Good Quality, Poor Quality in the Pharmaceutical Industry

Creating a Workplace with the Right Quality Mindset

The following is a guest article from quality executive Anders Vinther, PhD.

How do you create and maintain a quality culture in your organization, one that “produces good quality?”

I was asked to speak about that at a conference because that is what I have done for years. When you try to describe what good quality looks like, sometimes it is helpful to start with what the opposite of good quality looks like. 

“What are examples or signs of a poor quality?” was the question I asked on LinkedIn. I received so many great and insightful responses. Thank you to all who gave me their feedback! This article discusses what good quality is and what it is not.

I have worked in the pharmaceutical industry for many years in senior leadership roles both in startups and large pharma companies. I lead industry-wide initiatives and external influencing organizations, and I have audited a good number of pharma companies. Hence, I have my views and experience as to what works and what does not when it comes to the quality mindset. 

If you have the right quality mindset in an organization, everyone at all levels pulls in the same direction, and decisions are made based on science, compliance, and data, which then translates to good quality performance and cGMP compliance in an environment of continual improvement.  

First, I want to clarify that it is not as simple as putting a few variables into an equation that equals “good quality.” Quality maturity models (i.e., methods to assess an organization’s progress toward maturity in quality operations based on answering a number of questions), which are gaining interest, can only get you part of the way. At best, they can indicate good quality, but not how you get there; even less so, how you maintain good quality and the right quality mindset. The main reason for this is that a company’s culture involves people and how they interact with each other. Taking an “engineering” or “reducing variability” approach is not going to work. I will come back to this later in the article.

Let us start with the feedback I received. These are examples or indicators of poor quality from those who responded to my LinkedIn query.

• Lack of adherence to timelines for quality-related activities
• Many recurring deviations and a high number of failures
• A highly complex quality management system (QMS)
• Inadequate resources and investment in employee education
• Blame culture
• Metrics and objectives that drive the wrong behavior
• One-way leadership communication
• Lack of critical thinking and judgment
• Loss of patient focus

Quite a list, right? Do you agree? You have likely experienced some of this in your own work life. One might add risk aversion, training in lieu of education, setting the bar too low at minimal compliance, and short-termism to the list.

Now, I want to discuss what a good quality mindset is and how you get there at all levels throughout an organization.

Senior Leadership

It starts with the CEO. Joseph M Juran stated it this way. “It is most important that top management be quality-minded. In the absence of sincere manifestation at the top, little will happen below”. That is very true. Without the CEO and the C-Suite’s active support, long-term focus, and leadership, it is very hard to create the right quality culture. Here are some indicators that the CEO is “quality-minded.”

• The CEO communicates the importance of quality and engages in quality improvement activities, including the creation and review of the Quality Plan and attendance at the Quality Management Review. What people do is what they prioritize. Employees will watch what the CEO does.
• The communication is mostly dialog (rather than top-down only), and the CEO and Executive Management Team are not only listening but encouraging and allowing employees at all levels to take on leadership roles for large and small quality and cGMP compliance improvement projects.
• The CEO and the Head of Quality meet on a regular basis and the Head of Quality has a high-level position in the organization. This signals the importance of quality. 

What do you do as the Head of Quality if the CEO is not visibly supportive? It is important that you speak the language of the C-Suite, which includes articulating quality and cGMP from a value and not purely cost perspective. Examples of this include:

1. Avoiding the cost of failures by mitigating risks before they happen, and
2. Identifying root causes of deviations and taking action to avoid recurrence, drug shortages, and more.

Try to speak in financial terms rather than compliance language only. This requires that the Head of Quality is both proficient in risk management to be able to weigh benefits and risks and commercially savvy, thus, understanding how quality activities can enable good business results overall.

Rewards and Recognition

Throughout my career, I have seen that people prioritize what they are rewarded and given a bonus for. That obviously makes sense from a personal financial perspective. Thus, it is important that the Head of Quality, the C-Suite, and Human Resources discuss how the rewards and recognition system is geared toward demonstrating a behavior of quality improvement and cGMP compliance. The first question to ask is “what key behavior is vital?” followed by “what incentive will drive this behavior?”

