1 / 5

Process Capability Analysis using Confidence/Reliability Cal

The seminar begins with a discussion of relevant regulatory requirements, as motivation for calculating "confidence/reliability". Then, some vocabulary and basic concepts are discussed.

compliancetrainings
Download Presentation

Process Capability Analysis using Confidence/Reliability Cal

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. ContactUs:416-915-4458 Webinar On Webinar On Process Capability Analysis using Confidence/Reliability Calculations Presented By John N. Zorich Thursday, April 9, 2015 at 13:00 Hrs Hosting By Compliance Trainings Please visit us at https://compliancetrainings.com

  2. ContactUs:416-915-4458 WeEmpower,YouComply! Process Capability Analysis using Confidence/Reliability Calculations Product Id MD1277 Category Medical Devices Thursday, April 9, 2015 at 13:00 Hrs Scheduled On Duration 90 Minutes Speaker John N. Zorich Login at https://compliancetrainings.com/siteengine/Login.aspx WebinarDescription: 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 "in-specification"). 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 % in-specification 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 % in-specification, which conclusion we can state with a specific level of confidence (e.g., 95% confidence of 99% reliability, or 90% confident of 93% reliability").

  3. 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

  4. 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.

  5. To Register This Webinar Please Visit https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1277 Contact Us For Immediate Assistance At 416-915-4458 or Mail Us At uttam@compliancetrainings.com support@compliancetrainings.com

More Related