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Create an overview of Fdbd risk assessments

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Create an overview of Fdbd risk assessments

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Inform my collegues of my new learnings.

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Inform my collegues of my new learnings.

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Revisit HACCP
Remember risk review
Less one track focus

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CAPA creation - often document updates (easy, cheap, less resources required” - consider QRM, risk control, advocate for elimination

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Look at risk reviews. Which and how often should it be performed.

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Look at risk reviews. Which and how often should it be performed.

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Use risk assessment for supplier evaluation and selection (before supplier qualification)

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Use risk assessment for supplier evaluation and selection (before supplier qualification)

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Be more sharp when choosing words to describe the justification for a risk assessment

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Controle and investigate the quality oversight even more to limit “slips”

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Connect knowledge to the science riskbased lifecycle process periodic evaluation.

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- Proposals internal from management.
- improved awareness to employees that preform or might preform QRM
- challenging stakeholders

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Remember the risk review as part of my QA review. (Ask for it😊)

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1. Have same understanding with team mates on where and how to use QRM in our  work
2. Implementation of QRM in change requests depending on the criticality of the change on patient safety
3. Use QRM to determine the level of qualification for new/modification of equipment/process
4. Learn more on using Risk Analysis tools

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Consider to include supplier reliability in the current FDB Supplier and Risk evaluation in 2022

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Consider to include supplier reliability in the current FDB Supplier and Risk evaluation in 2022

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Apply a critical mindset AND be more open minded, when assessing the need for risk assessments.
Consider how to better revisit existing risk assessments

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Risk review
Effectiveness check

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Use the 3 phases of:
Risk assessment
Risk control
Risk review

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Evaluate existing processes for QRM enhancements

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Evaluate existing processes for QRM enhancements

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Put on QRM glasses in current work and focus on sound, elaborate justifications and pinpoint risk areas

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Treat Risk Assessments (FMEA/ FMECA etc.) as live documents and not ignore them after they have been approved.

Read the new/old guidelines

Always include a robust justification

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Justification and clarification

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I will read the new guideline as soon as it comes out 

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I will read the new guideline as soon as it comes out 

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Always ad a justification.