1. Determine if the situation calls for corrective action.
Not every issue warrants a corrective action. The purpose of issuing a corrective action plan is to identify and resolve problems that are systemic, something that endangers a company’s QMS.
Quality managers and their teams can choose an appropriate risk analysis technique to determine the severity of a non-conformity and decide if a corrective action is needed. The most frequently used approaches are FMEA and HAZOP. This is a good way to inculcate risk management right at the start of the process and help qualify the level of risk and impact an issue brings to the organization, product, and/or services.
Once a corrective action is deemed necessary, the quality team and process owners can collaborate and use an ISO 9001:2015 - compliant corrective action report template to document their plan’s progress.