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A friend recommended a restaurant to me saying the food there was to die for. When I dined there I thought the food wasn’t that extraordinary and the service was slow.
Later that month I bought a bookcase that required assembly. Putting it together was a nightmare. Not because I can’t follow directions; I’m pretty handy around the house. No, it was a nightmare because the predrilled holes did not align. I had to make new holes to get the pieces to fit together.
A surgeon tried out a new cauterizing instrument. It was supposed to be far superior to what they were currently using. When the surgeon tried the new instrument. They felt the ergonomics of the instrument were awkward and the cauterizing was not consistent; they went back to their old instrument.
In each of the above scenarios quality was the factor in the person’s experience. But what kind of quality exactly? Was it a measured quality or was it an appearance of quality? We easily categorize quality into two main types.
The first is type of quality is VARIABLE. This type of quality is typically a measurable requirement; where a numerical value can be obtained. An example of a variable quality would be the misaligned holes in the bookcase scenario. The holes were predrilled in the wrong locations. You can usually determine if a quality issue is variable by asking yourself ‘Can I measure the defect?’
The second type of quality is ATTRIBUTE. This type is typically a non-functioning requirement. Examples in the above scenarios would be the ergonomic feel of the cauterizing instrument or the food and service in the restaurant. Attribute quality are difficult to quantify. For example, take the restaurant scenario. My friend thought the food was fabulous, but I found the food to be nothing special. Was it because I ordered something different? Was it because my taste is more or less refined? Take that same scenario with a different person who feels the ambiance is most important when dining out and they come away with a very different view of the restaurant’s quality.
I like to define a third type of quality- perception. This could be argued to be an attribute, but I like to consider it as a separate form of quality because it is associated with feelings. The way the product is marketed and communicated to the user creates an aura or a feeling about a product. In our example of the Acura and Lexus car brands, both brands are marketed as luxury cars- the epitome of luxury. How many people purchase such vehicles because they project success to others? It is this type of intangible that I refer to as the perception of quality.
Where quality is concerned, simply designing a device to accommodate variable quality is not enough. You must look beyond functionality, beyond how durable it is or how well the pieces fit together. You also need to consider attribute quality. How does the device look and feel? Would you buy a car that has paint blemishes? Would a surgeon use a device on a patient that has what appear to be rust spots on its surface? If a device looks ‘dirty’ or has scratches or discoloration upon it, the user may perceive the quality of the device is suspect. For medical devices, an end-user may wonder about the sterility of the device. And lastly, you must look beyond attribute quality to the perception of quality.
Marketing is a good example of the perception of quality. Ads promote the luxuriousness of a product, its amazing properties, or how the product makes one feel. These perceptions drive the experience and drive the perception of quality.
Take as an example product made in Japan after World War II. No one demanded Japanese products. The definition of junk was associated with Japanese products. Japan knew they needed to do something about how their products were viewed. They got serious about quality- all aspects of quality. They drove quality through the introduction of statistical control in manufacturing, they drove costs down through KaiBan and Just-in-Time philosophies. They honed their marketing to create the perception of luxury through brands such as Lexus and Acura. They drove quality in providing what the customer wanted rather than dictate what the customer will get as the Big Three of Detroit was doing. The result was a transformation of Japan from a perception of poor quality to one when they are today the benchmark of quality and performance.
What Japan realized is that quality is not just functionality but also perception. Quality can be both measurable and unmeasurable. We can easily measure defects per thousand and tolerance, but we have a difficult time measuring or quantifying defect avoidance or how many customers we lost because of a misperception or misunderstanding on how a device functions.
This is why quality can be elusive in many aspects. Take the famous Coke dilemma. Coke thought they could improve the taste by altering the formula to make it more desirable over Pepsi. The result was a marketing disaster. Coke reeled from the backlash and had to quickly respond by ‘reintroducing’ the old Coke formula as ‘Classic Coke”. This too was a quality issue. A quality issue related to perception. There was nothing inherently bad about the taste or the packaging that was the issue. What occurred was the perception of the public that Coke had tampered with an iconic product. They wanted their ‘old’ Coke and they were not having anything to do with this ‘new’ Coke.
The takeaway from this is that quality is defined by measured values, attribute values, and the perception of quality. They go hand-in-hand. It is like a three-legged stool. You need all three legs for the stool to function. You need to control the measured values for consistency in performance (variable quality). You need to control the product appearance of quality (attribute) to maintain the look of quality. Lastly, you need to control the perception of quality which is the overall experience the user has with the product. Public perception is key to a successful product. Don’t believe me? Just ask any public figure.
As you can see what we have the most difficulty in measuring – product attribute and the perception of quality- is, in many ways, as important, if not more important, than what can be easily measured- product variation. A company that can successfully control and monitor all three of these aspects of their product quality is a company that can be successful for a very long time.
Eric Hinrichs has more than 31 years in the medical field in R&D on new products and processes, in operations on improving processes, and in quality on leading process and product validations and performing data analysis. He developed and led the implementation of numerous process redesigns while at Ethicon to improve product performance. He authored an ASTM standard on surgical needle penetration, worked on updates to United States Pharmacopeia (USP) medical standards, and helped develop new medical standards for the European Association of Surgical Suture Industry (EASSI) in Europe. He has also co-authored a medical standard for India that is currently under consideration for adoption. He recently released a book on career advice, Perceptions and Expectations.

Eric Hinrichs has more than 31 years in the medical device field in research and development on new products and processes, in operations on improving processes, and in quality on leading process and product validations and performing data analysis. He developed and led the implementation of numerous process redesigns while at Ethicon to improve product support execution. Eric authored an ASTM standard, worked on updates to United States Pharmacopeia (USP) medical standards, and helped develop new medical standards for the European Association of the Surgical Suture Industry (EASSI) in Europe. He has also co-authored a medical standard for India that is currently under consideration for adoption. He recently released a book on career advice, Perceptions and Expectations.