QUALITY MANAGEMENT Document Code QP12

SYSTEM Version No. 1.0

Date Effective November 4, 2019
Root Cause Analysis Procedure
Page No. Page 1 of 9

Table of Contents

1. Distribution of copies ….……………………………… Page2

2. Purpose ….……………………………… Page3
3. Scope ….……………………………… Page3
4. Definition ….……………………………… Page3
5. Reference ….……………………………… Page3
6. Responsibilities ….……………………………… Page3
7. Process description ….……………………………… Page4
8. Operation Procedure ….……………………………… Page4
9. Procedure flowchart ….……………………………… Page7
10. Quality Records ….……………………………… Page9
 QUALITY MANAGEMENT Document Code QP12
SYSTEM Version No. 1.0
Date Effective November 4, 2019
Root Cause Analysis Procedure
Page No. Page 2 of 9

1. Distribution list

Process/ Department Name Position Date Signature

Name Position Signature

Mr. Jovannie A. Ceriaco QMS Specialist
Prepared by:
Mr. Gregor P. Fajardo Internal Auditor
Master Copy Stamp
Reviewed by: Mr. Mohamad Malke QMS Manager

Approved by: Mr. Mohamad Malke QMS Manager

 QUALITY MANAGEMENT Document Code QP12
SYSTEM Version No. 1.0
Date Effective November 4, 2019
Root Cause Analysis Procedure
Page No. Page 3 of 9

2. Purpose
2.1 The purpose of this procedure is to describe the activities exerted to conduct Root Cause
Analysis for the identified Non-conformities in order to determine the root cause of the
identified problem/non-conformance and to ensure that the proper corrective action is
implemented.

3. Scope
3.1 This procedure is applied to all processes and/or areas (parts of the organization) within
the Quality Management System (QMS).

4. Definition

Terms
Nonconformity (NC)
Corrective Action (CA)
Root Cause Analysis (RCA)
Concerned Manager
Internal Auditors
Assigned Team/ Member
Users
Issuer
5 WHY’s assessment
Definition
A Non-fulfillment of a requirement (a Standard or a
:
Procedure).
Action taken to rectify the non-conformity, eliminate
:
the cause, and to prevent recurrence thereof.
A method used in identifying and determining the
:
root cause in order to solve the problem
: Department, Project and / or Unit Manager.
An independent body that performs auditing activities
: to ensure conformance with the requirements of the
standard and define quality plan in the organization
A selected individual in the process to perform root
cause analysis to identify the root cause and propose
:
corrective action to address the non conformity
identified
The top management of Al Bawani, as well as the
: owner of the processes in which the non conformity
occurred.
A person responsible in the issuance of the non
: conformance report based on the identified non
conformities within the organization
One of the method in performing the root cause
: analysis in order to determine the root cause of the
problem.

5. Reference Documents
 ISO 9001:2015, clauses 8.7; 10.2
 Quality Manual
 QP08 - Management of Non-conformities & Corrective Actions Procedure

6. Responsibilities
6.1 Department Head/ Project Managers responsible to
 Identify the needs for initiating Root Cause Analysis
 Ensure that recommended solutions/ corrective actions provided were implemented
without undue delay to solve problem/NC and prevent recurrence of a
nonconformity, and eliminate potential risk.
6.2 Assigned Team members
 Responsible for conducting root cause analysis and recommend appropriate
Solutions/ Corrective Actions, and controlling their effective implementation.
6.3 Internal auditors
 Responsible to ensure that the recommended solutions/ corrective actions
addressed the identified non-conformance and the problem is solved.
 QUALITY MANAGEMENT Document Code QP12
SYSTEM Version No. 1.0
Date Effective November 4, 2019
Root Cause Analysis Procedure
Page No. Page 4 of 9

