insufficient

What was the conclusion of the investigation

Insufficient Information

Multiple Choice

What work instruction should be used to select conclusion of Investigation?

• Appendix D – Determine Further Escalation of 027-WI186 Rev E – Complaint Investigation

• Appendix F – Determine Further Escalation of 027-WI186 Rev E – Complaint Investigation

Multiple Choice

What is the the most commonly used as most events are foreseen through a risk assessment, trended and monitored?

• Existing Corrective Action / Inv

• Foreseen in risk/included in Monitoring

• Insufficient information

Multiple Choice

What is used if existing Formal Investigation applies?

• Existing Corrective Action / Inv

• Foreseen in risk/included in Monitoring

• Insufficient information

Multiple Choice

When do we use Insufficient information?

• for known events when there is no sufficient info available such as Serial/lot # and the device is not returned for analysis to determine the most likely cause.

• Let us escalate first to TL/SME

• no prod return, broad allegation, no lot/ serial and product ID