Product and service quality is key in any industry. For life science companies, quality is mission-critical.
The consequences of getting quality management wrong are significant. But getting it right is becoming more and more difficult. Staying up to date with ever-evolving regulatory frameworks and compliance requirements is increasingly challenging, while at the same time pressure to manage and reduce costs is increasing.
Increasing supply chain complexity is a contributing factor. As well as maintaining quality standards for their inhouse production facilities, companies are also responsible for ensuring standards are maintained across an increasing number of external suppliers.
The supplanting of traditional functional and hierarchical structures by newer ways of working such as value stream organization and cross-functional team set-ups presents additional challenges. Supporting these emerging operating models requires a fundamental redesign of quality organizations. Meanwhile, as in every other industry, the Covid-19 pandemic has heightened these challenges and created new ones - such as the difficulty in achieving quality objectives with significantly reduced on-site access.
But there are also significant benefits for those who do get it right. Reduced costs, improved productivity, increased consumer trust and more constructive relationships with regulators are all sources of tangible competitive advantage. Genioo’s combination of deep industry knowledge with hands-on quality and program management expertise can help you get it right - and reap the benefits.
How we help
We work with clients to implement practical changes that directly impact quality performance in three critical areas:
- Quality improvement: We work jointly with individual sites to prepare for FDA audits and remediate any issues arising from them, including detailed visit preparation, strict program management for readiness, cross-functional improvement planning and rigorous prioritization of issues with subject matter experts. We have an outstanding track record of turning around sites with FDA 483 letters and ensuring subsequent inspections after passed. We also work closely with your people to develop and implement quality culture change programs with strong local leadership to drive improved quality performance over the long term.
- Quality Spend Efficiency: Our proprietary Quality Spend Efficiency (QSE) program employs a proven four step approach to capture send improvements from both quick wins and structural changes.
- Quality organization: We help businesses review their quality organization to match emerging production models aligned around the value stream. Our approach reviews your existing organization through three lenses: structure, processes and activities, to identify what needs to happen on a local, regional, or global basis to achieve your objectives.
Lasting change, lasting value
We work alongside you to implement effective quality culture change initiatives. We ensure your people retain ownership and accountability – so the changes and benefits endure long after we have gone.
We have a strong track record of quality improvement, including turning around sites with FDA 483 letters across all continents, delivering improvements without adding risk to existing systems and ensuring subsequent inspections are passed.
Through our proprietary Quality Spend Efficiency (QSE) program we typically deliver 6-8% recurring spend reduction, while improving the output delivered.
Consultants & SMEs with Quality expertise
Quality projects for global brands