TRAINING –WORKSHOP

on ISO 9001:2015 Documentation

and Internal Quality Audit for
DARRO XI
May 24-27, 2022
at Malagos, Davao City
Course Outline:
Day 1 Day 2 Day 3
9:00 am-12:00 nn -
9:00 am-10:00 am - Opening 9:00- 12:00 nn- Evaluation
Continuation on Interpreting
Program and Competence of Auditors
ISO 9001:2015 Requirements
10:01 am-12:00 nn-
Lunch Break Lunch Break
Introduction to ISO 9001:2015
1:30 pm-5:00 pm - Key 1:00 pm-3:00 pm - Written
Lunch Break
Elements of ISO Audit Examination
1:00 pm-5:00 pm -
3:01-4:00 pm –Closing
Interpreting ISO 9001:2015
Program
Requirements
Criteria for passing the Course: 70%

Workshop Output - 30% Participation – 30% Written Exams-40%

 WORKSHOP No. 1: Your perception about ISO 9001:2015?

In Terms of: Skeptics/Critics Advocate/Believers

Certification
Quality Management
System
Financial
Leadership
Benefits
A Brief History of ISO –
the International Organization
for Standardization
ISO (International Organization for Standardization) is
the world’s largest developer of voluntary International
Standards. Founded on February 23, 1947, and since then
have published 23075 International Standards covering
almost all aspects of technology and business. ISO 20022-
Payment platform that adapts to changing needs. Deadline –
December 2022.

Isos (Greek) meaning- equal, similar, identical

Headquarters: Geneva Switzerland
President: John Walter
Website: iso.org
Founded in 1947 by a group of delegates from 25
countries, the 67 original technical committees of ISO
came together with a unified goal of ensuring products and
services are safe, reliable, and of good quality. The very
first ISO standard, called “ISO/R 1:1951” – was first
published in 1951 to set a standard reference temperature
for industrial length measurements (geometrical product
specification) . Today, that standard still exists (after
many updates) as ISO 1:2002.
In 1987 British Standard 5750 became the guidance
document of ISO 9000 with 91 member nations.
 The ISO Standardization Process
• Each member body who has an interest in the work of a committee is entitled to be a member of
that committee. Standards are reached by consensus with each member organization representing
the interests of the vendors, manufacturers, consumers, professionals, and government of it's
country.
• Each standard goes through a six stage process before being published as an ISO standard.
• The first stage - the proposal stage in which a need for a standard is determined and members are
identified who are willing to work on it.
• The second stage - The standards then enters the preparatory stage where a working draft of the
standard is developed. When the working draft is completed, it enters the committee stage and is
sent out for comments until a consensus is reached. The output of this stage is the Draft
International Standard (DIS).
• The Third stage – The DIS then enters the enquiry stage where it is circulated among all member
bodies and then voted upon. If a DIS does not receive 75% of the vote, it returns to lower stages
and work on it continues.
• The fourth stage - If it passes the enquiry stage , it becomes a Final Draft International Standard
• The fifth stage - the approval stage. During this stage it will again circulate through all member
bodies for a final vote and again it must pass this stage with 75% of the vote.
• The sixth stage- If the standard passes this stage, it enters the publication stage and is sent to
the ISO Central Secretariat for publication.
With 22,401 International Standards covering all aspects of
business and technology, and members from 161 countries, ISO has
its eye on the future of quality and safety certification.
ACCREDITATION CERTIFICATION

• Procedure by which an • Procedure by which a

authoritative body gives
formal recognition that a
body or person (signatory)
is competent to carry out
specific tasks
third-party (certification
body) gives a written
assurance that a product,
process or service (of an
organization) conforms to
specification requirements

• Governed by Standards such • Provided based on ISO

as ISO 17011/ 17021/ 9001/ 14001/ 27001 etc.
17024
 ACCREDITATION BODIES
(UKAS / ANAB / JAS ANZ / ETC.
ACCREDITS

CERTIFICATION BODIES CERTIFICATION BODIES FOR

(WQA / GIC / etc.) PERSON (CQI-IRCA)

CERTIFY ORGANIZATIONS CERTIFY TRAINING ORGANIZATIONS

APPROVED TRAINING
AUDITEE
PARTNERS (e.g. Edullence)
TRAIN AUDITORS

AUDITORS
AUDIT THE AUDITEES
 TEN (10) Top Quality Gurus

1. Dr. Walter Shewhart

Dr. Walter Shewhart developed
the Plan, Do, Check, Act
(PDCA) cycle (known as
“Plan-Do-Study-Act” in some
circles) as well as theories of
process control and the
Shewhart transformation
process.
2. Dr. W. Edwards Deming
Dr. Deming developed his complete philosophy of management, which he
encapsulated into his “fourteen points” and the “seven deadly diseases of
management”. He advanced the state of quality, originally based on work done
by Shewhart with his explanations of variation, use of control charts, and his
theories on knowledge, psychology and variation.
Deming greatly helped to focus the responsibility of quality on management
and popularized the PDCA cycle, which led to it being referred to as the
“Deming Cycle”.
3. Dr. Joseph M. Juran
Dr. Juran developed the quality trilogy – quality planning, quality improvement,
and quality control. Quality assurance policy statement and procedures quality
improvements that raise the level of performance, which then must be
controlled or sustained at that level in order to start the cycle again.
4. Armand V. Feigenbaum
Mr. Feigenbaum developed the idea of total quality control based on
three steps to quality consisting of quality leadership, modern quality
technology, and an organizational commitment to quality.

5. Dr. Kaoru Ishikawa

Dr. Ishikawa developed the
Ishikawa diagram, also known as
the fishbone or cause-effect
diagram. He was known for
popularizing the seven basic
tools of quality and the
philosophy of total quality.
6. Dr. Genichi Taguchi
Dr. Taguchi developed the “Taguchi methodology” of robust design, which focused on
making the design less sensitive to variation in the manufacturing process, instead of
trying to control manufacturing variation. This idea of “designing in quality” has become
an important tenent of six sigma today.
7. Shigeo Shingo
Shigeo Shingo developed lean concepts such as Single Minute Exchange of Die (SMED) or
reduced set-up times instead of increased batch sizes, as well as Poka-Yoke (mistake
proofing) to eliminate obvious opportunities for mistakes. He also worked with Taiichi
Ohno to refine Just-In-Time (JIT) manufacturing into an integrated manufacturing
strategy, which is widely used to define the lean manufacturing used in the Toyota
production system (TPS).
8. Philip B. Crosby
Philip B. Crosby was the quality guru that developed the idea of Cost of Poor Quality
(COPQ) to explain how “quality is free”. He believed implementing quality improvement
pays for itself through the savings from the improvement, increased revenue from
greater customer satisfaction, and the improved competitive advantage that results. He
popularized “zero defects” to define the goal of a quality program as the elimination of
all defects and not the reduction of defects to an acceptable quality level.
9. Dr. Eliyahu M. Goldratt
Dr. Goldratt developed the Theory of Constraints which focuses
on a single element in a process chain as having the greatest
leverage for improvement (i.e., “1% can have a 99% impact”). This
compares to the Pareto principle which states that 20% of the
factors have an 80% effect on the process.
.
10. Maasaki Imai
He developed the Kai-Change Zen-Better Method and Philosopy
Continuous Improvement Process (CIP) , is an ongoing effort to
improve products or services or processes constantly evaluated in
order to improve effectiveness, efficiency and quality.
Seven (7)
Quality
Management
Principles
1: Customer Focus

As an organization, your success depends on customer

satisfaction. Therefore you need to understand
current and future customer needs, meet customer
requirements and strive to exceed their expectations.
Managing customer satisfaction is key.
Do you carefully review your customer’s requirements?
How do you know if your customers are satisfied?
2: Leadership

• Your organization’s leaders are the top level of management.

