Success in making business processes efficient is often determined by the ease of flow of the mechanism defined. Processes that have a logical cadence about their implementation are often those that have inherent simplicity and adherence to the “Kiss Principle”. Or Keep It Simple Solution approach.
Simplicity is elegant and frequently the approach that is most efficient to implement and maintain.
In relation to non-conformances and non-conformance management, developing a process that will maintain a state of control, but one which will not create bottlenecks is of paramount importance.
Today the competing needs of quality compliance and operational efficiency will create conflict if the operating cost of maintaining compliance is high, due to inefficient business process management. How to manage this apparent conflict, which actually needs not be a conflict, is a driver for the structural architecture required.
As pharmaceutical consultants, we see deviations in production that require investigation, because they can have a major effect on the product. In certain cases, this type of deviation may have the potential to cause a serious impact on the quality of the product that may impact patient safety. In these cases, we term these cases “critical deviations.”
Conversely, there are others that may have no effect on product quality and these we would term as minor deviations.
All these situations require an investigation to be performed and depending upon the severity of the situation they can be short or lengthy.
For certain non-conformances such as “events”, where the cause is frequently known, a lesser investigation utilizing a template form may be used to close out those situations based upon a previously defined set of circumstances. In all cases these have zero impact on product quality and may be termed “NIRDS” (non-investigation required deviations).
In all these other cases, the approach to use to minimize disruption to the process flow is to describe a standardized work pattern for the investigation and to assure that all personnel are appropriately trained to the same level of competency.
By adapting the type of approach, errors in terms of classification of deviations and approaches related to how they are resolved in a uniform way, reduces the time to resolution. This uniformity of approach then affects both the immediate time to resolution as well as affecting future preventive measures to reduce potential deviations entering the system.
Through standardization then, the need for escalation for resolution to a formal “Review Board” is minimized, since with good training on the standardized approach, its possible to enable appropriate decisions to be delegated to shop floor level Quality Specialists in association with operational staff. These processes are inherently Lean in their design and enhance quality operations by virtue of their attention to efficient smooth flow.
The benefits of this smooth flow are that it enables personnel to focus on the more pressing problems and reduces time wasted on those issues that have little impact.