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