They establish unity of purpose and direction of the
organization. They should create and maintain the internal
environment in which people can become fully involved in
achieving the organization’s objectives. To establish a great
environment you should build trust, equip and empower
employees, recognize employee achievements and hard work,
and set challenging goals to keep employees motivated.
• The captain guides the ship, and likewise, Top Management has
a responsibility to embrace these principles and your quality
management system. Specifically, your organization’s
leadership should hold management review meetings to keep
your QMS (and organization) running smoothly.
3: Engagement of People

• People at all levels are the essence of an organization and

their full involvement enables their abilities to be used
for the organization’s benefit. ISO 9001 requires training
to ensure employees have the tools they need to do their
job and contribute to the success of your organization.
• In order for people to support your quality initiatives,
they must understand them. Additionally, you must create
an environment where employees feel confident and
comfortable asking questions, learning and sharing
knowledge. To benefit your employees we recommend an
employee overview of ISO 9001.
4: Process Approach

• A desired result is achieved more efficiently when

activities and related resources are managed as a
process.
• A process is a set of activities that use resources
(people, machines, etc.) to transform inputs into
outputs. Every organization is made up of a series of
interacting processes.
5: Improvement

• Continual improvement of the organization’s overall

performance should be a permanent objective of the
organization. Top management should encourage their
employees to make improvements and also measure
improvement consistency.
• Auditing your QMS and improving your processes is a
key requirement of ISO 9001.
6: Evidence Based Decision Making

• Effective decisions are based on the analysis of data

and information.
• When the data reveals that an area is
underperforming, it is important to take corrective
actions to improve performance.
• Root Cause Analysis is a good way to determine the
source of the problem for knowing what corrective
actions should be taken.
7: Relationship Management

• The organization needs to identify and select suppliers

(and other interested parties) that can manage costs,
optimize resources and create value. When you are
establishing relationships you want to collaborate to
ensure that you are both focuses on continual
improvement.
• Your organization is unique, so there is not one right
answer as to the application of these principles above.
However, implementing ISO 9001 can help establish a
solid basis for improved quality and customer
satisfaction.
Are you willing
to be ISO
9001:2015
Certified?
To Get Certified
 Quality
Environmental Management Occupational
Management Systems-Requ Health and
System irement Safety
Management
System
WORKSHOP No. 2: ISO 9001:2015

WORD

SEARCH

PUZZLE

15 Minutes
 VISION STATEMENT : Where the DAR be, tot meet the needs and expectation of the stakeholders.
It describes dreams and aspirations for the future.

Ex. “The worldwide leader in retailing”

“A just, safe and equitable society that upholds the rights of tillers to own, control, secure, cultivate and enhance
their agricultural lands, improve their quality of life towards rural development and national industrialization.”

MISSION STATEMENT- is the statement of the role by which DAR intends to serve it’s stakeholder . It describes
why an organization operates and thus provides framework within which strategies are formulated.
It describes:
1. Present capabilities
2. Who it serves
3. Reason for existence

Ex. “To give an ordinary folk the chance to buy the same thing as the rich people”

“DAR is the lead government agency that holds and implements comprehensive and genuine agrarian reform which
actualizes equitable land distribution, ownership, agricultural productivity, and tenurial security for, and with the
tillers of the land towards the improvement of their quality of life.”
Strategic Direction is a course of action that leads
to the achievement of the goals of an organization’s
strategy. The word “strategy” is derived from the Greek
word “stratgos”; stratus (meaning army) and “ago”
(meaning leading/moving). Strategy is an action that
managers take to attain one or more of the organization’s
goals.

- Forward Thinking - PLAN

- Indicate organizational goals
-Determine the constraints to quality and other
related issues
Strategic Direction as stated in ISO 9001:2015
Clause 4.1: The organization shall determine external and internal
issues that are relevant to its purpose and its strategic direction and
that affects its ability to achieve the intended results of its quality
management system.

Clause 5.2: Top management shall establish, implement and maintain

a quality policy that is appropriate to the purpose and context of the
organization and supports its strategic direction

Clause 9.3: Top management shall-review the organization’s quality

management system, at planned intervals, to ensure its continuing
suitability, adequacy, effectiveness and alignment with the strategic
direction of the organization.
PERFORMANCE
What is a SWOT analysis?
A SWOT analysis is a simple and practical form of evaluation model. SWOTs look
at a combination of internal and external factors, as well as assessing strengths
and weaknesses. It allows you to think about your own internal strengths and
weaknesses, and well as begin to think about external opportunities and threats
that could affect your organization’s performance. It also allows you to explore
what the differentiators between yourself and your competitors is.
SWOTs have been around since at least the 1960s, although their origins are
unclear, and are still used today in businesses across the world. A good SWOT
should always be followed by further planning and development.
The simplest way to build a SWOT analysis is to use a SWOT analysis template.
What does SWOT stand for?

SWOT is an acronym which stands for:

Strengths Weaknesses OpportunitiesThreats
Why Would You Use A SWOT Analysis?
• The benefit of a SWOT analysis is that you can
directly compare every individual letter to its three
counterparts. You can explore the relationship
between your strengths and your weaknesses, but also
look at how your strengths could be used to help
leverage opportunities, and assess the potential your
strengths have to help improve your weaknesses.
How to write a SWOT analysis?
• Once you have decided on a goal, you can start to think about SWOT analysis
questions that related to:
Issues Positive (+) or Negative (-) Internal Factors External Factors
Your customers Values Legal
Your partner agencies Culture Technological
Accomplishment (Rank) Knowledge Competition
Performance Performance of the Organization Market

