This insight helps you learn more about the steps you can take to establish a successful Non-Conformances and CAPA process, and the benefits of implementing an effective CAPA system as part of an enterprise quality management system.

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Manufacturers across the globe - whether they make equipment, apparel, food, drugs, medical devices, or high-tech products encounter varied challenges when managing quality - be it in terms of regulations, standards, or non-conformances. However, the solutions to manage and resolve these non-conformances are often similar.

In recent years, regulatory bodies have upped the pressure on manufacturers to track non-conformances or defects at every stage of the production cycle, and to report key details to the relevant authorities and impacted parties. Multiple aspects have to be considered: Have the right standard of components or raw materials been used? Are tools and machinery compliant with regulations? Do employees have the desired skill sets?

For a steel rope manufacturer, a non-conformance might lie in the thickness of a steel sheet being used, while for an apparel manufacturer, it might be a problem with the fineness of rayon. Similarly, a food or drug manufacturer may neglect to store products at the right temperature, or fail to explicitly label their ingredients and compositions.

In other words, the definition of a non-conformance may vary from one manufacturer to the next. However, all of them have to take the right measures to ensure product or process quality, continuous improvement, and process discipline.

Identifying Quality Failures or Deviations

Till a few years ago, the process of collecting and communicating data on deviations or non-conformances was a timeconsuming and resource-intensive affair. Manufacturers would typically have to aggregate information manually from multiple, disparate sources across their manufacturing plants and supply chains.

Today, technology has made things simpler. Using a centralized quality management system, manufacturers can document, track, and correlate data from across the quality lifecycle in an integrated manner. Non-conformances logged at a particular location can be quickly mapped to other locations, so that teams learn from each other, and take proactive steps to prevent the recurrence of these incidents. Improved visibility into quality and non-conformance data makes companies better-informed and better-prepared.

Another challenge with earlier approaches to quality management was the lack of consistency in the parameters and values that defined a non-conformance. Here too, technology has made a difference by providing the ability to map quality related regulations to policies, risks, and associated metrics all in one system. With this cohesive data framework, it becomes easier for quality teams to define a set of clear parameters for non-conformance management, and to ensure that they are followed consistently across the enterprise.

Establishing a Context

With the identification of a non-conformance arise questions on its relevance and existence. Where was the nonconformance found? What products or processes have been affected? Who is responsible? Here, context matters. The right people need to have the right information, at the right time to make informed decisions. What may be a crucial non-conformance for one business function, may not be of much significance to another.

The key is to have clearly-defined parameters to capture non-conformances very precisely, and then notify the responsible personnel through pre-defined business hierarchies and process flows. By streamlining and automating these processes, organizations can accelerate the capture and routing of relevant information to the responsible teams. And by implementing Good Manufacturing Practices (GMPs), organizations can lay the foundation for a defectfree manufacturing environment which, in turn, minimizes the need for non-conformance or CAPA management.

Developing a Closed-Loop CAPA Process

Companies typically encounter various types and levels of non-conformances - mistakes or errors pertaining to GMPs, reprocessing or rework, unapproved changes, activities that are performed without proper training or outside of operating parameters, and failure to follow written SOPs or approved batch record instructions.

These deviations could be planned or unplanned. Moreover, the data on them could come in from various sources, both inside and outside the enterprise. Ensuring that all these data points are connected is very important for nonconformances to be managed in a uniform and collaborative manner.

An automated, closed-loop CAPA process is also essential to resolve non-conformances swiftly and permanently. The first step in this process is to understand the severity of the non-conformance. A minor incident might require only a few remediation steps, while a severe incident would require much more detailed investigation and corrective action.

Depending on the severity of the non-conformance, containment action might need to be implemented to keep the issue in check, and to prevent it from snowballing into a larger problem. Some companies have pre-defined warning systems and emergency actions in place to halt production. Others might trigger an immediate market recall of all potentially affected products.

Whatever the strategy, it’s important to remember that containment action is only temporary. It might treat the symptoms of the problem, but doesn’t always get to the root of it. The more important question is, why did the nonconformance occur? Was it due to an equipment malfunction? Or was it caused by a defect in a supplier’s components? By understanding the root cause, stakeholders can prevent the issue from recurring and, in doing so, save costs, strengthen compliance, and improve customer trust.

To conduct a root cause analysis, there are many industry-standard methodologies such as 8D, 5-Why, Ishikawa, and FMEA. Companies can also use tools like cause and effect diagrams, flowcharts, Pareto charts, and scatter diagrams. Choosing the right approach and implementing it in a disciplined manner is key to accurately finding the source of the issue.

The penultimate step in a closed loop CAPA process is implementing the appropriate corrective action - be it updating equipment maintenance policies, retraining personnel, or re-defining quality clauses in supplier contracts. This step must be followed by an effectiveness evaluation that verifies if the corrective action, as well as the preventive action, have been implemented properly. The evaluation could take the form of an audit, a spot check, product review, realtime monitoring, or sampling. Each of these approaches plays a critical role in determining if the problem behind the non-conformance has been eliminated, and if process or product outcomes have improved as a result.

Meeting Federal Regulations and Industry Standards

One of the lasting advantages of a robust non-conformance management process is improved compliance with federal regulations, as well as safety and production standards. Regulatory authorities do not expect deviations to be eliminated completely, but they often demand evidence that the proper procedures have been implemented to minimize the impact and frequency of non-conformances. The FDA, for instance, requires organizations to notify regulatory authorities of deviations – both internal and supplier related – immediately or within specified timelines. Meanwhile, a growing number of standards like ISO 9001 and GMPs are being introduced to help manufacturers reduce non-conformances significantly. By following these guidelines, companies will be able to assure stakeholders and customers that they are committed to producing safe, high quality products.

Better Quality, Better Performance

In a world where manufacturers have to work harder than ever to stand out from the competition, quality can often be a strong distinguishing factor. Part of an effective quality management program is a robust approach towards identifying and addressing any non-conformances that could arise.

While customers are often forgiving of the occasional non-conformance, what they don’t tolerate are stop-gap or halfhearted measures to resolve the issue. That’s where a well-thought out, comprehensive, and closed-loop approach to non-conformance and CAPA management can make a big difference. Companies that resolve their non-conformances quickly and effectively set themselves up not only for better quality, but also for stronger customer loyalty, lower costs, and higher profitability.

About MetricStream Non-Conformance and CAPA Management App

The MetricStream app standardizes non-conformance and CAPA management processes across the enterprise. It provides a unified system to capture non-conformances, conduct investigations, manage interim containment action, as well as long-term CAPAs, and verify the effectiveness of each action. The app also facilitates cross-functional teamwork on non-conformance and CAPA management, while providing real-time visibility into related metrics and trends.

With the MetricStream app, you can:

  • Integrate all non-conformance documentation and action plans in a centralized database
  • Reduce repeat non-conformances with a consistent and closed-loop investigation and CAPA process, leveraging industry standard methodologies like 8D, 5-Why, and Ishikawa
  • Cut across organizational siloes, improving collaboration on non-conformance management
  • Gain real-time visibility into non-conformance data, metrics, and trends
  • Implement various root cause analysis methodologies, as well as actions such as sales stop, production stop, product recall, and regulatory reporting
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