Internal Audit

Prof. Eng. Rham Mahmoud

27.7.2020
Problem Solving and Root Cause Analysis

➢ Problem solving approach

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Q
What is a Problem ?

A
A “problem” is the gap between the present
situation and the ideal situation or objective

➢ It is a matter that must be resolved

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 What is a Problem ?

Ideal situation or objective

Control Characteristic

Good

Gab Problem = ( Ideal situation or objective – Present value )

Present Level

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 The Problem Solving Process

• Catch problem.
Expose problem Expose problem • Set target.
• Identify gab.

Experience, intuition
Analyze causes
and inspiration

Plan and implement Plan and implement

countermeasures countermeasures

The conventional problem- The QC problem-solving

solving approach approach 5
 We think that if the symptom
disappears, the problem solved.
Act against We think problem
Problem Symptom Problem
phenomenon solved but
arises disappears solved
(symptom) actually, it hasn’t.

The conventional problem-solving approach

Problem Identify its Act against

arises causes the causes

The problem
Symptom Problem
really has been
disappears solved
solved

The QC problem-solving approach 6

Q
Is the problem-solving ability an inborn talent
possessed by only a few special people?

A
NO

It is a cumulative result of individual acts and is molded

and improved through repeated experience and study
➢ To become a competent problem solver,
You must understand:

How to manage a quality related problem ?

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Defect:
A product’s or service’s nonfulfillment of an intended
requirement or reasonable expectation for use.

Company Related
Internal (inside the company)
Could be
Defect Detected Supplier Related
External(at the customer)

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Defective:

A defective unit of product is a unit of product that

contains one or more defects with respect to the
quality characteristic under consideration.

Failure:

The inability of an item, product or service to perform

required functions on demand due to one or more
defects.
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Conformance – Non Conformance:

An affirmative indication or judgment that a product

or service has met (hasn’t met) the requirements of a
relevant specification, contract or regulation.

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Cause:
An identified reason for the presence of a defect or
problem.

Root Cause:
A factor that caused a nonconformance and should be
permanently eliminated through process improvement.

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 Examples

Difference Between the Cause and Root Cause

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Containment Action:

Is the first action organization take to protect it’s

customer by restraining the problem/defect effects on
the customer using the proper actions until defining the
root cause and implementing permanent corrective
actions.

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Correction:
Action to eliminate a detected nonconformity. For example;
rework, regrade, repair ..etc.

▪ Rework:
Action on a nonconforming product or service to make it
conform to the requirements.
▪ Repair:
Action on a nonconforming product or service to make it
acceptable for the intended use.
▪ Regrade:
Alteration of the grade of a nonconforming product in order
to make it conform to different requirements. 15
Corrective Action:

An action to eliminate the cause of nonconformity in

order to prevent recurrence.

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➢ Requirements for Corrective Action (Closed-Loop):

▪ Reviewing the nonconformities including customer complaints.

▪ Determine the root causes of nonconformities.
▪ Evaluating the need for action to ensure that nonconformities
do not recur.
▪ Determine and implement actions needed.
▪ Record the results of actions taken.
▪ Review the effectiveness of actions taken.
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Employees involvement in the
corrective action improvement
cycle (Teamwork)

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Preventive Action:

An action to eliminate the causes of potential

nonconformities in order to prevent their occurrence.

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➢ Requirements for Preventive Action:

▪ Determine potential nonconformities and their causes.

▪ Evaluating the need for action to prevent occurrence of
nonconformities.
▪ Determine and implement actions needed.
▪ Record the results of actions taken.
▪ Review the effectiveness of actions taken.

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Employees involvement in the
preventive action cycle
(Teamwork)

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 Examples

Difference Between the Corrective and Preventive Actions

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 Analyze Stage

➢ Root Cause Analysis

▪ Ask 5 Why’s
▪ Brainstorming
▪ Cause and Effect Diagram

Prof. Eng. Rham Mahmoud Lean Six Sigma Improvement Methodology

 ❖ 5 Why’s

RCA may be as simple as asking “5 Why’s”:

o By repeatedly asking “Why” (five is a good rule of

thumb)
o It’s often require asking why five times or more or less
before identifying the root cause.

