We offer a wide range of services

specific to highly technical industries.

 

Successful quality management requires a structured pursuit of corporate objectives. An appropriate professional and target-oriented application of proven quality management methods is helpful.

Achievement through method

QM methods are not an end in themselves; their existence is justified in the systematic and analytical procedure for processing complex tasks. The selection of the correct method and the alignment of the method to priorities for the respective objectives are decisive for success.

Our moderators and trainers are competent in their fields and through further training, exchanging experiences, and changing topics, they continually expand their personal and our corporate horizon. We concentrate on our core competences. Many years of varied experience have heightened our sense of what is important. We know the difficulties and are convinced of the high value of a professional method moderation.

We act according to our guiding principle: “Success comes from making other people successful!”. Experience the sense of a target-oriented use of methods and independent professional moderation — GPG is happy to support you.

Our services

  • Moderation of Failure Mode and Effects Analyses (FMEA) as a tool for technical risk management
  • Training in FMEA basics and moderation, as well as training in the practice-based use of APIS IQ-RM
  • Assessment of your FMEA processes and results
  • Moderation of Fault Tree Analyses (FTA) and Failure Mode Effect and Diagnostic Analysis (FMEDA), e.g. in connection with the determination of required metrics from ISO 26262
  • Consulting and support with regard to Design Review Based on Failure Mode (DRBFM)
  • Moderation of Quality Function Development (QFD)
  • Individual consulting to improve the use of methods in your company

 

 Planning & Assessment

  • GAP Analysis
  • Remediation Plans
  • Risk Management Assessments
  • Strategic Planning
  • Project Timelines Development
  • Project Management

 Improvements

  • Lean Manufacturing Projects
  • Six Sigma Principles
  • Quality Risk Management Approach
  • Quality Systems
  • Manufacturing Processes

 Implementation

  • Validations / Technology Transfer
  • Remediation Plans
  • Equipment Commissioning
  • Equipment Decommissioning
  • Equipment Qualification (IQ/OQ/PQ)and Automation

Sustainability Compliance

 Analytical Laboratory Support

Specialized analysis of lab processes and results

  • Data Review
  • Laboratory Investigation
  • Environmental Monitoring Support

 Manufacturing Support

Critical processes support for technical industries

  • Shop Floor Support
  • Startup Support
  • Documentation Review
  • Manufacturing Controls
  • Business & Quality Metrics Design and Monitoring

 Documentation Management

  • Document Control
  • Lifecycle Documentation
  • Document Retention
  • Document Archiving
  • Control Security Documentation

 Training

  • On-Site and Off-Site Training
  • Technical Training
  • On the Job Training
  • Train the Trainers Certifications
  • New Hire Trainings

 Engineering Control Support

  • Equipment Calibrations
  • Equipments Preventive Maintenance
  • Equipment Inventory
  • Equipment Qualification

 Regulatory Affairs Support

  • NDA Documentation
  • NDA Filings & Post Approval Changes
  • PAI Readiness
  • CMC Sections

 Quality Audit Management

  • Audit Preparation
  • Audit & GMP Inspections
  • Audit Response
  • Annual Product Reviews
  • Annual Product Reports

 Quality Systems

  • APR’s
  • Change Controls
  • Investigations
  • Complaints
  • Out of Tolerance
  • SOP Revision
  • Quality Metrics Design and Monitoring

 Validation

  • Re-validation
  • Re-qualification
  • Cleaning Validations
  • Process Improvements
  • Equipment Qualification

 Components Specifications

For Products, Raw Materials and Packaging

  • Review, Management and Control

 Environmental Health & Safety

  • OSHA
  • Disaster Recovery Plan
  • MSDS