Journal of Developing Drugs
Open Access

Maintenance: An overlooked source of value added improvement

5^th International Summit on GMP, GCP & Quality Control

August 12-13, 2016 Toronto, Canada

Michael Chellson

Pathways to Success Consulting, USA

Posters & Accepted Abstracts: J Develop Drugs

Abstract :

One of the most overlooked opportunities for value add improvement in functionally mature operational quality systems is within the realm of maintenance. It seems that somehow, we donâ�?�?t particularly view maintenance as a value added best practices activity. Rather, it is often viewed as a â�?�?choreâ�? that has to be done and documented. At best, it is viewed as a method to minimize operational downtime, but not as an activity that adds value and increases productivity and quality. Recalls and nonconformance from sterility barrier failures, foreign material contamination, incomplete bonding, sterilization aberrations, lost productivity and efficiency from process downtime, employee injury, part non-conformance, and significant remediation activity from regulatory non-compliance are all potential results of a â�?�?less-than-robustâ�? maintenance program. Making the effort â�?�?up-frontâ�? to establish robust and validated time to failure based preventive maintenance processes rapidly pays for itself in improved regulatory compliance, less operational downtime, reduced costs of operation, improved product quality, and improved quality of work life for those using well maintained tools.

Biography :

Email: mikechellson@gmail.com