Risk Management Posts

Make Risk Work for You

Mark Crawford

Risk is everywhere—from the time you get up to the time you go to bed, and even while you sleep (earthquake, fire, carbon monoxide poisoning, sleep apnea, alien landing, etc.). The question always is: How much risk is tolerable, or reasonable? What kinds of risk need to be controlled the most? What is the cost benefit in doing so? Where is the trade-off? (more…)

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…)

Risk Management: An Opportunity or a Challenge?

All organizations at some point face issues in their operational activities related to product complexity, organizational inefficiencies, supply chain management and outsourcing, as well as internal and external risk. A series of highly publicized blunders, from BP’s oil disaster and Toyota’s massive recalls, to the egg recall, along with regulatory mandates and more active involvement among shareholders, are prompting organizations to focus their efforts more closely than ever on identifying areas of potential risk across their enterprise. (more…)

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…)