People & Culture
This chapter will cover:
- Training
- Task and responsibility defining
- Embedding a culture of quality
A critical element of any technology is the human element and so people become an important consideration.
Staff must be provided with effective and appropriate training in systems usage, as well as data and document creation, processing, management i.e., good documentation practice.
Tasks and responsibilities need to be clearly defined, communicated, and monitored to ensure that staff are adopting best practice, operating efficiently as well as to prevent, detect, and correct poor habits.
Culture
So, to ensure inspection preparedness and readiness in relation to data integrity, organisations need to focus not just on the data and documents, but also the enabling technologies, the governance frameworks (aka good documentation practices), and the people.
This naturally embeds a culture of quality within the organisation as a whole, a culture in which employees and management see “doing it right first time” and inspection readiness as a state of mind, learn to appreciate Quality Assurance colleagues as friends not foes, and see inspections as opportunities, not threats.