They can see whether employees feel comfortable escalating concerns, whether quality teams take those concerns seriously and whether investigations lead to meaningful preventive action.
They may also identify patterns in documentation that suggest a company is repeatedly assigning the same root cause without resolving the underlying issue.
If the same root cause appears every time, an investigator may question whether you are really investigating.
The expectation is not that a site will never experience a mistake, deviation or unexpected event. The more important questions are:
- Was the issue recognised?
- Was it escalated promptly?
- Was it documented appropriately?
- Was its potential risk assessed?
- Was the underlying cause investigated?
- Did the organisation take action to prevent recurrence?
- If the same root cause appears repeatedly, an investigator may question whether the investigations are sufficiently thorough or whether the resulting actions are effective.
An effective quality system gives investigators confidence that the organisation can recognise and control risk even when a regulator is not present.
Watch the full podcast episode HERE
