QSP 04 Non Conformance Corrective and Preventive Action
QSP 04 Non Conformance Corrective and Preventive Action
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Master Management
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1. Certification Body
Document Definition:
Hard copy of this document is for reference purpose only. Please refer to the controlled
softcopy in the in the PIS - Knowledge management - Quality Document
1. OBJECTIVE
The purpose of this procedure is to ensure that effective corrective / preventive actions are
taken at the appropriate time in order to eliminate the cause of non-conformities in order to
prevent recurrence in the process and system.
2. SCOPE
This is applicable to all non-conformities identified during any stage of the processes and also
problems encountered during implementation of Quality management system and for any
feedback/complaint from the customer.
Role Responsibilities
4. ENTRY CRITERIA
5. Procedure
Corrective actions are initiated by concerned team leaders of recurring nature or with
high potential of recurrence based upon the feedback from the following data:
1. Internal Audit
2. Customer feedback/Client Satisfaction Survey /Customer complaint
3. Service/Process non-conformities
a. The Issues and Queries of Customers are handled as per the procedure for End to
End Process Flow chart.
b. The concerned team leader/ Process Owner collect the data related to non-
conformities from the above and address the same in custom build application,
Nonconformance classify the non-conformities of repeated nature.
c. Based on this, Process Owner determines the root cause of the non-conformity and
the action required to prevent the conformity of recurring nature.
d. Before implementation, the concerned Heads shall review the corrective action
initiated by the team leader.
e. The concerned department head/Director is also responsible for the implementation of
the agreed corrective action that ensure effective implementation.
f. The investigation of the non-conformity and the implementation of the corrective action
is prioritized based on the magnitude of the non-conformity and its long-term
implications.
g. The results of agreed corrective actions are recorded in the Issue List
h. The effectiveness of the corrective action implemented is discussed during the
management review.
Customer Feedback
The customer feedback is received by the process owners and is directed to the team
leaders for analysis. Status of the complaint is monitored through mail
communications, after the detailed analysis on the same, the concerned process
owner and director reviews the corrective action required for the same, before
implementation.
Internal Audit
The nonconformities raised during internal audit are analyzed and corrective action is
initiated to avoid recurrence of the same. The steps involved in handling the
conformities during internal audit are defined in the Procedure for Internal Audit.
Corrective Action
RH will take action to eliminate the cause of non-conformities in order to prevent
recurrence. Corrective action will be appropriate to the effects of the non-conformities
encountered during reviews or internal/external audits. Corrective actions are taken by
Identifying the root causes for non-conformities
Taking corrective actions
Preventive Action
RH will determine actions to eliminate potential non-conformities in order to prevent their
occurrence. Preventive actions will be appropriate to the effects of the potential
problems and will be taken by
Identifying causes for potential non-conformities
Evaluating the need for action for preventing occurrence of non-conformance
Checking the effectiveness of actions through evidence
6. REFERENCE
7. STANDARDS COMPLIANCE