The recent pandemic challenged manufacturers across the globe to allow society to adapt to the problems caused by the Covid-19 virus. In the UK, one major issue was the potential impact on the NHS caused by the influx of patients requiring admission into intensive care and access to a ventilator to assist breathing. It was clear the NHS did not have enough ventilators and there was a sudden global increase in demand, meaning that we were going to have to find ways of producing them domestically. There are some smaller scale manufacturers of ventilators in the UK, such as Penlon and Smiths Medical, and it became clear that part of the solution lay in rapidly upscaling the production of their models. The government asked Dick Elsy, CEO of the High Value Manufacturing Catapult, to convene a group of the UK’s top manufacturers to work out how to use spare manufacturing capacity in the automotive and aerospace sectors to help plug the gaps.
Penlon and Smiths Medical would usually be able to produce 50-60 ventilators per week. However, the consortium figured out that they could produce a combined total of up to 1,500 units a week of the Penlon and Smiths Medical models within a matter of weeks. A major difficulty they faced was the complexity of these devices. Their safe deployment and use was of paramount importance, if patient safety was to be assured.
This process has been successful, with the MHRA approving both devices by the middle of April. But how did such a disparate group of manufacturers from a wide range of sectors manage to rally round and respond to the challenge so quickly and effectively. The answer lies in achieving excellence in collaboration, and it is this development that gives rise to several opportunities for manufactures in future years, even when Covid-19 is no longer a problem. Supply chains that can react and adapt to rapidly changing circumstances will be able to compete effectively, and manufacturers need to be able to put those good collaborative practices into place now in order to be part of that exciting future. Global supply chains have been shown to be fragile and the race is now on to create more resilient ones, building on better collaboration and technology adoption.
1. Better collaboration
BSI is a leader in good collaborative practice, and it was UK leadership that led to the development of ISO 44001 Collaborative business relationship management systems. ISO 44001 describes good practice in several areas that will lead to better collaboration and business improvement through:
- Improved engagement
- Stronger processes
- Improved risk management
- Enhanced skills
- Sustainable relationships
Within ISO 44001 there is an eight-stage journey of a collaborative business relationship and what organizations need to do throughout the process do collaborate better. These stages are:
- Awareness: identify if collaboration is an option for the organization
- Knowledge: identify the benefits of, and build the business case for, collaboration
- Internal assessment: identify if an organization is able to collaborate
- Partner selection: set the process to find appropriate partners
- Working together: develop a model for collaboration
- Value creation: develop a process for continual improvement
- Staying together: manage, monitor and measure the relationship
- Exit strategy: develop a mutually beneficial way to end a collaborative relationship
Find out more about how ISO 44001 can help your manufacturing business improve its performance through better collaboration.
2. Working across sectors
A major risk factor in the Ventilator Challenge has been the assurance of patient safety. Recent fires caused by ventilators attached to Covid-19 patients in Russia has highlighted the need for stringent safety checks on these devices. The manufacturers from the automotive and aerospace sectors are highly skilled and well used to designing and manufacturing machines that operate effectively in a highly regulated and safety conscious sector. The demands of ventilators, however, are very specific and it was essential that these manufacturers from other sectors could quickly learn what was required, and make it clear to the MHRA that they were aware of what was needed and could demonstrate that the ventilators being produced were not going to put patients at risk.
Across the globe medical device manufacturers show that their quality systems comply with ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes, and are able to demonstrate that they can market their products both legally and safely. In the automotive sector there is a management system standard known as IATF 16949, a management systems standard that harmonizes the different assessment and certification systems in the global automotive industry. Within aviation there is AS 9100 that performs a similar function in the aerospace sector.
In the case of the Ventilator Challenge companies from the automotive and aerospace sectors, while being certified to at least one of the latter two management systems standards, needed to rapidly adapt their processes to be compliant with ISO 13485. BSI, by working with teams of experts, was able to establish what was common among the different standards and what was different, and published these in the form of comparison tables on the dedicated Covid-19 ventilators webpage.
The ability to be able to operate across a number of highly regulated sectors helps manufacturers to be more resilient and also to contribute to more resilient supply chains.
3. Digital adoption
Once a manufacturer has put into place processes that create business improvement from better collaboration and has a quality system that can work across different regulated sectors, then it can experience further improvement by using digital technologies for even better collaboration and higher levels of quality. Once again, the manufacturer has to establish what business benefit will arise from digital technologies, and assess what digital technologies would best deliver those positive results.
BSI has developed PAS 1040 to help manufacturers assess their own digital readiness and to be able to make better, more informed investments in digital capabilities. This guide is free to download.