Introduction to

Quality
Management
Quality Management

Project managers should incorporate

sound
quality management practices into
their
work/project, etc.

Why bother: to meet customer,

client, or
public requirements on time and
Quality should be concerned
with :

1. The product/service/process that is

the
deliverable from the project.

2. The project management process

itself.
What do we mean by “quality’?

What is quality?
 Quality of life
 quality of the environment
 quality of service
 quality of product
Hard to define
Everyone wants quality work,
performance, goods and services
Some Definitions

Philip B. Crosby
 quality is defined as conformance to
requirements, not as goodness
W. Edwards Deming
 Quality means the effective production
of the quality that the market expects, it
does not mean achieving perfection. He
viewed quality
as a responsibility of management.
Some more definitions

Farrell
 Quality means products, services,
processes & conditions that effectively,
efficiently & consistently meet or
exceed the requirements & expectations
of all customers
Joseph Juran
 Quality is fitness for use. Freedom from
deficiencies (errors that require rework
or cause product failure)
The project management
institute says quality is

The degree to which a set of inherent

characteristics fulfills requirements.
What does it really mean?
 Consensus is difficult to achieve
 manufacturers
meeting a particular specification for a
particular customer
 corporate customer
product can be used for intended purpose
 consumer
perception that standards have been met
Quality to Manufacturers
 buzz word to be used in ads
 quality sells
 quality is important in battling
competition
 for manufacturers, the product must;
be free of defects
meet or exceed design requirements
be perceived as being good value by end
user
on time delivery
competitive pricing
Quality to Consumers
 consumer evaluates quality in a
subjective manner
 quality perception is important.
 The product must
look, feel, taste, smell, sound good
do the intended job
be good value for their money
 expectations differ between consumers
What does quality mean
in

terms of Public Health?

Any ideas?
What does quality mean in
terms of Public Health?

Does it mean PHIs inspecting

restaurants,
meat packing facilities, fish plants, etc.
to
make sure these places are doing
quality
work?
What does quality mean in
terms of Public Health?

Could it mean PH Inspectors doing

quality
work?
What does quality mean in
terms of Public Health?

Does it mean the public is assured

that the
facts given to them by PHIs and other
government health officials are based
on
reliable current data backed up by a
good
quality program to ensure the best
What does quality mean in
terms of Public Health?

Could it mean all of these things and

more?
What does quality mean in terms of
healthcare?

Any ideas?
Where do quality and project
management merge?

Every project aims to reach a certain

standard of quality.

-External, such as ISO certification,

accreditation, etc

-Internal, quality standards of the

organization
Where do quality and project
management merge?
The project must define the standards
that
each of the major deliverables or
outcomes
must meet.
The project must define who needs to be
satisfied with the quality achieved.

Need to consult with unions in

Quality versus project
constraints

Project constraints include time, cost

and scope
Quality may be closely associated
with scope because both are tied to
customer/public requirements.
A good project manager should
never trade off quality at the
expense of the above three
constraints.
Managing Quality

Performance criteria must be defined in

the
planning phase.

Ensure this is made explicit and

understood
by all stakeholders.
Managing Quality

Set up quality assurance mechanisms

which
are transparent and require reporting
to the
sponsor or project steering committee
on a
regular basis.
Managing Quality

Ensure any variations from the quality

plan
are logged, documented and resolved
at a
high level.

A procedure to accept variations from

the
quality plan should be formalized.
Quality partner

Some project teams will appoint a

friendly
expert advisor who works
confidentially with
the team to ensure problems don’t
occur;
rather than wait for them to happen
then
Aspects of Quality

inspection
quality control
quality assurance
quality system
Inspection
 process of measuring, examining,
testing, gauging, or otherwise
comparing one or more units of product
with the applicable requirements
 this is an acceptance function involving:
receiving
in process inspection & testing
final inspection & testing
control of nonconformances
day to day monitoring
etc
Quality control

The set of materials and practices

used
throughout the measurement process
to
ensure that each discrete part
contributes
a minimum amount of error to the
results.
Quality control

QC for the most part is a required part

of
the QA program.

