Quality Blog

Length and breadth of a quality management system
John Mason - Friday, April 28, 2017

So we have determined what we do. We have tried to explain what we do. We have even taken into consideration what others, both internally and externally want to do. Now it is time to determine and possibly describe the length and breadth of the quality management system and its processes to enable us to do what we do and to continually do it better. So easy, I hear you read. Well there is a beautiful caveat at the end of this post which will make it easy, but I won’t spoil it here. And so the all the standard really wants is…. That your company has established, implemented, maintains and continually improves the Quality Management System, including the processes needed and their interactions with themselves, and finally in accordance with the requirements of the standard itself. Total quality speak. But it does go on to state that the company has determined the processes needed for the Quality Management System and their application throughout the company. Yes, the whole company. No longer can we ignore accounts, marketing, R&D and so many others. So now that the standard has become all encompassing, it then goes on to require the following 8 criteria to make you compliant. Read on.  

The first four and indeed the next following four is purely a list of actions for review. More specifically the first four are determinations. Have you determined; the inputs required and the outputs expected from these processes; the sequence and interaction of these processes; the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes; and finally, the resources needed for these processes and ensure their availability. A bit of a checklist really and rather pointless as each is described and prescribed in at least one other clause or sub clause in the standard.

The next four have their very own action words to help us assess. These are, have you; assigned the responsibilities and authorities for these processes; do addressed the risks and opportunities as determined in accordance with the requirements of 6.1 (oh please the first double cross reference to stymie the uninitiated); evaluated these processes and implemented any changes needed to ensure that these processes achieve their intended results; and finally, improved the processes and the Quality Management System. Deep breath.

But then comes the caveat, and one buried deep in a sub sub sub clause of the standard goes on to say…. To the extent necessary, your company maintains documented information (policy, procedure, instruction, etc) to support the operation of its processes; and retains documented information (records) to have confidence that the processes are being carried out as planned.

To the extent that is necessary. No requirements from the standard. No requirements from industry, market and let’s hope no perceived requirements from your chosen certification provider. I also hope the person you have chosen to design, implement and support your quality management system also has the commercial acumen to build you a system your company deserves to the extent that is necessary, not what is expected.

Length and breadth of a quality management system

John Mason - Wednesday, March 29, 2017

It is in the context?

Following hot on the heels of last month’s ‘what do you do?’ comes a further explanation of context. The standard itself wants answers to the following; internal and external issues; needs and expectations of interested parties; the scope of your quality management system; interaction and controls between the quality management system and processes. There is no all-embracing formula, template, document to manage context, but rather a series of interrelating documentation to ensure the overall context can be established. Perhaps the closest would be a strategic plan, that would then be underpinned by a business plan, which would then be underpinned by process specific or risk specific set of documentations which can be in any format or media that you think is appropriate to the reader. Sheesh. What ever happened to …’I am a baker. I bake bread!’, but sadly no. What we need to do is spell it out and do so in detail appropriate to ourselves, then to others. But how does this help me, the poor old business person? Read on.  

When thinking all things quality and quality management systems, I normally try and address context with a wonderful document called a quality manual. Not a re-engineered piece of clever literacy, but one that addresses each clause of the standard. In true unadulterated quality speak. Why? Because it brings the business into context with the standard.

Oh yeah, the standard. That wonderful document you are trying to benchmark against. So, address it and take the time to look at context. Hopefully, this will then link and or reference the ‘higher’ end documents of strategic plans and business plans that will bring everything into focus.

The standard goes on to want to know about; interested parties; the scope of your quality management system; interaction and the effect or potential effect on the company's ability to consistently provide products and services and that meet customer and applicable statutory and regulatory requirements. Ouch, all of that huh. Yes.

And last, but not least, we need to have documented information that describes our context. This means it must be available in a format suitable to yourself and your interested parties, so that we all know what we are doing or at least what we are supposed to be doing. No rocket science here to address this need and to address your own governance as a business owner. Just make it happen.