A corrective action is a term that
encompasses the process of reacting to product problems, customer complaints or
other nonconformity's and fixing them. The process includes:
• Reviewing and defining the
problem or nonconformity
• Finding the cause of the problem
• Developing an action plan to
correct the problem and prevent a recurrence
• Implementing the plan
• Evaluating the effectiveness of
the correction.
Inputs
to the Corrective Action Request process (CAR) are the following
1. Customer complaints, including
the return of defective products,
2. Quality system non conformances
discovered during internal or external audits,
3. Evaluated reports of product or
process nonconformity's, and
4. Reports of employee safety or
material hazards.
The
process for resolving problems includes:
1. Problem identification,
evaluation and description,
2. Creating a Corrective Action
Team and assigning responsibilities,
3. Selection of the Resolver, the person
/ department responsible for the corrective action,
4. Identification of the underlying
(Root) cause,
5. Creation of a corrective action
plan to eliminate the problem,
6. Implementation of the action
plan,
7. Verification that the actions
taken were effective,
8. Application of controls to
prevent recurrence.
The
output of the Corrective Action Request process include:
1. Analysis of the problem
2. Determination of the root cause
of the problem
3. Action plan to resolve the
problem and prevent recurrence,
4. Application of controls to
determine the effectiveness of the solution,
5. Verification that the problem
has been resolved and that the controls are effective, and
6. Examination of other similar
products / processes where similar problems may be prevented.
Returned
Product Test / Analysis
Parts returned by a customer are
analyzed to determine the mode of failure and detailed reports are made for
each return involving failed parts. Records of analysis are available to
the customer upon request. Corrective and preventive actions are
initiated as appropriate.
Corrective
Action Impact
Where appropriate, corrective
actions are taken to eliminate the causes of nonconformity in similar products
or processes.
The Quality Manager is responsible
for the overall operation of the corrective and preventive action processes and for preparing and presenting
corrective and preventive action reports at management review meetings.
The
corrective action process follows these steps
Step
|
Action
|
Corrective Action
|
1
|
Identify the non conformance
|
Identify the non conformance
from:
1.Faulty or
missing procedures
2.Internal and
external audit findings
3.Deviations from
Environmental Policy
5.Regulatory
requirements
|
2
|
Investigate the Root Cause
|
Investigate the root cause
of the non conformance relating to the activity, process, service, or
environmental system.
|
3
|
Corrective Action
|
Determine the corrective
action needed to eliminate the root cause of the non conformance.
|
4
|
Control
|
Apply controls to ensure
the corrective action is implemented and effective.
|
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