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A strong Quality Management System is the foundation of a resilient company


Penelope Spence

Differentiators

  • Partners with aerospace and medical device clients to build audit-ready, risk-based Quality Management Systems (QMS) that align with AS9100 and ISO 13485 requirements.
  • Treats every engagement as a true partnership — because a stronger QMS means a stronger business.
  • Develops tailor-made solutions that match the way each company does business — never a one-size-fits-all.
  • Recognized for a unique ability to identify risks early and coach teams on root cause and corrective actions that actually stick.
  • Helps clients understand why requirements matter and how the right systems protect and strengthen operations.
  • Continuously learns and evolves to stay ahead of industry standards, best practices, and regulatory expectations.
  • Brings a highly technical background in engineering, combined with a strong focus on quality, process improvement, and compliance.

Core Competencies

  • AS9100 & ISO 13485 Compliance Consulting  — Ensuring compliance with AS9100D and ISO 13485:2016 standards in aerospace and medical device industries.
  • Internal Audit Execution & Readiness — Planning and performing internal audits that prepare companies for registrar and customer audits.
  • Quality Management System (QMS) Development — Establishing or Enhancing tailor-made QMS aligned to how each client does business.
  • Supplier Audit & Oversight — Specialized in evaluating and improving supplier quality systems and audit performance.
  • Kepner-Tregoe Problem Solving — Trained in structured root cause analysis and decision making methodologies. 
  • Process Improvement & Optimization — Applying Lean and Six Sigma principles to reduce waste, improve performance, and close audit gaps.
  • Risk Management & Assessment — Identifying hidden risks and implementing risk-based thinking across QMS processes.
  • Certified Six Sigma Green Belt — Leveraging data-driven improvement techniques to strengthen quality outcomes.

Past Performance & Technical Expertise

  • Provided QMS and audit consulting for NASA Jet Propulsion Laboratory, a major aerospace company, ensuring supplier compliance with AS9100 and ESD standards.
  • Extensive experience auditing and consulting for companies in electrical/electronic/electromechanical (EEE), raw materials, machine shops, robotics, and optical systems.
  • Nearly 10 years as the Subject Matter Expert for passive and magnetic devices, including root cause, quality control, and risk management.
  • Recognized Subject Matter Expert in Electrostatic Discharge (ESD); provided ESD certification audits, training, and system development
  • Deep expertise in supplier audits, risk mitigation, and technical assessment of manufacturing and quality processes.

About P Spence & Associates, LLC

Founder & Chief Executive Officer

Penelope Spence is the founder and Chief Executive Officer of P Spence & Associates, LLC, a certified woman-owned quality management consultancy based in Northern California. She brings more than a decade of hands-on experience in aerospace and regulated manufacturing, including her role as Senior Quality Engineer and Subject Matter Expert at NASA’s Jet Propulsion Laboratory (JPL). 


Penelope is a Lead Auditor in AS9100, ISO 9001:2015, and ISO 13485:2016, with deep expertise in supplier audits, internal audit execution, root cause analysis, and Electrostatic Discharge (ESD) certification.


She's a firm believer that Quality Management Systems should be tailor made, not copy-paste templates — because every business has its own risks, processes, and priorities. Her approach is highly technical, results-focused, and built on real-world experience helping companies close gaps and improve quality performance.

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