The choice of QC requirements

depends on
the project being undertaken.
Quality assurance

A system of activities whose purpose

is to
provide to the producer or user of a
product
(or a service) the assurance that it
meets
defined standards of quality with a
stated
QA versus QC

The terms are often used

interchangeably,
but they are quite different in meaning.

QA is concerned with the quality of the

information provided by the data.
QC is concerned with the quality of the
measurement process involved.
Quality system

This is the overall program that an

organization undertakes in regards to
quality issues. It encompasses QA and
QC.

QS > QA > QC
Quality
Assurance
Quality Assurance
- management goals

The QA program should give

management
the opportunity to provide input and
take
responsibility at the planning,
implementation and assessment
stages of
the project at hand.
Quality Assurance
- management goals

The QA staff and their relationships to

management and technical staff are
important to an organization in order
to
ensure coordinated efforts and logical
flow
of information.
Quality Assurance
- Division of responsibility

Divisions of responsibility among the

technical staff, management,
supervisory
staff and contractors should be made
clear.

The responsibility for quality lies with

all
employees.
Quality Assurance highlights
- Time Costs

There is a time cost to running a good

QA
program.
In a lab setting, up to 20% of one
person’s
time may be dedicated to the QA
program

Up to 15% of total measurement time

Quality Assurance highlights
- Time Costs

Organizations must add in the cost of

time
to be spent on a QA program when
they are
adopting one or developing their own.

The organization must be fully aware

of the
time involved in this process and have
The QA program - standards

It is often convenient to base the QA

program on a national standard.
Such as USEPA documents.

Standards can be embellished to

create a
program tailored to an organization’s
philosophy.
The QA program contains

Management reviews
QA plans or procedures
Technical plans and procedures
Stepwise description of work

Audits or assessments, performance

evaluations, compliance evaluations
The QA program contains

Details regarding an employees

qualifications and training in order to
satisfy:

Safety requirements
Compliance with QA requirements
Efficiency
The QA program contains

A procurement system to ensure

suppliers provide the goods and
services
required on time.
QA document control

A system for handling documents and

records to assure;

only the most recent version of a

procedure
is being used,

they accurately reflect completed

work.
Quality Assurance
- Records

Some programs require extensive

documentation and record keeping.

Especially those involved in enforcing

regulations.
Quality Assurance
- Records

A QA record is a completed document

that
provides evidence of the quality of
items or
activities or study (research) results.
Quality Assurance
– The QA Record

Includes plans and procedures used

during
the project, raw data (if any),
procurement
documents, computer documents,
chain-of-
custody documents.

The record must be legible, accurate,

Quality Assurance
- The QA Record

Provisions must be made for storage,

length
of storage, preservation and
disposition of
records, including electronic data.

Records must be traceable to samples,

sites, data, reports and the project
they
Quality Assurance
– Work Processes

Must be documented to ensure that

work is
performed as planned and/or that
work can
be repeated if necessary.

Processes performed the same way

each
time can be written up as a standard
Quality Assurance
– Graded approach

This means the QA requirements

should be
tailored to the needs or importance of
the
specific project by undertaken.
Quality assurance
–Audits and assessments

Designed to be a review of routine

work
or may involve visits to the laboratory
or
field for an on-site evaluation.

Emphasize to project personnel the

importance of complying with the QA
program and documents
Quality assurance
–Audits and assessments

Audits can be internal (within

organization)
or
External – Done by people external to
the
defined organization
Types of audits

[Link] written audit.

Auditors inspect records and
documents for
evidence of compliance.

2. Surveillance audit.
Auditors observe work as it is being
performed.
Types of audits

3. Performance evaluations.

Procedure in which a system, process

or
work group is evaluated against a
performance sample. If results are not
comparable to the standard, corrective
action is needed.
Types of audits

4. Data quality assessment

A set of data is evaluated against

specific
criteria contained in a check sheet.

