Deviation Report: Impact Analysis

What is the purpose of the Impact Analysis section in a deviation report?

• To assess the potential risks and impacts of the deviation

• To determine the root cause of the deviation

• To evaluate the effectiveness of the corrective actions

• To identify the responsible individuals for implementing corrective actions

Which of the following is a potential impact of a deviation?

• Financial implications such as additional costs for rework or replacement

• Harm or adverse events for patients or users

• Regulatory implications or non-compliance issues

• All of the above

How does the deviation impact the organization's ability to meet quality standards?

• It may lead to disruptions in operations or delays in service delivery

• It may result in violations of legal or contractual requirements

• It may affect the organization's reputation and customer relations

• All of the above