CAPA is both a precursor to and component of RCA that helps people prevent non-conformances from occurring and if all else fails; answer the question of why the non-conformance occurred in the first place. Root Cause Analysis (RCA) is a popular and often-used technique that helps people answer the question of why the problem. What is a non-conformance? When you have a non-conformance in the laboratory..
This presentation is intended to provide the needed documentation practices associated with documentation creation, document approval, handwritten entries, copies of documents, document maintenance and document modification. This document details the minimum documentation requirements for MEDIn still personnel, contractors and consultants completing cGMP documents. Specific operational procedures using more..
This webinar will introduce attendees to the foundations of statistical process control (SPC), including the effects of variation and accuracy on process quality. The definition of a Six Sigma process will be illustrated. Attendees will learn how to construct SPC charts that provide visual controls (easily understood signals) that tell production workers when the process requires adjustment to prevent the m..
Traditional statistical process control (SPC) and process capability assessment techniques assume that the critical to quality (CTQ) variable follows a normal (bell curve) distribution. This condition is fulfilled far more often in textbooks than in real factories, laboratories, and so on. If the statistical distribution is not a bell curve, estimates of the nonconforming fraction (defects per million oppor..
A Leer, A Pat, A Joke, A Gesture, An Innuendo, A Kiss: Are You Prepared To Be the Next Social Media Blitz, Identified on #MeToo, or a Headline in the Newspaper?
Harvey Weinstein, Matt Lauer, Charlie Rose, Al Franken, Garrison Keillor, members of Congress, and various State lawmakers have been accused of sexual harassment and/or sexual assault. But there is a difference between pulling one’s pants down in front of a female colleague at work and touching a woman on her buttocks during a photo op—isn’t there? What is that difference? Are both examples considered sexua..
A whistleblower or qui tam action can provide financial rewards to individuals who provide information that a company, hospital or individual has defrauded the government. The primary statutes under which this relief may be sought are the federal and state False Claims Acts (“FCAs”). State and federal governments pay hundreds of billions of dollars each year for pharmaceutical drugs, medical devices, hospit..
This webinar will show how to expand Shingo maps from individual project applications into evolving, data-driven process documentation for an ISO 9001:2015 or related quality management system. Shingo maps support ISO 9001's process orientation, and also identify opportunities to reduce or eliminate wastes of time, material, and energy (muda). The latter applications support ISO 14001 and ISO 50001 as well ..
Failure mode effects analysis (FMEA) and the control plan are both parts of advanced quality planning (AQP). FMEA, in fact, defines the control points or critical nodes of the control plan; process activities that must be controlled to ensure conformance of the critical to quality (CTQ) product characteristics. The dynamic control plan is a natural combination of the process FMEA and control plan into a sin..
ISO 14001 is an internationally agreed standard that sets the requirements for environmental management systems. It helps organizations improve their environmental performance through more efficient use of resources and reduction of waste, gaining a competitive advantage and the trust of stakeholders. ISO 14001 is suitable for any organization -- all types and sizes, be they private, not-for-profit or gover..
Everyone in a laboratory under compliance knows about 3-sigma out-of-control issues. Can the operation be monitored to avoid these? How? This webinar will cover the basic statistics of compliance and non-compliance and how to use a statistical approach to monitor the operation to ensure that it is under control and to see when a problem is arising, but before it is outside of 3-sigma.Data quality and compli..
Understanding the value of GD&T in downstream applications during the product life cycle is only the first step to rolling out Model-Based Design. GD&T quickly becomes the source for understanding specifications and designing inspection plans used by manufacturing and quality groups at the plant. Because GD&T is intended to drive the process, it is important that it’s correct. Learning the langu..
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allow it. To work with these challenges, it is essential to understand human behavior and the psychology of error as well as understand exactly where the ..
The most important parts of this knowledge are understanding the system - learning how it performs when functioning as designed, verifying how the system performs when applied under worst‐case conditions and experiencing faulty conditions (including mission‐critical failures and safety‐critical failures). A system is defined as a network or group of interdependent components and operational processes that w..
We need a paradigm shift. We need it in a hurry! You cannot cross the sea merely by standing and staring at the water. Do not be afraid to take a big step if one is indicated. No noble thing can be done without risksThis webinar is not a theory. It is about the lessons learned from my experience of over 30 years on safety in medical devices, aerospace, healthcare, nuclear power, subways, consumer products, ..
Most manufacturing problems can be eliminated by better design of components and assemblies. One can call this approach the Design for Manufacturability, meaning the ability to produce the assembly without known defects. Then none or very little inspection is required, no rejects, no rework, no warranty costs, and therefore high quality at low cost!The tool of understanding production-related defects overlo..