July 2010 Posts

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…)