Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC

<< Go Back

Overview The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglias C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product. The advantages of "confidence/reliability" calculations are explained. Such calculations are demonstrated for Attribute data (pass/fail, yes/no data) as well as for variables data (i.e., measurements). If variables data is "Normally distributed" the calculations are extremely simple. T he webinar explains how to handle "non-Normal" data, and provides the methods, formulas, and tools to handle non-normality. The webinar includes a discussion of how one OEM manufacturer has implemented "confidence/reliability" calculations instead of AQL sampling plans for all of its clients. And suggestions are given for how to use "confidence/reliability" QC specifications instead of "AQL" QC specifications. The use of "reliability plotting" for assessing product reliability during R&D is also discussed. The webinar also includes an examination of ISO and FDA regulations and guidelines regarding the use of statistics, especially in regards to Sampling Plans. Why should you Attend Almost all manufacturing companies spend time and money to inspect purchased parts upon receipt, in order to evaluate part quality before the parts Supplier is paid. "AQL" sampling plans are used almost universally for such inspections. However, AQL plans actually provide very little information about part quality. A better way to assess the quality of purchased parts is to use "confidence/reliability" calculations. Such calculations are very easy to perform using tables and/or an electronic spreadsheet. ISO 9001 and ISO 13485 requirements include establishing "processes needed to demonstrate [product] conformity"; FDAs GMP (21CFR820) requires that "sampling methods are ad-equate for their use". An AQL sampling plan does not provide what is needed to meet either of those requirements. FDA guidelines state that "A manufacturer shall be prepared to demonstrate the statistical rationale for any sampling plan used" it is not possible to "demonstrate" that an AQL sampling plan ensures product quality. On the other hand, confidence/reliability calculations can be easily shown to provide evidence of product quality, and the statistical rationale for such calculations is easy to explain and demonstrate. Areas Covered in the Session AQL and LQL sampling plans OC Curves AOQL ANSI Z1.4 Squeglias C=0 Confidence/Reliability calculations for Attribute data Normally-distributed variables data Non-Normal data Transformations to Normality K-tables Normal Probability Plot Reliability Plotting Who Will Benefit QA/QC Supervisor Process Engineer Manufacturing Engineer QA/QC Technician Manufacturing Technician R&D Engineer Speaker Profile John N. Zorich has spent almost 40 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 next 15 years were as a consultant in the areas of QA/QC and Statistics. These last few years were as a trainer and consultant in the area of Applied Statistics only. 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. Event link: https://www.traininng.com/webinar/-200873live?channel=internationalfair-May_2019_SEO Contact Info Traininng.com LLC Email: traininngdotcom@gmail.com Phone: US: (510) 962-8903 Phone: Zurich: +41 - 43 434 80 33 Website : https://www.traininng.com

