Operational Excellence

Get value-added results from your quality systems, manufacturing processes and business practices with improved efficiency, higher customer satisfaction and superior quality and delivery.

Consulting and Training in Operational Excellence


  • Development and implementation of effective, self-sustaining quality systems and manufacturing processes
  • FDA and ISO quality systems for medical devices and pharmaceuticals
    • 21 CFR Part 820 and Parts 210/211
    • ISO 13485
    • ISO 14971
    • ICH Q7, ICH Q10
  • Quality life cycle management
  • Assessments, audits and gap-analysis of quality systems and manufacturing processes; due diligence for mergers and acquisitions
  • Quality manuals — procedures and template development

Operational Excellence


  • Operational Excellence
    • Six Sigma champions, yellow belt, and green belt training
    • Voice of the customer
    • Critical to Quality (CTQ) characteristics
    • Quality function deployment (QFD)
    • Process mapping
    • Benchmarking
    • Gap analysis
    • Measurement Systems Analysis (MSA)
    • Gage Repeatability and Reproducibility (Gage R&R)
    • Design of Experiments (DoE)
    • Transfer functions
    • Response surface analysis
    • Critical parameter identification and controls
    • Capability scorecards
    • Statistical Process Control (SPC) and Statistical Quality Control (SQC)
    • Control plans
    • Sustainability and process effectiveness metrics
  • Statistical methods and data analysis
  • Change management
  • Process validation for medical devices and pharmaceuticals
  • Test Method Validation (TMV)
  • Corrective Action and Preventive Action (CAPA)


I would definitely hire Dr Sastri again for product, process, or quality initiatives, and I would strongly recommend him to any organization that wants to avail of his experience and know-how.
— Dr Luca Fontana, CEO
Aditya Birla Science & Technology Company, Ltd.