Acceptance Sampling - The Total Picture
Dan O'Leary, President at Ombu Enterprises, LLC
Coming soon.. Please contact customer care for new schedule
How well do you understand sampling plans and their application in your company? Many companies have procedures and program that fall short of the regulatory requirements and good statistical practice. In some cases, FDA may give the firm a 483 or even a Warning Letter. In other cases, the firm may not use the best methods, resulting in waste of resources.
This unique hands-on course will provide attendees with a solid understanding of acceptance sampling methods and their application to medical device manufacturing. The course delivers tools, templates, and insight that will allow participants to implement sampling methods within their firm.
This two-day hands-on course provides a clear understanding of the underlying statistics used in acceptance sampling. The course uses exercises to solidify understanding. As part of the practical implementation, the course explains common standards such as Z1.4 for attribute sampling and Z1.9 for variables sampling. In addition, the course covers other, less well known, methods such as sequential sampling, continuous sampling, and chain sampling.
The course also covers specific applications of sampling including incoming inspection, design validation, design verification, process validation, and quality audits.
Upon course completion, participants will:
- Understand FDA QSR and ISO 13485 requirements for acceptance sampling
- Perform calculations using the binomial distribution
- Perform calculations using the hypergeometric distribution
- Perform calculation using the normal distribution
- Apply tests of normality to a data set
- Understand Acceptable Quality Limit (AQL) and apply it
- Understand Operating Characteristic (OC) curves
- Select sampling plans from Z1.4
- Select sampling plans from Z1.9
- Implement sequential sampling plans (using the Wald method)
- Implement continuous sampling plans (CSP)
- Implement skip-lot sampling plans (SkSP)
- Implement chain sampling plans (ChSP)
Who will Benefit:
- Quality Managers
- Quality Engineers
- Supplier Quality Engineers
- Quality Analysts
- Production and Process Engineers
- Design and Development Engineers
- Verification and Validation Specialists
|Day One (8:30 AM – 4:30 PM)
||Day Two (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
- Introduction/Fundamentals – Regulatory Requirements
Introduction/Fundamentals – Statistics
- Statistical techniques in FDA QSR
- Statistical techniques in ISO 13485
- Validated processes
- Process and product monitoring
- Design verification and validation
- FDA Warning Letters
- Descriptive Statistics
- Graphical Techniques
- The binomial distribution
- The hypergeometric distribution
- The normal distribution
- Tests for normality
Attribute Sampling using Z1.4
- Understanding Acceptable Quality Level (AQL)
- Defining the Operating Characteristic (OC) curve
- Risk (producer and consumer) and the Sampling Plan
Attribute Sampling Using the Dodge-Romig System
- Setting the sampling parameters (AQL and lot size)
- Single, double, or multiple sampling
- Acceptance history (normal, reduced, or tightened sampling)
- Describing the sampling plan
- OC curve
- Average sample number (ASN)
- Average total inspected (ATI)
- Average outgoing quality (AOQ)
- Using Accept on Zero (AOZ) plans instead
- Average Outgoing Quality Limit (AOQL)
- Limiting Quality Level (LQL)
- Using the system
- Variables Sampling Using Z1.9
Sequential Sampling Plans
- The methods (variability known and variability unknown)
- Variability unknown methods (range and standard deviation)
- Calculating the process parameters – the modern approach
- Comparative sample sizes
- Combining attributes and variables plans
Continuous Sampling Plans (CSP)
- The sequential probability ratio
- Calculating the accept and reject regions
- The fan chart as a special case
Skip-Lot Sampling Plans (SkSP)
- Processes that don’t produce lots
- Clearing interval
- Sampling fraction
- OC curve and Average Outgoing Quality Limit (AOQL)
- CSP-1, CSP-2, and CSP-3
Chain Sampling Plans (ChSP)
- Defining the parameters
- The OC curve
- An alternate to Z1.4 reduced inspection (ANSI/ASQC S1)
- Defining the parameters
- The OC curve
- Design verification and validation
- Process validation
- Incoming inspection
Meet Your Instructor
President at Ombu Enterprises, LLC
Dan O'Leary has more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a master’s degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.
