Quality at the Source

A 90-minute, 4-round basic Express simulation on quality inspection at the source from a quality inspector's seat on a medical-device molding line: reading a control chart and reacting only to real signals (run rules, not tampering), first-article and sampling inspection to the control plan, containment of every suspect lot after a customer complaint, root-cause analysis with 5 Whys and a fishbone instead of blaming the operator, disposition of nonconforming product (sort, scrap, rework or use as is), honest inspection records, and a corrective action verified for effectiveness and reported in an 8D, under FDA's Quality Management System Regulation (21 CFR Part 820) and ISO 13485:2016, for high-school Career and Technical Education in advanced manufacturing and quality, pre-apprenticeship programs and courses preparing the MSSC Certified Production Technician quality module and quality-inspection foundations.

Ifrah Warsame, 19, a fictional second-shift quality inspector at Kettle River Molding & Assembly, a contract manufacturer in Brooklyn Park, Minnesota, inspects a quarter of oral dosing syringes made for Birchwood Health Products in 2027, with a customer complaint in week 6.

Round by round you decide how to read the control chart and how the press is inspected, what to hold and how to find the cause after the complaint, what to do with the quarantined syringes and with a missing night-shift check before an audit, and what corrective action to take and what to tell the customer; at each decision point the quarter is projected again with the decisions taken so far.

Each round is scored on good lots delivered, suspect syringes at the customer, the escape rate, the quarter's margin and the customer's scorecard, with open violations shown alongside; shipping suspect product without a disposition or falsifying an inspection record caps the score. English with Spanish.

An introductory simulation that assumes no prior knowledge of the subject, designed for undergraduate courses. It also works in vocational and high-school programmes and in onboarding sessions.