Optimising organisational culture and quality maturity is crucial in promoting consistent, reliable business processes and to minimise supply disruptions. This involves understanding the visible and invisible aspects of culture, and their impact on the quality system.
Organisational culture change requires time, effort, commitment, and alignment with the organisation’s vision. Organisations with lower Quality Management Maturity often exhibit outdated procedures, lack of innovation, and high levels of unplanned work, among other traits. To avoid stagnation, leaders must identify early warning signals and take corrective actions.
Changing course requires recognition that the organisation is indeed off course, identification of misalignments across the organisation that are driving undesirable behaviours, seeking out root causes, and developing and implementing a corrective and preventative plan.
This process requires sustained leadership commitment and a coordinated effort across the organisation. Implemented well, this will drive desired behaviours and culture, enhanced employee experience and as a result, high organisational performance.
It is well recognised that regulatory authorities are looking deeper into ongoing supply disruptions caused by quality system issues. There are signs and agreements from industry and regulators alike, that the reason for such ongoing challenges needs to be understood and resolved.
Several of the regulatory authorities have highlighted culture and behaviors as a clear factor. Indeed, the US FDA has been considering the best mechanism to operationalise its Quality Management Maturity (QMM) Assessment as part of its regulatory oversight of the sector.
The US FDA describes QMM as “the state attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement,” but where does culture fit in?
Schein’s definition of organisational culture is often referred to as three levels:
- Artefacts that may reflect culture (for example, symbols and language)
- Norms and values about appropriate attitudes and behaviours (espoused or real)
- Underlying assumptions and beliefs (conscious or unconscious).
In short, it is the visible and the invisible.
If not, everything is visible, it is difficult then to consider what the impact of organisation culture might be on an organisation’s quality system, its effectiveness and robustness, even its maturity state. Furthermore, how would an organisation measure the impact of these cultural attributes or go about improving culture to enhance quality maturity?
