Who Exactly Owns Quality?
By Eric Hinrichs, Senior Principal Quality Engineer (retired), Ethicon, part of the Johnson & Johnson Medical Device Companies
We’ve all heard management ask the rhetorical question, “Who owns quality?” And we all reply with the answer they expect to hear: “We all do!” It sounds trite, but it is truly the appropriate answer. However, just saying something does not mean it is fully integrated into the minds, systems, and the heartbeat of a company. Try this at your company. Ask around, “Who do you think owns quality?” Ask people in maintenance, the mailroom, machine operators, engineers, regulatory, quality (especially note these responses!), compliance, etc. You may be surprised at the answers you receive. The collective responses will tell you the true picture of how the culture and the associates in your company actually view quality and quality ownership. It is a telling indicator of how well management integrated quality into the mindset and operations of the company.
Quality Is Everyone’s Responsibility
Yes, it is trite to say that quality is everyone’s responsibility, but there is a difference between what you say and how it is interpreted by your associates at all levels. I wouldn’t be surprised if the majority of the responses you received said that the quality department owns quality. The truth is, the quality department is the caretaker of quality for the company. They ensure procedures and guiding regulations are being followed and being met. In effect, they work on administrating quality for the company.
As far as who owns quality, yes, it is everyone, because everyone in the company touches your products in one way or another and to varying degrees. The shipping department makes sure the product is shipped correctly so as not to get damaged and that it is shipped to the right place in the right quantity. The testing technicians have the responsibility to ensure the product meets requirements and to isolate those products that don’t so they can be addressed accordingly. Regulatory makes sure all aspects of the product meet all applicable government rules and regulations. Sterilization ensures the product was properly sterilized and the integrity of the sterilization is not compromised, while packaging ensures that the product is protected from excessive handling, temperatures, and humidity, as applicable.
It’s obvious from these few examples that every department plays a role in the quality and performance of the product. The analogy of a chain that is only as good as the weakest link is appropriate in that a failure of quality in any one area can mean a nonconformance, a customer complaint, or a poor outcome or complication for the patient.
The Need For A Quality Culture
If the majority of respondents say the quality department is the owner of quality, then the culture of the company regarding quality needs to be addressed. Quality awareness and ownership need to be second nature to all. When asked, everyone must acknowledge that they are owners of quality and it is their responsibility to ensure they perform their role and execute with quality in mind. The quality department oversees all operations and is integral to ensuring procedures are followed, but the quality of the product, through testing and during manufacturing, is dependent upon each individual worker. If they do not perceive quality as their main concern, then product quality can be negatively impacted.
I once asked a line operator who owned quality. They stopped what they were doing and gave me a quizzical look, pointed to the in-process quality technician, and went back to performing their assigned task. Imagine my surprise. Did the mantra of everyone owning quality reach that line worker? No. At some point in the chain from management to line operator, the concept of quality ownership broke down. This wasn’t the line operator’s fault. In their mind, the roving quality technician was the owner, ensuring all work was being performed properly. What the line operator was not made aware of was that every one of their actions was a quality step. A roving quality technician cannot possibly detect or find every potential error in production. That is why everyone needs to be educated and trained in how quality is reliant upon their efforts and diligence when they perform their assigned task.
I took my questioning of the line operator a step further and asked them what process document they were working under, that is, what document detailed the steps they were to follow when performing their assigned task. The line operator didn’t know. I asked them how they know what specifications or requirements to follow. The operator looked at me as if he was wondering if he could trust me. I had worked with this particular operator in the past, so he was comfortable in being candid. He looked around to see if anyone was paying attention to our conversation. Noticing no one was watching, he reached over to an electrical box and opened in. Inside, he had written in black marker the parameters he used. “This is what I work against; these work the best for what I am doing,” he said. I took note of them, thanked him for his openness and left. Later, when I checked the process specification, I found that the values he was using were outside of the process specification! So much for roving quality technician checks.
In another instance of “quality improvement,” which, in this case, was an effort to reduce costs, management decided to eliminate the roving quality inspection and have operators check each other’s work! Was anyone surprised that rejections went down significantly? I wasn’t. Did anyone think that an operator would reject a fellow operator’s work? You know that if they did, that operator would not hesitate to reject the other operator’s work when it came time. This concept was, in principle, great, if operators were properly trained, educated, and monitored, but that was not how this change was implemented.
What I feel is overlooked is the actual cost of a complaint, not just in the impact to a company’s reputation or the cost of a lawsuit. Think about it. What is the cost of a bit more time or better training to prevent errors versus the cost to process a complaint from the time the complaint is received to the time (if it ever is) it is addressed to prevent a reoccurrence?
Back in the late 1990s, I tracked a complaint from the time it was received to when it was deemed resolved and the complaint closed. I monitored the time each department took, their overhead, material costs, etc., leaving nothing out. When I analyzed everything, the total cost to handle a complaint from simple to complex was anywhere from $3,000 to $5,000 per complaint. In 2026 net present value terms, that would equal approximately $6,573 to $13,146! Multiple that by the number of complaints received, add it to the cost of a lawsuit and the impact on a company’s reputation, and the true cost of quality can be seen.
Make Quality The Culture
No one ever said quality is easy or cheap. However, your company’s vitality and relationship to your customer and the patient is dependent on quality being the center of your company’s culture. Quality is owned by everyone, is the responsibility of everyone, and should be the core of any company’s decision-making. A company’s revenue, reputation, and growth are intimately linked to quality. It is not something that is touted in a yearly feel-good campaign, nor is it a flavor-of-the-month topic. Quality must be the core of your business. It should be something that is driven into every aspect of your business and training programs. Management should ensure quality is the first thing thought of throughout the organization.
Most companies that started small and grew accomplished it by fulfilling a niche, but did so with a quality-driven product. Never lose sight of what made you successful over your competition. So, when someone asks, “Who owns quality?”, the answer is not a trite or lip service response but a deeply rooted companywide, “I do.”
About The Author:
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. He authored an ASTM standard, worked on updates to United States Pharmacopeia (USP) medical standards, and helped developed 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 has also authored a book on career advice titled Perceptions and Expectations.