Corrective Action Request (CAR)
A Corrective Action Request (CAR) is a way to resolve and document a systemic problem by describing the nonconformance and assigning it to a person or team that will work to immediately contain the problem, complete a root cause analysis and implement a remedial action. The ultimate goal is to prevent future recurrence of nonconformances found within a product, process, or service.
STAGES
Here is a predefined set of stages that needs to be followed for each CAR. The Quality Systems Manager (QSM), supported by the leadership or executive team, is responsible for predefining the time required to complete each stage.
Identify and document the problem or nonconformance
To truly help in containing and resolving the problem, the Creator must write a very detailed description of the problem. They must include all details such as what is wrong with the product, process or service, where and when the issue was discovered such as the specific area, department or customer, and how it is impacting the company, customer or the operations. At this stage, the problem should be classified as internal or external, and objective evidence such as images, samples and/or written documentation should be provided. External CARs are typically initiated based on customer feedback. Sometimes the customer can issue the CAR directly to the company. After submission, the QSM should approve this step to ensure that all the initial CAR requirements are met.
Identify an investigator and an auditor
The QSM will then review the CAR, assign a CAR number and a criticality level, confirm if containment is required, and assign it to an investigator or team to be held responsible. The need to contain the problem must be evaluated, since it will not always apply or be mandatory. The QSM will also assign a person to audit, verify and validate the corrective action after it has been implemented.
Contain the problem
If containment has been deemed necessary, it is important for the Investigator to act quickly and treat the situation with high urgency. Forms of containment can include the immediate segregation of stock, stopping the service or halting production while the root cause is being investigated. The Investigator should have enough authority to make such decisions or should immediately escalate the problem to someone with the right authority. The containment plan must ensure that the customer and/or the employees are fully secluded from the problem, especially if there is an environmental or safety concern. Containment is commonly required to be completed within 3 to 5 business days. A review and approval of the containment plan by the QSM is ideal to increase visibility and awareness.
Perform root cause analysis
There are many tools to help achieve effective root cause analysis such as 5 Whys, Pareto Charts and/or Fishbone Diagrams. Each company can define which tool(s) to use. Targeting the systemic issue will help to eliminate the problem, improve the reliability, and in some cases the safety of the product, process or service. In addition, finding the underlying cause and addressing it directly is important to prevent the problem from taking place again. It is the Investigator or designee’s responsibility to perform the root cause analysis.
Implement a long term remedial corrective action
Once the root cause has been identified, it is time to put the corrective action in place. Depending on the severity and criticality of the problem, some companies may want to launch a Kaizen project to further improve the process. (See the Kaizen Compendium provided by Regrello to learn more about it). Once the process has been changed, it is important to update policies, work instructions, guides or standard operations procedures to fully document the change and prevent recurrence. Employee training on the new process may be required and must be taken into consideration. The corrective action is commonly required to be completed within 30 to 60 days from notification date.
Verify the corrective action
In order to close the CAR, the auditor will need to verify and validate the implemented solution. The auditor should ensure that any existing documentation has been updated and fully coincides with the new process. Documenting supporting evidence of the verification of the new process is a good practice.
Capture and share lessons learned and metrics
Very often, other areas, departments or sites could potentially have the same or similar problem, and it is very valuable to share the findings with them. In addition to sharing the lessons learned, metrics should be captured and shared with the leadership or executive team. It is the responsibility of the QSM to capture and publish CAR metrics.
Check for effectiveness
After a specific period of time, commonly 3 to 6 months, or as specified by the company, the QSM should assign a follow up verification to an auditor to prove the effectiveness of the corrective action. It is recommended, one more time during this stage, to document supporting evidence of the process or service observed and/or the product samples.
Re-open CAR
This last and undesirable stage should only be completed if the final verification of the CAR failed, and the solution was not effective. For instance, if customer complaints continue to happen or if defects are observed on the product again. At this point, the QSM should re-open the CAR or create a new CAR and start the process again.
WHY USE THIS PROCESS
Implementing an effective CAR process is essential to the success of the business, since it empowers the company and teams to take ownership of the problems and implement solutions that will eliminate future and repetitive unwanted results. By following a predefined set of steps, having the ability to monitor the progress and centralizing documentation, this problem solving process will aid in the road to achieve a solid and robust quality management system. In addition to being able to assign CARs to the organization's internal departments, including but not limited to production, warehouse, administration, supply chain, facilities, maintenance or safety, a CAR can also be assigned to external collaborators and business partners such as suppliers.
Many certifications, such as ISO 9001, also require companies to have a corrective action process in place that is followed in detail and thoroughly. When incorrectly implemented, this process can easily become unproductive and ineffective. It is important to avoid inefficiencies and redundancy within the process to prevent it from becoming bureaucratic, and it is critical to have the correct methods of communication.
Nonconformance in products, processes and/or services can lead to unhappy and unsatisfied customers; therefore, it is crucial for the success of the business to ensure that they can contain, resolve and prevent problems timely and effectively. Failure to do so could cost the company large amounts of money in returns or refunds, or temporary loss of sales and revenue. Most undesirable, it can damage important business relationships and lead to a total loss of customer loyalty.
WHO SHOULD USE THIS PROCESS
This collaborative problem solving approach is widely used across in-house or contract manufacturers, but it can also be applied by any type and size of company that is making, receiving, and/or delivering a product, process, or service. Primarily owned by the Quality Department, the CAR process procedure must be consented and supported by the company leadership or executive team.