QMS – Quality Management System
Implementing a quality management system affects every aspect of an organization’s performance. Benefits of a documented quality management system include: These benefits of a QMS offer additional advantages to your business, including: Each element of a quality management system helps achieve the overall goals of meeting the customers, and organization’s requirements. The elements include:
Process Equipment Interchangeability Studies
Interchangeability studies aim to ensure that the technical, functional and performance conditions between two or more pieces of equipment are similar and, therefore, they can be used interchangeably in a process without deviations or any impact on the performance of the process and/or final product. Interchangeability studies are evidence that equipment of the same class […]
Quality Tools – 5S
5S is a program of Japanese origin that was created from the application of five concepts: 1. Seiri = Utilization 2. Seiton = Organization 3. Seiso = Cleanliness 4. Seiketsu = Standardization 5. Shitsuke = Discipline The goal of 5S is to improve certain aspects, such as cleanliness, organization, and standardization. The program is usually implemented as a strategic plan so […]
The cost of Quality by Ana Paula Bertelle
As defined by Philip B. Crosby in his book Quality Is Free, the cost of quality has two main components: the cost of good quality (or the cost of conformity) and the cost of poor quality (or the cost of nonconformity). The cost of poor quality affects: Internal and external costs arising from non-compliance with requirements. […]
Computerized System Validation (CSV) by Ana Paula Bertelle
Computerized system validation consists of the execution of a series of tests that generate documented evidence that the system meets the user’s requirements, the technical and functional specifications, and the regulatory requirements in force for the industry where it will be used. CSV is important because it aims to ensure that the acquired system operates […]