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Quality System ProcedureQSP- 643-01 Preventive Action
Revision No. : 2
Effective Date:
Preventive ActionDoc. Id No. REVISIONQSP-643-01 2
DATE PAGE03.04.14 1 OF 11
1 Purpose
The purpose of this procedure is to determine the cause of, and any action necessary to prevent
the occurrence of non-conformance or potential non-compliance. Preventive actions must be
appropriate to the effects of potential problems.
2 Scope
This procedure is applicable to all the departments in the PT Borneo Mandiri Investment.
3 Responsibility
a) QA/QC Officer or Supervisor
Review document root cause and Preventive Action Plan for approval.
File and maintain all Preventive Action documentation.
Facilitate the preparation and implementation of Preventive Action Plans.
Investigation and/or causes of potential non-conformities.
b) QA/QC Managers shall:
Participate in review or respond to Preventive Action raised.
Investigate potential causes of non-conformance
Assist in the development and implementation of a Preventive Action Plan such as
proposed immediate action, underlying/root cause and proposed action for immediate or
short term action (preventive action).
c) Top Management shall:
Monitoring and review Implementation of Preventive Action
d) All PT BORNEO MANDIRI INVESTMENT
Raised up any potential nonconformities which occur.
Involved in the process of preventive action.
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DATE PAGE03.04.14 2 OF 11
4 Details of Procedure
In accordance with API Specification Q1 Ninth Edition, Section 6.4.3, PT Borneo Mandiri
Investment recognizes the importance of preventive action procedure.
The procedure shall identify requirements for:
a. Identifying opportunities for improvements;
b. Identifying a potential nonconformity and its potential cause(s);
c. Evaluating the need for preventive action, including any immediate or short-term action
required, to prevent occurrence of a nonconformity;
d. Identifying the timeframe and responsible person(s) for implementing a preventive action;
e. Reviewing the effectiveness of the preventive action taken; and
f. MOC when the preventive action requires new or changed controls within the quality
management system.
4.1 Identifying Opportunities for Improvements.
Opportunities for improvement may be identified through:
a. Audits (internal and external)
b. Complaints (internal and external)
c. Customer feedback
d. Quality assessments include:
Observation of field work
Internal review of quality system procedures
Quality control checks
Management reviews
4.2 Identifying a Potential Nonconformity and its Potential Cause(s)
Potential nonconformities identification may include:
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DATE PAGE03.04.14 3 OF 11
a. Potential nonconformities may be identified during audits which includes:
i. Potential nonconformities may be identified during internal (1st party)
audits, client (2nd party) audits or external (3rd party) audits.
ii. Potential nonconformities identified during internal audit conducted as per
Internal audit procedure QSP-622-01 shall be recorded by the internal
auditors and summarized in the audit reports by the Management
Representatives.
iii. Potential nonconformities identified during supplier audits shall be
recorded in the client audit reports compiled by the auditors and submitted
to PT Borneo Mandiri Investment through the Management Representative
for preventive actions.
iv. Potential nonconformities identified during external audits by external
agencies on the PT Borneo Mandiri Investment shall be recorded by the
auditors and captured in their audit summary reports compiled and
circulated to the PT Borneo Mandiri Investment for action.
b. Potential nonconformities identified by employees during daily activities which
includes:
i. The employees shall also record in the preventive action form potential
complaints brought to their attention by the customers.
ii. The employee having recorded the potential nonconformity shall notify the
concerned personnel like QC for preventive action for follow up.
c. Potential nonconformities identified from risk assessments
d. Potential nonconformities identified from supplier performance and
nonconforming product
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DATE PAGE03.04.14 4 OF 11
e. Potential nonconformities identified from final inspection
f. Potential nonconformities identified from design changes and complaints
After identifying the potential nonconformity, it will be followed by the investigation of
the potential causes of potential non-conformity. Where the root cause of the potential
nonconformity is not readily identifiable, the person responsible for taking the preventive
action:
a. Investigate and identify the root cause.
b. Establish the preventive action to be undertaken.
The preventive action to be undertaken is recorded in the Preventive Action Form.
