Regulatory Compliance Associates® (RCA) Distinguished Fellow, Susan Schniepp discusses establishing a quality culture from the top of an organization down.
Quality culture is a patient-focused approach to quality that is proactive not reactive or procedural, according to Rick Friedman of FDA, in a conference presentation. When an organization is focused on quality, it can detect problems earlier. Further, quality culture helps manufacturers experience fewer deviations, costly remediations and protect its brand, according to Friedman.
Creating a quality culture means an investment in quality including organizational structure and actions. Moreover, the highest quality standards include support for all levels of the company and making business decisions.
“Companies with good quality cultures usually have transparency and collaboration between departments,” says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates. “This is critical when there are problems that impact manufacturing. In addition, companies with a robust culture usually solve the problem faster, which helps them maintain high productivity rates,” she says.
Need help establishing a culture of quality in your organization? Talk to our Experts →
The quality department in a bio/pharmaceutical company plays a critical, but not exclusive, role when it comes to ensuring that biologics and drugs are safe and effective. The entire organization, however, must be involved in ensuring quality is built-in.
“Let’s clear up one issue right away,” says Schniepp. “When we refer to quality culture, we are referring to the culture of the company and not the culture of the quality department. Having an established quality department does not mean a company has a culture of quality.”
“In a robust culture, the attention to quality is a responsibility of all employees, not just those who work in the quality department. In a robust quality culture, the quality department is a partner with regulatory affairs and operations, it’s a policing function,” Schniepp stresses.
“Quality culture is an all-pervading attitude and sense of purpose in which quality is foremost in everybody’s activities. A quality department is a part of the organization that monitors quality, (e.g., by end-product testing). However, quality cannot be tested into the product. It is inherent, and has to be built in—by design controls,” agrees Chris Moreton, PhD, vice president of pharmaceutical sciences at Finnbrit Consulting.
According to Friedman, “senior management has a critical ongoing oversight role to ensure suitability of operational design, compliance assurance, and maintenance.” Friedman points to behaviors that can lead to the development of quality culture that includes shared accountability, teamwork, listening, continual improvement, coaching, and integrity.
Moreton agrees. “In my opinion, a quality culture means everyone from the CEO down. This includes production management and the most junior staff put quality (and patient safety) at the top of their agendas.”
Quality requires ‘top-down’ and ‘bottom-up’ approaches. If senior management is not committed/interested, then the junior staff will find it difficult to implement and maintain quality activities.
Similarly, if the junior staff are not properly trained and committed to and interested in quality, then quality assurance will not be properly implemented. “I have seen organizations where the commitment to quality was lacking, and there was, in effect, a lack of a quality culture,” says Moreton.
Creating Quality Culture
Creating a quality culture starts with the head of the organization, according to Moreton.
“The CEO has to be committed in both words and deeds. [The CEO] has to hire people who will help shoulder the burden while maintaining the business. This then goes on down through to the most junior staff.”
“Performance feedback means employees understand how to enforce the rules. There is a line beyond which an individual must not step, because once they have stepped over it, they will be asked to do so again and again—to thine own self be true!,” he says.
Communication is key, says Schniepp. “Robust quality cultures have data integrity and welcome feedback from all employees regardless of position within the company. When a company has a poor culture, the communication is top down, and employee opinion and input [are] not valued.”
How does one take stock in the robustness of quality culture in a bio/pharmaceutical company? “There are studies and data that suggest you can measure the quality culture of an organization by looking at the maturity level of the attributes in their quality management system,” says Schniepp. “Certainly, the premise is if you can measure a company’s attributes (CAPA [corrective action and preventive action] system, communications), you can measure the quality culture of an organization.”
Regulatory agencies may take the organization’s history into consideration when assessing the effectiveness of a company’s quality practices, especially during an inspection. “How many FDA 483 observations have there been, and how efficiently did they respond and rectify the issues? Undeniably, the FDA inspector will take note of how people are working during an inspection.”
In some ways, it all comes down to the inspection process and the FDA inspector,” says Moreton. “[Regulators] want quality (and patient safety) to be taken seriously, and not simply paid lip-service to. They will look at the operation plan to see who makes the decisions affecting quality.”
“The general state of the manufacturing facility and the attitude of staff is apparent during an on-site inspections. Consequently, they will analyze how complaints are handled and recall-readiness—how the organization would cope during a recall,” says Moreton.
“Regulators have linked the lack of a quality culture with data integrity issues. Further, guidance documents released from the Pharmaceutical Inspection Co-operation Scheme, the UK’s Medicines and Healthcare products Regulatory Agency, the World Health Organization, and FDA all stress the link between a robust quality culture and reliable and consistent data.
One thing they all stress is an open culture that embraces employee feedback and values employee contributions. “Additionally, senior management can often follow the employee’s lead when establishing a culture of quality,” says Schniepp.
Is the investment in creating a company-wide culture of quality worth the time and effort? In fact, it seems the alternative is worse. The repercussions of not having a robust quality culture include higher costs and increased scrutiny by regulators.
“Ultimately, [the impact] is likely to be financial because there will be FDA 483 observations to remedy. After all, product recalls and the possibility of a consent decree takes time and money. (If people think quality is expensive, try a long FDA 483 list, a product recall, or a consent decree). The company’s stock price will also likely take a hit,” stresses Moreton.
“Companies that lack a good quality culture usually have high deviation and FDA investigation rates. For the same reason, this impacts their ability to provide safe and effective medicine to patients. It also costs them more money to perform the investigations making them less efficient,” agrees Schniepp. “In the end, the safety of the patient is what matters most.”
About the author
Susan Haigney is the managing editor of Pharmaceutical Technology.
Volume 46, Number 5
About RCA’s Pharmaceutical Services
Regulatory Compliance Associates (RCA)® has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, RCA offers leading pharmaceutical consultants that can help you navigate through the challenges associated with evolving industry regulations.
Our team of over 500 seasoned FDA, Health Canada and EU compliance consultants and regulatory affairs experts can understand the complexities surrounding the pharmaceutical industry and the unique inner workings of the regulatory process.
Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, RCA® Inc. will guide you through every step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our clients include:
- Companies new to FDA, Health Canada or EU regulations and the pharmaceutical industry
- Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
- Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
- Law firms seeking expertise in the remediation of warning letters, consent decrees, 483’s or import bans
Regulatory affairs is Regulatory Compliance Associates® Inc.’s backbone and we fully understand the complexities of the pharmaceutical and biopharmaceutical industries. Our expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.
As your partner, we can negotiate the potential assessment minefield of pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience. We offer the following four regulatory affairs services for pharmaceutical companies.
- New Product Support
- Product Lifecycle
- Other Regulatory Services
The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand, and just one misstep could mean significant and lasting consequences for your business. At RCA® Inc., we offer the experience and resources necessary to guide you in quality compliance.
- Regulatory Agency Response
- Preparation and Training
- Inspection Readiness
Regulatory Compliance Associates® Inc.’s Quality Assurance services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.
- 21 CFR Part 11
- Data Integrity
- Manufacturing Support
- Facility Support
Regulatory Compliance Associates® Inc. has significant experience and a proven approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. We know how to partner with executive, legal, and communication teams, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute.
We can develop a comprehensive proof book of documented objective evidence demonstrating the corrective actions taken to remediate non-compliant issues. In addition, RCA can help prepare a comprehensive strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance with the regulations.
- Regulatory Action
- Warning Letter
- 483 Observation
- Oversight Services
Regulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.