What are the benefits of QMS for a Fertility Centre and how to measure them
1. Sandro Esteves
ANDROFERT, BRAZIL
L9: What are the benefits of
QMS for a fertility center
and how to measure them?
IVF Preceptorship Hamburg, 4-5 July 2014
QMS in the Fertility Centre
ISO 9001:2008
2. Learning objectives
At the completion of this presentation,
participants should be able to:
• Understand how an organization could
benefit from establishing an effective QMS
• Learn how to measure quality as per QMS
perspective
• Learn what we achieved at Androfert after
having implemented ISO 9001:2008
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3. What of the following does
your fertility center have?
Strong customer focus
customer needs/expectations are determined and converted into service requirements
Top managers have leadership
provide unity of purpose by quality policies, ensuring that measurable objectives are
established, and demonstrate that they are fully committed to developing, sustaining
and improving your center
People are involved at all levels
awareness of the importance of meeting customer requirements and responsibilities to
do this, and people are competent on the basis of appropriate training and experience
Process approach
key processes are supported by rigidly-defined procedures determining what is to be
done when undertaking a task
Systems approach
processes are managed so that the most efficient use is made of available resources,
to ensure that the needs of all stakeholders are met
Continual improvement for factual decision-making
attention is given to the voice of the customer and the voice of the processes
(measurement, monitoring, analysis)
4. A set of coordinated activities to
direct and control an
organization to continuously
improve the effectiveness and
efficiency of its performance
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5. Know your customers and define the processes
to meet their expectations
Define goals and objectives, so that procedures
and processes help you achieve them
Offer resources and infrastructure to fulfill
objectives
Systematically correct and prevent non-
conformities
Measure your performance and your customers’
satisfaction periodically
Make changes, adjustments, and improvements
based on measured results and not on
assumptions
Essentials of a successful QMS
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6. ISO 9001: Conceptual Model
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7. Customers are not only our
patients…
• Doctors who use our services
• Our employees
• Suppliers
• People in our community
• Regulatory authorities
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8. Adoption of QMS is a strategic
decision of a fertility center
Influenced by:
Regulatory directives
Concerns about quality of services
Effectiveness & efficiency
Safety
Customer requirements and satisfaction
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9. Worldwide tendency is IVF guidelines
including 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
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10. What regulatory bodies ask for
Document control system
Personnel training
Periodic audits
Procedures for detection, registration,
correction and prevention of errors and
non-conformities
Compliance with biosafety regulations
System to evaluate and control materials
and equipment
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11. Concerns about quality of services
Dancet et al.
Hum Reprod 2013
0% 50% 100%
Doctors &
embryologists
Nurses
Patients Safety
Effectiveness
Patient-
centeredness
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How stakeholders value the top 3 quality
dimensions of infertility care
12. QM focuses on customer requirements
and satisfaction
Lack of psychological support
and poor quality of service ~60%
treatment discontinuation
22 studies sampling
21,453 patients from
8 countries
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13. A QMS will ensure that two
important requirements are met…
1. Customer’s requirements
confidence in the ability of the center to deliver
the desired service consistently meeting their
needs and expectations
2. Fertility center’s requirements
both internally and externally, and at an
optimum cost with the efficient use of the
available resources (materials, human,
technology and information)
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15. Key points (1)
The benefits are…
1. Enables fertility center to provide
consistency in terms of methods,
materials, equipment, etc.
Safety and effectiveness
2. Ensures that services conform with
customers' needs and requirements
Customer-centeredness
3. Allows an increase in efficiency
Profitability
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16. QMS benefits can only be achieved
if evidence is provided
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17. How to get information
Internal and External Audits
Registration of quality actions
Non-conformities, preventive
actions, improvement actions,
complaints
Satisfaction surveys/questionnaires
Data collection
Key performance indicators
Main
Tools
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18. How to measure & analyze
Pareto diagram
Diagram of cause and effect
Control chart
Histogram
Flowchart
Quality
Tools
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PDCA
Balanced score card (BSC)
Six sigma
Quality
Methods
19. 0
5
10
15
20
25
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
Frequency
Andrology Lab - Patients' complaints
Pareto Diagram
Prioritize problems to be solved
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20. Diagram of cause and effect
Prioritize factors that may cause undesired effect
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21. Control chart
Monitor the stability or instability of a process
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24. Flow chart
Visualize a process and identify improvement
opportunities
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25. PDCA
Method to monitor, correct and improve a
process
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26. 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 5 5
Balanced Score Card
Provide a hierarchized view of the organization’s
performance management system
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27. Multiple Perspectives of BSC
How do we look to shareholders?
(Financial)
How do customers see us?
(Customer)
What must we excel at?
(Internal)
Can we continue to improve and create
value?
