Chapter - 1

TQM- introduction
TQM- introduction
TQM - Introduction
What is Quality?
In technical usage, quality can have two meanings:
(1) the characteristics of a product or service that bear on
its
ability to satisfy stated or implied needs
(2) a product or service free of deficiencies.

It is also defined as:
Quality of design

Quality of conformance

Quality of performance



Quality of Conformance
Traditional QA deals mainly with means and practices to
achieve and ensure achievement of:

QUALITY OF CONFORMANCE:
Quality of conformance relates to the fidelity with which the
product conforms to the design.
Does Quality cost?
Quality of Conformance is profitable not costly

POOR QUALITY IS COSTLY!

Companies that measure their poor qualitycosts for the first
time are usually shocked at what they find

Reducing poor quality costs has been compared
by J.M. Juran to mining gold (Gold in the Mine),
because it may translate directly into increased
profits and higher production capacity (Hidden Plant)

What is a quality system?
Product quality depends on many variables. The processes,
organisation, resources and procedures that manufacturers and
suppliers use to control these variables to produce a product of
consistent quality which meets defined specifications is called a
QUALITY SYSTEM*








* manufacturing environment case


PERSONNEL MATERIAL MEANS DOCUMENTATION
QUALITY SYSTEM
The four QS controlled elements
PERSONNEL: to perform or supervise the production tasks
[Competence, training, identification, motivation, attributes]

MATERIAL: on which to apply production processes
(component, sub-assembly, etc.)[Type, condition, capability,
quantity, identification]

MEANS: tools, equipment and facilities required to perform the
task
[Type, condition, capability, identification, location, environment]

DOCUMENTATION: input/output (specifications, drawings,
records, reports, orders, etc.) [Content, control, condition,
identification, distribution]

Quality system as business strategy
There are companies which enforce QA rules only when
required by the customer. Such companies miss the strategic
business value of the Quality System for:

competitiveness improvement
product improvement
organisational continuity/growth
personnel motivation
Quality System as assurance technique
The ability not only to achieve Quality (meet customer
requirements) but to demonstrate that an effective system is in
place and maintained for that purpose

For the European Union (as for any organisation having
regulatory responsibilities for safety), the implementation of a
Quality Assurance system by a company is a pre-condition for
valid certification assessment of their products compliance to
relevant norms

Safety and high reliability required by space systems has made
QA systems implementation mandatory during any project
phase (design, manufacturing and operations)
Quality Assurance








- write what you do - perform
verifications
- do as written
- prevent mistakes - prove verifications
- learn from mistakes
QUALITY ASSURANCE
METHOD
(to obtain)
OBJECTIVE
(to demonstrate)
Q U A L I T Y

Quality Assurance (contd)
Quality assurance is the planned and systematic activities
implemented within the quality system and demonstrated as
needed to provide adequate confidence that an entity will fulfill
requirements for quality (ISO-Vocabulary).
TOTAL QUALITY MANAGEMENT:
TQM




Origins, Evolution & key
elements
Evolution of Quality Management
Inspection
Quality
Control
Quality
Assurance
TQM
Salvage, sorting, grading, blending, corrective
actions, identify sources of non-conformance
Develop quality manual, process performance
data, self-inspection, product testing, basic
quality planning, use of basic statistics,
paperwork control.
Quality systems development, advanced quality
planning, comprehensive quality manuals, use of
quality costs, involvement of non-production
operations, failure mode and effects analysis, SPC.
Policy deployment, involve supplier & customers,
involve all operations, process management,
performance measurement, teamwork, employee
involvement.
Cost Of Quality
100% defective Point of Enough
quality
Total
Costs
Unavoidable
costs
Avoidable
costs
Costs
What is TQM?
Constant drive
for continuous
improvement and
learning.
Concern for
employee
involvement and
development
Management
by Fact
Result Focus
Passion to deliver
customer value /
excellence
Organisation
response
ability
Actions not just
words
(implementation)
Process
Management
Partnership
perspective
(internal /
external)
BASIC PRINCIPLES OF TQM
Approach Management Led
Scope Company Wide
Scale Everyone is responsible for Quality
Philosophy Prevention not Detection
Standard Right First Time
Control Cost of Quality
Theme On going Improvement
FOUR KEY PRINCIPLES
Measure quality so you can affect it
Focus on a moving customer
Involve every employee
Think long term - Act short term
Quality is a Journey,
not a Destination
Best
Practices


