“MILLIONS of J&J COVID VACCINES RUINED DUE TO HUMAN ERROR” - REALLY?
Martin Lush
Quality System Simplification (Agility) & QMM Specialist : Culture (behavioural change) expert : Biotech Ops & QA Executive Leader : AI Innovator : NED : Leadership Coach : Qualified Person
Reading time:One minute
Human error is rarely the cause of mistakes. On reading the New York Times report, my first reaction was: Please don’t blame the person – as human error is usually the consequence of broken systems.
My second response was, on behalf of all patients, one of gratitude. After all, the company’s systems safeguards worked. The mistake was detected, and the distribution of defective vaccines prevented.
Lastly, I wasn’t surprised. Mistakes happen. Making vaccines is complex, and people aren’t perfect, particularly when working 24/7 with new processes and complex procedures under such public and political scrutiny. This will not be the first or last ‘mistake’ that leads to vaccine shortages.
BUT it doesn’t have to be this way. The probability of so-called human error can be significantly reduced by taking some simple steps.
Your call to action: If you want to reduce the probability of errors, this 1-minute read provides access to a range of error reduction tools and techniques. Please share widely so others may benefit.
The NYT article concluded with "the causes will be further investigated".
So, to those responsible for the investigation, please DON’T:
- Blame anyone, particularly those at the ‘sharp end.’ Blame only creates fear, promotes ‘scapegoating,’ and prevents any meaningful root cause investigation. All blame does is allow mistakes to happen again, drive future problems underground, and demotivate people trying to do their best when you need them most.
- Add additional complexity to systems. Over complexity is the single greatest cause of so-called human error. Don’t make it worse by adding more dangerous distractions (complexity).
- Additional checks or signatures to give the illusion of risk reduction when they do the exact opposite: more boxes to check = more distraction + dilution of accountability = increased risk of errors and mistakes.
- Let management run the investigation in isolation without including those involved, hands-on, in the manufacturing process. These are the experts with the practical solutions.
AND Please remember:
- So-called ‘human error’ is usually the consequence, rarely the cause of mistakes. It should be the investigation starting point. Rarely its conclusion.
- Before you start investigating, make sure you truly understand the causes and prevention of human error. NSF built an entire webinar around why we make mistakes.
- Most mistakes are due to overly complex systems, so focus on the systems, not the person. Errors are due to multiple systems-related factors and not a single root cause. So, fix the system, don’t blame the person. If your final preventive actions include ‘improving motivation,’ ‘retraining,’ ‘disciplinary action,’ ‘additional checks’ or ‘writing a new procedure.’ Start again. You’ve missed the point. Your investigation and its conclusion will make the situation worse.
- If you’re serious about error reduction, you must become obsessed with simplification. You can’t achieve one without the other. If you’re sick of over-complexity, here's your medicine chest
- Don’t focus on this single incident. Broaden your investigation. Ask yourself, ’Do similar risks (system failures) exist elsewhere?’ In my experience, the answer is usually yes. One error usually means similar risks in other areas.
- Remember. Your key question is not who blundered but how and why systems failed? This includes critical business systems from workload management to IT infrastructure and everything else in between.
And finally, please share your findings so others may prevent errors and mistakes just waiting to happen.
For those of you serious about reducing error, take a look at these free resources and let me know if you need more ([email protected])
· NSF's 6-2-Fix-in-6 Video: Human Error Prevention
· NSF’s 6-2-Fix-in-6 Video: SOP Complexity
· Simplification Case Study Part 1 and Part 2.
And Finally - I need YOUR help:
Apart from human error, I’ve been considering some of the most impactful ways COVID-19 has changed the world of health sciences in the run up to my panel in the Financial Times Global Boardroom on May 4 – 6. Tell me what cultural shifts YOU think my panel should focus on and your views on the questions raised here – I want to represent you and help bring your ideas to the panel. And of course, if you wish to attend any of the panels between May 4 – 6, you can register here, use promo code NSF10 to save 10%. I hope to see you there and please send your thoughts and ideas ([email protected])
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3 年Very Interesting read.
Associate Director Upstream Drug Substance Manufacturing hos FUJIFILM Diosynth Biotechnologies
3 年Excellent written - please read!
Compliance Consultant--Audits, Responses and Remediation.
3 年Good article. Couldn't agree more. We have all seen 'More training" as the "corrective action" without delving deeper into the root causes. Simplifying complex systems takes a lot of work, think of the iPhone with a single button having multiple functions. Equally, "More training" often belies complex systematic failures - especially when the used for repeat failures.
Expert consultant in pharmaceutical quality and compliance Consultor en calidad farmaceutica
3 年I’ve Not read this through yet, but here’s the 483 for your edification. https://www.fda.gov/media/147762/download
Senior Director Quality Assurance
3 年Like they say "Cannot agree with you more"