Nonconformity management is undoubtedly one of the most important aspects of any quality management system (QMS). This is because it is through this process that we address problems, increase customer satisfaction, and even identify, implement, and standardize improvements!
On the other hand, managing nonconformities is not easy, especially in newer and less mature QMSs. The number of nonconformities (NCs) tends to be high, and even a few occurrences can involve many responsible parties. Additionally, these actions are usually “scattered” throughout the company, which complicates matters further.
These and other difficulties often put the process at risk, leading to delays and even leaving some nonconformities untreated. This is extremely complex, as it can jeopardize your certification and cause the NCs to continue negatively affecting the company and its stakeholders.
Therefore, in today’s article, we will talk a little about the nonconformity management process and how to execute it correctly. Keeping NCs up to date is undoubtedly one of the actions that will bring the most results to your company! That said, let’s get to the content!
Steps of Nonconformity Management
The first and most important step is to thoroughly understand your handling process; only then will you be able to view management systematically. This way, you can act both centrally on specific stages and on the process as a whole.
Let’s look at the main stages of a good nonconformity handling process:
- Identification of Nonconformity: An NC can be detected in various ways; however, the main ones are internal and external audits. Additionally, they can arise from inspections, customer feedback, and even daily observations. At this stage, it is necessary to train people to correctly record the occurrence, ensuring it will be handled by the system. Here, the registration must be as detailed as possible (including, for example, problem description, date, location, people involved, etc.).
- Investigation of Root Cause: After registration, the root cause of the occurrence needs to be identified, the factor that led to its incidence. For this, use tools such as the Ishikawa Diagram (fishbone), 5 Whys analysis, or FMEA (Failure Mode and Effects Analysis), among others. This stage may involve further data collection and will be crucial for defining the action plan.
- Determination of Corrective Action: First and foremost, it is necessary to define how to eliminate the causes of the NC. To do this, develop an action plan that will directly depend on the occurrence and its context. Thus, it may include the possibility of altering procedures, retraining employees, replacing inputs and raw materials, and a wide range of possibilities.
- Execution of the Action Plan: Once the corrective action is planned, we move to the execution of the plan. Here, each responsible party will carry out the actions according to the plan, respecting deadlines and the established order.
- Effectiveness Verification: After executing the action plan, it is necessary to monitor the treated NC. Here, it is evaluated whether the corrective actions were effective and if the nonconformity was truly eliminated. If the root cause is not corrected, the occurrence will most likely happen again (recurrence) and the problem will reoccur.
- Standardization of Best Practices: If everything goes well and the handling is successful, we standardize the new ways of executing and the actions in the process, as well as applying the learning (if possible) to other processes in the company.
As mentioned, these are the basic steps. Depending on your company’s context, other steps may be necessary, such as possible preventive actions or even separating the identification and registration stages. Evaluate your process and understand how to best meet it.
How to Manage Nonconformity Handling
Basically, managing this process means being able to see the workflow in an agile and holistic manner.
Having good management tools will help a lot. Ideally, you should have quality management software. This tool is organized to standardize and control the flow, which makes it much easier. However, it is possible to do this in spreadsheets, organizing the process so that you can see each occurrence and its stages.
In addition, some factors can strengthen your process and its management. Let’s look at them:
Definition of Responsibilities
The biggest factor leading to non-treatment of NCs is the lack of definition of responsibilities. When designing your process, it must be very clear who is responsible for each activity. This will ensure that people are attentive to NCs and, therefore, that they are addressed.
Similarly, when defining the action plan, each activity needs to have an owner, a responsible party, which will help you understand the current state of the occurrence’s handling and hold people accountable for their actions. It is worth remembering that the same needs to happen for the effectiveness analysis.
Records and Documented Information
Effective nonconformity management requires many records to be generated. First, this will demonstrate conformity in audits, facilitating the maintenance of possible certifications and ensuring evidence. Second, and more importantly, these records will help understand the handling and analyze it in case of failure, as well as provide even more insights for improvement.
Finally, remember that nonconformity management is an essential topic in Critical Analysis meetings. Therefore, having good records and an updated status of each occurrence, as well as the overall panorama, will be extremely useful!
Nonconformity Management: Navigating Towards Good Results!
In a simple metaphor, imagine your company as a large ship in the ocean (market). We can say that nonconformity management is like the crew that identifies and repairs leaks and mechanical problems. Each NC is a hole in the hull (which can be small or large, depending on the context), and if it is not addressed, it can compromise the integrity of the ship and flood everything!
Only with well-executed nonconformity management can the ship sail safely, ensuring customer satisfaction and everyone’s safety. In other words, only with good management can you guarantee good results for all stakeholders. Based on the steps described here, you are ready to captain your handling process and solve all the problems in your company!
