Keynote Speaker Announced for Minnesota Quality Conference

MNASQ is pleased to announce the keynote speaker for the Minnesota Quality Conference to be held on November 13th at Earle Brown Heritage Center. We are thrilled that Captain Scott A. Colburn will speak about Quality & Risk Management: Connecting Stakeholders in a Fast-Paced World.

Captain Colburn is the Director of the Standards and Conformity Assessment Program at the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH). In this role, he is responsible for the Center’s standards recognition and related development activities in ~600 national and international consensus standards committees. In addition, Capt Colburn oversees the programs new Accreditation Scheme for Conformity Assessment [ASCA] pilot program and the Center's efforts in harmonizing standards within the International Medical Device Regulators Forum (IMDRF). Learn More.
 

This year’s conference is comprised of three tracks – Technical Skills, Risk Management Skills, and Project Soft Skills – to equip organizations and individuals with tools, concepts and skills to effectively apply risk-based thinking.

Conference Presentation Spotlight: Simplify the Design and Automate the Data Analysis to Reduce Project Risk Track: Risk Management Skills Speaker: Edward Jaeck Many of us have been on teams that had overly complex designs with the majority of features being called critical.  If you are in a regulated industry and work with design freeze, design validation, or process validations then you will enjoy this presentation as we will share ideas and tools on how to keep the designs simple, the validation strategies flexible and the data analysis a breeze.  We will discuss a custom Minitab Macro that we developed based on years of experience teaching and using Minitab in the medical device space. The macro takes data from a standard Excel template and brings it into Minitab, checks for outliers, checks normality, then runs confidence/reliability tolerance interval calculations and Ppk calculations.  It outputs all the graphics into simple to read and understand Word or PowerPoint formats. The macro takes mundane data analysis and automates it which improves data integrity and helps to create standard work across the organization. The user is free to add to the Minitab file for ad-hoc analysis where needed. Lastly, the macro reduces data analysis and summary time by 85-95% which saves time and money for those doing supplier validations or internal DF, DV and OQ/PQ validations.  Using the tools and techniques discussed, risk to the project is minimized due to simpler designs, flexible validation strategies and automated validation data analysis. The presentation material here has several targeted audiences.  Senior management will appreciate the ideas on ways to simplify the design complexity as this is something, we all face in new product development. Quality engineers and managers will see how they can help keep the design less complex and how they can help create a validation strategy that is bullet proof and has a high likelihood of passing on the first pass.  The project management office team will enjoy the methods as tools that enable first pass validation success which keeps projects on schedule and under budget. While the concepts shared are simple to watch and listen to (basic to intermediate), the validation discussion and macro are advanced in what they do and how they do it so seasoned data analysts and statisticians will enjoy this talk as well. About the Presenter  Edward Jaeck is Vice President of Strategic Growth and Business Development at Lowell Inc in Minnesota.  Prior to his current role he was VP of Operations and Quality at Lowell. Prior to Lowell, he worked at Medtronic in the Endovascular and Coronary business units in California and at Intel in AZ where he worked in the advanced electronics packaging groups.  He has collaborated with suppliers in Japan, China, Taiwan, Singapore, Malaysia, Philippines, Republic of Korea, Costa Rica, Germany, Italy, Mexico, and Ireland. Edward has a Bachelor’s degree in Mechanical Engineering, a Master’s degree in Industrial Engineering and a Master’s degree in Engineering Management.   Check out this link to the latest Lowell article in ODT magazine on innovative ways to streamline data analysis for validations.

Conference Presentation Spotlight: Key Skills for Acceptance Sampling

Track: Technical Skills
Speaker: Karen Hulting

Acceptance sampling can be used to protect both producers and consumers against the release of highly defective lots of product.  The definition of “highly defective” depends on the application and the method can be tuned to meet the needs of a wide range of product types and use conditions.  On the other hand, acceptance sampling does not guarantee that products released are defect-free. This session will discuss the strengths and challenges of the method.

Skill at acceptance sampling requires understanding of many terms and acronyms:  AQL, RQL, LTPD, P(Acceptance), proportion defective, OC Curve, alpha, beta and more.  These terms will be defined and illustrated with graphs and real applications. The calculations used in acceptance sampling rely on binomial and normal-distribution probabilities and can be carried out in Minitab ™ software.  Detailed instructions for acceptance sampling in Minitab plus application to real-world problems will be provided.

About the Presenter