Traceability in EQMS: Why It is One of The Critical Requirements? 

Qualityze Podcast : Traceability in EQMS: Why It is One of The Critical Requirements?

Traceability is becoming increasingly important for companies in various industries. Despite some misconceptions, traceability should be part of every manufacturer’s process, whether food, automobiles, or aircraft.

Undoubtedly, it provides significant efficiency, cost, and productivity advantages. Organizations can exercise better control over their production processes by implementing systems encouraging tracking and tracing capabilities at the highest level. In addition, making products that are safer, more reliable, and more efficient products allows them to improve their processes continuously.

Most companies likely use traceability procedures to comply with customer and market mandates and improve service, safety, and processes. Manual processes, however, leave you vulnerable to errors in the production process, as you will miss crucial steps. You also risk financial loss, illness, and even death if your business is involved in a recall. This is the reason, companies must implement the system that provides traceability into processes, data, and failure trends so they can make informed business decisions.

What is traceability?

The concept of traceability has been used in manufacturing for decades. Based on current research, the automotive and food industries are reportedly leading the way regarding implementation. Recent interdisciplinary studies of traceability have outlined the relationships between traceability concepts using a framework. To summarize, traceability is: “The ability to locate a lot, its components, and predict their location.”

What is the need for traceability?

Manufacturing systems require intelligent products to have the ability to provide their virtual image. This makes it possible to react more efficiently to product-specific parameters during production, initiate decentralized decisions and identify areas for process optimization. Intelligent automation of processing steps for production plants is equally advantageous if the products and the plant are digitally connected. Real-time tracing of objects is essential for this.

It is crucial to have traceability to trace product deviations back to the root cause within the production process and figure out how to fix them. The implementation of traceability also reduces the extent to which product recalls affect products and the uniformity of production lots. With traceability, we can make fact-based decisions and continue to improve.

Traceability is also not only beneficial to companies. This service is in high demand in various industries like aerospace, chemical, pharmaceutical, food, and automotive. End customers expect safety, quality, and a minimum level of risk from the vendor. In the B2B realm, the question is primarily one of liability or, in the case of recourse between companies, avoiding business risks.

According to ISO 9001, an international standard defining quality management system (QMS) requirements, the following criteria are defined for identification and traceability: “Identify outputs in a way that ensures conformity with product and service standards. Measure and monitor results throughout production and service provision to determine the status of the outcome. Finally, maintain the documentation of the outcomes to enable traceability when traceability is a requirement (ISO 9001, 2015). Three elements can thus be separated: output identification, process stage, and traceable identification.

You can use various traceability methods, ranging from unique stamping or barcoding for each component to whole lot/batch identification, combined with manual or electronic documentation of information gathered during processing and from suppliers. There are several ways to trace inputs, including part labels, forms, work orders, production plans, validation sheets, lot/batch controls, calibration/maintenance certificates, labels indicating that the output has been inspected, etc.

Traceability in EQMS: Why It is One of The Critical Requirements?

Without a specifically designed quality system capable of achieving full life cycle traceability, cross-referencing items between spreadsheets and documents could take weeks, if not months.

Here are three reasons why your EQMS must provide traceability:

Traceability allows for better control of complex records and documents.

Your QMS will become more complex as time goes by, and all documents and records about your medical devices will require traceability. Legacy systems cannot effectively handle a large number of interconnected relationships. Traceability requires considerable effort and time. In addition, manual traceability becomes more error-prone the more complex your system becomes. You can have ripple effects throughout your QMS if you make one small error.

Effective EQMS software allows teams to utilize traceability and remove uncertainty from quality data analysis. By implementing a quality system that provides traceability, teams can concentrate on value-added activities rather than manual, disconnected information management.

The traceability of your quality management makes it possible to track and view the relationships between documents. It will save you time and effort too.

Qualityze EQMS Suite is a next-generation Quality Management System that gives organizations the required traceability to manage their controlled documents and quality-related records. Using Qualityze, companies can visualize, understand, explore, and communicate data within their quality systems more intuitively than with any other quality management solution.

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Traceability improves root cause analysis.

Product life cycles are full of opportunities for failure points. However, an effective medical device development team has a quality system that allows them to track every step of their medical device development process.

The traceability of products and processes is the connective tissue in a quality system. Having this critical function accomplished improves the ability to determine the root cause of quality events, effectively resolving all associated issues and resolving problems.

The absence of traceability in quality systems can result in misaligned teams and inefficient processes. Traceability is essential for adequately determining the root cause of quality incidents.

With traceability capabilities, we can determine root causes using data-driven methods. Real-time visibility of quality data is enabled with these solutions, which allow teams to identify issues and address them as quickly as possible. By proactively monitoring and mitigating risk throughout the product life cycle, teams can create a safe and effective product.

EQMS with traceability allows teams to view data at a granular level to identify relationships among items to determine root causes and address them effectively.

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Traceability streamlines audits and inspections.

It can be stressful to prepare for an upcoming audit. Many prepare by sleeping through the night and working long hours before the audit. If things don’t work out as planned (or as the manufacturer intended), they are remedial efforts that result in citations, fines, or recalls. This is likely to happen when legacy tools manage audits.

You could receive a 483-form observation for a non-compliant process if the FDA finds it during an inspection, whether announced or unannounced. Within 15 days, you must respond. A form 483 observation can lead to a warning letter, resulting in millions of dollars in corrective fees and months of working together to resolve.

Your quality system needs more traceability throughout the process, leaving you unable to deliver what’s most crucial. Moreover, you must rely on others to do their jobs properly and hope that all procedures are documented and followed as described.

Auditors or inspectors can trace any records or documents they request. The click of a button gives you access to everything you need rather than digging for documents.

Qualityze gives you granular insights into any project or quality event, allowing you to filter and layer the data based on what is most relevant to you.

It’s easier than ever to achieve traceability.

In highly regulated industries, traceability is becoming increasingly expected throughout every stage of the product life cycle.

With the right tools, teams can accomplish this more efficiently. These specifically designed tools offer multiple benefits. By enabling teams to manage and visualize their quality system’s connectedness in a proactive, preventative way, Qualityze EQMS Suite makes achieving traceability easy than ever.

Please take a virtual tour of our EQMS software by requesting a free demo. 

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Are you looking for a QMS solution that integrates post market activities with product development to ensure the success of your in-market products? Learn more about Qualityze EQMS here.