The different processes involving multiple roles like supplier, production, manufacturer, and pieces of equipment for designing or marketing a product will inevitably invite some non-conformance within the organization. A non-conformance occurs when a product or service, or process deviates from the industry specifications. Therefore, it is not surprising that product delivery is crucial when satisfying customer expectations, market trends, management profits, and compliance.  

With regular Non-Conformances (NC), the organization’s efficiency, product-process effectiveness, brand reputation, and company finances are questionable as customers’ health and safety can be adversely affected. So, when a non-conformance occurs, rather than seeing it as an issue, see it as an opportunity to fuel the continuous improvement of the product/processes using the findings. The key to opportunity lies in how well the investigation findings are documented and how well the non-conformance report is constructed.  

In this article, let us learn step-by-step instructions for writing an effective non-conformance report and its importance.  

Non-Conformance Report 

Non-Conformance Report is a document, in short NCR, outlines the details of the product failure in meeting the standards. The record holds information like how a non-conformance occurred, the investigation-analysis information, and how to deal with the non-conformance before determining the corrective action plan.  

It is essential to know that the Non-conformance report is to deal with the defects and correct the failure, if needed, to eliminate the cause of failure. It is not just to comply with the standards and regulations of the FDA (Food and Drug Administration), ISO (International Standards Organization).  

The Non-Conformance report must be complied with by the Quality Management team, the quality manager, or the head of quality, or other relevant positions of the quality management team.  

Step-by-step instructions to write an effective Non-Conformance Report (NCR) 

To write an effective Non-Conformance Report, follow the below-listed steps. 

Identify and Control the Non-Conformance 

The NCR starts with the identification of a product or process failure. A NC can occur at any stage in the manufacturing or production, or operation process. When identified, the description of the event should be made clear as it is the base for the investigation process. At times, the Non-conformance identification could be challenging as it leads to product recalls or CAPA (Corrective and Preventive Action), where more resources and costs are involved with the former. And, with CAPA, the complete process gets shut down until implementing corrective actions and preventive actions.  

With the identification of non-conformance, controlling action is prescribed by the Quality Control Board to hold the non-conformance issue on the floor to properly access the non-conformance management process to take the appropriate action.  

Non-Conformance Review 

The life science industries handle this step by summoning a stand-by Material Review Board (MRB). The MRB is responsible for reviewing the non-conformance event and determining the actionable steps. The review process involves the controlling and segregation of non-conformance and addressing the violated requirement or specification. 

Determine the action plan

With the reviewal of the source and occurrence details of non-conformance, this step determines the correct actions to dispose of the non-conformances. Disposition is an action plan that defines the corrective measures laid for resolving the non-conformances.  

According to FDA, the organizations have the flexibility to decide the necessity of the investigation process for non-conformance. Additionally, dispositions can cover corrections or can be no actions at times. If the non-conformance is a defect identified for the first time, then the organizations should call for an investigation process; if it is due to the previous process failure, then organizations may not require initiating an additional investigation process.  

Listed are the five disposition categories, and the non-conformances fall into one of the following: 

• Rework – When a product or process fails to meet the specification, the disposition takes a minor correction action and allows the product or process to meet the specifications.  

• Recall – Call off the process or product, i.e., Destroy the product or method instead of using it.  
• Return to Supplier – When the supplier ships the wrong or defective pieces of product, they must be returned.  
• Use as is – When a product is found defective, but that doesn’t cause harm to the end-users, and that is determined to use as intended.  
• Downgrade – When the need for an updated version for resolving a product defect but the previous version is in use until the resolution.  

Any minimal action or no action after identifying Non-conformance should be tracked and recorded for inspections and audits.  

Analyze the Root Cause 

Analyzing the root cause of the problem is the only way to determine the necessity of an investigation process. The organizations should look for the probable causes for the occurrence of non-conformance, and finding the actual cause is the most challenging. The aim is to reach the cause that triggered its events.  