ISO 9000


Total Quality
Management

Evolution of quality system concepts
Major changes of focus:
- from external quality to internal quality
- from product/service improvement to process
improvement
- from second-party certification to third-party
certification



Artisan



Inspection



Quality
Control


Statistical
Quality
Control
Statistical
Process
Control
Statistical quality control
O Statistical Quality Control was initially the application of
statistical techniques and economical considerations to
acceptance sampling (pioneered by H.Dodge and H.Romig of
Bell Telephone Labs)

O The purpose was to avoid the cost of 100% lot inspection, while
lowering the customers risk to receive a defective product, and
the manufacturers risk to reject a good one
Statistical process control
E Statistical Process Control (SPC) is an analytical tool invented
by W.A.Shewhart of the Bell Telephone Labs to assess, monitor
and control manufacturing processes

E SPC is applicable to areas in which a large number of parts are
being produced or a process is being repeated many times




Notes:
E the term Statistical Quality Control includes nowadays statistical process control and
statistical acceptance sampling
E SPC cannot be applied to software products because all copies of software are exactly
identical
Total Quality
Management
Total Quality Management
Why TQM?
Ford Motor Company had operating losses
of $3.3 billion between 1980 and 1982.
Xerox market share dropped from 93% in
1971 to 40% in 1981.
Attention to quality was seen as a way to
combat the competition.
Total Quality Management
TQM
Total - Made up of the whole
Quality - degree of excellence a product or
service provides
Management - Act, art or manner of
planning, controlling, directing,.

Therefore, TQM is the art of managing
the whole to achieve excellence.


Total Quality Management
What does TQM mean?
Total Quality Management means that the
organization's culture is defined by and
supports the constant attainment of
customer satisfaction through an
integrated system of tools, techniques,
and training. This involves the continuous
improvement of organizational processes,
resulting in high quality products and
services.
Statistical Process Control
Quality Control (QC)
Control the activity of ensuring
conformance to requirements and taking
corrective action when necessary to
correct problems
Importance
Daily management of processes
Prerequisite to longer-term improvements
Designing the QC System
Quality Policy and Quality Manual
Contract management, design control and purchasing
Process control, inspection and testing
Corrective action and continual improvement
Controlling inspection, measuring and test equipment
(metrology, measurement system analysis and
calibration)
Records, documentation and audits
29
Inspection/Testing Points
Receiving inspection
In-process inspection
Final inspection
30
Receiving Inspection
Spot check procedures
100 percent inspection
Acceptance sampling
Pros and Cons
of Acceptance Sampling
Arguments for:
Provides an assessment
of risk
Inexpensive and suited
for destructive testing
Requires less time than
other approaches
Requires less handling
Reduces inspector
fatigue
Arguments against:
Does not make sense for
stable processes
Only detects poor
quality; does not help to
prevent it
Is non-value-added
Does not help suppliers
improve
32
Statistical Process Control
(SPC)
A methodology for monitoring a
process to identify special causes of
variation and signal the need to take
corrective action when appropriate
SPC relies on control charts
Common
Causes
Special
Causes
34
SPC Implementation
Requirements
Top management commitment
Project champion
Initial workable project
Employee education and training
Accurate measurement system
Total Quality Management
Whats the goal of TQM?

Do the right things right the first
time, every time.
Total Quality Management
Another way to put it
At its simplest, TQM is all managers
leading and facilitating all contributors in
everyones two main objectives:
_(1) total client satisfaction through
quality products and services; and
_(2) continuous improvements to
processes, systems, people, suppliers,
partners, products, and services.
Total Quality Management
Productivity and TQM
Traditional view:
Quality cannot be improved without significant
losses in productivity.
TQM view:
Improved quality leads to improved
productivity.

