Klean manufactures refillable trigger-spray bottles for hospitals. The bottle is made from recycled PET and must reliably deliver a 1.2mL dose per trigger pull (target) to meet cleaning protocol requirements. In the last month, several hospitals reported inconsistent spray output: some bottles dribbled, some produced a weak mist, and a small number leaked during transport.
An internal investigation found multiple potential sources of variation: two suppliers provide the small check-valve, operators adjust the crimping force on the pump head by feel, and the resin moisture level varies by shift. A senior manager proposes “checking every finished bottle before shipping.” The production engineer argues for monitoring the process instead and preventing defects rather than detecting them late.
Klean is deciding how to redesign its quality approach before launching a new higher-volume contract. The team has access to basic metrology tools (calipers, digital scales), a pressure/flow test rig, and production data from the last 10 days. They must choose an approach that satisfies customers, reduces cost of poor quality, and ensures consistent performance at scale.
Figure 1: Klean spray bottle and pump head assembly
