Detection of Non Conformity

(Inspection, testing, customer complaints, Quality audits, mockups)

Identify & understand the problem

Refer 6 step methodology pt no 1

Establishing a response team

Refer 6 step methodology pt no 2
Note -

All the details as per SOP

must be captured in the Define a Problem Statement
format F-STC-040 by
Execution person & keep
record of it with signs Gather & Verify the Data
which shall be sent to 1)Pareto Analysis
Quality Department on 2)FMEA analysis
closure 3)Fishbone Analysis
4)5 Why Analysis
Refer to Responsibility
and Accountability point
no 8 (Important)
Determine Causes

Other Probable Causes

Causes observed Root cause
for not referring to
QMS

Propose Corrective
Action Plan

Implement Preventive
Implement Actions
if problem re-occur
Corrective Action
Plan
Validate Action
if problem does not re-occur

Implement the
Process Change