FDA’s Quality Metrics help Quality by Design?
Are you searching for business cases for QbD to persuade senior executives? As a QbD evangelist, I am. If you are constantly trying to sell the benefits of Quality-by-Design, then FDA’s new Quality Metrics is worth a look. The new FDA Quality Metrics should help many QbD (Quality by Design) professionals , whether you are in Quality, Regulatory or Operational Excellence to sell their case in the near future.
When FDA talks, our industry listens. It’s the perfect business case for senior executives. Initially, I think this is more powerful than the internal benefits case – the typical cost reduction story. Sometimes you need an external impetus like the FDA to kickstart an initiative. When companies start implementing, they will self-recognize the business benefits. Therefore, this could be a “black swan” (big change driver) to drive Quality by Design.
I summarized the relevant points from ISPE’s proposal on Quality Metrics.
(References: ISPE Whitepaper on Quality Metrics, Quality Metrics Initiative)
Below are the potential Quality Metrics proposed by the working group.
1.Lagging metrics:
- Batch Failure Rate
- Right First Time
- Out of Specification (OOS) / Laboratory Failure Investigation Rates
2. Leading metrics:
- Quality System Effectiveness
- Process Capability
- Quality Culture Index
Interesting to the QbD community is the “Quality Culture Index.”
The whitepaper defines, it as metrics to “evaluate evidence of investment in resources, time and money in building a company’s quality culture.”
Under the quality culture index, below are the attributes that could be measured :
i. People
- Technical/QA Training/Education Rate – All employees with direct impact on product/data (Design of Experiments, SPC, Six Sigma, etc.)
- Effectiveness of Training/Education
- Management Accountability for Cultural development; promoting and supporting quality
ii. Places
- Investment spent in new and existing facilities, equipment, utilities (possibly PAT investments?)
iii. Performance
- Frequency of Quality Management Performance Review Meetings
- Level of proactive actions and assessing trends for signals to drive Continual Improvement projects
iv. Prevention
- Quality Risk Management Processes (Risk Assessment linking QTPP-CQA-CPP)
- Internal Audit Programs
- Global CAPAs – Systemic Assessment across networks
- Best Practice Sharing to drive continual improvement
I’m not sure whether reporting quality metrics will be voluntary or mandatory yet. However if I was the head of Quality or Business Excellence, this would be an external impetus to drive continuous improvement. At the same time, industry may resist, claiming FDA has gone too far.
If this ranking of drug companies were to be public, it will have PR effects much like the USNews’ University rankings. People will start paying attention and this will inevitably influence business decisions. It will certainly put pressure on companies to improve their processes, rather than merely having “in-spec” products.
We could certainly take a proactive position to leverage this info. I plan to use this information to make a stronger case for Quality-by-Design.
What are your plans to take advantage of FDA’s Quality Metrics initiative? Please share with the community by commenting!