CR and NC Training

NC question: Nonconformity source can be from:

• Competitor

• BPOM

• Indonesia FDA

• Out of Specification (OOS)

NC question: Materials or product that do not meet the standards/requirements, or do not meet with the established processes, etc. is definition from:

• Correction

• Prevention Action

• Nonconformity

• Change Request

NC question: Investigation process can be using 5M method. The parameter issue that must be investigate under this method is:

• Man. Money, Machine, Method, Milieu

• Man. Material, Machine, Method, Milieu

• Man. Material, Machine, Method, Measurement

• Man. Material, Machine, Method, Mobility

NC question: Who should inform or initiate nonconformance report if found the nonconformity situation?

• All Employees

• Quality Manager

• Top Management

• Supplier

NC question: "State the information of the personnel involved". This statement is related to 5M parameter for:

• Material Issue

• Man Issue

• Method Issue

• Machine Issue

CR question: Below is the change type that is available in PT Virtue Diagnostics Indonesia, except:

• Engineering Change

• Production Process Change

• Non Design Change

• Design Change

CR question: Below is the impact and risk assessment as per mention in the change request form (DCR) part B, except:

• (May) affect financial software

• (May) affect regulatory compliance

• (May) affect product performance

• (Potential) affect Environmental Health and Safety

CR question: Which class category for change request that need to have preliminary review by Change Committee:

• A

• B

• C

• D

CR question: Change input can be from, except:  

• Audit

• Competitor

• Complaint

• Quality Notification from Virtue Groups

CR question: In the change description, as initiator, he/she must mention:  

• Root Cause

• Closing date

• Reason for Change

• Change approval