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QMS Project
Management
Tyrone (TC) Presley Crossland
QMS/EH&S/Regulatory and
compliance Integration Professional
Previously Deputy Management Representative
(Quality and Environmental Compliance
Manager) at Flex
Bio  Tyrone (TC)Presley Crossland
 Has been on a continuous-learning journey within various industries for 38 years  20 with IBM and 18 with
Solectron/Flextronics
 Lead the establishment, management/governance, and facilitated the on-going maintenance of an audit-
ready integrated management system based on the following:
 ISO 9001, TL 9000 HW (Telecommunications), AS 9100 (Aerospace, Aviation, & Defense), ISO 13485
(Medical Devices), ISO 14001 (Environmental),
 Corporate Social and environmental Responsibilities (includes health & safety)
 Customer  specific flow-down standards, expectations, and requirements (including regulatory)
 Government Regulations and NGOs (such as FDA, ITAR, Osha, Hazardous waste management)
 Local alignment with Corporate global infrastructure, tools, and priorities
 Established, deployed, managed & sustained benchmarked integrated programs for Internal audit,
CAPA, and management reviews
 Has maintained a leadership role in ASQ for over 20 years in many roles from Section Chair, Program Chair,
Newsletter Chair, Voice of the Customer Chair, Deputy Regional Director, and Special Interest Group Chair
Coined the equation Conformance + Compliance + Performance = Effectiveness
2
Document Owner: Tyrone TC Crossland
Value Proposition
As an QMS/EH&S Integration Professional:
 Dedicated to the on on-going research, sharing and cost-effective improvements within American
Industry that provides value to an organization, their people, and their customers.
 Have a passion for learning, sharing and implementing leading edge cost-efficient integrated
management system principles and methods that align with business and customer expectations
 Brings years of practical knowledge and experience in implementing, improving, and sustaining cost-
efficient integrated management systems in a dynamic, global high-tech regulated manufacturing
environment (serving a diverse customer base across many industries)
 Brings years of experience in working in Cross functional team environments driving practical cost-
efficient business, organizational, and customer solutions
3
Document Owner: Tyrone TC Crossland
Personal Work Mission:
As a personal passion , apply skills and experience to the on-going research and optimization of various
integrated management systems (while considering regulatory requirements/impacts). The purpose of
which is for sharing and driving cost-effective improvements within American Industry that provides
value to organizations, their people, and their customers.
ISO 9001:2008 QMS
Baseline (all processes)
TL 9000 R4 Adders
(Telecommunications)
ISO 14001:2004
Alignment (EMS)
AS9100C Adders
(Aviation, Aerospace, & Defense)
 Progressed from initial implementation thru all
changes of the standard (including the new ISO 9001:2015)
 Progressed from initial implementation thru all
changes of the standard
 Progressed from initial implementation thru all changes to the standard
 Collaborative facilitation with EH&S SMEs, external regulatory
agencies, and other company facility certifications
 Introduced and refined Risk-based thinking model
 Introduced the Process Effectiveness Assessment Reporting (PEAR)
model to the system
 Introduced an aligned Quality Planning process
Quality Management System (QMS) Project
Management
ISO 13485
(Medical Device)
 Led implementation, deployment, integration, and maintenance
based on company strategy
QS 9000/TS 16949
(Automotive)
 Led implementation, deployment, integration, and maintenance
based on company strategy
Document Owner: Tyrone TC Crossland
Quality Management System (QMS) Project
Management  AS9100C Site Certification
Project Charter
HL - Project Plan
GAP Analysis
GAP Assessment
log
Execution/Monitoring
log - Actions
Document Owner: Tyrone TC Crossland
Execution/Monitoring
Results

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QMS Project Management

  • 1. QMS Project Management Tyrone (TC) Presley Crossland QMS/EH&S/Regulatory and compliance Integration Professional Previously Deputy Management Representative (Quality and Environmental Compliance Manager) at Flex
  • 2. Bio Tyrone (TC)Presley Crossland Has been on a continuous-learning journey within various industries for 38 years 20 with IBM and 18 with Solectron/Flextronics Lead the establishment, management/governance, and facilitated the on-going maintenance of an audit- ready integrated management system based on the following: ISO 9001, TL 9000 HW (Telecommunications), AS 9100 (Aerospace, Aviation, & Defense), ISO 13485 (Medical Devices), ISO 14001 (Environmental), Corporate Social and environmental Responsibilities (includes health & safety) Customer specific flow-down standards, expectations, and requirements (including regulatory) Government Regulations and NGOs (such as FDA, ITAR, Osha, Hazardous waste management) Local alignment with Corporate global infrastructure, tools, and priorities Established, deployed, managed & sustained benchmarked integrated programs for Internal audit, CAPA, and management reviews Has maintained a leadership role in ASQ for over 20 years in many roles from Section Chair, Program Chair, Newsletter Chair, Voice of the Customer Chair, Deputy Regional Director, and Special Interest Group Chair Coined the equation Conformance + Compliance + Performance = Effectiveness 2 Document Owner: Tyrone TC Crossland
  • 3. Value Proposition As an QMS/EH&S Integration Professional: Dedicated to the on on-going research, sharing and cost-effective improvements within American Industry that provides value to an organization, their people, and their customers. Have a passion for learning, sharing and implementing leading edge cost-efficient integrated management system principles and methods that align with business and customer expectations Brings years of practical knowledge and experience in implementing, improving, and sustaining cost- efficient integrated management systems in a dynamic, global high-tech regulated manufacturing environment (serving a diverse customer base across many industries) Brings years of experience in working in Cross functional team environments driving practical cost- efficient business, organizational, and customer solutions 3 Document Owner: Tyrone TC Crossland Personal Work Mission: As a personal passion , apply skills and experience to the on-going research and optimization of various integrated management systems (while considering regulatory requirements/impacts). The purpose of which is for sharing and driving cost-effective improvements within American Industry that provides value to organizations, their people, and their customers.
  • 4. ISO 9001:2008 QMS Baseline (all processes) TL 9000 R4 Adders (Telecommunications) ISO 14001:2004 Alignment (EMS) AS9100C Adders (Aviation, Aerospace, & Defense) Progressed from initial implementation thru all changes of the standard (including the new ISO 9001:2015) Progressed from initial implementation thru all changes of the standard Progressed from initial implementation thru all changes to the standard Collaborative facilitation with EH&S SMEs, external regulatory agencies, and other company facility certifications Introduced and refined Risk-based thinking model Introduced the Process Effectiveness Assessment Reporting (PEAR) model to the system Introduced an aligned Quality Planning process Quality Management System (QMS) Project Management ISO 13485 (Medical Device) Led implementation, deployment, integration, and maintenance based on company strategy QS 9000/TS 16949 (Automotive) Led implementation, deployment, integration, and maintenance based on company strategy Document Owner: Tyrone TC Crossland
  • 5. Quality Management System (QMS) Project Management AS9100C Site Certification Project Charter HL - Project Plan GAP Analysis GAP Assessment log Execution/Monitoring log - Actions Document Owner: Tyrone TC Crossland Execution/Monitoring Results