Corrective Action

• How is corrective action defined by ISO 9001:2015?
• How do companies create a corrective action process for their organizations?
• What are some common auditing questions related to corrective action plans?

What is A Corrective Action?

Corrective actions (Clause 10.2) are designated steps organizations use to improve quality management by eliminating process nonconformities and preventing recurrences of their root causes. When a nonconformity is identified, the responsible organization is required to rectify the situation and to investigate the root cause of the deficiency. Proper identification of the root cause prevents nonconformity recurrence. Corrective action aims to support continual improvement and eliminate undesirable effects of tasks, processes, products, or even human behaviors. The corrective action process can be implemented wherever needed, even entire projects or departments, when deliverables deviate from the required output.

In the previous versions of ISO 9001, corrective action and preventive action have been required to be separate with their own set of requirements. ISO 9001:2015 eliminates the need for predefined preventive action plans, but instead calls for corrective action to be implemented using a risk-based approach. Risk-based integration encourages involvement from all levels of business management in the process of identifying, removing, mitigating and recording risk. The support of information from upper to lower management ensures the removal and mitigation of overall risk and the effectiveness of the quality system. Each quality system is to contain a general corrective action plan that details a standard way to address deficiencies. The corrective action plan aids in the creation and implementation of the corrective action process. 

How Do I Create a Corrective Action Process for My Organization?

The corrective action process is intended to support continual improvement of the overall quality system. The details of the plan should be documented as specifically as possible, which will vary based on the scope of the problem. Through documentation, the plan should clearly identify the root problem and the intended steps to fix it. There are a multitude of resources to aid in developing a corrective action plan, including specific softwares and guidelines, but they all seem to follow the same general flow outlined below.

Define the problem

In general, a nonconformity is any failure to meet a requirement, so not all identified nonconformities warrant corrective action. A pertinent evaluation should determine if similar nonconformities exist or could potentially occur, indicating the nature of the identified requirement failure. Understanding the magnitude and extent of the issue includes defining the scope. The scope should include all affected outputs: types of products, production areas, documentation, etc. 

Identifying the root cause

As previously addressed, properly identifying the root cause prevents recurrence, which is the purpose of implementing corrective action. Using the information gathered to define the problem, root cause analysis uses a variety of problem-solving methods to identify underlying issues. Once this stage is complete, the scope should be reevaluated to ensure that documentation has accounted for the entirety of the scope. 

Containment Actions

Containment actions are interim measures to mitigate the situation before a more comprehensive and long-term solution is implemented. Based on the nature of the problem, these actions can entail a variety of measures intended to prevent progression of the problem and catch the problem again if it recurs.

Plan and Execute

The corrective action plan should outline and document the intended steps to eliminate the root cause. This includes clear validation criteria and techniques for the end results, as well as for different stages throughout the process as needed. Documenting this plan as detailed as possible to ensure the effectiveness of the plan, including team member roles and responsibilities, general timelines, and budgets. 

Follow-up 

Evaluate the situation over a suitable amount of time to ensure the problem does not reoccur. Details of this stage are often subjective and general, but documentation and final analysis will confirm that the root cause has been eliminated (10.2.1 e): update risks and opportunities determined during planning, if necessary). 

Common Auditing Questions About Corrective Action

Some common auditing concerns related to corrective action plans are identified below. 

What should organizations do after a corrective action has been identified?

Effective root cause analysis is essential to actually fixing the problem. The investigation process should be sufficiently documented, including concrete details of overall nonconformity. Once a corrective action plan has been created, it’s important that organizations assess the risks and opportunities related to the introduction of that plan. Secondly, organizations should account for cost and any time considerations that would impact the implementation of the planned changes. Finally, after implementation of the corrective action, organizations should take the time necessary to verify the effectiveness of the corrective action plan. The entire corrective action process is important to addressing and preventing operational issues, and auditors will look for documentation of all parts of this process.

What is the timeline of the corrective action process?

This will depend on the corrective action plan. Make sure to identify the deadlines of the various stages and the general priority level of implementing the steps. Realistic timelines for completion ensure appropriate progress without rushing through the process.

Who is responsible for carrying out corrective action within the organization?

There may be multiple personnel involved in implementing corrective action plans. Outline the roles of the team members involved in completing each step. Identify who is responsible for the overall completion, monitoring progress, and verifying effectiveness.

How can effectiveness be verified?

If you are having difficulty defining the effectiveness of your corrective action plan, it could be the result of:

• A poorly-defined issue
• A failure to determine the root cause
• Overthinking a simple solution
• A failure to identify a single issue as a priority for correction

The verification procedures should be documented with specific acceptance criteria. Verification should be upon completion of the corrective action process as well as during various stages throughout as needed. This kind of verification can be conducted in a variety of ways, some of which are listed below:

• Audit
• Service record analysis
• Customer surveys/feedback
• Spot checks
• Employee interviews
• Sampling
• Formal monitoring/assessments
• Product reviews
• Procedure reviews
• Trend analysis
• Training record reviews