Prof. Eng. Rham Mahmoud Lean Six Sigma Improvement Methodology

Prof. Eng. Rham Mahmoud Lean Six Sigma Improvement Methodology
 Brainstorming
(A creativity tool)

▪ A technique teams use to generate ideas on a particular

subject.
▪ Each person on the team is asked to think creatively and
write down as many ideas as possible.
▪ The ideas are not discussed or reviewed until after the
brainstorming session.
▪ Used for problem solving and root cause analysis.
Prof. Eng. Rham Mahmoud Lean Six Sigma Improvement Methodology
 Cause-and-Effect Diagram
(Ishikawa Diagram)
(Fishbone Diagram)

Prof. Eng. Rham Mahmoud Lean Six Sigma Improvement Methodology

 Cause-and-Effect Diagrams
(Root Cause Analysis Tool)

❖ In 1953, Kaoru Ishikawa, Professor of the university of Tokyo

presented the Cause-and-Effect Diagram:
➢ Expressing a chain of causes and effects.
➢ Provides a graphical representation of your understanding of
the potential causes for a particular problem (the effect).
Cause

Effect

Sub-Cause Sub-cause

Sub-Cause
Prof. Eng. Rham Mahmoud Cause Lean Six Sigma Improvement Methodology
 Structure of Cause-and-Effect Diagram
Prof. Eng. Rham Mahmoud Lean Six Sigma Improvement Methodology
 Sources of Variation (5M’s + E)

✓ Manpower,
✓ Material,
✓ Machine,
✓ Method
✓ Measurement techniques
✓ Environment
Prof. Eng. Rham Mahmoud Lean Six Sigma Improvement Methodology
 Find the root cause

M/C :
Ishikawa Diagram
Man :

Environment : Method : Material :

Problem

Brainstorming & Ask 5 Whys

Prof. Eng. Rham Mahmoud Lean Six Sigma Improvement Methodology

 When to use ?

Analyze Stage
▪ To brainstorm potential underlying process factors that can
be investigated in a designed experiment.

Improve Stage
▪ To generate a list of potential failure modes that should be
addressed in the solution

Prof. Eng. Rham Mahmoud Lean Six Sigma Improvement Methodology

Example

Prof. Eng. Rham Mahmoud Practical Solution Of Quality Related Problems

 Material Waste Machine
No designated area Color of machine
Repairs get last priority,
for special tools Make special tool for not repaired (surface grinder)
No cleaning materials job and keep on hand,
& supplies no organization We don’t fix properly,
take shortcuts,
Don’t know where it Not enough don’t prevent future issues
goes so we put in maint. trash cans Dust and chips create
Place for scrap mess during use
No places for short Some jobs sit
pieces of steel
that is easy to dump
on machine overnight What will prevent
us from keeping
Empty space seems the maint. shop clean
to fill up (steel area)
People don’t know expections of clean
Start jobs no parts
People don’t clean up after themselves
Maint people don’t have time to
finish items/ change priority
Communication for maint jobs
No time set aside for clean-up
No process to show
Tool & Die folks sharing communication of status of repairs
equipment w/maint. Don’t have priority to improve

Everyone uses welders Machines not kept clean daily

(no one assigned)

Can’t tell if parts on order

Manpower
Method
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QMS Auditing
 Audit

Systematic, independent and documented process for:

• Obtaining objective evidence and
• Evaluating it objectively

To determine the extent to which the audit criteria are

fulfilled.

Prof. Eng. Rham Mahmoud Abd El Hamid Quality Assurance

Audit Criteria

Set of policies, procedures or requirements used as a

reference against which objective evidence is compared

Prof. Eng. Rham Mahmoud Abd El Hamid Quality Assurance

Audit Evidence

Records, statements of fact or other information, which

are relevant to the audit criteria and verifiable.

