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CR and NC Training

Authored by Fairus Z

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CR and NC Training
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10 questions

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1.

MULTIPLE CHOICE QUESTION

30 sec • 1 pt

NC question: Nonconformity source can be from:

Competitor

BPOM

Indonesia FDA

Out of Specification (OOS)

2.

MULTIPLE CHOICE QUESTION

30 sec • 1 pt

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

3.

MULTIPLE CHOICE QUESTION

30 sec • 1 pt

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

4.

MULTIPLE CHOICE QUESTION

30 sec • 1 pt

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

All Employees

Quality Manager

Top Management

Supplier

5.

MULTIPLE CHOICE QUESTION

30 sec • 1 pt

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

6.

MULTIPLE CHOICE QUESTION

30 sec • 1 pt

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

7.

MULTIPLE CHOICE QUESTION

30 sec • 1 pt

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

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