The journey of a product or service begins with identifying a pain point it must address and then deciding on the features and raw materials required to address the issue. During the journey from ideation to release, the concept can undergo several changes based on the availability of raw materials in the necessary quantity and quality, the company’s production capabilities, customer feedback, or even changing market trends. These factors can affect the development lifecycle, impacting quality and leading to nonconformance or nonconformity. Nonconformance is an output that does not meet the finalized specifications, requirements, or expectations. Non-conformities can be in the materials, final product, embedded software, or services and processes.
Regulatory bodies and standards such as ISO 9001 and ISO 13485 require businesses to detect non-conformance, also called deviation, and document it as a non-conformance report (NCR). The deviation can be from specifications, established internal and external standards, or specifications. The root cause of the deviation must be analyzed, and appropriate corrective and preventive action must be implemented to prevent recurrence.
How Non-conformances Impact Quality
One of the key definitions of quality is when a product or service meets the requirements. When a product does not conform to the specifications a variety of factors could be the cause:
- A component was damaged at the factory
- The documented SOPs were not followed
- The raw materials did not meet the quality requirements
- A process needed to be followed properly
If the real cause is not addressed and corrective action is taken, the problem is expected to recur, causing similar or other new problems. Over time, repeated recurrence will erode brand value, increase the cost of production, lead to wastage and rework, and workers will feel demotivated.
The problem may be minor—like scratches or raw finish—which may not affect performance but impact the aesthetics—or serious, affecting product quality and safety. Prioritizing analytics on NCR data for major deviations and predicting future potential risks can help proactively improve quality management.
How to Leverage NCR Data for Proactive Quality Management
A centralized document management system will enable all authorized personnel access to NCR data, enabling reports that can help capture trends and identify patterns. The data can be categorized to identify specific areas that trigger the non-conformance. This can help quality leaders and business managers develop a strategy to address the issue and take corrective action.
Some of the best practices to use NCR Data for predictive analytics and proactive QMS solutions include:
- Automating Data Collection: Integrating workflows in a unified platform will help automate data collection. This helps with deduplication, complete data collection, classification, and categorization. Once the unified data is available, running AI analytics becomes easier.
- Pattern Recognition: Identifying patterns is critical for implementing a mitigation measure. One-off quality incidents may not require major corrections or disruptions to operations. However, some others could be recurring and require a long-term solution to prevent their recurrence.
- Root Cause Analysis: A root cause analysis is important for such recurring events. This helps identify the real cause of the problem so that it can be addressed effectively to prevent recurrence.
- Risk Assessment: Having centralized NCR data also helps identify potential risks that can lead to nonconformance and their severity and frequency, so that they can be ranked and high risks addressed on priority.
- AI-Based Prediction: Combining the NCR data with other error data can help understand potential issues. AI-infused analytics can uncover hidden risks and recommend innovative solutions for managers.
- Mitigation: Based on the findings, the team can implement specific controls to mitigate the risks of non-conformance and deviations.
- Monitor and Tracking: The impact of the implemented controls can ensure the desired outcomes are met or allow mid-course corrections.
- Supplier Management: The NCR and CAPA data can also provide valuable insights into your supplier performance for further action and training.
ComplianceQuest NCR for Continuous Improvement
ComplianceQuest is a cloud-based EQMS that is aligned with ISO standards. It enables managing non-conformance to prevent product recalls with an automated, data-driven process.
Whatever the cause, the CQ Nonconformance Management Solution enables quick and effective capturing, triaging, investigating, and closing nonconformances to reduce the cost of poor quality.
ComplianceQuest’s Nonconformance Management Solution uses Einstein Predictive Analytics to capture non-conformance trends and draw insights from data. It helps with:
- Spotting key risks
- Escalating to a CAPA ahead of time
- Driving continuous improvement (CI) of the entire quality management process
Data insights help identify recurring errors, patterns of issues, the stage of production at which the error originates frequently, the process variation causing the error, and so on. CQ’s Nonconformance Management Solution automates finding a permanent and effective solution with agility and skill to improve quality management.
To know more, visit: https://www.compliancequest.com/nonconformance-and-cost-of-conformance/
