The purpose of this article is to show how a Quality practitioner can effectively enhance their Lean Six Sigma improvement efforts using available technology. Following the established framework of Define, Measure, Analyze, Improve, and Control, technology can enhance the coverage, predictability, and effectiveness of these in ways that exceed the limitations of manual work.
This article explains how a Quality leader can establish external requirements by defining products in a specific region, using medical devices as an example based on FDA regulation Section 201(h) and the 513g Request process. Following this prevents wasting time, funds, and resources on incorrect regulatory assumptions.
A robust supply chain should be successfully reconciled across five sources of information: Approved Vendors, Master Agreements, Transactions, Deliveries, and Payments.
This article considers how quality professionals and practitioners can more effectively prepare for their certification exams which are proctored or supervised as they complete a selection of responses from multiple-choice questions.
There are times when a Quality practitioner may be called upon to support team members in ways that go beyond the strict interpretation of the role. These are described in a way that indicates the necessary situation, along with the constructive outcomes from such involvement.
The purpose of this article is to show different examples of how a quality professional can exert influence on colleagues and team members, without having direct authority over those participants.