1. Are there preconfigured risk elements?
No, the tool is provided empty. During onboarding we help with configuring risk assessment types, but right now the user should define the risks manually. However, we might create a list of predefined and editable items in future versions.
2. Is it possible to add a photo to a risk?
It's only possible to add text when describing a risk in the risk assessment module at the moment. Once you link it to a CAPA, you have the opportunity to upload attachments in the CAPAs module.
3. How do you add information about scoring?
You can add this information in the remarks field.
4. Can the reviewer add changes or comments during reviewing?
In short, no, approvers cant make direct modifications, but they can leave a comment. You can add more than one person that's going to work on the risk assessment, and then there's an approval step. An approver can only reject the risk assessment and send it back to the responsible person with a remark, as they must specify a reason for the rejection.
5. How can you work on risk assessments as a team?
You can add more users in as 'responsible persons' for the risk assessment. You can see and track who makes changes and who saved what. You can also download and view all the risk assessment versions. You can also add multiple approvers that all need to sign off, or just one, it’s up to you.
6. What is the level of access needed to create the risk assessment type?
Usually, you need to be a manager to create risk assessment types. However, this is configurable by you. Under the 'manage' tab you can define who can create risk assessment types and choose between admin, regular user, or manager.
7. Can a risk assessment be closed only after a mitigation or CAPA completion?
No, you cannot close your CAPA if the risk assessment is still open. First you do your risk assessment, create mitigating actions for your risk, then automatically create a new CAPA, and that CAPA goes into implementing status where everyone closes their actions and uploads proof . You can close your risk assessment before the CAPA is closed.
8. Is there any dependence on the approval of risk assessment and CAPAs?
Yes, there is a dependency. You cannot close your CAPA if the risk assessment that's linked to it is not closed.
9. If there are two mitigation measures to reduce a risk, is it possible to deal with them without the CAPA module?
Yes, you can still define a mitigation plan without the CAPA module. However, you need the CAPA module to assign risk assessment tasks to the right people so they can perform and sign off on the risk assessment and upload proof. That's why we advise everyone to link their risk assessments to CAPAs.
10. Is it possible to export the risk assessments in a table to facilitate the transition with auditors?
Yes, there are two options for this. Clicking 'Download as PDF' creates a report of your whole risk assessment. You define your own PDF template and layout with custom variables through the Document Control module, which will include electronic signatures etc. If you only want to download the FMEA as an Excel then you can hit 'Download as Excel'.
11. Is it possible to print a record of the FMEA to send it to a customer?
Yes, in the same way as described above, by downloading a detailed PDF report.
12. Is it possible to link Risk Assessments to CAPAs or Change Control within those modules too? Or can you only make these links in the Risk Assessment module?
Yes, both ways are possible. All modules are interlinked.
13. Can you add more than one mitigation plan to a single risk or is it only one on one? can you add more actions in the main CAPA?
The mitigation plan is an open text field, you can put as many options there as you want. If you link it to a CAPA, and you don't want to put everything under one action, you're free to add additional actions within that CAPA and then split your mitigation of a risk into several actions. Right now, the mitigation that you define is linked one-on-one to the risk. You can add several different mitigating actions for a risk in the text field of the mitigation plan.
14. How are the rows ordered in the FMEA?
According to the order you created. You can add and remove rows as you wish
15. Is Scilife going to implement the HACCP risk assessment tool?
At the moment we're implementing the most widely used methodology first, as time goes on we'll add more features and tools in our next iterations.
