title: Analysis of non-conformity in continuous quality improvement in a Hospital Radiopharmacy Unit.
abstract: OBJECTIVE
  To perform an analysis of non-conformities (NC) registered between 2012 and 2015, as a part of the review process of the Quality Management System of our Radiopharmacy Unit.
  
  
  METHODS
  Non-conformities registered in the Radiopharmacy Unit in the period 2012-2015 are analyzed and sorted by their impact on the process (critical, major, and minor), cause/origin of the non-conformity, and nature of radiopharmaceutical (PET vs. SPECT).
  
  
  RESULTS
  A decrease in the NC of 20% per year is observed, especially in PET radiopharmaceuticals. Non-conformities in SPECT make up about 62-84% of the total of the NC, mainly related to the high number of doses prepared and not administered, which is about 1.5-3% in the ratio of non-administered/administered per year.
  
  
  CONCLUSIONS
  Analysis of the NC can be considered as a useful indicator in assessment of quality assurance, and in our particular case, the decrease in the registration of NC indicates effectiveness in the corrective and preventive actions implemented.
authors.affiliation: Unidad de Radiofarmacia, Hospital General Universitario Santa Lucía, Cartagena, Murcia, Spain. Electronic address: mteresa.martinez5@carm.es.
authors.forename: T
authors.initials: T
authors.lastname: Martinez
authors.affiliation: Servicio de Medicina Nuclear, Hospital General Universitario Santa Lucía, Cartagena, Murcia, Spain.
authors.forename: J F
authors.initials: JF
authors.lastname: Contreras
mesh_terms: D004363:Drug Utilization; D019983:Guideline Adherence; D009684:Nuclear Medicine Department, Hospital / Q000458:organization & administration / Q000592:standards; D010607:Pharmacy Service, Hospital / Q000458:organization & administration / Q000592:standards; D049268:Positron-Emission Tomography; D019275:Radiopharmaceuticals / Q000008:administration & dosage; D013030:Spain; D015899:Tomography, Emission-Computed, Single-Photon; D017749:Total Quality Management / Q000331:legislation & jurisprudence; D057188:Workflow
chemical_list: D019275:Radiopharmaceuticals
keywords: Acciones correctivas y preventivas; Corrective and preventive actions; No conformidad; Non-conformity; Quality Management System; Quality assurance; Radiofarmacia; Radiopharmacy; Sistema de gestión de calidad