How do the bad units know where to go?

When your customer returns a failed product, there are things you regularly do to understand the problem. Depending on the product, you might check its serial number against your production logs, to see when it was manufactured. Was it part of a batch that you already know had problems? Maybe you check its composition. Does it include components that have given you trouble before? There are multiple avenues you can explore, as part of your root-cause analysis investigation. But do you remember to ask your customer, What exactly were you doing when the product stopped working?

This is not who the story is about!
But I found the illustration on the
Internet and couldn't resist. 

Last week I heard the craziest story. Some customer had an accident that left him unable to walk. But his job required him to move around a lot, so he got a motorized wheelchair. After a month, the engine burned out, and he had it replaced. A month later, the new engine burned out, so he had that one replaced too. And the month after that ... well, you get the idea.

It seems that the wheelchair manufacturer and the customer's insurance company let this cycle go on for some time before they finally began to investigate. What exactly was this guy's job, anyway? It turns out he was a high school football coach. And his idea of how to do the job involved racing back and forth on the sidelines during games, so he could get a close look at what was going on. On the grass. In the mud. All through football season. If he got stuck in a mud patch or a gopher hole, he just jammed the wheelchair into overdrive until he got free. And somehow the engines in his wheelchair kept burning out.

Gosh, who would have guessed?

It reminded me of a story I heard years before, in a problem-solving class. A large manufacturer of high-end cookware kept getting pans returned where the ceramic finish had melted in a way that made the pans unusable.* They studied their manufacturing process, spent a lot of time and money on improvements, and it made no difference to the return rate for this particular failure.

Finally, after a lot of frustration, they hired a problem-solving expert who looked at the overall return data. This company shipped product throughout North America, but all the returns with this problem came from Toronto. Right away he told the company to stop wasting time and money reengineering their manufacturing process.

"Why?" they asked. "How can you be sure that's not the problem?"

"If the problem was caused by manufacturing, it would be evenly distributed across all your customers. But look at this map. How do all the bad pans know to go to Toronto?" 

"Then what's the cause?"

"Put me on the next flight to Toronto, and I'll tell you."

In the end, he discovered there was a popular cooking program on a local TV station which recommended that viewers clean their pans in a certain way. That cleaning method just so happened to destroy the ceramic finish on this company's pans. I don't remember how they finally solved the problem. But until they asked how their customers were using the products, their investigations were fruitless.

So remember to ask. If you see failure data that doesn't fit the patterns you expect, what other pattern does it fit instead? There has to be one. And when you have all the facts, the picture is going to make sense. As long as the failures make no sense, you don't have all the facts.

Just remember: How do all the bad pans know to go to Toronto?

It's a powerful question.

__________

* I heard this story years ago, so I may have some parts of the story slightly garbled. But the point should be clear.      

Upcoming Changes in ISO 9001

Late last week, Quality Magazine published my article, "Upcoming Changes in ISO 9001." In it, I review the recent DIS9001 and explain the changes that it introduced:

Quality culture and ethical behavior

Opportunity-based thinking

Changes to the terms and definitions

Other changes 

I also explain my conclusion (which I have already stated in other venues) that any company which is securely certified to ISO 9001:2015 should have no trouble upgrading to the new version ... unless some new, massive, unforeseen change is snuck in at the last minute. 

It's their article now so I won't post the text of it here, but you can find it by following the link. I hope you find it useful!

Write documentation you can use

People often associate Quality with documentation. To some extent, this is unavoidable: you need a written record of inputs and outputs to make sure they both match the requirements, for example. But it's also partly because of the enormous influence of ISO 9001, which—especially in its earlier editions—stated a number of specific documentation requirements.

In principle the association isn't a bad thing. Documentation is incredibly useful. The problem comes when companies start documenting things without regard to whether someone is going to use the documentation later. Pro tip: If nobody is ever going to read it, then writing it down might have been a waste of time.* By the same token, if you write something down it is only considerate to think about who is going to read it, and what it will take for your writing to be useful.

One of the best examples I ever saw for the latter point was implemented by a contract-manufacturing company my firm used to do business with. They were a small company, but they had carved out a specialty niche in the larger ecosystem of manufacturing for the high-tech market. Because they were a small company, they had only a few large machines and the rest of their product assembly was done by hand. This meant that each workstation along their assembly line needed work instructions, to tell the people there what to do.

Manufacturing work instructions can be handled in a lot of different ways. This company started with the drawings we gave them, along with all of our assembly notes, but then wrote their own instructions based on them. 

