Nonconformity, Corrective Action

and Preventive Action

ISO 9001:2008 Corrective Action says:
The organization shall take action to eliminate the cause of nonconformities
in order to prevent recurrence. Corrective actions shall be appropriate to the
effects of the nonconformities encountered .
A documented procedure shall be established to define requirements for :
A) Reviewing nonconformities ( including customer complaints )
B) Determining the causes of nonconformities
C) Evaluating the need for action to ensure
D) Determining the implementing action needed
E) Records of implementing action taken
F) Reviewing corrective action taken

Nonconformity, Corrective Action
and Preventive Action
ISO 9001:2008 Preventive Action says:

The organization shall determine action to eliminate the causes of the potential
nonconformities in order to prevent their occurrence .

Preventive actions shall be appropriate to the effects of the potential problems.

A documented procedure shall be established to define requirements for :
A) Determining potential nonconformities and their causes
B) Evaluating the need for action to prevent occurrence of nonconformities
C) Determining and implementing action taken
D) Records of results of action taken
E) Reviewing preventive action taken




Non Conformanity Is
The non-fulfillment of a specified ISO 9001:2008 requirement.

The departure or absence of one or more Product characteristics or Quality
Management System elements from specified requirements.

The non-fulfillment of a specified QMS requirement.

Verifiable evidence that an element of the QMS is not documented or that the
documented system is not being followed (evaluation of implementation).

Usually found and reported as part of an QMS Audit.

Results in a corrective or preventive action request

Nonconformity, Corrective Action
and Preventive Action
Corrective action action to eliminate cause of
detected nonconformity

Preventive action action to eliminate cause of
potential nonconformity
Nonconformity, Corrective Action
and Preventive Action
Corrective action = reactive action taken to avoid
re-occurrence Fixes immediate problem including
mitigation of any environmental impact caused
Determine if problem possible in other locations
Preventive action = proactive action take to avoid
occurrence Addresses underlying cause (s) of
non-conformances May take longer to implement
as may be dealing with longer-term solutions

Nonconformity, Corrective Action
and Preventive Action

Corrective action = reactive action taken to avoid re-
occurrence Fixes immediate problem including
mitigation of any environmental impact caused
Determine if problem possible in other locations
Preventive action = proactive action take to avoid
occurrence Addresses underlying cause (s) of non-
conformancesMay take longer to implement as may be
dealing with longer-term solutions

Nonconformity, Corrective Action
and Preventive Action

The Quality Management Representative (MR) is responsible for
handling the investigation of any nonconformance to the QMS.

Section Managers are responsible for taking action to mitigate
any impacts and for initiating and completing corrective and
preventive action.

All employees are responsible for bringing suspected
non-conformities to the attention of their supervisor or the MR.
Nonconformity, Corrective Action
and Preventive Action
C/PAR (Corrective/Preventive Action Request)
Date:

Impact/ Concern:(For additional information, use back and/or
attach additional sheets)

Area/ Location:
Name:______________________________
Section:____________________Phone:
_____________________________
Return to:Your Supervisor or to: MR

MR Use Only: C/PAR Opened : Yes, Control # _________ No,
Resolution ______________________
Nonconformity, Corrective Action
and Preventive Action


Corrective Action Requests (CARs) are issued as a result of non-
conformances identified during internal and external audits.

All CARs are handled and investigated the same way as C/PARs.

What are Corrective
and Preventive Actions?

Corrective action fixes the immediate problem (e.g., repair a leaking
valve)
Preventive action is designed to stop the problem occurring again,
or stop problems before they happen (e.g., improved maintenance
procedures)
Effective preventive actions are a key to
CONTINUAL IMPROVEMENT
Nonconformity, Corrective Action
and Preventive Action

Deficiencies in communication
Deficiencies in documentation
Deficiencies in personnel training and motivation
Deficiencies in materials
Deficiencies in tools and equipment
Deficiencies in the operating environment

Nonconformity, Corrective Action
and Preventive Action
Steps to Identify and Correct Non-Conformance

Identify problem through routine inspection, monitoring, audit
findings, trend analysis, employee comments, complaint, experience
Investigate problem and its underlying causes.
Involve persons with first-hand knowledge of the issues, and
authority to achieve solutions
Identify best solution (s) and persons responsible for implementing
them
Nonconformity, Corrective Action
and Preventive Action
Ensure solution is adequate for the size and nature of the problem,
i.e., fix the underlying cause (s) once and for all

Follow-up with monitoring to confirm that implemented solution
is effective long-term

Involve people throughout with sufficient influence to make
things happen promptly
Nonconformity, Corrective Action
and Preventive Action
C/P Actions Paraphrased
a) Identify, correct and mitigate problem
b) Determine cause (s) and take actions to prevent recurrence (i.e.
root cause)
c) Take any action needed to prevent problems
d) Write down results of corrective and preventive action (s) taken
e) Review effectiveness of either corrective or preventive action (s)
taken

Non-Conformance
Investigation Example
PROBLEM:
Monitoring results not submitted to process on time
Possible underlying causes:
Responsibility for reporting not clearly communicated
Inadequate training or awareness of reporting
schedule requirements
Written procedure not available
Insufficient supervision and checking
Principles of Corrective
and Preventive Action
Dont ignore problems and hope theyll go away
Ask:
Who? What? When? How? Where? WHY? until
you arrive at the root cause of the problem
Fix deficiencies in the system, not just symptoms
of the problem
Nonconformity, Corrective Action
and Preventive Action
One More Thing
The organization shall implement and record any changes in the
documented procedures resulting from corrective and preventive
action

This means that procedures must be kept up to date (i.e.,
maintained) to include new actions required to prevent previous
problems
Nonconformity, Corrective Action
and Preventive Action
Consequences of Non-Conformance
MAJOR NON-CONFORMANCE
Registration to ISO 9001 delayed until problem is corrected and re-
audited
MINOR NON-CONFORMANCE
Can receive registration to ISO 9001 but must commit to fix
problem within 30 days; correction will be confirmed on next audit
Nonconformity, Corrective Action
and Preventive Action
More Consequences of Non-Conformance

QMS is an inter-dependent system; if one component is
defective, the whole system is broken

One problem usually leads to another; pay now or pay
much more later if first problem, and underlying causes, is
not fixed quickly
Nonconformity, Corrective Action
and Preventive Action
Important points to remember are:
Need open communication, without fear of punishment
for identifying a non-conformance
Need somebody with authority in charge of responding to
non-conformances
Need thorough investigation of symptoms and
underlying causes of each non-conformance
involving knowledgeable persons and those affected by
the non-conformance
Nonconformity, Corrective Action
and Preventive Action
Additional points to remember are:
Need identification and implementation of lasting solutions that
change the system (i.e., the way things are done), not just the
symptoms

Need follow-up to ensure the solution provides lasting
improvement

Need update documented procedures to
include corrective and preventive actions
Nonconformity, Corrective Action
and Preventive Action
QUESTIONS






Nonconformity, Corrective Action
and Preventive Action

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