The Process Approach

The Process Approach

ISO 9001: 2000 introduced us to the idea of the process approach and still today I come across clients and interested parties who cannot wrap their heads around this requirement, “what does it mean by process approach?” is the question asked followed by some kind of statement that everything they do is a process of one kind or another. In the 2008 version things remained pretty much the same but in the 2015 version ISO re-wrote things and the idea of what a process approach is just got more confusing, not less.

So to give you an example of what I mean just take a look at clause 8.5. The first half of the clause talks of “products and services” where the second half talks of “outputs”.?The explanation I guess is that two people wrote the two halves, I don’t know this for a fact but it’s my best guess.

What to do about it, how to tackle it – clause 4.4 is where the “process approach” requirements are set out so if there’s any confusion go back to these and use these as your measure. 4.4.1 provides a handy a – h points list to use as a set of rules to use to help decide what a process is.

In very simple terms a process is an activity (any activity) that turns inputs into outputs. What this means to you is that you apply the “process approach” to any activity you intend to manage under the requirements of clause 4.4.1. And it’s also worth understanding that ISO gives you the opportunity to decide what processes are to be managed under the ISO 9001 Quality Management System, what’s not (but don’t call them processes, call them something else) but it’s up to you to describe them.

So once you’ve figured out what a process is and if it’s going to be managed under your ISO 9001 Quality Management System the next thing you’ll want to do is to put them into some kind of order. This is the point where you start with a blank sheet of paper and pen, then draw them out in a flow-chart. You might have to do this a couple of times to get it just about right, but its well worth it in the end. If you have a small company or a non-complex overall process then this should prove fairly simple, but it’s still worth doing and making sure all concerned agree the overall flow. This way anyone who might have something to add has the opportunity avoiding re-writes later on.

What to look out for and make a note of:

1.?????Decide what the inputs and outputs you expect, my own approach is meet with those who might have something to say and/or gain, and this includes operators as well as supervisors and managers. This way we come together to get a rich picture of what this needs to look like going forwards. My experience is that this is invaluable in uncovering problems and tackling assumptions.

2.?????Figure out what resources are going to be needed – people, equipment, facilities …

3.?????Assign responsibilities, decide who’s going to “own” this or that part of the process, this is more than just making someone responsible, if means you have to know they’re going to be able to do what’s required of them

4.?????Okay so far, now you’re going to set some measures in place, decide on KPI’s (key performance indicators), these are going to tell you if you’re performing to plan or not

5.?????And now you’ve got it all in place you’re going to start using those measures to gather data and then evaluate what you’ve found so that management can decide if change is necessary and what that change might look like

6.?????From your analysis and evaluation activities you’ll likely find there are some issues or problems that need to be dealt with. These of course can be converted into risks which you’ll have to mitigate against or opportunities which you may then decide on a plan of action to take advantage of (you’ll have already in some form done some sort of assessment of risk and opportunities, but this new data can feed into this knowledge to inform if you’re close to correct or not)

7.?????Finally you’re now in a position to improve the process based on the data you have available, this is done through the corrective action system

Right, it looks like a lot to get through so you don’t want to be doing this for those mundane processes, no, you do this for the main activities your organisation is going to be involved in, your primary processes if you like. From my own experiences SME’s (small-medium enterprises) will have a limited number of key processes:

1.?????Quoting and Order Taking

2.?????Purchasing Materials and Services

3.?????Manufacturing/Providing the Service

4.?????Packing Goods

5.?????Shipment of the Finished Goods

Some of these might them be split up into a series of processes, but I’m sure you get the picture. You’re also going to add in a few administrative processes to help make things flow as an organisation.

Assign ISO 9001 Clauses

The standard doesn’t require it but it helps (a lot) if you go through what you do and how you administer things and assign the ISO 9001 clauses. This way you’ll be sure you’ve got everything covered or you might find a gap to be plugged.

My own approach is to pull together clauses 4, 5 and 6 into a process for management to follow. 7, which is concerned with resources is probably worth looking at in isolation. 9 and 10 are all about improvement so you can normally pull these two together. Clause 8 is all about operations, or in other words what you actually do to create value for your customers, so naturally this will be a single process or a series of processes to form a whole.

Some thoughts on Measures or Objective Setting

Ideally each of the Quality Management System processes will be measured to establish effectiveness, this isn’t always the case but I have to confess as a Management Systems Advocate this is my preferred approach. As an example, if you’re looking at the administrative process then you’ll be thinking about if the administrative systems used meets the requirements of ISO 9001, things dated and uniquely identified with issue status and the like. Or you might look at resource provision, where you might use a more technical measure of SMED from the Lean Management playbook.

Closing Words

A Quality Management System is a system like any other and a system is a bunch of processes that have been pulled together in some kind of order. If one of the main processes is missing or defective then you’ll have some serious difficulty going forward. By using a process approach in line with ISO 9001 clauses you’ll fairly well ensure you’re managing your Quality Management System in such a way that it captures information about performance and you’re able to respond with improvements that add to overall organisational performance.

If you want to know more or would like some help then get in touch:

[email protected] with your questions.

Philip Dawson MBA, Lead Auditor ISO 9001/14001/45001/27001, L6∑Practitioner

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