Total Quality Management
Basic Tenets of TQM
1. The customer makes the ultimate
determination of quality.
2. Top Management must provide leadership
and support for all quality initiatives.
3. Preventing variability is the key to producing
high quality.
4. Quality goals are a moving target, thereby
requiring a commitment toward continuous
improvement.
5. Improving quality requires the establishment
of effective metrics. We must speak with data
and facts not just opinions.
Total Quality Management
The three aspects of TQM
Counting


Customers


Culture
Tools, techniques, and training in
their use for analyzing,
understanding, and solving quality
problems
Quality for the customer as a
driving force and central concern.
Shared values and beliefs,
expressed by leaders, that define
and support quality.
Flow of Activities Necessary to
Achieve Total Quality
Management
Organizational Practices
Quality Principles
Employee Fulfillment
Customer Satisfaction
Organizational Practices
Leadership
Mission statement
Effective operating procedure
Staff support
Training
Yields: What is important and what is to
be accomplished
Quality Principles
Customer focus
Continuous improvement
Employee empowerment
Benchmarking
Just-in-time
Tools of TQM
Yields: How to do what is important and to
be accomplished
Employment Fulfillment
Empowerment
Organizational commitment
Yields: Employees attitudes that they can
accomplish what is important and to be
accomplished
Customer Satisfaction
Winning orders
Repeat customers
Yields: An effective organization with a
competitive advantage
Operation
Reliability & durability
Conformance
Serviceability
Appearance
Perceived quality
Quality
Dimensions of Quality for
Goods
Under-
standing
Tangibles
Reliability
Communication Credibility
Security
Responsiveness
Competence
Courtesy
Access
1995 Corel Corp.
Service Quality Attributes
Importance of Quality
Costs &
market share
Companys
reputation
Product
liability
International
implications
Increased
Profits
Lower Costs
Productivity
Rework/Scrap
Warranty
Market Gains
Reputation
Volume
Price
Improved
Quality
Quality cost
Quality & costs
Quality costs are all the costs incurred by a
business to ensure that the total service it
provide to customers conforms to the
customers requirement
First suggested by Quality experts Philip Crosby
In his book Quality is Free introduced the concept of
quality cost
Quality is free
It is not the quality that costs, but the lack of quality
He estimated 30% of a companys expenditure are quality
costs related
Quality related activities
Costs are considered to be the efforts devoted to
products that do not meet specification or which fail to
meet customer satisfaction. These costs would not exist
if the product has been made right in the first time.
Quality-related activities are those which
concerns with PAF
Prevention
Effects devoted to planning the quality system
Appraisal
Efforts to verify that quality is being obtained
Failure
Failures resulting from inadequate systems
Prevention Costs
Costs incurred in planning, implementing and
maintaining a quality management system that is
intended to ensure conformance to quality
requirement.
These costs are related to activities which
concern keeping failure and appraisal costs at a
minimum
Examples of prevention Cost
Application screening
Capability studies
Controlled storage
Design review
Equipment maintenance &
repair
Field testing
Fixture design and
fabrication
Forecasting
Housekeeping

Job descriptions
Market analysis
Pilot projects
Procedure writing
Prototype testing
Procedure reviews
Quality incentives
Safety reviews
Time and motion studies
Survey
Quality training
Vendor evaluation and
selection
Personnel reviews
Appraisal Costs
Costs incurred in measuring and suiting
design, product, components, and
materials in order to establish the design
of conformance with quality requirements.
These costs are related to appraisal of the
state of products and processes in order to
assess whether or not the
products/process satisfy given
requirement
Examples of appraisal cost
Audit
Document checking
Drawing checking
Equipment calibration
Final inspection
In-process inspection
Laboratory test
Personnel testing
Procedure testing
Prototype inspection
Receiving inspection
Shipping inspection
Failure costs
External failure cost
Costs incurred when
products fail to conform to
quality requirements after
transfer of ownership to the
customer
Internal failure cost
Costs that arise where
products, components,
and materials fail to
conform to quality
requirements before
transfer of ownership to
the customer
Costs are considered to be the efforts devoted to
products that do not meet specification or which fail
to meet customer satisfaction. These costs would
not exist if the product has been made right in the
first time.
Examples of internal failure cost
Accidents
Accounting error corrections
Employee turnover
Engineering change
Equipment downtime
Excess interest expense
Excess inventory
Excess material handling
Excess travel expense
Failure review
Obsolescence due to design
changes
Overpayments
Premium freight
Redesign
Re-inspection
Repair cost
Re-testing
Rework
Scrap allowances
Sorting

Examples of external failure cost
Bad debts
Customer dissatisfaction
Engineering change notice
Equipment downtime
Excess installation costs
Excess interest expense
Excess inventory
Excess material handling
Excess travel expense
Failure travel expense
Failure reviews
Liability
Loss of market share
Obsolescence due to design changes
Overpayments
Penalties
Premium freight
Price concessions
Price errors
Re-calls
Redesign
Re-inspection
Repair cost
Restocking costs
Re-testing
Rework
Scrap
Sorting
Warranty expense

