Increasing laboratory analysis capacity - Standard Work Kaizen Event

Situation

Medical device QC laboratory faced significant challenges with the quality control process for six major analytes and the productivity of analysis work was insufficient, requiring two-man shifts (13-15 hours) instead of the goal of one-man shifts (7.5 hours). This inefficiency was problematic due to the increasing volumes of production, which were growing by about 40% yearly. The existing process lacked standard work (SW) and exhibited time variations between operators. Additionally, there was a need to optimize resources, improve Overall Equipment Effectiveness (OEE), and reduce lead time of the analysis.

Approach

To address these issues, a SW Kaizen event was initiated with the goal of developing standard work for the analysis process. The team aimed to reduce the barcoding productivity time from 14 hours per batch to 7-7.5 hours per batch, ensuring that the process could be handled by one operator. The team focused on the following key actions:

1. Elemental Time Measurements: Conducting time measurements for work elements for several operators to understand the current state.

2. Current State Analysis: Observing and measuring the current state, identifying waste, and visualizing opportunities for improvement.

3. Weekly Standard Work Preparation: Generating options for weekly standard work schedules for different demand levels.

4. Future State Planning: Testing the improvements and mapping the future state, documenting standard work, and creating weekly standard work schedules.

5. Sustainability: Finalizing roll-out plan and standard work documentation and sustainability metrics.

Results

The Kaizen event led to significant improvements in the quality control process for the six analytes. The lead time was successfully reduced to an average of 7.5-8.5 hours per analyte which could be done with one operator only, achieving the target of one-man shift. This improvement was sustained over the following weeks after the Kaizen. The implementation of standard work and ergonomic improvements supported efficient workflow and reduced time variations between operators. The successful optimization of resources and increased OEE allowed the laboratory to handle the growing production volumes more effectively.