(Innovation and learning)
Kaplan and Norton
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28. 6 Sigma
Provides a general map that helps to reduce
variability
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29. Key points (2)
Measurement is carried out by…
Getting information
Audits, registration of quality actions, data
collection of (key performance indicators)
Applying quality tools
Pareto diagram, diagram of cause/effect,
histogram, flow chart
Integrating quality tools with quality
methods
PDCA, BSC & 6 Sigma
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30. 1996 – Androfert Foundation
2000 – IVF Program started
2006 – Started QMS implementation
2010 – ISO Certification
2013 – Recertification
ISO 9001:2008
What we achieved…
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31. Organizational Framework of Androfert
Quality and
Administrative
Manager
Clinical Director
Urology
/Andrology
Microsurgery
Gynecology
Endoscopy
Nursing
Complementary
health services
Psychologist
Nutritionist
Acupuncture
Anesthesia Ultrasound
Quality &
Administrative
Manager
General
services
Biomedicine
engineer
Maintenance
IT dept.
Data entry
Website &
Intranet
Administrative
assistant
Secretaries
Legal dept.
Lab Director
Lab Supervisor
Andrology Lab
technicians
Cryopreservation
Lab technicians
IVF Lab
Scientific
Director
Research Training
Associated
services
Endocrine
Laboratory
Genetics Laundry Sterilization Hospital Pathology Immunology Radiology
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32. Main reasons we
implemented QMS
Core reasons
Concerns about quality of services
Regulatory directives
Beyond the core
Image and reputation
Customer satisfaction
Market share (customer retention/acquisition)
Profitability
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33. Core Reasons Achieved
• Quality of services
– Certified and recertified with
“zero” non-conformities
• Compliance with regulatory
authorities
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35. Image and Reputation
Elected Top-quality ART
Center
– Germinative cell and
tissue bank; ANVISA-
Brazil
– Training center for
ANVISA inspectors
(QMS)
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36. 0
5
10
15
20
25
Total number of doctors using Androfert
services after QMS
Market share
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37. 0
2
4
6
8
10
12
14
16
18
20
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
Percent
growth
per
year
Year
IVF Program
Profitability
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38. And more…
Set direction & met customers’
expectations
Improved process control & reduced
wastage
Created a proper documentation system
Facilitated training
Involved staff & raised morale
Improved communication & feed-back
with all team members
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39. Key points (3)
What we achieved was …
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o A very well-organized workflow
o Excellence in service provided
o Focus on patient needs and
satisfaction
o Continuous improvement
o Increased operational efficiency
and profitability
Notas del editor
1. The requirements and expectations of clients are taken into consideration in making decisions and procedures.
2. The quality policies & quality objectives are clearly defined and understood inside the organization.
3. Processes & responsibilities to realize objectives are executed and managed;
4. Resources and infrastructure to fulfill objectives are offered.
5. Ways to measure processes, in addition to services, are defined and implemented.
6. Apply measurements results for improvement (measurement without action is usually a waste and resources).
7. Preventing non-conformities and eliminating reasons for non-conformities are systematic and managed to be a process.
8. Framework for verification of processes and services is clearly defined and understood in the business.
9. Management involvement within the system and thorough management reviews in the system. (This needs to be working meetings and not simply "dog and pony" shows
A QMS enables an organization to achieve the goals and objectives set out in its policy and strategy. It provides consistency and satisfaction in terms of methods, materials, equipment, etc, and interacts with all activities of the organization, beginning with the identification of customer requirements and ending with their satisfaction, at every transaction interface.
Doctors often assume that the patient has to adapt to treatment and not the opposite
TQM is important to infertility care, as new ARTs are frequently introduced without prior safety and effectiveness studies in vulnerable patients burdened emotionally, socially and also physically
TQM is a solution to take into account patients’ perspectives
That both holds the gains achieved through the quality “journey” and prevents good practices from slipping.
Quality indicators are measurable. They are used to quantify and evaluate the organization’s success. They also measure how much progress you’ve made relative to the objectives you wish to achieve.
They are critical to make improvements and support decision making.
Quality indicators are measurable. They are used to quantify and evaluate the organization’s success. They also measure how much progress you’ve made relative to the objectives you wish to achieve.
They are critical to make improvements and support decision making.
Select the problem to be compared
Decide what measurement is appropriate (eg. Frequency, quantitiy, etc)
Select the time period for analysis
Describe the problem clearly
Brainstorm and record data on those involved
Draw diagram with given problem on the right side
Indicate the categories of causes
Group the brainstorm result by category
Elect the most important causes
Define mean values generated by the process
Define the maximum variation the process reaches
Obtain the maximum values allowed by the specification
Prepare chart and record the values obtained in a given period of time
Register the values found in a given process
Accumulate the data
Assemble all information about the process to be studied
Draw the current flowchart
Study the critical points and draw flowchart with the steps that need to be followed
Compare and analyze the differences between what is intended and what is being done
Green: stable process and on target
Yellow: stable but not on target
Red: not stable and not on target
It allows the organisation to benchmark itself against similar organisations.
Accreditation provides evidence to external parties that the organisation has reached the standard required to carry out prescribed functions