Internal Audit EQE Eng.-Amsol

Welcome
Engineering and Quality Experts (EQE)

WELCOMES DELEGATES TO THIS
COURSE
QU29/ohp/Issue 7/August 00
Session 1
Quality concepts
Quality assurance
Part of quality management, focused on providing
confidence that quality requirements are fulfilled
ISO 9000:2000
Definition 2.2.11
Quality control
Part of quality management, focussed on fulfilling
requirements for quality
ISO 9000:2000
Definition 2.2.10
Quality management
Coordinate activities to direct and control an
organization with regard to quality
ISO 9000:2000
Definition 2.2.8
Quality management, assurance

and control
QC is part of quality management
QC is regulation of process
Quality management applies to all activities
affecting quality
QA aimed at prevention of defects
QC outcomes give a measure of the success
of quality management and QA
The systematic approach

Planning
- Anticipating all needs
Organization - Providing for all resources

Performance - Conducting all activities
Evaluation
- Measuring plan fulfilment
Quality management
Systems - processes, procedures, controls,
materials
and
People
- objectives, ability, motivation
Session 2
Introduction to quality systems auditing
Quality audit
Systematic, independent and documented process
for obtaining evidence and evaluating it objectively
to determine the extent to which audit criteria are
fulfilled
ISO 9000:2000
Definition 2.9.1
10
Audit criteria
Set of policies, procedures or requirements
against which collected audit evidence is
compared
ISO 9000:2000
Definition 2.9.4
11
ISO 19011:2001- Scope

It is applicable to all organizations implementing,
maintaining or auditing a quality and/or
environmental management system and thus
having a need to conduct and management internal
and/or external management system audits
12
Quality and environmental

systems auditing - ISO 19011:2001
A Guidelines standard published in one part containing
seven clauses:
Clauses 1, 2 and 3; Scope normative references and terms
and definitions.
Clause 4; describes fundamentals of auditing
Clause 5; guidance on establishing and managing audit
programmes.
Clause 6; guidance on conducting audits
Clause 7; guidance on auditors qualifications
13
Quality system audit types

1st Party - WE auditing our own system
(Internal)
2nd Party - WE auditing our supplier
(External)
3rd Party - WE being audited by a registration body,
(External)
14
Audit objectives
Objectives for an audit might be any of the following: (taken from
clause 6.2.1 of ISO 19011)
a) determining the extent of conformity of the auditees
management system to specified requirements.
b) evaluating the capability of the management system to
ensure compliance with legislative requirements
c) evaluating the effectiveness of the implemented management
system in meeting specified objectives
d) identifying areas of potential improvement of the management
system
15
Auditing benefits
Verifying compliance
Providing information for management review
Increasing quality awareness
Reducing risk of product/service failures
Identifying improvement opportunities
16
Auditors responsibilities
Complying with company requirements
Assist with preparing audit schedule
Carrying out the audit
Record and report the findings
Carry out follow-up audit
Maintain independence and confidentiality
Maintain audit records
17
Session 3
Audit basis
18
Audit criteria
Customer requirements
Documented quality system
Company standards
ISO 9001:2000
19
ISO 9001:2000 family of quality

management standards
Enables an organization to establish and maintain a
documented quality management system which will
demonstrate to its customers that it has the
capability of satisfying its customers and that it is
intent on a programme of continual improvement
20
ISO 9001:2000 quality

management standard
Clause 4 Quality management system (general)
Clause 5 Management responsibility (PLAN)
Clause 6 Resource management (PLAN)
Clause 7 Product realization (DO)
Clause 8 Measurement, analysis and improvement (CHECK
& ACT)
21
Clause 4
Quality management system
4.1 General requirements
4.2 General documentation requirements
22
The PLAN clause

5. Management responsibility
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.5 Administration
5.6 Management review
23
The PLAN clause (continued)

6. Resource management
6.1 Provision of resources
6.2 Human resources
6.3 Facilities
6.4 Working environment
24
The DO clause
7. Product realisation
7.1 Planning of realization processes
7.2 Customer-related processes
7.3 Design and/or development
7.4 Purchasing
7.5 Production and service operations
7.6 Control of measuring and monitoring devices
25
The CHECK clause

