U.S., UK Regulators Share Passion for Quality Culture

Quality culture has often been characterized as the driver behind effective quality systems (1), and it has become even more important as the U.S. FDA seeks to collect quality metrics data from pharmaceutical manufacturers.

The 2017 PDA Pharmaceutical Quality Metrics and Quality Culture Conference in Bethesda, Md., Feb. 21-22, provided insight into both the U.S. and UK regulatory perspectives on quality culture. Jeffrey Baker, Deputy Director, Office of Biotechnology Products, CDER, FDA, and David Churchward, Expert GMP Inspector, UK MHRA, represented these agencies in the session, “Quality Culture and What We Are Learning as an Industry.”

Baker opened his talk by acknowledging that quality culture can be interpreted in many different ways.

“This is something where everyone has passionate opinions because it’s very close to our hearts and our day-today lives,” he said. “But that’s okay, because it makes for a very rich marketplace of ideas.”

His presentation offered a different take on quality culture, taking a more etymological approach, starting with the word “quality” itself. While there are books and publications that list different types of quality, Baker worries that “we’re using the same word but in very nuanced ways.” He then cited CDER Director Janet Woodcock, who in 2014 defined the quality of a pharmaceutical product as “fitness for use,” meaning it “delivers the properties described on the drug label and is not contaminated.” The rest of his talk explored the meaning of “culture” and its relation to “quality.” He noted that in 2014, according to Merriam-Webster, “the No. 1 word was culture.” And this word carries many connotations: Cultivation; development of intellectual abilities through education; familiarity with the fine arts and humanities; shared values within social groups; and the act of cultivating living material such as bacteria or viruses in nutrient media. He focused the last portion of his talk on this last connotation.

In his presentation, Baker used the analogy of quality culture as living cells on a petri dish, to which many of the microbiologists in the audience could relate. To culture healthy cells, a microbiologist requires an appropriate growth medium, a stable environment, and must guard against the accumulation of dead cells and contaminating cultures.

Turning the analogy to quality culture, Baker said a healthy one requires a stable environment that supports it and protection from contamination by “viruses.” The “viruses” that can impact a healthy quality culture are just as fastgrowing as the ones in the lab.

“Culturing quality is an exercise in providing experiences that promote and support healthy stable cultures of behaviors we value,” he said. “Just as with ‘management,’ when we refer to ‘quality culture,’ we need to understand whether we are talking about the noun or the verb. One of my great frustrations is when ‘management’ becomes what you are rather than what you do. I want management the verb.”

When it comes to quality culture as a noun, Baker pointed out that “acceptable” is always relative in the viewpoint of the assessor. And the assessor could be a regulatory agency, large company, small biotech firm, etc. Either way, the culture conforms to who is looking.

“When we think about quality culture the verb, we get to a much better place. The culturing of quality is about us going and making something really good and stable happen.”

By taking the active stance of “let’s go culture some quality,” this makes all involved with quality the actors instead of observers, he explained. In other words, it’s a decision of action.

Quality: Embedded at All Levels

While Baker’s talk ended with a call to action, Churchward’s presentation offered a look back into quality culture’s past and its impact on MHRA, the UK regulatory agency.

“Quality culture, it’s nothing new,” he said. “In 1972, a failure to sterilize a batch of intravenous fluids led to a public health emergency in the United Kingdom. These products weren’t just killing patients, there were 500 units in the supply chain that nobody could locate. And at the time, the UK Department of Health initiated a ‘life or death’ search to find those units before they were administered to patients.”

This incident led to the Clothier Report, an enquiry into the contamination of intravenous fluids. It also led to the UK’s GMP regulations. While the report contained a number of conclusions, Churchward pointed to a few that specifically related to quality culture. First, there was no technology available that eliminated “the need for skillful men devoted to their work.” Second, too many in the field believed that sterilization of fluids could be easily achieved by unskilled workers operating under minimal supervision. And third, that “public safety depends ultimately on untiring vigilance by both industry and government.” At the same time, regulations and inspections are not necessarily a panacea from similar events occurring.

“So we need that quality mindset,” he said.

When MHRA looks at a company’s quality culture, the Agency wants to see:

• Confidence that the company is (and remains) in control
• Understanding of how quality attributes impact patients
• Quality-related decision-making
• Mature organizational mind-set, i.e., avoiding a compliancedriven mind-set of “I do this because I have to”

MHRA expects a firm’s quality culture to manifest in a number of ways. “First of all, we require knowledge by personnel of what is important…We need diligence by personnel at all levels of an organization, so that everybody understands their contribution to quality,” Churchward said.

No matter how removed someone is from the patient, they need to understand that their actions impact the patient and the organization. This awareness should extend across the organization so that employees are empowered to bring quality issues up with all levels of management.

Second, management should be committed to promoting this holistic view of quality and be transparent about that support.“This is more than just the mission statement,” he said. “This is senior management walking the talk. Otherwise, no one’s going to report things.”

Churchward suggests companies send personnel out to see their products administered to patients. Prior to joining MHRA, Churchward managed a manufacturing unit in a hospital that produced a range of aseptic products, some of it for the hospital’s pediatric intensive care unit. To instill a greater awareness of the importance of the product’s quality, he established a program in which technicians had to go to the unit and see the infants receiving the medicine.

“The effect was remarkable,” he said. “It turned an acceptable technician into a good technician, because they really ‘got’ the importance of what they were making.”

Metrics Tied to Quality Culture

Regarding quality metrics, MHRA looks for flexible metrics based on compliance that augments existing regulatory practices.

“Some of the indicators we are looking for are the ones that we feel foster an environment of commitment, diligence, vigilance and knowledge of staff,” Churchward said. “And clearly that requires strong leadership, but it also needs empowerment for staff at all levels.”

Both talks illustrated that quality culture is a crucial underpining for any successful quality metrics plan. A company’s quality metrics are only as good as the culture that supports them. And that support has to be ingrained at all levels of the organization, starting from the top.

[Author’s Note: Learn more about PDA’s quality culture activities in the “On the Issue” video, “Defining the Quality Culture,” featuring Amgen’s Cylia Chen-Ooi, available on the PDA Letter website.]

Reference

1. Morris, W. “Want to Make the FDA Quality Dean’s List? Take a Look at Your Metrics.”PDA Letter. 51 (March 2015) 22 –29.