MHRA Looking for Quality Risk Management Systems — Sound Familiar?

The UK is on to something. British inspectors will be looking for a “risk register” and a defined document management control system including periodic reviews of risk management assessments when inspecting drug manufacturers. It seems both sides of the Atlantic are on board with quality risk management, and for good reason. (more…)

Get Lean! Using Six Sigma and Lean Strategies to Improve Quality

The goal of lean is to eliminate waste and non-value-added steps at all points in the manufacturing process. To accomplish this, lean implements continuous improvement practices and eliminating waste across the enterprise. Technology has been successful as key to achieving this end. While saving money might be an initial consideration with lean strategies, customer satisfaction is of utmost importance to any organization. By concentrating on customer satisfaction and value while eliminating waste, a company can build profits as well. (more…)

Moving Into the New Generation of 21 CFR Part II

In 1997, it wasn’t uncommon to hear “You’ve got mail!” when you used your telephone to log onto the Internet. This is the same year that the Food and Drug Administration (FDA) issued 21 CFR Part 11, electronic records. Six years later, in 2003, you were probably using broadband and going directly to the Internet. In this year, the FDA issued a Guidance for Industry of Part 11, Electronic Records; Electronic Signatures. It shouldn’t be any surprise that seven years later, the FDA is piping up about Part 11 again. This time, it is in the form of revised enforcement discretion of Part 11.  (more…)

Quality and Safety Systems Need to Break Out of their Shells

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.  (more…)

Taking Risks for Profitability – What Can We Learn from BP?

Taking Risks for Profitability – What Can We Learn from BP?

A series of internal BP memos were recently published by Congressional investigators which, they say, are proof that the British company systematically and negligently put safety at risk on the Deepwater Horizon oil rig in exchange for the prospect of increased profits.  Henry Waxman, chairman of the House Energy and Commerce Committee and head of its oil spill investigation, accused BP of making at least five questionable decisions prior to the disaster (see Times Online).  Every time BP had a decision to make, they  chose to cut corners; to do things more quickly than they should have; and, to take the less expensive route.  The consequence of these decisions is what has left us a blackened  Gulf of Mexico.  Time after time, it appeared that BP made selfish decisions that increased wide-scale risk for the sake of saving the company time or money. (more…)

eMDR to Become Mandatory – Ready, Aim… WAIT!

eMDR to Become Mandatory – Ready, Aim… WAIT!

The FDA’s Center for Device and Radiological Health (CDRH)  has had a focused project team engaged in developing, educating, communicating and assisting medical device companies on how to submit Adverse Event reports (MedWatch 3500A) in an electronic format, now known as eMDR (electronic Medical Device Report). In 2005, Indira Konduri, eMDR Project Manager, solicited help from industry to move forward on the testing and confirmation of the eMDR requirements.  The solution leveraged the Health Level 7 standards (HL7) and the outcome was an Individual Case Safety Record (ICSR version 1).  Kudos to the eMDR team during this period when the FDA showed an incredible ability to “listen” to the voice of industry and displayed a willingness to engage in joint discussions on the best way to handle issues. (more…)

Are They Just Pulling Our (Supply) Chain?

The FDA, Congress, the US Consumer Products Safety Commission, US Immigrations and Customs Enforcement, the Department of Justice. These and countless other regulatory bodies are more proactively evaluating the potential risk and liability to our country’s goods and products; and as we’ve seen, the sharing of information among these regulatory bodies is leading to more cohesive enforcement activities with the continuous goal of protecting the consumer. (more…)

The FDA Devotes Almost Half of its Staff to Product Regulation – Shouldn’t They Eat Their Own Dog Food?

Compliance and Quality management is crucial issue for almost any business, large or small. No matter what medical product your company manufactures or services, it’s a virtual certainty that you are beholden to an array of different regulations, both internal and from the FDA such as cGMP quality systems. Ensuring that your company remains in compliance with these regulations and proving the quality and safety of products and services at all times is something that can’t be left to chance. (more…)

Wake Up and Watch Out: Getting Serious About QMS

“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. (more…)

Risk Management Software is Crucial

Every company, no matter how large or small, faces a number of pressing internal and external risks, any of which, whether singly or in combination, could pose a serious threat to long-term viability and short-term revenues. Some organizations treat risk management as an art, and allow their management to use their best judgment in order to avert disaster–but increasingly, savvy corporations are taking another tack. Risk management software can help take the guesswork out of avoiding unknown pitfalls, and put the power of self-determination back in the hands of your company’s decision-makers. (more…)