ISO standards state top management is required to ensure a QMS is fit for purpose. Is this top management across the organization or just in the Quality function? How would you explain to top management in the commercial side of the business why they need to complete quality training for example?
One of the objectives of ISO standards is to improve customer satisfaction, so it involves the whole company, not just quality. You have to look into the claims, the feedback from your customers, information about audits and supplier management, and the full chain.
In terms of how to talk to top management, it depends on your quality culture. Of course, they need to be aware of how important quality management is. So you not only have to train them, but also work collaboratively with them, as well as other departments, such as Human Resources, and Quality Department.
What is the relationship between Product Quality review and Annual Product Quality review? Which one is mandatory according to updated regulatory guidelines?
The Quality Management Review is cited in the ISO, so this is a standard, and it is not mandatory. However, the Annual Product Review is more of a comprehensive evaluation of your pharma products' quality which includes manufacturing processing data, specifications from quality control, deviations, and out-of-specifications. This is a regulatory requirement. So with the KPIs dashboard, you can go over both at the same time. You perform a Quality Management Review which is needed if you are accredited against the ISO 9001 2015 standard. But also the same information can be really useful in preparing your Product Quality Review.
Could you please explain what is meant by real-time KPI monitoring?
The concept of real-time KPI monitoring refers to the continuous tracking and analysis of KPIs to provide real-time insight into performance trends. Scilife provides real-time monitoring by retrieving data from multiple sources, updating metrics automatically, and presenting them in the KPI dashboard for easy access and decision-making.
Can you use the KPI module to see the amount of overdue CAPA of change request tasks for each user or only the overdue CAPAs or Change requests?
In KPI version 3.0, you can only see overdue CAPAs and Change Requests. In future versions, you will also be able to see CAPA actions and Change Requests tasks.
In your dashboards, you said you can only have access to data/KPIs of your entity. How do you have oversight on the KPIs of the interfacing entities that impact your activity?
In your dashboard, you can see all the information related to the Groups you have access to. If you have access to a Group in Scilife, you can see all the information about that Group. If you don't have access to a Group, you will not be able to see the information for that Group in KPI or any other module in Scilife.
As you know, the remote audit process has started due to the pandemic. Can we define the 3rd party audit firm within the system during the remote audit process? Can they log in with their passwords and retrieve any data they want from the system?
Yes, you can give them access to the platform by creating a read-only user for auditors within Scilife.
What type of KPIs on "quality culture" do you have? Can you give 1 or 2 examples?
Several key performance indicators (KPIs) can be used to measure the health of quality culture. For example:
- Reducing the number of quality events caused by human error
- Reducing the number of overdue tasks (training, CAPAs, maintenance, ...)
- Measure CAPA effectiveness
- Measuring quality delivery with a Net Promoter Score (NPS) or customer satisfaction score
- Improving productivity (time to perform a task)
How could you implement these KPIs into management review and approve it?
To implement KPIs into management review and approval processes, you can follow several best practices:
- Align KPIs with strategic objectives.
- Regular KPIs Monitoring (real-time) and review.
- Establish clear communication channels and promote accountability.
- Use KPIs to get data and insights to enable data-driven decision-making.
