What will you do more of or different in future regarding QRM? by Malene Grøn https://padlet.com/mgr17/tstbq8xruk2mdz8a Share your thoughts en-us 2021-04-09 08:26:43 UTC 2022-08-16 13:36:19 UTC hello@padlet.com Justification https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262241051 Always ad a justification.]]> 2022-08-16 13:31:48 UTC https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262241051 I will read the new guideline as soon as it comes out https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262241095 2022-08-16 13:31:50 UTC https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262241095 https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262241418 Justification and clarification ]]> 2022-08-16 13:32:10 UTC https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262241418 https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262242162 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 ]]> 2022-08-16 13:32:50 UTC https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262242162 Evaluate existing processes for QRM enhancements https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262242370 Put on QRM glasses in current work and focus on sound, elaborate justifications and pinpoint risk areas]]> 2022-08-16 13:33:05 UTC https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262242370 Systematic approach to risk https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262242375 Use the 3 phases of:
Risk assessment 
Risk control 
Risk review ]]> 2022-08-16 13:33:06 UTC https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262242375 https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262242438 Risk review
Effectiveness check ]]> 2022-08-16 13:33:10 UTC https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262242438 https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262242697 Apply a critical mindset AND be more open minded, when assessing the need for risk assessments. 
Consider how to better revisit existing risk assessments]]> 2022-08-16 13:33:17 UTC https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262242697 Consider to include supplier reliability in the current FDB Supplier and Risk evaluation in 2022 https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262242981 2022-08-16 13:33:35 UTC https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262242981 Keywords https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262243169 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 ]]> 2022-08-16 13:33:46 UTC https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262243169 https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262243219 Remember the risk review as part of my QA review. (Ask for it😊)]]> 2022-08-16 13:33:51 UTC https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262243219 https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262243229 - Proposals internal from management.
- improved awareness to employees that preform or might preform QRM
- challenging stakeholders ]]> 2022-08-16 13:33:51 UTC https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262243229 https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262243529 Connect knowledge to the science riskbased lifecycle process periodic evaluation.]]> 2022-08-16 13:34:08 UTC https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262243529 Check for crocodiles 🐊 https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262243822 2022-08-16 13:34:30 UTC https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262243822 https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262244024 Controle and investigate the quality oversight even more to limit “slips” ]]> 2022-08-16 13:34:41 UTC https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262244024 https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262244077 Be more sharp when choosing words to describe the justification for a risk assessment ]]> 2022-08-16 13:34:45 UTC https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262244077 Use risk assessment for supplier evaluation and selection (before supplier qualification) https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262244089 2022-08-16 13:34:46 UTC https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262244089 Look at risk reviews. Which and how often should it be performed. https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262244262 2022-08-16 13:34:58 UTC https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262244262 https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262244287 CAPA creation - often document updates (easy, cheap, less resources required” - consider QRM, risk control, advocate for elimination ]]> 2022-08-16 13:35:00 UTC https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262244287 https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262244596 Revisit HACCP
Remember risk review
Less one track focus]]> 2022-08-16 13:35:21 UTC https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262244596 Inform my collegues of my new learnings. https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262244680 2022-08-16 13:35:27 UTC https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262244680 Create an overview of Fdbd risk assessments https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262245511 2022-08-16 13:36:19 UTC https://padlet.com/mgr17/tstbq8xruk2mdz8a/wish/2262245511