Many organizations, especially those involved in manufacturing, engineering, and production, must develop and adhere to strict standards to ensure the output of what they produce meets quality and safety expectations. Quality control guidelines take a considerable amount of forethought and planning. It’s an ongoing process that requires continual evaluation and adjustment to ensure processes run smoothly and output expectations are met. That’s why it’s important to quickly identify and systematically respond to issues that arise that may hinder the efficiency of processes or the quality and expectations of what is being produced.
Non-Conformance and NCRs
Non-conformance happens when there is a discrepancy between the output of a process and what is expected. For example, if a company is producing parts and 25% of those parts do not meet specifications, then a non-conformance has occurred and must be evaluated. Sometimes it can be the result of a minor mishap, or it may be a more impactful problem. Regardless, it’s important to keep track of and respond to non-conformances. Organizations that take quality control seriously will require that a nonconformance report (NCR) is created when problems or deviations from the standard arise. An NCR is simply a quality control document that includes (but is not limited to) a description of the problem, how the problem occurred, and possible solutions for preventing the issue in the future. Depending on the nature and complexity of the process, NCRs can be simple or complex, and are tailored to the needs and requirement of the organization. An NCR might contain the following information:
- A detailed description of the problem or incident and when it occurred.
- Whether the incident is believed to be minor or highly impactful.
- An explanation of why expectations were not met.
- A list of employees or departments associated with or impacted by the occurrence.
- Suggestions on what can be done to prevent the problem in the future.
- Details regarding what corrective actions were taken, or if further corrective action is needed.
The Importance of NCRs
Whether a nonconformity is perceived to be minor or highly impactful, it’s important to document and track occurrences. Minor incidences are often easily corrected, but if they continue over time, it might be an indication of a larger issue. Reporting nonconformities helps to keep a record of occurrences that may be useful in identifying more impactful problems.
It’s easy to see how NCRs can improve quality and safety. However, they provide other benefits that may not be directly observable. Addressing issues early and not repeating mistakes can improve efficiency and cost. Bottlenecks can be identified quickly and the cost of wasted or scrapped materials might be reduced. It can also help to meet regulatory obligations, especially those that require reporting when conformances are not met.
Managing NCRs
It’s important that NCRs are managed properly. Non-Conformance Boards are often established to examine and respond to nonconformances. These boards usually consist of various individuals from different areas of the company that work together to determine the impact of the non-conformance and find a solution. For example, if a product does not conform to standards, it would be left to the Non-Conformance board to determine if the product should be scrapped, reworked, repaired, regraded, or to simply left as is.
Corrective Action, Preventative Action, and CARs
As mentioned previously, non-conformances can vary from minor to highly impactful, and the solution to fix the problem might be simple or complex. Sometimes an NCR is enough to shed light on the problem and provide a solution. However, if the rate of non-conformance is high or the impacts are severe, corrective action may be necessary to provide a root cause analysis and make changes to the process. Additionally, it may be necessary to deploy measures that deter or prevent non-conformances from happening in the first place. These measures are known as preventative actions. Both corrective and preventive actions consist of a series of steps and actions taken to prevent the occurrence or reoccurrence of non-conformances. Many organizations combine corrective action and preventative action into a single term, known as CAPA (Corrective Action and Preventative Action), because they follow very similar procedures.
Corrective action is initiated via a CAR (Corrective Action Report). Like NCRs, organizations have their own CAR forms and protocols depending on the nature of their products and processes. To minimize the impacts of nonconformances and prevent future occurrences, CARs often aim to:
- Better understand the non-conformance to determine why it happened, who or what is responsible, and what is the root cause.
- Understand the severity of the issue and the impacts.
- Determine what actions should be taken.
- Create a plan of action to fix the problem and communicate and assign roles to necessary staff and stakeholders.
- Evaluate and track actions taken to determine if the plan is solving the problem or if further action is needed.
The Role of Document Control Software for NCR and CAR Management
Document control plays an important role in the creation, communication, and implementation of NCRs and CARs. Both NCRs and CARs are types of documentation that serve in reaching a desired outcome, in this case tracking non-conformances and ensuring that a corrective or preventative action is taken. Like quality control processes, the processes for submitting and following through with NCRs and CARs can be challenging because it involves multiple steps and requires input and action from various people. Document Control Software can help by automating tasks, facilitating proper communication and approvals, organizing documents so they properly stored and easily accessible, and more.
Document Control Features for NCR and CAR Management
NCR and CAR File Storage and Organization
At a fundamental level, a document control system provides a way to store and manage NCR and CAR files in a central location and allows for organizational standards to be set. Files stored on paper, or on a shared file drive, are at risk of mismanagement, data loss, security breaches, and general confusion. A document control system enforces file management and storage practices that can be determined in advance. Certain actions can be automated to ensure files are named and stored properly. For example, the system can automatically generate an NCR number and append that number to the file name, without relying on users to take that action.
NCR and CAR Templates
NCRs and CARs are typically structured based on the needs and requirements of the organization and its processes. NCR and CAR forms are created to collect necessary information to make determinations and take appropriate actions. Whether it’s a Word document, a form fillable PDF, or any other type of file format, the document itself must be accessible and formatted in a way that makes it easy for people to understand what information they must provide. Document Control Software allows an organization to provide staff with ready to use templates that are stored in a central location. It is often the case that NCR and CAR forms require information from multiple people or departments. With document control software, a form can be initiated from a template, then passed on to the appropriate team members or departments via automated workflows until all sections of the form are complete.
Metadata
When an NCR or CAR is created, metadata values can be applied to the document. These are profile and property values that are associated with the file, making them easier to organize, store, and locate. Some values, such as “NCR number” or “date reported”, may be added automatically or manually when the document is created, while other values, such as “incident date”, can be pulled from the document itself after that information has been provided in the report. Metadata values allow NCR and CAR files to be properly categorized and easily searchable inside the document control system. They also make it easier to generate reports, giving users insights they normally might not have.
Document Routing and Workflow
It is often the case that NCR and CAR documents must be filled out and examined by multiple people and tasks must be allocated and acted upon. Without the aid of a document control system, this process is manual and typically relies on email or assigning employees to manage the process. This is cumbersome and comes with many pitfalls. Multiple copies of the same NCR or CAR file are created, and as they are passed along to various stakeholders it becomes difficult to know where the latest version of the document is located and at what stage the process is in. A document control system with workflow capabilities can automate the routing of NCR and CAR files to ensure the process is streamlined. Certain tasks, such as appending the NCR number to the filename or transitioning from NCR to CAR can be automated by the system when input or actions is taken by users. For example, a quality management representative (QMR) may determine that an NCR needs to be escalated to a CAR so further analysis and corrective action can be taken. The QMR can input this decision into the system, which kicks of a workflow that automatically creates the new CAR template and initiates the process. Relevant values from the NCR are automatically inserted into the CAR and tasks are assigned to individuals who are automatically notified of the transition. Throughout the process, the file remains in a central location and automated workflow steps ensure the process is orderly.
NCR and CAR Reporting
NCR and CAR processes that are automated and controlled via a document control system allow for powerful reporting capabilities that provide information that would not be available with manual methods. Metadata values allow the system to track and record properties of the NRC and CAR files and organize this information into meaningful insights that can be displayed in reports. For example, a CAR Pareto Analysis report could be generated illustrating which departments have the most CARs and how that compares to other departments. Reports from the system can be exported to Excel or other formats and provided to auditors or staff in charge of efficiency and improvement.
