Over the last decade, as outsourcing has evolved into the rule rather than the exception in the pharmaceutical industry, many lessons have been gleaned by those involved in the day-to-day business of contracted operations. Experience has shown that it is imperative to assess and qualify a contract organization to ensure it is capable and compliant, but this practice alone rarely ensures that contracted operations will go as smoothly as hoped. Just as we have used risk assessment and risk management techniques in identifying the critical quality parameters of our products and processes, we can likewise use them in our efforts to identify those factors essential to monitoring and managing outsourced activities. The application of risk assessment principles to these supporting fundamentals will help us to realize the full benefit of these partnerships, while at the same time ensuring appropriate and adequate oversight of outsourced activities.
If assessment and qualification practices cannot secure successful execution, what other practices should an organization adopt to help ensure that contracted activities meet user group requirements and expectations? There may be a host of technical causal factors behind outsourcing disaster stories, but, ultimately, most of them can be traced back to a breakdown in systems or a disregard of certain fundamentals. As with so many other elements within a thriving quality system, risk assessment can play a critical role, and support the three fundamentals of successful engagement listed below.