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Quality systems, business processes and the skills your people need to make it all work.
The last article we did was to provide general information on process approach. Now we would like to provide more specific direction so if you were just starting out you can have a complete picture, or if you have done this work for some time – there may be just pieces of the puzzle that need to be included, enhanced or changed because the organization and it’s customers have changed.
Maybe the risk has changed such that something that was not recognized as risk in the past – or recognized as minimal or non-existent risk – has now become significant. I remember some of the WARDAIR ads and brochures (I know, I’m ancient) showing smiling pilots with adults and children in the front of the aircraft looking at pilots and the controls. With 9/11/2001 that world changed. Protective reinforced doors were installed so no one could get in the cockpit to protect the pilots and plane.
Then when the pilot of the Germanwings Flight 9525 went for a “nature” break, the co-pilot locked the door and flew the plane into the French Alps. The captain could not get back in because of the locked door. There was a need to recognize a different risk – and somehow deal with it. (We don’t want to make you afraid to fly – just to use these dramatic situations to illustrate how quickly our situations can change – and how our process which seemed to be stable and sound – can change in a heartbeat.)
The clarity with which we see and understand our organizations – and how quickly they can change – is essential with how we effectively/efficiently operate and how we see and understand the risks. Again, the process approach will help.
It is our belief that the information we share with you provides you with a tool – whether in whole or in part – that will benefit you and your organization – regardless of what you do. Now to be absolutely clear – the structure and credit should go to the really “smart” people who brought you 544R3 (currently) “Guidance on Concept and use of Process approach. (We are just adding some simple, practical examples to help understand what is expected and how to carry this out.) While there is no specific requirement to use this standard, it provides a simple, straightforward methodology to identify and use the process approach.
Many of your organizations already have processes in place which can be used as is. The question is do your current practices (processes) get done what you need to have done – as effectively an efficiently as they could? Is the system which encompasses all of these processes the effective and efficient “system” that you need to be competitive and to satisfy customers? Even once you have a working system in place – there is a need to review. Change will occur and some of this change either not recognized or well adapted to can/will lead to business pain and potentially failure.
a) Define the purpose of the organization
Who are your customers? Who are other interested parties in the organization? What are their needs and expectations? Is success based on being the low cost provider or the innovator and benchmark?
b) Define the policies and objectives of the organization
How is the organization expected to operate? How does it see its responsibilities? Do the policies and objectives provide clear support and direction for the “purpose” of the organization?
c) Determine the processes in the organization, including ownership
Are operations defined and carried out with clear responsibilities and authority? Is there clarity in what needs to be done – and at least carried out within defined areas of responsibility?
Everything you do to provide product or service to your customer – within your system – could and should at least fit into macro process categories. (Having an automotive background I’ve found the COP’s, and MOP’s and SOP’s work very well (identified in Part 1). The amount and nature of the detail is up to you. How does your organization actually work – what departments do you have? Almost every organization has functions which are similar – and functions that are unique. Start at a very high level and detail only to the level which is necessary. The right answer, and detail, is what works for you – with clarity of how the organization works without so much detail that the system is restrictive and confusing.
d) Define process “supporting” documentation
The amount and nature of the documentation is up to you. ISO 9001:2015 no longer requires a “Quality manual” or “documented procedures”. To me the “Quality manual” regardless of what you call it was always equivalent to a map of Canada. This is the big picture. While we know (or should) the general geographical layout of provinces and bodies of water – this ensures “ALL” of us know the same things about the big picture.
Procedures are equivalent of the actual provinces. This is giving you more specific detail in a defined area. It should primarily give you the who, what, where, when, and why.
Work instructions or “standard work” should be the equivalent of our cities and towns. This gives more precise detail, especially of the “how”. (If you never travel/work in Toronto you don’t need that map/work instruction.) Common sense should tell if you need to make the effort for more or less documentation.
The means you use to document – process maps, flow charts, astrological signs, etc. – or some combination of these – is up to you. Who is the audience for your communication and do you communicate in a manner that ensures the audience will clearly understand what has been communicated?
Your processes are identified, but you’re not done yet. In Part 3 we will talk about planning, implementing, analyzing and improving your processes…
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