Why calculate Quality Cost
Quality Costs represent 10-20% of total costs
Management will give special attention is quality is measured in
monetary terms
Quality costing is one of the tools
to provide initial assessments and hard evidence that improvement is
needed or had been made
To monitor the effectiveness of quality improvement initiatives
To be used in a generic term by senior management, shareholders and
financial institutions, so that they can readily understand implication of
quality the in term of money
Cost of quality failure is calculated as a percentage of profit or annual
turnover
It is easy to understand
By front-line operator
By middle management
Benefits of using quality costing
Greater accuracy in the evaluation and
forecasting of resource utilization
Justification for investment in the prevention and
appraisal of failures
Ability to cost and compare performance across
all departments functions and activities
Identification and prioritization of activities,
processes and departments in terms of
corrective action, investment, or quality
improvement initiatives
Benefits of using quality costing (2)
Ability to set cost-reduction targets and then to measure
and report progress
Ability to produce local data which improves
understanding of resource utilization objectives and
targets at all levels throughout the company
Provision of data to support formal quality management
system (including, especially; those based upon the
ISO9000)
Enable decisions about quality to be made in an
objective and systematic manner
Promoting TQM and a company-wide quality
improvement culture
Difficulties in using Quality costing
Management have not believed in the possibilities of
improvement
Quality costing is demanding
It requires a lot of data of each activity related to quality
Other limitations
Does not resolve quality problems
Does not provide specific actions
susceptible to short-term mismanagement
difficult to match effort and accomplishment
susceptible to measurement errors
may omit important or include inappropriate costs
Steps in implementing quality cost
1. Involve accountants right from the outset
2. Decide purpose and objectives
3. Decide how to deal with overheads
4. Distinguish between basic work and quality related
activities
5. Collection data which offers the prospect of real gains
6. Start by examining failure costs
7. Evaluate the costs of inspection
8. Analyze and use the data
9. Collecting and reporting quality cost data
Quality costs reduction
It helps business
to:
Satisfy the
requirements of
their customers.
Makes the work
of their
employees more
interesting.
Quality cost cannot eliminate the costs of
non-conformance, it is only a tool to
measure.
Quality cost is measure of effectiveness
and efficiency of a Quality Improvement
Programme


TQM - Services
Service quality is more difficult to
measure than for goods
Service quality perceptions depend on
Expectations versus reality
Process and outcome
Types of service quality
Normal: Routine service delivery
Exceptional: How problems are handled
TQM In Services
Under-
standing
Tangibles
Reliability
Communication Credibility
Security
Responsiveness
Competence
Courtesy
Access
1995 Corel Corp.
Service Quality Attributes
Determinants of Service Quality
Reliability consistency and dependability
Responsiveness willingness/readiness
of employees to provide service;
timeliness
Competence possession of skills and
knowledge required to perform service
Access approachability and ease of
contact
Courtesy politeness, respect,
consideration, friendliness of contact
personnel

Determinants of Service Quality
-Continued
Communication keeping customers
informed in languages they understand
Credibility trustworthiness, believability,
honesty
Security freedom from danger, risk or
doubt
Understanding/knowing the customer
making the effort to understands the
customers needs
Tangibles the physical evidence of the
service

Total Quality Management
Total Quality Management
and Continuous Improvement
TQM is the management process used to
make continuous improvements to all
functions.
TQM represents an ongoing, continuous
commitment to improvement.
The foundation of total quality is a
management philosophy that supports
meeting customer requirements through
continuous improvement.

