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, size or complexity.

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) Center for Biologics ...

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 stored on a …

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 important step in …

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 to access process …

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 for 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 miles. The …