Prof. Eng. Rham Mahmoud Abd El Hamid Quality Assurance

 Types of Audits

Internal Audit External Audit

{ First Party Audit }

Second Third Party

Party Audit Audit

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Prof. Eng. Rham Mahmoud Abd El Hamid Quality Assurance
 Summary

2nd. Party Audit 1st. Party 2nd. Party Audit

Audit

Supplier/ Input Output

Organization Customer
Sub-contractor

3rd. Party Audit

Certification/
Governmental
Body
Prof. Eng. Rham Mahmoud Abd El Hamid Quality Assurance
Auditor
Auditor – Do
• Advance notification to Auditee and agree on the specified escort.
• Be aware of safety rules and requirements concerning the audited
site. Wear the necessary PPE’s
• Ensure emergency procedures are communicated (e.g.
emergency exits, assembly points)
• Take permission in advance of taking copies or photos
• Listen, Listen and Listen…suspend judgement
• Select the audit sample by yourself 43
Prof. Eng. Rham Mahmoud Abd El Hamid Quality Assurance
Auditor – Do
• Summarize the interview results before leaving
• Take notes…explain the need
• Be punctual, prepared, calm and polite
• As little talking as possible
• Avoid arguing and misunderstandings
• Keep questions clear and concise
• Be aware of local culture 44
Prof. Eng. Rham Mahmoud Abd El Hamid Quality Assurance
Auditor – Do
• Put the individual being interviewed at ease prior to and during
the interview
• Interview during normal working hours and at the normal
workplace
• Avoid any unnecessary disturbance of the operational processes
• Be aware of missing documents, people and information
• Insist on the person being questioned answer for themselves
• Give compliments 45
Prof. Eng. Rham Mahmoud Abd El Hamid Quality Assurance
Auditor – Do Not
• Be side tracked
• Be misled or led
• Let the auditee control the audit
• Make assumptions
• Accept emotional blackmail
• Accept pre-prepared samples
• Accept “quick fix”
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Prof. Eng. Rham Mahmoud Abd El Hamid Quality Assurance
Audit Phases

1 Audit Planning Initiate Prepare Plan

2 Audit Execution

3 Audit Reporting

4 Audit Closure Completion Follow-up

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Prof. Eng. Rham Mahmoud Abd El Hamid Quality Assurance
Audit Main Questions

▪ Who
▪ What
▪ How
▪ Where
▪ When
▪ Why
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Prof. Eng. Rham Mahmoud Abd El Hamid Quality Assurance
Audit Questioning

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Prof. Eng. Rham Mahmoud Abd El Hamid Quality Assurance
 Sources of Information

• Interviews
• Observations of activities and the surrounding work
environment and conditions
• Documented information (ex. policies, objectives, plans,
procedures, standards, instructions, licences and permits,
specifications, drawings, contracts and orders)
• Records (ex. inspection records, minutes of meetings, audit
reports, records of monitoring and measurements)
Prof. Eng. Rham Mahmoud Abd El Hamid Quality Assurance
 Sources of Information

• Auditee’s sampling plan, procedures and measurement.

• Reports on (customer feedback, external surveys and

measurements and external provider ratings)

• Data summaries, analyses and performance indicators

• Database and website

Prof. Eng. Rham Mahmoud Abd El Hamid Quality Assurance

 How to ensure information accuracy ?
▪ Ask for objective evidence
▪ Ask for information in a different way
▪ Asking several people the same question
▪ Observe the activity on site
▪ Validate with another auditor

Prof. Eng. Rham Mahmoud Abd El Hamid Quality Assurance 52

 Conducting Audit Activities

Audit findings includes:

o Conformity
(Compliance vs. legal)
o Nonconformity (Noncompliance vs.
legal)
o Good practice
o OFI
Prof. Eng. Rham Mahmoud Abd El Hamid Quality Assurance
 Recording Audit Finding

1) Description of or reference to audit criteria against which

audit finding (conformity, good practice, nonconformity)
observed
2) Audit evidence to support the audit finding
3) Declaration (statement) of conformity, nonconformity, good
practice
4) Related audit findings
5) Auditor recommendations

Prof. Eng. Rham Mahmoud Abd El Hamid Quality Assurance

 Nonconformity

❑ For any nonconformity (NC), specify:

What is the problem ?

Why it is a NC ? (reference)
Where it is observed ?
What is the objective evidence ?
(qualitative or quantitative information)

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Prof. Eng. Rham Mahmoud Abd El Hamid Quality Assurance