Understanding QMS

1. QUALITY MANAGEMENT
SYSTEM

2. Agenda
I. Introduction
A. Quality Policy
B. Quality Manual
C. Risk Management Guidelines
II. Context of the Organization
A. Identification of External and Internal Issues
B. Relevant Interested Parties & Legal Requirements
III. Risk Management (Risk Management and Control of Non-
Conforming Services)/ Risk Registers
IV. Problem Solving and Root Cause Analysis
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3. Commitment of an ISO Certified Organization
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Continuous improvement
Compliance with legal and regulatory requirements
Customer satisfaction
3Cs

4. Process of an ISO Certified Organization
4
Pla
n
What is our context?
What do we want to
achieve?
What will we do?
What are our risks and
opportunities?
Do
Chec
k
Did we achieve what we
planned?

5. 7 Quality Management Principles
5
Client and Partner
Focus
Engagement of People
and Stakeholders
Continual
Improvement
Evidence-Based
Decision Making
Leadership
Process
Approach
Relationship
Management
Risk
Management*

6. Quality Policy
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The Office of the Vice President continues to adopt the following Quality Policy,
which governs day-to-day operations to ensure quality service delivery. The
Quality Policy is communicated and implemented throughout the organization and
is stated as follows:
We are committed to exemplary public service as we –
•Ensure that programs are strategic and responsive to the needs of the
marginalized and engagements contribute to nation-building and the promotion
of democracy,
•Maintain integrity in our quality management system through risk-based
approaches to the development of our policies and programs in compliance with
applicable legal requirements, and
•Engage everyone’s commitment to continual improvement by cultivating a high-
performing culture through teamwork.

7. DAY 1
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8. Context of the Organization
CLAUSE 4.0 Explained
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9. References
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A. Identification of External and Internal Issues/ Relevant Interested Parties & Legal
Requirements
1. EII and RIP Guide 2022.pdf
2. How to determine interested parties and their requirements according to ISO
9001.pdf
B. ISO 9001 2015 - Quality Management System .pdf
C. ISO 9000 2015 - QMS Fundamentals and Vocabulary .pdf

10. List of Internal and External Issues
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A. Steps to be Taken

11. List of Internal and External Issues
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B. Internal Issues
An organization’s internal context is the environment in which it aims
to achieve its objectives.

12. List of Internal and External Issues
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C. Recommended Tool to be used
To define the internal issues, it is recommended to do a SWOT analysis:

13. List of Internal and External Issues
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B. External Issues
To determine the external context, we should consider issues arising from its
social, technological, environmental, ethical, political, legal, and economic
environment.

14. List of Internal and External Issues
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C. Recommended Tool to be used
The best way to identify external issues is to create a PESTLE analysis:

15. Relevant Interested Parties
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Interested parties will have an impact on the organization’s ability to provide
products and services that consistently meet customer needs and legal
requirements.

16. IV. Problem-Solving and Root Cause Analysis
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17. IV. Problem-Solving and Root Cause Analysis
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Objectives
1.To have an understanding of when and how to use structured problem-
solving techniques
References:
ISO 31010 (Risk Management - Risk Assessment Techniques; OVPs – Office Order on Risk Management & Control of
Non-conforming Services)
2.To understand and apply Root Cause Analysis techniques, such as Brain Storming,
5Whys, and Fishbone)
3. Overall, to develop the mindset of “Solution-Focus” and effectively find
solution/s to the problem and manage the risks & opportunities.

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“ A process to determine the problem, analyze its root
cause/s and implement an effective solution based on the
root cause “
What is Problem Solving?

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•What’s the problem?
•Why did it happen?
•What will be done to prevent it from happening again?
Within an organization, problem-solving, incident
investigation, and root cause analysis are all
fundamentally connected by three basic questions:

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Organization’s Response to the Problem?
1.Problem Denying
2.Problem Accepting
3.Problem Solving

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A problem can be:
•Within Control
•The process is fully owned by the team members themselves
•The boundaries of the process are within the team’s
responsibilities
•Team members are the ones performing the activities within
the process
•Beyond Control
•The process is not owned by the team members and its
boundaries are outside the responsibilities of the team members.
•Interface
•The process may not be owned by some of the team members
and needs the involvement of other units.

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What is a Root Cause?
Root Cause –
is the fundamental breakdown or failure of a process which, when
resolved, prevents a recurrence of the problem.

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What is a Root Cause Analysis?
Root Cause Analysis –
Root cause analysis is an approach for identifying the underlying causes
of an incident so that the most effective solutions can be identified and
implemented.
It’s typically used when something goes badly, but can also be used when
something goes well.
(Ref. thinkreliability.com)

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Root Cause Analysis
Root Cause Analysis is
a systematic approach to
get to the true root
cause/s of our
process/service/product-
related problems.

