Building a quality management system is never a quick and simple process. But in medical device development, where regulation is tight and penalties for non-compliance can be severe, the danger of ‘over-processing’ in your QMS solution is always present.What is over-processing?
‘Over-processing’ is one of the 7 ‘wastes’ that LEAN manufacturing looks to eliminate in its drive for more frictionless, efficient and profitable procedures. When it comes to documentation in a business, over-processing can include generating more detailed reports than needed, requiring unnecessary signatures on a document, or micro-documenting processes and workflows in a way that adds no real value to an end user.
Is over-processing affecting your Quality Management System?
In his latest article on LinkedIn, our client Shaun Knights, Head of Quality and Continuous Improvement at Callaly notes that this habit of ‘over-processing’ often adversely affects the efficiency and efficacy of medical device Quality Management Systems.
But how does it happen?
Too much documentation can obstruct quality objectives
Established medical device developers may be clinging on to legacy quality management systems, with all the layers of process and complexity added to them over time. Throughout a product’s lifecycle new quality documents may have been created and new steps to SOPs added as part of corrective actions or product upgrades. As changes to process are made and documentation grows, without regular review and overhaul, they can easily end up in an unwieldy state.
At the other end of the scale, start-ups often choose to adopt expensive, heavy-duty med-tech eQMS systems (as used by big pharma companies) in an attempt to make themselves as ‘bullet-proof’ as possible when it comes to regulation. Having signed up to an eQMS package they can find the templated SOPs far too complicated for what they require, but still they’re stuck with them.
In both cases developers may end up with a QMS that is too large, cumbersome and stuffed with overly complex documents and SOPs. They can describe required procedures in ways that are difficult to follow or are so detailed and onerous that they simply end up being ignored.
Over-processing is a compliance risk
Shaun Knight reminds us that for some businesses “having 60+ page policies or procedures detailing a particular process is not unusual.”
And this not only represents a waste of time and effort, it can often end up adversely affecting the very quality outcomes they are intended to assure:
“a regulation might have four or five bullet points for a given topic which you are required to demonstrate compliance with through your QMS. By having procedures which require well beyond the given regulation, you are not only over-processing and doing more work than is required, but you have given yourself a higher risk of non-compliance due to the size of your documented process.”
Becoming leaner - 6 ways your eQMS can help stop you ‘over-processing’
Documenting and prescribing too much process within your quality system can be as dangerous as documenting too little. And as Shaun Knights points out, if your quality system is convoluted, bogged down in detail and hard to use, auditors may
“question whether all relevant employees are performing your process as you state that you do in your procedure.”
So, what eQMS will help you ‘right size’ your approach to quality documentation and reduce the wasted time and effort of maintaining a sprawling and unnavigable system?
1. Focus on clarity and concision: Many of the required quality processes in standards such as ISO 9001 and ISO 13485 are described only in a few lines. And, in fact, there are only a handful of clauses in ISO 13485 that prescribe exactly how a task must be undertaken. Developers should, therefore, focus on refining their process and their documentation, so that it reflects ‘how they do things’ in a way that will make sense to the people who need to learn and refine the task. Make sure your chosen eQMS is flexible enough for you to define and develop your own SOP workflows – rather than insisting you work in ways prescribed by your supplier.
2. Adopt a graphical approach It’s a cliche that ‘a picture paints a thousand words’ - but it’s true. A graphical eQMS helps you build out visualisations for your SOPs that provide a clear breakdown of what is required of those performing them. It can help you focus on describing tasks with economy and immediacy so they can drive the adoption of best practice. Compared to a 60 page document of densely written instructions, a flow chart can show you the crucial decision making moments within a process that really affect quality outcomes, rather than over-prescribing actions and getting the reader lost in a maze of extraneous detail.
3. Use different formats where appropriate A good eQMS supports the use of other documentation formats to help the business record and replicate their quality processes. Photos and videos can and should be integrated into your quality system to help ‘show’ workers what is required. LEAN documentation techniques like these minimise time wasted by workers in trawling through and interpreting overly complex written instructions.
4. Make information easily accessible Published via an intranet, and indexed properly with meta-text, the contents of your eQMS can become more easily accessible and searchable. It can help those who need to access SOPS for their work quickly find what is required of them. It minimises ‘waste’ by providing exactly the information ‘that is needed, at the right time, to the right audience — and nothing more.’
5. Ditch the ‘wasted paper’ Printing and binding written paper training manuals can be a waste of time and energy, as they quickly become outdated. An eQMS can replace physical training materials with digitised learning guides that always show the most up-to-date version of your documentation. In cloud-based system, documents are digitally linked with each other to provide a structured and consistent introduction to all your quality processes that is faster to access and easier to keep up-to-date.
6. Strive for continuous improvement The LEAN methodology looks to make operations ever more efficient by continually improving your process. To achieve this you should choose an eQMS that makes worker engagement and the optimisation of your quality system central to the ‘way you do things’ The right eQMS should prompt your business to:
- Regularly review process and documentation
- Make changes to make them leaner and more effective
- Record what has been done
- Notify you to check that changes have had the desired effect.
Choosing the digital QMS tools that lets your company create SOPs that are ‘right-sized’ to your business will make it more likely that they are followed and achieve the required outcomes. Ensuing that you are continually reviewing and optimising the way you work will ensure you are keeping your processes and documents as LEAN, effective and compliant as possible.