Mastering Quality Assurance: Essential Strategies for Efficient Supply Chain Risk Management

Overview of Daily Tasks

Daily Tasks Overview for Quality Assurance Manager

Quality Oversight and Risk Management

- Approve and maintain quality oversight for the supply of strategic chemicals, intermediates, and drug substances to Novartis Technical Operation (NTO) sites.

- Assess and mitigate quality risks that may impact the supply chain, ensuring adherence to cGMPs, legal, and regulatory requirements.

- Ensure that all supplier relationships comply with the Novartis Quality Manual and Policies.

Supplier Qualification and System Maintenance

- Participate in and approve changes in supplier qualification and certification status.

- Maintain and update documents related to supplier qualification and monitoring.

Quality Issue Escalation and Management

- Participate in the escalation of potential quality issues to higher-level management as per Novartis escalation policy.

- Manage critical quality issues such as complaints, deviations, recalls, and regulatory non-compliance according to Quality Agreements.

- Ensure investigations are correctly executed.

Risk Assessments and Market Actions

- Perform risk assessments in case of quality events at suppliers and approve site-specific risk assessments as required.

- Evaluate risks related to product quality and patient safety; propose market actions.

- Provide direction and support to third parties to ensure compliance with Novartis quality standards.

Audits and Continuous Improvement

- Travel to external supplier sites for audits, resolving issues, and continuous improvement activities.

- Prepare Quality Agreements and Risk Assessments; maintain relevant documentation.

- Address any gaps identified in Quality Systems and ensure issues are resolved.

Technical Meetings and Supplier Coordination

- Attend technical meetings with external suppliers, fostering good relationships through clear communication and action plans.

- Coordinate and ensure quality auditing of external suppliers as per Novartis Quality Manual.

- Manage an annual auditing program, lead audits, and follow up on corrective actions and preventive measures.

Change Control and Cross-Functional Coordination

- Manage change requests through the Novartis Change Control system, ensuring compliance with Quality Agreements and SOPs.

- Maintain contact and coordinate with other Novartis functions including Purchasing, Legal, Supply Chain, Regulatory Affairs, and Group Quality Operations.

Regulatory Support and Compliance

- Support site readiness for regulatory inspections at external suppliers.

- Provide support to NTO sites for Novartis or Health Authority inspections.

- Assist Regulatory CMC in compiling responses to Health Authority queries and review source documents for regulatory submissions.

By skillfully managing these tasks, a Quality Assurance Manager safeguards Novartis's supply chain integrity, ensuring that strategic ESO chemicals meet the highest efficacy, safety, and quality standards.

Mapping Tasks to KanBo Features

Applicable KanBo Feature for Quality Assurance Tasks

The Gantt Chart View in KanBo is highly applicable for managing timelines and dependencies involved in Quality Oversight and Risk Management tasks.

Steps to Set Up Gantt Chart View

1. Navigate to the Space:

- Access the KanBo dashboard and enter the relevant Space where your quality assurance tasks are organized.

2. Activate Gantt Chart View:

- Click on the “View” options in the top-right corner of the Space.

- Select “Gantt Chart View” from the dropdown menu.

3. Add Tasks to the Timeline:

- Ensure each task or Card has a start and end date set. This can be done within each Card by selecting the date fields.

- Cards with date dependencies can be linked to reflect the order and hierarchy of tasks using the Card relations feature (parent-child, next-previous).

4. Adjust Task Dependencies:

- In the Gantt View, use drag-and-drop functionality to adjust the timeline and dependencies between tasks as needed.

5. Review and Monitor Progress:

- Regularly check the Gantt Chart to track ongoing task progress, highlight any delays, and ensure alignment with project timelines.

- Use the chart to visualize task progressions and manage any changes to priorities or deadlines.

Benefits

- Visual Clarity: Provides a clear visual representation of all tasks, their durations, and interdependencies, enabling easy tracking of where each task stands in relation to the entire project.

- Efficiency in Task Coordination: By visualizing timelines, teams can better coordinate task completions, especially in managing escalation processes or managing audits.

