|Review existing quality systems architecture, identifying areas where the system is vulnerable to non-compliance issues.|
|Recommend, where appropriate, electronic quality management systems to control the flow of process information, data and feedback.|
|Facilitate efforts to integrate electronic quality management systems.|
|Apply Cost of Quality principles and process improvement analysis across the value stream to identify and reduce sources of product and process variation.|
Ron managed and directed a multi-disciplined team effort to implement the pilot phase of a corporate-wide Product Data Management (PDM) system within the DuPont Medical Products Diagnostics group. Through this work, the team was able to demonstrate product development and manufacturing cycle time reduction feasibility and annual manufacturing cost reduction of over $100,000.
Ron led an effort to implement an enterprise quality management system (www.etq.com) within DuPont, which was utilized for customer complaint handling and CAPA. This resulted in a more effective management of customer complaints, enabling co-located complaint management units to manage customer complaints in a single system.
“Ron is one of the best quality managers that I have worked with in my career and I have been lucky to work with some great ones. He is excellent at what he does.”
“Ron is very thorough and meticulous about details – two extremely important attributes for a quality system professional.”
Are People Dependent Processes Causing Problems?
If the organization’s processes depend too much on people to remember:
- what procedures to follow,
- how to document the execution of them,
- what records to approve,
- where to put the records,
- what to do with the data, etc.,
there is a significant probability that nonconformances against documented processes and quality system regulations and requirements will occur.
Automate Control Where Possible
There are many off-the-shelf options available today to control the flow of quality system processes, procedures and records and . The cost of appropriate systems will, in the long run, be a value add to the organization, relative to the cost of noncompliance and potential product safety and efficacy issues.
Whatever can be done to remove the people variable from business and quality management systems, the more effective, consistent, controlled and compliant the systems are likely to be. Trained, competent and experienced people should be doing the work, not be the process!