Quality Culture in Regulated Industries: A Critical Attribute for Success

While it once seemed like an alternative, unmeasurable principle, the health of a company’s culture has now entered the mainstream. Phrases like “family feel” and “cut-throat” can be used to describe the atmosphere of a workplace, and a company’s culture is frequently at the top of the list for an interviewee’s questions when considering a new job. Especially for regulated industries where a product is delivered to a consumer, the Quality Culture can be the foundation of success and has been recognized by regulatory bodies, business analysts, and industry professionals as a critical attribute of a robust quality system.

Aligned Goals

In their White Paper on “Quality Management Maturity”,¹ the FDA notes “Quality Culture is an environment in which those who have responsibility for oversight and control over manufacturing take ownership for quality”. Gone are the days when the Quality Department acts as a police department within an organization. A culture that waits to be caught, will only be successful part of the time. How many people hit their brakes on the highway when a police officer is noticed? Aligned objectives are critical for success and establishing common goals is a good first step when beginning a quality culture initiative. One or more common quality goals that could be impacted by all levels of an organization should be established and communicated, and efforts to achieve this goal (or goals) should be incorporated into existing work practices. These goals need to be more than just a paper exercise – they need to have a practical impact at all levels of the organization.

An example of a high-level (or corporate level) company quality goal might be “Reduce audit nonconformities during customer and certification audits”. The Quality Unit could have a lower-level goal that feeds into this goal that aims to improve corrective and preventive actions (CAPA) and measures this improvement through effectiveness percentage. The Manufacturing group may have an even more specific goal of creating an internal walkthrough process within their department so potential non-conformities are identified internally before being caught by an external auditing organization. In this example, the Quality Department may still own the “official” internal audit program, but moving some of this responsibility and accountability outside of Quality can prove very impactful. This goal could be measured by the on-time completion of the Manufacturing group’s walkthroughs or several nonconformities caught and corrected during the walkthroughs. While the measurements of the Quality Unit’s goal and the Manufacturing department’s goal may be different, having alignment on what is important to the organization from a quality standpoint (reducing audit nonconformities) is a building block of a strong quality culture.

Measuring Culture

While a well-written goal should be easy to measure, assessing the health of an organization’s quality culture may prove more challenging. At a previous employer, I once had to put together an annual plan to “improve quality culture”. I knew that to successfully achieve this goal, I needed to establish a baseline. However, measuring something like Quality Culture is not as straightforward as measuring something like on-time training completion. Quality Performance Indicators (QPIs), if properly established, can partly indicate the health of a company’s quality culture. QPIs should include metrics that look at internal failure rates, compliance, continuous improvement initiatives, and a measurement of customer satisfaction. Customer satisfaction, especially in cGMP-regulated industries, should be more than just their approval or willingness to continue to buy a product. While product satisfaction is important, protecting the safety of a consumer is the ultimate critical measurement of success. Therefore, complaint trending and adverse event monitoring would be an important measurement of customer satisfaction within cGMP-regulated industries.

QPQPIslone likely does not provide enough insight into an organization’s internal commitment to quality. Therefore, anonymous surveys, which analyze the opinions concerning quality at all levels of the organization, may be an important tool when assessing quality culture. Surveys should analyze factors like Leadership’s commitment to quality, focus on prevention, ownership, and accountability, and how metrics and values are communicated throughout the organization. When I established a baseline quality culture measurement as part of my annual improvement plan, I ultimately used a combination of QPI measurements, survey results, and external audit trends.

Leadership

A strong quality culture always includes Leadership’s commitment to quality, and it is well-recognized that world-class leaders support quality. However, Senior Management’s commitment to quality must be more than just drafting a quality policy and verbalizing they are committed to quality at an annual company meeting. In the Forbes Insights article “Culture of Quality”² the following comments and data were obtained from their survey of 2,291 executives and managers: “Nearly three out of five survey respondents (59%) say their organization exhibits a comprehensive, group-wide culture of quality’. But there is often a disconnect—while 75% of senior or C-suite titles believe this, responses drop to less than half among those with quality job titles.” Leaders must be aware of their potential blind spots and “walk the talk” outside of the boardroom. They also must be open to receiving feedback and not adverse to conflict. Leaders should accept the reality that sometimes changes to “the way we’ve always done it” are necessary for real improvement. A simple, impactful way to demonstrate Leadership’s commitment to quality is through a periodic walk-through of the manufacturing floor. During these walks, communication with employees is open and casual and is often much more meaningful than posting a quality policy on a communication board in the lunchroom. “Walking the talk” in this manner often garners more respect than more formal communication methods.

