They can be used for training purposes by new joiners or existing staff members as a way to ‘top up’ their understanding of internal procedures and best practice. Having these diagrams easily accessible to a workforce is one of the requirements of ISO 9001 and ISO 13485. They’re vital, not only to ensure quality and consistency in your output, but also as a way of facilitating continual improvement of all your business processes.
A closer look at Document Control for ISO 9001
The method by which these maps are created in the first place is hugely important.
It can make the difference between process maps that define ‘the way you do things’ as a company - and process maps that are unhelpful, theoretical, and never referred to again.
In this blog post, using the experience of the companies and quality consultants we’ve worked with over the years, we make some recommendations about the best way to map your business processes and make them an essential part of your Quality Management System:
Even if you’re working in the high tech sector, you can begin business process mapping in a fairly low tech way. Don’t try and start mapping immediately in Visio, Powerpoint or Word. Start as simply as possible with a pen and a flip chart, it’ll help you really stand back and look at your process as a whole as you go along. It’ll also help you collaborate more successfully with other members of your team.
Bring together the people who carry out the task you are documenting to help you get it down on paper. The people who do the job know everything about it, after all, and are best placed to understand and explain the pressures involved in carrying it out. It’s no good someone who is removed from the process deciding how it is done or how it should be done without consulting others. If the ‘process maps’ are worked on and developed by the team who deliver the tasks they describe, they will be much more accurate representations of the task itself, and there will be a greater sense of ownership of the output.
Although you need the people who undertake the task to help you document it, it can be useful to employ someone from outside the team to manage and adjudicate the mapping process. A neutral observer can bring a fresh perspective on thinking that has become entrenched and ask important questions to prompt new ideas as you proceed.
With one person leading the session - start describing the process you are mapping out in detail. What are the inputs? What are the desired outputs? What are the things that need to happen along the way to achieve that output. Draw the process out as a simple flow diagram, note the task’s requirements and dependencies. See the moments in the process where key decisions need to be made and the possible outcomes of each. Like a real-world map, your workflow diagram should allow you to orient yourself precisely within a task, letting you trace your steps backwards and forwards from any point within it. All this will help you understand the process more deeply and help you optimise it more effectively.
This is a key part of this stage of Business Process Mapping. If you are working with the team who undertake the task on a daily basis, they may all approach the job in different ways. You need to understand how and why these approaches differ. As your objective is to document ‘the way you do things’, at this stage you need to decide definitively how a task should be done in the future. A collaborative approach will help you agree the best way of tweaking processes so that particular objectives can be met and the risk of process failure minimised. Collectively, it will help you decide on and agree the best and most efficient way to perform a task, so that it can be replicated consistently and to the same standards time and time again.
While you need to capture all the elements of a process and record them in a QMS, you should avoid creating documents that are too complicated or dense to be useful as quick reference materials. By the same token, a guide to carrying out a task can’t be too sparse otherwise it won’t help anyone grasp the basic procedure it is describing. Using a lightweight intranet solution may be the answer, in which these process maps become dynamic, on line, flow diagrams. With these kind of products a process can be described simply and visually, but with deep hyperlinks to more substantial detail that might be required, such as regulatory documentation or technical manuals
Created by the teams who own each business task and transcribed onto a centrally accessible intranet, these process maps can now be used as a dynamic resource by everyone in your organisation. And this kind of resource is exactly what ISO 9001 and ISO 13485 suggest can embed ‘risk based thinking’ within your organisation and encourage a more proactive approach to quality management. As an easy to use reference guide sitting at the heart of a business, these process maps can become a focus for efforts to identify new solutions to old problems within your operations, eliminating waste, creating more efficiencies - helping your business to evolve and grow.