What the benefits are to implement TQM in ART Units and how to measure them

What
the
beneﬁts
are
to

implement
TQM
in
ART
units

and
how
to
measure
them

ISO 9001:2008
4th International Congress - Academy of Clinical Embryologists
18-20 September 2015, Kochi INDIA
Sandro
C.
Esteves,
MD.,
PhD.

Medical
&
Scien,ﬁc
Director,
ANDROFERT

Andrology
&
Human
Reproduc,on
Clinic

Campinas,
BRAZIL

Learning
objecEves

At
the
compleEon
of
this
presentaEon,

parEcipants
should
be
able
to:

•  Understand
how
an
organiza,on
beneﬁt
from

implemen,ng
TQM

•  Learn
how
to
measure
quality
as
per
QMS

perspec,ve

•  Learn
what
we
achieved
at
Androfert
aOer

having
implemented
ISO
9001

ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
S ESTEVES, 2
2015
ANDROFERT

A
set
of
coordinated
acEviEes
to
direct

and
control
an
organizaEon
to

conEnuously
improve
the
eﬀecEveness

and
eﬃciency
(safety
and
paEent-‐
centeredness)
of
its
performance

S ESTEVES, 3
2015
ANDROFERT

ImplementaEon
of
TQM
is
a
strategic

decision

Concerns
about
quality
of
services

Ø 
Eﬀec&veness
&
eﬃciency

Ø  Safety

Ø 
Customer
requirements/sa&sfac&on

Regulatory
direcEves

S ESTEVES, 4
2015
ANDROFERT

Worldwide
tendency
is
to
QMS
become

mandatory

Australia
Code of practice for assisted
reproductive technology units,
Reproductive Technology Accreditation
Committee (RTAC)
Brazil
RDC 33 and 23, National Agency of
Sanitary Surveillance (ANVISA)
European
Union
EU directive 2004/23/EG, 2006/17/EG,
2006/86/EG
South Africa
National Health Act 61/2003; Human
Tissue Act
USA
CLIA for Andrology laboratories; FDA
for cryobiology
S ESTEVES, 5
2015
ANDROFERT

A
QMS
ensures
quality
requirements
are

met
in
different
levels

1.  Customer’s
requirements

Confidence
in
the
ability
of
the
center
to

deliver
the
desired
service
consistently

mee,ng
their
needs
and
expecta,ons

2.  FerElity
center’s
requirements

Both
internally
and
externally,
and
at
an

op,mum
cost
with
the
efficient
use
of
the

available
resources
(materials,
human,

technology
and
informa,on)

S ESTEVES, 6
2015
ANDROFERT

Customers
are
not
only
our
paEents…

• 
Doctors
who
use
our
services

• 
Our
employees

• 
Suppliers

• 
People
in
our
community

• 
Regulatory
authoriEes

S ESTEVES, 7
2015
ANDROFERT

ISO
9001:
Conceptual
Model

S ESTEVES, 8
2015
ANDROFERT

ISO
9001
TQM
model
easily
adapted
to
ART
Units

ü Customer satisfaction
ü Document control system
ü Personnel training
ü Periodic audits
ü Procedures for detection, registration,
correction and prevention of errors and non-
conformities
ü Compliance with biosafety regulations
ü System to evaluate and control materials and
equipment
S ESTEVES, 9
2015
ANDROFERT

SOPs

QMS expresses the organizational structure,
policies, procedures, processes and resources
used to implement quality actions
•  Laboratories

descripEon

•  Personnel,
job

descripEons,

responsibiliEes

•  Training
program

•  Safety
instrucEons

•  General
rules

•  Mission

•  Quality
policies,
objecEves

&
indicators

•  Document
control
system

•  Reviews,
audiEng,

retenEon

•  How
to
register
and

control
non-‐conformiEes,

correcEve
&
prevenEve

acEons

•  AudiEng
system

•  Improvement
system

Technical

manual

Clinical
and

laboratory
SOP

manual

Quality

manual

S ESTEVES, 10
2015
ANDROFERT

Quality
management
is
not
only

quality
control
in
the
lab

ANDROFERTANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
S ESTEVES, 11
2015

Determine
needs
and
expectaEons
of
customers
and

others
(legislaEon,
professional
socieEes,
etc.)

Mission

Establish
a
quality
policy,
quality
objecEves,
and

quality
indicators
for
the
organizaEon

QM
focus

Determine
processes/procedures
to
achieve
the

quality
objecEves;
IdenEfy
and
provide
necessary

resources

Process

Determine
means
to
prevent
nonconformiEes
(NC)

(variaEon)
and
eliminate
their
causes;
Register

quality
acEons;
Verify
compliance
(audiEng)

NC;
Registering;

AudiEng

Establish
and
apply
methods
to
measure

eﬀecEveness/eﬃciency
of
each
process

Monitoring

Establish
and
implement
a
process
that
involves
all

personnel
for
conEnual
improvement

ConEnual

improvement

Say
what
you
do
and
what

your
requirements
are

Show
how
you
do

Show
how
you
ensure
you

follow
what
you
say
you
do

Show
what
you
do
to
improve

what
you
do

QMS
-‐
ISO
9001

S ESTEVES, 12
2015
ANDROFERT

Fabiola
Bento,
MBE

Quality
Manager,

ANDROFERT

Establish
unity
of
purpose
and

direcEon
of
the
internal

environment

Create
an
environment
where

people
are
fully
involved
in

achieving
the
organizaEon’s

objecEves

S ESTEVES, 13
2015
ANDROFERT
Quality
manager
is
essenEal

A
powerful
“wedge”

S ESTEVES, 14
2015
ANDROFERT

The
benefits

1.  Enables
ferElity
center
to
provide
consistency
in

terms
of
methods,
materials,
equipment,
etc.