8. Measurement and analysis
8.1 Planning
8.2 Measurement and monitoring
8.3 Control of nonconformity
8.4 Analysis of data
26
The ACT clause

8.5 Improvement
8.5.1 Planning for continual improvement
8.5.2 Corrective action
8.5.3 Preventive action
27

Four possible levels:
A - the quality manual
B - quality procedures
C - quality records
D - detailed working documents
28
Session 4
Audit planning
29
Audit preparation
Auditor attributes
30
Auditor attributes
Open mindedness
Tenacity
diplomacy
decisiveness
observant
self-reliance
perceptiveness
integrity
31
Avoiding problems
Prior notification
Ensure importance of audit is known
Be empathetic
Keep people informed
32
Good practices
ask the right person
ensure questions are clear and understood
give time to answer
stay impartial
always be polite
33
Unhelpful practices
asking too many questions at once
saying you understand when you dont
arguing
criticising individuals
34
Human differences
Communicating skills
Personality
Relationship
Ability
Experience
35
Audit planning and preparation

Six phases of a structured audit:
audit scheduling
preparation
conducting the audit
reporting the results
recording proposed corrective action and
timescales
following up actions
36
Audit planning
The organization shall plan the audit programme
taking into account the status and importance of the
activities and areas to be audited as well as the
results of previous audits.
ISO 9001:2000
Clause 8.2.2
37
Audit planning
Departments
Principals office
Jan
Feb Mar Apr
Agricultural Coll.
Eastlands college
Chem. Laboratory
Food store
Aug Sep Oct

P
Nov Dec
A
A
A
P
A
A
P
Documents/records
Auditing
Purchasing
Kitchen
Jul
City college
Technical college
May Jun
P
A
P
P
Key: P = Audits scheduled on the basis of IMPORTANCE only

A = Additional audits taking into account the STATUS and IMPORTANCE.
38
Planning decisions
frequency
timing
scope
objectives
auditors
39
Session 5
Audit preparation
40
Preparing for the audit

An audit plan needs to be prepared which includes as appropriate:
a) audit objectives and scope
b) audit criteria and reference documents
c) areas and /or activities to be audited and the agreed dates of the
audit(s)
d) identification of any processes to be audited
e) audit duration
f) the need for guides and their responsibilities
g) audit method
41
Audit preparation - information

quality manual / procedures
managements priorities
nonconforming product
previous audit findings
product / service information
specialist knowledge needed by auditors
preliminary visit
42
Audit duration
Depends on:
Size of department/area to be audited
Complexity of process to be audited
Scope of audit, including activities and
processes to be audited
Resources required
43
Guides
Health and safety reasons.
Security reasons
Help with technical interpretations
Guides should not exercise undue influence or interference.
(ISO 19011:2001, clause 6.5.2)
44
Audit documents
audit procedures
nonconformity report forms
audit summary report forms
corrective action schedule
checklists
45
Checklist benefits
Maintains clear audit objectives
Evidence of planning
Maintains audit pace and continuity
Reduces risk of auditor bias
Manages auditor workload
Records sample of activities in the audit
46
Checklist preparation - basic

approach
Look AT
Look FOR
documents
material
identification; inspection
status
measuring devices
calibration status
processes
availability of control systems
47
authorisation; currency
Checklist - simplified example

Look FOR
Look AT
a) range of products included
Order entry procedure
b) justification for any product not

included.
c) records of product review, including
those involved.
d) record of order acceptance
authorisation.
e) Records of comparing order with
tender document
Appropriate evidence to Look

FOR
Plus: other Look AT topics

48
Audit method
Vertical
Horizontal
Upstream/ downstream
49
Session 6
Conducting the audit
50
Conducting the audit

Opening meeting
Collecting and verifying information
Record audit findings
Keep auditee informed
Prepare reports
Report audit findings
51
Opening meeting
Two possible styles. Procedures must define the
organizations defined method.
Informal: Let management know
Brief introduction
Formal: Follow procedure/documented agenda
Maintain records
52
Audit evidence
Records, verified statements of fact or other
information relevant to the audit
ISO 9000:2000
Definition 2.9.5
53
Establish the facts

