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  

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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  

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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        

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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

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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)  

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Customers  are  not  only  our  paEents…  

•   Doctors  who  use  our  services  •   Our  employees  •   Suppliers  •   People  in  our  community  •   Regulatory  authoriEes    

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ISO  9001:  Conceptual  Model  

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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

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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  

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Quality  management  is  not  only  quality  control  in  the  lab  

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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  

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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  

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Quality  manager  is  essenEal  

A  powerful  “wedge”  

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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  

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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  To

ols  

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How  to  measure  &  analyze  Pareto  diagram  Diagram  of  cause  and  effect  Control  chart  Histogram  Flowchart  

Qua

lity  

Tools  

PDCA  Balanced  score  card  (BSC)  Six  sigma  Q

uality  

Metho

ds  

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Pareto  diagram  Priori,ze  problems  to  be  solved  

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                       Diagram  of  cause  and  effect  Priori,ze  factors  that  may  cause  undesired  effect  

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Control  chart      Monitor  the  stability  or  instability  of  a  process  

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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  

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Histogram  

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                                                     Flow  chart      Visualize  a  process  and  idenEfy  improvement  

opportuniEes  

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How  to  measure  &  analyze  Pareto  diagram  Diagram  of  cause  and  effect  Control  chart  Histogram  Flowchart  

Qua

lity  

Tools  

PDCA  Balanced  score  card  (BSC)  Six  sigma  Q

uality  

Metho

ds  

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PDCA    Method  to  monitor,  correct  and  improve  a  process  

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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  

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                                                             6  Sigma    Provides  a  general  map  that  helps  to  reduce  

variability  

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         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  

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ISO 9001 Certification since 2010 BSI; British Standards Institution

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0 5

10 15 20 25

Total  number  of  doctors  associated  to  the  IVF  program  

Market  share  

ISO  9001  

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0 2 4 6 8

10 12 14 16 18 20

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

Perc

ent g

row

th p

er y

ear

Year

IVF Program

Profitability  

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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  

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         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    

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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