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Total Quality Management in Pharma – A Quick Introductory Guide


Total Quality Management is a managerial theory, used by Pharmaceutical companies to improve the quality of medicines. This practice leads to exceed and meet customers’ expectations.

Pharmaceutical companies play a significant role in the healthcare sector and for this; these firms are also regulated by regulatory bodies. In India, it is regulated by CDSCO (Central Drugs Standard Control Organization and in the USA it is the US Food and Drug Administration.  Any mistake in the manufacturing process can lead to unwanted consequences. So to clear the regulatory requirements, Pharma firms need to continuously bring improvement in their manufacturing process by implementing TQM.

Implementation of Total Quality Management in the Pharmaceuticals Industry

For the implementation of TQM, all the stakeholders need to be involved in the process of product quality improvement.  Here value and best managerial practices are focused on business growth and cost savings.

Benefits of Total Quality Management in the Pharmaceutical Industry

Total Quality Management (TQM) always welcomes the Pharma Industry with the following benefits

  • Cost Savings
  • Increase in Profit
  • Accelerate Innovation
  • Facilitate entry to Global Market
  • Faster time to market

Elements of Total Quality Management in the Pharmaceutical Industry

For the implementation of Total Quality Management, an organisation must focus on the following elements:

  • Business Ethics
  • Trust
  • Integrity
  • Training
  • Team Effort
  • Leadership
  • Communication
  • Recognition

Components of the Total Quality Management Approach

  • Customer-centric: Identification of consumers is beneficial
  • Employee Involvement:  It brings different perspectives for innovation and product improvement
  • Continuous Improvement: The objective to bring the best product in the market is an endless cycle in which interested parties constantly contribute to improving product quality

Pharma firms that wish to be successful need to establish a culture of integrity and compliance and consider the needs and expectations of internal and external stakeholders.

Principles of Total Quality Management (TQM)  

Plan: In this stage, employees tell their existing challenges to the management

Do: A solution to the problem is given by the employees and evaluation of the same is also done here.

Check: Effectiveness of the processes is checked here

Act:  This stage is related to the documentation of the results

6Cs for implementation of Total Quality Management (TQM)

  1. A commitment to quality improvement is required by all the employees
  2. The organization must embrace modern  quality improvement culture
  3. From time to time new reforms in all policies, procedures and activities are required for continuous improvement
  4. Harness employees expertise and cooperation  for the improvement of strategies
  5. Focus on customer requirements for staying  relevant in the market
  6. Control, monitor and measure of performance

Concept of Total Quality Management

The basic concept of total quality management lies in its first name. The first word total indicates that all employees of the organization are required to improve operations.  It should be a focused effort. Leaders of the organization should set clearly defined goals, provide training, funding and hire required staff, if necessary for improving product quality continuously.

What leads to the Failure of TQM implementation?

Below are the reasons which lead to the failure of TQM implementation

  • Focus only on  better financial outcomes and ignoring the existing system improvement
  • Unnecessary intervention that leads to delay
  • Undefined process and strategies
  • Lack of training and education resources

What are the Training Options available for TQM?

TQM training is required for the growth of the organization. This may look like to you it affects man-hours but there is a long-term benefit.

If you are planning to implement TQM, proper training is always required. Nowadays, there are three available for TQM training

Onsite TQM Training: In this training, leading SMEs comes to your unit to provide TQM training. It enables all the interested parties to actively participate as a group.

Offsite TQM Training: It enables a candidate to hold his/her daily work activities and focus only on learning. This type of training is preferred by companies that require few candidates to train.

Online TQM Training: Online training material is designed to make the entire session interactive. So that users can easily grasp the learning material and even ask his/her doubt later on. It enables candidates to access training material from anywhere and once the training is completed a certificate in quality management is also issued. This helps candidates to share his achievement in job portals like LinkedIn.

Definition of Management System:

It is a way of managing inter-related parts of the business for achieving the objective.

Objectives can be product or service quality, operational efficiency, existing environmental performance and safety in the organization.

In Pharma and Healthcare sector need to meet all the legal obligations

In some organizations, it means organization owner providing guidelines to its employees on what is expected from them and how their contribution matter

Ending Note

Total Quality Management is concerned with the continuous improvement in decision-making to execution. It is not only related to improvement in results but also improvement in people, technology, processes and capabilities.

There are five areas of focus for capability improvement which are:

  • Demand Generation
  • Supply Generation
  • Technology Capability
  • Operations Capability
  • People Capability

A central principle of TQM is that the mistakes may be made by the employees but sometimes the root cause of the mistake lies within the existing process. This means mistakes could be avoided if we identify and change such process. By doing this, time and cost can be saved.

In case you want to avoid investing man-hours in training, there is an alternative option available which is used by many forward-thinking companies to provide training for TQM. It enables employees to access training from anywhere with less effort and earn a certificate in quality management after the completion of the course.

PharmaState Blog
This is a platform for people working in the pharmaceuticals industry for Discussions, Jobs, News updates, Professional Profile display space and company business pages. PharmaState DNA is having four pillars: Quality, Transparency, Innovation & Benchmarks.

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