Team Leadership & Quality Management

• Examples given relate to challenges at PCI Pharma Services, Indus Pharma, GlaxoSmithKline and DOX Pharma

Leading a Team to Achieve a Challenging Goal

• Improving pack-per-head capacity was needed
• Increase capacity while reducing labor costs and ensuring compliance with quality standards was set as a goal
• A project to implement auto-plugging and capping in the packaging process was initiated
• Workflows were redesigned and operators were trained on the new system
• The pack-per-head capacity increased by 4,000 units
• The workforce requirement was reduced, saving the company €19,999 annually

Managing a Quality Issue

• Significant sedimentation was noticed in a pharmaceutical product, which was leading to product rejection
• Responsibility included identifying the root cause and implementing corrective measures to maintain product quality
• Close collaborations with the formulation and process engineering teams occurred
• Optimizing the formulation and process parameters resulted from trials
• The sedimentation issue was resolved, resulting in a financial gain of €3,000
• Product consistency was ensured

Optimisation to Save Costs

• The secondary packaging process was complex and generated unnecessary waste
• The goal was to simplify the process to reduce waste and improve efficiency
• Lean and Kaizen principles were used
• Workshops were conducted with the team to eliminate non-value-added steps
• SKUs were redesigned to eliminate components like rubber bands
• €28,793 was saved annually and completely eliminated non-hazardous waste

Ensuring Compliance and Maintained Quality

• An Ambisome batch was packed with different lot numbers, creating a compliance risk
• An investigation to prevent similar incidents in the future was required
• A root cause analysis was conducted, identifying operator error and inadequate training as key issues.
• Refresher training was implemented and stricter inspection protocols were enforced
• Compliance was restored, and future errors were avoided, reinforcing a culture of quality and accountability

Successfully Resolving Conflict

• The scenario involved conflict between team members over prioritizing tasks, which disrupted workflow and delayed production
• The goal was to mediate the conflict and restore productivity
• Individual meetings with team members were conducted
• A team meeting was then organised to realign everyone on shared goals and roles
• A prioritization framework was introduced to avoid future disagreements
• Team cohesion was restored, and productivity improved by 80%, ensuring production targets were met

Leading Change in a Fast-Paced Environment

• Inefficiencies in manual batch records were identified as causing delays in production
• The objective was to modernize the system and improve real-time tracking of production
• A paperless batch manufacturing and packing records system was introduced
• Over 80 employees were trained to use the new system.
• Deviations were reduced
• Costs were lowered by 30%
• Real-time monitoring of production was improved

Implementing Health and Safety Improvements

• Ergonomic risks were identified in the secondary packaging process
• The task was to mitigate these risks to ensure employee safety
• Workflows and equipment layouts to reduce ergonomic strain were redesigned
• Safety awareness training sessions were introduced
• Employee safety improved significantly
• Ergonomic risks were completely eliminated, enhancing overall productivity

Managing Stakeholders to Achieve a Goal

• Buy-in for replacing outdated checkweighers with counters in the Ambisome packaging process was needed
• The task was to convince management of the cost-benefit of this investment
• A detailed cost-benefit analysis highlighting potential gains of €3,000 from improved accuracy was presented
• Regular communication was maintained to address concerns and ensure alignment
• Management approved the project, and the new system increased process accuracy to 99.5%

Handling a Crisis During Production

• Leaking bottles were identified during the Fintapla packaging process, threatening to halt production
• Resolving the issue quickly to prevent delays and losses was set as the task
• Leaking and low-weight bottles were segregated
• Unaffected bottles were packed
• A torque tester at the end of the line was implemented to prevent future leaks
• The crisis was averted without major delays
• The new system ensured consistent quality moving forward

Using Technology to Improve Processes

• Manual monitoring of batch records was time-consuming and error-prone
• The task was to improve efficiency and accuracy in the process
• An ERP system for real-time batch monitoring was implemented
• The team was trained to use the system effectively
• The new system significantly reduced errors, streamlined processes, and improved data visibility across departments

