Leverage Nonconformance Data to Improve Your Overall Quality Management System (QMS)

Even in the best-run operations, errors and deviations may be introduced in the process, product, or service due to internal and external factors such as human error, machine malfunction, contamination, or deviant inputs. This results in the product or process not meeting the specifications and is called nonconformance.

The nonconformance must be identified before the product is released in the market. Mostly, the deviation is caught during the testing phase, though it may also be detected earlier depending on the efficiency of the quality management systems of the organization. If a faulty product is released in the market, it can attract warning letters from the regulatory bodies for being noncompliant, product recalls, and customer complaints due to performance and quality issues. This can damage brand reputation and lead to litigation and penalties depending on the severity of the issue. Therefore, businesses must have a nonconformance process to proactively identify, document, and rectify the deviations in the processes, products, or services.

Nonconformance investigation and quality management are intricately intertwined. While a stringent quality process reduces the risk of nonconformance, businesses can also use the nonconformance data for continuous improvement of the quality management system. In a virtuous cycle, the two feed each other and enable improving the overall quality, performance, and compliance of the processes and products.

The main goal is to prevent nonconformities from occurring in the future and to continuously improve the organization’s performance. Ensuring compliance with internal and external procedures leads to increased customer satisfaction and better performance. Moreover, this process provides company improvement detection points and implements corrective actions accordingly.

Nonconformance Management in Medical Device & Manufacturing Sectors: Best Practices

The key practices in managing nonconformance include:

Best Practice 1: Identifying and Documenting the Nonconformance

The first step is to detect and report nonconformance. This can be through internal feedback, inspections, tracking key performance indicators, testing, and audits. Once a nonconformance has been reported, it must be documented in detail, including all valuable information such as:

• The nature of nonconformance
• Its type
• The date when it occurred
• The location
• The person responsible
• Its potential impact

The input data must be error-free and permit analyzing the situation to identify causes and methods of rectification.

Best Practice 2: Robust Investigations and Agile Implementation of CAPAs

Nonconformance can be major or minor. While corrective action must be taken to address the error, based on severity, root cause analysis must be done to identify the source of the problem. Some of the methods that can be used include:

• Pareto Chart
• The 5 Whys
• Fishbone Diagram
• Scatter Diagram
• Failure Mode and Effects Analysis (FMEA)

If it’s a recurring problem, corrective and preventive action must be taken to ensure it does not recur. 

Best Practice 3: Change Management

The implementation of corrective action involves changes to processes and sometimes even policies to meet evolving needs. This can introduce new errors and therefore, a cost-benefit analysis must be performed to understand the risks of the new approaches versus the improvement effect. Once the decision to implement the changes has been made, the next step is to create an action plan that delineates the following:

• The action plan – implementing change
• Roles and responsibilities
• Timelines
• Resource allocation
• Metrics to measure the success
• Monitoring and tracking

Using the PDCA approach (Plan-Do-Check-Act), the changes can be validated and implemented.

Best Practice 4: Communication and Training

The decisions must be communicated to all the stakeholders. Leadership buy-in is as important as employee involvement to ensure the success of the proposed changes in achieving the desired outcomes. At this stage, any gaps in skills to meet the new requirements must be addressed through appropriate training. Systems to report progress and periodic reviews must be put in place to monitor progress and report any challenges.

Best Practice 5: Monitoring and Tracking Progress

Along with expected changes, there can be unexpected consequences of implementing corrective actions. Likewise, the changes may not yield the benefits as expected. Therefore, the key performance indicators decided earlier must be tracked periodically to ensure the project is on track and delivering the expected results. If not, this requires course correction. 

The nonconformance data as well as the documentation at each stage of nonconformance management act as the base material for management review to ensure the rectification process is on course. This helps with the continuous improvement of the Quality Management System (QMS), improving compliance in the process.

Automating Nonconformance Management for Continuous Improvement

ComplianceQuest is a cloud-based quality management system with nonconformance management as one of its key features. It helps with reducing the Cost of Quality (CoQ) by preventing product recalls using an automated, data-driven nonconformance management process.

It facilitates collaboration between teams to perform root cause investigations of every nonconformance or unplanned deviation on the shop floor, laboratory, or office.

Further, the in-built Einstein Predictive Analytics capability enables capturing nonconformance trends and drawing insights from data. This helps spot key risks, escalate to a CAPA, and drive continuous improvement (CI) of the entire quality management process. The insights drawn from data help with identifying recurring errors, patterns of issues, the stage of production at which the error originates frequently, the process variation that is causing the error and so on. CQ’s Nonconformance in Management Solution automates the process of finding a permanent and effective solution, with agility and nimbleness.

To know more, visit: https://www.compliancequest.com/nonconformance-and-cost-of-conformance/