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.
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.
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.
Laboratory equipment qualification, also referred to as analytical instrument qualification (AIQ), is an essential component of good analytical practice. It provides assurance that the instrument will perform accurately and consistently in accordance with specifications and user requirements. The ultimate objective for equipment qualification is the documented and demonstrated assurance that the unit will produce valid data. Qualifications must be performed initially and on an ongoing basis (no less than annually).
Gateway Analytical is currently working through the final stages of the ASCLD/LAB-International accreditation process. After completing the initial stages as well as the on-site audit, compliance with the standards of ASCLD/LAB are continuing to be demonstrated through both the written procedures and practices at the laboratory. Upon final review of all items needed for accreditation approval, Gateway Analytical will be operating in compliance with the guidelines outlined by both ASCLD/LAB-International and ISO 17025:2005. All sub-disciplines, upon final review and approval, will fall under the scope of trace evidence testing.
Method validation is the process of demonstrating that the performance characteristics of an analytical method meet the requirements of the intended use and extended range of interest. Although the parameters may vary depending on the type of the method to be validated, common validation elements that need to be considered are:
I'm excited to say that Gateway Analytical is one step closer to achieving its 2012 goal of ASLCD/LAB accreditation for our forensic trace evidence analysis services. We've submitted the required application materials including the Quality Management System Manual, Statement of Qualifications (SOQs), and Standard Operating Procedures (SOPs), among others, which have been accepted by the assigned assessor and we are now undergoing a document gap analysis. We expect our certification audit to be in May or June and look forward to meeting our goal of ASCLD/LAB accreditation in late Q3 or early Q4!