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Root Cause
Analysis Tree:

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Steps in Root Cause Analysis
PDCA Approach
Plan
-Form a Team (those who have a stake in solving the problem)
-Define a problem (RISK) or OPPORTUNITY
-Analyze the situation. Study and define the problem
-Brainstorm for causes and countermeasures. Think creatively to determine
the best approach and best possible countermeasures
-Choose appropriate tools/techniques for RCA (Brainstorming, 5 Why Analysis,
Fishbone Diagram (Cause and Effect- Or Combination of this
Do - Implement countermeasures, Document the procedure and observation,
Use data gathering tools to collect information
Check - Confirm the effectiveness of countermeasures
Act - Standardize and establish control

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OVP’s Context of Application of RCA:
1. Problem-Solving for the Nonconformity raised
– CAF (Corrective Action Form)
2. Addressing the Risks and Opportunities using
- CIF (Continual Improvement Form)

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Takeaway on the application of RCA:
RCA typically applies when there is an occurrence of
NONCONFORMITY.
Or when there is CAF issued.
This could also be applied for Identified Risk
“Consequence / Effect” triggered by the Identified
“Issue” or Risk Event
Refer to CIF.

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Root Cause Analysis
Identification Problem
Classify the problems according to their significance
based on the initial data gathered, then decide whether
the problem is:
• Significant – with complicated entwined interrelated causes
• Simple concern – with obvious cause and obvious solution
Prioritize problems through data-based
consensus
RISK-BASED THINKING!

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Consensus
Consensus – A decision of the group to reach an agreement
•Not 100% agreement
•100% commitment to decisions
•Achieve through a thorough discussion and participation
•Takes time and trust

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Understanding the Present System/Context of the Organization
•Review the current system and standard
• Establish the area of concern
• May use 5W + 1H, other tools, and techniques whenever necessary.
•Agree on the scope of the problem
• Based on the answer to 5W + 1H
• Take note of the “input” and “output” of the process under study.

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Effective Problem Statement
•Summarizes the problem / risk
•Indicates complete information about the problem / risk
•Contains the following
•What
•Where
•When
•Extent

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Corrective Actions
• The process of reacting to an existing problem, customer complaint
or other nonconforming activities and fixing it.
Action to eliminate the causes of nonconformities in order to
prevent a recurrence.

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Tools and Techniques
Structured analysis techniques may consist of one or combination of
the following:
• “5 whys” technique, i.e. repeatedly asking ‘why?’
to peel away layers of cause and sub cause);
• Failure mode and effects analysis;
• Fault tree analysis;
• Fishbone or Ishikawa diagrams;
• Pareto analysis;
• Brainstorming

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The 5 Whys
Although this technique is called “5 Whys,” you may find that you will need
to ask the question fewer or more times than five before you find the issue
related to a problem.

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Problem Description
5W’s
What – what is the problem? What is the magnitude of the problem?
(Quantify the problem)
When – When does the problem occur? (Frequency of occurrence)
Where – Where does the problem occur?(What process/operation does
problem occur)
Why - Why is it a problem? (Quantify the impact of the problem)
Who are primarily affected by the problem?.

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Sample_ 5 Whys
Goal: I want to have my own business
1. Why do I want to do this?
-It will allow me to have greater control over how I spend my time.
2. Why do I want to do this?
-I can have more flexibility in my life.
3. Why do I want to do this?
-I will be able to work from home.
4. Why do I want to do this?
-I will be able to spend more time with my children
5. Why do I want to do this?
-Supporting my family is the most important thing in me.

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Sample_ 5 Whys
Scenario: Your Organization’s website is down.
1. Why did it happen?
-It ran out of memory.
2. Why?
-Because it was incorrectly configured.
3. Why?
-Because the site administrator made a mistake
4. Why?
-Because the development team hadn’t provided adequate instructions
5. Why?
-Because they assumed it that the administrator is capable to maintain the
website.

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Fish Bone Diagram
WHAT IS IT?
The Fishbone Diagram (also known as the Cause & Effect Diagram) is a
technique to graphically identify and organize many possible causes of a
problem (effect).
WHY IS IT USEFUL?
Fishbone Diagrams help identify the most likely ROOT CAUSES of a problem. They
can also help teach a team to reach a common understanding of the problem.
This tool can help focus problem solving and reduce subjective decision making.

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Fish Bone Diagram

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Fish Bone Diagram
• Using a fishbone diagram while brainstorming possible causes helps you to focus on
the various possibilities. Some useful categories:

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Fish Bone Diagram
HOW IS IT DONE?
•Name the effect; determine the specific problem to be analyzed. Draw the
diagram with a process arrow to the effect and draw a box around it.
•Decide what the major categories of the causes are (i.e., people, machines,
measurement, materials, methods, environment, policies,etc.).
• Label categories important to your situation.
Make it work for you.

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Fish Bone Diagram
HOW IS IT DONE?
•Brainstorm all possible causes and label each cause under the appropriate
category.
•Post the diagram where others can add causes to it (i.e., experts, affected
people, process owners, etc..).
•Analyze causes and eliminate trivial and/or irrelevant ideas.
•Rank causes and circle the most likely ones for further consideration and
study.
•Investigate the circled causes. Use other techniques to gather data and
prioritize findings.

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Summary of RCA
• Root Cause Analysis is a method to focus our efforts on the true “Root
Cause/s” of escapees so that we truly prevent their recurrence.
• Root Cause Analysis helps us reduce turnbacks and frustration,
maintain customer satisfaction, manage information security problems,
and reduce costs significantly.
• Each problem is an opportunity. It contains the information needed to
eliminate the problem. But to identify the root cause, we have to ask
“Why?” over and over, until we reach it.