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Quality and regulatory work doesn’t stop when the design moves into production. Our experts can help smooth the transition into volume manufacture.

We bring knowledge of the design into process risk assessments, utilising a cross functional team to highlight the critical to quality features. These aspects are then given special attention using a document control plan. This allows the sample size, frequency and dimensions or aspects which are critical to be clearly communicated to production. More advanced control plans also indicate the actions to be conducted if “out of control” events are detected.

We are also adept in the creation of manufacturing work instructions, ensuring the manufacturing steps are identified succinctly and communicated using a visual language to the process operator.

We can also help identify the manufacturing supply chain. Working in collaboration with our manufacturing team, we can audit potential suppliers against custom criteria, providing an independent view of their strengths and weaknesses.

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