The purpose if this paper is to explain the process approach in ISO 9001:2015. The process approach can be applied to any organization and any management system regardless of type, …

Process Validation: General Principles and Practices U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) …

This information may be included as an annex to the Special Process Operation, Validation & Process Control document, or alternatively, it can be provided as a reference to a spreadsheet …

Flowchart A flowchart — also known as a “process map” — is a visual representation of the sequence of steps in a process. Understanding the process as it currently operates is an …

APQC’s Process Classification Framework (PCF)® creates a common language to discuss, benchmark, and organize the work that businesses perform. In this article, you will learn: how …

This guide provides instructions on performing a capability analysis using the Distribution and Control Chart platforms. A process capability analysis is used to evaluate the performance of a …

Process Piping Fundamentals, Codes and Standards One of the most important components of the process infrastructure is the vast network of pipelines —literally millions and millions of …