Visitors Attending

+Attend Now

okwchjso

1
Acunetix

3137 Laguna Street

Omowumi

Executive Director, GoldenTech
GoldenTech

6, Birkenhead suit

Dada Seun Deborah

Nursing officer
Lagos State health service commission

No 70,college road, idiagbon bus stop, Lagos, Nigeria

Dada Seun Deborah

Nursing officer
Lagos State health service commission

No 70,college road, Idiagbon bus stop, Lagos, Nigeria

Exhibitors Attending

+Attend Now

wbvfanpy

1
Acunetix

3137 Laguna Street

Gallery

Video Presentation

Teaser

Our Projects

1- Fruit Expo 2019
2- CEIE 2018 China Qingdao International Education and Information Exhibition
3- Hi and Fi Guangzhou 2018
4- 2018 Children Nutrition Expo
5- XR China 2018 China VR AR and Visual Entertainment Show
6- CWFE 2018 China West Forestry Expo
7- Qingdao International Beauty Expo 2018
8- The 2nd World KungFu Exhibition
9- The 2nd World Sports Fitness Exhibition
10- China Zhengzhou International Sports Industry Expo 2018
11- Internet powered by CEBIT 2018
12- The 11th China International Auto Parts Jinan Exhibition
13- The 11th China Jinan Lubricating Oil Grease Maintenance Equipment Exhibition
14- FHC Food And Hotel China 2018
15- HFAIR 2018 The 18th China Beijing International Food And Beverage Exhibition
16- AHIA 2018 Wuhan International Industrial Assembly and Handling Expo and Wuhan International Factory and Process Automation Technology Exhibition
17- The 8th Beijing International Rehabilitation Home Medical and Pension Industry Expo
18- West Lake Art Fair
19- The 20th Shanghai International Wine and Spirits Exhibition 2018
20- China Shanghai International Emergency and Fire Safety Expo 2018
21- RES 2018 International Chain Restaurants Equipment and Supply Exhibition
22- ECOTECH CHINA WASTE 2018
23- The 12th China Beijing International Outdoor Sporting Goods and Equipment Exhibition
24- Beijing 14th International Theme Parks Childrens Parks and Amusement Parks Exhibition 2018
25- HNC 2018 Healthplex Expo Natural and Nutraceutical Products China
26- Hi China 2018 Health Ingredients China
27- ECOTECH CHINA AIR 2018
28- ISGS 2018 China Beijing International Sporting Goods Expo
29- Shanghai Gift Show 2018 16th Shanghai International Gifts Premiums Household Products Exhibition
30- Fastener Expo Shanghai 2018
31- P MEC China 2018 co located with CPhi China
32- The 15th Shanghai International Footwear Fair
33- Shanghai Gift Show 2018 16th Shanghai International Gifts Premiums Household Products Exhibition
34- PTCBJ 2018 The 14th China Beijing International Power Transmission and Control Technology Exhibition
35- SIAL China 2018 Asia largest food innovation exhibition
36- 2018 China Yiwu Hardware and Electrical Appliances Trade Fair
37- China Beauty Expo 2018
38- Bakery China 2018
39- The 15th Guangzhou International Musical Instruments Expo Music Guangzhou 2018
40- FLOWTECH CHINA 2018
41- 2018 Fashion Source Exhibition for Clothing Supply Chain Spring
42- IAMD Beijing Integrated Automation Motion and Drives Exhibition 2018
43- CRAFT BEER CHINA CBCE 2018
44- The 20th China Guangzhou Intertwine Wine and Spirits Exhibition
45- The 6th Shanghai International Aerospace Technology and Equipment Exhibition 2018
46- The 4th China International Food Meat and Aquatic Products Exhibition FMA CHINA 2018
47- The 9th China Guangrao International Rubber Tire and Auto Accessory Exhibition
48- 7th China Forex Expo of 2018
49- SREX 2018 Shenzhen Real Estate Expo
50- 11th Franchise Investment and Entrepreneurship Exhibition Hunan
51- The 16th Wenzhou INTL Optics Fair WOF
52- Kitchen and Bath China KBC 2018
53- The 6th Shanghai International Aerospace Technology and Equipment Exhibition 2018
54- International Apparel & Textile fair 2018
55- Construct Ghana 2018
56- Morrocco Automotive 2018
57- POWERELEC GHANA 2018
58- TEXTYLE EXPO 2018
59- THE WOMENS LIFE STYLE EXPO 2018
60- HI TECH EXPO 2018
61- ARAB MEDICAL TRAVEL 2018
62- SIPREMIUM 2018
63- Intex South Asia 2018
64- AUTO PARTS WEST AFRICA 2018

Premium Partners

Image: 
       
Image: 
       
Image: 
       
Image: 
       
Image: 
       
Image: 
       

About Us

"TAKE YOUR EVENT TO WORLD AND BRING WORLD TO YOUR EVENT ". We are a media...
Read More

Contact

  • query@internationalfair.in
          internationalfair.in@gmail.com
  • +86-13710256146
  • +86-13924210874

Stay Connected on:

India Address

599 West Parmanand Colony Mukherjee Nagar Delhi 110009 - India

  • query@internationalfair.in
          internationalfair.in@gmail.com
  • +91-9278157157
  • +91-9711192356
  • Member Of