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


ZDM Process and Product Validation

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