Risk

Risk Management greatly reduces inefficiencies resulting from unanticipated operational disruptions.

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Compliance

For regulated organizations, quality problems & non-compliance have serious consequences

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Quality

An integrated and effective quality system is key to improve efficiency & compliance in manufacturing operations.

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Posts Tagged ‘HACCP’

Quality and Safety Systems Need to Break Out of their Shells

Wednesday, September 22nd, 2010

The Senate reconvened this month with a very important bill on its plate – the Food Safety Modernization Act (S. 510). With the recall of more than 550 million eggs and over 1,500 people sickened from salmonella fresh on their minds, this bill couldn’t be served up at a better time. Many of the backers of this bill feel strongly that this could have prevented or at least minimized the outbreak, and are hopeful that it will “solve” all potential future outbreaks. However, the 483 violations found at the two facilities were mostly facility-focused and clear violations of the Salmonella Prevention Plan. While the FDA has focused on the state of the facility’s environment, where is the focus on the quality and safety systems that are supposed to be in place at the company to prevent it from becoming a national crisis? As food safety issues continue to grow, regardless of whether S.510 is passed or not, manufacturers need to take control of their quality and safety issues in-house to prevent such disasters. 

With 60 percent of fresh fruits and vegetables and 80 percent of seafood coming from outside the U.S., imported food makes up a substantial and growing portion of our food supply. Also, we are increasingly eating foods that are consumed raw and that have often been associated with foodborne illness outbreaks, including leafy greens such as spinach. How are you managing your suppliers? Are you still using paper systems and fragmented IT systems? A recall like the egg recall severely hurts consumer confidence. When consumer confidence in the nation’s food supply is weakened, it often causes a company irreparable damage in reputation and bottom line. 

Yet it continues to happen. Is it really because our laws aren’t strict enough? Do we need to have an FDA inspector on every food manufacturers site? It’s true that food processing companies are faced with the continuous challenge of maximizing food safety while adhering to the growing number of regulations, such as ISO 22000, FDA 21 CFR Part 110, FDA Bioterrorism Act of 2002 and HACCP. But the real problem lies within the organization’s processes. In the majority of cases, they are fragmented and disconnected. Procedures are not always well documented. Required process steps are not always completed. Employees don’t always know or understand their responsibility or authority. Suppliers are not always closely monitored or enforced to continue their own quality process improvements. 

Food processing companies need to take a look into the same principles of industrial automation and apply it to best practices in quality and safety management automation and think of the system as a whole – a global program, trained employees, well-documented SOPs and utilizing technology properly to put global practices and procedures in place. 

The focus should be on continuous process improvement and the implementation of an automated and integrated Safety and Quality system across the enterprise. A well-designed and implemented safety and quality management system can reduce risk and improve performance and profitability. 

By having total automated quality and safety process control, food processing companies can look at achieving consistent yield and uniformity from product to product, and from batch to batch, with increased traceability and trust along your entire production process for complete sustainability. 

September is National Food Safety Education Month. This month-long campaign is held every September and focuses on the importance of food safety education for the restaurant and foodservice industry, while raising awareness of the industry’s commitment to food safety. Perhaps this is a good time to load up your own plate with a Quality and Safety system that will keep you out of the news.

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Wake Up and Watch Out: Getting Serious About QMS

Thursday, July 15th, 2010

“If it’s not broken, don’t fix it.” Really? If you only want to maintain the status quo, you might get away with letting sleeping dogs lie. But no one really wants to get hauled off by the dog catcher during a pleasant nap. Unfortunately, it’s happening every day to manufacturers who don’t take quality management seriously.

Quality management is about continuous improvement and product safety. And each time we optimize, we strengthen our preventive measures for avoiding unwanted surprises and disruptions in our operations.

For manufacturers, those surprises don’t just lie behind Door #1, or Door #2. Those surprises can come from regulatory bodies in the way of standards like ISO, cGMP, HACCP, or Lean and Six Sigma Objectives. Equally, if not more frightening, is what lies behind the Consumer Door.

Since consumer activist agencies and public awareness at large—fueled, for example, in the case of recent toy recalls involving lead and cadmium controversies, by clear test results and common sense—tend to be a few steps ahead of legislators and regulatory bodies on public safety concerns, it is imperative manufacturers stay a few steps ahead of the game. This can be achieved with a comprehensive Quality Management System (QMS). By enabling quality management throughout the lifecycle and detecting defects early in the process, companies benefit from improved credibility, and – bonus! – reduced costs.

Sure, a QMS doesn’t ensure perfection. The laws of probability and the inevitabilities of human behavior still come into play. However, implementation of an enterprise-wide QMS (engaging the entire supply chain) does allow the flexibility to identify, contain, and adapt to foreseeable and unforeseeable issues. Proactive, responsible companies that engage a comprehensive process review program and performance tracking system as components of their overall QMS, will be prepared to ensure smooth responses to potentially devastating scenarios.

Consider the cadmium situation: In January of this year, an Associated Press (AP) investigation revealed a number of children’s trinkets and jewelry promoting a Disney’s children’s franchise and sold exclusively at the world’s largest retailer, Wal-Mart, contained significant amounts of the highly toxic heavy metal cadmium. A known carcinogen, cadmium can inhibit brain development in young children. Subsequently, the Consumer Product Safety Commission (CPSC) took only a few weeks to confirm the results of the AP investigation before issuing a recall. However, though, though the CPSC has acted quickly by issuing recalls on a handful of products known to contain cadmium, the organization has indicated it is by no means finished, and that more recalls may be coming down the pipeline.

Regulatory agencies are working continuously to protect the consumer, and consumers have long memories that continuously question the quality of the products they buy. Therefore, being a proactive manufacturer calls for continuously going above and beyond the call of duty. By establishing a QMS built on internal standards that exceed federal regulatory requirements and make sense in terms of consumer health and safety, manufacturers can keep the dog catchers at bay and save millions of dollars in the long term.

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