Knowledge management & effective change management

At ASQ BOSCON 2019 I spoke on “Knowledge management & effective change management.” From my proposal: An effective change management system includes active knowledge management, leveraging existing process and product knowledge; capturing new knowledge gained during implementation of the change; and, transferring that knowledge in appropriate ways to all stakeholders. This session will focus on … Continue reading Knowledge management & effective change management

Knowledge management as continuous improvement

An effective change management system includes active knowledge management, leveraging existing process and product knowledge; capturing new knowledge gained during implementation of the change; and, transferring that knowledge in appropriate ways to all stakeholders. Any quality system (any system) has as part of it’s major function transforming data into information; the acquisition and creation of … Continue reading Knowledge management as continuous improvement

Knowledge Management

ICH Q10 “Pharmaceutical Quality System” describes a lifecycle approach, from development through product discontinuation. The knowledge about a pharmaceutical product and the processes required to reliably produce that product starts with product and process development. An effective pharmaceutical quality system (PQS) uses the knowledge acquired throughout the lifecycle of the product, builds on that knowledge, … Continue reading Knowledge Management

Q9 (r1) Risk Management Draft

Q9 (r1) starts with all the same sections on scope and purpose. There are slight differences in ordering in scope, mainly because of the new sections below, but there isn’t much substantially different. 4.1 Responsibilities This is the first major change with added paragraphs on subjectivity, which basically admits that it exists and everyone should … Continue reading Q9 (r1) Risk Management Draft

Risk Management is our Ability to Anticipate

Risk assessment is a pillar of the quality system because it gives us the ability to anticipate in a consistent manner. It is built on some fundamental criteria: Criteria Asks Ensure Expertise What sort of expertise is relied upon to look into the future Diversity in expertise. Drive out subjectivity Frequency How often are future … Continue reading Risk Management is our Ability to Anticipate