use of software solutions that enable regulatory compliance and increase operations efficiency. Through our enterprise-class quality and compliance management solutions (QMS) we can help power organizations by reducing administrative and operating costs, achieve business objectives, competitive advantage and increased market share. For more information on implementing solutions for your enterprise, please contact us at 1-650-620-2955, or by email at info@metricstream.com.