91AV

Introduction

SPC is a statistical tool that objectively identifies when it is worthwhile to perform a formal investigation of manufacturing variation, in order to identify and reduce its cause. SPC continually adjusts its sensitivity in order to ensure that such investigations are performed only when there is a reasonable chance of identifying causes of variation. SPC also provides information that can be used to estimate what % of items is being produced "in specification".

Why should you attend: All companies want to improve the quality of their products. Attempts to improve product quality need to be structured in such a way that they have a reasonable chance of success and the cost/benefit ratio is appropriate. The most successful method available for such endeavors is called SPC (statistical process control). SPC can also be used to meet ISO requirements for "continual improvement" as well as FDA requirements to "control and monitor production processes". SPC can even be used to monitor complaint rates, to determine if there has been a "significant" increase in complaints, which would therefore trigger an MDD "vigilance report" and/or an FDA MDR submission.

Areas Covered in the Session:

Definition of relevant terms
Types of control charts
Calculation of control limits for an XbarR chart
Rules for detecting "out of control"
Sampling
Process Capability Indices (Cp, Cpk, Pp, Ppk)
SPC Program implementation

Useful links

Speakers

• John N. Zorich John N. Zorich has spent 35 years in the medical device manufacturing industry; the first 20 years were as a "regular" employee in the areas of R&D, Manufacturing, QA/QC, and Regulatory; the last 15 years were as consultant in the areas of QA/QC and Statistics. His consulting clients in the area of statistics have included numerous start-ups as well as large corporations such as Boston Scientific, Novellus, and Siemens Medical. His experience as an instructor in statistics includes having given 3-day workshop/seminars for the past several years at Ohlone College (San Jose CA), 1-day training workshops in SPC for Silicon Valley Polytechnic Institute (San Jose CA) for several years, several 3-day courses for ASQ Biomedical, numerous seminars at ASQ meetings and conferences, and half-day seminars for numerous private clients. He creates and sells formally-validated statistical application spreadsheets that have been purchased by more than 75 companies, world-wide., United States

---

Venue

online event

online event , NetZealous LLC, 161 Mission Falls Lane , Suite 216, California, Fremont, 94539, United States

Useful links

Organised by

Compliance4All, the ultimate continuing professional education provider offers you regulatory and compliance trainings from the industry's leading experts, but with one crucial difference -the cost. Compliance4All's objective is to be a platform that provides regulatory and compliance trainings with all the class and features that come with these trainings, at a lower price. Compliance4All seeks to make regulatory and compliance trainings low-hanging fruits.

Compliance4All

Contact information

Adam Fleaming
Compliance4All
8004479407
Contact us by email

---