Statistically Sound Product and Process Validation for World Class Productivity and Quality

 

Convert your validation process from a necessary evil to an asset which assures you success in meeting productivity and quality goals. The ZDM Group offers a progressive and comprehensive approach to process and product validation derived from our work in implementation of Six Sigma manufacturing systems and turn-key engineering projects for the beverage, packaging and plastics industries. We can supplement your company's validation and compliance staff or provide complete turn-key validation projects.

Our strategic alliance with Thomas King Consulting, Inc. brings expertise in document control, related to FDA's Quality System Regulation, ISO 9000/13845 Quality System, Medical Device Directive, ISO 14971 Risk Management, ISO 14001 Environmental Management, and other related standards as well as the National Baldrige Quality Program.

The validation process:

Services include:

• Implementation of statistically-based equipment, process, and product qualification and validation including Operational Qualification (OQ) and Performance Qualification (PQ)
• Education in:

   

  • Functional Analysis
  • Problem Solving Tools
  • Basic Statistics
  • Statistical Process Control (SPC)
  • Process and Quality Measurement Precision and Reliability (Gauge R&R)
  • Statistical Design and Analysis of Experiments (DOE)
  • ANOVA, regression, hypothesis testing, box and whisker, confidence interval plots
  • Reporting methods
  • SOP Documentation
  • Performance Measurement