Manufacturing Site Electro-Mechanical Medical Devices: New York

QSCS was hired to identify opportunities and implement solutions to increase the efficiency of the Quality Assurance department for a manufacturing plant in New York that produced electro-mechanical medical devices. While working with the QA department, the QSCS consultant also teamed with QA and Operations on the following activities:

  • QSCS identified an opportunity within the existing quality system at incoming inspection. By utilizing proper statistical tools and applying a compliant, risk based, dock to stock strategy, the plant was able to reduce QA overhead by 3 FTEs in the incoming inspection department.
  • Regulatory Compliance improvements and an increased Yield were realized from the identification, analysis, and correction of a gap between in-process inspection criteria and design control documentation/customer requirements.
  • While closing the gap between in-process inspection and design control documentation above, the QSCS consultant identified LEAN opportunities with respect to operator task management on the line in question. A Kaizen event saw the line balanced and rearranged leading to the reduction of required personnel from seven (7) to four (4) FTEs.
  • Two additional Kaizens were conducted on other process lines focusing on labor efficiency. These efforts increased labor efficiency on those lines by 40% each.
  • The QSCS consultant trained a client engineer who (during the QSCS contract) ran his own Kaizen events with labor efficiency gains of 35% each on two additional lines.

Over the course of six months the implementation of these solutions helped the client realize $1.9 MM in annual savings

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