Quality and Leadership

World Quality Day is celebrated on 14th November and this year is special as it marks 100 years of ‘Quality’. Well, what I mean is, it was in 1919 at the end of the 1st world war that it was realized that standardization in weapons production was an important requirement which caused several issues like shells not fitting into guns etc, which lead to the formation of the first ever technical committee that met on ‘Quality’. So, how have we progressed on Quality in the last 100 years? Sure, Quality is now the focal point around which every product or service revolves, however there is always room for improvement and to do better. I would like to touch upon an important aspect of ‘Quality & Leadership’.

As I deal with the Pharmaceutical Industry hence it is pertinent to put this concept of ‘Quality and Leadership’ in context of the Pharmaceutical manufacturing industry.

Over the past few years there has been a spate of incidences where the Pharmaceutical Industry has been pulled up by Regulatory agencies for ‘Quality Failures’ in its products and processes. Is this something recent or has this always existed? The feedback from regulatory auditors suggests that these issues have always been inherent in our manufacturing systems and processes however now the auditors are focussing on these issues which has led to a substantial increase in instances of quality failures.

Some of the issues highlighted are: Data Integrity, Record keeping, Falsification of data, poor risk management etc. On the face of it these are elementary issues which form the foundation of any good quality management system and should not be in question.

If we also look at the typical assignment of the root causes to these failures majority of them point out to ‘Human Error’ or ‘Machine Error’.

In my opinion the single most important reason for Quality Failures is lack of top management commitment or an effective leadership for quality. Strange as it may seem, quality should be the cornerstone of any company but in many cases the top management seems distanced from it.

Coming back to the why quality failures happen in the Pharmaceutical industry the below graphic is an interesting food for thought:

All of the above traits directly stem from the leadership or a lack of it. The juniors simply follow the ‘Accepted Culture’ of the organisation and hence even if there is a system to assure quality its implementation is half-hearted at best. This quick Fix may be Ok for one time goal achievement but quality is not one time goal. It has to be a process or way of life. 

The responsibility of leaders consists of creating and maintaining the internal environment. Good leadership is essential in order to improve quality across the organisation, as the leading force that sets objectives and assists employees to implement these objectives. The challenge is to develop a robust culture where the idea of quality improvement is not only widely understood across departments, but becomes a fundamental, deep-seated value within each function area as well.

The current emphasis on quality as a competitive strategy has produced many views regarding the actions necessary to achieve it. Leaders in the quality movement (Deming, Juran, Crosby) have proposed similar approaches which share certain themes. These themes can be summarized as five basic principles:

  • Focus on customers’ needs;
  • Focus on problem prevention, not correction;
  • Make continuous improvements: seek to meet customers’ requirements on time, the first time, every time.    
  • Train employees in ways to improve quality; and
  • Apply the team approach to problem solving

Leaders can put this in operation by implementing following points

  • Be proactive and lead through example rather than dictating – true leaders lead in a way that is active in implementing and following through on actions, rather than simply dictating actions without leading by example.
  • Understand and react to fluctuations in the external environment – the external environment is every bit as important as the internal environment, which is why leaders need to fully comprehend and correctly react to various changes within this environment.
  • Teach, train and coach employees – through learning and coaching on various improvement strategies and other initiatives, employees are able to have a better understanding of not only what are they doing, but why are they performing their tasks.

Amidst the economic challenges that many industries are facing these days, it may be pertinent for the Leadership team in an organisation to re-look at Quality and empower their teams to do the right thing.

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