• Their manufacturing engineer wrote one document per workstation, so the people at Workstation 2 wouldn't get distracted by instructions for Workstation 3.
• Since most employees had a native language other than English, each document was bilingual in English and the other language.
• Each document included a photograph showing what the product was supposed to look like when it came into that workstation, and then when it left.
• After their manufacturing engineer generated this series of documents (based on our drawing), he sat down with his contact on our side to review the whole stack of them, to clarify any confusing points, and to get our approval.
• And of course these documents were kept under strict version control.  

Ironically, this company was not certified to ISO 9001. They had investigated what certification would require, and concluded that they already had plenty of business and didn't need it. They were also the only supplier of ours that never once caused us a serious problem! (I allude to them briefly in this post here.)

But they understood what they needed in order to do excellent manufacturing in their specific industry niche. So they focused on that, ignored distractions that didn't matter to them or weren't useful, and turned out flawless work. Every time. 

_____

* Of course there are exceptions. If I write something down, the very act of writing also helps me remember it. That's why I said "might have been."     

      

Feedback on Santa's audit!

Wow! I got a lot of comments on last week's post about how far Santa Claus complies with ISO 9001. Thanks especially to Pia Hamrin, Dawn Ringrose, Petro Shoturma, and Jeremy Panitz for their detailed feedback!

What interested me was the remarkable level of unanimity among the responses. Of course each commenter had a unique perspective. But since Santa Claus is fictional,* any commonality among the responses must be traceable to the second half of the discussion—namely, to the expectations that grow naturally out of working with ISO 9001. Those of us who work with the standard regularly have come to know that some clauses need a lot more attention than others, because the impact they have on organizations is so consequential.

Even if you aren't worried about Santa Claus, ask yourself whether these same clauses aren't important topics in your organization.

Common concerns

It was no surprise to me that the two topics which attracted the most attention were Internal controls and Complaint handling. Businesses differ a lot: organizational contexts can be very different, as can the quality of customer requirements. For some companies those topics might require a lot of attention, while for others the same topics might manage themselves. But internal controls always matter—to everyone. And without complaint handling, you have no feedback on your operations to make sure your customers are satisfied. So nearly everyone agreed to focus on those areas.

Naughty or nice?

Everyone knows that Santa Claus checks whether each child is "naughty or nice," but how does this happen? Dawn's reply assured me that Santa uses a proprietary algorithm. But Pia asked how that algorithm is validated, and whether the sources are documented? Jeremy suggested that Santa consults with children's deities around the world to make his determinations.

Complaint handling

Petro and Pia both raised the issue that there is no publicized mechanism for complaint handling. Jeremy suggested a resolution to this topic, though, by arguing that "If the customer isn't satisfied with the gift they got from Santa Claus, the gift did not come from Santa Claus."**

Less worried

By contrast, nobody was very worried about document retention. Dawn suggested that the children's letters must be fully digitized, and nobody else took up the subject. I think this lack of concern reflects our common experience that yes, of course document retention is important; but on the other hand documentation findings are generally the weakest kind of finding in any audit.

Similarly, Dawn and Jeremy both assured me that internal audits were done by impartial elves, where "no one audits their own toy line." And I think we have all experienced that even in organizations where the Quality Management System is informal or not very mature, it is generally possible to find people who can treat the process objectively, and who can therefore do reliable audits.

Unique observations

Then there were the unique observations, that pushed the discussion in an unexpected direction.

Jeremy argued that Santa Claus is thought of as a toymaker, but that the real focus of his design expertise is in logistics. In commenting on clause 8.3.2 (Design and development planning), he explains, "Santa has only 24 hours to deliver toys and other gifts all across the world. That means he's got to know the weather patterns. So his design and planning is less on toys and gifts and more on safety and delivery of the goods." Jeremy doesn't use this example, but I assume he would compare Santa (in this respect) to McDonald's, who didn't redesign the hamburger but revolutionized how it was delivered to the customer.

For her part, Dawn answered the question about children changing their minds by enunciating the rule, "Last Wish Wins." But that rule means that the audit plan has to spend a lot more time checking scrap and rework under clause 8.7 (Control of nonconforming outputs). As long as the only topic was the elves' workmanship, we could assume that the elves are magical and don't make mistakes; so overall scrap should be minimal. But if children can change their minds late in the game, there is sure to be scrap as earlier gifts are replaced with later ones. Thus does any answer in one part of the audit open up new trails in another part—and this, too, is a familiar experience to all of us.

Naturally I don't mean to suggest that any clause is unimportant. In the right (or wrong) circumstances, any clause can trip you up. But I found it interesting and reassuring that the feedback on this topic aligned so closely with my own sense about where the critical risks are in any ISO 9001 implementation. Again, even if the North Pole doesn't interest you much, your own organization does. And it is worth looking over where your own risks are.

__________

* Or at any rate I'll assume so for the purposes of this post! 

** It's an interesting idea, to which I note only that, however this principle might work for Santa, it's not available for the rest of us.