1. Quality Chain Management
Regulatory compliance and ever stricter quality requirements are among the reasons why the pharmaceutical and medical device industries require a high level of quality management and assurance practices. Unfortunately, the physically separate locations of data such as manufacturing records and quality information mean that collecting information requires a huge number of manhours, one of the consequences of which is a reliance on the expertise of individuals in tasks such as identifying the causes of problems and the impacts of changes. This in turn impedes the sharing of skills and know-how.
To address this issue, Hitachi has developed quality chain management (QCM) as a way to achieve continuous quality improvement through centralized management that links together the quality information scattered across different systems, thereby making quality information from manufacturing both traceable and visualizable. By linking deviance data and product specification changes that occur in the manufacturing process, and user complaint data to the production operation data and man-machine-material-method (4M) data that comprise the data model in Hitachi’s digital twin solution, this provides an efficient way to search for the data that indicate the root causes of product quality problems while also presenting a broad overview of the manufacturing process. Through interoperation with Hitachi’s digital twin solution, the use of QCM also has the potential to be extended to supply chain management (SCM) and engineering chain management (ECM).