qsp 643 01 preventive action

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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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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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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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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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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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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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)

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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



ppendix C: Customer-Supplied Property Label (QC-575-002)

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DATE PAGE03.04.14 10 OF 11

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qsp 643 01 preventive action

Documents

preventive action revision

process of preventive

proposed action

action necessary

shortterm action

preventive actions

proposed immediate action

potential nonconformity