How to Increase Quality Through Risk-Based Business Process Mapping

Introduction 

Nowadays, more and more companies start to grow and lose visibility of the organization’s global landscape. This causes some issues, such as a lack of communication between the sites, work duplication, and a loss of control of the company’s culture (Salomon, 2016). In the pharmaceutical industry, this problem can escalate to lowered quality or compliance gaps that are overseen which eventually turns into a risk for patient safety, product quality or data integrity. 

To fix this lack of visibility, business process mapping has been identified as not only a solution but also the first step to start improving the processes of the company and increase effectiveness (Page, 2015). 

To map and improve the business processes, it is important to correctly understand the company’s environment: what are the criteria of success? What is the structure of the organization? How can we align the company’s culture and stakeholders to fit the improvement? 

Theoretical Analysis of the Environment 

Before jumping into the subject, some theoretical frames need to be explained. The increase in quality and effectiveness through business process mapping is hard to measure, a distinct set of criteria can be used based on the company’s structure and organization (Cameron, 2015).  

Different theoretical models have been set in place over the years to reflect the different ideals that companies see. The standard criteria are the presence of achievable goals, and customer and employee satisfaction. A recent study (Kulachai and Tedjakusuma, 2020) also showed the importance of conflicts and diverging opinions in a company to increase effectiveness. 

Understanding and optimizing customer and employee satisfaction can be complicated as this is a subjective criterion. The stakeholder theory allows us to understand better “who and what really counts” and bring more objectivity and measurable criteria. This theory enables the categorization of the stakeholder in function of their power, legitimacy, and urgency. If this theory comes from 1984 then 1997 (Mitchell et al., 1997), recent studies used this theory as a base to build and perform stakeholder management. (Pedrini and Ferri, 2019). 

One used model to understand the relationship between the different stakeholders is the internal customer/supplier model. Any hierarchy is represented by this relationship, the higher ranked is the internal customer and the other the supplier. The idea is to treat hierarchal superiors as customers (Pfau et al., 91). This frame allows identifying who are the most important internal customers of the company to be able to satisfy their needs. 

Satisfying internal customers needs can be complicated, a recent framework (Grace and Iacono, 2015) explains that satisfying a customer means meeting the functional and monetary values without forgetting the emotional and social values. A theory called the common pool resources theory explains that an individual will maximize their personal payoff when not aware of all the information. Communication is therefore key in the decision-making process to provide a correct allocation of the resources and prevent stakeholder conflict (Carbone, 2017). 

Total Quality Management and Risk-based Approach 

The internal customer/supplier relationship has been defined in a study to be a consequence and aspect of total quality management. (Slack and Roden, 2015) Total quality management is described as the management philosophy where all the importance is put on customers’ requirements, continuous improvement, long-range thinking and team-based problem-solving. Satisfying an internal customer is therefore a way of improving both the effectiveness and the quality. A more recent review (Aquilani et al., 2017) also include the objective quality (actual quality of a product) and subjective quality (the ability to deliver a product). 


In healthcare, regulations act as the inseparable link between patient safety and product quality. Total quality management is not only advised but required. Moreover, in a previously mentioned study (Cameron, 2015), it is written that quality tends to be clearly articulated as corporate (internal customers) objective. Quality will therefore contribute to internal and external customer satisfaction, thus improving the overall effectiveness of the organization. Moreover, quality has a positive impact on innovation (Kim et al., 2012) which can ultimately lead to a competitive advantage through the appropriate use of quality management practices (Schniederjans and Schniederjans, 2015). Business process mapping is one of those quality management practices. 

Process of Mapping the Business process  

Based on the theoretical frames previously defined, the process of mapping the business process can be only be done after analyzing the general organization of the company. Then understanding who the important and relevant stakeholders are, which reveals the internal customers that need to be satisfied. To improve communication, a system that is culture and project-specific is recommended to be used, this will also increase the digital innovation of the company (Bider and Perjons, 2018). The engineering team is often separated from business analysts, however being assisted by an engineering team member could greatly help increase digital innovation when mapping business processes as proved by a recent cross-functional study (Mendling et al. 2020). 

Once the pre-requisites are analyzed and fulfilled, the business process mapping is divided into 5 phases: process identification, information gathering, map generation, process analysis and process improvement. (Antonacci et al., 2018) This last point is also important in terms of innovation and quality, improving a process means to also try to satisfy the stakeholders to the new usage. 

Improving the Processes 

According to (Page, 2015), there are multiple steps to improve a business process: 

– Step 1 is to verify the budget and cost for each process. 

– Step 2 is to verify the process map with different stakeholders. 

