Pediatric IV Catheter

A global health-care corporation had a product development project in progress to increase the range of its intravenous(IV) catheter line with the introduction of a pediatric IV catheter. The project was about 50% complete when the VP of the division returned from a meeting with the president to inform the project manager that they must move up the completion date by six months.

The most important part of any product development project is the validation of the product design and the manufacturing process. That requires that the critical dimensions of each component be produced at extremes of the specified tolerances. A full range of component combinations is used to manufacture samples for product testing, using typical variations of manufacturing process parameters (i.e., speed, temperature, pressure, humidity, time, etc.).

In order to move up the completion date by six¬† months, only nominal values for critical dimension specifications, and manufacturing process conditions used for similar sizes in the product line, were used to produce samples for validation testing. Tolerance extremes for component parts and manufacturing process parameters were not considered. Validation testing did not raise any red flags, and the project was completed “on time”.

During the first production run on the manufacturing floor everything went wrong! Not all components could be assembled. Those that got assembled could not be joined by the RF welding parameters specified. Investigations revealed that:

* Component vendors met specifications but values clustered around the high and low limits, which were not validated.

* Manufacturing process parameters were set as specified, but the smaller sizes of the pediatric catheter components could not be handled at the tolerances extremes; which were not validated.



* Which supports and barriers were in play?

* What were the dynamics?

* Who, or what, won the Tug-Of-War?

* Discuss the outcome with your friends and family.

* Use Post #4 as a reference for the dynamics and the relationships between supports and barriers.