This is the first in a five-part article series, Identifying And Resolving Errors, Defects, And Problems Within Your Organization. This article will enhance your understanding and prime you for visual detection of real trends in your organization by looking at a couple of examples. (You will understand the relationship between this picture and your quest for the quantitative truth by the end of this article.)
This article will address the expected roles of quality control and quality assurance, how these roles are related and how they are different, and how they must work together to create a sound quality management system (QMS).
When he was home for the holidays, my 23-year-old son and I had intense, heated discussions about generational differences. We are still on speaking terms, but it got me thinking about how well we understand and value young people — and if we understand the people who make up our future workforce well enough to adequately train them. That is, are we doing everything we can to create a sustainable future workforce that feels valued and — just as important — is engaged, excited, and efficient (the “3Es”)?
In today’s fast-paced environment, everything needs to be done right the first time. This is especially important when releasing pharmaceutical and biological products to the market. To accomplish this, firms employ a special group of quality professionals, called the batch review/release group, to review executed batch records and be that all-important final sign-off for release to market. This is no easy task. Much of the time, these executed batch records are many pages long with complex information and data to review for accuracy. Effective and efficient management of this review process is the key to a successful process.
Because a training program is a compliance requirement for GMP operations, similar to the compliance requirement to have a QA organization, it is typically considered part of the cost of quality for regulated operations. But, the requirement to have a training program is more than a means to assure compliance; it is an opportunity for companies to increase profits and reduce costs. These avoidable costs are referred to as the cost of poor quality (CoPQ).