Many times, I have seen rewards linked to metrics that drive the wrong behavior. Examples are:

• Annual goals of fewer deviations (I have seen multiple deviations combined into one, thus, falsely showing a reduction in deviations, deviations recategorized so as to not count as deviations, etc.)
• Batches released on time despite deviations that have not been fully resolved beyond impact to the batch produced (which indicates the production schedule trumps quality and cGMP compliance)
• CAPA on-time closure (I have seen deadlines moved multiple times)

This type of metric is what is also called watermelon metrics. Green on the outside, red on the inside. You only fool yourself and the company with this kind of reporting. What I would expect to see is honest transparent reporting and a focus on continuous improvement.

Getting to Root Cause

I once audited a company where I found that almost half of all investigations into deviations or failures stated human error as the root cause. To me, that indicates poor training, poor investigations, poor systems, poor leadership, and, ultimately, poor quality. If you apply a 5-Why approach, the root cause often is not human error, but inadequate training or inadequate details of the SOP, fail-safe procedures of equipment operations that may not have been implemented, etc. Getting to the true root cause is really the best way to avoid recurring deviations. A good metric in my view is the percentage of deviations where the true root cause has been found, the issue corrected, and recurrence avoided. Eliminating human error as a root cause category is one way of forcing the investigation to find the true root cause.  

The list of examples of poor quality outlined at the beginning of the article mentions “blame culture.” Do you have an environment where you “do not shoot the messenger” and it is psychologically safe to speak up? If not, you certainly must work on changing that. If you do not know where there are issues, it makes it hard for the Head of Quality and the CEO to facilitate solving them. 

Building trust and transparency are usually one of the first things I focus on in a job if it is not already there. Failures are often some of the best learning opportunities. If they are seen and treated as bad, that can lead to a blame culture. Lessons learned sessions require an environment of “see something, say something, do something.”

Engaging Employees

As we know, it takes every employee to make a successful batch of medicine, and it only takes one employee’s mistake to lose a batch. It is therefore important that every employee is competent and motivated. Every company in the health care business has a purpose or mission statement that ultimately is about improving health—preventing, treating, or curing disease. Sometimes people can forget this purpose in their daily job if they are not reminded. Motivation comes through being part of a team, achieving something every day, and being given opportunities to develop. 

As a Quality leader, it is your job to create opportunities where employees can contribute, not only because they have to, but because they want to. In a quality-minded organization, the patient is at the center of every decision. Translate the company mission statement into words that resonate with employees at all levels. Remind your employees to ask themselves “what would be the right thing to do for patients?” If every employee has this and the company’s purpose and mission in mind when they make decisions and perform their job duties, it is easier to get to the right quality mindset. 

Many times, I have seen rewards linked to metrics that drive the wrong behavior

Employees are the most important asset in a company. Is your company allocating adequate resources and investing enough in employee education? This is not only about people attending external training courses. Do you perform lessons learned activities on a regular basis (after each batch or campaign for instance)? As stated above, internal failures provide some of the best learnings for all employees in the organization. Does every employee have a training plan with the objective of being proficient? Have you moved away from training being a “read and understand” checkbox activity? Are employees engaged to participate in or lead improvement activities? And how much of your time as a senior Quality leader is devoted to educating your staff?

The Quality System

One very common theme I hear when people say they are not being fully engaged in quality and cGMP compliance activities is that the company’s pharmaceutical quality system (PQS) is too complex. Let us make this clear: increasing complexity does not translate into increasing cGMP compliance. In many cases, it works the opposite way. If SOPs are too complex, employees will miss the important things that they are supposed to do, or they might create their own “cheat sheet.” Both actions are not compliant with cGMPs. 

