121: Risk Acceptance Issue

Definition/Typical Issues

Were the risk acceptance criteria used during the audits and inspections set inappropriately? Were the risk acceptance criteria used for the metrics program set inappropriately? Were the risk acceptance criteria improperly applied? Were risks deemed acceptable that should have been reduced?

Examples

Example 1

• Inspection of metal grid straps resulted in a rejection rate of about 5%. Although this was an unacceptably high rate, the quality assurance personnel did not identify this as a condition adverse to quality.

Example 2

• During an audit, it was found that several isolation valves were closed upstream of vessel relief valves. Operators opened the valves as soon as the situation was identified. Because the corrective action was taken promptly, no further actions were identified by the auditor. Because of the serious nature of the situation, a report of a Condition Adverse to Quality should have been generated and an incident investigation initiated. During a subsequent incident, a vessel violently ruptured when it was overpressurized and its relief was isolated because of a closed upstream isolation valve.

Typical Recommendations

• Ensure that a diverse team (able to reasonably assess the appropriate risks) is involved in setting audit and inspection review criteria.
• Develop more objective criteria for judging risk levels (e.g., a simplified risk-scoring scheme or listing required safeguards for specific situations).
• Provide guidance to team members to help ensure that the reviews are conducted properly.
• Develop the appropriate risk tolerance criteria or guidance for use in risk-based decision-making situations.