It is a known fact that we are in a new ‘world economy’, not through governments but on the level of common businesses. Many small and mid-size companies need a how-to course on interacting with larger businesses. Of course doing business in such a diverse environment is a trial unto itself as we’ve seen with a major US economic collapse and a 100% rise in oil prices. Continue reading
The end result objective of a corrective and preventative action (CAPA) is, quite simply, a solution to the issue from which the CAPA was generated. If it is not driving toward a solution, a CAPA is a waste of time and resources. For organizations in regulatory environments, CAPA is an overarching umbrella—all control points flow through to the CAPA system.
From the perspective of regulatory agencies like the U.S. Food and Drug Administration (FDA), CAPA is viewed as the central component that affects all control points including design controls, production and process controls, records and documents change controls, material controls, and facility and equipment controls. Since more than half of Form 483 observations and warning letters cite CAPA deficiencies, it is evident that FDA investigators are likely to look first at a company’s CAPA system during their inspections. In recent years the FDA has been promoting the adoption of closed loop CAPA systems where CAPA is the tool that drives reports and keeps management informed. Continue reading
INTRODUCTION
There seem to be a lot of sightings of ‘black swans’ lately. Should we be concerned or are we wishfully thinking, caught up in media hype; or are we misinterpreting what a black swan event really is? The term black swan has become a popular buzzword for many; including, contingency planners, risk managers and consultants. However, are there really that many occurrences that qualify to meet the requirement of being termed a black swan or are we just caught up in the popularity of the moment? Continue reading
EXECUTIVE SUMMARY
Due to schedule delays, cost overruns, and several canceled software projects the Chairman of a Fortune 500 company decided to bring in outside experts to identify major software risks and develop solutions for those risks.
Initially the new risk abatement team reported directly to the Chairman, which is unusual but effective. The team visited more than 20 software locations in a dozen countries and met with many software managers and technical personnel. Continue reading
“To do something very dangerous takes a certain lack of imagination”
– Anonymous
INTRODUCTION
Governments and companies worldwide are emerging from the current financial crisis and subsequent recession. While governments are crafting new regulations, businesses around the world are walking in shifting sand as risk exposures are high and new regulations will create compliance challenges. According to a recent survey by Korn/Ferry International, corporate leaders are focusing more attention on risk management after what is considered by many to be excessive risk-taking during the boom times that factored into the global financial crisis. Continue reading