Rachael Shagott
Expertise: Consulting Business Leader
Languages
English
★★★★★
Spanish
★★
French
★
Mandarin
★
Rachael Shagott Bio
Rachael Shagott is the Founder and Principal Consultant of Best Practice Quality LLC. Known for her boundless energy, she works passionately on behalf of client companies. Her deep expertise empowers teams to navigate challenges such as increasingly complex global regulatory oversight, the development of in-house regulatory and quality management system capabilities, and comprehensive cradle-to-cradle product support—from risk management to product recalls.
Rachael is a respected figure in the quality and regulatory communities, known for her extensive network and ability to assemble teams precisely tailored to meet each client’s unique needs. She actively mentors emerging professionals and has served as an adjunct professor, teaching upper-level Global Business courses at Grand Canyon University.
Rachael was awarded ASTM’s Margaret Dana lifetime achievement award for her contributions to product safety. Rachael is involved with ASTM, sitting on several F15 Sub-Committees including Chair and Task Group Leadership positions. She sits on the JPMA Certification Committee and has participated as a volunteer, panelist and ICPHSO member at annual ICPHSO Symposiums.
She was also a founding leader and member of the Society of Product Licensors Committed to Excellence (SPLiCE). Rachael brings over 40 years of experience in product integrity, supplier quality assurance, product safety, and regulatory compliance.
She has expertise in ISO 13485 Quality Management Systems, ISO 17025 Laboratory Management Systems, and various other Quality / Compliance programs. She has worked closely with the CPSC, FDA, and more than 100 international vendors.
Rachael holds a variety of ASQ certifications including Audit (CQA, CMDA), Engineering (CQE, CRE), Quality Management CQM/OE), and Six Sigma (CSSGB). She has also held the position of Certified Reliability Engineering Exam Chair at ASQ (American Society of Quality). Rachael graduated Summa Cum Laude with a BS in Management Engineering Technology from SUNY Buffalo State College and an MBA from Canisius College in Buffalo NY.
She earned certificates in Statistics, Six Sigma, and Consumer Product Safety Management.
Rachael resides in the greater Phoenix area. She enjoys spending time with her family, reading, hiking, skiing, and traveling the world.
Education
MBA
BS Industrial Technology
Certifications, Awards
ASQ – CQE, CQA, CRE, CQM, CSSGB, CMDA
ASTM Margaret Dana Lifetime Achievement Award
Product Safety Management
Six Sigma Green Belt
Key Company Experience
Trico Products
Moog
Fisher-Price
Tomy
Munchkin
Associations
ASQ
ASTM
ICPHSO
JPMA
TA
Product Category Experience
Automotive components
Motion System components
Consumer Goods – Children’s Products, Electronics, Hard Lines, Soft Lines, Sports Equipment
Medical Devices
Primary Skill Categories / Skills
Leadership
Business Strategy
Cross Functional Teams
Kaizen
SWOT
Manufacturing
Process Control Plans
Quality Control Plans
Inspection Procedures
Test Protocols
Six Sigma applications
5 S and other Lean tools
Market Surveillance
Monitoring reports
Government reporting eg 15B
Recall Readiness Toolbox
New Product Development
Claim Substantiation
Concept Reviews
Design Reviews
Development Testing
Risk Assessments
Labeling & Marketing Review
Pre-Production Qualification
Quality Management Systems
Manuals
Procedures
Process Flow
ISO9001
ISO13485
Regulatory Compliance
FDA Registrations
FDA Pre-Market Approval
GMP
Supply Chain
Supplier Manuals
Supply Chain Monitoring
Audits
Sustainability
End of Life planning
EPR/PRO Guidance
Testing & Certification
Component, Development, Qualification, In-Process, Pre-Shipment, Warehouse, Retail Shelf
Children's Product Certifications CPC
General Compliance Certifications GCC, UL