Assess the probability of severity versus occurrence

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Reference no: EM133393693

What are Hydrophilic Wire Guides and the type of risk which could be associated with such devices. with adequate references

- Define the risk index, taking into consideration the level of risk (1 -5).

- Assess the probability of severity versus occurrence.

- Describe the probable root cause(s) which caused this issue leading to recall.

Include in your analysis and CAPA write-up, the following:

- Identify the issue

- Analyze

- Cause Analysis

Proposed strategy for resolution

- Proposed Root Cause Analysis.

- Proposal for continuous improvement.

- Other action plan topics as applicable

Reference no: EM133393693

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