Show:
Intracompany Supplier Management
External Supplier Audit
GA/ China Design Control/Process Validation Network/RM Harmonization
100
This process was released in Phase 1, year 1 of multi-year journey.
What is standardized Intracompany Supplier Management?
100
1. Define & Rollout Auditor certification process 2. Integrated Auditing Process 3. Shift Focus to Performance Based Audits
What will be implemented in Phase 2 across BDX in one external supplier audit process?
100
This process Supports growth and innovation in the region by delivering a modular design control process to support the China Design Center.
What is the Greater Asia/China Design Control Process?
200
This process will be updated in Phase 2 for Regions & DCs Beyond 2016.
What is Intracompany Supplier Management Process?
200
This process once rolled out will provide the: "Ability to leverage resources across BDX without extensive learning curve".
What is Auditor Certification process?
200
1. Training Session and Needs 2. Policy and procedure updates 3. Audit finding review 4. Metrics review
What are the benefits of the Validation Network?
300
1. Internal Audits 2. ISO Certifications
What is reviewed for initial setup of Intracompany Suppliers?
300
These BDX Guidelines & Forms were released in phase one /2016.
What is Standardized Compliance Audit Templates and Guidelines for external suppliers?
300
1. FDA Human Factors/Usability 2. Software and Cyber Security RM 3. Occurrence Guidance and Harmonization 4. Index table alignment: RM and HHE
What is Potential FY17 Opportunities for RM Harmonization?
400
On-site compliance audits of the supplying site by the receiving site is not a pre-requisite for the initial setup and approval.
What is Intracompany Supplier Management in BDX?
400
This process once rolled out beyond 2016 will provide: "Common Language & Practice across BDX".
What is Integrated Auditing Process?
400
Daniel Kim (Network Leader)
Who is the contact point in CQE for Process Validation Network
500
1. Intracompany supplier Management 2. External Supplier Audit
What will provide a pathway to Implementation of Preventive Supplier Quality in BDX.
500
The "Risk Based External Supplier Audit Process across BDX"
What is an outcome of phases 1 and 2?
500
1. Enable local product development and acquisition for the region. 2. Enhanced efficiency by creating an agile and nimble resource pool trained to work across all businesses. 3. Regional pilots provide opportunity to develop and hone process for potential BDX implementation.
What are the benefits of Greater Asia/China Design Control?