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Webinar On Webinar On Process

Capability Analysis using
Confidence/Reliability Calculations

Presented By John N. Zorich

Thursday, April 9, 2015 at 13:00
Hrs

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Compliance
Trainings

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Process Capability Analysis using Confidence/Reliability

Calculations
Product
Product Id
Id
Category
Category

MD1277
MD1277
Medical
Medical Devices
Devices

Scheduled
Scheduled On
On
Duration
Duration

Thursday,
Thursday, April
April 9,
9, 2015
2015 at
at 13:00
13:00 Hrs
Hrs
90
90 Minutes
Minutes

Speaker
Speaker

John
John N.
N. Zorich
Zorich

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https://compliancetrainings.com/siteengine/Login.aspx
Webinar Description:
All manufacturing and development companies perform testing
and/or inspections that involve concluding whether or not a product
or lot is acceptable vs. design or QC specifications. Such
test/inspections may occur during design verification/validation or
during incoming or final QC.
The most informative method for analyzing the data that results from
such activities is the calculation of the product's or lot's "reliability" at
a chosen "confidence" level (where "reliability" means "inspecification"). Such a method produces information that is more
valuable than simply that the given product or lot "passed" (as is the
case when "AQL Attribute Sampling Plans" are used) or a % inspecification statement without any corresponding confidence
statement (as is the case with AQL Variables Sampling Plans and with
Process Capability calculations).
The output of a "Confidence/Reliability" calculation is a definitive
statement that the given product or lot has a specific % inspecification, which conclusion we can state with a specific level of
confidence (e.g., 95% confidence of 99% reliability, or 90% confident
of 93% reliability").

Areas Covered in the Session :

The seminar begins with a discussion of relevant regulatory
requirements, as motivation for calculating "confidence/reliability".
Then, some vocabulary and basic concepts are discussed.
Next, detailed descriptions are given for how to calculate
confidence/reliability for data that is either pass/fail (i.e., "attribute"
data), normally-distributed measurement data, non-normally
distributed measurement data that can be transformed into
normality, or non-normally distributed measurement data that
cannot be transformed into normality. Spreadsheets are shown as
examples of how to implement the methods described in the
seminar. A final discussion is provided on how to introduce the
methods into a company.
All the above is captured in these bullet points:
Regulatory Requirements
Vocabulary and Concepts
Attribute Data
Normal Data
Normal Probability Plotting
Non-Normal Data that can be normalized
Reliability Plotting (for data that cannot be normalized)
Implementation Recommendations

Who will Benefit

A must attend webinar for all

QA / QC Supervisors
Process Engineers
Manufacturing Enginee
QA / QC Technicians
Manufacturing Technicians
R&D Engineers

Speaker Profile:

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.

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