Listening to the Customer

As previously referenced, customer confidence and satisfaction, and most importantly their safety, should be the primary focus in a regulated industry. Ultimately, a commitment to the customer is foundational to a quality program, and demonstrating this commitment within an organization can become core to an organization’s quality culture. Adverse events and customer complaints provide a measure of customer dissatisfaction and steps should be taken to openly recognize weaknesses and risks. Correcting product safety issues is likely a straightforward message to deliver within an organization, but communication regarding other quality-related changes is also important. If a product continually receives complaints for a difficult-to-open container, for example, before corrective actions are implemented and pushed to the packaging floor, the background and reasoning for changes should be communicated. This will provide insight to the employees tasked with implementing the packaging changes and empower them to be part of the solution. If the complaining customers begin switching to a competitor’s product because their complaints are being ignored, this clees the connection between quality improvement and business or financial success. When corrective actions are successful, they should be celebrated. Companies should also intentionally share customer wins and successes. New product commercials, increased sales results, medical breakthroughs, innovative technology, and general positive customer comments are typically appreciated when shared throughout the company.

Employee Recognition

Along with empowering employees by involving them in solutions, rewarding employees who identify opportunities and take steps to improve quality is also a piece of the quality culture improvement puzzle. It is widely accepted that companies who intentionally focus on employee recognition create more loyalty and job satisfaction, and a properly implemented recognition and reward program can improve an organization’s quality culture. Recognition and rewards can take many forms and do not always have to be costly. Showcasing best practices and highlighting quality solutions that are driven directly by the employees involved in producing the product can have a positive impact on performance and help to reinforce quality objectives. If a company’s product is something that could be consumed and enjoyed by employees, rewarding them with free products as an incentive also helps to drive company and product pride while indirectly creating a new customer. Though the most effective method may differ between employees, I doubt you will ever find an employee who would not appreciate being recognized for a quality improvement idea or solution.

While working as a compliance and quality leader in the industry for 22 years, it became clear to me that the key to a company’s success often lies in the intangible. Being successful in the regulated world is more than just following regulations or meeting all the established QPIs. If you ask a Manufacturing Manager where the highest risks for quality failures exist, they will often say with new employees or on the night shift. However, a company with a strong company culture relies on the tenured employees to demonstrate how to do things the right way and can trust that during the times when there is less oversight (like on night shift) product quality standards will still be achieved. Assessing a company’s quality culture and identifying the ways to improve it may be one of the toughest tasks of one’s career. However, just like technological innovation is a requirement to compete in the present climate, a strong quality culture is necessary for regulated industries to improve, grow, and retain customers and talent.

References

1. Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals https://www.fda.gov/ media/157432/download
2. Forbes Insights; Culture of Quality; 2014

Author Biography

Shelly Blackwell brings over 22 years of quality and compliance experience in highly regulated environments to the EAS Consulting Group. After starting her career as a Microbiologist, she gained expert knowledge of a variety of domestic and international regulations while holding senior leadership positions in the dietary supplement, pharmaceutical, and medical device industries. These positions include 7 years as the Quality Assurance Director for GNC / Nutra Manufacturing and most recently leading the Quality Systems and Compliance Team at Bausch and Lomb in Greenville, SC.

Shelly’s accomplishments while leading Quality teams include developing supplier qualification programs, sourcing and implementing electronic QMS systems, implementing inspection readiness programs resulting in improved regulatory standing, risk-based quality system development, data integrity program development, and numerous successful continuous improvement initiatives. She has led FDA and other regulatory inspections throughout her career and is also a lead auditor herself, auditing raw material suppliers and finished product manufacturers all over the world. Shelly holds certifications from the American Society of Quality and the Institute of Food Technology and has a Biology degree from James Madison University.

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Shelly Blackwell, Senior Director for Dietary Supplement and Tobacco Services - EAS Consulting Group

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