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The QSE UPDATE

 

The QSE UPDATE is published each quarter on this Website. It is intended to provide information, discussion and commentary on current topics of interest to individuals working in the medical device and diagnostics industry. Please visit our site each quarter to view the latest update.

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January - March 2010 - UPDATE

What device manufacturers can learn from the food industry.

By Tim Gaskin QSE Senior Consultant

 

Recent events within the food industry, noted in high profile media articles and announcements, have highlighted more than the usual announcements of E Coli and Salmonella contamination. Companies within the food industry, acknowledged by their peers as the ‘best of the best’, have taken quality system and process controls to new levels of effectiveness. Many of these best practices have also found their way into the USDA which in the past purchased food products for the USA Student Lunch Program solely on the basis of cost – purchasing the lowest cost foods available.

 

USDA has recently acknowledged that the primary focus on cost was not in synch with their primary customers (the public, children) and their needs (safe and wholesome food products). Criticized for making advocacy for the food industry more important than ensuring the safety of the country’s food supply, the USDA has re-thought its’ primary mission and is now applying purchasing and supplier quality management practices for the Student Lunch Program similar to best practices within the device industry. These best practices remove cost as the primary driver and instead focus on higher standards (improved and tighter specifications), increased testing and inspections (including increased and better site inspections and audits), improved process controls (rigorous quality and inspection plans, process validation, process and product monitoring). In many cases the USDA is playing ‘catch up’ with the best in the industry as these companies move aggressively to improve the quality of their processes and products. These companies are seeing improvements in overall food safety, customer perceptions and reductions in product liability costs. And along the way they build a culture of quality that is sustainable and cost effective. As USDA purchasing agents work with these leading companies they often find that their internal standards and practices are beyond what USDA is currently specifying. These improved purchasing and supplier quality management practices are realized by working in partnership with key suppliers, a partnership based on rigorous quality plans and specifications and requiring robust inspection and process controls at the suppliers.

 

Similar improvements are being made by these industry leaders in their audit and inspection programs. In the highly publicized peanut contamination case (Salmonella) from last year a Virginia company was found to have serious contamination and process control issues that went unrecognized by many of their customers, including USDA. Despite these companies having performed numerous on-site audits at the offending site they continued to do business with this peanut products producer without requiring any corrective action measures. Companies with better audit practices, like Nestlés, had recognized the deficiencies and refused to do business with the company. Those who took the easy way out saw great harm to their reputation, immediate loss of business and losses in the hundreds of millions of dollars due to liability settlements. The best companies maintain effective audit programs that form the basis of their process and product monitoring and quality improvement programs. Again, immediate costs are not the primary concern.

 

An excellent program of integrated product and process controls can be seen in McDonalds Corporation efforts to ensure product safety and consistency. These efforts begin with their suppliers as noted above but are also seamlessly integrated with controls at the franchise level where process procedures and rigorous and redundant inspections ensure that validated processes are consistently followed. The immediate outcome is a safe and consistent product but benefits also include increased customer satisfaction and lower liability costs.

 

Another important aspect of such high quality operations is the involvement and leadership of management. In fact, most would agree that such efforts cannot be successful without the direct leadership of progressive management. State of the art food safety and quality programs have in many cases been catalyzed by adverse events such as high-visibility food contamination cases but the difference between companies now setting the new standards and expectations and those lagging behind is the involvement of management with the vision, drive and perseverance to make these new practices a part of the company culture.

 

Out of adversity comes great opportunity. If your company is looking for smart ways to integrate quality system functions and processes and to achieve higher levels of product safety and process quality consider contacting QSE and our quality systems experts. Our consultants have spent decades in the device industry. We’ve seen what works and what doesn’t and we can help you integrate your quality system functions and processes to achieve higher levels of product safety and quality and to establish you as one of the industry leaders in quality and safety.

 

 

 
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