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Corrective Action Process
Corrective Action Process
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Document Title:
Approval of
Department / ISO JOWELL P. MAX
Section / Process DEPARTMENT CABRERA FANKHANEL MILA D. PEREZ
Owner
Department Originator Reviewed Approved
IMPORTANT:
This cover sheet is part of the procedure and is not to be discarded unless superseded by a revised issue.
Unauthorized reproduction is strictly prohibited.
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CORRECTIVE ACTION PROCESS
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REVISION HISTORY
Execution Revision Revision Description of Changes Page Originator Reviewed
Date Number Type Affected Date
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CONTENTS
1. OBJECTIVE ……………………………………………………………….……….……………… 4
2. SCOPE …………………………………….…………………………………….…………………. 4
6. PROCEDURE …………………………………………………………………………………….. 10
8. FORMS ……………………………………………………………………………………………. 20
9. APPENDICES …………………………………………………………………….………………. 22
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CORRECTIVE ACTION PROCESS
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1.0 OBJECTIVE
The objective of this procedure is establish and maintain a uniform and consistent
process of taking action to address nonconformities occurred at any stage of
implementation of the Integrated Management System of ISO 9001:2015, ISO
14001:2015 and OHSAS 18001:2007 through proper identification, issuance,
evaluation of corrective action, verification of its effectiveness and documentation of
non-conformities (NCs) identified during and after the delivery of products and
services.
2.0 SCOPE
Nonconformity (NC) Any instance where practice or evidence does not fulfill the
requirements. This may be also a condition of “work in place" or
"work in progress" that lacks agreement or conformity, and which
cannot be corrected in the normal course of action.
Minor Nonconformity A deficiency that may not lead to a breakdown of the company’s
Integrated Management System. This may be due to lapses, failure
or improper implementation of established system and
requirements. Several or continuous commission of Minor Non-
conformities could result to Major Nonconformity.
Major Nonconformity A deficiency that involves a serious non-compliance to the
standards that leads to the serious breakdown of the company’s
Integrated Management System.
Punchlist / Snags Workmanship deficiency that can be corrected in a manner that will
not require large amount of resources and time. Can be closed by
“Making Good” repairs.
Corrective Action A report detailing the nonconformity identified to make an
Report unambiguous, defensible, clear and concise definition of the
problem so that corrective action can and will be initiated. This
report also includes an analysis of the root cause of the
nonconformity, request for approval and execution of corrective
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CORRECTIVE ACTION PROCESS
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CORRECTIVE ACTION PROCESS
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CORRECTIVE ACTION PROCESS
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5.2.1 Investigating and evaluating the validity of the Corrective Action Report
prior to issuance.
5.2.2 Evaluating the need for action to eliminate the cause (s) of the
nonconformity, in order that it does not recur or occur elsewhere.
5.2.4 Reviewing the root cause analysis and corrective action/s proposed by
the Responsible Entity (RE).
5.2.6 Closing of Corrective Action Report (CAR) after corrective action/s and
its effectiveness have been demonstrated.
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CORRECTIVE ACTION PROCESS
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5.3.2 Proposing immediate and long term action to control and correct the
nonconformity.
5.4.3 Requesting closure of Corrective Action Report (CAR) from the Issuing
Entity (IE) after corrective actions and its effectiveness have been
demonstrated.
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CORRECTIVE ACTION PROCESS
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5.5.1 DMR shall be responsible for consolidating the CAR issued by the
Internal Auditors and Lead Auditor for update to CAR Control Register
6.0 PROCEDURE
6.1.2 Nonconformities may be identified but are not limited to the following
sources:
c) Internal Audit
d) Inspection, Checking, Examination and/or Investigation
e) Customer or any Third Party Complaints
f) Testing
g) Self-Generated / Self-Analysis
h) Review, Evaluation and/or Assessment
i) Or any other forms of Audits, Testing and Inspection
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CORRECTIVE ACTION PROCESS
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6.2.1 The person of the Issuing Entity (IE) who identified and has first-hand
knowledge of the nonconformity shall prepare the Corrective Action
Report (CAR) Section 1: Nonconformity Report.
