NCEs of External Origin

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NCEs of External Origin

How do we know when a problem or non-conformity has occurred? The identification of NCEs may come from several places, both within (internal) and outside (external) the laboratory. One obvious identification can result from a complaint from your clients/providers. These occurrences almost always initiate the corrective action process.
So what exactly constitutes a “complaint?” According to the Food and Drug Administration (FDA), "any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, reliability, safety, or effectiveness of a product or service after it is released for distribution."3
This is an example of an external source of quality data. It is information the laboratory obtains from outside of the organization or department.
Other external sources of data that trigger investigation include:
  • Complaints
  • Adverse events
  • Regular customer feedback (questionnaires)
  • 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.
3. Food and Drug Administration (FDA). "Code of Federal Regulations Title 21, part 820 Quality System Regulation, subpart A General Provisions, section 820.3 Definitions.", 2021, Accessed October 6, 2021.