483s Can Be a Good Thing (Really)

483s Can Be a Good Thing (Really)

Mark Crawford

According to FDANews, the increasing rate of FDA inspections and warning letters is continuing this year—as of June 2011 the FDA had issued 874 letters in fiscal 2011, compared with 673 last year. If FY 2011 is like 2010, leading issues will be quality unit deficiencies, inadequate batch failure investigations, lack of follow-up procedures, validation of manufacturing processes, and handling deviations. For international inspections, deficient laboratory controls, quality unit deficiencies, and deficient procedures led the list last year.

It usually starts with Form 483, which “lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance.” (more…)

FDA Struggles with Rising Imports

FDA Struggles with Rising Imports

Mark Crawford

It’s been a long time coming—overwhelmed by an ever-increasing flood of imported products that need be inspected, in June the FDA announced a plan to better address monitoring and regulating these goods. And, facing the stark realities of restricted funding, outdated technology, and sometimes less-than-willing global partners, it won’t be easy.

Over the last 10 years, FDA-regulated imports rose from 6 million shipments to about 24 million for 2011—an estimated annual growth rate of 15 percent. In the food industry, according to the FDA, about 45 percent of fresh fruit and vegetables and 70-80 percent of the seafood Americans consume are shipped from other countries. In the medical field, about 80 percent of all active pharmaceutical ingredients in U.S. drugs come from overseas, as well as about half of all medical devices used in the U.S. (more…)

Perfect Harmony Across Your Global Organization

Perfect Harmony Across Your Global Organization

When you think of harmony, you’re more likely to think of a group of people singing in perfect key together than a global organization working in total agreement. Just like in singing, not all people are singing the same notes, but the notes that they do sing are in perfect alignment and compatibility with the others. That’s what global harmonization is – alignment of business processes and data for global standardization and enforcement. It’s not performing identically, but in a way that complements performances of others.

The Benefits of Global Harmonization are many, including:

  • Global consistency
  • Business process improvement
  • More operational control
  • Leverage best-practices for success
  • Enterprise visibility
  • IT cost-savings

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Monitoring Supplier Performance throughout the Product Life Cycle

Monitoring Supplier Performance throughout the Product Life Cycle

Knowing your suppliers is as important as knowing the resources themselves. If you have a product defect, it doesn’t matter if it was a supplier’s fault or your own – the only thing the public will see and react to is your product and brand. Ouch. It pays to keep a tight control on supplier management.

The first step in understanding suppliers is through an evaluation and acceptance process. What are their business systems? Are they financially stable? What does Dunn & Bradstreet have to say about them? What percent of their sales is the product or resource you need? If it’s not substantial, will that affect the quality? (more…)

Little Things Mean a Lot

Little Things Mean a Lot

Skinny jeans, 100-calorie snacks, smart cars – everyone is focused on smaller and leaner. So why not manufacturing? Research has shown that almost all activities in manufacturing fail to add value to a product. Nielsen Research reports that a minute of downtime can cost a manufacturer more than $20,000! A MINUTE! Success lies in efficiencies. It’s about being lean.

Lean principles have been with us for a while in quality and manufacturing. You’re probably familiar with Six Sigma, TQM, Kaizan, etc. Lean is about getting the right things in the right place at the right time and always looking for continuous improvement. It can apply to processes throughout the value chain. (more…)

A New Focus on Information Security

A New Focus on Information Security

According to the FCC, American small businesses lose billions to cyber attacks annually, and 74 percent of small and medium businesses reported being affected by cyber attacks in the past 12 months. The average cost of these attacks for business, per incident, was $188,242. The most important step your company can take is securing your data. This is not only a good idea financially, but also from a legal and regulatory standpoint.

No information system is without vulnerabilities. Hackers, terrorists, viruses, spam, fraud, data theft, system failures, power outages and more can have a significant impact on an organization’s profitability and sustainability. (more…)

Impact of the New 510(k) / PMA Process on Companies for Quality Management

Impact of the New 510(k) / PMA Process on Companies for Quality Management

The entire medical device community is waiting patiently to see how the U.S. Food and Drug Administration changes the 510(k) clearance process. In January 2011, the Agency announced a plan containing 25 actions it intends to implement during the year to improve the most common path to market for medical devices.

According to a press release, the FDA’s key actions include:

  • Streamlining the “de novo” review process for certain innovative, lower-risk medical devices
  • Clarifying when clinical data should be submitted in a premarket submission, guidance that will increase the efficiency and transparency of the review process
  • Establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making

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The Impact of SOX on Quality

The Impact of SOX on Quality

Risk is a subject prone to irrationality. We worry about mere possibilities. We ignore probabilities. We focus on perception. We ignore reality. Twenty percent of adults still smoke. Twenty percent of drivers still don’t wear seat belts. Two-thirds of the population is overweight/obese.

Risk is everywhere: market risks, operational risks, business risks, strategic risks, financial risks, environmental risks, etc. It’s too easy to think, “It’ll never happen to me” and ignore risks. Designing a solid risk management model requires attention to all risk areas. (more…)

Is the FDA Keeping the U.S. from Innovation?

Is the FDA Keeping the U.S. from Innovation?

This past January, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) announced its plan of action for implementation of its 510(k) and science recommendations. Under section 510(k) of the Act, announced in August 2010, a person who intends to introduce a device into commercial distribution is required to submit a premarket notification, or 510(k), to FDA at least 90 days before commercial distribution is to begin.  While safety is at the core of this regulation, is it also limiting the possibilities for innovation and delivering products to market? (more…)

Managing Quality, Compliance and Risk in a Global Economy

Managing Quality, Compliance and Risk in a Global Economy

Time to market is one of the major reasons we look to the global economy. Acquisitions and mergers can take us across international borders to quickly gain the intellectual property we need. International supplier sourcing can get products more quickly to our manufacturing sites and our customers, or broaden our foot print in a country quicker and faster. (more…)