Guidance on corrective action and preventive action and related QMS processes GHTF/SG3/N18:2010
November 4, 2010 Page 26 of 26
Identify
Root Cause
The output of the root cause analy-
sis should be a clear statement of
the most fundamental cause(s) re-
sulting in the nonconformity
It has been concluded that the root cause of the tubing sur-
face finish issue is inadequate line clearance procedures
established at the supplier.
Planned
actions
Specify:
What the action is
Who will do it
When it should be done
Corrective action: Supplier to add line clearance require-
ments to documented procedures by [date].
Preventive action: Not applicable.
Verification
of actions
Verification activities are to ensure
that all the elements of the pro-
posed action (documentation,
training etc) will satisfy the re-
quirements of the proposed action
Validation activities generate data
and information that confirm the
likelihood of the effectiveness of
the corrective action to eliminate
the nonconformity or proposed
nonconformity.
General examples are included below. Actual documenta-
tion would need to be more specific.
Review and approval of the procedural changes prior
to use
Conduct a pilot of new procedure on a specific pro-
ject/department/time frame prior to full scale imple-
mentation
Verification that the updated supplier procedure ad-
dresses the process that caused the nonconformity
Verification that the training materials address the
specific process that caused the nonconformity
Comparing a new design specification with a similar
proven design specification
Performing calculations using an alternative method
Perform validation of equipment, software, production
processes, test method, component, etc.
Specific example:
Review and approval of supplier procedure XXX by the
supplier and the customer to ensure adequacy of the up-
dated line clearance process.
Verification
of effective-
ness
Method or data for the determination of
effectiveness with acceptance criteria.
The improvement goal
The evidence (data sources) that
will be used to support effective-
ness (e.g., a data source could be
where the problem was initially
found)
The time frame that effectiveness
will be monitored (e.g., upon com-
pletion of actions or three months,
six months as appropriate)
OR
Sample size required to demon-
strate effectiveness
X months after implementation:
Conduct a query of the electronic manufacturing data
system to verify there are zero surface finish rejects
for this component at finished Product A final inspec-
tion.
Supplier Quality Engineer to conduct on site review at
the supplier of the action to confirm the procedures
are in place, are known to the operators, and there is
evidence that the procedures are being followed.
Winterhufen 1.0