Total Quality Management
Continuous Improvement versus
Traditional Approach
Market-share focus
Individuals
Focus on who and why
Short-term focus
Status quo focus
Product focus
Innovation
Fire fighting
Customer focus
Cross-functional teams
Focus on what and how
Long-term focus
Continuous improvement
Process improvement focus
Incremental improvements
Problem solving

Traditional Approach
Continuous Improvement
Total Quality Management
Value-based Approach
Manufacturing
Dimensions
Performance
Features
Reliability
Conformance
Durability
Serviceability
Aesthetics
Perceived quality
Service Dimensions
Reliability
Responsiveness
Assurance
Empathy
Tangibles
Total Quality Management
The TQM System
Customer
Focus
Process
Improvement
Total
Involvement
Leadership
Education and Training Supportive structure
Communications Reward and recognition
Measurement
Continuous
Improvement
Objective
Principles
Elements
Total quality management (TQM)


E Total quality management is the management approach of an
organization, centered on quality, based on the participation of
all of its members, and aiming at long-term success through
customer satisfaction and benefits to all members of the
organization and to society (ISO-Vocabulary)

Total quality management and
continuous quality improvement
Core principles
The TQM Formula
TQM = CQI through
Customer Focus +
Process Improvement +
Total Involvement
Non TQM vs. TQM
WORST CASE NON - TQM TQM
Dictates quality to the customer Focused on satisfying the customer
Passively waits for complaints
before attempting improvement,
therefore reactive
Intent on continuously improving
quality as measured by customer
satisfaction, therefore proactive
Blames individuals for problems
and solves problems piece-meal
Improves the total process of work
rather than blaming individuals
Feeling of powerlessness among
members
Involves everyone and achieves
commitment and pride
How quality management differs
from conventional management
Defines progress based on the purpose of
the organization, not just formal measures
Improves processes instead of working
only on structure, outputs or individuals.
Avoids blame.
Ensures that every person understands
how the system works, what it is supposed
to do and how well it is doing
Optimizes the performance of the system
instead of only components of the system

Basic principles and values of QA
<<>>
Quality Assurance: basic principles and values
Integrity

Independence

Prevention/Improvement

Objective Evidence

Identification/Traceability

Segregation
Steps of a quality improvement process
A quality improvement process includes the following steps:

assess current state and problems
define preferred state
identify barriers and root causes
develop improvement solutions
implement solutions
monitor results
Main Elements/Techniques of QA
<<>>
Quality Assurance: main elements/techniques
Organisation

Manual, Procedures, Plans and
Records

Inspections

Audits

Nonconformance Control

Training

Qualifications/Certifications


Organisation
This is the story of four people:
EVERYBODY, SOMEBODY, ANYBODY and NOBODY
There was an important job to be done and EVERYBODY
was asked to do it.
EVERYBODY assumed that SOMEBODY would do it.
ANYBODY could have done it but NOBODY did it.
SOMEBODY got angry about that because it was EVERYBODYs
job.
EVERYBODY thought ANYBODY ought to do it, but NOBODY
realised EVERYBODY wouldnt do it.
Finally, ANYBODY blamed EVERYBODY for not helping
NOBODY and SOMEBODY wisely concluded that NOBODY is the
most helpful person in the company.

Organisation
Good organisation means:

clear responsibilities and authorities

well defined management system

adequate communication lines

quality function independence
Organisation: clear responsibilities/authorities
defined company organisation
structure
written job descriptions
no conflicting responsibilities
no overlap of duties
responsibilities commensurate to
authority
adequate competence and abilities
adequate positions

Quality Assurance: main elements/techniques
Organisation

Manual, Procedures, Plans and Records

Inspections

Audits

Nonconformance Control

Training

Qualifications/Certifications

Quality system documentation structure
Quality policies, standards, organisations,
responsibilities and documentation
Quality system key processes and activities
QM tailoring for a specific project
Detailed descriptions of specific tasks
Objective evidence of conformance
to a quality system requirements
Quality manual
A Quality Manual is a compilation of company policies and
requirements meant to guide day-to-day practices, in particular
to:

- make customer and employee aware of the companys
quality philosophy and standards

- establish responsibilities of each organisational unit

- provide written guidance and instructions for quality

- serve as the basis from which audits are performed




Quality procedures: short and concise
Procedures should be as short and concise as possible (i.e., no
more than five pages). Inclusion of flow-diagrams is always
encouraged to summarise the sequence of steps.

QA plans
In general, a plan is a method or strategy for achieving an
objective.

The QA plan is the contractors management strategy for
fulfilling the specific quality requirements of a contract

ISO 8402:
Document setting out the specific quality practices, resources,
and sequence of activities relevant to a particular product,
project or contract
- The quality plan usually references parts of the suppliers
quality manual applicable to the specific case
- The quality plan may be called quality program plan or
quality assurance plan depending on the scope
Work instructions
In some cases, it is necessary to provide step-by-step
instructions to the work force for specific activities. It is
beneficial to separate this type of instruction from the more
generalised procedures.
Quality records
Quality records are documents which are maintained to provide
objective evidence of activities performed or results achieved
demonstrating:
conformance to specified requirements
effective operation of the quality system


A freshly minted test procedure is not a quality record, but it
becomes a quality record when filled in with the results of the
test.