7. Process Description

INPUT PROCESS OUTPUT

Concern/ Project
Manager
Root Cause Identify the Root
Non-
Cause and make
Conforming Analysis Procedure corrective action
Report Top Mgmt. &
Concerned
Manager
DESCRIPTIVE STATEMENT:
The Concern Manager/ Project Manager will assign team member to investigate the problem stated in the
received Non conformity Report QF08-01. The Assigned Team Members will study the problems in the NCR
and collect data or gather information related to the problem. Then, the member assigned will perform the 5
Why’s analysis or root cause analysis method in order to identify and to determine the root cause of the
problems. After capturing the root cause, team members will recommend solutions/corrective actions to the
problem. The root cause analysis report (QF12-01) shall be review and approve by the concern manager. The
implementation of the corrective action shall be perform by the assigned team members and verified by the
concern manager to ensure that the problem/non-conformity is solved and to prevent recurrence of the identified
problem/non-nonconformity. The assigned team member shall close the non conformance report (QF08-01)
when corrective action is satisfactorily performed.

8. Operation Procedure

DETAILED ACTIVITY Responsible Reference documents

and records
8.1 Assign team member to conduct root cause analysis
8.3.1 The concern manager will select a team members Concern manager
to investigate the problem/NC depending on the
process in which the problem/NC has occurred or
was discovered prior to conducting root cause
analysis.

Team members may be composed of staff within

the concerned department or external party who
has expertise on the subject matter of NC.

8.2 Defining the Problem

8.3.1 Team members will formulate the problem Assigned Team  Non conformance report
statement based on the identified problem/NCR. (QF08-01)
The problem statement should have the following  Root Cause Analysis
in its content: Report (QF12-01)
 Vision;
 Issue Statement; and,
 Method

8.3 Data Collection (Objective Evidence)

8.3.1 Team members will collect data and gather Assigned Team  Customer complain
evidence in order to determine the following:  Inspection report
 Proof that problem/ NC exist.  Statistical data analysis
 How long has the problem/ NC existed.  Process monitoring /
 The impact. evaluation report
 Internal audit report
 Training evaluation
 Policies and Procedures
 Root Cause Analysis
Report (QF12)
 QUALITY MANAGEMENT Document Code QP12
SYSTEM Version No. 1.0
Date Effective November 4, 2019
Root Cause Analysis Procedure
Page No. Page 5 of 9

DETAILED ACTIVITY Responsible Reference documents

and records
8.4 Identification of Possible Causal Factors
8.4.1 From the gathered evidence, the assigned team Assigned Team  Customer complain
will determine the possible causal factors in  Inspection report
consideration of the following:  Statistical data analysis
 Sequence of events that led to the NC.  Process monitoring /
 Conditions that allowed the NC to occur. evaluation report
 Other problems surrounding the occurrence of  Internal audit report
the central problem.  Root Cause Analysis
Report (QF12-01)
The assigned team shall use tools to identify
causal factors especially the 5 WHYs method.

8.5 Identification of Root Cause

8.5.1 Team members will identify root causes of each Assigned Team  Customer complain
causal factors identified in order to determine the  Inspection report
reason for the existence of causal factors and the  Statistical data analysis
real reason the NC occurred.  Process monitoring /
evaluation report
Team members may use the same tool in  Internal audit report
identifying causal factors.  Root Cause Analysis
Report

8.6 Validation of Root Cause

8.6.1 Each member should conduct tests to validate the Assigned Member  Root Cause Analysis
identified root cause. Member assigned should Report
analyze cause and effect to ensure determination
of correct root cause.

8.7 Review and Approved RCA Report

8.7.1 The concern manager will review and approve Concerned Manager  Non conformance report
the root cause analysis conducted by the assigned (QF08-01)
team members.  Root Cause Analysis
Report

8.8 Recommend Solutions and Completion of Corrective

Action Report
8.8.1 Assigned Team shall make recommendations to Assigned Member  Non conformance report
address problem/NC and complete the CAR. (QF08-01)
Recommended solution(s) should be SMART.  Root Cause Analysis
Report

8.9 Review and Approved Recommended Solution/

Corrective Action
8.9.1 Concerned Manager will review recommended Concerned Manager  Non conformance report
solution/ corrective action and approved the (QF08-01)
report if the recommended solution has captured  Root Cause Analysis
the root cause. Report

