Debunking the Fear of Corrective and Preventive Actions
The Communicator: Volume 5, Issue 12, December 2024
Hello and welcome to the second month of the Accreditation Corner. If you missed last month’s, it was a big one as we announced and congratulated the first NPDN Core Accredited lab, Michigan Department of Agriculture and Rural Development! In today’s edition, we are hoping to debunk the fears of noncompliance, corrective action, and preventive action by fully explaining these terms with examples and two short YouTube videos. But first, congratulations to University of Florida for applying for Core Accreditation in November!
Now, onto some spicy and often feared terms in accreditation. Each lab’s development of a quality management system that meets the requirements of the Core Standard demonstrates our commitment to excellence in plant diagnostics. Core Accreditation ensures NPDN labs will meet quality standards. In addition, quality management systems promote continuous improvement, and the Noncompliance and Corrective and Preventive Action sections of the Core Standard, are one example of continuous improvement. Please feel free to skip the text below and simply watch the YouTube videos linked in the text to get a quick and useful overview of these terms.
According to the Core Standard, Nonconformance is defined as: Any activity that does not meet the requirements set in the NPDN standards and NPDN/laboratory quality system documents. It is an issue discovered after it has happened. Corrective Action is defined as: The steps taken to reduce or eliminate the cause of an existing nonconformity or other undesirable situation. Corrective actions prevent recurrence of nonconformities. Preventive Action is defined as: Action taken to eliminate or prevent the cause of a potential nonconformity or other potentially undesirable situation.
You may still be wondering how to incorporate these terms and their definitions into your quality management system, which is fair, these are complex terms with complex implications. However, their implementation can be simple. Essentially, a nonconformance is a red flag indicating something has gone wrong in a process or that a product/service does not meet the intended criteria. Furthermore, this red flag indicates that Core Standard requirements were not met because procedures/protocols were not properly followed. Watch this brief 1 minute video for further explanation. Real life examples of nonconformances are a house catching on fire, forgetting your debit card in the ATM, your car running out of gas, etc. These are instances where something has gone wrong in a process or procedure. Hopefully none of these have happened to you, thanks to procedures in place to ensure compliance (smoke detectors and/or electrical regulations, alerts to collect your debit card, or low fuel notifications).
For instance, in NPDN labs, it is a requirement of the Core Standard to utilize quality controls to ensure molecular equipment is performing as intended. Sally in the ACME Diagnostic Clinic forgot to use quality controls and reported the results to the client which indicated that she did not detect the pathogen in the plant tissue. Her colleague Bill was surprised by these results because he thought the symptoms were strongly indicative of the specific pathogen. He looked at the results and recognized that Sally forgot to use a positive control. Therefore, the results are invalid, and the test needs to be re-run using appropriate quality controls. Unfortunately, Sally already reported the results to the client. This is a nonconformance because something has gone wrong with the process that resulted in invalid results being conveyed to the client.
Okay, I understand that is a nonconformance, what do we do about it? This is where Corrective Action comes in. View this brief 3.5min video about corrective and preventive actions that put these complex terms into regular life settings.
Back to our example. First, an initial correction occurs that fixes the immediate issue. In this case, the client must be contacted, and the PCR must be re-run using the appropriate quality controls (like putting out the fire in the video). Assuming the quality controls perform as expected, the results can be dictated to the client. The next step is the corrective action. This is the part where steps are taken to ensure this nonconformance (forgetting to use a positive control and contacting the client with invalid results) does not occur again. First, the root cause must be identified (like investigating the cause of the fire). The root cause(s) may be that (1) the positive control was not easily accessible and/or labeled and (2) the diagnostician simply forgot to use a quality control. Each would have different corrective actions. For the former, perhaps the corrective action is creating a better system for quality control storage, labelling, and usage to ensure they are easily accessible and identifiable. For number 2 above, perhaps the corrective action is requiring the inclusion of the quality control information when setting up the plate map and recording information for the PCR run. This would make it difficult to forget to include the quality control information when setting up the PCR run. Another corrective action is to also require the reporting of quality control results when reporting the sample results. In this case, the next time the diagnostician reports results to the client, they would have to report quality control results as well, and if there were none to report, this mistake/error would be caught before reporting it to the client. Implementing these corrective actions would likely result in changes to written procedures/protocols on PCR set up and reporting results/diagnoses to clients and would prevent this nonconformance from occurring again.
Preventive Actions are like Corrective Actions except the red flag is identified before the nonconformance has occurred and is a form of proactive management. In this case, Sally was just about to put the PCR plate on the PCR machine, when she realized she did not have a positive quality control. She rectified this by making more master mix and adding the positive control to the plate before running it. The quality controls performed as expected and she reported the results to the client. No nonconformance occurred. However, she recognized that she could have easily forgotten to add the positive control and considers the root cause of this potential occurrence and identifies and implements various preventive actions that may prevent this potential nonconformance from occurring in the future (essentially the same as the Corrective Actions listed above).
Quality management systems contain documents that describe reporting and recording a nonconformance, identifying the root cause and an appropriate corrective action, and implementing a monitoring plan. There are also people in the lab who are granted the authority to stop work and resume work when a nonconformance has occurred, and this designation must be identified in quality management system documents. Similarly, for preventive actions, the red flag is documented, the potential root cause and preventive action are identified, and a monitoring plan is implemented.
More information about the specific NPDN requirements related to these terms and sections are found in the Core Standard. If you have any questions, please reach out to the accreditation committee and/or the accreditation program manager.
