Process Harmonization & The Pursuit of Operational Excellence

by Pedro Felipe Raymundo Executive Consultant - Associate Partner @PQE Group

Quality Management Systems are essential frameworks in the pharmaceutical industry , serving as cohesive structures that bring together diverse elements, ensuring consistency and effectiveness in processes, procedures, and metrics across all facets and locations of an organization. Harmonization , in pharmaceuticals, just as in other industries, serves as the glue that binds everything together to ensure a smooth and consistent operation.

When coupled with a robust Quality Management System, harmonization augments the organization's capacity to streamline processes, establish uniform standards, and facilitate effective communication. However, harmonization does not mean enforcing uniformity across all your organization's processes and locations; rather, it should act as the bedrock on which the transfer and exchange of best practices that drive the organization forward takes place. As organizations grow and expand, their operations become more complex and intricate, necessitating a reassessment of existing Quality Management Systems to ensure processes are standardized , and every new element has been correctly integrated to work seamlessly within the evolving framework.

In this article, we will assess scenarios where harmonizing should be prioritized and the implications of not doing so on organizational efficiency and performance. 

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Why Harmonization and Integration Should be a Top Priority

As organizations operating in a highly regulated environment, pharmaceutical companies should ensure adherence to procedures and requirements across the entire spectrum of their operations to maintain compliance, uphold quality standards, and mitigate the risk of issues during audits by clients and regulatory authorities. These organizations are responsible for ensuring that their most valuable resources, the employees, are well-trained and committed to following established protocols, contributing to establishing and maintaining a culture of quality and regulatory adherence. 

Case Study Example

For the purposes of this article, XYZ, a hypothetical pharmaceutical company, has undergone a merger, resulting in significant changes to its organizational structure and operational processes. This has led to some confusion and resistance within the organization as it adapts to a single and standardized modus operandi. We will analyze the changes, their impact, and assess the reasons why such challenges occur in such scenarios. 

 This hypothetical organization has two locations, X and Y. While employees in location Y had no issues with the new document templates and operational procedures after a risk-based assessment, the same cannot be said about employees in location X. These alterations pose a challenge to employees in location X, leading to deviations from the correct procedures despite efforts by employees from Y to organize training sessions addressing and explaining the changes. Despite these initiatives, employees at location X are unwilling to learn and adjust, negatively impacting the quality and integrity of the work and necessitating the repetition of  several key steps.

Why Harmonization Problems Like These Arise

Challenges like these are typical of growing and expanding organizations, especially after mergers. These issues stem from several factors, chief among them low levels of receptiveness to change and resistance to new ways of doing things. Although training often helps, the nature of the training and its effectiveness should be assessed to ensure it is addressing employee pain points. While cultural differences play an important role in the adaptation process, clear communication and targeted initiatives can bridge these gaps and foster a smoother transition. 

Scenarios Where Harmonization Makes Sense 

Harmonization in Quality Management Systems becomes a critical strategy for growing pharmaceutical organizations facing the challenges of expansion and growth. As these organizations expand, aligning and standardizing processes becomes imperative to efficiently manage the heightened complexity that accompanies growth. This becomes even more important when businesses merge and acquire other organizations that have their own operational methods and techniques. Harmonization in these kinds of scenarios comes in as a way to ensure the seamless integration of these two elements to function as one well-oiled machine with the same purpose and unified objectives. Repeated nonconformities across various operations and locations are an indication of the pressing need for a harmonized approach, highlighting the importance of consistent processes to rectify and prevent issues that may compromise the organization's compliance with regulations. Whether an organization is aiming for operational efficiency, performance optimization, or regulatory excellence, harmonization serves as the linchpin for achieving these objectives and ensuring compliance across all operations and levels of the company. 

Ready To Start Your Harmonization Journey?

Harmonization in Quality Management Systems is an essential component of every growing pharma business's regulatory compliance and operational excellence. Expansion should bring you more opportunities and success, not additional challenges and compliance issues. Working with PQE Group is the first step to navigating the complexities of integrating diverse operational frameworks and overcoming the limitations that may hinder your potential growth.

Get in touch with one of our experts today and start your harmonization journey with the confidence and support of PQE Group's 25 years of industry experience.  



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