Quality Management

With increasing product complexity and shortening development cycles, ensuring product quality and regulatory compliance can be challenging for companies focused on fast innovation.

However, many business use stand-alone systems and spreadsheets for managing quality, creating information silos and process gaps.

The result of this disconnected approach is reflected in the growing number of product recalls, leading to costly fines and damage to brands.

  • Implement Advanced Product Quality Planning (APQP) processes to achieve compliance with regulatory requirements and quality standards including TS/16949, AS9100, FDA QSR
  • Closed-loop corrective action/preventive action (CAPA) and Root Cause Analysis (RCA) to accelerate identification, containment & analysis of issues, and tracking of affected items
  • Create and maintain critical quality documents, including:
    • Design/Process Failure Modes Effects Analyses (DFMEA/PFMEA)
    • Process Control Plans (PCP) & Process Flow Diagrams (PFD)
    • Fault Tree Analysis, Fishbone, and Five whys
  • Manage libraries of critical characteristics, failure modes, effects, and control mechanisms
  • Integrate quality throughout the concept, design, and manufacturing lifecycles and related change processes
  • Coordinate quality reviews through Visual Collaboration, business rules & workflow, and aggregation & packaging of CAP items

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    Essig PLM
    1 Tara Blvd, Suite 104
    Nashua, NH 03062
    info@essigplm.com
    Phone: (978) 203-5150