Sandro C. Esteves
ANDROFERT, BRAZIL
L6: How to implement
QMS in a fertility center
IVF Preceptorship Hamburg, 4-5 July 201...
Learning objectives
ANDROFERT
androfert.com.br
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUC...
o It varies from person to
person, and it’s
influenced by feelings
o Despite being a relative
concept, it cannot be
establ...
Quality is how well the output of
our processes comply with a set
of pre-defined requirements
Process = Any activity or se...
A set of coordinated activities to
direct and control an
organization to continuously
improve the effectiveness and
effici...
Activities
continuously improve
performance
ANDROFERT
androfert.com.br
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL ...
QMS - ISO 9001:2008
Determine needs and expectations of customers and
others (legislation, professional societies, etc.)
M...
ISO 9001:2008 - QMS
Determine needs and expectations of customers and
others (legislation, professional societies, etc.)
M...
Key points (1)
Quality is relative to a set of requirements
how well the output of our processes
comply with pre-defined r...
How to
implement
QMS in a
fertility
center
ANDROFERT
androfert.com.br
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL C...
1. Create your mission statement
Define who your clients areWHO
Define what services you provideWHAT
Define your methods, ...
2. Define your QM focus
Brief, simple and direct statements that
define top management’s commitment to
quality (general qu...
ANDROFERT
androfert.com.br
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
S ESTEVES, 13
2...
3. Describe your processes and
procedures
Any activity or set of activities that uses
resources to transform raw material,...
ANDROFERT
androfert.com.br
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
S ESTEVES, 15
2...
Standard Operating Procedure (SOP)
sequence of steps that have been
standardized to execute a task, which is
used every ti...
Top 5 reasons why Fertility
Centers need SOPs
1. Repetitive highly-complex critically
important tasks
2. Variation must be...
Lab SOP key points
I. General information:
• Name of test or procedure
• Principles (goals and general information)
II. Pr...
Document Control
Quality Manual
– Describe document control system
– Documents must be reviewed and
authorized
– Audit & u...
TechnicalManual
ANDROFERT
androfert.com.br
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION...
Clinical Needs
Determine
tests/procedures
Write SOP
Does it provide
information for
clinical decision?
What does the
docto...
Designing a SOP - Example
How can I avoid
unnecessary
surgical sperm
retrieval in men
with NOA?
Semen analysis
at day of s...
How can I avoid
unnecessary
surgical sperm
retrieval in men
with NOA?
Semen analysis
at sperm retrieval
day
Presence of
sp...
Clinical
decision
based on Lab
SOP
information
Key points (2)
1. Explain why the organization exists
2. Create quality policies to generate quality
objectives; they serv...
4. Training
personnel
Getting to know each
other
each sector presents who
they are, what and how they
work
Interdepartment...
ANDROFERT
androfert.com.br
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
S ESTEVES, 27
2...
4. Training personnel (cont.)
Initial and recurrent training clearly outlined
SOPs are key elements
Staff performance peri...
Personnel & Training
Summary
• Job descriptions
• Personnel policies
• Induction training
• Professional qualifications
• ...
Infrastructure
Entire system of facilities, equipment, and
services that a fertility center needs in
order to function
Bui...
5. Register quality actions
Actions taken to improve the
service provided
Improvement
Actions
Actions taken to avoid a pot...
ANDROFERT
androfert.com.br
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
S ESTEVES, 32
2...
Implement a
culture of reporting
NC, preventive
action,
improvement
opportunity
Electronic-based
records
Data collection m...
6. Auditing
Verify conformity
Main
Objective
Processes, Procedures,
Documents and Records
Types
ANDROFERT
androfert.com.br...
ANDROFERT
androfert.com.br
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
S ESTEVES, 35
2...
7. Information
Quantify and evaluate the
organization’s success;
Measure how much progress you’ve
made relative to the obj...
ANDROFERT
androfert.com.br
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
S ESTEVES, 37
2...
8. Continual improvement
Set of recurring activities
carried out to enhance the
ability to meet requirements
• Audits (int...
ANDROFERT
androfert.com.br
ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION
S ESTEVES, 39
2...
8. Continuous improvement (cont.)
Fabiola Bento, MBA
Quality Manager, ANDROFERT
Quality manager
Establish unity of purpose...
Key points (3)
How we implemented
1. Taught the ISO standard to the whole team
2. Engaged the management team so that thei...
5. Created ways to control (internal auditing) and
guarantee SOPs were being followed without
variations
6. Defined and mo...
“The real voyage of discovery
consists not in seeking new
landscapes, but in having new
eyes.”
Marcel Proust
ANDROFERT
and...
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How to implement QMS in a Fertility Centre

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  • 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.