A minimum retention period must be defined and documented.
Periods of 5 to 7 years are commonly used.
Quality records (contd)
Examples of Quality Records:

Inspection and test records
Shop-travelers (after completion)
Nonconformance records
Calibration records
Audit plan
Audit results/reports
Training/certification records
Identification and traceability records
Special processes records
Preventive actions records
Quality Assurance: main elements/techniques
Organisation

Manual, Procedures, Plans and Records

Inspections

Audits

Nonconformance Control

Training

Qualifications/Certifications


What is an Inspection?
A basic QA function is that of deciding through inspections
whether the product is conforming. Such inspections are
generally called acceptance inspections or QA inspections
and consist of:

a) Interpretation of the applicable technical documents
b) Measurement/assessment of the product
c) Comparison of a) and b)
d) Judgement as to conformance (a/r criteria)
e) Disposition of the product
f) Recording of data
Inspection types/techniques
Incoming inspection

In-process inspection

Self-inspection

Final inspection

Source inspection

Non-destructive
inspection

Incoming inspection
Inspections performed to assure the conformity of received
items to purchase orders. Mandatory use of holding areas until
acceptance.

Purchase Orders
- identify deliverable items and quality documents/records
- must be readily available at Incoming Inspection location

Incoming Inspection Instructions
- establish for group of items the verifications to be
performed

Rejected materials
- usually processed for return to supplier
- sometimes processed via in-house MRB (impact on
costs)
Incoming inspection (contd)
Use of suppliers data
Normally comprehensive inspections/testing must be performed
to verify conformity of received items to relevant specifications.
Such activities may be considered redundant ( and therefore
skipped) if relevant data are requested to the vendor, and the
vendors Quality Assurance system has been audited/certified
directly or by a reliable third party (e.g., ISO).The bottom line on
use of suppliers data is to be cost effective without
compromising the overall control of end-product conformance

Shipping damages
Incoming items must be always examined for shipping damages
Incoming inspection (contd)
Sometimes specific incoming inspections are anyhow
performed to:

prevent potentially severe schedule and cost
impacts on
the project due to late discovery

comply with applicable standards (e.g., procurement
of EEE)

prevent warranty time expiration for costly item not
of immediate use


In-process inspection
In-process inspection serve to provide early detection of
nonconformances before items are completed or processed
into higher assemblies
Self-inspection
Consist of allowing performance of in-process inspection by the
same operator who has performed the manufacturing operation.
SI requires:

written quality procedure
trained/certified operators
written specific instructions and a/r criteria
quantitative record of results
operator traceability
sampling re-verifications by QA

Self-inspection of critical characteristics is allowed only for
operations which will be directly or indirectly verified by QA at a
later time.
Final inspection
Consist of inspecting the product and the manufacturing
documentation at the time of production completion to verify:

conformity to contract requirements
(including as-designed/ as built)
completion of all manufacturing activities
( including inspection and testing)
close-out of any previous NCR disposition
correct marking, including serialisation (if
applicable)
complete/correct accompanying documents

Source inspection
Inspection performed by the customers QA to confirm products
compliance to contractual requirements prior to shipment

Source inspection may also involve Engineering in a
coordinated fashion for issues related to technical performance

Acceptance at source: inspection and acceptance at suppliers
facility prior to shipment to the extent that no further inspection
is required

Source inspection is recommended for critical items when no
incoming inspection is feasible at customers premises (e.g.,
due to lack of special equipment)
Quality Assurance: main elements/techniques
Organisation

Manual, Procedures, Plans and Records

Inspections

Audits

Nonconformance Control

Training

Qualifications/Certifications

What is an audit ?
An audit is an independent examination of objective evidence
performed by competent personnel, to determine whether or not
the auditee
- is able to achieve its policies and objectives, and/or
- is capable to fulfil its contractual and legal obligations;
and
- is effectively implementing a QA system

It is also the true and fair presentation of the results of such
examination. When conducting an audit, it is vital constantly to
remember that ones aim is
FACT FINDING NOT FAULT FINDING
Obviously, there will be occasions when faults will be found, but
that is a fact!
Audits
System audit
Process audit
Compliance audit
Product audit
System audit
Documented activity performed to verify, by examination and
evaluation of objective evidence, that applicable elements of the
quality system are suitable and have been developed,
documented, and effectively implemented in accordance with
specified requirements

A system audit probes whether or not there is an organisation
and a quality assurance system in existence and assesses their
adequacy to meet the requirements invoked by a contract.

