"But it's such a small change!"

Now that ISO TC 176 has formally announced the decision to start work on a revision of ISO 9001 (see this announcement from 3 August 2023), this may be a good time to revisit the question what constitutes a big change rather than a small one. What's interesting is that often you can't tell from the outside how big an impact a change is going to have.

The question matters because every change introduces churn and disruption. When a global standard like ISO 9001 introduces new requirements or changes old ones, organizations across the world have to stop what they are doing, evaluate the change to see what it means for them, and then make the appropriate changes in their own operations; that last step includes planning the changes (clause 6.3), updating the relevant documented information (clause 7.5.3.2c), introducing the changes in a controlled way (clause 8.5.6), auditing them for effectiveness (clause 9.2.2a) and reviewing the results (clause 9.3.2b). 

Is the serving large or small? Depending on your context (in this case,
the size of the plate) the same serving can look very different!

It's never easy. So it's always a relief when the changes turn out to be small and not big. But what makes for a big change?

It turns out that the answer depends very narrowly on the specific organization's current Quality Management System. Changes that are trivial for one organization might be huge for another.

This point was driven home to me back when the 2008 edition of the standard was being rolled out. At that time I worked for a regional office of a mid-sized global company. My office had started as an independent company of its own, and we still handled many of our operations the way we always had in the past (rather than integrating fully into all of our parent's systems). It made our QMS a little complicated 😀, but in practice it worked fine.

When ISO 9001 rolled from the 2000 edition to the 2008 edition, I looked through the changes. Mostly they looked superficial—minor changes to wording or sentence structure that made the text less ambiguous or more readable. 

• Passive verbs were replaced by active verbs. 
• The phrase "regulatory requirements" was replaced by "statutory or regulatory requirements." 
• Instead of being told to "identify" the processes in its QMS, the organization was told to "determine" them. 

This was the kind of change that I found throughout the document. And when I discussed the changes with our certification auditor (who was always very collegial when he was off-duty), he agreed completely. Neither of us found anything in the document to worry about.

Meanwhile the Home Office reacted to these same changes with panic. During Quality department staff meetings, I kept hearing that the updates in the 2008 edition were momentous, that they could require us to change everything. I didn't like to tell my colleagues they were wrong, but for some time I had no idea what worried them so.

Turns out they were worried over one provision. At one point, seemingly as an afterthought, the authors of the 2008 edition shed light on a requirement that had been more or less implicit before but never spelled out in words: in a clarification of clause 4.1 ("General requirements") the new edition now stated:

NOTE 3: Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements.

Why did this alarm the Home Office? I learned that they regularly outsourced certain processes that they did not have the capability to perform themselves, and the contracts with their suppliers made the suppliers responsible for all conformity issues involved. In other words, the Home Office had no systems in place to allow them to accept or exercise this level of responsibility; and the new edition of the standard meant they had to build those systems from scratch in a hurry. 

Our office, by contrast, had always taken that responsibility for granted, even when it wasn't explicitly stated. (You remember I said that many of our operations were left over from when we had been independent.) So for us, locally, this Note required literally no change at all to anything we were doing. And I'm pretty sure (from talking to other people later) that the authors of the standard thought the Note was no more than a restatement of something that had been implied all along.

You never can tell what changes are going to look big until you check the individual cases one at a time. It's remarkable, really.      

           

"Does ISO 9001 really require THAT?"

Everyone who works with ISO 9001 has run into That Person—the one who is convinced that the standard requires something crazy. Maybe it's the person who insists you have to document your paper clip usage ... or the one who tells you that auditors can write findings based on their judgement or opinions, or on a hunch that you might be doing something they personally don't like. Maybe it's The Stupid Label Guy. (See also this post here.) Sometimes, regrettably, it can even be your auditor, so that you have to have a long conversation during the Closing Meeting about why this or that topic really has no place in the report.

Arguing with these people can be exhausting. And sometimes it leaves you wondering, "Am I the crazy one?" When the plain sense of the words obviously means one thing to you, but That Person is totally convinced that it means something else instead, it's natural to wonder if maybe you are confused. Is there anywhere you can go to get an answer? Can anyone provide a clear, unambiguous, authoritative ruling on what the standard really means?

Yes, someone can. For myself, I spent way too many years in this business before I found out about them. So let me save you a little time, I hope, by telling you about them now.  

The authorities in question are a subgroup of the ISO Technical Committee 176, the committee responsible for writing ISO 9001. Their formal designation is ISO/TC 176/SC 2/TG 04, or ISO Technical Committee 176, Subcommittee 2, Task Group 4. And their whole job is to give authoritative answers to questions about what the standard requires.

Note the limitations. They are not there to give advice on how you might best implement the requirements of the standard. They won't analyze your business's special circumstances to suggest what you in particular will find efficient or useful. That's consulting, and there are lots of people willing to do it for a fee. But if you have a straightforward, Yes/No question—something like, "Does ISO 9001 require us to hang a printed copy of our Quality Policy in the lobby, signed by the CEO?"—TG 04 can give you a clear Yes or No that settles what the standard actually means.