  • How to implement QMS in a Fertility Centre

    1. 1. Sandro C. Esteves ANDROFERT, BRAZIL L6: How to implement QMS in a fertility center IVF Preceptorship Hamburg, 4-5 July 2014 QMS in the Fertility Centre ISO 9001:2008
    2. 2. Learning objectives ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 2 2014 JULY ANDROFERT At the completion of this presentation, participants should be able to: • Understand what QMS stand for • Understand the basic concepts of ISO 9001 as a model for QMS to fertility centers • Learn how we implemented ISO 9001:2008 at Androfert and how to adapt what we did to your own center
    3. 3. o It varies from person to person, and it’s influenced by feelings o Despite being a relative concept, it cannot be established in a vacuum o Always relative to a set of requirements Quality is subjective… ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 3 2014 JULY ANDROFERT
    4. 4. Quality is how well the output of our processes comply with a set of pre-defined requirements Process = Any activity or set of activities that uses resources to transform raw material, supplies and labor (inputs) into products or services (outputs) ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 4 2014 JULY ANDROFERT
    5. 5. A set of coordinated activities to direct and control an organization to continuously improve the effectiveness and efficiency of its performance ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 5 2014 JULY ANDROFERT
    6. 6. Activities continuously improve performance ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 6 2014 JULY ANDROFERT
    7. 7. QMS - ISO 9001:2008 Determine needs and expectations of customers and others (legislation, professional societies, etc.) Mission Establish a quality policy, quality objectives, and quality indicators for the organization QM focus Determine processes/procedures to achieve the quality objectives; Identify and provide necessary resources Process Determine means to prevent nonconformities (NC) (variation) and eliminate their causes; Register quality actions; Verify compliance (auditing) NC; Registering; Auditing Establish and apply methods to measure effectiveness/efficiency of each process Monitoring Establish and implement a process that involves all personnel for continual improvement Continual improvement ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 7 2014 JULY ANDROFERT
    8. 8. ISO 9001:2008 - QMS Determine needs and expectations of customers and others (legislation, professional societies, etc.) Mission Establish a quality policy, quality objectives, and quality indicators for the organization QM focus Determine processes/procedures to achieve the quality objectives; Identify and provide necessary resources Process Determine means to prevent nonconformities (NC) (variation) and eliminate their causes; Register quality actions; Verify compliance NC; Registering; Auditing Establish and apply methods to measure effectiveness/efficiency of each process Monitoring Establish and implement a process that involves all personnel for continual improvement Continual improvement ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 8 2014 JULY ANDROFERT
    9. 9. Key points (1) Quality is relative to a set of requirements how well the output of our processes comply with pre-defined requirements QMS: coordinated activities to direct and control an organization to continuously improve the effectiveness and efficiency of its performance expresses organizational structure, policies, procedures, processes and resources needed to implement quality management ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 9 2014 JULY ANDROFERT
    10. 10. How to implement QMS in a fertility center ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 10 2014 JULY ANDROFERT
    11. 11. 1. Create your mission statement Define who your clients areWHO Define what services you provideWHAT Define your methods, philosophy, objectives, etc. HOW Our mission is to help couples with conception difficulties become parents, especially when the difficulty is partially or totally related to men, through counseling, diagnosis and treatment, offering personalized professional service of excellence, and using all available technologic resources ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 11 2014 JULY ANDROFERT
    12. 12. 2. Define your QM focus Brief, simple and direct statements that define top management’s commitment to quality (general quality orientation and basic intentions) Quality Policy Goals of each quality policy (they have to be measurable) Quality Objectives How you monitor your quality objectives (tools to check if your objectives, and therefore your policies are being achieved) Quality Indicators ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 12 2014 JULY ANDROFERT
    13. 13. ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 13 2014 JULY ANDROFERT QMFocus
    14. 14. 3. Describe your processes and procedures Any activity or set of activities that uses resources to transform raw material, supplies and labor (inputs) into products or services (outputs) Process Sequence of steps to execute a task Important for standardization and replication Procedure ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 14 2014 JULY ANDROFERT
    15. 15. ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 15 2014 JULY ANDROFERT
    16. 16. Standard Operating Procedure (SOP) sequence of steps that have been standardized to execute a task, which is used every time a given task is done, to ensure it is done the same way each time Detailed instructions to achieve uniformity on the performance of a specific procedure Usually written and hierarchical, but also expressed as flowcharts or drawings ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 16 2014 JULY ANDROFERT
    17. 17. Top 5 reasons why Fertility Centers need SOPs 1. Repetitive highly-complex critically important tasks 2. Variation must be controlled 3. More than one person could perform the same task 4. Safety risks are present 5. Quality control needs to be ensured ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 17 2014 JULY ANDROFERT
    18. 18. Lab SOP key points I. General information: • Name of test or procedure • Principles (goals and general information) II. Pre-analytic information: • Patient instruction for test/procedure preparation • Specimen collection instructions • Specimen labeling, transport, referral • Specimen acceptability (including rejection criteria) III. Analytic information: • Equipment, materials and reagents • Conditions required (e.g. laminar flow cabinet) • Instrument calibration and verification • Quality control (negative/positive control if required) • Step-by-step procedure description • Assay/procedure performance limitations • Troubleshooting IV. Post-analytic information: • Calculations (if required) • Normal ranges (reference intervals or expected results) • Policy for handling alert or panic values • Report • References ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 18 2014 JULY ANDROFERT
