Achieving Operational Excellence with EQMS: A Roadmap for Pharma Companies

For businesses in the pharmaceutical sector, overall market success depends on several aspects of the organization coming together. It requires a coordinated approach from different departments, including drug development, marketing and sales, operations, and manufacturing, to work together as a unified unit. It also requires agility and flexibility to adapt to new trends quickly and efficiently to meet new demands, adopt new technologies, and comply with new regulations.

Continuous improvement has become critical to enabling this and is also required for regulatory compliance. Therefore, businesses need to implement an operational excellence model to manage their complexities while continuing to innovate and grow. In the pharma industry, scalability also becomes key due to the unique and sensitive nature of the products on offer, and economies of scale are critical to meeting financial goals.

Operational Excellence in the Pharma Industry: Six Key Aspects to Focus On

For the successful implementation of the Operational Excellence Model in a pharmaceutical company, it is essential to do the following:

• Create a Culture of Quality: Quality and performance are often viewed as the domain of the management and the quality team, while employees focus on their tasks without active participation. However, when each worker is committed to a common business goal and empowered to introduce change, they become more proactive and contribute significantly. They identify risks and become invested in improving customer satisfaction.
• Focus on Value Addition: Improving customer delight is another focus area of businesses working towards operational excellence. This is achieved through a clear definition of roles and responsibilities, empowering the workers with the tools and skills to innovate and enhance agility, efficiency, and effectiveness.
• Be Data-Driven: Operational Excellence requires data-driven decision-making to introduce new ideas and innovate. Data is also used to identify the root cause of issues instead of blaming workers and implementing corrective and preventive action.
• Input Quality: The quality of the input materials impacts the quality of the output. Therefore, the quality of inputs must be ensured to achieve the desired output. This is not limited to the raw materials alone but also to the skills of the workers, the machinery, and the tools and processes.
• Measure Performance: Tracking the progress of the operational excellence model in the company is important to assess its success or failure. In case of failure, course correction may be required to meet the objectives. Therefore, setting quantifiable goals (KPIs) and timelines is crucial to monitoring and evaluating success.
• Communication and Collaboration: Communicating the goals to all stakeholders and getting their buy-in is important for aligning the workflows to achieve the desired outcomes. Different teams may need to collaborate to ensure the goals are achieved. Therefore, establishing communication channels and review and approval processes is just as critical.

Benefits of the Operational Excellence Model

Implementing the Operational Excellence Model helps businesses with the following:

Optimization of Workflows: Since the model relies on data, communication, and collaboration – identifying potential hurdles to the workflow across the organization becomes visible and transparent. This helps in taking timely action to eliminate or bypass the hurdle, thereby achieving greater efficiency.

Improved Risk Management: Visibility and transparency also help uncover potential risks and implement mitigation strategies. This can improve cost efficiency, resource optimization, and competitive advantage.

Standardization of Processes: Repeatable processes lend themselves to automation, which further improves efficiency and consistency while reducing the risk of errors due to manual intervention. This also helps make processes more efficient.

Implementing Best Practices for Operational Excellence in the Pharma Industry with ComplianceQuest EQMS

ComplianceQuest’s Enterprise-wide Quality Management System provides features and capabilities that can help pharma companies implement the Operational Excellence Model quickly and effectively.

Some of the best practices that the EQMS facilitates for the effective implementation of operational excellence in pharmaceutical companies include:

Documentation: This helps with ensuring standardization of processes, business continuity, and compliance. All document-related processes can be streamlined with greater accuracy and on time. The centralized repository helps with version control, authorized access, and timely reviews and approvals.

Training: Periodic training of workers following a gap analysis will help them upskill and meet the needs of the business goals and objectives. This training needs to be ongoing to ensure continuous improvement in capabilities.

Predictive Maintenance: Businesses can plan downtimes to minimize unscheduled disruptions while improving machine life and accuracy. This helps with delivering according to specifications and minimizing nonconformance.

Audits and Inspections: Periodic inspections and audits of the shop floor will help uncover deviations and identify gaps proactively. This can prove a valuable tool for continuous improvement in operations and systems.

Supplier Quality: To ensure the quality of inputs, it is crucial to source only from reliable suppliers. Supplier management plays a critical role in this, and a cloud-based EQMS such as ComplianceQuest helps with the supplier onboarding process right from evaluation to training or replacement as needed.

Digital SOPs and Connected Worker: The ComplianceQuest EQMS also provides digital SOPs to help workers stay current with standardized processes. It also improves communication and collaboration between teams on a unified platform.

CAPA and Root Cause Analysis: The cloud-based solution also helps experts collaborate on root cause analysis and take corrective and preventive action to reduce the risk of recurrence of the issue by going to the root of it.

Change: The solution also facilitates change management, from initiation to reviews, risk assessment, piloting, and scaling up. It enables cost-benefit analysis for changes before they are implemented and tracking and monitoring for course correction.

Risk Management: Identification, scoring, and ranking of risks are critical for operational excellence as well as compliance with regulatory requirements. The ComplianceQuest solution helps businesses use their resources wisely in addressing critical risks on priority—monitoring and tracking help with keeping pace as new risks emerge and old ones change for timely action.

Built on Salesforce, the solution is scalable and flexible, allowing pharmaceutical companies to meet new challenges with minimum effort.

Case Study: Driving Operational Excellence with EQMS and Integrated Software Tools

A leading pharmaceutical company implemented ComplianceQuest’s EQMS to streamline its quality management processes - especially for new drug development efforts. In addition to EQMS, they integrated their enterprise resource planning (ERP) and laboratory information management system (LIMS) to create a seamless, end-to-end operational workflow. This integration allowed for real-time data exchange between departments, significantly reducing manual data entry errors and improving overall data accuracy.

By utilizing EQMS for document control, training management, and CAPA processes, alongside their ERP for resource planning and LIMS for managing laboratory data, the pharma company was able to achieve remarkable improvements in operational efficiency. They saw a significant reduction in product release times and a 20% decrease in non-compliance incidents. The comprehensive visibility into quality metrics and operational data enabled them to make informed decisions quickly, driving continuous improvement and maintaining regulatory compliance with ease.