For Quality Professionals


  • MasterControl Revs Operational Excellence Using Six Sigma - The de facto standard for excellent business operations is Lean Six Sigma. Only five years ago you could not say that. But today, in every industry and every geography, companies have determined that the principles and practices of Lean and Six Sigma are the world-class standard for designing, configuring, improving, and controlling business.

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  • Quality Professionals: How to Increase Your Job Security - The life science industry has not been immune to the global economic downturn, with pharmaceutical companies such as AstraZeneca, Roche, and AMAG Pharmaceuticals recently announcing layoffs. Similarly, medical device companies such as Stryker, Medtronic, and Smith & Nephew have announced job cuts. So, is there such a thing as job security anymore?

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  • What SOPs Do You Need As A Dietary Supplement Distributor? - If you look at the cGMP regulations for dietary supplements, you'll notice that only one subpart includes the words "holding" or "distributing" in its title. With only 10 or so individual requirements, the aptly-named Subpart M, "Holding and Distributing," is shorter than most. If you're thinking this means there's a much lighter regulatory burden placed on companies that simply hold or distribute dietary supplements than on companies that manufacture them, you'd be right. At the same time, you'd be incorrect to assume that regulations for holding and distributing dietary supplements are restricted to this single subpart. At least eight of the 16 subparts that comprise 21 CFR Part 111 are applicable to holders and distributors and all the activities outlined in these subparts require SOPs.

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  • How to "Sell" Quality - ASQ CEO Paul Borawski asked us to comment on the question, "How do you 'sell' quality to decision makers?" While everyone theoretically believes in the importance of quality, there are times when the demands of the customer cause the focus to shift to speed and cost. Probably many quality heads of departments have been asked to compromise quality requirements at some point to get product out the door. Others find that they have to "sell" the rationale for their very existence as quality departments, with leaders eager to cut costs on staffing for quality. Why do we need so much money for labor that doesn't make product/service? Why can't we just build quality into what we do, so quality auditors are unnecessary?

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  • Can You Use Automated Testing Tools as an FDA-Regulated Company? - Software test tools help development and testing teams verify functionality, ensure both the reliability and security of the software they develop, and investigate software bugs. Off-the-shelf tools are available for all stages of software development. Examples include static code analyzers, record and replay, regression testing, and bug tracking. Some software testing tool vendors offer an integrated suite that starts with the gathering of requirements and continues through software development and testing throughout the life of a project, including supporting the live system. Other vendors concentrate on a single part of the application development life cycle, such as just testing.

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  • How to Build a Strong Supply Chain Team - In today's fiercely competitive global market, finding good suppliers that help create efficiencies, reduce cost, and support compliance efforts is critical to the success of manufacturers in regulated environments. Let's say you have found excellent suppliers, the question is: How do you maintain control over your suppliers and also keep good relations with them?

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  • 100% Training Complete ≠ 100% Effectively Trained - "Can you run me a training report? I need to know where we stand with our training effectiveness program!" For a training manager, this is a double-edged sword. While it is very encouraging that upper management is taking an interest in the training program, focusing merely on the percentage of completion does not measure training effectiveness.

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  • Remote Audit: Out of Sight but Not Out of Mind - Fortunately, it is now possible to conduct an audit without being physically present at the facility under audit. The development of web-based systems, video conferencing and desktop share technology can allow auditors to see information from virtually anywhere in the world.

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  • Implementing a New System: Why Training Reinforcement is Critical - It all sounds familiar: You attend a training course that you are excited about. You spend two or more days soaking up new information. You take notes diligently. Before you know it, the training is over. You go back to the office. And after a while, it happens: The new knowledge fades. You're not alone. It is estimated that up to 80 percent of what we learn from training courses are lost within 30 days—unless the knowledge is reinforced.

