Recently we announced the publication of Xavier University & PWC Quality Metrics Paper, which you can download here. Presentations from the recent Pharmalink conference where findings were presented is also likely to be made available online in the coming weeks for a deeper look into the paper.
We decided to explore some of the most practical or immediately applicable aspects as a way to show how the findings might be an important first step in the journey towards future FDA requirements. Big changes could see many organisations struggling to adapt, so there are parts you may want to begin to implement sooner rather than later to give your business time to get into the swing of good habits before those habits become an urgent regulatory necessity. Perhaps of more interest, it's also a good idea for quality and your business overall to help your organisation become more competitive.
The purpose of the paper stems from this upcoming change:
“The Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 gave FDA authority to request data and information from the industry in advance of or in lieu of an inspection to identify potential risk for drug supply disruption, improve the efficiency and effectiveness of establishment inspections, and improve FDA’s evaluation of drug manufacturing and control operations.”
The three main focus points of the paper were to:
- Identify metrics that would enable the industry and FDA to understand proactively the risk to product quality.
- Assess risk to product quality across the total product lifecycle to drive a mindset of designing quality into products at the source.
- And provide a framework that could be used by FDA to assess data gathered during an inspection and therefore, within the context in which it was generated.
Practical & Immediate Benefits of & Uses for the Paper
1. Gap Analysis and Benchmarking
How is your organisation handling quality needs now, and how ready is it to meet new reporting requirements once FDA reporting changes come into play?
The paper gives a good sense of the scale and procedures these quality changes in the industry are going to require. It's no small feat, considering the working group for this paper identified 101 metrics, deciding to focus on 91 of these which were then tied to relevant quality systems. The metrics and subsequent new processes were also identified as needing to become part of a system of continual improvement, which would include feedback loops and to have quality embedded proactively at the source, as opposed to an environment that is currently all to often reactive when it comes to quality management and reporting.
It would be beneficial for an organisation to take some time to study the metrics, the methodology and the purposes behind the chosen metrics, in order to see where the organisation sits in relation to each of these now, to begin to see the route to the to-be metrics and processes for their collection, and to gain an understanding of the bigger picture to see what other metrics needs or improvement needs may pop-up based on understandings gleaned from the paper.
2. Implementing New Measures
The working group identified a large number of metrics and grouped these to quality systems. The team wished to ensure that metrics were associated with these systems as they're critical to reducing product quality risk. In order to identify potential gaps, the team agreed on eleven critical product quality systems, shown below, and mapped 91 metrics to those systems.
Five critical customer requirements were also identified to provide insight to product quality risk, these were:
- Patient safety
- Supply assurance
- Process reliability
- Quality system robustness
- Failure costs
If your examination of the paper gives you a good overview of the types of changes required, looking at specific measures will help you bring it back to an understanding that is highly relevant and highly specific to your company, meeting quaity, compliance and business needs. Socialisation of this will also help get everyone on board in supporting changes, and assist in making the reasoning behind these measures visible and beneficial.
3. Quality Management & Reporting
Once you have defined, or at least begin to understand your desired to-be quality metrics, the processes and systems for data collection, and the processes to embed the necessary feedback loops, quality and continual improvement, you'll need to look at how you're going to manage what may look like a very different quality measurement landscape than the one you're currently operating within. You'll also need to decide how frequently you're reporting on these and what these reports will look like, what systems will you use to collect them, who collects them and when! Without FDA changes in play yet, there's no cadence set out. It may suit your organisation to do this monthly, or quarterly, and adapt that decision later to fit with requirements.
You'll need to support the changes with a clear route to change, governance and engage support across the organisation, from the top down. That all adds up to a lot of process work and those who have already got a BPMS and BPM skills in place will develop and operationalise the new reporting framework more efficiently and with a lot less fuss and organisational angst than those who have yet to invest in BPM practices.
Regardless of your current position, be aware that there are strong indications that FDA will implement FDASIA, they will demand the collection of metrics and they will use the metrics to inform a risk based approach to inspection.
Ask yourself, will your organisation be ready (and don’t you need these metrics anyhow?)
As always, if this is something Torque Management can assist with, don't hesitate to contact us to find out more about our rigorous process methodologies and consultation services.