I’ve noticed an interesting trend in my recent GMP courses relating to the answer to this question:
Who is ultimately responsible for quality/the quality management system?
I’ll even give you options to choose from:
- All personnel working for the company
- The quality assurance department
- Company management — including top executives
Note your answer somewhere before reading on …
Imagine we’re in GMP training, discussing the responsibility of the quality control unit (QCU) as defined by the GMPs (21 CFR 211). We talk about the QCU being responsible for reviewing and approving procedures, records, specifications, components, and many more things that affect the quality of the finished product, along with the final product itself; reviewing and approving manufacturing and testing data, among other things, to ensure no errors have occurred or were corrected; and ensuring adequate facilities are available.
Usually at this point I ask who has ultimate responsibility for quality. The answers I get vary, but more often than not, I hear, “everyone,” “we all do,” etc.
While I love hearing this — and I’m not trying to dissuade this thinking that every one of us has a hand in the quality of our operations — I find myself a little disappointed by this answer.
(And while the example I’ve given is GMP or bio/pharma environments, it’s also happened in discussions about the FDA quality system regulation and ISO 13485 in medical device environments.)
Why It’s a Disappointment
When “everyone” is responsible for something, “no one” is — no one is ultimately accountable. I’d rather hear, “I am.”
It’s bad enough when individual contributors tell me “everyone is responsible for quality.”
It’s worse when the management in the room says the same thing.
What does it say about our cultures that our personnel don’t expect management to be responsible for company operations and output? And that our managers don’t outwardly accept that responsibility?
What’s The Basis For The Concern?
Management responsibility has been a topic with regulatory agencies for quite some time, as evidenced in the various regulations and guidances we work within. For example:
- 21 CFR 211 states procedures must be in place to notify responsible corporate officials in writing of any complaints, recalls, or actions pertaining to GMP that are taken against the company (21 CFR 211.180(f)) and those in supervisory positions must be able to perform their functions in such a way to assure the quality of work performed (21 CFR 211.25(b)).
- 21 CFR 820 and ISO 13485 each have an entire section on management responsibility (21 CFR 820.20 and ISO 13485:2016 Clause 5, respectively), which includes having ultimate responsibility for ensuring the quality management system (QMS) is functioning effectively and appropriately resourced to ensure the quality of the products.
- EU GMP applies ultimate responsibility for quality and the QMS to senior management and assigns specific responsibilities for product and process quality to the heads of quality and production (Eudralex V4, Chapter 2, sections 2.4, 2.7 – 2.9) along with the head of quality control (Eudralex V4, Chapter 6, section 6.2).
- ICH Q10 defines senior management as having ultimate responsibility for ensuring an effective QMS is in place, along with management responsibility being integral to a functioning pharmaceutical quality system (ICH Q10, section 2).
And there have been various examples where company management, along with others, have been held accountable for quality failures, including:
- The strict liability cases of U.S. v. Dotterweich and U.S. v. Park, where company management was held responsible for activities performed by subordinates that led to adulterated or misbranded product being shipped
- The 2017 case against Baxter, where failure of the company’s management to respond appropriately to an employee’s complaint of mold in a cleanroom HEPA filter led to a corporate integrity agreement
- The 2012 New England Compounding Center disaster, which led to forfeitures and criminal convictions of the owner and cleanroom supervisor in 2017, for which a total of 14 people were arrested for their parts in the quality failures, which included falsifying records
- The European company that lost its marketing authorization in 2017 because of poor quality practices (including falsification of expiration dates on repackaged product). The Danish regulators even went so far as to require the company to replace their CEO before the company’s marketing authorization would be reinstated.
So how is it, with all of this available information, that people don’t know “responsible corporate officers” — like top management of the company all the way down to the operational area management — are ultimately responsible for the quality of the product made and the company’s operations, including those under their supervision?
How Did We Get Here?
While GMP behaviors basically describe a code of ethics, no one is born an aseptic operator or a quality assurance analyst — these behaviors must be taught, learned, and developed through mentoring. And most companies spend a lot of time teaching aseptic operators what is expected of them and monitoring their performance, via direct oversight or environmental monitoring that provides evidence of their aseptic techniques performance. I’ve seen a number of good manufacturing and laboratory personnel become terrific quality assurance people using knowledge gained from years of experience in their prior roles.
Yet, most companies do not provide specific training to the management staff on their specific responsibilities in a GMP/QSR environment. Wouldn’t it stand to reason that these also would be learned — and not necessarily inherent — behaviors for our management staff? Many companies do offer management training/management development opportunities, but most have to do with how to be a manager, strategic planning abilities, and the like, versus discussing and developing the behaviors that make a difference in a quality environment. And many times, the available management training is optional, even for managers who are identified as not having the appropriate skill sets.
Take, for example, one of the worst examples of management behaviors I’ve seen: A company had a bad FDA inspection that involved multiple investigators over several weeks and resulted in a lengthy list of 483 observations. At the close of the inspection, the FDA investigators presented the plant manager with an affidavit that stated, “I, (their name), am responsible for the state of compliance at this site.” The plant manager described this at a site management meeting after the inspection, followed by their response, “I’m not signing that — I’m not going to jail for this.”