Safety
and
effec&veness

2.  Ensures
that
services
conform
with
customers'

needs
and
requirements

Customer-‐centeredness

3.  Allows
an
increase
in
efficiency

Profitability

S ESTEVES, 15
2015
ANDROFERT

S ESTEVES, 16
2015
ANDROFERT
QMS
beneﬁts
can
only
be
achieved
if

evidence
is
provided

How
to
get
informaEon

Internal
and
external
audits

RegistraEon
of
quality
acEons

Non-‐conformi,es,
preven,ve

ac,ons,
improvement
ac,ons,

complaints

SaEsfacEon
surveys/quesEonnaires

QC
and
QA
reports

Key
performance
indicators

Main
Tools

S ESTEVES, 17
2015
ANDROFERT

How
to
measure
&
analyze

Pareto
diagram

Diagram
of
cause
and
eﬀect

Control
chart

Histogram

Flowchart

Quality

Tools

PDCA

Balanced
score
card
(BSC)

Six
sigma

Quality

Methods

S ESTEVES, 19
2015
ANDROFERT

Pareto
diagram

Priori,ze
problems
to
be
solved

S ESTEVES, 20
2015
ANDROFERT

Diagram
of
cause
and
eﬀect

Priori,ze
factors
that
may
cause
undesired
eﬀect

S ESTEVES, 21
2015
ANDROFERT

Control
chart

Monitor
the
stability
or
instability
of
a
process

S ESTEVES, 22
2015
ANDROFERT

0
2
4
6
8
10
12
Q1
2010
Q2
2010
Q3
2010
Q4
2010
Q1
2011
Q2
2011
Q3
2011
Q4
2011
Q1
2012
Q2
2012
Q3
2012
Q4
2012
Number of non-conformities
Histogram

Distribute
data
and
shows
how
a
given

process
varies

S ESTEVES, 23
2015
ANDROFERT

Histogram

S ESTEVES, 24
2015
ANDROFERT

Flow
chart

Visualize
a
process
and
idenEfy
improvement

opportuniEes

S ESTEVES, 25
2015
ANDROFERT

How
to
measure
&
analyze

Pareto
diagram

Diagram
of
cause
and
eﬀect

Control
chart

Histogram

Flowchart

Quality

Tools

PDCA

Balanced
score
card
(BSC)

Six
sigma

Quality

Methods

S ESTEVES, 26
2015
ANDROFERT

PDCA

Method
to
monitor,
correct
and
improve
a
process

S ESTEVES, 27
2015
ANDROFERT

Category
Metric
Target
Status
Customer
satisfaction
Repeat customer
% IVF drop-out
<50%
50%
Service
% IVF cycles w/
complaints
<5%
2%
Financial
No. IVF cycles
% Annual growth
>5%
8%
No. tests Andrology lab
% Annual growth
+/- 10%
8%
Payment rate sperm/
embryo bank
% clients in debt
<35%
40%
Employee
satisfaction
Turnover
2-yr. period
<5%
9%
Absenteeism
Days
year/employee
4
2
Quality
ISO
recertiﬁcation
approval
Non-conformities
No. year
reduction
-10%
Balanced
Score
Card

Provide
a
hierarchized
view
of
the
organizaEon’s

performance
management
system

S ESTEVES, 28
2015
ANDROFERT

6
Sigma

Provides
a
general
map
that
helps
to
reduce

variability

S ESTEVES, 29
2015
ANDROFERT

How
to
Measure

Geing
informaEon

Audits,
registraEon
of
quality
acEons,
data

collecEon
of
(key
performance
indicators)

Applying
quality
tools

Pareto
diagram,
diagram
of
cause/eﬀect,

histogram,
ﬂow
chart

IntegraEng
quality
tools
with
quality
methods

PDCA,
BSC
&
6
Sigma

S ESTEVES, 30
2015
ANDROFERT

ISO 9001 Certiﬁcation
since 2010
BSI; British Standards Institution
S ESTEVES, 31
2015
ANDROFERT

0
5
10
15
20
25
Total
number
of
doctors
associated

to
the
IVF
program

Market
share

ISO
9001

S ESTEVES, 32
2015
ANDROFERT

0
2
4
6
8
10
12
14
16
18
20
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
Percentgrowthperyear
Year
IVF Program
Proﬁtability

S ESTEVES, 33
2015
ANDROFERT

And
more…

ü Set
direcEon
&
met
customers’
expectaEons

ü Improved
process
control
&
reduced

wastage

ü Created
a
proper
documentaEon
system

ü Facilitated
training

ü Involved
staﬀ
&
raised
morale

ü Improved
communicaEon
&
feed-‐back
with

all
team
members

S ESTEVES, 34
2015
ANDROFERT

Key
points
(3)

What
we
achieved
was
…

u 
A
very
well-‐organized
workflow

u Excellence
in
service
provided

u Focus
on
customers
needs/saEsfacEon

u Increased
operaEonal
efficiency
and

profitability

u ConEnuous
improvement

S ESTEVES, 35
2015
ANDROFERT

S ESTEVES, 36
2015
ANDROFERT

Thank
you

This
presentaEon
is
available
at

hmp://www.slideshare.net/
sandroesteves

4th International Congress - Academy of Clinical Embryologists
18-20 September 2015, Kochi INDIA

What the benefits are to implement TQM in ART Units and how to measure them

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