Paperless Manufacturing Required to Achieve Operational Excellence Through a Smart Factory
Seabrook Technology Group presents a whitepaper on the topic of ‘The Requirement for Paperless Manufacturing in Achieving Operational Excellence through a Smart Factory’. Seabrook Technology Group improves customer business processes by imparting knowledge and excellence. Our focus is on the use of modern technology and software for business optimization. This whitepaper is of relevance to those in the medical device manufacturing
“Additional standards, regulation and greater levels of competitiveness are changing the medical device manufacturing industry. Further industry drivers include demand for electronic medical records for collaboration and improved patient care. Medical Devices/Equipment is one of the most highly regulated industries, requiring intensive reporting to support internal and external reporting requirements. Medical device manufacturers have reported the changing regulatory environment as the biggest challenge facing them today (Emergo, 2017). In 2017, 61% (up from 35%) of respondents in Europe and 36% (up from 30%) of respondents in the U.S. felt that the current process of obtaining regulatory approval for a medical device as more difficult (Schorre, 2017). Medical device companies continue to look for cost efficient methods to ‘navigate the increased regulatory burden’ (Hughes and Valyko, 2012). Increasingly stringent standards place a requirement on medical device manufacturers to produce more detailed labeling, dating, use-by dates, sourcing, detailed manufacturing records and accountability. Industry discussion forms on overcoming these challenges through the investment in an Industry 4.0 centre, otherwise know as a ‘Factory of the Future’ or ‘Smart Factory’.
At present, many medical device manufacturer floors are paper-driven. This operation simply cannot compete efficiently and effectively whilst in compliance with new regulation. In fact, publications have shown that paper-driven processes increase costs, introduce errors and thus contribute to compliance issues. Applied in industry, 75.9% of medical device companies reported business risks due to inefficient paper-based document driven processes (Oeters, 2013). Further studies on the topic by the Association for Information and Image Management (AIIM) found the true cost of paper-based manufacturing on the floor line to be ‘$20 in labor to file a document, $120 in labour to find a misfiled document and $220 in labour to reproduce a lost document’ (Oracle, 2009).
The following paper will look to explore how going paperless in a manufacturing process for a medical device manufacturer can lead to operation excellence through the implementation and investment in a factory of the future.”
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