Think about what just happened: The plant manager disowned the responsibility of their position with the entire site management staff as witnesses. If the plant manager isn’t responsible for compliant operation of their site, who is? And if the plant manager can walk away from their responsibility for compliance, it gives permission to everyone under them — everyone in that room — to do the same thing. And they did — “operator error” was the identified root cause for everything that went wrong.
Contrast this with a very different example: In another company, the plant manager and the head of quality sat next to each other, and the quality and operations personnel were interspersed as well by area of focus versus being segregated into departments. In management meetings, if the quality head said something was important, the plant manager was always the next voice, supporting the item’s importance and asking the rest of the group how we would make it happen. The plant manager was a vocal proponent of the importance of quality in everyday activities and discussed quality at site meetings. They also attended and actively participated in every GMP training session with plant personnel and set expectations that other senior leaders did the same.
One of the most significant differences between these two plant managers? One worked as an aseptic operator earlier in their career while the other never worked in operations, just managed them. It shouldn’t be difficult to figure out which is which.
So What Does This Mean To Us As An Industry?
Quality management is a learned behavior. So, we need to teach it, along with a variety of regulatory expectations, in conjunction with quality management principles and practices (such as W. Edwards Deming’s “14 Points,” his red bead experiment, and quality risk management) that are part of a training program for the management staff in GxP industries.
One of the most important things to teach our responsible personnel is that we have a “license” to operate and it’s their job to ensure we maintain that license. (I’ve often heard people who lack the correct quality perspective call this a “right” to operate. There is no such thing in the GxP environment — it’s the worst kind of arrogance to believe anyone has a “right” to perform activities that can impact someone else’s life. We must show that we can meet the standards that protect the patient.) We must earn our “license” by demonstrating our products are safe, effective, and of good quality through submitting applications (e.g., new drug applications, marketing authorization applications) describing our process to regulators for review; obtaining their approval of our applications; and then continuing to uphold the behaviors and activities that enabled us to earn that license by training personnel to correctly execute our defined, approved processes in compliance with regulations — and ensuring they do so.
This means we need to teach our management what their roles really entail in a GxP environment, which goes above and beyond the management functions in a typical business. ICH Q10 and the medical device regulations do a great job of describing what we need our management staff to do to support a quality operation. Other important management activities include:
- Providing performance oversight and being on the floor during operations to assist if something out of the ordinary happens and to monitor personnel performance to ensure appropriate behaviors during operations
- Providing regular, timely feedback to personnel and teaching in the moment to encourage desired behaviors and correct problematic behaviors before they become a habit or cause a significant issue
- Mentoring people in day-to-day activities and developing what they need to know beyond what their initial on-the-job training provides. Knowledge comes with experience, and learning how to apply that knowledge is where mentoring provides a lot of benefit.
- Driving the working culture and setting an example for the group to emulate.
I’ve seen a few area managers do this extremely well. Earlier in my career, my manager would stop by every morning, and we’d have a conversation that would address:
- my priorities/what I was planning for that day
- whether I needed help with anything, such as navigating a difficult situation
- anything he needed to tell me (additional assignments, scheduling, or feedback on assignments/tasks I had performed)
- questions or clarification I needed, and anything was fair game: work projects, departmental or business direction, industry events/information and what it meant to us, etc.
Then, he would move on to the next person, until he had a conversation with everyone in the group. It wasn’t always possible to talk every day, but it was rare that we went more than a day or two without talking.
Think about what he accomplished with this daily activity: staying in touch with all of his people, monitoring operations, communicating expectations, getting status updates, mentoring, and driving performance — all in a way people looked forward to.
Speaking as someone who tried this when I became a manager myself, you have to make these interactions a top priority in your day. Otherwise, day-to-day meetings and other activities get in the way. It’s not easy, and I wasn’t as successful as I would have liked, but it highlighted how much effort it actually took to make happen – and how strongly this manager felt about this communication.
Contrast this with the manager who doesn’t make the effort. Interactions can take on a negative connotation very quickly when you only see your manager to be given more work or to hear negative feedback.
The Bottom Line
So the message to any GxP business is teach your management staff what they need to know to do their jobs, which entails owning and driving quality performance, and then let them do their jobs.
Supervisors need to supervise their operations, not be in meetings all day. Managers need to manage the needs of their groups so supervisors can do their jobs.
And those further up the chain need to understand how important their role is in making this happen throughout the company, and then fulfill that role.
If you got my opening question correct, give yourself a pat on the back. I’ve been marking that one wrong on quizzes a lot lately.
About The Author:
Joanna Gallant is an experienced, solutions-driven quality and training professional who has spent the last 25 years in pharmaceutical, biotechnology, tissue culture, and medical device development and manufacturing environments. Over her career, she has provided regulatory, technical, skill, and management development training support to all operations functions, as well as IT, R&D, customer service, and senior management. Now, as a consultant, she works with clients to design and deliver custom training and build/remediate training systems, including in support of regulatory audit observations and commitments.
Joanna has been a GMP TEA member since 2001, and now serves on the Board of Directors as an advisor. She is one of the founders of the Biomanufacturing Certificate Program at Worcester Polytechnic Institute, and became an Adjunct Professor at the Boston University School of Medicine’s Biotechnology degree program in 2011.