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The page below is a sample from the LabCE course The Basics of Non-Conforming Event Management for Clinical Laboratory Services. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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Examples of NCEs of External Origin

Let’s look at some other external sources of data that indicate a CAPA process may be started:

  • Complaints
  • Adverse events
  • Regular customer feedback (questionnaires)
  • Service calls to outreach offices
  • Deficiencies cited by inspectors from regulating and accrediting agencies
  • Proficiency Testing failures
  • Corrected reports
  • Peer group QC data comparisons
  • Manufacturer’s notifications of material recalls
Each of these types of information can help improve the quality of services when investigated more closely.
It is not always obvious, such as in the above situations, when to initiate a non-conformity report. The corrective action process does not have to be reserved for only those high-risk events. Any potential, problem-prone process in the laboratory can be an opportunity for improvement.