Have you ever heard of Goodhart’s Law? Developed by British economist Charles Goodhart, the simple version is:
“When a measure becomes a target, it ceases to be a good measure.”
On its own, it’s a beneficial concept for Quality Management. For example, if you record the time it takes good, well-trained inspectors to measure a part, it won’t provide any benefits to broadcast the result to the inspectors. Since there is now a defined time that constitutes a good inspection, all inspectors can focus on hitting that time, instead of concerning themselves with the quality of the parts. The metric, inspection time, is no longer accurate.
But today, I’m talking about “Good Manufacturing Practices” and Quality Management Systems and introducing my twist:
When a Good Manufacturing Practice becomes a requirement, it ceases being a useful indicator of a Good Manufacturing Practice.
If you look at well-run manufacturing companies, you’ll discover that they have documented processes. If you survey enough of these companies, you’ll find that many of these processes are similar.
From there, you can create a guideline or “standard” that includes all these processes. Then, you can build an audit plan for that standard that gives you criteria for ensuring the company has all the practices in place. If a company shows they have the required documented processes, you can issue them a certificate that allows them to display their competency to customers and regulators.
However, people who have spent a decent amount of time in Quality know of companies that are certified to different QMS standards, and yet you can’t shake the feeling that they have no idea what they’re doing. It might not be something that can be traced in an audit finding. But the Quality is just…off. The processes are there, but they’re bad or inefficient.
On the flip side, have you ever spent time with a luxury watch in person? I mean, really spent time and looked at every machining technique, every detail, every texture?
A Cartier watch is a beautiful work of art. It’s amazing.
And yet, and this may surprise you, Cartier is not ISO 9001 certified. So, how can they be producing such a high-quality product, over and over and over again?
I’m sure Cartier has processes in place for manufacturing their watches. If you look at their Quality and Performance page, they list some of the different tests their watches endure to get them up to Cartier standards. However, these processes weren’t put in place to match GMP criteria or receive a QMS certification.
How is Cartier able to do this?
How are there companies that are legally obligated to follow Good Manufacturing Practices and are bad at manufacturing, while unregulated, non-certified companies produce high-quality products?
Cartier’s quality is built around its internal goals and meeting customer expectations instead of conforming to a standard.
The luxury watch market is extremely competitive. No one needs a luxury watch. Timekeeping has been solved, and a mechanical watch is a poor solution. So, if you are a luxury watchmaker, you need to listen to your customers and create the best quality product you can put in a display case.
Every single time.
Looking at other excellent manufacturing companies, you’ll see that the processes they put in place have a purpose. They understand the “why” behind the processes.
A company can put in place any process it wants to conform to GMPs, but unless it understands and cares about the “why” of that process, it won’t lead to better quality.
Take training as an example. If a company is not required to meet any GMPs and is not ISO certified but still has an effective documented training system, you would think highly of that company. You might trust that they are making something of good quality.
However, in certain regulated industries, organizations are required to have a documented training system. Many companies choose to have a superficial training program that technically meets requirements but does not create the intended value.
Therefore, an organization in this industry having a training program in place does not tell you anything about the quality of the organization, by the very fact that a training program is required.
This is one of my pet peeves when I see something like “ISO 13485 certification guarantees that an organization is producing high-quality medical devices.” No, it doesn’t. ISO 13485 certification guarantees (or at least hopefully guarantees) that a company is meeting the requirements of ISO 13485. This and good quality are two separate things.
Unfortunately, this cannot be solved by better regulations or standards. Anything regulatory agencies or certification bodies do, anything they define as a Good Manufacturing Practice will still fall victim to Goodhart’s Law. Once a practice is established as a requirement or goal, it allows a company to put a superficial process in place to meet that requirement.
The funny thing is, they know it themselves.
If you read through the MDSAP audit approach section on supplier management, it says (and I’m embellishing here): “Yeah, you can check if a supplier has a third-party certification, but for god’s sake don’t rely on that to think the supplier is good quality.”
So what can you do about it?
If you need to evaluate a company from the outside, there are talented, experienced auditors and professionals who can tell the difference between good quality and meeting requirements (smell the BS). However, these people need to be empowered. If the organization that sent the auditor is itself just trying to check a box, it will ignore the auditor’s advice. “Do they meet the standard? Good enough.”
It becomes harder when a company internally faces this reckoning.
Ultimately it is the responsibility of top management and Quality Professionals to understand the “why” behind the processes they put in place, and deeply care about the quality of their products.
To not only know how to comply with an ISO standard, but why the processes are beneficial to the company and can lead to higher quality. Not just teach people how to do tasks, but also the purpose of those tasks.
Anyone can find out the requirements of “Good Manufacturing Practices” and standards, but just following them does not lead to good manufacturing.
There are no Good Manufacturing Practices that will show you the way.
The only way a company can achieve good quality is through a true, internal, continual commitment to creating the best possible processes, products, and services it possibly can.
Every single time.
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