Corrective Actions

Strengthen the quality management system with risk-based corrective actions to demonstrate compliance with ISO 9001:2015

What is corrective action according to 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.




1. Determine whether the situation requires corrective action.


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.




2. Conduct a root cause analysis.


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.




3. Work as a team on the corrective action plan as a template.


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.




4. Communication and implementation of corrective actions.


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.




5. Carry out follow-up actions to ensure the effectiveness of the corrective action.


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.




Featured templates

HAZOP Template

HAZOP Template

Use this template to conduct HAZOP studies. With its help, you can identify potential hazards and functional errors at an early stage. See template

8D Report Template

8D Report Template

An 8D report template is used to document an understandable root-cause inspection based on the 8 Disciplines of Problem-Solving. See template

FMEA Template

FMEA Template

This template intends to recognise and document potential problems in FMEA. See template

ISO 9001:2015 Audit Checklist

ISO 9001:2015 Audit Checklist

Use this template to check your quality management system for compliance with ISO 9001:2015. See template

5 Whys Analysis Template

5 Whys Analysis Template

Use this template to identify the three-part cause of a problem in sales or marketing. See template

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