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INS-106-1-rev.A_Handling Deviations

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INS-106-1-rev.A_Handling Deviations

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1. Who can propose a deviation?
The CEO. The CTO. All departments.
2. Which team is responsible for monitoring and reporting the status of deviations?
INTOPS. RAQA. R&D.
3. What is included in the documentation of a proposed deviation by the QA team?
Description, origin, justification, financial impact, actions, and potential impact on the product or QMS Description and approval date of the deviation. The names of the team members involved.