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  • U.S. Agencies Should TAke Steps to Boost Developing Nations' Regulatory Capacity - WASHINGTON — Many low- and middle-income nations do not have technologically advanced regulatory systems, which limits their oversight of food and drug safety, says a new report from the Institute of Medicine. The discovery of a counterfeit version of the cancer drug Avastin earlier this year underscores the challenges for U.S. regulators as imports increasingly dominate the American market.

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  • When Good Teams Go Wrong - How's your team doing? Are you hitting your targets without leaving "dead bodies" in the wake? Do you sense trust, commitment, and accountability from your fellow team members? If the answer is yes, fantastic—you're in an elite club! But if your team is like many others, sometimes (or more often than not) you feel "dysfunctional." Not quite working on all cylinders... not cooperating or communicating well... not making decisions that stick. Dealing with power struggles that exhaust and frustrate everyone. Running on empty.

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  • When Good Teams Go Wrong - How's your team doing? Are you hitting your targets without leaving "dead bodies" in the wake? Do you sense trust, commitment, and accountability from your fellow team members? If the answer is yes, fantastic—you're in an elite club! But if your team is like many others, sometimes (or more often than not) you feel "dysfunctional." Not quite working on all cylinders... not cooperating or communicating well... not making decisions that stick. Dealing with power struggles that exhaust and frustrate everyone. Running on empty.

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  • One Year Later: The FSMA and the Food and Beverage Industry - A year has passed since the Food Safety Modernization Act (FSMA) was signed into law. Some of the changes envisioned under the FSMA are already in place, such as the FDA's new mandatory food-recall authority and the authority to detain food products that the agency has reason to believe are adulterated or misbranded. The FDA said in its one-year progress report that it has already used its "food detention" authority three times. It has also met its mandate of inspecting 600 foreign facilities in 2011.

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  • End-to-End Supply Chain Visibility: It's no VUCA-tion for Supply Chain Professionals - In a survey conducted by ChainLink Research, pollsters found that "the vast majority of respondents (nearly 80 percent) do not manage risks beyond their immediate first-tier suppliers. Instead, they rely on their immediate suppliers to manage those risks." With so many well-respected supply chain analysts talking about the importance of developing end-to-end supply chain visibility, 80 percent seems like a big number of non-believers. Perhaps it is the phrase "managing risks" that causes that number to be so high. After all, having supply chain visibility is not exactly the same thing as managing risk. Regardless, I suspect that most supply chain analysts would tell respondents who fall into the 80 percent group that they are being shortsighted. Enterprise strategist, Lora Cecere, believes that companies need to develop "value networks that extend from the customer's customer to the supplier's supplier, and that [they need to] sense, shape and respond by listening, testing and learning with minimal latency."

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  • How to Build a Business Case for a Quality Management System - It is impossible for FDA-regulated manufacturers to conduct business without paying close attention to regulatory compliance. FDA regulations can introduce increasing complexity into internal business processes, delaying the pace of innovation and new product introduction. And complying with regulations is expensive, with the cost of compliance now estimated at two percent of revenues. The expense, however, pales in comparison to the potential costs and risks associated with non-compliance.

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  • Writing and Enforcing Your SOPs for GxP Compliance Success - This paper addresses the fundamentals of writing and enforcing your SOPs not only for compliance and in accordance with internal company policies and requirements but certainly for ensuring compliance with FDA requirements as well. Typical definitions include the procedures and processes that you utilize and operate under. These procedures and processes have been standardized to ensure they are done the same way every time. A "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function."

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  • Certification and Advanced Degrees: Are They Worth It? - The value of certification and/or advanced degrees, such as an MBA, often comes into question in the wake of economic downturns. There are two camps on the issue. On the one side you have those who spent time and money earning these achievements and now may be questioning the value of these achievements in light of job loss or, at least, job insecurity. The other camp consists of those who don't have advanced education and wonder if obtaining it would help their job search efforts or career aspirations.

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  • Implementation of the Food Safety Modernization Act - As of July 3rd, the Food and Drug Administration (FDA) will have increased authority to use administrative detention as an enforcement tool. For this reason, companies that manufacture, prepare, pack or hold food should ensure strong record keeping practices. Under the current criteria of the Food Drug and Cosmetics Act, the FDA may order the detention of human or animal food where there is credible evidence or information indicating an article of food presents a threat of serious adverse health consequences or death to humans or animals.

