How to Pivot to the Culture of Quality Assurance

Leoraj Devaraj

October 21, 2020

The position of QA engineers has evolved from finding errors to enhancing user experiences. It indicates that QA engineers and testing must align themselves with business objectives and the larger picture.  

While technology plays a vital role in the entire quality ecosystem, here are five ways how it aids in improving quality processes.  

1. Advance data analysis and Machine Learning   

Artificial Intelligence (AI) is steadily gaining ground in the market. Machine learningsubset of AI, ‘learns’ programs by finding patterns from which results are predicted. An example may be a medical device company that analyzes complaint data to determine when a problem occurs. All complaint data are stored in a centralized digital archive for consistency in identifying and mitigating the problem.  

20% of businesses have already made use of on-demand applications such as Internet of Things (IoT), Robotics Process Automation, AI, and Machine Learning, according to 2019 KPMG report. In the same survey, 52% of organizations estimated their technology spending to be increased in the next year.  

2. Value beyond regulatory compliance  

While compliance is critical, quality also affects business. Sometimes quality takes a band-aid approach to solve problems quickly and does not examine the root cause or prevent future problems. Some companies are sufficiently taking a forward-thinking approach for proactive management of quality. It is becoming a necessity in today’s regulatory landscape. Firstly, many businesses globally sell through several regulatory bodies’ jurisdictions. Although specific regulations overlap, the effort to improve overall quality is always rewarded. In comparison to solving a single problem, this significant picture is changing an organization.  

Quality goes beyond its department as part of this significant approach. It must be part of the culture of an organization that permeates all the activities of the business. Quality 2030 is subjected to remove departmental siloes between quality and production, between manufacturers, suppliers, and regulatory agencies. Quality 2050 is predicted to eliminate siloes. By digitizing software systems that interact through several divisions, businesses are now able to take steps in that direction to eliminate these siloes.  

3. Customer analysis to find and resolve problems  

Medical device or pharmaceutical service departments usually do not communicate with patients who benefit from their products. Healthcare is becoming customer-focused and applies to companies in the life sciences space that supply consumer goods. The 21st Century Cures Act requires patient data to collected in drug development processes. It is mentioned in the Cures Act.  

Companies learn to improve quality beyond regulations when talking to consumers. However, given that patients play an active role in their healthcare, their perception of pharmaceutical and medical device companies becomes essential.  

4. Harmonization and monitoring of processes to reduce total costs  

The importance of quality can never be overemphasized. Excellence for all organizations is a competitive priority. Cost and quality were considered as two different ends of the same continuum but this view has changed dramatically over time. Improved quality has reduced the total cost function on a long-term basis thanks to the continuous improvement of processes. Doing things right for the first time, managing transactions based on facts, and applying statistical process controls has led to better quality for organizations and reduced costs.  

5. Training and communication systems to build quality competence and culture  

Training and learning programs used by organizations are successful ways to address quality proactively. The problem could mean a significant overhaul of the company’s current processes and systems. For example, if a company has a different Quality Management System (QMS) for each site, data for those sites must be compiled manually to be used. Manual data input increases the likelihood of human error and compromises the integrity of the data. It is better to switch from paper-based or silo-based systems to digital, centralized ones.  

Digitization and automation would not remove quality jobs – only the value-added activities would return to the focus of work. The tasks that are eliminated are repetitive and monotonous.  


Like software development, QA testing is a constantly changing field, with new developments every day. The need for dedicated QA professionals is only growing, as businesses are recognizing the need to produce high-quality software in a competitive market. The success of their products and businesses as a whole will depend on quality assurance.   


Leoraj Devaraj

QA Manager

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