Note: the audit process often presents

a tense situation for those being
audited.
QA - nonconformance

A deficiency in characteristic,
documentation, or procedure that
renders
the quality of an item or activity
unacceptable or indeterminate.

Nonconformance is considered a
serious
deficiency and requires corrective
QA - nonconformance

Example

Measuring samples with an instrument

that
doesn’t meet calibration requirements.
QA - Calibration

Users must demonstrate that

measuring
systems are operating properly.

Equipment and instrumentation are

calibrated and checked at prescribed
times
Quality
Control
Quality control

Must determine which parameters,

measurements systems, and sets of
data
are critical and to what extent
detection of
problems can be predicted using
various
indicators.
Quality control

Results of QC determinations must fall

within certain limits of acceptance.
Quality control methods

1. Use reference material with certain

well
established properties.
2. Confirm measurements/results
using a
second method.
[Link] control chart to indicate trends.
4. Proficiency test the analysts.
5. Compare to other
Typical control chart

Blue line is the average value

Green line is upper and lower limits
Black line with boxes are the measured data points
Why Implement a Quality
System?
 Good business sense
can assist you in producing & sustaining a
higher quality of product & service. This
can lead to:
• customer satisfaction
• repeat business
• greater share of the market
• higher profits
• reduced costs for rework
• reduced costs of after sales service
• reduced customer complaints
• reduced scrap
Are additional staff needed?

May need to add an inspector (if none

exists)
may need to add more than one
depends on complexity of the process

May need to add internal auditors

different from inspectors
ensure no conflict of interest
How difficult is
Implementation?
 Can be straight forward

 disaster can result if

inadequate planning
lack of understanding
lack of training
 requires a substantial amount of time,
effort and conviction
How much does it cost?
 Varies with

size of organization
complexity of product or service
requirements of the quality standard
selected
commitment & effort generated by
management
extent of inspection & control procedures
already in place
Who is involved in
implementation?
 Everyone
 To be successful, everyone must be
committed to
implementation
maintenance
continual improvement
of the quality system
Who is responsible for
Quality?
 Everyone
misconception that only manager or quality
dept. responsible
• similar to health and safety
 quality dept will have specific duties
identify and document quality issues
some companies don’t want process or line
stopped
need to have power of corrective actions
necessary
authority must be given
But

Does everyone adhere to

producing
quality products/processes, etc?
China seizes more melamine-
tainted milk powder
BEIJING (Reuters, Feb 7 2010) -
Chinese inspectors tracing new
cases of contaminated milk have
shut dairy firms in the northwest and
seized 72 metric tons of milk powder
tainted with melamine, an industrial
compound that killed at least six
children in 2008.

 Nearly 100 metric tons of tainted milk

Melamine
 Is used in the manufacture of plastics

 It can cause kidney stones and kidney

failure.

 It was added to watered-down milk (baby

formula) to fool inspectors testing for
protein and stretch profits.

 Both melamine and protein are high in

nitrogen.
Protein molecule Melamine molecule
End results (Feb 2010)

300,000 get sick, six children die.

Dozens of officials, dairy executives

and farmers were punished.

Two officials were executed over this

scandal.
China’s reputation for food quality is
seriously harmed.
2013 research report
8% of the patients still had kidney abnormalities one year
after diagnosis or treatment initiation. The lack of up-to-
date data on recovery status of the affected children
indicates the need for further investigation
No more melamine:
Then what came next?
Hydrolyzate of bovine leather, Peter
Leedham, a China-based food testing
executive, recently said in a NY Times
article Feb 18 2011.

"Because it's actually protein and

derived from a cow, it's almost
impossible to detect as an additive.”
Hydrolyzate of bovine leather

To find out if the substance has been

added to dairy, authorities look for
telltale leather-curing residues. The
protein extracted from cow leather is
not known to be dangerous to
human health, but the curing
chemicals are, Leedham said.
Hydrolyzate of bovine leather

The China Daily newspaper said the

chemicals could be fatal for children
in high doses and put adults at risk
for osteoporosis.