– Step 3 is to apply improvement techniques by reducing formalism, removing redundancy, simplifying the process, applying automation. 

– Step 4 is to create internal controls, tools, and metrics to properly follow up the process. 

– Step 5 is to test the process and rework what was not working properly or what could be improved. 

– Step 6 is to implement the changes, and keep track of the change management, testing, communication, and training. 

– The final step is continuous improvement, adapting the mindset, and defining the critical quality attributes to preserve. 

The subjective dimension to some of the criteria corroborates with the vision of stakeholders previously explained. To improve a business process, it is important to consider all the stakeholders’ preferences. The first stakeholder will be the patient, which means product quality must be prioritized, then satisfy the needs of the customers based on the stakeholder analysis previously done. Not performing the pre-requisites to the business mapping might lead to redundancy, inefficiency, loss of interest or understanding. It is important that the relevant stakeholders keep an interest in the process so the engagement is important enough for the goals to be fitted to the company’s needs (Beringer et al., 2012). 

Conclusion 

Mapping the business processes is one of the most efficient quality management practices that also acts as a baseline to improve the current processes to increase quality and overall effectiveness in an organization. This article has shown from multiple studies that the most important criteria are the stakeholders. This starts with patient safety and thus product quality and proceeds to other internal or external stakeholders. Imaging every work relationship as a supplier/customer model allows us to better understand who matters to contribute to growing a company’s quality and thus competitive advantage. 

Antonacci, G., Reed, J. E., Lennox, L., & Barlow, J. (2018). The use of process mapping in healthcare quality improvement projects. Health Services Management Research, 31(2), 7484. 

Aquilani, B., Silvestri, C., Ruggieri, A., & Gatti, C. (2017). A systematic literature review on total quality management critical success factors and the identification of new avenues of research. The TQM Journal. 

Beringer, C., Jonas, D., & Gemünden, H. G. (2012). Establishing Project Portfolio Management: An Exploratory Analysis of the Influence of Internal Stakeholders’ Interactions. Project Management Journal, 43(6), 1632. 

Bider, I., & Perjons, E. (2018). Defining transformational patterns for business model innovation. International Conference on Business Informatics Research, 8195. 

Carbone, J. T. (2017). Applying Game Theory to Understand the Role of Stakeholder Engagement in Community Development Outcomes. 

Cameron, K. (2015). Organizational effectiveness. Wiley Encyclopedia of Management, 14. 

Grace, D., & Iacono, J. L. (2015). Value creation: An internal customers’ perspective. Journal of Services Marketing. 

Kim, D.-Y., Kumar, V., & Kumar, U. (2012). Relationship between quality management practices and innovation. Journal of operations management, 30(4), 295315. 

Kulachai, W., & Tedjakusuma, A. P. (2020). A Study of How Political Behaviors Influence Organizational Effectiveness. 17th International Symposium on Management (INSYMA 2020), 398402. 

Mendling, J., Pentland, B. T., & Recker, J. (2020). Building a complementary agenda for business process management and digital innovation. Taylor & Francis. 

Mitchell, R. K., Agle, B. R., & Wood, D. J. (1997). Toward a theory of stakeholder identification and salience: Defining the principle of who and what really counts. Academy of management review, 22(4), 853886. 

Page, S. (2015). The Power of Business Process Improvement: 10 Simple Steps to Increase Effectiveness, Efficiency, and Adaptability. AMACOM. 

Pedrini, M., & Ferri, L. M. (2019). Stakeholder management: A systematic literature review. Corporate Governance: The International Journal of Business in Society. 

Pfau, B., Detzel, D., & Geller, A. (1991). Satisfy your internal customers. Journal of Business Strategy. 

Salomon, R. (2016). Global vision: How companies can overcome the pitfalls of globalization. Springer. 

Schniederjans, D., & Schniederjans, M. (2015). Quality management and innovation: New insights on a structural contingency framework. International Journal of Quality Innovation, 1(1), 2. 

Slack, N., & Roden, S. (2015). Internal customer-supplier relationships. Wiley Encyclopedia of Management, 11. 

 

Author: Jeremy Olivier, Life Science Consultant KVALITO 

 

KVALITO is a strategic partner and global quality and compliance services and network for regulated industries. To learn more about our services, please visit us onwww.kvalito.ch  and feel free to send us an email atcontact@kvalito.ch

 

 

 

 

You May Also Like…

Top 5 GxP Controls

Top 5 GxP Controls

The quality and safety of a product have always been one of the biggest concerns in the pharmaceutical industry. To...

Pin It on Pinterest

Share This