The ability to be flexible and responsive to your customer’s needs is a critical success criterion in the clinical arena, and as things can change so quickly, agility is equally as important.
Alongside internal factors that can affect a study, there are also the external factors to monitor and respond to: political, economic, social, technical, environmental, and legal.
The arrival of Covid-19 has been quite clearly an exceptional situation; one that has had a significant impact on the industry, with ClinicalTrial.gov reporting 200 oncology trials being suspended between March and April 2020.
The ability of an organisation to be agile to both these internal and external factors is more important now more than ever.
When my Chief Operating Officer, Phil Hargreaves, and I established Cryosphere Services, rebranded to Cryoniss in May 2020, we set out our vision for the company: to be a truly customer-focussed sample storage and logistics management company, that can guarantee the quality of our customer’s irreplaceable samples.
Building an Agile Company
To achieve these two primary aims, we had to build a company based on expertise, transparency, agility, honesty, and consistency.
This last quality is the key challenge to any organisation, consistency. It is straightforward to implement a process that delivers a high-quality service, but future proofing delivery against both internal and external factors is the recipe to success.
The first step is to acknowledge that change is inevitable, and that we cannot guess every challenge that the future holds. Despite being incredibly risk averse, my crystal ball certainly did not foresee SARS-Cov-2!
Secondly, is to understand that we are all human, and even the most skilled people will make mistakes. Therefore, processes must address these unknowns.
When first establishing Cryoniss, we focused on developing a continual improvement culture based on the principles of Lean Six Sigma, of which the first principle is ‘always focus on the customer’.
I called it Kaizen Philosophy and Phil called it Common Sense. This flippant comment highlighted a key decision point; do we spend resource training current and future staff in the acronyms of PDCA, DMAIC & DOWN TIME?
After a combined 25 years working in large corporations, this would break our resolution to shelve the acronyms and embrace plain speaking English. Plus, I was already losing too much money to the “acronym jar.”
Therefore, we built a Quality Management System founded on the principles and toolkit of Lean Six Sigma but removed the need for a Japanese-to-English dictionary. This continual improvement philosophy is an integral part of every aspect of our processes and procedures, and more importantly our culture.
Identifying opportunities to improve is the first step. These can come from customer feedback, formal audits, deviations and errors in service, tasks taking too long, official process review sessions (Kaizen) or that 3am “Eureka” moment.
No matter how big or small, improvements all add up over time; capturing them is the key.
For Cryoniss, aside from the important Corrective Action Preventative Action, Key Performance Indicators and Customer Feedback trackers, the little ad hoc thoughts of ‘could this be improved’ are captured in a SharePoint Planner bucket.
Whilst a focus on continual improvement is important, any potential changes must be considered based upon their impact, resourcing, and potential for affecting other internal and external processes.
Cryoniss leadership reviews all the ideas captured and initiates a plan of action for each suggestion: just do it; start a project to investigate (Define, Measure, Analyse, Improve, Control); great incremental improvement idea to be included in the annual November process review (Kaizen event), or not viable at this point in time but captured for future consideration.
Identification of root-cause analysis is a key step in identifying potential solutions to problems. We have implemented the ‘5 Whys’ approach for significant change control projects or for incidents/accidents as part of any Corrective Action and Preventative Action investigations.
Implementation of changes is a critical step, especially with customer focusing processes, therefore solutions, once identified, must be rolled out carefully and the customer should not experience any disruption to service. This is where the existing mechanisms for capturing feedback and deviations are already in place.
Ongoing monitoring of these improvements, and the continual improvement mechanism itself, is critical to ensure the consistency of service delivery. At Cryoniss, this is managed by the Compliance and Ethics committee, which includes an external Quality Assurance Consultant.
This team reviews the trends in key performance indicators, Corrective Action Preventative Action (CAPA) investigations and customer feedback, alongside the Continual Improvement Tracker opportunities.
This provides a clear view of how our team is truly performing against our companies ISO9001 Quality Objectives, including the delivery of a high-quality customer-focused service.
To date, this mechanism has been 99% successful at addressing the root causes of problems. To tackle that last remaining 1%, I admit, I will get the team together, with a plethora of post-it notes, brown paper everywhere, and use every tool in the Lean Six Sigma toolbox to resolve the issue.
Having a mechanism to capture ideas, carefully consider solutions, implement changes, and monitor and review implications is one thing, however this is only ever successfully achieved with the right team with the right attitudes.
The key to this is ensuring a no-blame culture is in place, and this must be lived by Senior Leadership. At the end of the day, in a highly regulated company such as Cryoniss, employees are recruited based upon their capabilities and competency to carry out a role.
Everyone is provided with extensive training, tailored to both their role and the best way they learn. Trainers sign off employees as being competent to complete a task, therefore if a genuine mistake is made, either an employee has not had sufficient training or there is an opportunity to prevent human error in the process (mistake proofing, or Poka-Yoke). In this situation, the mechanism picks this up to review and proceed depending upon the best way forward.
World-Class Facilities and Processes
Whilst Cryoniss has world-class facilities and processes in place to ensure customer’s samples remain of the highest quality, our customers stay with us because our entire team has ownership of the service and takes pride in what we do.
There also is a slight competitive edge provided by the challenge as to who can implement the most impactful solution to the business, impartially judged by the Board. Last year, Phil triumphed with his suggestion to implement a UK Electronic Communications Act compliant e-signature application for chain-of-custody documentation.
We now have 100% compliance, up from 60%, in the completion of chain-of-custody sign-off and have saved 1.1 billion kg of carbon dioxide to date.
This ownership by the team is the reason we have not implemented any tie-in periods, or reservation fees to our customers’ contracts. We believe that by placing the customer at the centre of our values, and by listening to their needs and feedback, we will continue to deliver an exceptional service.
2020 has been quite the year for Cryoniss. Our headquarters are at Alderley Park, where we have our world class vapour phase liquid nitrogen facility. However, a week before lockdown we opened our brand-new second premises at The Heath Business and Technical Park for storage of samples from ambient, +4°C, -20°C and -80°C.
With all the latest toys in place, including two independent laboratory monitoring systems, including watchdog functionality, all the storage units cleaned, serviced, UKAS validated temperature mapped and full end-to-end validation in place, including a fully stress-tested Business Continuity Management System, we were ready to hold a well-earned opening party.
Aside from continuing to provide next-day access to their samples, we have helped customers move labs to continue trading and implement logistics solutions with our courier partners that guarantee sample integrity when flights are cancelled repeatedly due to Covid-19.
We have attained accreditation for the new facility including MHRA WDA (Human), Human Tissue Authority (HTA), Animal and Plant Health Agency (APHA), Health and Safety Executive (HSE) and ISO9001.
We launched our new corporate brand and new quality control testing service for cell lines used in pre-clinical research, recruited a Documents Manager and supported two virtual internships.
As I receive a meeting request from Anna for the next Compliance and Ethics Committee meeting, I am pleased with how our Kaizen/Common Sense Philosophy has enabled us to truly be agile to our customers’ needs during such a uncertain time.
This is real testament to both our amazing team and our partner network of experts that support our efforts to provide an excellent service, ensuring our customers can focus on what they do best – exceptional science.