Leadership
Competence Political
Online following Economic Environments
Customer retention rate (volume)
Budget restrictions
Suppliers
• Note:
Company Rate the issues on its importance and impact to the organization.
culture
Reputation
• The first two letters of our SWOT, Strengths and Weaknesses are internal
factors that you have control over, and you should look within your company or
business to complete these letters. Opportunities and Threats are external
factors that you do not have control over, and you should look outside of your
organization .
SWOT Analysis Template (horizontal table)
INTERNAL EXTERNAL
STRENGTHS WEAKNESSES OPPORTUNITIES THREATS
∙ ∙ ∙ ∙
∙ ∙ ∙ ∙
∙ ∙ ∙ ∙
∙ ∙ ∙ ∙
∙ ∙ ∙ ∙
Strengths
• Strengths are the areas that you excel in. What do you do better than anybody else?
What do people praise you for?
• To identify your Strengths, spend some time thinking about what you’ve done well,
what tasks were well within your comfort zone, and times that you’ve exceeded
expectations, or achieved fantastic results. A SWOT could be conducted during
recruitment to help identify the strengths of candidates, and directly compare them
effectively.
Weaknesses
• Next you identify the areas that need improvement. Think about things you find
difficult to achieve, times you’ve struggled to meet expectations, and areas that you
don’t feel confident in. Look back at your Strengths list and think about the inverse.
• Weaknesses should always be things you have control over, and things that you can put
steps in place to improve upon. For example, you could use a SWOT to help analyze your
brand, and understand why your customers chose your competitors over you, or if
there are any services you are not currently providing.
Opportunities
• Opportunities are areas that your business could take advantage of. When
conducting a SWOT for internal company analysis, is there an unserved or
underserved market that you could grow into? Are you maximizing your media
coverage? Could you change or develop a product to better serve a wider
audience?
• Within Opportunities, you should also look back at your Strengths and
Weaknesses lists, and include any weaknesses that could be turned into a
strength as an opportunity.
Threats
• Finally, threats are potential or upcoming obstacles that you should be wary of.
In this case, by threat we mean emerging competitors, changes in the market,
things that would negatively affect your business. Most commonly, you will not
have any control over your threats but it’s still important to be aware of them
so that you can develop contingency plans.
The organization shall formulate
A procedure to review its present
and future issues and its relevant
and interested paties.
8.8.388888 8.3
Required
ENSURE

EXPECTED
TO ENSURE EFFECTIVE NEEDED AND
OPERATION AND AVAILABLE
CONTROL
 Input/
Activity/ Details Time Person
No. Source of Output
of Activity Frame Responsible
input
1.0 1.1

1.2

Control Points:

Risk involved:

Note:
QMS PROCESSES OR PROCEDURES ( 4.4)
ORGANIZATIONAL KNOWLEDGE (7.1.6)
OPERATIONAL PLANNING AND CONTROL (8.1)
Mission, Vision, Intended Result and Strategic Direction

6.1 Actions to Address Risks and

Opportunities
 T
VIDEO PRESENTATION

“THE CART”
 A Quality Policy is a brief statement that aligns with your organization’s purpose and strategic
direction, provides a framework for quality objectives, and includes a commitment to meet applicable
requirements (ISO 9001, customer, statutory or regulatory) as well as to continually improve.
Must be:
1. Simple
2. Concise
3. Easily remembered and understand
4. Practiced

Contents:
• Understanding our customer’s needs;
• Delivery of service with highest quality, promptly and professionally;
• Recognizing that each person is accountable for achieving the goal of delivering superior quality
products and services; and
• Ensuring that work is performed in a safe manner and commitment for continual improvement.

A quality policy statement is a short document of an organization to establish what quality means to
that organization.
 Quality Policy
We will continuously strive to delight our customers with outstanding Quality
of our products and services. In our endeavor to achieve this objective, we
will;
• Create and nurture people of quality through continuous education and
training.
• Maintain and improve standards of manufacturing.
• Establish a “Total Quality” framework to continually improve the quality
Management System and realize challenging Quality objectives.
• Record & control the change points at each stage.
• Prevent defect outflow to next process, and feedback to previous process
for enhanced ply chain by effective traceability system.
-Toyota -
ARBDSP Top AJDP LTSP/ DARMOs IQA/ QAU/ STOD
Management QIU/ QDA
Deeper dive into leadership
Anyone who is certified to ISO 9001 or is embarking on the
road to certification should know that Leadership is one of the
key elements of ISO 9001 and there is now more of an
emphasis on having leadership control and involvement.

Gone are the days where top management can just ask the
“Quality Representative” or external consultant to maintain
the system, they now have to take more ownership of the
management system and business direction. (Clause 5
Leadership and Commitment )
General overview
ISO 9004 states that:
Top Management, through its leadership, should:
a. Promote the adoption of the mission, vision, values and
culture in a way that is concise and easy to understand, to
achieve unity of purpose;
b. Create an internal environment in which people are engaged
and committed to the achievement of the organizations
objectives;
c. Encourage and support managements at appropriate levels to
promote and maintain the unity of purpose and direction as
established by the top management.
Are your employees aware of your mission, values
and culture in their own language? Keep the mission
and vision simple. It is not a piece of paper and
sticking it on the wall. Leaders should be
communicating this to your employees verbally, allow
them to ask you questions and get a better
understanding of what you are trying to achieve.

Who are the leaders of your organization?

• Workshop No. 4

“SCRAMBLE WORDS”
The Organizational shall:
a) determine the necessary competence of person(s) doing work
under its control that affects the performance and effectiveness of
the quality management system;
b) ensure that these persons are competent on the basis of
appropriate education, training, or experience;
c) where applicable, take actions to acquire the necessary
competence, and evaluation the effectiveness of the actions taken;
d) retain appropriate documented information as evidence of
competence.
NOTE: Applicable actions can include, the provision of training to, the
mentoring of, or the re-assignment of currently employed persons,
or the hiring or contracting of competent persons. ( Competency
Matrix or Competency Development Plan )
MANDATORY DOCUMENTATION FOR (ISO 9001:2015)
1. Quality Manual
a. Vision, Mission, Purpose Strategic Direction, Intended Result
b. SWOT Analysis
b.1 Internal and External Issues
b.2. Stakeholder Analysis
c. Strategic Action Plan
c.1 Top Mgt
c.2 By MFOs
d. Quality Policy
e. Quality Objectives
e.1 Top Mgt
e.2 By MFOs
f. Business Process Mapping
f.1 Top Mgt
f.2 By MFOs
g. Failure Mode and Effect Analysis (FMEA) Tool
g.1 Risk Management Plan (form)
g.1.1 Top Mgt
g.1.2 By MFOs
g.2 Risk Register (Database)
2. Procedures of the Quality Manual
1. Risk Management Procedure (Clause 6)
2. Control of Document (Clause 7)
3. Quality Assurance Procedure (Clause 8)
4. Management Review (Clause 9)
5. Monitoring, Measurement, Analysis and Evaluation (Clause 9)
6. Interested Parties Satisfaction (Clause 9)
7. Internal Audit (Clause 9)
8. Procedure in Handling Complaints (Clause 9)
9. Management Review
10. Control of Non-conforming outputs and Corrective Action (Clause 10)
11. Quality Improvement (Clause 10)

3. Operation’s Procedures by MFOs

3.1 Major Services Offered
3.2. Post Delivery Services
Procedure Format:
TITLE
1. Objective
2. Scope
3. Definition of Terms/Acronyms
4. Responsibility and Authority
5. Reference
6. Flowchart
7. Procedure Details

Input/
Activity/ Details Person
No. Source of Time Frame Output
of Activity Responsible
input
1.0

