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Quality Corrective Action Procedure

The document outlines procedures for corrective and preventive actions. It describes evaluating nonconformities, investigating possible causes, analyzing problems to determine root causes, eliminating causes by revising processes or specifications, monitoring corrective actions, and making permanent changes to documentation. For preventive actions, it involves analyzing sources of information to determine causes, dealing with problems, ensuring effectiveness of controls, and making permanent changes to documentation.

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26 views2 pages

Quality Corrective Action Procedure

The document outlines procedures for corrective and preventive actions. It describes evaluating nonconformities, investigating possible causes, analyzing problems to determine root causes, eliminating causes by revising processes or specifications, monitoring corrective actions, and making permanent changes to documentation. For preventive actions, it involves analyzing sources of information to determine causes, dealing with problems, ensuring effectiveness of controls, and making permanent changes to documentation.

Uploaded by

Tutis05
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

1 PROCEDURE

5.1 Corrective Actions:-


5.1.1 Evaluation of Importance:
The significance of a nonconformity affecting quality is evaluated in terms of its potential
impact on such aspects as processing costs, quality related costs, performance, dependability,
safety and customer satisfaction.
5.1.2 Investigation of Possible Cause:
Important variables affecting the capability of the process to meet specified requirements are
identified e.g. machining capability. The relationship between cause and effect is determined
with all potential causes considered and recorded.
5.1.3 Analysis of Problem:
In the analysis of a quality-related problem, the root cause or causes have to be determined
before corrective action is planned. Often the root cause is not obvious, thus requiring careful
analysis of the product specifications and of all related processes, operations, quality records
and any customer complaints. During Management Review, the registers of nonconformities
are reviewed to help identify those problems having a common source, contrasted with those
that are unique occurrences.
5.1.4 Elimination of Causes:
Identification of a cause may result in changes to production, packing, transit or storage
processes, product specification and/or revision of the quality system. The action to be taken
is to be appropriate to the magnitude of the problem, and to avoid the recurrence of
nonconformities.
5.1.5 Process Controls:
When corrective action is implemented, its effect is monitored in order to ensure that desired
goals are met. Any necessary changes in the controls of processes and procedures shall be
implemented to avoid recurrence of the problem.
5.1.6 Permanent Changes:
Permanent changes resulting from corrective action shall be recorded in the appropriate
work instructions, process documentation, product specifications and/or the quality system
documentation.
5.2 Preventive Actions:-
5.2.1 Analysis:
In the analysis, the cause has to be determined and this can be obtained by examining:
- Appropriate sources of information such as processes and work operations that affect
product quality.
- Concessions, audit results, quality records, customer complaints that enable detection
and subsequent analysis to eliminate causes of nonconformities.
5.2.2 Permanent Change:
Once the cause(s) are determined, the necessary actions are:
- Determine the steps required to deal with any problems.
- Indicate the action and application of controls to ensure effectiveness.
- Record the necessary permanent change in work instructions, process documentation,
product specifications and/or the quality system documentation.

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