FILLING AND REPLYING OF NON-CONFORMITY REPORT (NCR)

WHAT IS NON-CONFORMITY (NC)?

• Non-compliance of anything

• Non-conformance to a size

• Non-fulfillment of a requirement

Why we Need Non-Conformity Report (NCR)? (Multiple answers)

• used as part of quality control processes by ensuring correction and corrective action is taken and the effectiveness of actions taken are monitored and verified

• a tool for monitoring the effectiveness of action taken and prevent its recurrence

• describes the non-conformity, address the non compliance and explain the consequences

• for continual improvement

Main contents in the Non-Conformity Report (NCR) (Multiple answers):

• Category / nature of NC

• Description / explanation of NC and its consequences

• Correction / immediate action taken

• Root causes

• Corrective action taken

What is correction?

• an action to eliminate the causes of a Non-Conformity and prevent recurrence

• an immediate action to eliminate detected Non-Conformity without undue delay

• Correction on typo

Who is responsible to respond to the non-conformity and initiate correction and corrective action? (Multiple answers)

• Managers

• Process owner

• Head of department / process

• Technicians / operators

What is corrective action?

• an immediate action to eliminate detected Non-Conformity without undue delay

• an action to eliminate the causes of a Non-Conformity and prevent recurrence

• an action to correct the mistakes

Below are few types of Root Cause Analysis (RCA) Method (Multiple answers):

• PARETO Chart Analysis

• 5-Why(s) Analysis

• Fish Bone (Cause and Effect) Diagram Analysis

• 5M2E / 5M1E

• CSQ Analysis

Why we need to verify the correction and corrective action taken? (Multiple answers)

• To monitor the effectiveness of the action taken

• To monitor any recurrence is happening

• Actions are completed within commitment date

• For record purpose and show to the auditor / assessor during audit

• Improvement made from the actions taken

Which below are Non-Conformity? (Multiple answers)

• Turbidity reference solutions used for verification is expired

• Test result is wrongly calculated for pressure force

• The analytical balance is well positioned on a concrete bench / table

• The heating block does not apply the latest correction factor during oil digestion

• Titration and result calculation does not apply the latest standardized normality value

What is Root Cause?

• The root under the trees

• The underlying causes of a problem/ effects, why this is happening

• The person who cause the problem/ effects