8. Forms
a. Tool
b. Electronic (Data Base)
Quality Assurance – Part of quality management focused on providing
confidence that quality requirements will be fulfilled.
Quality Assurance – Part of quality management
focused on providing confidence that quality
requirements will be fulfilled.
 How to Audit Clause 8?
• Documented information to have confidence that the
processes have been carried out as planned (clause 8.1 e1).
• Documented information to demonstrate the conformity of
products and Services to their requirements (clause 8.1 e2).
• Results of the review and new requirements for the products
and services (clause 8.2.3.2).
• Records of the evaluation, selection, monitoring of
performance and re‐evaluation of external providers and any
and actions arising from these activities (clause 8.4.1)
• Evidence of the unique identification of the outputs when
traceability is a requirement (clause 8.5.2).
• Records of property of the customer or external
provider that is lost, damaged or otherwise found to be
unsuitable for use and of its communication to the
owner (clause 8.5.3).
• Results of the review of changes for production or
service provision, the persons authorizing the change,
and necessary actions taken (clause 8.5.6).
• Records of the authorized release of products and
services for delivery to the customer including
acceptance criteria and traceability to the authorizing
person(s) (clause 8.6)
• Records of nonconformities, the actions taken,
concessions obtained and the identification of the
authority deciding the action in respect of the
nonconformity (clause 8.7)
Monitoring, Measurement, Analysis and
Evaluation

IMPORTANCE:
WHEN . . . . to analyze and evaluate the
measurements.
………… decisions based on facts, not
conjecture.
 CF

RC

MR QO

QM

AR

QIU

ES

QAU
PMT

PAR
IQA

DCC RMS

NCR
 SYSTEM PARAMETERS
2017 2nd Semester 2018 as of 3rd Quarter
PARTICULAR TARGET
RATING % Accomp. RATING % Accomp.
CLIENT FEEDBACK 5.00 3.67 73% 3.33 67%
REGULAR COMPLAINTS 5.00 4.00 80% 2.00 40%
QUALITY OBJECTIVES 5.00 4.21 84% 4.22 84%
ACCOMPLISHMENT REPORT 5.00 3.50 70% 3.35 67%
EVALUATION EXTERNAL SUPPLIERS 5.00 4.33 87% 4.33 87%
PQPMT 5.00 5.00 100% 4.00 80%
PARCCOM 5.00 No rating 0% 4.33 87%
RMS MONITORING 5.00 5.00 100% 4.33 87%
REPORTS OF NON CONFORMANCE 5.00 5.00 100% 5.00 100%
DOCUMENT CONTROL 5.00 No rating 0% 5.00 100%
INTERNAL AUDIT RESULTS 5.00 4.00 80% 2.83 57%
No rating yet, still
QUALITY ASSURANCE 5.00 3.55 71%
comply matrix
QUALITY IMPROVEMENT 5.00 cannot be verified 3.74 75%
QMST MEETING 5.00 No rating yet 4.00 80%
MANAGEMENT REVIEW 5.00 No rating yet 2.00 40%
AVERAGE RATING 4.30 VS 3.73 S
EQ. Point Adjectival Rating of
Quantity Time Quality
score Total Point Score
130% or more 25% of planned time 5 100% Outstanding
115-129 % of target 50% of planned time 4 95-99 Very Satisfactory
90-114 % of target task completed 3 90-94 Satisfactory
51-89% of target 50% of planned quantity started 2 85-89 Unsatisfactory
50% below of planned target Less than 50% of task begun 1 84 below Poor
- Feedback Mechanism

- Handling Customer Complaints

- Trends on Customer Needs

- Procedure to Monitor, Review and Evaluate

 objectives, criteria
and scope
 ISO 19011:2018

Guidelines for Auditing Management

Systems
What exactly is an “audit”?
“[the] systematic, independent and documented process for
obtaining objective evidence and evaluating it objectively to
determine the extent to which the audit criteria are
fulfilled.” ISO 19011:2018
That’s another way of saying someone takes a look at what
you’re doing, gathers some evidence, and compares that
evidence to what you’re supposed to be doing (in other words,
a set of clearly documented requirements).
Importantly, this understanding of audit implies that there
are a few main things being considered by the auditor:
• What are the documents established by the organization.
(e.g. manual, internal processes, policies, and guidelines)
• Evidences gathered to support how these policies,
procedures, and guidelines are implemented in practice.
• The requirements defined by the ISO standard being
audited against (e.g. ISO 9001 and/or legal requirements)
Audits performed by organization and analyze its own
management systems are known as INTERNAL AUDITS.
As such, ISO 19011 defines a set of guidelines; a framework
for an organization to plan, implement, and improve upon their
audit programs, for auditing the implementation of
management systems.

Since the first edition of ISO 19011 was published in 2002,

many new management system standards have been published.
These standards often share a common structure, including
certain requirements, terms, and definitions being used.
That means ISO 19011 can be used to devise highly
economic audit programs, wherein knowledge and processes
can be shared and applied across various management
systems.

By considering how they might take a broader approach to

management system auditing and integration, companies
implementing ISO management systems stand to save time,
money, and confusion when preparing for and implementing
internal audits.
 ISO 19011:2018 (Guidelines for auditing management systems), was published in July 2018 in
response to demand for guidance on combined management system audits.

It’s sort of like a meta-standard designed to inform organizations how to prepare audit programs
for auditing their management systems (quality management systems, environmental management
systems, risk management systems, health and occupational safety, etc).

ISO 19011 has three important sections concerning auditing management systems:
• How to manage an audit program
• The 7 principles of auditing
• Approaches for evaluating the competence of auditors

There’s also a big focus on applying principles of continuous improvement to an audit program.
One of the main tenets of such an approach is making sure that the objectives of the audit
program are well-aligned with the main business objectives of the organization, and that the
needs and best-interests of customers and other stakeholders are prioritized.

An area of increasing importance in the auditing of management systems is the principle of risk
management..
There’s also a big focus on applying principles of continuous
improvement to an audit program.

One of the main tenets of such an approach is making sure

that the objectives of the audit program are well-aligned
with the main business objectives of the organization, and
that the needs and best-interests of customers and other
stakeholders are prioritized. (Costumer Focus)

