Henry Ford once said, “Quality means doing it right when no one is looking.” Here at Gateway Analytical we take great pride in the quality of the work we do, knowing that we provide our customers with a top notch product. The quality of the work is directly related to the commitment to overall quality, starting at the top of our organization.
In the day and age of emails, texts and social media; communication has become an ever present topic of discussion. After all, why would Led Zepplin take the time to sing about communication (and its breakdown…) if it wasn’t such a large part of our lives? But even with all the new technology we have at our fingertips today, communication has always been something that professionals are expected to master and execute with ease. This is an especially important skill set when considering quality, as communication is imperative to not only the maintenance of quality systems but also their proliferation.
When everything within your quality system seems to be running like a well-oiled machine, it is easy to get stuck in a rut and perceive a lack of corrective actions or deviations as a signal that nothing needs to change. However, just because something works well does not negate the fact that it can be improved.
The day the certificate arrives in the mail, it finally sinks in – all that hard work, extra time in the office, hours spent preparing has finally paid off! As you adjust to the idea that the fruits of your labor have finally (FINALLY!) been recognized, another realization begins to come to light. Along with the satisfaction of hanging your accreditation certificate on the wall, you've also come to the realization that the journey has just begun. As with any complex and detailed structure, your newly accredited quality management system is going to need continued TLC to guarantee its success.
ISO 9001:2008 clause 5.4.1 requires top management to establish quality objectives. The objectives selected must be measurable and consistent with the quality policy. The real sign of a high quality objective is its alignment with the overall goals of the organization. Keep in mind that the manner in which quality objectives are selected and monitored can greatly impact an organization’s success.
It may seem a little nitpicky to point out the difference between conformance and compliance, validation and qualification, or even registered and certified. After all, how often is someone going to ask you to correctly define compliance and use it properly in a sentence? Unless your employer exercises their right to hand out pop quizzes, probably never.
On May 14th, Rebekah Byrne, Scientist I and David Exline, Senior Vice President at Gateway Analytical hosted a webinar designed for developers of parenteral drug products. During this webinar, our presenters identified commonly found contaminants in parenteral drug products, how these contaminants are introduced into the manufacturing process, how they can be detected both visibly and non-visibly and laboratory techniques used to identify contaminates. They provided insight into terminology used when discussing parenteral contamination including the difference between particle-free vs. sterile and the standards for visual inspection. They also discussed the importance of taking a pro-active approach to quickly source and manage contaminant issues in the manufacturing process to reduce the risk of future contamination and potentially save your company money by preventing potential recalls.
Every time I do training, I try to ask myself, “What is it that I am hoping to get out of this”? Typically in answering that question I also answer, “What do I hope the trainees get out of this?” Although many types of training are required on an annual basis, there is no reason for those doing the training to fall into a routine where they deliver the same set of PowerPoint slides year after year. Granted, there are important messages that must be delivered each and every time a particular topic is presented; however, that does not excuse the trainer from finding a dynamic, inventive and useful approach to deliver that message.