BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240329T154924Z UID:a6699c41-2c97-44d7-94f2-e8b32a338196 DTSTART:20210215T090000 DTEND:20210216T090000 CLASS:PRIVATE DESCRIPTION:
The 2-day seminar explains how to apply stat istics to manage risks and verify/validate processes in R&\;D\, QA/QC\, and Manufacturing\, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as fo llows:
\n\nAlmost all design and/or manufacturing companies evaluate product and processes eith er to manage risks\, to validate processes\, to establish product/process specifications\, to QC to such specifications\, and/or to monitor complian ce to such specifications.
\n\nThe various statistical methods used to support such activities can be intimidating. If used incorrectly or ina ppropriately\, statistical methods can result in new products being launch ed that should have been kept in R&\;D\; or\, conversely\, new products not being launched that\, if analyzed correctly\, would have met all requ irements. In QC\, mistakenly chosen sample sizes and inappropriate statist ical methods may result in purchased product being rejected that should ha ve passed\, and vice-versa.
\n\nThis seminar provides a practical ap proach to understanding how to interpret and use more than just a standard tool-box of statistical methods\; topics include: Confidence intervals\, t-tests\, Normal K-tables\, Normality tests\, Confidence/reliability calcu lations\, Reliability plotting (for extremely non-normal data)\, AQL sampl ing plans\, Metrology (i.e.\, statistical analysis of measurement uncertai nty )\, and Statistical Process Control. Without a clear understanding and correct implementation of such methods\, a company risks not only signifi cantly increasing its complaint rates\, scrap rates\, and time-to-market\, but also risks significantly reducing its product and service quality\, i ts customer satisfaction levels\, and its profit margins.
\n\nRegula tory Requirements
\n\nVocabulary and Concepts
\n\nConfidence Int ervals (attribute and variables data)
\n\nStatistical Process Control (with focus on Xba rR charts)
\n\nConfidence/Reliab ility calculations for Proportions
\n\n< strong>Confidence/Reliability calculations for Normally distributed data ( K-tables)
\n\nProcess Capability Indices calculations(Cp\, Cpk\, Pp\, Ppk)
\nConfidence/Reliability calculations for MTTF and MTBF (th is typically applies only to electronic equipment)
\n\nStatistical Significance: t-Tests and related " \;power"\; estimations
\n\nM etrology (Gage R&\;R\, Correlation\, Linearity\, Bias\, and Uncertainty Budgets)
\n\nQC Sampling Plans (C=0 and Z1.4 attribute AQL plans\, and alternatives to such plans)\, incl uding OC curves\, AQL vs. LQL/LTPD\, AOQL\, and calculation of acceptance rates.
\n\nStatistically valid s tatements for use in reports
\n\nSummary and Implementation Recommendations
\nJohn 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& amp\;D\, Manufacturing\, QA/QC\, and Regulatory\; the last 15 years were a s 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 larg e 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 Insti tute (San Jose CA) for several years\, several 3-day courses for ASQ Biome dical\, numerous seminars at ASQ meetings and conferences\, and half-day s eminars for numerous private clients. He creates and sells formally-valida ted statistical application spreadsheets that have been purchased by more than 75 companies\, world-wide
\n