Quality Control
Continuous Improvement Program
Through the implementation of accepted and proven disciplines used in various manufacturing operations today, the Roe Bio-Medical Continuous Improvement Program initiated in 2008 is showing very encouraging results.
Root Cause Analysis
Data gathered from field service, customer installed base, engineering, development, and manufacturing is logged into a pareto chart. The pareto chart identifies 20% of system problems that cause 80% of the failures. This allows us to focus on the top 3-5 issues and take the corrective action needed with a timely and methodical approach. These strategic actions are reviewed monthly to determine progress. Decisions are made on documented specifications and then incorporated into the test bed. A pre-determined “burn-in” timeframe is adopted and the EC (engineering change) is evaluated at the conclusion. At this time the decision is made to either incorporate this change or take a different approach. All successful EC’s are then locked in as part of system design going forward. EC’s that are system fixes are turned over to field service to be installed at all customer locations, EC's that are system enhancements are offered as upgrades for customers to evaluate and purchase if they choose to do so.
Overall System Quality
Roe Bio-Medical Products is encouraging a “partnership” philosophy with our customer base. This partnership will be crucial for gathering data to enable Roe Bio-Medical to evaluate system performance and make the necessary changes to increase overall availability time. These communications may also indicate user operations that need to be evaluated and modified for system optimization.
Data Required for CIP
- MTBF: Mean Time Between Failure. Daily system availability log needs to be kept by the customer. This log simply identifies that the system is running or is down needing repair or maintenance. This log should run on a weekly basis and only cover the timeframe that a system can be used. For example, if the lab runs 24/7, the benchmark would be 168 hours. We will tailor this to each individual location.
- MTTR: Mean Time To Repair. When it is determined that a system is down due to failure we want to track how long it takes to bring the system back on line.
Using these two data points we can determine system availability time. This tracking method has not yet been implemented at our installed base but will be initiated by our field service group and with the approval of our customers it is our hope that we will start gathering this data in Q2 ’09.
Conclusion
The continuous improvement program is a proven entity that Roe Bio-Medical has adopted to mature our tool set and enable us to offer LAS systems that will perform reliably. We have taken measures that have already sown significant results, however we need the working partnership with our customers, outlined above, to make the biggest leap forward for the mutual benefit.