8.10 Implement Corrective Action

8.10.1 The assigned team will implement the approved Assigned Team  Corrective Action
Corrective Action(s). Report (QF08-02)
 Root Cause Analysis
Report

8.11 Review, Validate and Approved RCA Report

8.11.1 The internal audit will examine the effectiveness Internal Audit  Non conformance report
of the recommended solutions/corrective actions (QF08-01)
taken to ensure that the problem/NC is solved and  Corrective Action
will prevent its recurrence. Report (QF08-02)
8.11.2 The internal audit will provide disposition to the  Root Cause Analysis
RCA Report and CAR status once the corrective Report (QF12-01)
action was satisfactorily performed.
 QUALITY MANAGEMENT Document Code QP12
SYSTEM Version No. 1.0
Date Effective November 4, 2019
Root Cause Analysis Procedure
Page No. Page 6 of 9

DETAILED ACTIVITY Responsible Reference documents

and records
8.12 Update Registry
8.12.1 Internal Audit will update registry and status of Internal Audit  Corrective Action
NC and CA after verifying the effectiveness of Report (QF08-02)
CAR.  Non-Conformity and
Corrective Action
Register (QF08-03)
8.13 Update of Concerned Department/Project Registry
8.13.1 The Concerned Manager will update its registry Concerned Manager  Non-Conformity and
of the status of its NC and CAR after notification Corrective Action
from internal audit of its approval of the CAR. Register (QF08-03)
8.14 Close Non-conformance Report
8.14.1 The assigned team shall close the non Assigned Team  Non conformance report
conformance report (QF08-01) as per decision (QF08-01)
making of the internal auditor and/or concern
manager. Stamped “Closed” to determine the
status.

Assigned Team or Concerned Manager shall

retain records as per QP03.
 QUALITY MANAGEMENT Document Code QP12
SYSTEM Version No. 1.0
Date Effective November 4, 2019
Root Cause Analysis Procedure
Page No. Page 7 of 9

9. Procedure flowchart

Root Cause Analysis Process Flowchart

Concerned Manager/ Project
Assigned Team Members Internal Audit
Director

Received NCR
Review NCR (QF08-01)
(QF08-01)

Define the Problem/ Assign Team to

Create Problem perform Root Cause
Statement (QF12-01) Analysis (RCA)

Collect Data
Information and
Evidence

Identify the causal

factors and perform 5
WHYs assessment

NO
Determine and validate Review and
the Root Cause approve Root
Cause

YES

NO

Recommend Corrective Review if CA

Action captured Root
Cause

YES
NO
NO

Implement Corrective Verified CA

Action (QF08-02) Implemented?
Effectiveness?

YES

YES

Update Registry and

Status of NC and CA
(QF08-03)
 QUALITY MANAGEMENT Document Code QP12
SYSTEM Version No. 1.0
Date Effective November 4, 2019
Root Cause Analysis Procedure
Page No. Page 8 of 9

Root Cause Analysis Process Flowchart

Concerned Manager/ Project
Assigned Team Members Internal Audit
Director

Notification

Update Registry and

Status of
Close Corrective Action Non-conformties and
Corrective Action
(QF08-03)

Stamp “CLOSED”

Retain Records as per

QP03
 QUALITY MANAGEMENT Document Code QP12
SYSTEM Version No. 1.0
Date Effective November 4, 2019
Root Cause Analysis Procedure
Page No. Page 9 of 9

10. Quality Records

All records pertaining to this procedure shall be maintained in accordance with Control of
Document and Record Control Procedure (QP03)

Storage (Hard
Retention
D.I. Code D.I. Title Retained By copy/
Period
Electronics)
Concerned Manager/ Electronic/ Hard
QF12-01 Root Cause Analysis Report 3 years
Document Controller copy
QMS
Electronic/ Hard
QF08-01 Non-conformance Report 3 years Manager/concerned
copy
Manager
QMS
Electronic/ Hard
QF08-02 Corrective Action Report 3 years Manager/concerned
copy
Manager
QMS
Non-conformity & Corrective Electronic/ Hard
QF08-03 3 years Manager/concerned
Action Register Report copy
Manager