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Quality systems, business processes and the skills your people need to make it all work.
A couple of months ago a U.S. government lab sent shipments of “dead” Anthrax virus to 9 different locations in the United States. The only problem – the virus was quite “undead”.
(I know there are more professional ways to say this – this just seemed more current.)
There is no way that this should/could happen. How did it??
About 2-3 years ago a B-52 was loaded with nuclear cruise missiles and flown across the United States. It was sitting on a runway on the East Coast before someone recognized that it wasn’t supposed to be there – at least with that payload. There was undoubtedly a process methodology for time, place, circumstances of loading nuclear weapons on bombers – that was not followed. For all the checks and balances…
I use these examples because they are extreme. Because the nature of the incidents and those responsible we (I) have a very high expectation that these things will not occur. But they will and they do!!!
Processes are intended to be set up so that – whatever the responsibility or mission – there is clarity in the expectation that it will be accomplished. People change, systems change, organizational understanding and expectations change – the one constant is change. The methods that give us the best possibilities for the outcomes we chose, expect and want – come from a clear understanding of how the organization is expected to operate – and then the “assurance” that it in fact operates in that manner.
While there is no “magic bullet”, there are methods that give us the best opportunity to be and do what we want. My opinion – the best methods include a clear and accurate understanding of how the organization needs to operate and how it actually operates. There is also a need to expect change – subtle or dramatic – whether we want it or not. The “Process Approach” provides us with a great methodology (tool) when properly applied – regardless of the size and nature of the organization.
We have made an effort to take the “544R3 – Guidance for Process Approach” guidance document and simplify. This should allow a practical, value-adding tool that can be used by any organization to understand and apply its “process activities”. For most of us this just means – how it actually works. (We will provide the detail and comment in the next edition of the newsletter. While you could read it on your own, we do try to simplify and add examples.)
What is a process? A process is asset of interrelated or interacting activities which transforms inputs into outputs. Is building a Tim Horton’s facility a process? Sure. Is making a cup of coffee a process? Sure. The good news is the amount of detail and complexity in the process should lead us to the amount of detail and methods we should use in our identification and understanding of the process. The means by which you identify and manage your processes are up to you – mostly!
In ISO 9001:2015 you are required to identify the processes that are necessary within the organization to manage your system. These processes will cover the requirements of this International Standard. While you may “parse” words there is very little difference between what was originally required, or intended, in the ISO 9001 standard in 2000, 2008 or even now in 2015. What should be done is what makes sense and is most likely obvious to you. The key is that the organization continues to operate in an effective and efficient manner while covering all requirements.
The Technical Committee included an approach of identifying the organization’s processes using PDCA (Plan, Do, Check, Act). This is shown in the 9001:2015 document (section 0.3.2). I think it works fine. Because of particular industry experience I like to use a system that has worked particularly well for me. This would be – COPs, MOPs and SOPs.
The basic core process – what happens when a customer requests our product or service. What is needed to directly support or provide this product or service to our customer? What are the sequence of activities?
MOP – Management Oriented Process
The management direction that is provided in carrying out these processes.
SOP – Support Oriented Processes
The support processes necessary to carry out these requirements. This could include inspection and testing, purchasing, calibration of equipment, etc.
Within these high level processes you will determine how they fit or work together. What are logical operating segments of the organization? By having a clear picture, you will also understand how activities may be improved – to fit or work together better – or what is no longer working as expected.
It is extremely important that not only the individual departments (or processes) work well – but they work and fit well in support of each other and the organization as a whole (the complete system). The process approach is a tool – a look at the organization that most employees never see.
While there are no specific requirements to audit by process – except in certain industry segments – with this layout, assignments for internal auditing can be made to accomplish auditing by process quite clearly and simply. We are just your practical, common sense advocates who have tried and will try to make whatever we can simple and understandable.
The next article will include the clear structure and comment on the systematic approach detailed in 544R3. As I usually try to end with just a little “philosophy”, I would like to share:
“You can ignore reality, but you cannot ignore the consequences of ignoring reality”.
– Ayn Rand
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