    19. 19. Document Control Quality Manual – Describe document control system – Documents must be reviewed and authorized – Audit & update quality documents annually – SOP for retention and storage of records – SOP for control of archive documentation Technical Manual – Master list of documents and retention times ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 19 2014 JULY ANDROFERT
    20. 20. TechnicalManual ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 20 2014 JULY ANDROFERT
    21. 21. Clinical Needs Determine tests/procedures Write SOP Does it provide information for clinical decision? What does the doctor need to know? Designing SOPs ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 21 2014 JULY ANDROFERT
    22. 22. Designing a SOP - Example How can I avoid unnecessary surgical sperm retrieval in men with NOA? Semen analysis at day of sperm retrieval Presence of sperm for ICSI What does the doctor need to know? Determine test Lab SOP with post-analytical info for clinical decision ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 22 2014 JULY ANDROFERT
    23. 23. How can I avoid unnecessary surgical sperm retrieval in men with NOA? Semen analysis at sperm retrieval day Presence of sperm for ICSI Does SOP provide solution for panic/alert values? Panic value: No sperm What to do next? eg.: Centrifugation ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 23 2014 JULY ANDROFERT
    24. 24. Clinical decision based on Lab SOP information
    25. 25. Key points (2) 1. Explain why the organization exists 2. Create quality policies to generate quality objectives; they serve as a general framework for action 3. Define all processes needed to meet a desired outcome Design workable SOPs Implement, control (verify conformity) and improve (update) SOPs ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 25 2014 JULY ANDROFERT
    26. 26. 4. Training personnel Getting to know each other each sector presents who they are, what and how they work Interdepartmental observations provides a realistic view daily work activities Internalizing ethical and moral values understand their individual roles and importance within the organization ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 26 2014 JULY ANDROFERT
    27. 27. ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 27 2014 JULY ANDROFERT QM training 4. Training personnel (cont.)
    28. 28. 4. Training personnel (cont.) Initial and recurrent training clearly outlined SOPs are key elements Staff performance periodically evaluated Feedback given Continual training program established cover both new training as well as reviewing concepts and procedures, to guarantee internalization ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 28 2014 JULY ANDROFERT
    29. 29. Personnel & Training Summary • Job descriptions • Personnel policies • Induction training • Professional qualifications • Competency testing • Responsibilities clearly defined • Training/ retraining • Informed of ethical issues/moral values ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 29 2014 JULY ANDROFERT
    30. 30. Infrastructure Entire system of facilities, equipment, and services that a fertility center needs in order to function Buildings Workspaces Equipment hardware & software Support services ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 30 2014 JULY ANDROFERT
    31. 31. 5. Register quality actions Actions taken to improve the service provided Improvement Actions Actions taken to avoid a potential non-conformity before it actually happen Preventive Actions Actions taken after detecting a non- conformity to correct it Corrective Actions ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 31 2014 JULY ANDROFERT
    32. 32. ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 32 2014 JULY ANDROFERT Non-conformities Every deviation from what is established. Identify inconsistencies, weaknesses, and improvement opportunities
    33. 33. Implement a culture of reporting NC, preventive action, improvement opportunity Electronic-based records Data collection more uniform 5. Registering (cont.) ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 33 2014 JULY ANDROFERT
    34. 34. 6. Auditing Verify conformity Main Objective Processes, Procedures, Documents and Records Types ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 34 2014 JULY ANDROFERT
    35. 35. ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 35 2014 JULY ANDROFERT
    36. 36. 7. Information Quantify and evaluate the organization’s success; Measure how much progress you’ve made relative to the objectives you wish to achieve; Critical to make improvements and support decision making. Mainobjectives ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 36 2014 JULY ANDROFERT
    37. 37. ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 37 2014 JULY ANDROFERT
    38. 38. 8. Continual improvement Set of recurring activities carried out to enhance the ability to meet requirements • Audits (internal & external) • Self-assessments • Management reviews • Implement corrective and preventive actions • Improvement group ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 38 2014 JULY ANDROFERT
    39. 39. ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 39 2014 JULY ANDROFERT
    40. 40. 8. Continuous improvement (cont.) Fabiola Bento, MBA Quality Manager, ANDROFERT Quality manager Establish unity of purpose and direction of the internal environment Create an environment where people are fully involved in achieving the organization’s objectives ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 40 2014 JULY ANDROFERT
    41. 41. Key points (3) How we implemented 1. Taught the ISO standard to the whole team 2. Engaged the management team so that their work reflected the new concept and was used as an example for the rest of the team 3. Identified the processes and procedures involved in the realization of our service 4. Standardized all procedures necessary to offer the service we provided, writing SOPs and training our team ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 41 2014 JULY ANDROFERT
    42. 42. 5. Created ways to control (internal auditing) and guarantee SOPs were being followed without variations 6. Defined and monitored key performance indicators to improve the quality of services provided 7. Formally documented the implemented system 8. We were surveyed and ISO certified ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 42 2014 JULY ANDROFERT Key points (3) How we implemented
    43. 43. “The real voyage of discovery consists not in seeking new landscapes, but in having new eyes.” Marcel Proust ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 43 2014 MARCH ANDROFERT
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