Question: 5. (5 marks) a) Explain using flow charts where necessary how a documentation change for a change to a manufacturing process may be brought through

5. (5 marks) a) Explain using flow charts where

5. (5 marks) a) Explain using flow charts where necessary how a documentation change for a change to a manufacturing process may be brought through approval. b) Why is incoming inspection an important part of the manufacturing process for a medical device manufacturing company? Define a set of simple specifications for a piece of tubing for a catheter manufacturer that can be used during incoming inspection. (6 marks) c) Is there any alternative to process validation within the medical device industry? Explain your answer. (3 marks) (6 marks) d) Validation for a machine process comprises of three main parts. Explain the differences between these three stages of validation. e) What statistics are used for assessing validation results? Explain these statistics

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