An area of increasing importance in the auditing of

management systems is the principle of risk management.
Management System Standard (MSS)
The management system standard (MSS) refers to the shared structure
that ISO management systems use to make it easier for organizations to
integrate multiple management systems by re-using knowledge and steps
required for implementation.
Based on a core structure of ten clauses, Annex L is shared by many ISO
management system standards, such as:
ISO 9001:2015 - Quality Management System
ISO 14001:2015 - Environmental Management System, and
ISO 45001:2018- Occupational Health and Safety Management System.
(Joint Memo Circular No. 1 Series of 2020- promotion of wellness of
workers and their rights to safety environment)
ISO 19011 defines 7 key principles that help to ensure audits are
effective and reliable tools, supporting the management systems
they are auditing by providing actionable information that
organizations can use to improve performance.
These principles are designed to enable auditors working
independently from one another to reach similar conclusions in
similar circumstances.
They also form the basis for the guidance outlined in the three
key elements of an ISO audit ( ISO 19011, clauses 5 to 7).
1. Integrity: The foundation of professionalism
Auditors and audit programme managers should perform
their work ethically, in an honest and responsible manner, and
using their best judgement shall:
Undertake audit activities only if competent to do so
Perform work in a fair and unbiased manner
Remain sensitive to influences exerted upon their judgement
while carrying out audits
2. Fair presentation: the obligation to report truthfully and
accurately
All audit findings, including documented evidences, conclusions
and written reports should reflect truthfully and accurately the
activities of the audit.
This includes any obstacles, disagreements with other auditors,
or difficulties faced during the audit. Everything must be
adequately documented.
All communication, not just documented and reported
information, should be truthful, timely, rational, clear, and
complete.
3. Due professional care: Diligence and judgment in
auditing
Auditors should exercise due professional care in all tasks
performed during the audit, in accordance with the
confidence placed in them by the auditee and in recognition
of the importance of the task they are performing.
One of the most important requirements of this principle is
that auditors have the ability to make reasoned judgments
in all situations during the audit.
4. Confidentiality: Security of information
Auditors should respect the confidentiality of all information
they’re dealing with throughout the audit.

This means exercising due diligence in making sure all information

acquired during the course of their duties as auditors is
respected and adequately protected.

Making sure information is secure includes taking special

precautions where necessary, such as handling sensitive or
confidential information.
5. Independence: Audit impartiality and objectivity
Audits, by nature, should be independent of the activity being
audited, to the furthest extent possible. They should not
interfere nor should they hold any bias or conflict of interest.
Internal audits should preferably be independent from the
function being audited.
Key to all audits is the pursuit of objectivity via rational process,
to make sure all findings and results from the audit are based
only on audit evidence.
Smaller organizations may find it difficult to enlist truly
independent auditors; as such every effort should be made to
eliminate bias and encourage the pursuit of rational objectivity.
6. Evidence-based approach: Rational, reliable, reproducible results
Evidence is one of the pillars of a successful audit, and the foundation of rational, reliable, reproducible
results.
Audit evidence should be based on samples of available information, in acknowledgement of the fact that
audits are conducted within limited periods of time, with limited resources.
Collection of audit evidence is based on a formalized process known as audit sampling.
Audit sampling typically involves the following steps:
• Setting clear sampling objectives
• Determining how much of, and what will be sampled
• Selecting a sampling method
• Deciding on a sample size
• Carrying out the sampling
• Documenting and reporting all results
Known as the : “The acceptable confidence level”- level of sampling risk the auditor is willing to
accept to arrive at a conclusion.
7. Risk-based approach: Considering risks and
opportunities
Risk management is a substantial factor when planning
for, conducting, and documenting an audit.

The goal of a risk-based approach is simply to orient the

audits more clearly towards matters that are important
for audit clients and the achievement of audit objectives.
ISO 19011 is a standard designed to help companies perform
audits.
When it comes to ISO standards, there are two main different
types of audit:
• Internal audits (first-party)
• External audits (second-party and third-party)
ISO 19011 specializes in first and second-party audits, and is
designed for use by audit teams of all types and sizes, from single
auditors to larger teams suited for full-scale enterprise audits.
ISO 19011 is a set of guidelines; it’s not a complete set of
requirements that needs to be followed step-by-step. The
guidance offered by ISO 19011 should be adopted as
appropriate to suit the specific needs and requirements of the
audit program in question.

ISO 19011 can also be used as additional guidance for

third-party audits, but the specific requirements for auditing
management systems are set out in ISO/IEC 17021-1; these
requirements are for use by certified lead auditors or
registered bodies when carrying out certification audits.
First-party
This is simply an internal audit.
Internal audits are conducted by (or on behalf of) the
organization itself. These audits are typically in the context of
assessing conformity, evaluating effectiveness, identifying areas
that could be improved, or as requirements for certain ISO
standards specifying that internal audits need to be carried out.
First-party audits may also be done as a preparation for a 3rd
party audit; however, first party audits can never result in an
ISO certification.
Second-party
External audits encompass both second and third-party audits.
Second-party audits are conducted by, or at the request of
relevant interested parties outside of the organization, like
customers or contracted organizations on behalf of a customer.
For example, a client and vendor have a contract, and goods or
services are being exchanged. Typically, second-party audits will
be more formal than first-party, because they will influence the
relations with customers or other relevant interested parties.
Third-party
Third party audits are done by independent organizations that have no
vested or conflict of interest in the organization being audited, like
those that provide certification, or government agencies.
Independence of the audit organization is one of the defining factors
of a third-party audit.
Customers can also request third-party audits, and this will usually be
in order to verify you conform to some specific requirements.
Only third-party audits can be used to get ISO certified. Third-party
audits may also result in other types of registration, recognition, or
licensing.
Equally, failing a third-party audit might also result in a fine or
citation, suspension or revocation of certification.
Key elements of an ISO audit
Generally speaking, an ISO audit will consist of the following key
elements, or stages:
• Audit management
• Audit process
• Competence and evaluation of auditors
Each of these stages will involve various sub-tasks and requirements,
depending on the specific standard being audited to.
Since ISO 19011 is a standard providing guidelines for auditing
management systems, it is structured in a way that deals with
preparing for and conducting the audit, but also covers how
organizations might evaluate the competence and selection of the
actual auditors.
 ISO 19011 offers invaluable information on how to approach an audit of any
ISO management system standard.
Remember that an audit implies comparison against a set of requirements.
In this case, ISO 9001:2015.
So, how would an organization’s QMS be audited to the requirements of ISO
9001:2015?
In simple terms, the auditor would have to look at two things:
• How the QMS is documented
• How the evidence gathered compares with the requirements of ISO
9001:2015
Based on this information, the auditor will then be able to determine
conformities and nonconformities, and offer corrective actions to the
auditee about how they can improve their QMS.
Three (3) core elements set out in ISO 19011 for approaching an
ISO audit are:

1.Audit Management
Audit management starts with the establishment of an audit
program. The purpose of the audit program is to oversee the
whole audit process, including planning and scope, which includes
determining which management system (or systems) will be
audited, and the specific requirements.
The full scope of the audit system will also depend on the size of
the auditee ( organization being audited), as well as the nature
and complexity of the management system being audited.
During this stage, audit planning and preparations are made,
including review of all available documented information for
the management system being audited, and establishment of
clear audit scope, objectives and criteria. Making sure that
the entire audit unit has adequately reviewed all documented
information for the management system being audited.

Workshop 3: How to prepare an AUDIT PLAN.