Resolving Conflict With Interpersonal Skills

• There was a miscommunication between the quality and production teams regarding lot numbers, leading to a compliance issue
• The role was to mediate and resolve the conflict to maintain operational harmony and compliance
• A joint meeting was facilitated where each team's concerns were addressed
• A new communication protocol for cross-checking lot numbers was introduced and refresher training was provided
• The conflict was resolved
• Compliance was restored, and teamwork improved
• There were zero lot-related errors in the following quarter

Being Proactive as a Self-Starter

• Inefficiencies were noticed in the secondary packaging process that were causing delays
• To address this issue proactively, the workflow was analyzed and bottlenecks were identified
• Lean improvements were proposed, including SKU redesigns to remove unnecessary components
• €28,793 was saved annually and process delays were significantly reduced

Instance of Innovation Leading To Significant Improvements

• Persistent sedimentation issues were encountered in a key product, leading to high rejection rates
• The task was to find a creative solution to fix the issue while maintaining product integrity
• Collaboration with the formulation team to tweak the process parameters and conducted trials to optimize stability were conducted
• Sedimentation was eliminated, product consistency improved, and €3,000 in financial losses were recovered

Successful Management of a Team During a Project

• 80 employees were led in a team during the transition to a paperless batch monitoring system
• The responsibility ensured the team adapted to the new system without affecting production timelines
• Training sessions were conducted, ongoing support was provided, and open feedback was encouraged
• The system was implemented on time, reducing deviations and cutting costs by 30%

Demonstrating Customer Focus

• A key client raised concerns about leaking bottles in a Fintapla batch
• To maintain customer satisfaction and trust it was crucial to address the issue quickly
• The root cause (inadequate torque application) was identified
• Defective products were segregated
• Torque testing at the end of the line was implemented
• The customer was satisfied with the resolution
• The improved process prevented future occurrences

Critical Decision Making Under Pressure

• During packaging operations, a batch of Ambisome had been packed with different lot numbers
• The decision was whether to halt production or resolve the issue on the go
• Production was temporarily paused, an inspection to identify affected samples was conducted and refresher training to the operator involved was given.
• The issue was contained
• Compliance was maintained
• Production resumed without further delays

Demonstrating Trustworthiness

• Entrusted with leading a high-profile cost-saving initiative for packaging
• The goal Reduce costs while maintaining product quality and compliance
• Cost drivers were analyzed, collaborated transparently with stakeholders and Implemented a packaging redesign
• The project saved €19,999 annually and solidified reputation as a reliable leader

Using Communication Skills

• Rolling out of a new ERP system needed to align multiple departments with varying levels of technical expertise
• Ensured all stakeholders understood the system's benefits and functionality
• Clear and tailored communication through presentations, emails, and one-on-one meetings were conduced
• The system was adopted smoothly, reducing manual errors and improving efficiency across the organization

Providing Attention to Detail

• While overseeing Voxzogo vials' acclimatization, the operator mistakenly assumed 15 minutes was sufficient instead of the required 30 minutes
• Ensured that no product was compromised due to this oversight
• A risk assessment was conducted and confirmed there was no condensation.
• IPC check sheets were updated to include acclimatization checks and set alarms for start and end times
• The issue was resolved without any impact on product quality

Adapting Speedily to Implemented Change

• Asked to manage the transition to auto-plugging and capping in the middle of an ongoing production cycle
• Ensured the transition was smooth and did not disrupt production
• The production schedule was quickly adjusted, the team was trained on the new process and The initial output was monitored for any issues
• The change was implemented seamlessly, leading to increased capacity and reduced costs

Explore team leadership through examples at PCI Pharma Services, Indus Pharma, GlaxoSmithKline and DOX Pharma. Learn to improve capacity, cut costs, and resolve quality issues, such as sedimentation in pharmaceutical products, with strategic collaborations and optimized processes.