Starting the journey to design and implement a quality management system (QMS) or even maintaining the one you have can seem an incredibly daunting task. It's not always easy to know where to start, and it’s often even more difficult to know where you are trying to get to. Having worked in a number of different sectors designing and implementing bespoke quality management systems, I want to share some common challenges I have seen and the lessons I have learned over the years.
1. There is no set way to do it!
Of course, there are ‘off the shelf’ systems out there that are ready to roll out, but this really misses one of the most fundamental points of the ISO 9001:2015 standard. Yes, the standard identifies aspects of the QMS that must exist: it does not, however, give you a blueprint to follow, but encourages you to design the system around your business needs and expects you to focus on those things that pose the greatest threat to success. Just because another company has KPIs around cashflow and quote conversion that doesn’t make it right for you.
Don’t set out with a pre-conception of how your management system should look or feel based on what has been done before. Only use existing templates if they really add value to your process, reflect the things you want to record and allow you to describe processes in the way you need. Identify those elements that have the greatest effect on your business and build your systems and processes to manage them.
2. Develop an implementation plan
I have seen companies that have enormous vision and ambition fail by trying to do too much too quickly. Improvement is a critical part of a QMS, but it is a journey, not just a single step, and needs to be planned accordingly. A perfect example of this was a company who implemented an electronic tracking system throughout their entire production facility in a single improvement project and managed to decrease productivity by 20%. The issue was certainly not the vision of what the technology could do for them or the benefits it could undoubtedly bring, it was simply too big a step too soon.
Break bigger improvement projects down into manageable steps and make sure you allow time to reflect on any lessons learned before moving on to the next stage. Change management is a delicate process, especially when it affects a lot of people, and so communication and collaboration are key. See our change management blog for some more helpful tips.
3. Start small and build
Resource is a precious thing. Many companies have found maintaining all the requirements of a quality management system can be a drain on resource, and in almost all cases it isn’t a lack of resource, it’s a lack of focus. One of the common areas I see where systems start to struggle with resource is non-conformance management, and while this is a major component to an effective system, BSI’s audit statistics show that the majority of QMS audit non-conformances are associated with this very aspect. Companies fall into the trap of believing they have to thoroughly investigate every non-conformance, develop an improvement plan and then monitor the improvements because that’s what the standard requires.
What the standard requires is proportionate action and risk-based decision making: it does not mean every non-conformance demands the same level of response. Ask yourself these questions, ‘What is the risk of this happening again if we do nothing? How often could it happen, and what would be the impact?’ If the answer is that the risk is very low, then concentrate your valuable resource on the areas where the answer is that the risk is high.
4. Seeing it through!
Often companies get halfway through an implementation, and enthusiasm dips, focus starts to wander back to the day to day tasks, and progress limps along until it’s cast aside as yet another fad.
Of course, I have a slight bias towards recommending the use of a consultant – to some extent however, with or without one, the lessons remain the same. Be realistic from the outset with both the resource available to undertake the design and implementation and the competence and sustainability of that resource. An effective system needs a significant amount of input internally, and even with the use of a consultant, there needs to be a commitment to ensuring this resource is made available so focus isn’t lost to day to day activities.
Make the system work for you!
A well-defined management system should be the result of collaborative efforts and ownership, not the vision of a single person. It should be designed and implemented with the intention of helping you consistently meet customer and regulatory requirements in the most efficient way possible. It should be a living, breathing environment that supports and drives a company to improve itself and adapt to changing needs through continuous improvement, and should never become an inconvenience or an obstacle to achieving objectives.
If you’re setting out on the journey, or facing similar challenges already, have a chat with one of our experienced consultants today to see how we could help you ensure your QMS adds value without draining your resources.