4.3 Evaluating the Need for Preventive Action, Including any Immediate or Short-term
Action Required, to Prevent Occurrence of Nonconformity
It includes:
a. Top management will decide the appropriate level of action to be implemented based
on the evaluation and if preventive action is necessary then the preventive action
request is developed and forwarded to the Quality Control who will record the details.
b. The problems must be evaluated to determine the need for immediate, short term or
preventive actions and the level of action required, based on the impact and risk of the
problem. The evaluation should include:
Potential impact of the problem.
Risk to its customers or the company (i.e. risk to the client related to the
product quality, condition, and safety; risk for the reputation of the
company)
c. Immediate action is necessary when the quality, efficacy or safety may be
compromised by the problem. Examples for immediate action:
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DATE PAGE03.04.14 5 OF 11
Product recall
Rejection of a batch
Interruption of the production (i.e. until the problem is assessed and fixed)
4.4 Identifying the Time Frame and the Responsible Person(s) for Implementing a
Preventive Action
a. Determining and implementing action needed.
b. Recording of the results of any investigations and of action taken,
c. The person who responsible for taking the preventive action, he must ensure that the
action taken is completed on or before the suggested completion date.
4.5 Validation and Verification of Taken Preventive Action
a. The personnel who responsible for preventive action must obtain the signature and
approval of the Operation Manager/Requestor in the form of Preventive Action Form
and submit it to QC for closed out with supporting evidence.
b. QC will verify the preventive action taken is effective.
4.6 Reviewing the Effectiveness of the Preventive Action Taken
a. After verification and validation of taken preventive action, it will be followed by Top
Management who reviews the preventive action taken.
b. Review the effectiveness of the preventive actions by reviewing data to determine if
similar quality problems exist after the implementation.
c. Operation manager will liaise with the Quality Manager to ensure all documents with
details of the actions taken (preventive action) are retained as evidence for review and
close out of the preventive action.
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DATE PAGE03.04.14 6 OF 11
d. If preventive actions are determined to be not effective, the original preventive action
request will be closed and a new preventive action request will be issued in order to
reinitiate the process.
e. The preventive action will not be regarded as closed out until all evidence has been
recorded and the item updated on the Preventive Action Form as per the following:
Preventive Action resolved date; month/ year
Comments/ Action status- Closed or Action Implemented
4.7 MOC When the Preventive Action Requires New or Changed Controls Within the
Quality Management System
Refer to section 4.4 and 5.0 of Management of Change (QSP-511-01).
4.8 Follow Up and Closed Out
a. On or before the date of completion of preventive action, the Top Management
follow-up with the function responsible for taking preventive action and ensure
that the preventive action has been carried out and that all the verification
signatures has been obtained.
b. The Top Management may then go ahead and close out Preventive Action.
c. In situations where the preventive action has not been completed or action taken is
not effective, then a supplementary nonconformance is raised assigning a new date
for completion of the preventive action.
Records of the activities for control of potential process nonconformities shall be
maintained by QC department. Preventive action process flowchart is attached in
Appendix A.
5 Reference
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DATE PAGE03.04.14 7 OF 11
a) Quality Management System (QSM-01 Rev.2)
b) Management of Change (QSP-511-01)
7 Appendix
Appendix A Preventive Action Process Flow chart
Appendix B Preventive Action Form (QC-643-001)
Appendix A: Preventive Action Process Flow chart
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Activity Responsibility
If No,
If Yes
All staff
Top management
Top management,
requestor, and QC
Top management
Relevant personnel
QC, Requestor or
Operation Manager
Top Management
Top Management
Appendix B: Preventive Action Form (QC-643-001)
Page 8
Identification opportunities for improvements
Identification of potential non-conformity and its potential causes
Evaluating the need for preventive action
Identifying the time frame and the responsible person for preventive action implementation
Implementation
Validation and verification of taken preventive action
Review the effectiveness of preventive action taken
Effective?
Closed out
Preventive ActionDoc. Id No. REVISIONQSP-643-01 2
DATE PAGE03.04.14 9 OF 11
ppendix C: Customer-Supplied Property Label (QC-575-002)
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