1:
Performance Improvement
2:
Process Management
3:
Team Development
Case Study 1: Performance Improvement
A bio-pharmaceutical company declared to have an issue in their Quality Assurance and Material Management process.
Portland Consulting, LLC conducted an assessment and investigated Commercial Operational Effectiveness. We evaluated the organizational structure, processes and procedures which uncovered internal alignments along six major organizational elements encompassing: Leadership, Organizational Capabilities, Structure, People, Processes and Culture.
We explored major cross-functional interactions and linkages which revealed significant organizational gaps and redundancies between client’s R&D business and the emerging Commercial Operations.
We performed a topside evaluation of several key partner relationships and recognized that serious FDA 483 warning letters exacerbated existing gaps between clients and key partners. This highlighted communications’, processes and systems shortcomings and played a role in clients’ product recall, which had aggravated serious internal and inter-company strains.
Portland Consulting, LLC assisted in a implementation plan for improvements in critical areas:
- Improvement for performance, effectiveness and integration of the Quality and Operations functions in support of Commercial Operations. This included structure, leadership, roles and responsibilities, and core competencies.
- Improvement for the management process, systems, and infrastructure required to support the Quality & Compliance functions and the contractor relationship.
- Improvement for key partners, contract manufactures and contract laboratories regarding vendor management. This included communication, relationships, process, controls and competencies.
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Case Study 2: Process Management
Contract Manufacturing company had indicated they had serious communication issues within the organization in the following departments: Manufacturing, Inventory Control, QC, Purchasing, Receiving, Cell Therapy Acquisition, QA Documentation, QA Inspection, Technology Transfer, Manufacturing Systems (Finished Product, Intermediates, and Raw Material), and Change Control.
Portland Consulting, LLC had provided services for process development, project management, and process improvements of Supply Chain methods. We collaborated with each member of each department to determine the root cause of the communication breakdown.
We were able to decipher internal barriers and provide these groups with a project plan for this organization which enabled them to work as a team. Although this organization was ISO 9000 certified, processes were not being followed and procedures were being bypassed to meet project demands.
Portland Consulting, LLC was able to identify key areas that needed to be addressed, process improvements were implemented and within 8 months we were able to get the organization back on track.
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Case Study 3: Team Development
A quasi-government organization wanted to improve their IT department’s operation. New management wanted to bring in a more team-oriented environment, but they were conflicted with the department’s personnel working in silos. Management did not have the ability to communicate their vision and develop a cross-functional atmosphere between the individual sub-departments: Hardware, Software, Services and Retail.
In addition to improving the team environment, this organization wanted to create internal training workbooks to train new employees, utilizing their internal employees' knowledge and experience.
Portland Consulting, LLC worked with management to identify key issues in their processes and developed programs with cross-functional teams for process improvements.
Portland Consulting, LLC introduced DISC®, which is a tool to help project teams learn each others strengths and weaknesses. Team members eventually learned how to communicate with one another and develop charters and project plans. We were able to identify key commodities that were similar within the IT department and assist the group in developing internal training workbooks.
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