CASE STUDY 05

Solving a Quality Problem by Fixing the Supply Chain Behind It

Supplier Quality, Root-Cause Analysis & Forecasting | FDA-Regulated Medical Device

Customer complaint trend reversed | Measurable quality controls established | Supply planning and supplier coordination improved

The Challenge

Customer complaints were increasing on a well-established FDA-regulated medical device manufactured in China using specialized wood supplied by a U.S. lumber mill. Consumers reported that the wooden picks were breaking during use.

The factory blamed the lumber. The lumber mill blamed the factory. Distance, time-zone differences and a language barrier made resolving the problem even more difficult.

I decided we needed to understand both ends of the supply chain firsthand.

What We Found

I traveled first to the lumber mill and the surrounding forest where the trees were harvested and learned that raw-material selection was far more important than it appeared. Harvesting season, the portion of the tree used, growth-ring characteristics, grain direction, moisture and density all affected how the wood processed and the strength of the finished pick.

There was also a planning problem. Without an adequate annual forecast, the mill couldn't reserve enough of the appropriate winter-cut material. Additional requirements often had to be purchased on the spot market, contributing to higher costs, late deliveries, production backlogs and additional quality pressure.

What appeared to be a defective-material problem was actually a combination of raw-material selection, quality control, forecasting and supplier coordination.

What We Did

I traveled next to the manufacturing facility in Shanghai and spent a week on the production floor. Working with the factory team, we translated what we had learned into measurable requirements for critical dimensions, growth-ring characteristics, grain direction, moisture and density.

Go/no-go gauges and inspection criteria were used from incoming lumber inspection through key production stages, giving operators objective standards for evaluating material and work-in-process.

We also established a 12-month forecast each fall, allowing the lumber mill to reserve the appropriate winter-cut material for the following year's requirements. Forecasting became part of the quality-control system, not simply a purchasing tool.

The Result

Better forecasting allowed the lumber mill to plan its raw-material requirements more efficiently and reduce reliance on higher-cost spot purchases. At the factory, measurable specifications and process controls improved raw-material consistency and finished-product quality.

Most importantly, the upward customer-complaint trend was reversed, and two suppliers that had been blaming one another were now working from common requirements and a shared demand plan.