A culture of quality is one in which everybody in the organisation, not just the quality controllers, is responsible for quality. A central feature of such organisations is that each worker or team of workers is both a customer of, and supplier to, other workers in the organisation: they form a chain of internal customers and suppliers. It is the responsibility of each unit to ensure the quality of their own work. The emphasis is on ensuring that things are ‘done right first time’. When they are not then the process that has led to an unsatisfactory output is analysed so that corrections can be made in the process to ensure that the problem does not arise again. In a quality culture there is no need to check final output. Indeed to do so, is to shift responsibility away from those involved at each stage.
Over the last 20-odd years working in 'controlling functions' in the pharmaceutical and allied industries we have heard variously about:
- GMPs for the 21st Century
- the 'cost of quality'
- the 'cost of compliance'
- Quality By Design
- Design for Validation
- Right First Time
- Governance and policy
- Data-driven decision making
plus a whole host of other buzzwords. But at the end of the day the attitude towards Quality, Ethics and Compliance is based on the MINDSET of the company and it's employees.
The commitment and understanding of Senior Leadership, Middle Management, Team Management and the individual is critical. If any of these groups mess up, you can forget all about 'GxP'. In essence, GxP relates to some very simple questions:
- 'How well managed is the company?'
- 'Does the company plan to succeed or fail?'
- 'How does the company deal with and learn from its mistakes?'
- Is the company driven by its shareholders, the senior leadership team, the good of the patient or simply the dollar bill?
More recently, in 2014 in the Harvard Business Review, Srinivasan & Kurey concluded the following:
A company with a highly developed culture of quality spends, on average, $350 million less annually fixing mistakes than a company with a poorly developed one
The purpose of this presentation is to consider and identify the way companies are managed and how this impacts the consistent provision of effective, efficacious and good value products. After all, who picks up the cost when it all goes wrong?