6.2.3 If the source of the complaint is from external sources such as Customer
or Third Party Stakeholders, the Head of Issuing Entity (HIE) shall
validate the report accordingly. If the report is found to be valid, the
HIE shall issue Corrective Action Report (CAR) described in this process
to the Responsible Entity (RE) adapting/endorsing the complaint/report
from external sources.
a) Source
b) CAR No.
c) Classification
d) Issuing Entity (IE)
e) Responsible Entity (RI)
f) Affected Clause(s) or Procedure(s)
g) Time limit to reply
h) Statement of Nonconformity
i) Reason for re-issuance
j) Does this problem can potentially occur elsewhere?
6.2.7 The Head of Issuing Entity (HIE) shall review and assess the Corrective
Action Report (CAR) Section 1 if:
a) The CAR Section 1 contains all the related facts, accurately conveys
the facts, fully explained in brief terms, can be understood for
prompt action, categorized, traceable and verifiable.
6.2.8 Upon conformity, the Head of Issuing Entity (HIE) shall issue the
Corrective Action Report to the Responsible Entity (RE). All issued CAR
shall be assigned with its own CAR control no. in accordance with
Control of Documents Procedure.
6.2.10 The process described in 6.2.1 to 6.2.5 shall be repeated until the Head
of Issuing Entity accepts/recommends the issuance of the Corrective
Action Report (CAR).
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CORRECTIVE ACTION PROCESS
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6.3.1 Upon receipt of the Corrective Action Report (CAR), the Responsible
Entity (RE) shall identify and fill up Section 2: Analysis and Corrective
Action with includes the following:
a) Root Cause
b) Correction/Immediate Action
c) Corrective Action
d) Preventive Action (for OH&S)
e) Completion date
6.3.3 In case of dispute, the Responsible Entity after careful evaluation found
that the provision or the entirety of Corrective Action Report (CAR)
issued is invalid, the Head of Responsible Entity (HRE) shall
communicate in writing to the Head of Issuing Entity to repudiate the
Corrective Action Report (CAR) issued. Resolution of dispute shall be
decided by the next/higher level of authority who have jurisdiction and
governance over both the Issuing Entity (IE) and Responsible Entity
(RE). The matrix of jurisdiction/authority over disputes is described in
the Appendix 3: Jurisdiction Guide.
6.3.4 The Responsible Entity (RE) shall submit the accomplished Corrective
Action Report (CAR) Section 2: Analysis and Corrective Action to the
Head of Responsible Entity (HRE) for review prior to submission to the
Head of Issuing Entity (HIE).
6.3.5 The Head of Responsible Entity (HRE) shall review and assess the
Corrective Action Report (CAR) Section 2 if:
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6.3.7 Upon conformity, the Head of Responsible Entity shall submit the
Corrective Action Report (CAR) Section 2 to the Head of Issuing Entity
(HIE) for approval.
6.3.8 The Head of Issuing Entity (HIE) shall evaluate the Corrective Action
Report (CAR) Section 2 if conforming to the conditions described in
6.3.5. The HIE shall identify and coordinate with other concerned
parties relevant to review the submitted CAR Section 2.
6.3.9 The relevant parties shall review the implications of the proposed
corrective actions in terms of safety, quality, cost, and time. The Head
of Issuing Entity (HIE) shall collate and integrate the comments and
suggestions of the concerned parties. The decision to approve or reject
the Corrective Action Report (CAR) Section 2 shall be based on this
collective comments.
6.3.10 The Head of Issuing Party shall approve the Corrective Action Report
(CAR) Section 2 if the proposed corrective action and other provisions
are acceptable.
6.3.12 The Responsible Entity (RE) shall revise the Corrective Action Report
(CAR) Section 2 to comply with the comments and suggestions of the
Head Issuing Entity (HIE) and resubmit the revised CAR to the HIE for
approval. The process described in 6.3.1 to 6.3.9 shall be repeated until
approval of the CAR.
6.4.1 The Responsible Entity (RE) shall notify the Issuing Entity (IE) of the
schedule when actions to correct the nonconformity will take place and
other activities thereafter deemed necessary to show evidence that the
corrections (immediate) and corrective actions (final) made is in
accordance with the approved Corrective Action Report Section 2
(CAR).
