What the benefits are to implement TQM in ART Units and how to measure them
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Implementing a Total Quality Management (TQM) system like ISO 9001 in assisted reproductive technology (ART) units has several key benefits: 1) It ensures consistency in methods, materials, and equipment used, improving safety and effectiveness. 2) It ensures services meet customers' needs and requirements, improving customer-centeredness. 3) It allows for increased efficiency and profitability by standardizing processes. Implementing a quality management system provides a framework for ART units to continuously improve performance and satisfy all stakeholders.
What the benefits are to implement TQM in ART Units and how to measure them
- 1. 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
- 2. 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
- 3. 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 ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 3 2015 ANDROFERT
- 4. 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 ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 4 2015 ANDROFERT
- 5. 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 ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 5 2015 ANDROFERT
- 6. 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) ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 6 2015 ANDROFERT
- 7. Customers are not only our paEents… • Doctors who use our services • Our employees • Suppliers • People in our community • Regulatory authoriEes ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 7 2015 ANDROFERT
- 8. ISO 9001: Conceptual Model ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 8 2015 ANDROFERT
- 9. 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 ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 9 2015 ANDROFERT
- 10. 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 ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 10 2015 ANDROFERT
- 11. Quality management is not only quality control in the lab ANDROFERTANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 11 2015
- 12. 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 ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 12 2015 ANDROFERT
- 13. 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 ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 13 2015 ANDROFERT Quality manager is essenEal
- 14. A powerful “wedge” ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 14 2015 ANDROFERT
- 15. 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 ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 15 2015 ANDROFERT
- 16. ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 16 2015 ANDROFERT QMS benefits can only be achieved if evidence is provided
- 17. 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 ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 17 2015 ANDROFERT
- 19. 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 ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 19 2015 ANDROFERT
- 20. Pareto diagram Priori,ze problems to be solved ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 20 2015 ANDROFERT
- 21. Diagram of cause and effect Priori,ze factors that may cause undesired effect ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 21 2015 ANDROFERT
- 22. Control chart Monitor the stability or instability of a process ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 22 2015 ANDROFERT
- 23. 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 ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 23 2015 ANDROFERT
- 24. Histogram ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 24 2015 ANDROFERT
- 25. Flow chart Visualize a process and idenEfy improvement opportuniEes ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 25 2015 ANDROFERT
- 26. 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 ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 26 2015 ANDROFERT
- 27. PDCA Method to monitor, correct and improve a process ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 27 2015 ANDROFERT
- 28. 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 ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 28 2015 ANDROFERT
- 29. 6 Sigma Provides a general map that helps to reduce variability ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 29 2015 ANDROFERT
- 30. 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 ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 30 2015 ANDROFERT
- 31. ISO 9001 Certification since 2010 BSI; British Standards Institution ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 31 2015 ANDROFERT
- 32. 0 5 10 15 20 25 Total number of doctors associated to the IVF program Market share ISO 9001 ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 32 2015 ANDROFERT
- 33. 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 ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 33 2015 ANDROFERT
- 34. 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 ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 34 2015 ANDROFERT
- 35. 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 ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 35 2015 ANDROFERT
- 36. ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 36 2015 ANDROFERT
- 37. 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