If Today an FDA auditor arrives unannounced to your Pharmaceutical Plant, there is a 54.1% chance that you will be receiving a dreaded 483 with a list of observations.As a professional you need to know, for yourself, what the FDA is focusing when assessing Pharmaceutical operations.You will find here:5 FDA Observations:1.Observation for Training.2.Observation for Facilities and Equipment.3.Observation for Quality systems4.Observation for Pro...

Theyre supposed to be useful tools, but whether theyre printouts, computer files, flowcharts, or forms, documents can often give more headaches than help. And yet without them, most organizations couldnt function. ISO 9001 and other quality management systems place great emphasis on documents, and for good reason. Documents arent individual, stand-alone elements of the management process. Theyre interrelated, formatted in different media, and controlled by various and distinct functions. Keep...

Do you have recurring problems that are costing you time and money? Unresolved problems do more than aggravate. They can increase costs, lower quality, and drive customers away. Plus, quality management processes, such as ISO 9001, require organizations to have a corrective and preventive action process in place. Root cause analysis is integral to the success of any corrective action or problem-solving process. Unfortunately, root cause analysis is an often maligned, misunderstood, an...

Here is a chapter from Six Sigma Statistics with Excel and MINITAB . This is a comprehensive and easy-to-use guide for understanding and using Excel and MINITAB programs for Six Sigma statistical data analysis. Each chapter includes relevant theory and technique, step-by-step exercises, case studies, graphical illustrations and screen shots for performing the techniques in both Excel and MINITAB.

Continual improvement is not optional. It is a condition of survival. Every organization must have systematic methods for making smart decisions, attacking problems, improving its products and services, and repelling competitors. Anything less than a systematic, disciplined approach is leaving your future in the hands of chance.This book presents a range of practical methods for driving continual improvement throughout the organization. The starting point is leadership, with a clear d...

Here is a chapter from Six Sigma Statistics with Excel and MINITAB . This is a comprehensive and easy-to-use guide for understanding and using Excel and MINITAB programs for Six Sigma statistical data analysis. Each chapter includes relevant theory and technique, step-by-step exercises, case studies, graphical illustrations and screen shots for performing the techniques in both Excel and MINITAB.

Here is a chapter from Six Sigma Statistics with Excel and MINITAB . This is a comprehensive and easy-to-use guide for understanding and using Excel and MINITAB programs for Six Sigma statistical data analysis. Each chapter includes relevant theory and technique, step-by-step exercises, case studies, graphical illustrations and screen shots for performing the techniques in both Excel and MINITAB.

In The ENCORE Approach for Financial Advisors: Delivering the Ultimate Client Experience, Rob Brown, founder of Encore Partners, lays out a surprisingly straightforward, step-by-step approach advisory firms and broker-dealers can follow to re-energize business and move to the highest level of success. Walking the reader through a precise process for “Delivering the Ultimate Client Experience,” the book utilizes unique information design principles to ensure that you climb quickly ...

Here is a chapter from Six Sigma Statistics with Excel and MINITAB . This is a comprehensive and easy-to-use guide for understanding and using Excel and MINITAB programs for Six Sigma statistical data analysis. Each chapter includes relevant theory and technique, step-by-step exercises, case studies, graphical illustrations and screen shots for performing the techniques in both Excel and MINITAB.

Make breakthroughs in project quality by combining project management with quality management - this books shows you how. Guiding you from project initiation through closure, the book provides a detailed stage-specific flowchart of activities correlated with appropriate tools to give you new power to meet customer expectations and institutionalize project quality.

As distinguished from autonomous maintenance, where the main goal is to restore basic conditions of cleanliness, lubrication, and proper fastening to prevent accelerated deterioration, FEI looks at specific losses or design weaknesses that everyone previously thought they just had to live with. Once your TPM operator teams are progressing with their daily autonomous maintenance activities, you will want to take the next advanced step in TPM training with this book.Key Featu...

The change from traditional ways of producing and managing healthcare services to a just-in-time approach requires a new understanding about what adds value for the patient or customer, and what does not. Just-in-Time for Healthcare is intended to share powerful knowledge that will help you participate effectively in the change to just-in-time.Part of the Lean Tools for Healthcare series, this user-friendly book is designed to improve understandin...