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.
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.
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.
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: