By Nicola Brady
What is a Quality Culture?
A Quality Culture within an organisation can be defined as a culture where everyone is focused on quality. It sounds pretty obvious doesn’t it? But this can be difficult to achieve.
How do you achieve a Quality Culture?
To achieve a Quality Culture, it must start at the top and filter down to all personnel in all functions, irrespective of their level in the organisation. The leadership team must be committed to the Quality Mandate. They must lead by example and empower their teams to act in accordance with good quality practices. This is only achieved through clear articulation and communication of expectations. The Leadership Team must ensure that expectations are supported by policies and procedures, that individuals have the appropriate skills and are provided the required training to perform in accordance with these expectations.
Processes are fundamental to achieving a successful Quality Culture. Uniform and robust processes must be in place to ensure consistency and standardisation of work. There should only be one way of doing things – the right way. Having processes in place through procedures, policies and methods ensures continuity and stability. It is important that continuous improvement is also encouraged. If there is a more optimised or streamlined way to do something that is science based and quality centric then personnel should feel empowered to propose alternative approaches and challenge the status quo.
The next essential element to achieving and maintaining a Quality Culture is Teamwork. Teamwork is vital at all levels of the organisation. Cross functionally, personnel must be able to work together, to share experience and best practices, to learn lessons. Trust is key. Team members must feel that they can trust their colleagues to do the right thing every time and they themselves must be trusted to operate in the same manner.This ties in closely with the final element of a Quality Culture, Code of Conduct. The Code of Conduct for the organisation must be established and appropriately communicated to ensure that personnel at all levels of the organisation understand the importance of conducting themselves in an honest, trustworthy, ethical manner. The Code of Conduct should clarify acceptable behaviours and practices as well as organisation expectations ultimately promoting the Quality Culture. All personnel at all levels of the organisation must observe the established Code of Conduct.
The culture of an organisation directly correlates with the validity and accuracy of the data that it generates.
HOW DOES QUALITY CULTURE IMPACT DATA INTEGRITY?
The culture of an organisation directly correlates with the validity and accuracy of the data that it generates. In the on data integrity (Data Integrity and Compliance with Drug cGMP: Questions and Answers Guidance for Industry (2018)) the following is stated ‘it is the role of management with executive responsibility to create a quality culture where employees understand that data integrity is an organisational core value and employees are encouraged to identify and promptly report data integrity issues’. An organisation with a poor or immature Quality Culture can often have poor or immature quality practices, whereby issues are not appropriately documented, investigated and remediated. These organisations inevitably encounter challenges in adhering to and often have poor regulatory inspection records with repeat observations and violations. Conversely, organisations with a strong Quality Culture perform well with the regulators. These organisations are not error-free but their quality culture promotes a ‘do the right thing’ ethos when errors and issues arise.This transparency and openness gives the regulators confidence that the organisations data integrity is assured.