- Improved Risk Management: Early identification of potential delays in critical tasks allows proactive risk mitigation, ensuring compliance with quality standards and timelines.

- Enhanced Communication: Shareable view aids in communicating project status effectively with stakeholders, aligning team efforts towards strategic goals.

Implementing the Gantt Chart View in KanBo facilitates organized and efficient oversight of Quality Assurance tasks, ensuring adherence to timelines and quality standards.

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Glossary and terms

Introduction to KanBo Glossary

In the fast-paced world of business, efficient work coordination and effective resource management are critical to achieving organizational success. KanBo is an integrated platform designed to seamlessly connect company strategy with daily operations. By providing robust tools for task management, communication, and collaboration, KanBo enables organizations to align their workflows with strategic goals, ensuring transparency and productivity. This glossary will provide you with key terms and concepts associated with KanBo, helping you navigate and leverage the platform effectively.

Glossary of KanBo Terms

- Integrated Platform: KanBo is described as an integrated platform, meaning it combines various tools and capabilities to provide a comprehensive solution for managing work coordination and resource management.

- Hybrid Environment: KanBo offers a hybrid deployment model, allowing for both on-premises and cloud-based operations. This provides flexibility and compliance with legal and geographical data requirements, unlike traditional SaaS applications that are purely cloud-based.

- Customization: Refers to the ability to modify and tailor the KanBo platform according to the specific needs and requirements of an organization, particularly for on-premises systems.

- Integration: KanBo's capability to work seamlessly with Microsoft products like SharePoint, Teams, and Office 365, ensuring a consistent user experience across different platforms.

- Data Management: The balanced approach KanBo provides by storing sensitive data on-premises while managing other data in the cloud, enhancing data security and accessibility.

Understanding the KanBo Hierarchy

- Workspaces: The top-level organizational structure in KanBo, used to categorize and segregate different areas, departments, teams, or clients.

- Spaces: Subdivisions within Workspaces that represent specific projects or focus areas, facilitating targeted collaboration.

- Cards: The fundamental units within Spaces, representing tasks or actionable items with details such as notes, files, comments, and to-do lists.

Steps to Set Up KanBo

1. Create a Workspace: Establish the primary organizational structure by providing a name, description, and setting the type and permissions.

2. Create Spaces: Develop specific project or focus area settings within Workspaces, selecting from different types like Workflow or Informational Spaces.

3. Add and Customize Cards: Initiate tasks by creating and detailing Cards within Spaces.

4. Invite Users: Engage team members by assigning roles and conducting a kickoff meeting for a platform introduction and training.

5. Set Up MySpace: Organize personal tasks with views like the Eisenhower Matrix or Status-based grouping.

6. Collaboration and Communication: Utilize tools like comments, mention features, activity streams, and document management within Cards or Spaces.

7. Advanced Features: Explore functionalities like filtering, card grouping, progress tracking, emailing capabilities, external collaboration, and templates for efficiency and consistency.

KanBo Resource Management

- Resources: Entities requiring management of time and availability, including employees, contractors, machines, and rooms.

- Resource Allocation: Assigning resources to tasks or projects, managing time and cost effectively.

- Time Tracking: Monitoring actual vs. planned effort to optimize resource use and project costs.

- Conflict Management: Identifying and resolving over-allocations or unavailability of resources.

- Integration: Linking with external systems for automatic updates on resource information.

- Data Visualization: Tools for visual insights into resource allocation and potential bottlenecks.

Base Data in KanBo Resource Management

- Resource Types and Attributes: Classifications for internal employees, external contractors, machines, rooms, and their attributes like name, short name, type, location, and skills.

- Work Schedule and Cost Structures: Definitions of working hours, internal costs, and external rates, aiding in financial management and project budgeting.

- Manager and Roles: Hierarchical and functional classifications within the organization, contributing to streamlined management and financial calculations.

By understanding these terms and setups within KanBo, organizations can fully leverage its functionalities for streamlined operations, enhanced resource management, and successful project execution. KanBo's comprehensive approach ensures all aspects of work coordination are well-connected to strategic objectives, fostering an environment of productivity and growth.