While communication is not the sole responsibility of the quality department, it certainly plays a large role in the management and execution of an effective quality system. Even for the most organized and well documented quality system, successful communication is a must. Although I have discussed effective communication in the past, I want to focus on written communication. In the day and age of texting and social media, it seems as though with all of means for personal interface that we would become better at communication. However, I have noticed when it comes to thorough and precise written communication, it now seems to be a coveted skill rather than an inherent capability.
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.
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.
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.
During the course of my 25 year career in QA/QC, I have hosted and/or participated in an estimated 70 audits. This includes both certification and customer audits. Over the course of those years, my approach has changed quite a bit. Early on, I would approach audits with angst and trepidation. In other words, I would dread them. But over the years, experience (and yes age) has changed that view, as I now see audits as tools for improvement. I’ve also come to realize that auditors are people too and not to be feared—especially since I have conducted many audits myself.
PITTSBURGH, PA – Gateway Analytical announced today that the company received its 17025:2005 accreditation from the American Association for Laboratory Accreditation (A2LA). This accreditation is another illustration of Gateway’s commitment to quality and technical expertise, and focuses on material science and industrial forensics laboratory testing.
By definition, management review is a formal meeting of top management with the purpose of reviewing and evaluating the effectiveness of the quality management system. Yes, I know, it sounds like another humdrum status report meeting. And unfortunately, that is the way it is viewed and conducted by many organizations. Management review is too often regarded as something to check off the list in order to satisfy a standard or an auditor. I must admit, when I first started holding management reviews, I shared that view. I would diligently set my agenda to include all of the required items; then I would simply steamroll through them. I’d write my report, file it away, and then proudly present it to the next auditor to examine. As a result, nothing was really gained and much valuable time was lost.
On November 14th, Dave Exline, Senior V.P. and Rebekah Wagurak, Forensic Scientist at Gateway Analytical hosted a webinar designed for laboratory and manufacturing personnel that are responsible for quality assurance and quality control of processes in the manufacturing of pharmaceuticals. This webinar discussed case studies and walked participants through the process of a failure analysis investigation, common methods used, and interpretation of analytical data to improve overall process development and quality control.