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.
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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.
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.
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.
One Monday morning in November, an FDA Inspector visited Gateway to perform an inspection. Although we are FDA registered, it came as a complete surprise. It is times like these when you realize how important it is to have a quality management system that is designed to be ‘audit-ready’ at all times. Implementing checks and double checks of all systems (e.g. training, calibration, CAPA, document control, etc.) is crucial for ensuring everything is kept up-to-date per internal procedures and regulatory requirements.