A sound approach to quality risk management utilizes the knowledge and experience of the entire team in your organization. The Team includes the people participating in the risk assessment, the people executing the mitigations as well as the internal auditors who need to evaluate the effectiveness of the process. Everyone needs to work together to assure Customer and Business satisfaction.
Auditors continue to struggle with effective and efficient audit execution of Risk Assessments. Common deficiencies include an over-reliance on checklists and inadequate understanding of the documentation risk assessments, including linkage of audit procedures to the risks they are designed to address. So what exactly does that mean? In plain English, this means the auditor needs to:
- Understand where, within the company’s quality/business system are the highest product/process risks.
- Tailor his or her audit program to evaluate risk management effectiveness.
- Understand the purpose and structure of FMEAs (or other risk assessment tools)
- Know how to audit the Severity, Occurrence and Detectability criteria
- Evaluate the effectiveness of the mitigations to reduce risk
- Audit for value
Expected Takeaways
You’ll learn to:
- Determine the right time to audit Risk Assessments
- Identify the critical requirements for the product or process to be included in a risk assessment
- Identify and classify potential failure modes
