The next step in the process is to create a robust QCP. QC information from the manufacturer will indicate what the manufacturer has already put in place to address quality requirements. Some sources of error may be detected by the measuring device and be corrected automatically. Other sources of error may need to be addressed by the laboratory.
It is important to recognize that statistical QC is often necessary to help monitor risk in the analytical phase of the testing process. The QCP should include both statistical and non-statistical elements to cover all the potential risks of error.
After identifying and assessing potential failures, add all necessary actions to the QCP that will reduce the possibility of failure. For any risk that needs to be mitigated, specific steps should be documented in the QCP. The outlined steps should be appropriate and realistic as opposed to all inclusive of any QC steps that may be appropriate for the process/method.
A carefully chosen, strong action is more effective in reducing errors than a weaker action. Examples of strong actions include:
- Automating processes, if possible
- Standardizing procedures and equipment
- Smoothing out workflow by eliminating batch testing
- Interfacing instruments with the LIS
Examples of weaker actions include:
- Telling employees to be more careful
- Retraining, especially without periodic monitoring
- Sending memos or e-mails to point out bad behavior