I see it as Quality’s role to keep simplifying the PQS as much as possible. Try changing the SOPs from words to include figures, pictures, flow diagrams, callouts/highlights of key activities, videos, etc. Have the people doing the work write the SOPs and apply critical thinking to simplify without losing critical steps. One thing that I have seen throughout my career is that regulatory agency inspectors come in for an inspection, write an observation, and expect companies to add more detail to the SOPs. That might be okay in some cases, but in many, it really is not, and the intended objective might not be met.

Contract Manufacturing

What I have written above has been with the assumption of the company manufacturing and testing the drug product in-house. What do you do with respect to good quality when the company is outsourcing production and testing? As a Contract Giver, you are ultimately responsible for cGMP compliance of outsourced operations. Thus, you only want to work with Contract Acceptors that have the right quality culture and provide you the service you expect and pay for. This seems obvious, but countless times I have seen Contract Acceptors that focus inward and forget about the core of their business: service for their customers. For the Contract Giver, it is important that you treat the Contract Acceptor as a partner, a part of the family, and not only focus on price, but also the relationship.

As the Contract Giver, the first task you perform is a quality and technical assessment of the Contract Acceptor. Obviously, the company must be able to technically perform the activities that you outsource. When I do an initial quality assessment, I review the PQS both from a cGMP compliance and Contract Acceptor’s point of view.      

Below are ten things to consider when performing an initial quality assessment:

1. What is their standing with regulatory agencies?
2. Does the pharmaceutical quality system SOP specifically state you are going to be involved in relevant deviations, changes, and out-of-specification results early and actively?
3. How transparent and willing is the company to share its procedures and facility data?     
4. From a quality culture perspective does the senior Quality leader(s) attend the initial audit (this indicates the importance of the future relationship seen from the Contract Giver’s perspective)?
5. What is the attrition rate in the company?
6. Is a Management Review performed? If so, how often, and does the CEO or Site General Manager and leadership team attend?
7. Who leads operational excellence activities, who contributes to these, and what types of continuous improvements are performed (cost-driven or quality and cGMP compliance-driven)?
8. When you tour the facility how does it feel? Is it tidy? Do people seem calm and well organized? Are quality metrics visible to all and discussed with all?
9. Do employees speak up with confidence and competence?
10. Is the training program comprehensive and have employees completed their training? When was the last time training was not just “read and understand?”

There is a lot you can learn about a Contract Acceptor’s culture of quality already during that first audit.

Once you have completed the initial assessment of the Contract Acceptor and found it acceptable, you must continually assess the Contract Acceptor’s service and quality mindset. Are reports well written and are issues solved competently? Are executed batch records and analytical testing documentation tidy and adhere to Good Documentation Practices? Are issues shared with you and solved timely? Is QA adequately involved in managing deviations? Are you involved in review and investigation of issues? Do you have access to senior Quality leaders for updates and reviews? There are many ways to assess the quality performance and culture of your Contract Acceptors. Common for all of this is that you want to establish and grow a partnership, build trust, and avoid issues not being brought to your attention.

Good Quality Every Day

Quality is often assessed in a snapshot of time. Good quality should also be expected even when no one is looking. This requires the right quality culture where everyone is motivated, competent, and understands the importance of doing a good job in every action. Some have traditionally seen the Quality leader in the role of “ensuring” cGMP compliance, i.e., the person you count on to fix issues. Of course, the Head of Quality needs to be highly proficient in the cGMP regulations and make decisions that are cGMP compliant. A reactive approach, however, will not get the organization to sustainable good quality. Applying a “minimal compliance” approach will not get you good quality in the longer (or even the shorter) run. 

Good quality, and the right quality mindset, require the Head of Quality to be proactive to avoid issues from happening in the first place and understand how you integrate quality processes into the overall business of the company, how you are an equal member of the management team, and how you motivate people to do what is right in their every action. The role of the Head of Quality and senior Quality leaders has never been more important than it is today in establishing the right quality culture to achieve good quality every day.

Let me know your reactions and thoughts.

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