An Argument for Continuous Improvement

An Argument for Continuous Improvement

Let’s say your company has been error-free for years. You pass every audit. You achieve all certifications. You have the ideal quality processes in place. Have you then reached a Quality Apex? You can go no higher?

Perhaps your company isn’t that perfect, but you feel that you have quality under control. You catch defects before they leave the plant. You might have an infraction or two from a regulations standpoint but you easily remedy the situation. Are you also in a position where your quality efforts have reached a plateau? (more…)

Medical Device Recalls: Creating a Balance

Medical Device Recalls: Creating a Balance

Right now, there are some 6.6 billion people in the world, and over the next 30 years, it will soar to over 9 billion. At the same time, the global population is aging, and mostly so in the U.S. and Europe. As the population ages, health care needs will likely increase, leading to an increase in medical device consumption, an industry currently valued at $290 billion dollars. (Kalorama Information, A division of MarketingResearch.com). The U.S. represents the largest medical device market with $130 billion dollars in revenues. (more…)

ISO 9001 – It’s All About Continuous Improvement

ISO 9001 – It’s All About Continuous Improvement

ISO 9001 was created in response to customers who wanted an assurance of quality. The concept was to limit the risk of delivering defective products to customers, with a focus on prevention, detection and correction. ISO 9001 replaced many customer-specific requirements, which suppliers needed to meet in order to make it easier for them to bid for work.

But ISO 9001 should be a quest for improving quality in all operations and not simply getting and keeping a certificate. It should be viewed as a guide for a management system to satisfy its customers and stakeholders with continual success. (more…)

So Now That the Food Safety Bill Has Passed, What’s Next?

So Now That the Food Safety Bill Has Passed, What’s Next?

On January 5, 2011, the Food Safety Modernization Act was passed into law by President Obama.  The new legislation gives the Food and Drug Administration the power to recall tainted food, quarantine geographical areas and access food producers’ records. According to the FDA, the burden of foodborne illness is considerable.  Every year, 1 out of 6 people in the United States — 48 million people — suffers from foodborne illness, more than a hundred thousand are hospitalized, and thousands die. So what does the new legislation mean to food processing companies and manufacturers now? (more…)

The New Year is a Good Time to Think About Audits

The New Year is a Good Time to Think About Audits

From December 26th on, you can’t help but see articles on the best and worst of 2010. We had Toyota, BP and eggs topping the news, and it didn’t shed much of a positive light on quality management. So as the new year kicks in, perhaps it’s time to examine your own products and processes in order to ensure compliance with organizational and industry regulations. (more…)

The Three-Legged Stool: Governance, Risk and Compliance (GRC)

The Three-Legged Stool: Governance, Risk and Compliance (GRC)

Guidelines for governance, risk and compliance (GRC) affect nearly every company in every industry today, with different areas of scrutiny in varying areas of operations. Regardless of industry, however, successful companies reach corporate accountability by proving to stakeholders that their business is reliable, compliant, and sustainable.  To achieve this, a unified GRC strategy that guides people, standardizes processes, and integrates technology to embed governance, risk, and compliance must be established. (more…)

Five Key Essentials for a Good Electronic Document Management System

Five Key Essentials for a Good Electronic Document Management System

Organizations need to accommodate continuous improvement activities, daily operations and change that correspond to document content – administering all these documents, making it accessible and keeping it current. Today’s regulated companies must track and manage all documents from different departments, plant locations, customers, vendors and regulatory agencies. To be competitive, a firm must automate its handling of documents with an effective electronic document management system (EDMS). EDMS is a set of products and services that lets users electronically store, locate, retrieve, share and track documents. (more…)

FDA tells Drug Makers, “Just the Facts, Ma’am”

FDA tells Drug Makers, “Just the Facts, Ma’am”

Beginning in March 2011, companies testing experimental drugs or medical products will be required to inform the FDA within 15 days about serious risks and adverse reactions that arise during clinical studies (FDA, Sept. 2010). This isn’t anything new … the FDA just wants to make it simpler. The final rule is a revision of a proposed rule that was issued in March 2003. Apparently, many companies were piling information on the FDA in droves, making it harder for the agency to sift through the data quagmire to find the necessary information. Wanna make it easier on yourself and the FDA? Think Electronic Regulatory Reporting.
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Risk Management: An Opportunity or a Challenge?

Risk Management: An Opportunity or a Challenge?

All organizations at some point face issues in their operational activities related to product complexity, organizational inefficiencies, supply chain management and outsourcing, as well as internal and external risk. A series of highly publicized blunders, from BP’s oil disaster and Toyota’s massive recalls, to the egg recall, along with regulatory mandates and more active involvement among shareholders, are prompting organizations to focus their efforts more closely than ever on identifying areas of potential risk across their enterprise. (more…)

The Pharmaceutical Industry Still Struggling with CAPA as Part of Overall Quality Management System

The Pharmaceutical Industry Still Struggling with CAPA as Part of Overall Quality Management System

One of the biggest challenges for pharmaceutical companies is to complete investigations and actions in a timely manner. In 2009, ICH Q10 adopted by the FDA as an industry guideline, names pharmaceutical Quality Management Systems as a necessity to detect and evaluate non-conformances and take respective corrective and preventative actions. Although it takes time, an efficient CAPA process is an effective tool that can significantly improve quality systems and processes. (more…)