Dan is a regular speaker at international conferences including ASQ, ISM, and RAMS. Dan teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. Dan is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; he holds an APICS certification in Resource Management.
Register by P.O. / Check
Yes, I want to attend "Acceptance Sampling - The Total Picture".
Click here to download P.O. form
If you are paying by check:
Checks should be payable to MetricStream Inc. (our parent company) and mailed to:
2479 East Bayshore Road
Palo Alto, CA 94303
Send your team for maximum benefit.
Get your team up to speed!
Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.
||Get 10% off
|3 to 6 Attendees
||Get 20% off
|7 to 10 Attendees
||Get 25% off
||Get 30% off
Call toll free on +1-888-717-2436 if you have any queries.
Register by Wire Transfer
If you wish to pay by wire transfer, please call us toll free on +1-888-717-2436
Terms & Conditions to register for the Seminar/Conference/Event
Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ email@example.com
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)
Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
Attendance confirmation and Documents to carry to the seminar venue:
After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.
Conference photograph / video:
By registering and attending ComplianceOnline conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by ComplianceOnline for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline for any kind of claims arising out of copyright or privacy violations.
If you wish to partner with us for this event
contact us: firstname.lastname@example.org
call us: +1-888-717-2436.
Media Partner Benefits
- Logo and company data on the event website.
- Logo on the conference material distributed during the conference.
- Media Partner’s brochure distributed along with conference material.
- Logo on all the mailings before and after the event.
- 10% discount to media partner's subscribers.
Media Partner to do
- Banner (min 728x90 or 468x60) on the Media Partner website.
- Insertion of the event in the event calendar, both printed and/or online.
- Announcement article of the conference on the Magazine and/or Website.
- Dedicated email blast to all subscribers of Media Partner.
- Article on the Magazine and/or Website after the conference.
If you wish to sponsor this event
contact Cruise Webster: email@example.com
call us: (207) 576-4173
San Diego Cabrillo National Monument
The first European to set foot in California was the Spanish explorer Juan Rodriguez Cabrillo, who stepped on shore near this spot in in 1542. He's the guy they made this statue to look like - and named the park after. We don't know if Cabrillo climbed all the way up to the top of this promontory or not, but people who make up here nowadays get some of the best views of San Diego, looking across the Bay and back toward downtown.
Sea Creatures at Birch Aquarium
Birch Aquarium is north of San Diego in La Jolla. It's not as big as some of the other aquariums in California or as flashy as the big sea-themed park down the road, but instead just right, filled with interesting exhibits and home to leafy sea dragons like the one above, creatures so improbably they look more like something from a children's book than from the ocean.
Legoland theme park takes its inspiration from Lego toys, those cute little bricks that snap together to build all kinds of fun things. It's one of several Legolands worldwide.
San Diego Zoo Safari Park
The San Diego Zoo's sister park offers a different kind of animal experience. Its name (Safari Park) is the clue and it indeed offers a more safari-like experience. Lots of large animals live in the same big, open areas here - predators kept away from prey, but otherwise much as they would in their natural habitat.
Coronado isn't really an island but a peninsula - a fact that doesn't get in the way of the name most people use for it. Whatever you call it, it's on a slender strip of land between the San Diego Bay and the Pacific Ocean, barely a few blocks wide. What it lacks in size it makes up for in fun, with a beach that's been named among the best in the country, a classic hotel and a compact, lively little downtown. Coronado's laid-back temperament makes a nice break from the busier parts of San Diego across the water.
Originally built for temporary use during the 1915-16 Panama-California Exposition in San Diego, Balboa Park boasts buildings beautiful enough to be considered attractions in themselves, especially if you're a photographer. They're surrounded by trees, lawns and fountains, but that's only the beginning.
In Spanish, La Jolla means "the jewel," an apt name for a pretty, Mediterranean-style seaside town - sitting on cliffs flanking the ocean.
La Jolla visitors like to shop and eat in the nice restaurants, some of them with lovely ocean views. There's a lot for the active visitor, too, including ocean kayaking, tide pool-hopping, surfing at Windansea Beach, biking or running along the waterfront.