Introduction

FDA and ISO have a defined set of guidelines to enable organizations to handle their quality processes effectively.  

Non-Conformance according to ISO 9001:2015The organizations certified for ISO 9001 are expected to ensure error-free quality processes and stringent mitigation plans to handle errors. In addition, the regulations mandate regular quality checks through internal and external audits to comply with efficient and better product delivery.  

Non-conformance management is one of the crucial elements in the quality process management lifecycle.  

Non-Conformance Types

Non-Conformance is categorized into two types – Minor Non-Conformance and Major Non-Conformance.  

Minor Non-Conformances are slight deviations that occur in a product, process, or service. It is less obstructive as it does not cause a problematic scenario for the organization. But it is essential to investigate and resolve an Non-Conformance, no matter how negligible the impact is. More often than not, the minor issues have been ignored that led to critical problems and failures. A minor Non-Conformance, when ignored, could lead to CAPA. So, there is a need for the organization to address immediately to avoid systematic issues in the future.  

Major Non-Conformance, on the other hand, is often critical and might lead to a CAPA. In addition, major Non-Conformance has higher chances to impact the credibility and reliability of the organizations.   

Reasons Why Non-Conformance Management is Important

The Non-Conformance management process aims to identify, investigate, and resolve Non-Conformance’s and document the Non-Conformances report. Also, examine the patterns of issue occurrences and help management streamline Corrective and Preventive Action to prevent recurrences and stay compliant with the regulations.   

• It helps the organizations identify the defects in products or processes and identify the critical issues that were to occur in the future.  
• It acts as a performance indicator of deficiencies, systematic issues, and operational procedures in place.   
• With critical documentation of Non-Conformance logs, organizations have the opportunity to identify patterns and promote better corrective and preventive measures and enhance proactive risk assessment.  
• Aids in delivering quality products and services improving customer satisfaction and company revenue.  

A functional Non-Conformance Quality Management Software allows the users to stay connected with the quality process.  Non-Conformance is not just a quality procedure of an organization; it is the core responsibility of users to report and handle potential NC to prove their quality of work.    

Consequences of an Non-Conformance failure

The above explains why non-conformance management is essential. Now, let us know what the consequences of a Non-Conformance are is ignored or failed to manage. The first and crucial is that Non-Conformance process negligence leads to product failures and increases product recalls frequency and customer dissatisfaction. It incurs production and operational costs. A continual trend of development recalls, complaints, poor procedures can harm patient health and consumer health. The whole point of handling non-conformances is not only the reputation of an organization; it is for the safety of humans using those devices and medicines. Deficient performance of an organization in audits leads to falling reputation and would further lead to cancellation of ISO certification or hinder from being ISO certified.   

The below is the pictorial representation of a functioning NC Management Process

Identification >>>> Initiate (document the information, identify for major or minor Non-Conformance, define why it occurred) >>> Investigation (Deep dive into the problem and identity what led to the non-conformance occurrence) >>> Actions (Review the findings, check the process gaps, decide the actions that are required to resolve the Non-Conformance and to prevent the same issue from occurring in future. A few of the common dispositions that arise during a Non-conformance management – Raise a CAPA, No CAPA but other actions required, no actions) >> Review (Once all the information has been documented, send over the analysis to the manager for approval) >>> Implementation < Once approved, implement the Non-Conformance actions) >> Verification (verify the executed actions) >>> Close Non-Conformance once the verification is a success.  

Digitizing Non-Conformance  

Handling non-conformances via paper-based processes might seem easy initially. However, an increase in the volume of data would lead to a lot of pain points. A few ways in which digitizing your non-conformance can help are:   

1. Retrieving years old non-conformance for audit might take a longer time. There is a higher risk of misplacing physical documentation  
2. Missed insights – What if most of your non-conformances in the previous years were because of a single supplier, and you could not connect the dots due to disparate paper-based data?  
3. Adherence to policy – Digital processes help you apply constraints that make it impossible to progress unless the required data is filled and help in reducing human errors/misses.  

eQMS design to ensure seamless Non-Conformance management process 

Quality Management Software holds a set of features that enable the employees of the life science industry to handle their non-conformance processes effectively. The Quality Management tool with close-loop configurable workflow helps companies organize their Non-Conformance process and documentation better. Furthermore, the quality tool provides traceability and visibility of information documented with just a click across the organization. It also provides actionable insights through analytics-powered reports.   

Would you like to know more about managing and streamlining the Non-conformance process in your organization? Contact sales@complianceg.com to discuss your needs?