Common mistakes about CAPA, corrective and preventive actions

In working with medical device and biopharma companies, I have gathered common mistakes about CAPA reporting:
  • not identifying other systemic issues
  • not documenting what was identified as not a contributor after testing each probable contributing causes
  • not identifying effectiveness checks
  • not monitoring (may use spreadsheet to document meeting minutes,updates ,records,files)
  • not all audit results that needs improvements needs to have a CAPA
  • not looking at trends from archive data for measurements,KPIs,test results,other quality data
  • not segragating and isolating defectives
  • no training for those who writes CAPA reports
  • no open communication to all parties and outside customers involved in the process
  • inadequate plan or forms, to document trace to complaints and other sources of deviations/variations/customer dissatisfaction

See Archiving SPC-related Data using Infinity QS Database Manager

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