Samples (of evidence)
Randomly selected
Chosen by the auditor
Facts agreed with the auditee
54
Establish the facts

Collect all the details
Exact observation
What (is the requirement, is happening)
Where (is it happening)
When (did it happen)
Who (was doing it)
Why (is it a nonconformity)
55
Audit evidence
Can be obtained from several sources including:
Interviews
documents within the quality management system
records
reports from various sources including customers
All audit evidence must be verified by the auditor
56
Objective evidence
Data supporting the existence or verity of something
(can be obtained through observation,
measurement, test, or other means)
ISO 9000:2000:
Definition 2.8.1
57
Questions
The six friends of an auditor:
The auditors seventh friend
What?
Show me (please)
Why?
Where?
When?
How?
Who?
58
Recording the facts

As objective evidence:
For investigation now
For investigation later
For use by colleague
Must be legible
Must be retrievable
59
Session 7
Recording the results
60
Evaluating
For compliance with:
Customer requirements
Company standards
ISO 9001:2000
61
Classifying
Minor nonconformity might be defined as:
A situation where there is a likelihood that
nonconforming product or service will occur, or
where the benefits of ISO 9001:2000 are not
being realised, because of the absence of, or
lack of adherence to a procedure.
62
Classifying
Major nonconformity might be defined as:
A nonconformity of such severity that its
existence would indicate that a nonconforming
product or service could be released to the
customer or, where the requirements of an
appropriate clause of ISO 9001:2000 has not
been adequately addressed.
63
Session 8
Documenting the findings
64
Documenting the findings

Includes:
nonconformity reports
audit summary reports
65
Documenting nonconformities
Nonconformity report:
Reference
Identified location
Date
Requirement
Objective evidence
66
The nonconformity report

Clear--------------------- no ambiguities
Complete---------------- includes all identifiers/facts
Correct------------------ indisputable facts
Concise------------------ if possible
THERE MUST BE A REQUIREMENT
Identified/retrievable-------------referenced
67
Audit summary report

Report reference
Date of audit(s)
Department(s) visited
Audit scope and basis
Key people seen
Procedure references
Summary of findings (positive and negative)
Distribution list
68
Session 9
Audit report meeting
69
Closing meeting
Summarise findings
Review nonconformities
Agree commitment for corrective actions
Agree timescales
70
Conduct of meetings
Control the meeting
Speak with authority
Listen with care
Maintain good manners
Watch body language
Finish with clear objectives
71
Session 10
Audit follow-up
72
Follow-up options
Verification at location of audit finding
Review of documentation
Verification at next audit
But always complete the relevant documentation
73
Successive audits
For successive audits give consideration at the
planning stage to varying the:
Methods:
Strategy
Auditors
Scope
74
Management review
System overview
Assessment of audit reports
Influence on audit programme
Corrective action/changes to system
75
Processes audit preparation Turtle diagram

With what?
With who?
Material/equipment
Competence/skills
(3)
(4)
Input
Process
(6)
(1)
How?
(7)
What results?
Procedures/methods
Performance indicators
(2)
Output
(5)
76
Processes audit preparation

Turtle diagram
1) Enter COP, support process name.
2) Enter details of linked process controls, support processes,
procedures, methods, etc.
3) Enter details of the machine, material, test equipment,
software, ..etc.
4) Enter resource requirements, required skills, competence
criteria, .etc.
5) Enter the measures of process effectiveness, targets, etc.
6) Enter details of actual inputs, this may be a document,
material, tooling, schedule, etc.
7) Enter details of the actual output, this may be a product,
document, and should be linked to actual measure of
effectiveness.
77
78
Processes audit preparation

