Where: Munich Haus, 13 Center St, Chicopee, MA 01013.
Dinner: Starts at 7 pm, $27.00 includes a full meal with 17 choices, drinks additional
Continuing Education: 0.5 CEU for attendance/participation
Registration: Please select the following link to register for the meeting
https://forms.office.com/r/Sk4NHzv6hu
Topic: Help! Our CAPA process needs a CAPA?!
Taking action to eliminate the cause of nonconformities to prevent recurrence is a requirement for several industry quality management system standards. An organization needs to define and document a corrective and preventive action process to manage their product and process nonconformities. The goal of the process is the timely implementation of systems and controls that are based on and proportionate to risk and effective at preventing occurrence and recurrence of issues. Often organizations struggle to meet the expectations of the standards and their customers when it comes to the implementation and management of an effective problem-solving system.
This presentation will describe the history and current state of the corrective action process utilized at my organization, delve into several root cause analysis tools that are useful to implement in problem solving teams, and share some lessons learned during the iterative journey to improve our corrective and preventive action process. As I’m certain everyone has some success and failure stories when it comes to this topic, please be ready to share your experiences. In the end, we can take all the help we can get when it comes to problem solving.
Presenter: Lauren Piela-ASQ member since 2009, Certifications: CQE, CMQ/OE, CSSGB-ISO 13485:2016 Lead Auditor (TPECS)-BS Chemical Engineering University of Massachusetts Amherst. Over 18 years of experience in Quality systems implementation, management, and compliance including multiple ERP system implementations. Experience with plastic films and components for industrial (ISO9001), automotive (ISO/TS16949), medical device (ISO13485; FDA 21 CFR Part820), food contact packaging (BRCGS Packaging) and with metal processing for firearms (ISO9001) and aerospace (AS9100) industries. Held positions as a quality and manufacturing engineer, supplier quality engineer, validations manager, quality manager, quality compliance manager, and quality director. Currently working as a Director of Quality at Dymotek.