This step in a Non-Conformance Report is essential. Document all your findings and investigative information of the actual and potential causes and their impact with the required objective evidence.  

After assembling the required data, involve the expert team to determine the factors that caused the non-conformance by using the root cause methodologies like 5 Why’s, Ishikawa Diagram, Fault tree analysis, or FEMA. Using one or more methods, you will achieve the potential cause. Be persistent and keep tracking the findings and documenting them.  

The Quality Management Software enables an easy and streamlined process to get to the insights of your quality, data, saving time and resources while improving the quality of work.

Verify the closure 

Concerning the root cause, if the non-conformance is minor, then with minimal actions, NC can be closed and verified. Such as: Implementing training for the employees, clear and defined work instructions, change in the process cycle, refraining the product acceptability, etc.  

What if the non-conformance is of major type? which impacts the multiple processes and can cause a systematic issue down the line leading to the requirement of Corrective and Preventive actions as Non-Conformances is the front-end mechanism for CAPA. Any activity in suggestion where the problem recurs will initiate a CAPA.  

Initiate a CAPA when the problem is systematic, critical, complex, and impacts multiple processes as it creates burdensome work and negatively impacts the reputation and profits of the company. 

Monitor Effectiveness 

After determining the corrections for non-conformances, this step may seem less critical. But monitoring the identified processes and products to ensure the problem does not recur is vital for a closer inspection of Non-Conformance Management. With that, the steps determined for problem elimination and the root cause analysis are proved accurate. If it recurs, move back to step three, drill down to the actionable plan, and check for additional issues.  

Documentation 

Documentation is vital in Non-Conformance Report. Therefore, every step of the process should include the documentation elaborating the process’s relevant findings and actionable plans. In addition, ensure  documentation has complete reviewal and approval actions finalizing the non-conformance closure.  

Non-Conformance Report Management Best Practices 

Writing a Non-Conformance Report is an opportunity to leverage the essential findings and improvements. So to write an effective Non-Conformance Report, follow the listed best practices. 

• Documentation – Document the non-conformance from identification to closure, describing the events and analysis performed with approvals and required signatures.  
• Categorization – Identify and segregate the Non-Conformances into minor and major, ensuring the required corrections are in place.  
• Ownership – Determine the owners of the Non-Conformances and review the open, in-progress, and closed NC’s periodically updating them in the documentation.  

• Tracking – Track the NC’s sources and causes in line with the processes noticing the systematic issues and escalating CAPA. 
• SOP (Standard Operating Procedures) – Provide SOP for the employees to follow. 
• Review – Regularly review the process followed as your organization scale. 

Leverage Quality Management Software to manage Non-Conformances, ensuring compliance 

The Non-Conformances identified are the result of a reactive and defensive action of a process or service followed by the organization. Therefore, a proactive and preventive approach process is required to resolve. But the methods identified by the quality heads often hamper the process ending up in a deviation. As the organizations depend on a paper-based process for managing non-conformances and quality integration with departments or different sections is tedious. The restrictions in storage and access are often violated with no proof of changes made or by whom. For effective quality delivery ensuring customer satisfaction requires well-established systematic processes and procedures. Additionally, to focus on meeting the standards of regulations, production, and management profits, an intelligent QMS is needed.  

QMS ensures non-conformances management leveraging quality policy, quality risk management, and quality objectives in compliance. 

With QMS,  

• Organizations can be sure of seamless inter-department collaboration facilitating non-conformances management. 
• A centralized system allows real-time management of recorded data with insights of similar patterns to get to the root cause of the issue faster and efficiently.  
• The data retrieval process is fast and easy as when needed for effective audits and inspections. 

• E-Signatures in compliant with 21 CFR (Code of Federal Regulations) Part 11 
• With integrated AI (Artificial Intelligence) and ML (Machine Learning) algorithm capabilities, get predictive analysis and dynamic insights into the organization’s critical gaps.   

Would like to learn more about non-conformance management and how to write NCR? We are just an email away from sales@complianceg.com.