-Audit Scope
-Audit Objective
-Audit Criteria
-Audit Complexity
-Audit Duration
-Risk Factors and Risk Impact
AUDIT OBJECTIVE
Why the audit is being conducted and could be for
a. Determining the readiness of organization (Stage 1)
b. Determining the implementation and effectiveness of system (Stage 2)
c. Determining continued compliance and ability to achieve improvements
(Surveillance / Recertification)

AUDIT SCOPE
The audit scope generally includes a description of the physical locations, organizational units,
activities and processes, as well as the time period covered

AUDIT CRITERIA
The basis on which audit is performed such as
a. Requirements of the standard
b. Requirements of law
c. Requirements of interested parties
d. Requirements of the system development by the client organization
2. Audit Process

“Audit process” might be a bit vague, but it basically means

everything that goes into actually conducting the audit, starting
from making contact with the auditee to prepare or request any
documented information, and ending with conducting closing
meetings and distributing the completed audit report.
It is to determine audit feasibility.
Working from the audit objectives established during the planning
stage of audit management, this basically asks: “can the auditor
achieve the audit objectives, based on time, resources,
information, and cooperation with the auditee?”.
The audit process also involves preparing a complete audit
plan, preparing additional documented information for the
audit (like reference standards and documents to bring with
you during on-site evidence collection), preparing for and
conducting opening meetings, collecting audit evidence,
evaluating evidence against audit criteria, and preparing the
final audit report.

This refers to the Audit Procedure duly established by the

Organization
Workshop No. 4 = Audit Matrix
 Workshop No. 5 Sample Checklist

INTERNAL QUALITY AUDIT CHECKLIST

Division/ Function
AUDIT DATE:
Area:

DOCUMENTED
ISO 9001:2015 Clause
QUALITY MANAGEMENT SYSTEM REQUIREMENTS INFORMATION EXPLANATORY NOTES AND COMMENTS RATING
#
REFERENCE

MN - Minor MJ - Major
RATING: C - Conformance OBS - Observation
Non-Conformance Non- Conformance

Auditor (s): Auditee (s):

What are the results
of audits?
ISO 9001:2005 standard requires organizations to have a
documented procedure for how audits will be carried out, however
it does not specify how exactly audit findings should be reported.

External audits are handled somewhat different. While each

registrar has their own procedure as to how audits are conducted
and how reports are issued, most registrars will issue various
types of findings, such as noteworthy efforts, observations,
opportunities for improvement and non-conformances. It is
important to note that registrars, based on accreditation body
guidelines, would not require action or response on any finding type
except for non-conformances.
What ISO audit findings are?
- Results of the evaluation of the collected audit evidence
against audit criteria.

1. Audit Findings indicate conformity or nonconformity.

2. Audit Findings can lead to the identification of risks,
opportunities for improvement or recording good practices.
3. If the criteria are selected from statutory requirements or
regulatory requirements, the audit findings is termed
compliance or non-compliance.
ISO Audits do not result in a grade, percentage or score. The
results of ISO audits are findings. Findings can be good or bad.
A few types of findings are:

• Praises or noteworthy efforts

These are areas that were observed during the audit and that
are seen as excellent examples of implementation of the
requirements of the standard. Noteworthy efforts are also
given when the practices are seen as best in class. They could
also be issued when the company has shown significant
improvement in certain areas from prior audits. Noteworthy
efforts do not require any action. When provided in the audit
report, it is done for reporting purposes only and to show to the
organization areas where they can feel proud of.
 •Opportunities for Improvement
Opportunities for improvement are areas that are not
necessarily wrong or not meeting the requirements of
the standard. Unlike observations, opportunities for
improvement are not accidents waiting to happen but
rather these are practices that have been implemented
poorly and either do not add value or consist of several
non value added steps. Auditor usually point
opportunities for improvement, when they believe –based
on their expertise and expanded view of quality
management systems-that those practices could be
enhanced or done more efficiently.
•Observations
Observation are simply pointed out by the auditor as
areas being in compliance but very close to becoming a
nonconformance or that given additional evidence could
transform into a nonconformance. Observations can be
looked as “accidents waiting to happen”. Organization
shall treat observation very seriously and in fact
incorporate them into the organization as preventive
actions and handle them as such.
•Non-conformances
Non-conformances or NCs are areas where the
organization’s quality management system does not
comply with one of the requirements of the standard or
where the organization failed to show evidence of
compliance. Non-conformances have a clear
requirement that was not met and there is clear
evidence of what was seen –or not seen.
Non-conformances have 3 elements:
• Requirement
• Non-conformance
• Evidence

Nonconformities are in essence, just another type of

finding, however it is the one that everyone
concentrates on and what the organization worries
more about.
 • Grading or classifying Nonconformities
Some registrars classify their non-conformances into major
and minor, such as in major nonconformance and minor
non-conformance. Other registrars classify non-conformances
as Category 1 and Category 2. Those terms are basically
interchangeable:

1. Major non-conformances or Category 1

2. Minor non-conformances or Category 2

•Major non-conformances or Category 1
Are those findings where an element of the ISO
standard has not been met or where there is a
significant breakdown in the quality management
system. A group of Minor NCs in the same specific area
of the standard may also be elevated to category 1.
Minor NCs that have not been properly addressed
after a whole audit cycle may also be elevated to
category 1.
 •Minor non-conformances or Category 2
Minor nonconformities are those where there is a minor
lapse on the quality management system and where
basically it is evident that the system or requirement
has been established and for the most part are
implemented correctly.

ISO Non-conformances generated from internal audits

are typically not even classified as major or minor and
are simply reported as Opportunities for Improvement
(OFI) and Observations (OBS) in the Audit Report.
SAMPLE OF AUDIT REPORT…..
 UNDERSTANDING NONCONFORMITY
Nonconformity arises when:
• An auditee failed to fulfill a certain requirement (the shall);
- Processes needed for the QMS were not systematically defined and
managed including their interactions (PDCA and Risk-base thinking);
- Processes were not able to consistently demonstrate fulfilment of
customer and legal requirements (the system or processes is not reliable
to assure conformity to requirements);
- Resources needed for the QMS were not adequately provided and
maintained;
- Authorities and Responsibilities were not properly assigned;
- Competence and awareness of employees were not properly
demonstrated;
- Documented information were not controlled and maintained;
- Evidences (records) were not reliable, not presented as required
and/or not retained properly.
 COMMON NONCONFORMITIES DURING AUDIT

7.5 Documented Information

•Working drawings and specs with unauthorized changes such as
whiteout, or changes in tolerances/dimensions.
•Unauthorized forms (i.e. Request for Document Copy and Client
Feedback) being used and in circulation to Clients.
•Found unauthorized Xerox copies of documents that are under
distribution control such as procedures and work instructions.
•Obsolete documents (i.e. Procedure, Control Plan) at the work
place.
•Uncontrolled postings, markings, and instructions at the
workplace.
•Uncontrolled documents of external origin (ISO, IPC standards)
9.2 Internal Audit

•No CARs issued per nonconformities in internal audit findings.

