Quality Corner
Quality assurance tips, tricks and advice from Gateway Analytical’s own Quality Assurance Specialist, Tricia Wood. Learn more about handling quality issues and more.
Robustness: An Often Overlooked and Under Appreciated Element of Method Validation
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: Accuracy Precision (repeatability/intermediate precision) [...]
A Discussion on Change Control
Change control is a formal process within the quality management system that ensures significant changes and related execution activities are identified, captured and recorded within a controlled system [...]
The Process Approach to Quality System Management
The process approach to quality is strategy used by many manufacturers and service providers to identify and manage the interaction between systems that comprise an organization. A process can be defined as an integrated set of activities that use various resources to convert inputs to outputs. When adopting the process approach, it is equally as important to identify each process as it is to characterize it. Characterization usually includes defining the following six (6) universal process affecters:
Ensuring Product Integrity Companywide
A quality management system manual (QMSM) is an essential document for any organization. The QMSM should present formally, concisely and systematically, the general principles which guide the management and operation of the organization in order to guarantee the quality and integrity of a product or service.
An Introduction to Quality Management
What is a Quality Management System (QMS)? Well, it can be defined in many ways. One definition is: a collection of policies, procedures, plans and supporting infrastructure by which an organization operates in order to reduce and eventually eliminate non-conformances to specifications, standards and customer expectations in the most cost effective and efficient manner. A [...]
