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Webinar Description:

Areas Covered in the Session :
Statistical Process Control (SPC)
Product Id FDB1270
Category Food, Drugs & Biologics
Scheduled On Tuesday, June 10, 2014 at 13:00 Hrs
Duration 90 Minutes
Speaker John N. Zorich


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.
Manufacturing involves an attempt to produce items that as closely as possible
meet design specifications (e.g., size, strength, etc.). However, all production processes exhibit
variation --- that is, no two items are identical. What method can we use to reduce such
variation? The classic and still most widely used method is called SPC or "statistical process
control". 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".
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



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Speaker Profile:


Who Will Benefit:
QA/QC Supervisors
Process Engineers
Manufacturing Engineers
QC/QC Technicians
Manufacturing Technicians
R&D Engineers
John 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.