6.4.2 The Responsible Entity shall perform necessary actions to correct the
nonconformity in accordance with the approved Corrective Action
Report (CAR) Section 2. In case of necessary deviation, the Responsible
Entity (RE) shall notify the Issuing Entity (IE) and amend the CAR in
agreement.
6.5.2 The Responsible Entity (RE) shall submit necessary compliance reports
together with Corrective Action Report (CAR) to the Issuing Entity (IE)
after the completion of correction and corrective action/s. These reports
shall include evidences or proof of conformance showing that the
corrections and corrective actions were performed in accordance with
the approved Corrective Action Request (CAR). This may include but
are not limited to the following:
6.5.3 The Issuing Entity (IE) upon the receipt of the compliance reports shall
conduct final verification if the approved corrective action/s were
performed accordingly and is implemented within the prescribed
duration described in the approved Corrective Action Report (CAR)
Section 2.
6.5.4 Deviations from the approved CAR Section 2 identified during the final
verification that can potentially affect or compromise the effectiveness
of the corrective action taken shall constitute a nonconformity and shall
be addressed accordingly with the same process of Corrective Action
Report issuance.
6.5.5 The process described from 6.5.1 to 6.5.3 shall be repeated until the
conformance to the approved corrective and/or preventive action/s is
demonstrated.
6.6.2 The Issuing Entity (IE) shall notify the Responsible Entity (RE) of the
schedule and scope of review to be conducted.
6.6.5 The process described from 6.6.1 to 6.6.4 shall be repeated until the
conformance to the approved Corrective Action Request (CAR) Section
3 is demonstrated.
6.7.1 If the corrective action/s during the review are found to be effective
and performed in accordance with the approved Correction Action
Report (CAR) Section, the Issuing Entity (IE) shall recommend closure
of the Corrective Action Report to the Head of the Issuing Entity (HIE).
The Head of Issuing Entity shall sign and affirm the closure of the
nonconformity by accomplishing the Corrective Action Report (CAR)
Section 4: Closing of Corrective Action Report.
6.8.1 In the event that the Responsible Entity (RE) failed to act on the
nonconformity issued within the prescribed period, the Issuing Entity
(IE) shall reissue the Corrective Action Report to the Responsible Entity
(RE). The Responsible Entity (RE) shall take the necessary actions
within seven (7) working days from the date of re-issuance.
6.8.2 In the event that the Responsible Entity (RE) deliberately delayed or
failed to act on the re-issued nonconformity within seven (7) working
days from the date of issuance, the Issuing Entity (IE) shall coordinate
with the Integrated Management Representative (IMR) to issue Second
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(2nd) Corrective Action Report (CAR) to the Strategic Business Unit Head
(SBU Head) for nonconformities identified within SBU level or the
General Manager (GM) for nonconformities identified on the corporate
level. The SBU Head or the General Manager shall take necessary
actions to resolve the nonconformity.
6.8.3 In the event that SBU Head or the General Manager failed to act within
fourteen (14) working days from the date of issuance, the IMR shall
issue the third (3rd) Corrective Action Report (CAR) to the President.
The President shall take necessary actions to resolve the
nonconformity.
6.9.1 The Project QA/QC Head/DMR shall update the Corrective Action Report
(CAR) control register to reflect the status of the corrections taken.
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8.0 FORMS
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CORRECTIVE ACTION PROCESS
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9.0 APPENDICES
Rejection: Acceptance:
Issuing Entity (IE) to revise the Corrective Head of Issuing Entity (HIE)
Action Report to issue the CAR to the
Responsible Entity (RE)
Checkpoint:
Responsible Entity to prepare a Corrective Action Report
Depart. Head of Responsible
(CAR) Section 2: Analysis and Corrective Action Plan Entity (HRE) check if the CAR
is correct
Rejection: Acceptance:
Responsible Entity (IE) to revise the CAR Responsible Entity (IE) to submit CAR
Section 2 Section 2 to Issuing Entity (IE)
Rejection: Acceptance:
Responsible Entity (IE) to revise the Responsible Entity (IE) to perform corrective action/s
CAR Section 2
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Checkpoint:
Issuing Entity (HIE) to conduct verification of corrective Head of Issuing Entity (HIE) to
action taken check if corrective action is
performed correctly
Rejection:
Responsible Entity (RE) to conform to
CAR Section 2
Acceptance:
Responsible Entity (RE) to conduct Review of Effectiveness
of Corrective Action and accomplish CAR Section 3
Rejection:
Acceptance:
Responsible Entity to revise CAR
Dept. Head of Issuing Entity (HIE) to close nonconformity
and sign-off CAR Section 4.
