Quality Management - 26 April 2017
A trait that many leaders in the life sciences share is that they don’t like surprises. Perhaps they don’t mind pleasant surprises, but generally, they want to hear about issues promptly.
While there are often formal notification requirements for quality issues, there are also sound business reasons for informing the leadership of an organization when issues arise that may have serious consequences. Exhibiting strong judgment and skill in this escalation process are traits that define capable quality leaders.
The following are some thoughts on good practices for the evaluation and escalation of issues:
Clearly Identify the Scope of the Problem
Identify the scope of the problem as clearly as possible. Is the issue related to part of a batch, an entire batch, multiple batches, multiple products? A good data management system can be invaluable in this regard to conduct data analysis to determine what the problem is, and what it is not.
Follow protocol on any formal notification requirements. This ensures that appropriate areas of responsibility such as regulatory affairs, planning, medical evaluation, etc., are aware so they may fulfill their responsibilities.
In all communication related to the issue, be as clear and informative as possible, and avoid conjecture on possible impact.
If In Doubt, Report It
If in doubt, report on issues even if you’re not certain of the significance of the deviation. This is where judgment and experience come into play. While it is not productive to escalate every minor issue, it builds trust with senior management to know that those on the front line of issue management will give a preliminary report if the scope may become significant.
Document every aspect of the investigation so that the obligation to conduct effective investigations can be shown to have been fulfilled.
One of the key areas to learn from the experience of others is what to do when quality issues arise. It is one of the most important ways that quality professionals add value to the organization.
About the Author
John Carkner is Senior Consultant in SOLABS’ Quality Assurance & Best Practices Unit and has had a career spanning more than 35 years in the pharmaceutical industry. A microbiologist by training, he began his career in Quality Control with Pfizer Canada. John gradually took on more responsibility, including overall Quality for Pfizer’s Canadian manufacturing operations, eventually became Site Leader of their Arnprior, Ontario manufacturing site. When Pfizer divested the Arnprior site in 2009, John began a new phase of his career leading a contract manufacturing organization. He concluded his career as President and CEO of Pillar5 Pharma Inc., and after five years in contract manufacturing, moved to a less structured role as a consultant to the industry.