•Incomplete audit conducted (all applicable ISO elements, all
Departments/activities) as specified in the Quality Manual audit
frequency of twice a year.
•Audit Findings with issued CARs were not verified on time,
deadline specified is long overdue (more than a year).
•Internal Audit Results was not reported to the top management.
•Audits conducted only to verify conformity with the
organizations QMS, while requirements of ISO standards were
not fully covered.
•Audit Checklist used by the auditors were not retained as
evidence of conduct of audits.
6.2 Quality Objectives

•Quality objectives does not fully address the quality policy

statement.
•Description of the Quality Objectives are not measurable.
•Quality objectives are not established in other functions
(Department/Sections/Processes) and levels.
•Quality objectives were not properly communicated to relevant
parties.
•There’s no high level objectives set by the top management.
•Plans on how to achieve the Quality Objectives was not fully
determined as required by the standard.
•Evidence that Quality objectives are being monitored and track
as to its achievement is not available.
7.2 Competence

•Necessary Competence of employees are not determined as to

its designated functions and positions.
•The organization was not able to demonstrate reliable system
that ensures employees are competent on the basis of
appropriate education, training or experience.
•Basis for developing the yearly training program is
un-verifiable during the audit.
•Effectiveness of the training provided to employees are not
evaluated.
•Training records are not kept accordingly.
•Process control to ensure appointment of competent personnel
and passing of required qualification is not established and
implemented.
9.3 Management Review

•Management review was not conducted as specified planned interval (twice

a year) in the quality manual.
•Inputs to the management review conducted was incomplete such as
status of previous management review, adequacy of resources and
opportunities for improvement are not included.
•The top management has not attended the recent management review.
•Records of the management review does not contain adequate information
on what transpire during the review and the actions to be taken on the
issues presented.
•Actions and decisions as committed by the organization was not monitored
and verified whether results are effective.
•Purpose of conducting management review is not clearly understood by the
organization, analysis of results to arrive at a conclusion was not being
practiced.
 Sample Audit Report
Workshop No.6
 Workshop No.7

CORRECTIVE ACTION REQUEST

Page 1
Page 2
Last Page
Flow Chart: The main 13 steps of an Internal Audit
Competence and evaluation of auditors
The final component of the ISO 19011 standard is aimed at
providing general guidelines for making sure the auditors are
competent to do their job.
Criteria:
Qualitative- such as demonstrated behavior, knowledge,
performance of skills in training or workplace
Quantitative- such as years of experience, education, number of
audits conducted and hours of training.
Such a process should also consider the specific needs,
objectives, and considerations of the audit program in question.
As with all ISO standards, requirements and guidelines
alike, the whole process of evaluating auditor competence
should be adequately documented, in order to maintain
consistency, and ensure fair and reliable results.

The process for evaluating auditor competence has four

main steps:

1. Determine the level of competence required for the job

2. Establish some criteria for evaluating competence
3. Choose a method for evaluating competence
4. Conduct the evaluation
The result of evaluation will contribute to the ongoing performance
evaluation of the auditors, and can be used to inform the following
decisions by Top Management:
-Selecting the audit team
-Determining whether there is a need for improved competence
(e.g. more training)
-Competence and evaluation of auditors also feeds back into and
supports the principle of continuous improvement, allowing an audit
team to maintain and improve competence via recurring
participation in audits.
Presentation – Auditor’s Performance Evaluation Tool
ISO 19011 doesn’t specify requirements, but a set of guidelines
for approaching ISO audits of management systems.
This checklist can however be used to guide you through the
internal audit process for any ISO management system. That
includes, but isn’t limited to:
• ISO 9001:2015 for quality management systems
• ISO 14001:2015 for environmental management systems
• ISO 45001:2018 for occupational health and safety management
systems
• ISO 27001:2013 for information security management systems
• ISO 9004:2018 – guidance to achieve sustained success
Perhaps one of ISO’s most
popular standards, ISO 9001
defines the requirements for
implementing, maintaining, and
optimizing a quality
management system.
Organizations value ISO 9001
because it allows them to
demonstrate to their
stakeholders that they can
consistently deliver products
and services that meet
specific customer and
regulatory requirements.
ISO 26000 is a standard that outlines a set of guiding principles for
corporate social responsibility.
Just like ISO 19011, ISO 26000 is a set of guidelines, as opposed to
requirements. ISO 26000 is voluntary and as such cannot be certified to.
Rather, organizations seeking to implement ISO 26000 will benefit from
(and sometimes require) performance assessments to determine their
success in understanding and clearly defining what social responsibility
means to them.
This checklist provides guidelines to assist with the deployment of best
practice principles and actionable solutions for organizations that are
trying to implement ISO 26000:2010.
ISO 45001 is designed to help organizations to improve employee safety,
reduce workplace risks and create better, safer working conditions.
Sharing the core structure of other management system standards like ISO
14001 and ISO 9001, it also takes into account other International Standards
in this area such as:
• OHSAS 18001
• International Labour Organization’s ILO-OSH Guidelines
• ILO’s international labour standards and conventions
• Various other (inter)national standards
This checklist will simplify the audit process for you, saving you time and
effort by eliminating manual tasks and utilizing Process Street features like
conditional logic and role assignments to automate recurring tasks and make
your life easier.
Internal audits are crucial
requirements for information
security management systems
(ISMS) following the ISO IEC
27001:2013 (ISO 27001)
standard.
They are also some of the most
challenging requirements to
successfully meet, especially for
smaller organizations.
As such, the importance of a
solid, reliable process is
paramount. This checklist will
guide you through the internal
audit process from start to
finish.
Similar in scope to the ISO 9001
internal audit checklist for quality
management systems, this
template is designed for
companies wanting to perform a
self-audits to ensure compliance
with ISO 14001 standards for
their EMS.
If you’re already familiar with
ISO 9001 or any similar ISO
management system standards,
this one should look very familiar,
and this checklist will help guide
you through the process.
ISO 9004 is a set of
guidelines designed to help
organizations achieve
sustained success, consistent
with the principles and
requirements for a quality
management system outlined
in ISO 9001:2015.
This internal audit checklist
will run you through the
entire process of examining
your organization against the
guidelines defined in the
standard.
Integrating multiple management system standards that share
the same or similar structure can save you time and effort in the
long run.
For example, perhaps you already have a quality management
system based on ISO 9001, and you want to integrate it together
with a new environmental management system based on the ISO
14001 requirements.
Or perhaps it’s the other way around, and you’re looking to
integrate the principles of a QMS alongside an existing
environmental management system.
Either way, this checklist will guide you through the whole
process, and save you tons of effort in the long run.
9.3.1

with the strategic

direction of the
organization
ADDRESSING NONCONFORMITY
7 Steps Closed Loop Corrective Action System:

Understand
Standardize
the
Action
Nonconformity

Verify Apply
Effectiveness Containment
of CA Action

Implement &
Determine
Monitor
Root
Corrective
Cause(s)
Action
Formulate
Corrective
Action

STEP 4
 HOW TO ADDRESS

*Containment is an immediate action not to aggravate the detected non

conformity

*Correction is an action taken to eliminate a detected nonconformity.

*Corrective Action is taken to eliminate the cause of a detected

nonconformity and to prevent recurrence.

