Any business that is involved in production understands the difficulties in ensuring a high level of quality, especially when mass producing a product. Even well-established corporations such as Tesla have experienced inconsistencies in their manufacturing of their various models of electric cars. While a manufacturing error looks bad on a business, there is one industry in which a manufacturing error could be deadly. This industry is the medical devices industry. Medical devices range from personal protective equipment to ventilators, a machine responsible for keeping a patient alive.
The definition of quality as stated by the International Organization for Standardization (ISO) is “the degree to which a set of inherent characteristics fulfills requirements where a requirement is a need or expectation.”
For medical devices, quality assurance is held in the highest regard throughout every stage of the manufacturing process. The vast majority of these medical devices have a designated group whose sole purpose is to ensure that the equipment meets or surpasses the required regulations as outlined by the specific manufacturer. Given the importance of a medical device, the manufacturers and quality inspection team are held to the highest level of accountability to ensure that no faults in the machinery slip through the cracks of production.
The practice of automated production of medical devices is governed by GAMP5 (Good Automated Manufacturing Processes) which falls under the title of the International Society for Pharmaceutical Engineering.
Additionally to the numerous regulations and procedures that a manufacturer is required to follow, bookkeeping is an essential aspect of ensuring accountability. Device History Records (DHR) manage the complete records of manufacturing, design, and testing of medical devices. It is a policy that the DHR is to be signed at each stage of manufacturing and this, in turn, provides a complete overview of the effectiveness of the product before being sold and operated.
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