Total Quality Management in Pharmaceutical Industry: Why Automation is Key

Across industries, from automotive and manufacturing to pharma and biotech, the fundamental principles of TQM remain the same. These include:

1. Deep focus on the customer
2. Aim to produce a high-quality product the first time; don’t settle for anything less.
3. Continuous Improvement doesn’t happen automatically; set up the processes for it.
4. Total Employee Involvement (TEI) is vital for improving quality metrics
5. Fact and data-driven decision-making is critical
6. Integrate people, systems, and processes
7. Put in place a TQM strategy document and communicate it to the right people
8. Measure what matters

TQM in the pharmaceutical industry is no different. While there are several regulatory requirements (21 CFR Part 210/211, 600; EU Directive 2003/94/EC, EU Annex 13; ICH Q8, Q9, Q10, Q11; etc.) that govern this industry, TQM is about going beyond compliance needs.

It is about building an enterprise-wide culture wherein a “quality-first mindset” drives all actions and activities across the product lifecycle.

Embracing TQM principles and setting up the required processes will play a key role in delivering customer delight while reducing manufacturing costs and improving financial performance. In today’s digital world, it is paramount that pharma companies that have TQM on their agenda use the power of automation and digital transformation.

The question is: What processes should we automate as part of our TQM efforts?

Short answer: Ideally, everything you can, but do it step by step.

Long answer: Over time, make sure you automate the following processes – Inspections and Audits, CAPA, Change, Training, Complaints Handling, Management Reviews, Documentation, Risk Management, and Regulatory Processes. Implement a next-generation EQMS that makes it easy for quality leaders and other stakeholders to access data at their fingertips. To implement TQM, it is important to have an EQMS platform that easily integrates with the ERP and CRM. A complaint that comes in from the CRM must flow through to the Complaints Handling and CAPA modules, in addition to triggering notifications for specific actions to be taken.

At ComplianceQuest, we’ve deep expertise in serving the pharmaceutical and biotech sector, in automating and digitalizing the entire QMS workflow. Based on this experience, we highlight here the common reasons why TQM efforts fail and how using the right digital tools can prevent failure.

#1 – TQM Implementation Fails When the Organization Lacks the Ability to Collaborate

Integrating people, processes, and systems is a key TQM principle. Let us say you spot a quality issue during an inspection. Without wasting any time, this issue must be fed into the CAPA management system to plan the next steps. In order to act with agility, automation is a must.

ComplianceQuest offers a truly connected, comprehensive EQMS platform that makes collaboration (and actioning) easy and seamless. Additionally, since it is built on the Salesforce platform, the Chatter feature can be used to power real-time collaboration and communication.

#2 – Lack of a Robust Audit Management System Prevents Continuous Improvement

Having a well-designed audit management process makes sure quality leaders “know their gaps”. With CQ’s Audit Management Software, we ensure enterprises have the ability to build a scalable and configurable audit management workflow. Depending on the specific needs of your company, you can automate a rapid audit process or configure a workflow for a complex audit.

The CQ Audit Management Software enables easy access to documents and reports of past audits, in addition to capturing failure trends and triggering corrective or preventive action for continuous improvement. This is a key requirement for Total Quality Management in the pharma industry.

#3 – Total Employee Involvement (TEI) Happens Only When Employees are Well-trained and Prepared

CQ Training Management allows you to train employees in a timely fashion and keep your workforce skilled and job-ready.

Integrating training into your EQMS supports a stable, reliable, and repeatable training management process, ensuring that your entire organization has the knowledge it needs, from GxP guidelines to international standards to government regulations. CQ Training Management tackles this challenge by helping businesses manage all personnel, job functions, requirements by job functions, courses, and documents to be trained on. For TQM efforts, it may be a good idea to include training content on the importance of bringing in a quality-first mindset to any activity.

#4 – Quality Leaders, Executive Management, and Other Stakeholders Need Data and Documents at Their Fingertips to Bring Agility into Quality Decision Making

World-class quality teams rely on real-time data to make decisions. With a modern EQMS like ComplianceQuest, which serves as a single source of truth for all key quality data, capturing insights from data becomes easier. With the right dashboards, charts, and the Quality Control Tower, the implementation of TQM becomes more meaningful and data-driven.

To know more about how ComplianceQuest EQMS can help automate TQM processes in your pharma or biotech company, request a demo here:
https://www.compliancequest.com/online-demo/