(Source: ISO 9000:2015)

 AUDITOR CHECKPOINTS - CORRECTIVE ACTION

❑ Followed-up timely?
❑ Records shows all actions have been completed successfully?
❑ Changes completed and verified?
❑ Was the actual root cause identified? How was it validated?
❑ Action taken to ensure it will not happen again?
❑ Actions taken have no adverse effects on products or services?
❑ Actions taken is appropriate to the effects of the nonconformity?
❑ Training performed and communications issued to all relevant
parties?
❑ Nonconformity statement is clear?
❑ Nature of nonconformity is understood?
❑ Immediate or containment action applied?
❑ Effects or consequences of nonconformity are determined?
❑ Determine the Root Cause and if similar/potential nonconformity exists?
❑ Root cause validated?
❑ Formulated action can eliminate the root cause(s) and prevent NC
recurrence?
❑ Formulated action is acceptable to the Requesting Auditor?
❑ Action is fully implemented and timely?
❑ Actions taken was reviewed and verified effective?
❑ Risk register updated when necessary?
❑ Make changes to the QMS if needed?
❑ Submit complete results and keep records?
WHAT IS A PROBLEM?
 SAMPLE PROBLEM IN PUBLIC SERVICE

• Uncooperative Community/Constituents (Stakeholders Resistant)

• Lack of Support in other Line Agencies
• Insufficient operating funds
• Communication errors
• In-adequate infrastructure
• Low performing staffs
• Client Complaints
• Graft and Corruption
• Red tape
• Un-successful projects/programs
• Non-compliance to requirements
• Improper filing of records/documents and absence of
storage/archive room
 HOW TO SOLVE A PROBLEM?

1. Identify the cause (or causes) of the problem.

2. Find ways to eliminate these causes and prevent them

from
recurring.
NATURE OF A PROBLEM

•Symptoms. These are not regarded as actual

causes, but rather as signs of existing problems.
•First-level causes. Causes that directly lead to a
Problem.
•Higher-level causes. Causes that lead to
first-level causes. Although they do not directly
cause the problem, higher-level causes form
links in the chain of cause-and-effect
relationships that ultimately create the problem.
•Root cause. The highest-level cause of a problem
is called the root cause; it is “the evil at the
bottom” that sets in motion cause-and-effect
chains.
PROBLEM SOLVING
 EXAMPLE WATER LEAK PROBLEM

PROBLEM (SYMPTOMS) Water leaks on the Ground or Floor

FIRST-LEVEL CAUSE(S) a. Water pipe was broken.
b. Water pipe was loose.
HIGHER-LEVEL CAUSE(S) a. The pipe was old and has deteriorated.
b. Some force struck the pipe.
c. The pipe was not tightened properly.
d. The pipe was not properly protected.
e. The pipe was laid down poorly.
f. The Plumber does not apply the correct
procedure.
ROOT CAUSE(S) a. Substandard pipe was used.
b. The Person that installed the pipe does not
have enough knowledge and skills.
ELIMINATE THE ROOT CAUSE!!

When you have removed the

root
cause, monitor the
symptoms to help ensure
that the problem will not
recur.
 WHAT IS ROOT CAUSE ANALYSIS?

Root cause analysis is a collective term used to

describe a wide range of approaches, tools, and
techniques used to uncover causes of problems.

An approach for identifying the underlying causes of

nonconformity so that the most effective solutions
can be identified and implemented to avoid
recurrence.
Goals

The primary goal of using RCA is to analyze problems or events to

identify:
• What happened
• How it happened
• Why it happened…so that
• Actions address the problem are developed

The nature of RCA is to identify all and multiple contributing factors to

a problem or event. This is most effectively accomplished through an
analysis method. Some methods used in RCA include:
•The “5-Why” Analysis” - A simple
problems-solving technique that helps users get
to the root of the problem quickly. It was made
popular in the 1970’s by the Toyota Production
System. This strategy involves looking at a
problem and asking “why” and “what caused this
problem.” Often the answer to the first “why”
prompts a second “why” and so on– providing the
basis for the “5-why” analysis.
 FIVE WHYS

Purpose:
Five whys is also known as the why–why chart and root cause analysis. Its
inherent nature is to delve ever more deeply into the levels of causes,
thus resembling the wider concept of root cause analysis itself.

Its main purpose is to constantly ask “Why?” when a cause has been
identified, thus progressing through the levels toward the root cause.

In a wider root cause analysis, five whys can be used to:

• Question whether each identified cause is a symptom, a
lower-level cause, or a root cause.
• Continue the search for true root causes even after a possible
cause has been found.
Just Keep Asking “Why?”
Event: Didn’t get to work on time.
EQ: Why were you late?

Car wouldn’t start.

Why didn’t the car start?

Battery was dead.

Why was the battery dead?

Dome light on all night.

Why was the light on?

Kids played in the car, left door ajar!

Why were the kids playing in the car?

Babysitter wasn’t watching them!

Solution: Prepare for work on time.

 5 W H Y S
Don’t forget, you can do more than 5 or less than!!

Problem: My Car Will Not Start

Why? The battery is dead.

Why? It did not charge.
Why? The belt is slipping.
Why? The belt is worn.
Why? I did not know belt was worn.
Why? I did not do scheduled service.
Why? I could not afford it.

Solution: Budget for regular car service.

•Fish-Bone Diagram from the Ishikawa
Diagram – derived for the quality management
process, it’s an analysis tool that provides a
systematic way of looking at effects and the
causes that create or contribute to those
effects. Because of the function of the
fishbone diagram, it may by referred to as a
cause-and-effect diagram. The design of the
diagram looks much like the skeleton of a fish
– hence the designation “fishbone” diagram.
 CAUSE-AND-EFFECT CHART

Purpose:
The name of the cause-and-effect chart tool defines what it is about: a
chart that analyzes relationships between a problem and its causes. It
combines aspects of brainstorming with systematic analysis to create a
powerful technique. The tool is also known as an Ishikawa diagram, named
for its inventor.

In the larger framework of root cause analysis, this tool’s main purpose
is to understand what causes a problem. It can be used to:

• Generate and group problem causes.

• Systematically evaluate the causes and determine which are
most likely to be root causes.
FISHBONE OR ISHIKAWA DIAGRAM
EXAMPLE CAUSE-AND-EFFECT CHART

Workshop No. 8 RCA

By: Masaaki Imai
ROLE : QUALITY IMPROVEMENT UNIT
Continuous Improvement Process (CIP) , is an ongoing
effort to improve products or services or processes
constantly evaluated in order to improve effectiveness,
efficiency and quality.

Feedback : Self-reflection of the processes

Efficiency: is the identification, reduction, and

elimination of suboptimal processes.

Evolution: emphasis on incremental, continual steps rather

than giant leaps.

MOTTO: “ GETTING BETTER ALL THE TIME”

ATTY. HENRY M. GELACIO
DAR 12 ISO 9001:2015 –Team Leader
Certified ISO 9001:2015 Lead Auditor
Certificate Number : EDU/QMS/LA 18/01927
Issued by EDULLENCE
IRCA-International Register of Certified Auditors
CQI-Chartered Quality Institute
CERTIFIED Training Course

Assisted by:

PARPO II Cenon S. Original – Asst. Team leader

CARPO Leah S. Ortega - Team member
SARPO Rechelle B. Cordero-Team member