What are the benefits of QMS for a Fertility Centre and how to measure them
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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 ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 2 2014 JULY ANDROFERT
- 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 ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 4 2014 JULY ANDROFERT
- 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 ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 5 2014 JULY ANDROFERT
- 6. ISO 9001: Conceptual Model ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 6 2014 JULY ANDROFERT
- 7. Customers are not only our patients… • Doctors who use our services • Our employees • Suppliers • People in our community • Regulatory authorities ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 7 2014 JULY ANDROFERT
- 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 ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 8 2014 JULY ANDROFERT
- 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 ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 9 2014 JULY ANDROFERT
- 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 ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 10 2014 JULY ANDROFERT
- 11. Concerns about quality of services Dancet et al. Hum Reprod 2013 0% 50% 100% Doctors & embryologists Nurses Patients Safety Effectiveness Patient- centeredness ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 11 2014 JULY ANDROFERT 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 ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 12 2014 JULY ANDROFERT
- 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) ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 13 2014 JULY ANDROFERT
- 14. A powerful “wedge” ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 14 2014 JULY ANDROFERT
- 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 ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 15 2014 JULY ANDROFERT
- 16. QMS benefits can only be achieved if evidence is provided ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 16 2014 JULY ANDROFERT
- 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 ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 17 2014 JULY ANDROFERT
- 18. How to measure & analyze Pareto diagram Diagram of cause and effect Control chart Histogram Flowchart Quality Tools ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 18 2014 JULY ANDROFERT 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 ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 19 2014 JULY ANDROFERT
- 20. Diagram of cause and effect Prioritize factors that may cause undesired effect ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 20 2014 JULY ANDROFERT
- 21. Control chart Monitor the stability or instability of a process ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 21 2014 JULY ANDROFERT
- 22. 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 ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 22 2014 JULY ANDROFERT
- 23. Histogram ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 23 2014 JULY ANDROFERT
- 24. Flow chart Visualize a process and identify improvement opportunities ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 24 2014 JULY ANDROFERT
- 25. PDCA Method to monitor, correct and improve a process ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 25 2014 JULY ANDROFERT
- 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 ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 26 2014 JULY ANDROFERT
- 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 ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 27 2014 JULY ANDROFERT
- 28. 6 Sigma Provides a general map that helps to reduce variability ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 28 2014 JULY ANDROFERT
- 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 ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 29 2014 JULY ANDROFERT
- 30. 1996 – Androfert Foundation 2000 – IVF Program started 2006 – Started QMS implementation 2010 – ISO Certification 2013 – Recertification ISO 9001:2008 What we achieved… ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 30 2014 JULY ANDROFERT
- 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 ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 31 2014 JULY ANDROFERT
- 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 ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 32 2014 JULY ANDROFERT
- 33. Core Reasons Achieved • Quality of services – Certified and recertified with “zero” non-conformities • Compliance with regulatory authorities ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 33 2014 JULY ANDROFERT
- 34. Quality of Laboratories ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 34 2014 JULY ANDROFERT
- 35. Image and Reputation Elected Top-quality ART Center – Germinative cell and tissue bank; ANVISA- Brazil – Training center for ANVISA inspectors (QMS) ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 35 2014 JULY ANDROFERT
- 36. 0 5 10 15 20 25 Total number of doctors using Androfert services after QMS Market share ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 36 2014 JULY ANDROFERT
- 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 ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 37 2014 JULY ANDROFERT
- 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 ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 38 2014 JULY ANDROFERT
- 39. Key points (3) What we achieved was … ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 39 2014 JULY ANDROFERT 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
Editor's Notes
- 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