Cara Plese, M.S., Senior Scientist
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.
On October 30th, David Exline, Senior V.P. and Antonio Scatena, Laboratory Manager at Gateway Analytical hosted a webinar designed for laboratory and manufacturing personnel that encounter contaminants and foreign particulate matter in the manufacturing, process/product development and customer returns. This webinar discussed the process by which contaminants and foreign particles are isolated, identified, tracked to find the source of the issue, and then addressed to ensure that the issue does not arise again.
We are now one (1) of only two (2) private labs in the country that is accredited to this standard for trace evidence, and we are the only private lab in the country to be accredited for gunshot residue analysis.
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).
Customer feedback is an invaluable tool for measuring the effectiveness of your quality management system. ISO 9001:2008 has made the customer the primary focus of the quality management system, as it is a recurring theme throughout the standard. As such, the standard recognizes the value in using customer feedback to gauge success, and as a tool for continuous quality improvement.
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.
On May 30th, David Exline, Senior V.P. at Gateway Analytical presented a webinar that covered an overview of wear debris characterization for laboratory personnel that evaluate quality issues with medical devices. This webinar focused on the causes of wear debris, the affects of such debris on product quality, acceptable limits and methods for ensuring quality products.
A solid equipment control program is an integral component of any laboratory quality management system. The goal of the equipment control program is to ensure that your equipment is under established controls at all times. Equipment control is an area too lengthy to comprehensively define in a short article, so I’ve included some key points to keep in mind.