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  • Developing a Supplier Scorecard - Organizations have attempted to measure supplier performance in a number of ways as a part of their quality management program, based on customer requests, or as part of the effort to manage supply chain risk. Supplier measurement systems have been in place since the mid 1970s with varying degrees of success, both in the product and service industries. Typically, suppliers are provided measures and targets as performance indicators, data is collected on performance and published, and the buyer works with the suppliers to evaluate shortfalls in performance and to develop corrective actions. In some rare cases, the supplier receives incentives and rewards such as being able to provide additional products or services or being designed into future products or services by the buyer. The Balanced Scorecard method has created a significant level of interest and compliance in determining how a specific organization is performing and a supplier measurement system is the underlying way to measure supply chain performance.

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  • Quality Inspiration: Six Quality Quotes for You to Consider - I enjoy insightful prose...I enjoy reading it, thinking about it and sharing it with others. I think memorialized words of wisdom from others not only define the originator, but they also contribute to our individualism. A few months ago, I was curious to know more about the words of wisdom that define the quality community. I reached out in the American Society for Quality's LinkedIn Group asking for personal favorites and have since enjoyed reading over 700 posts!

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  • Seven Signs that Your Quality Program is in Trouble - Product quality problems don't happen overnight, nor are they the result of a crippled procedure or one poorly conceived policy. The problems have brewed over time, sending out signals that risks to product quality are growing. Because of the unique nature of medical products and the expectations of prescribers and patients, failed product quality translates into a betrayal of trust. It is a safety and brand issue, and problems are on the rise, as evidenced by the 300 percent increase in drug recalls experienced this past year.

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  • Four Common Quality Misconceptions - For over a decade now, I've had the distinct pleasure of talking quality with professionals representing a myriad of industries. For the most part, people who reach me are experiencing a quality-related issue and are looking to quickly extinguish the fire and prevent recurrences. Or they may simply want to reduce their overall risks—and costs—by incorporating a specific quality initiative.

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  • Quality Basics Simplify Complex Engineering Document Management Challenge - In the spring of 2006, Ray Wilson, an internal business systems analyst for an investor-owned utility company, faced a monumental challenge: how to go about transferring the management of approximately 750,000 documents on paper, Mylar, microfiche, and other media from more than 150 different facilities to one centralized location.

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  • 19 Key Elements to Review for Effective Audits - Manufacturing organizations on a global scale have instituted ways of qualifying suppliers to ensure that their capabilities have been verified. The types of qualification methods used are multifold. Some include quality and business system components that are essential for effective production or service rendering. Others may simply focus on quality characteristics, and still others may only consider production and equipment capabilities. More effective methods, however, include a combination of business, production, service, and quality factors to provide a holistic impression of the supplier's organization. These factors play a critical role in providing excellent customer service.

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  • How Auditing Supports Supply Chain Management - One of the fundamental rules of auditing is to measure and evaluate against requirements. While requirements come from multiple sources in an internal and registration audit, for supplier audits these requirements always come from the contract. (Contracts come in a number of different forms, such as purchase orders, letter agreements, etc.) Three things need to be considered, when writing a supplier contract: technical requirements, accept-reject criteria and/or management system requirements.

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  • Quality Audit - A Tool for Continuous Improvement and Compliance - The word "audit," in the broadest sense, refers to a variety of activities. It may refer to an accounting firm examining the financial statements of a public corporation, or a consultant checking the process of lid sealant dispensing in a semiconductor package assembly line. It may even refer to a mystery shopper testing the patience of sales clerks in an upscale department store.