It is advantageous to conduct a systems audit well in advance
of the actual starting of an activity. System audits are akin to
readiness reviews.
Compliance audit
The compliance audit investigates whether or not the QA
system is implemented. The auditor will scrutinise the objective
evidence that should be generated by the implementation of the
system. The auditor checks that the auditee works to the letter
of the QA procedures.

Compliance audit must not be confused with an inspection.
The latter is concerned with product acceptance and release for
further processing. The former concerns itself with verifying that
the QA system is implemented satisfactorily.
Process audit
Analysis of elements of a process and appraisal of
completeness, correctness, or conditions
Product audit
Quantitative assessment of conformance to required
product characteristics
Internal audit
Internal audits are not performed in a single shot. At start of
each year an Internal Audit Plan is drawn up. Each area of the
company will be audited at least once annually

The objective is to ascertain if all personnel who have duties
and responsibilities in accordance to the Quality Manual (or PA
Plan), understand and satisfactorily perform their duties and
responsibilities

The audit of the QA/QC organisation is considered
accomplished by customers audits, third party maintenance of
certification checks (if any), MIPs
External audit
Preparation

Performance

Conclusions

Report

Follow-up


Quality Assurance: main elements/techniques
Organisation

Manual, Procedures and Plans

Inspections

Audits

Nonconformance Control

Training

Qualifications/Certifications

Non-conformance procedure
Usual elements of a nonconformance reporting (NCR)*
procedure:

- Forms definition for internal/external reporting

- Initiator responsibilities (is anybody authorised to issue a
report or
only inspectors/QA?)

- Processing/meetings (formal meeting often only in special
cases)

- Responsibility for investigation of causes, preventive actions
definition/concurrence and tracking

*often called SPR (S/W Problem Report) for S/W products

Non-conformance procedure (contd)
- Material Review Board responsibilities and membership (by
name)

- Serial or parallel NCR distribution distribution (e.g., next higher
level+customer)

- Interfaces with Configuration Control function (issuing of
waivers)

- Disposition implementation. [Repair: to be treated as any
manufacturing operation (written instructions) except for very
simple cases]

- Segregation of non-conforming product
Non-conformances: disposition
_ Return to supplier: Only applies to non-conforming procured
items

_ Use-as-is: The non-conformance is acceptable at the status

_ Rework: Re-application of process will eliminate the non-
conformity

_ Repair: It is basically a modification that will allow use of the
item

_ Scrap: The item is not acceptable at the status or recoverable


Dispositions Use-as-is and Repair may require issuing a
waiver.
Non-conformances: investigating root causes
Root cause is the real reason for a nonconformity. It is possible
that symptoms of the problem are identified as the cause, and it
is the symptoms that are treated rather than the cause.

A defect attributed to operator error may not be the real reason
if the operator has not been trained, had inadequate work
instructions, or was working with a poor design.

4 For each non conformity there is a root cause
4 Causes are preventable
4 Prevention is always cheaper

Non-conformances: corrective actions
Corrective actions shall be aimed to prevent recurrence:

- Determine and document action to remove root causes
- Plan corrective actions (what, who and when)
- Identify interim actions

A Corrective Actions System should be in place to:
- summarise and collect nonconformances data (including
costs)
- determine need/effectiveness of corrective actions
- initiate QIP (Quality Improvement Project) when appropriate
Quality Assurance: main elements/techniques
Organisation

Manual, Procedures, Plans and Records

Inspections

Audits

Nonconformance Control

Training

Qualifications/Certifications

Quality Assurance: main elements/techniques
Organisation

Manual, Procedures, Plans and Records

Inspections

Audits

Nonconformance Control

Training

Qualifications/Certifications
Qualification/certifications
Qualification
process qualification
product qualification

Certification
quality system certification
product conformity certification
personnel certification
stamp warranty