Strengthen the quality management system with risk-based corrective actions to demonstrate compliance with ISO 9001:2015
Corrective actions follow a specific set of steps that are designed to improve the overall quality management system. This involves eliminating process deviations and preventing the recurrence of causes. They are implemented to identify, solve and prevent problems in case of quality deviations.
Corrective and preventive actions (CAPA) and ISO 9001:2015, used to be separate action plans, each with its own requirements. Combined in a CAPA report, they outline the plans for how the existing problem can be solved immediately and how it can be avoided in the future. However, the latest ISO 9001:2015 standards make pre-defined procedures for preventive measures superfluous. Instead, they emphasize the importance of a risk-based approach throughout the process, rather than "preventive measures" being carried out and documented separately.
In this Quality Manager's Guide we describe in 5 steps how corrective actions that comply with ISO 9001:2015 can be implemented using compliance software.
Not every problem justifies corrective action. The purpose of a corrective action plan is to identify and resolve problems that threaten a company's QMS. Quality managers and their teams select an appropriate risk analysis technique to determine the severity of a QM non-conformity and decide whether corrective action is required. The most commonly used approaches are FMEA and HAZOP.
It is a good way to initiate risk management at the very beginning of the process. The level of risk and the impact that a problem will have on the organization, product or services are determined. Once a corrective action is deemed necessary, the quality team and process owners can work together and use an ISO 9001:2015 compliant corrective action report template to document the progress of their plan.
Root cause analysis is a methodical approach to identify the cause of systematic problems and to solve them. It is based on the assumption that problems are best solved by removing the root causes rather than just treating the apparent symptom. Root cause analysis is best used for problems that cannot be solved quickly, are repetitive and systematic.
ISO 9001:2015 strongly recommends that cross-functional team members and leaders be involved throughout the planning of corrective actions. Quality teams can promote this by using software to facilitate collaboration, even if they are located in different locations. The 5 Why method and 8 Disciplines of Problem Solving (8D) are good techniques for root cause analysis. They help to jointly develop a good problem statement, identify the causes and brainstorm on appropriate solutions to the problems to be solved.
Identifying causes and their effects helps to formulate the most appropriate corrective measures. A corrective action plan always includes two main actions: a "corrective" recommendation, the nonconformity identified and the corrective action.
In addition to the non-compliance and the recommended corrective action, specific details should be provided, such as the implementation schedule, key persons, signatories and costs. Once the digital plan for corrective action has been completed and reviewed, it can be distributed to key people to standardize the information.
Increased commitment of managers, helps to communicate the change and the reasons for implementing the corrective actions correctly. Notify key people about the QMS software and the assigned tasks. Provide a communication channel through which everyone can provide regular feedback during the implementation of the corrective action. All these factors are crucial to the success of implementing a corrective action plan.
IS0 9001:2015 insists that companies review the effectiveness of their corrective actions and update the level of risk and potential opportunities. After installation, process owners and the quality team should wait an appropriate period of time and perform follow-up audits.
Additional areas in the digital corrective action plan as a template are available to allow quality managers to enter comments during the review. Various functions of the QMS software can be used to document the results, such as attaching photos and notes to more clearly demonstrate the impact of the implemented corrective actions.
To integrate a corrective action plan as a template that is compliant with ISO 9001:2015, quality managers can use collaborative compliance software such as Lumiform. Digital technology allows them to manage implementation from root cause analysis to reviewing the effectiveness of corrective action plans.
An 8D report template is used to document an understandable root-cause inspection based on the 8 Disciplines of Problem-Solving. See template
This FMEA template intends to recognise and document potential problems in FMEA (Failure Mode and Effects Analysis ). See template