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Six Sigma Local Customization Enhancement
Project duration: 5 months
Brief description
The customer, a pharma Company has an issue with the process of local customization of diabetes care products in the Middle East Region covering 17 countries. The process is currently not being able to provide an overview of all local customization taking place within the scope of business which can have an impact on Regulatory v/s Non-Regulatory customizations and consequences. Our role is to review and revise the process considering, but not limiting to Objective, Process Initiation, Approval Cycles, Controls, Validation of Agreed Measures, and as a final step, finalize key metrics by using the Lean Six Sigma Methodology.
Supplement
The AS IS process shows that not all regions use the local customization process as required and deviations are existing but are not known in detail. Stakeholders expressed their need to resolve the delays in the approval process and have clarity on this process as the process has a genuine lack of controls. (Loop is not completed with post activity information and updates). Moreover, there are no key metrics which are being monitored by region (country level) at this point.
Subject description
Projected business benefits or strategic relevance: 1. Standardized process established with the inclusion of all stakeholders 2. Standard approach to local customization across the geographical boundary/scope of work 3. Minimize the risk of exposure from deviations (Reg v/s Non-Regulatory Customizations) 4. KPIs in place to monitor and control the process 5. Accuracy of data – Traceability / Costs / Activity 6. Improved GoTo market timeframes from intial request of customization
Overview
- Industries pharmaceutical industry
- Specialist tasks BPM: process design, BPM: process optimization, Change Management, Controlling, international communication systems, log, project controlling, project handling, project management, project manager, project planning, QM in the project, Reporting, Total Quality Management
- DV tasks project management
- System environment Cloud Computing, Internet/Intranet, standard software: CRM systems, standard software: ERP systems
- Procedure model Waterfall Model
- Standard software Minitab
Project period15.04.2019 - 31.08.2019
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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