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CORRECTIVE ACTION PROCESS
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APPENDIX 2: FORMS
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CORRECTIVE ACTION PROCESS
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A. Major Nonconformity
B. Minor Nonconformity
1 Discrepancy or lapse in discipline in the defined IMS which have not been addressed
properly by a CAR; and
2 Non-compliance to a certain aspect of a sub-clause of ISO 9001:2015, ISO 14001:2015
and ISO 18001:2007 standards.
Note: Audit findings that are reported as Potentially Nonconformity, Observation and
Opportunities for Improvement do not need CAR issuance but shall be logged and monitored
for actions taken.
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CORRECTIVE ACTION PROCESS
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A. Major Nonconformity
1 Any nonconformity which may result in failure or reduce the usability of the products or
services for the intended purpose and which cannot be completely eliminated by rework or
reduced to a Minor Nonconformity by an approved corrective action/s.
2 Any nonconformity which may result in hazardous or unsafe conditions for individuals using,
maintaining or depending upon the products or services.
3 Nonconforming products/services which reached the customer, recurring or with adverse
effect on the achievement of targets, which have not been addressed properly by CAR;
4 Valid & critical customer complaints which have not been properly attended and closed;
5 Repeated failure to meet quality standards requirement which drastically affects
product/service delivery due to lack of or poor quality and execution of CAR.
6 Non-performance of a process requirement/s which resulted to critical customer complaint
or non-compliance to statutory, regulatory or legal requirements.
7 Nonconforming products/services which may result to major cost overruns and major delays
that affect the customer’s schedule or the delivery of the product and services.
8 Non-performance of a process requirement/s which resulted in the rejection of incoming
resources, complete rework or the rejection of a batch of finished product.
9 Lack of or deficiency of existing process or procedure that may result to nonfulfillment of
quality requirements.
B. Minor Nonconformity
1 Any nonconformity which does not adversely affect the performance, durability,
interchangeability, reliability, maintainability, effective use or operation, appearance, health
or safety of a product.
2 Isolated occurrence of nonconformity that does not directly affect the customer which
creates little or no waste and can be rectified quickly, easily, and inexpensively.
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CORRECTIVE ACTION PROCESS
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A. Major Nonconformity
1 Any nonconformity which may result in hazardous or unsafe conditions for individuals using,
maintaining or depending upon the products or services.
2 Refusal or failure to conform to accepted standards, rules or laws resulting to detrimental
effect on individual’s well-being and safety.
3 Unsafe or hazardous products/services which reached the customer, recurring or which have
not been addressed properly by CPAR;
4 Valid & critical customer complaints which have not been properly attended and closed;
5 Repeated failure to meet OH&S standard requirement/s which drastically affects the safety
and well-being of individuals due to lack of or poor execution of CPAR.
6 Non-performance of a process requirement/s which resulted to critical customer complaint
or non-compliance to statutory, regulatory or legal requirements.
7 Nonconforming practices which may result to major accident or near miss.
8 Lack of or deficiency of existing process or procedure that may result to nonfulfillment of
OH&S requirements.
B. Minor Nonconformity
1 Any nonconformity which does not adversely affect the health or safety of an individual,
product produced or services rendered.
2 Isolated occurrence of nonconformity that does not directly affect an individual which
creates little or no waste and can be corrected quickly, easily, and inexpensively.
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CORRECTIVE ACTION PROCESS
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IV. ENVIRONMENT
A. Major Nonconformity
B. Minor Nonconformity
1 Any nonconformity which does not have significant impact on the environment in the
conduct of the business.
2 Isolated occurrence of nonconformity that does not have direct impact on the environment
which creates little or no waste and can be corrected quickly, easily, and inexpensively.
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