Turtle Diagram Example : Manufacturing
With who?
With what?
Plant and machinery (6.3)
Competence criteria (6.2.1)
Process equipment (6.3)
Induction/training records (6.2.2)
Measuring equipment (7.6)
Agency/contract labour (6.2.2.3)
Tooling (7.5.1.5)
Job responsibilities / authorities (5.5)
Maintenance (7.5.1.4)
Training effectiveness (6.2.2)
Packaging / labeling (7.5.5)
SPC awareness (8.1.2)
Cleanliness of premises (8.4.2)
Personnel safety (6.4.1)
Customer property (7.5.4)
Awareness of policy/objectives (6.2.2.4)
Transportation (6.3)
Input
Customer schedule (7.5.1.6)
Raw materials (7.4)
How?
Control plans (7.5.1.1)
Work instructions (7.5.1.2)
Preventive maintenance(7.5.1.4)
SPC (8.1.1)
Nonconforming product procedure (8.3)
Dispatch process (7.5.1.7)
Contingency plan (6.3.2)
Document control/records (4.2.3/4)
Change control (7.1.4)
Appearance items (8.2.4.2)
Outputs
Process
Manufacturing
Process (7-5)
Conforming product delivered to

customer schedule (8.2.1.1)
What Results?
Analysis of data (8.4.1)
(Support processes)
IT
Human resource
Logistics
Sales
Preventive maintenance
Customer satisfaction (8.2.1)

Other organizational objectives (5.4.1)
Maintenance objectives (7.5.1.4)
Cost of poor quality (5.6.1.1)
Process capability (8.2.3.1)
Management review (5.6.1)
Continual improvement results (8.5)
Audit records (8.2.2)
79
Processes audit preparation Turtle Diagram

With what?
With who?
(Materials / Equipment)
(Competence / Skits / Training)
Tube bending machines (6.3)
Operators, team leaders (6.2)
Welding machine
Skill matrix
Look test equipment (7.6)
Induction records
Measuring equipment (7.6)
Temporary labour
Tooling (7.5.1.5)
Job descriptions
Maintenance (7.5.1.4)
Input
Customer schedule (7.5.1.6)
Raw materials (7.4)
Process
Exhaust system
Manufacture (7.5)
Out to length
Bending
Catalyst assembly
Box build
Final assembly
personal appreciates
Outputs
Conforming product delivered to

customer schedule (8.2.1.1)
How?
What Results?
(support Processes, Procedures & Methods)

Control plans (7.5.1.1)
(Pantomimes Indicators)
(5.4.1)
Work instruction (7.5.1.2)

Prevention maintenance (7.5.1.4)
PPM
SPC ( 8.1.1)
Nonconforming product procedure (8.3)
Delivery performance
Scrap
Machine down time
Dispatch process (7.5.1.7)
Cost of poor quality
80

Internal Audit EQE Eng.-Amsol

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Welcome

Engineering and Quality Experts (EQE)

Quality management, assurance

The systematic approach

- Anticipating all needs

Organization - Providing for all resources

- Measuring plan fulfilment

- objectives, ability, motivation

ISO 19011:2001- Scope

Quality and environmental

Quality system audit types

ISO 9001:2000 family of quality

ISO 9001:2000 quality

The PLAN clause

The PLAN clause (continued)

The CHECK clause

The ACT clause

Documented quality system

Audit planning and preparation

Feb Mar Apr

Aug Sep Oct

Key: P = Audits scheduled on the basis of IMPORTANCE only

Preparing for the audit

Audit preparation - information

Checklist preparation - basic

availability of control systems

Checklist - simplified example

a) range of products included

Order entry procedure

b) justification for any product not

Appropriate evidence to Look

Plus: other Look AT topics

Conducting the audit

Establish the facts

Establish the facts

The auditors seventh friend

Recording the facts

Documenting the findings

The nonconformity report

Audit summary report

Processes audit preparation Turtle diagram

Processes audit preparation

Processes audit preparation

Competence criteria (6.2.1)

Process equipment (6.3)

Induction/training records (6.2.2)

Measuring equipment (7.6)

Agency/contract labour (6.2.2.3)

Job responsibilities / authorities (5.5)

Training effectiveness (6.2.2)

Packaging / labeling (7.5.5)

SPC awareness (8.1.2)

Cleanliness of premises (8.4.2)

Personnel safety (6.4.1)

Customer property (7.5.4)

Awareness of policy/objectives (6.2.2.4)

Conforming product delivered to

Customer satisfaction (8.2.1)

Processes audit preparation Turtle Diagram

(Competence / Skits / Training)

Tube bending machines (6.3)

Operators, team leaders (6.2)

Look test equipment (7.6)