QMS 9001 Corrective Actions

by avinash v

What is Corrective Action?

Corrective action is the process of identifying the cause of a nonconformity and taking steps to prevent it from reoccurring. In a quality management system (QMS), corrective action is one of the key components of the plan-do-check-act (PDCA) cycle. The purpose of corrective action is to ensure that the organisation identifies and eliminates the root cause of quality issues, rather than simply addressing the symptoms. This helps to improve overall quality and consistency in products and services, while reducing waste and rework.

There are several steps involved in taking corrective action, including:

  1. Identifying the problem or nonconformity
  2. Investigating the root cause of the problem
  3. Taking corrective action to prevent the problem from occurring again
  4. Evaluating the effectiveness of the corrective action
  5. Communicating the results of the corrective action.

When an organisation identifies a problem with a product, service, or process, corrective action is used to eliminate the cause and prevent a recurrence. The goal of corrective action is to make the problem go away so that it doesn’t cause any more problems down the line. It’s important to remember that corrective action isn’t just about fixing things that are broken—it’s also about preventing problems from happening in the first place.

There are 2 Types of Corrective Action:

  • Preventive action – anticipates potential problems and puts measures in place to avoid them before they happen
  • Corrective action – addresses existing problems and takes steps to prevent them from happening again in the future

    Preventive actions are typically taken as part of an organisation's continual improvement activities. Corrective actions, on the other hand, are typically taken in response to an incident or identified problem.

    Corrective Actions Template

    Why Do The Recent ISO Standards Require Corrective Action?

    ISO, the International Organisation for Standardisation, creates international standards for various areas of business. Recently, they updated their auditing standard to include a requirement for corrective action. This change has been made in response to findings that many organisations do not adequately address non-conformance when they arise.

    In order to comply with the new standard, organisations will need to put systems in place to ensure that all non-conformance are properly documented, tracked, and corrected. This can be a challenge for many organisation.

    Implementing a corrective action system can help your organisation to meet this new requirement. Corrective action provides a centralised location for storing and tracking all information related to non-conformance. This information can then be used to generate reports that show the status of corrective actions and their effectiveness.

    How Do the Corrective Actions Work in ISO 9001?

    In order to maintain compliance with ISO 9001, corrective actions must be taken when non-conformities are discovered. This process can seem a bit confusing, so let's take a closer look at what happens during a corrective action. Non-conformities can arise from any number of sources: customer complaints, audits, process measurements, and more. When one is identified, the organization's quality management system will be used to determine the root cause of the issue. This root cause is then addressed with specific corrective actions.
    There are four main steps in a corrective action:

    1. Identification of the non-conformity
    2. Investigation of the root cause
    3. Implementation of corrective actions
    4. Review of the effectiveness of the corrective actions taken.

    STEP – 1:

    Identification of the non-conformity - In order to identify and correct non-conformities, QMS9001 requires an organisation to establish and implement a procedure for the identification and reporting of any deviation from the specified requirements. A key part of this process is the identification of who within the organization is responsible for conducting this assessment and ensuring corrective action is taken. Additionally, QMS9001 requires that any non-conformity be investigated, and corrective action taken to prevent its recurrence.
    The focus of this process is on the evaluation, analysis and prevention of potential losses associated with non-conformity.

    STEP – 2:

    Investigation of the root cause - The investigation of the root cause is one of the most important aspects of the quality management system 9001. By understanding the root cause of any issue, it becomes possible to take corrective and preventive actions that will help to prevent that issue from arising again. The investigation of the root cause typically involves a process of troubleshooting in which potential causes are identified and eliminated until the root cause is identified. This can be a difficult process, but it is essential for ensuring that quality issues are corrected permanently.

    STEP – 3:

    Implementation of corrective actions - QMS 9001 is all about continuous improvement. As an organization identifies areas in which it can improve, it implements corrective actions to address those areas. Corrective actions are meant to fix the problem so that it does not happen again. They are typically taken after an organization has conducted a process audit and found deviations from the standard.
    There are three steps in the process of implementing corrective actions:

    1. Determining the root cause of the problem
    2. Developing a plan to address the root cause
    3. Implementing the plan and monitoring its effectiveness.

    STEP – 4:

    Review of the effectiveness of the corrective actions taken - Quality management system (QMS) 9001 is a set of guidelines that provides a framework for organizations to follow when they are designing, implementing, and improving their quality management systems. QMS9001 is designed to help organizations improve the effectiveness and efficiency of their quality management systems, with the goal of achieving continuous improvement in organizational performance. In order to achieve this goal, it is important for organizations to review the corrective actions taken as part of their QMS9001 implementation and determine whether they were effective in addressing the identified quality issue(s).

    Corrective Actions Template

    The Benefits of Corrective Actions in QMS 9001

    A quality management system (QMS) use to improve the quality of their products and services. A QMS helps organisations control their processes and products, measure performance, and take corrective actions when necessary. There are many benefits of corrective actions in a QMS 9001:

    1. They help ensure compliance with regulatory requirements.
    2. They improve the quality of products and services.
    3. They improve communication and collaboration within an organisation.
    4. They help identify and correct problems early, before they cause significant damage.
    5. They help reduce costs by preventing or correcting problems before they occur.
    6. They improve customer satisfaction by ensuring that products and services meet their expectations.
    7. They help ensure that all employees are aware of quality issues and are working to address them.