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complaints tbThe Ask:

A global pharmaceutical company wanted to develop a QMS narrative document to outline the vision for a business-oriented quality management system, that actively supports the competitiveness of a modern pharmaceutical company in a rapidly changing healthcare environment and which would maintain regulatory compliance in all markets.  Explic8 was asked to develop solutions to the following questions:

  • How do we create a rapid transition from traditional pharma product development to innovative and integrated healthcare solutions with expertise, processes and governance structures which are ideally suited to support complex projects?
  • What are the implications for leadership, structure, governance, and team composition to build mutual understanding and effective execution?

Results and Benefits

The novel QMS framework that was developed is characterized by two key statements:

  • The QMS contains three axes – People, Process, and Programs and provides a clear and stable structure, and the realignment and optimization of Teams, Plans, and Roles within it creates a dynamic environment that is agile and governable;
  • The emphasis on Teams, Plans, and Roles allows the execution of programs of all degrees of complexity and innovation, each with its own ‘sweet spot’ in the framework, to supporting maximum agility without being at risk of leaving the protective boundaries of the QMS.

The stakeholders agreed that the framework is a viable Transformation Framework for a successful PD transformation, to achieve the client’s vision.

Challenges:

  • The company produces pharmaceutical products, delivery devices, diagnostic services and Patient Health Care devices;
  • Each of these is governed by different sets of regulations and ICH guidelines;
  • It is extremely difficult to embrace all of these governance structures into one QMS;
  • The senior stakeholders were in disagreement over the structure that the new QMS should take;
  • There were serious concerns about:
  • the governance of such a complex model;
  • whether innovative development projects could remain compliant within the QMS; and
  • The company’s capability to adapt to the change.

Implications

  • Risk of non-compliance
  • Threat to market position if the transformation is not successful.

Objectives

  • Develop a novel QMS approach that is agile, governable and supports the successful execution of innovative projects, whilst providing a stable framework that ensures the protective boundaries of a QMS would not be exceeded.

The Approach:

The project was proposed as a four-week effort by an Explic8 senior consultant and a QMS consultant over a six-week period, with the following four phases:

  • Preparation phase: where Explic8 understands the context of the QMS narrative effort and prepares 5-10 key stakeholders for their role in the project;
  • Interview phase: where Explic8 engages said stakeholders to understand their requirements, expectations and potential concerns about the business-oriented quality management approach that should be reflected in the QMS narrative;
  • Analysis and consensus phase: where Explic8 summarises and characterises the superset of requirements, expectations and concerns and drives consensus in the stakeholder group;
  • Closing phase: where Explic8 redrafts the QMS narrative based on achieved consensus for adoption with final review, adoption by the stakeholder group and collective closeout meeting.

vaccine tbThe Ask:

A joint venture company was established in 1994 between the vaccine divisions of two global organisations to focus on marketing vaccines successfully in its territories.  A joint venture is an unusual commercial arrangement and brings its own challenges in managing the business in a highly regulated industry.  Explic8 consultants were asked to:

  • simplify and harmonize its current business processes into an integrated holistic process set that affords improved protection of patient safety and continues to meet all current and upcoming regulations, local capabilities, needs of its affiliates and shareholder requirements;
  • consolidate the safety management landscape from an organizational, process and technical perspective to improve performance and efficiency; and
  • take advantage of advancements in technology to realize the potential benefits of a new Safety Database implementation

Challenges:

  • Data entered into process from 12 disparate groups;
  • There were 8 different process variations between the groups;
  • There was variability in the time taken for each of the process steps
  • Process heavily paper dependent;
  • Case file took four days on average to complete;
  • Submission compliance targets were not being achieved;
  • Company was facing increasing pressure to improve timelines and submission compliance;
  • This review had to be conducted in a very short space of time because the company was preparing for another imminent inspection.

Implications

  • Risk of non-compliance
  • Team was operating under pressure and had hosted 18 audits and inspections without critical findings during the year.

Objectives

  • Simplify and harmonize its current business processes; and
  • Improve compliance performance (internal and external)

The Approach:

  • Interviews conducted with:
  • Affiliate Offices,
  • Vaccine Safety Assistants,
  • Vaccine Safety Managers,
  • Vaccine Safety Data Managers,
  • Vaccine Safety Officer,
  • All PVRM Division Heads.
  • “As is” ICSR process & Risk Management workshop held;
  • Case timing data collected from Corporate and Affiliates
  • SOPs reviewed (Case Processing, Safety Monitoring, Crisis Management);
  • Data from ARISg, AESI, RMPs and Safety Findings reviewed;
  • Findings compared to Industry Benchmark data.

The Challenge

A global pharmaceutical company’s conversion (manufacturing) cost in $USD per 1000 tablets had increased steadily in recent years and the company wished to take steps to reduce it.

Explic8 consultants defined the Lean strategy for the USA division.

case studiy pmo tbThe Ask:

A global pharmaceutical company was looking to setup a Project Management Office (PMO) to support their external manufacturing business.

Scale:

  • 100+ live projects
  • 102 products/3000+SKUs
  • 183 external network sites

Results and Benefits

  • Dashboard developed for live, up to date clarity on project status
  • Portfolio metrics, clarity on project status & reduced project report meetings
  • Standardised project tool kit developed for each phase of the project lifecycle
  • Budget management and reporting process developed
  • Portfolio governance board & Business Unit forums setup
  • Roles and responsibilities developed across the project lifecycle
  • PMO governance policies developed
  • Project managers trained to the same standard and ongoing PM support installed
  • Project portfolio reporting capability – Quarterly reports submitted to the executive team
  • Guideline documents and templates developed for each phase of the project lifecycle
  • Clarity for internal management on resource utilisation and approval

Challenges:

  • Extremely large and growing project portfolio
  • No definitive source of transparency on the capital investment & resource demands
  • No executive view for portfolio status
  • Highly diverse range of projects:
    • Extremely large and growing
    • Complex technical transfers
    • New market introductions
    • Equipment and facility upgrades
    • Business continuity projects
  • Project managers experience and training varied greatly
  • No effective budget tracking/reporting against projects
  • Key internal processes such as technical transfers not mapped to the project lifecycle

Implication

  • Significant company revenue tied to the project portfolio, not visible
  • Repeated questions & confusion surrounding project finances
  • Business risk: Lack of clarity surrounding business continuity projects
  • Over reporting, frustration, lost time and risk due to lack of transparency

Objective

  • Develop a standardised tool kit to support the project requirements
  • Develop a reporting structure to facilitate clear project status reporting
  • Roll out project management training to the internal team and across the divisions
  • Setup portfolio governance – Decision making and prioritisation forums
  • Minimise the amount of direct reporting required
  • Establish appropriate project portfolio metrics to support management
  • Develop resource management capability

The Approach:

case study pmo aproach

Toolkit

  • Voice of the Customer
  • PMO User Requirements Specification
  • Project Approval & Communications Plan
  • Process Mapping
  • Project Charter
  • Project Work Breakdown Structure (WBS)
  • Project Budget Template
  • Project Dashboard
  • Project Risk Register
  • Project Management Training
  • Business Unit Programme Reports
  • Resource Management Template
  • Resource Management Tracker