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  • Automating Training Control Processes for Compliance - FDA regulatory requirements and ISO quality standards mandate companies to execute and document employee training. (21 CFR 211.25 and 820.25) These requirements ensure employees understand how to perform their duties within company and industry guidelines. Well-managed training programs minimize the risk of non-compliance and improve product quality. This paper identifies the basis for the requirements and examines the associated challenges for meeting those requirements, and in addition, the shortcomings that lead to general system failures. A new approach for meeting and going beyond the tracking of requirements is presented.

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  • ISO 9001: Quality Objectives and Quality Dreams - This article reviews common practices for, and the positive results of, establishing measurable quality objectives for ISO 9001 and other quality management systems. The author suggests a practical model for identifying and documenting objectives to drive the continual improvement of management systems. This article also illustrates ineffectiveness that results from vague and poorly defined quality objectives, and demonstrates how well-structured and documented quality objectives can lead an organization to a more efficient quality management system that increases customer satisfaction. An example of a Quality Objectives Matrix (shown in the paper) presents a useful method for documenting and managing various aspects of quality management systems. The paper will be helpful to those organizations that have not yet formally documented their quality objectives and for those that are interested in improving the effectiveness of their quality management systems and the performance of their business.

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  • Quality Basics Simplify Complex Engineering Document Management Challenge - In the spring of 2006, Ray Wilson, an internal business systems analyst for an investor-owned utility company, faced a monumental challenge: how to go about transferring the management of approximately 750,000 documents on paper, Mylar, microfiche, and other media from more than 150 different facilities to one centralized location. Although the scope may have been once-in-a-lifetime, at the heart of the task was a common problem for engineers everywhere: content management for engineering drawings.

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  • Ten Signs Your CEO Still Has No Idea About ISO 9001 and Lean - It's pretty obvious (within many companies) that based on their actions and behaviors, CEOs and other top managers just don't get it when it comes to ISO 9001 and all the derivative standards. The following 10 signs that your CEO still has no idea about ISO 9001 and Lean are written in no particular order. You'll need to be the judge as to which ones are most prevalent within your own organization. How many can you relate to? After reading this article, you may also wish to forward it to someone who should probably read this, like maybe...oh, I don't know...your CEO...or ummmm...some other top executive? Directions for how to do so without getting into trouble are at the end of this article.

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  • Designing a Winning CAPA System - CAPA is a critical Quality System subsystem that, when executed correctly, can provide your organization with a clear payback in terms of improved compliance, effectiveness and operational efficiency. So what is required of a CAPA system to make it compliant, effective and efficient in the United States, Europe, Canada or Japan?

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  • Avoiding the CAPA Calamity - Anyone working in quality management is familiar with references to "Death by CAPA" or "CAPA Kills." The industry is rife with similar catch phrases. The "truth" is they are not far from the "truth." When my friend from FDA originally coined the expression "death by CAPA," it was with the best of intentions. Her concern was for those who were killing their respective companies with an overabundance of entries into the CAPA system. These employees were doing so in an effort to ensure all that needed to be examined was always caught. To avoid your own CAPA calamity, let's examine two key distinguishing features of a good approach to CAPA management.

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  • The 5 "W"s of Quality Agreements - Items to address in a Quality Agreement include all aspects of a project that affect the identity, quality, safety, potency, and purity of a product. Additionally, include aspects that may affect the compliance status of either the Contractor or Client. One of the most overlooked sections is the Definitions section - it is critical that everyone knows what is meant by every term used in the Quality Agreement; especially when contracting with non-U.S. parties, terminology can vary widely. Include abbreviations and acronyms, and define documents - one person's batch record is another person's data sheet. Define "subcontracting," and if/when it is acceptable. Also, what NOT to exclude from a Quality Agreement is also worth mentioning.

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  • Things Change - Plan On It - People often bemoan the requirements relating to monitoring and measuring. The general consensus is that it's a good idea to track error and defects, but to monitor that which appears to be running smoothly is a waste of precious resources. Within these tough economic times, that argument can't help but sway managers, unless a compelling counterbalance is offered. Time and again, quality professionals stake their justifications in "ISO says so" rather than in objective indicators.

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