There are a few other restrictions. To keep the volume of requests manageable, TG 04 replies only to member bodies—that is, national standards organizations who are themselves members of TC 176. If you or I, as private individuals, have questions of interpretation, our first stop should be our national standards organization. (Since I'm American, for me that means ANSI.) All questions must be phrased so that they can be answered Yes or No. And the website warns questioners not to expect an immediate reply: "As it is an official process, that involves developing consensus among the members of ISO/TC 176/SC 2 to agree on any proposed interpretation, a quick response cannot be expected." You can find a list of detailed guidelines at this link here. 

Still, it's nice to know that this group exists. When That Person tries to tie you in knots by insisting on something crazy because they think "ISO 9001 requires it," it's nice to know there's somewhere to turn to get a clear answer.

And it's especially nice to know you don't have to put a label on your coffee maker. 😀  

          

Life as a conductor

Last week I talked about the role Quality personnel have in an organization, even though they are not directly engaged in production or sales. And it put me in mind of a comparison that Rose Duncan made some weeks ago. (I've quoted Rose before, briefly in this post here.) Rose's image was simple and memorable, and it would have delighted me even more back when I was five years old and loved trains. 😀

She wrote:

Your quality management system / QSE is like a train.

You need an engine and carriages.

You can attach as many as you want: beautiful ones, compliant ones, expensive ones, simple ones, complex ones, unique ones, a few, or a lot...

But let's be clear:

The engine is the leadership.

Their job is to pull the train.

You [in Quality] are the conductor.

Her post went on from there, and mostly it was about leadership. Her main point was that without leadership, the organization goes nowhere.

But I was struck by the idea of Quality as the conductor. What I commented at the time was:

The conductor doesn't personally load the coal (or diesel). The conductor doesn't hop down into the yard to hook up the cars manually. The conductor doesn't choose what speed to go around a tight curve. The conductor doesn't personally do ANY of those things! But you've got to have a conductor.

But then I went to look up, What exactly does a conductor really do? According to Wikipedia, the tasks of a conductor include:

• Ensuring that the train follows applicable safety rules and practices
• Making sure that the train stays on schedule starting from the stations
• Opening and closing power operated doors
• Selling and checking tickets, and other customer service duties
• Ensuring that any cars and cargo are picked up and dropped off properly
• Completing en-route paperwork
• Directing the train's movement while operating in reverse
• Coupling or uncoupling cars
• Assisting with the setting out or picking up of rolling stock

And seriously? That doesn't look like a bad match, mutatis mutandis. Let's look at it again, more slowly.

• Ensuring that the train follows applicable safety rules and practices Quality regularly has to check that the organization is following all applicable regulations, including legal and contractual ones. Some of these checks might be carried out by a Facilities Department or a Safety Committee. And yes, strictly speaking legal or safety regulations might be out of scope for the QMS, depending on how it has been defined. But Quality has a clear interest in the topic of regulations in general.
• Making sure that the train stays on schedule starting from the stations Again, schedule maintenance might be most immediately managed by Project Management or Production Management. But if the organization regularly fails to meet its committed delivery dates, there's going to be a long talk during internal audits about why.
• Opening and closing power operated doors Remember that this is an analogy. If the train represents your system, then the doors are points in your process that accept inputs or release outputs. Presumably you have requirements that your inputs and outputs have to meet. Quality safeguards that those requirements are met, and therefore functions as a "doorkeeper."
• Selling and checking tickets, and other customer service duties Tickets are how you make sure that "passengers" (which Rose later identifies with your employees) are in the right places (roles / functions) at the right times. Quality checks that training requirements have been met, and that resources are adequate.
• Ensuring that any cars and cargo are picked up and dropped off properly This is again related to inputs and outputs, as above.
• Completing en-route paperwork Everyone knows we are all about paperwork. 😀 (Not solely, of course. But it is inevitably part of the picture.)
• Directing the train's movement while operating in reverse Under certain exceptional circumstances, when something tricky is being done, it is not unheard-of for Quality to be given—temporarily!—some kind of operational role for the duration of the special circumstance.
• Coupling or uncoupling cars ... and ...
• Assisting with the setting out or picking up of rolling stock I ran out of inspiration for these last two. No analogy is perfect.

So there you are. It's a fine analogy to explain to five-year-olds everywhere what a Quality professional does all day. We're conductors. And every train needs a conductor.

           

Is Quality really free?

A few weeks ago I was having lunch with a friend, and we were talking about work. She works for a small company struggling with growth, and when she started there her charter included implementing a Quality Management System. But there were always daily fires to put out first, and at this point she said she has shelved that project for the time. There are a lot more immediate things that have to be done first. Finally she sighed and said, "We just can't afford Quality right now."

This took me aback, just a little. Ever since Philip Crosby, we have all told each other that "Quality is Free." But how can that be? In fact, this slogan turns on the dual meaning of the word quality. On the one hand, quality just means doing things well. On the other hand, Quality [often with a capital Q] refers to a whole body of formal practices that organizations implement—a professional body of knowledge, with its own professional organizations and certifications. As I have said many times before (including as recently as last week), these two meanings are not the same.

