Sometimes, you need to do more than just create a corrective action in response to a problem. You may need to look more carefully at the mismatch between the operational process and the way it says it should be done in the compliance manual. This is where the concept of the non-conformity is useful. You may need to carry out a root cause analysis of the problem before creating any corrective or preventative actions. Once the actions have been carried out, someone should verify their effectiveness before making any changes to your processes.
Plio lets you record any non-conformities which arise in your business. You can allocate these to a department and link them to the appropriate compliance standards and to your corrective actions and preventative actions. Non-conformities can be managed according to pre-determined workflows. Depending on the magnitude of the non-conformity, this might need to be a simple, quick type of workflow, or a more structured type of workflow which allows for deeper analysis (see diagram below).
Just as in other Plio modules, Plio’s non-conformity manager automatically links in any corrective actions that people create. You can also create improvement plans for any of your non-conformities, and record lessons learned. Non-conformities can be viewed by magnitude, by status or by department. All of the information you need relating to a specific non-conformity is now accessible quickly, all in one place.
With these features, you can use Plio to implement a compliance improvement program, using the principles of continual improvement (or Kaizen). Plio meets the requirements of the ISO 9001:2015 quality management standard and also the new ISO 19600 international standard for compliance management.
When you want to create a nonconformities (or exceptions) report for your management team, Plio gives you a flexible data export facility. Select the data fields you wish to export, download the CSV file that Plio creates, open it up in Excel and create your custom report.