An IQCP will generally be created for those tests where the manufacturers' built in/procedural/electronic assessments will be used for daily QC. However, there are other reasons why a laboratory may consider developing a quality control plan based on risk assessment. Any of the following may prompt the assessment and mitigation of risk for a testing process:
- Complaints from patients and clients
- Incident reports
- Deficiencies cited by accreditation or governmental inspections (external assessments)
- Failed proficiency testing
If the test system has built-in (integrated) controls, they may not sufficiently address all the risks that are part of the total testing process. It is important to consult the manufacturer's product insert to determine what risk mitigation actions have been taken and what risks still needs to be assessed by the laboratory. For example, preanalytical risks, such as patient identification or introduction of the sample into the testing device are risks that may still need to be assessed.