Sophie Willink 
11 May 2021
Organisational agility is critical when operating in highly regulated industries. Without it, responding to changing regulatory requirements, customer demands, and fast-paced market conditions simply would not be possible. Implementing an agile QMS is a great way of facilitating agility and can positively impact every aspect of an organisation’s performance. Cost can be removed, processes can be streamlined, and a competitive advantage secured.
However, this is not achieved by the simple act alone of having a quality management system in place. Not all quality management systems are agile and choosing the wrong one risks making processes more cumbersome than not having one at all.
What does an agile quality management system look like?
An agile QMS will help your organisation achieve regulatory compliance and drive forward quality.
There are some key characteristics to look out for:
Quality goes beyond compliance
Companies should focus on implementing a system that allows them to pursue value beyond compliance. This means a system that is in a state of dynamic improvement. Quality policies should be in place to ensure processes, skills and systems are constantly improved.
Simplicity
Simplicity is an essential characteristic of an agile QMS. Highly regulated industries are often at risk of requiring overly complex processes. Such processes are not only more difficult to audit but can also pose a risk to compliance. An agile QMS should be lean and simple, purposefully streamlining and simplifying processes to save time and valuable resource. The simpler a QMS, the easier uptake will be and the simpler it is for employees to follow quality processes.
Create a culture of quality
The QMS should enable the organisation to operate flexibly and with a quality driven culture. It will ensure compliance with ISO, MHRA, FDA and other regulatory bodies, but a common pitfall for organisations is concentrating on complying with regulatory requirements to the detriment of agility. This can be more of a risk than organisations realise; for example, if your regulatory agency introduce new requirements which require a central change in processes, can you react quickly and appropriately? This could be a struggle if you work wholly with rigid operating procedures.
An agile QMS will help you achieve a quality-driven culture with the flexibility for process iteration.
Streamline software requirements to save money
An agile QMS will make full use of digital technology to help organisations operate flexibily, with transparent functions and streamlined processes. However, there can be a tendency for companies to pay for software features that do not give them any tangible benefits. This comes back to over-complicating workflow processes, which can eat through budget and sometimes not make sense to end users. This in turn can lead to resistance, confusion and quality issues.
This comes back to the simplicity of an agile QMS, purposefully designed to give you more visibility of the features you use and need.
What does this look like in practice?
Ideagen help organisations around the world implement agile quality management.
A useful example is to look at how a world-class academic and healthcare system, Duke University Medical Center, went from around 300 paper-based SOPs to completely paper free by implementing an agile QMS.
“In terms of paper, a lot of the labs we have are Biosafety Level 3 Labs (BSL) so once paper goes in, such as checklists and SOPs, it is very difficult for it to come out, without following appropriate quarantine procedures. The really great thing about the apps is that having everything on the tablet allows us to keep it on a clean surface and, if there is any doubt, we can simply wipe it down with ethanol.”
Here, the agile QMS allowed the team to operate flexibly whilst maintaining the necessarily high clinical standards and hygiene requirements. By enhancing their quality management’s agility, they were able to streamline their processes and maximise their operational efficiency.
Learn more about the benefits of applying an agile QMS in practice. Download the full Duke University Medical Center case study here.
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