Quality should be free, at the most basic level, because in a perfect world (where everyone always knows what to do) it should cost no more to do a job right than to do it wrong. In a more sophisticated sense, Quality is "free" because—even if it does cost a little bit more to do it right—you make that money back by avoiding the cost of rework or of replacing failures under warranty. This second line of thought is what justifies the cost spent on a formal QMS: yes, filling out the forms and following the procedures takes time (and time is money); and yes, you are paying inspectors and auditors who are not themselves engaged in production or sales. But without these forms and procedures and inspectors and auditors, your rework and warranty costs will eat you alive; so in the long run you are money ahead by having them.

"In the long run." That's the key. Or as one of my coworkers put it many years ago, "Therein lies the rub, bub." You have to have some time and money to spare first, before you can put the systems in place that will ultimately generate any savings.

Think of a paved road, as an analogy. Paved roads are a very basic—and very useful—piece of infrastructure. They enable the movement of human beings, the transportation of goods, and the delivery of services. Modern economies would be unthinkable without paved roads. For the economy as a whole, the net return on investment—the surplus of economic activity that they enable minus the cost of building and repairing them—is incalculably huge.

But paved roads don't grow on trees. For each paved road you see anywhere, someone had to decide where it was going to go; someone had to grade the land; someone had to lay out the road; and (only at the end of a long process) someone had to pave it. All of that required human effort, all of it took time, and all of it cost money. In an economy with no way to generate a surplus, no one can afford to pave a road.

And I think this is where my friend is, right now. There are just too many things that have to be done first, before a QMS will even be a meaningful concept. Maybe sometime in the next year she can move the inventory system out of Excel. Maybe she can regularize the purchasing activity. One thing at a time. And then in a while, when the company can afford it, she can go back to implementing a QMS.

Does that mean the company is doing a bad job in the meantime? Heavens, no! The company's day-to-day work is just fine, because the people who work there have mostly been there a long time and "just know" how to do it right. The overall level of competence across the team is very high. So yes, they are doing a good job today. The only problem is that their current methods aren't scalable, precisely because they depend on such a high level of competence. So if the company wants to grow, they are going to have to put systems in place. They are going to have to rely more on procedures and less on "just knowing." They are going to need a QMS.

Maybe next year.    

          

Focus and Quality

Back in January, I wrote that "the deepest source or spring of Quality is love: love for the work or love for the product." But it's not that love is some kind of cartoonish magic power that conquers all effortlessly. Rather, the point was that when you love something—the work or the product—you look deeply at it. And that deep looking is essential for doing a good job.

We all know this in reverse. Nobody can expect to do a good job while constantly distracted. This is why some people resent mobile phones so badly, or social media. It's why some executives declare that they will only open their email during certain hours and not the rest of the time. Matthew McConaughey makes the same point in a video attached to this LinkedIn post from about a month ago.

To be sure, your focus has to be on the work at hand. What you focus on is what you get good at. If you will forgive another LinkedIn reference, this post from last year makes the point that when you do a lot of any kind of work, usually you get better at it. You figure out what to do and what not to do. This is why experienced professionals generally turn out better work than dilettantes or amateurs. We read about exceptions from time to time: everyone has heard that Mozart began composing music when he was four or five years old. But the only reason we read about them is that they are exceptions.

But where in all of this do the familiar Quality tools show up? We all know that the implementation of a Quality Management System means the imposition of uniform procedures: but how do procedures and auditing generate a deep focus on the work?

The short answer is: they don't. No gimmick can make you care about your work. No procedure can make you brilliant or successful.

But the longer answer is: they help. In particular, they can help you focus.

A product design procedure won't guarantee that you design your product well. You need good design skills for that. But it should ensure that you have all the information up front about what you are supposed to be building: is it a fighter jet, a sound system, or a birdhouse? And if you know the requirements up front, you are less likely to be distracted by someone running in from the Marketing Department saying, "Oh, just one more thing ...!" (See also the cartoon at the bottom of this post. I once worked on a large project where nearly every single engineer had a copy of this cartoon over his desk. And yes, there was a reason.)

When something goes wrong in one of your products, a problem-solving tool can't guarantee that you will find it. But each problem-solving tool in the Quality arsenal helps reduce the number of possibilities so that you don't get distracted by irrelevancies:

• A fishbone diagram spurs you to broaden your thinking, so that you consider all possible causes and not just the first one that jumps to mind. 
• An IS / IS-NOT table helps you eliminate the ones that cannot be relevant.
• A Pareto chart points you to the specific areas of investigation that are likely to be most fruitful. 
• Even the overall 8-D structure of a problem-solving effort focuses your work in a way that has been compared to the scientific method.

So no, none of these tools can make you care. None of them can force you to do a good job. But with luck, if applied correctly, they can turn down the ambient noise so you can get back to work in peace and quiet.