Inundated Quality Systems and Personnel

This week, I will address the third of nine common CGMP Quality System shortcomings; Inundated Quality Systems and Personnel.

If your company is like most of the companies that I have encountered, the Quality Systems and Quality Personnel are pushed to their limits. Sometimes this is the result of working with a less than robust process and/or an unstable product, but often it is the result of an over extended Quality System. I once inspected a facility that had over 5,000 non-conformance investigations within one year. Can you image what it takes to adequately complete and manage that many investigations? It amazes me how a manufacturer can be content to tolerate such a large amount of investigations.

Yes, Quality Systems must have adequate product quality controls, but sometimes these controls can be so stringent and rigid that it becomes almost impossible to meet them consistently. An effective Quality Systems must be able to adequately control the process, product, and testing, while still provide sufficient flexibility to avoid redundant and/or needless investigations? Overly stringent requirements can quickly inundate a Quality System to where it becomes inefficient and non-functioning.

It is “the boy that cried wolf” syndrome. When everything becomes a crisis, then a real crisis may be lost in the busyness of the day. In biology, there is a term called “adaptation”, where organisms become desensitized to a regularly occurring event, stimulus, or condition. For example, if the fire alarm is constantly going off for no reason, then people start ignoring it and are not likely to react when the alarm goes off for a real fire.

One of those 5,000 investigations involved a detrimental product/container interaction that was not identified as such. I am convinced that this investigation was not given its due focus due to the overwhelming number of investigations being conducted on a daily basis.

To overcome this weakness, the Quality Unit needs to ensure procedures and processes have sufficient flexibility to allow for non-impacting variability and eliminate needless investigations. Monitoring parameters should be periodically adjusted to eliminate “background static” (i.e., non-essential alarms and/or notifications). Once the needless investigations and nuisance alarms have been eliminated, the Quality System can focus on addressing real issues and improving product / process robustness.