Medical Development Services, Inc. Technical Services
Home
About MDS
Technical Services
Community Service
Contact Us
 
Key Staff
Case Studies Menu
MDS Project Case Studies
(Highlights from twenty-five years of success!)


Case Study 4: Plastic Part Tolerance Study

An MDS customer was in the process of constructing a new plastic injection mold to increase its manufacturing capacity. This mold would be used to make two components of a Class III device. During the course of the development of the two components, the original mold had been revised many times and the parts drawings were out of date. During the construction of the new mold, the original material became unavailable. The new mold was being constructed by a different molding vendor who had never produced these parts.

Updated drawings needed to be created that were based on actual released parts that were produced by the previous vendor. Tolerances needed to be added to the revised drawings. The toolmaker had made rapid progress on construction of the new mold and needed the revised drawings within one calendar week in order not to significantly delay the tool construction. Unfortunately, four days of that week were customer company holidays.

MDS's customer requested that MDS initiate the tolerance study and do a red line of the part drawing that indicated the proper tolerance for each dimension while all personnel were on holiday. On their last workday, the customer's laboratory supplied MDS key dimension measurements that were taken from actual released old parts.

MDS took the laboratory data, conducted statistical analysis of the data, and calculated probability curves for each measurement. Interference fits were then determined. The plastic manufacturer data was obtained for the specific resin and reviewed for lot reproducibility. The design of the mold and mold flow were analyzed. A tolerance was then set for each dimension. Critical dimensions were identified. A set of the part drawings was red lined per ANSI standards. The red lined drawing set was supplied to the customer on the customer's first day back at work.

The customer updated its print and the mold was completed on schedule. The mold produced functional parts within specification on its initial production run.
  © 2000-2009 Medical Development Services, Inc.