Manufacturing traceability has become a critical requirement for today’s industrial businesses to reduce risks and stay competitive. A proven track and trace framework is essential not only in highly regulated industries such as medical, food and beverage, aerospace, defense and automotive, it has also become a vital tool for all manufacturers, across all industries to gain greater control over product and process quality and respond to customer demands.
Some area are more outstanding in these times, like the Medical Devices and Aerospace industries. Although both industries work in different concepts, we can find some similarity within their criteria, since for each of them it is of utmost importance for the human wellbeing and safety we talk about product quality, especially of the design, development, and manufacturing phases. Some may determine that the medical device industry is stricter in the procedures due to the strong regulations demanded by the FDA and other global regulatory bodies. Regulation in Aerospace is also very strict in the process of the creation of products and the equipment and materials that are used, but they tend to be more efficient and more rigorous than the FDA’s.
The principal regulations of both industries are ISO13485 and the AS9100 which are based on the requirements of ISO 9001. AS9100, takes ISO9001 standard requirements and adds specification on several parts such as planning for product realization, design and development, purchasing and purchased product, production and service provision, non-conforming process and product monitoring and measurement. Medical device manufacturers have seen a multitude of regulatory changes in the past few years, and every year there is an increased focus on identification and traceability to improve transparency. Device labels must now include a unique device identifier in both human- and machine-readable forms.
Both industries have many opportunities for improvement in manufacturing traceability. It has become a critical requirement for today’s industrial businesses to reduce risks and stay competitive. A proven track and trace framework is essential not only in highly regulated industries such as medical, food and beverage, aerospace, defense and automotive, it has also become a vital tool for all manufacturers, across all industries to gain greater control over product and process quality and respond to customer demands.
Manufacturing traceability means that you know which supplier lots and or serial numbers were used in which finished products, and who received those finished products. Aerospace components are serialized to build a digital thread through the product life cycle phases. FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use.
Part identification and traceability are essential to ISO 9000 because the standard demands reliable product quality and measurement, along with documented proof. In some situations, this requirement can be applied to individual parts, while in others it is applied to a bin of parts. The overall goal is to prevent “bad” parts from being mixed in with “good” material.
Some experts argue that the standard’s language surrounding traceability is ambiguous, making it one of the most misunderstood aspects of ISO 9000. For example, the standard states, “Where appropriate, the identification system should allow for traceability from the finished product back to incoming material records and customer specifications.” Though, it is up to the organization to decide where it is “appropriate” or not.
In 2020, a number of new and existing manufacturing laws and regulations will influence product identification and traceability across industries, including:
- How products should be labeled
- What information should be included in identifying and traceability marks
- The standards for readability and other quality factors of the mark
- Lifetime product traceability requirements
We recommend companies review traceability standards to ensure your processes are up to par.
Complete traceability can be achieved by creating individual component-level marks at the soonest possible moment in the manufacturing process. This allows manufacturers to digitally connect individual components to the subassembly, the major assembly, and the final assembly. Creating manufacturing traceability data, insights, and intelligence you need to track and trace goods from the supplier that sent the raw material through delivery to the customer, and all the production processes and stages in between.
A comprehensive digital thread can enable engineering teams to fully record and trace the product development process from start to finish. It can provides a mechanism to collect all relevant documents, files, and data that go into how products move from one stage of the process to the next. ENOVIA is the data management backbone of the unique 3DEXPERIENCE platform. The underlying technology empowers many of the world’s largest and most technically sophisticated manufacturing companies.
Get full traceability with a combination of change management, engineering definition management and project management capabilities with the power of PLM Analytics. Advance the ability to develop a holistic 3DEXPERIENCE TWIN of a product by improving the experience of managing complex product definitions.
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