As appeared in Pharmaceutical Manufacturing February 2014.

Manufacturing Operators are key to Quality Culture and the Whys of cGMP

Janet Woodcock was quite clear in her 2013 plenary speech at the national ISPE meeting in Washington DC. The Food and Drug Administration (FDA), she said, is interested in creation of quality culture inside organizations “from the shop floor to the boardroom.”

This is not a new message, but the urgency will more likely be translated into action, with the addition of hundreds of millions of additional budget dollars to the FDA budget in 2014, at a time when most government agencies are seeing budget cuts (1).

The vision of a quality culture across an entire organization appears to have become more critical to FDA for both the pharmaceutical industry and CMOs to execute than ever before. And what the FDA says, industry executes.

So, the question becomes: what is meant by across an entire organization when we are discussing quality culture? After all, don’t we usually hear that to be successful, a company’s strategic vision must be driven from the top, and communicated articulately, with passion and vigor, by a company’s CEO down through the organization?

There are hundreds of examples of great companies whose CEOs are synonymous with a company’s excellent execution of a CEO’s vision. Think about the late Steve Jobs of Apple, or James Dimon, CEO of JP Morgan Chase, both dynamic speakers with clear and passionate vision. But what about the line workers, the operators and technicians who make the products? Do they hear the speech?

In the pharmaceutical medical device industry, it is obviously more critical that those handling the actual processes that make our safe medicine, understand what a quality culture truly means for them, in their jobs, every day.

As we have moved two centuries beyond the Industrial Age and decades past the age where US manufacturing dominated the global economy, it might be expected that there be less attention paid to the role of the hands-on manufacturing, shop-floor employee. How often do we hear about a strategic vision being executed from the workforce of an organization?

Yet, how can a true quality culture, developed to manufacture safe medicine, exist without the buy-in and understanding of the hands that are producing those products – the workforce operators and technicians? Here, the vision must be focused from the bottom up – at the manufacturing levels of a pharmaceutical or medical device organization.

There are guidelines already in place, of course through Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMPs). But these are not enough. SOPs are looked at early on when an operator learns a process but repetition breeds boredom and often, mistakes.

After months and years, many times SOPs can be followed blindly. Poor handling and a laxity of attention to following SOPs are so rarely deliberate – it may simply be a lack of knowledge and a culture that encourages learning more about the “Whys of cGMP.”

This article discusses the value of educating technicians and manufacturing employees to understand the Whys of cGMP. FDA comments aside, it is simply good business to address a continuous quality improvement mindset, and to institute consistent quality based learning – learning that goes well beyond senior operators demonstrating SOPs to the junior operators in a plant.

Instead, tying your process to the science on which those processes are based, and showing employees why processes are performed the way the SOPs are written, creates an environment that invites your manufacturing staff to interact, question and potentially spot quality issues before they become a problem.

Commercial Advantages for CMOs

CMOs in particular, will find a real advantage in the marketplace if an operator education program is visible, measurable and consistent. Showing existing and potential pharmaceutical clients that such training is in place can be a true differentiator.

While most pharmaceutical organizations will audit and verify the quality and safety of products being produced on their behalf, many will not mandate training for their CMO’s operators unless there is an issue.

Mark Helouin, Director of Worldwide Audit for Astra Zeneca, says “AZ customizes training for our own specific scenarios.”, and often use video for on-line learning. Being able to show their own commitment to quality education could be quite valuable for a CMO trying to expand their customer base.

To truly showcase a company’s dedication to quality culture, the manufacturing floor operator training must go beyond just an understanding of Standard Operating Procedures (SOPs), to more comprehensive understanding of the “whys of cGMP.” Gerry Creaner understands this very well.

As CEO of a company that uses short, precise videos to convey its quality message to those in pharmaceutical and medical device manufacturing, GetReskilled’s CEO says, “Where FDA is focused, industry will align.” He goes on to say that “early adopters of this comprehensive view of quality culture development are clearly going to get the best treatment from FDA. The pharmaceutical industry needs to build continuous quality improvement into their process from the ground floor up.”

“It seems obvious, but developing a patient-centric philosophy and showing who will use the products being manufactured, go a long way towards driving the quality message,” says Creaner.

It seems intuitive to understand how training operators about why certain manufacturing practices make safer medicine, will lead to higher quality products, but that is not the full story about how manufacturing quality training can help organizations spot quality issues.

Customs and Behaviors Affect Quality Hand-Raising

Differences in customs and traditions can come into play when implementing a quality culture. In the East, manufacturing workforces represent a mindset which may emphasize deference to superiors, and the importance of status within an organization, and may result in manufacturing workforces less likely to speak up if a quality problem is observed.

Western cultures may not see it as a negative to speak up to a superior but could be wary of “whistleblowing.” However, experience has shown that if operators understand why a particular task is being performed in a particular way, and then see something amiss, the likelihood increases that they will raise a hand when a task is being performed incorrectly or a problem is spotted.

GetReskilled has trained over 3000 individuals since 2005, and develops its online learning curriculum around educating operators about the science underlying the SOPs and GMPs. A great example of this concerns injectables:

Example: Teaching manufacturing operators and technicians the simple science behind the SOPs comes alive when you talk about injectable products. Students who handle injectables in the manufacturing process are taught that injections bypasses all the body’s defense mechanisms because the drug goes directly into a vein.

This is explained within the context of food safety: i.e. the body is its own defense fortress, with natural filters such as stomach, liver, etc. But with injectables, there is no such natural defense; the drug goes directly from the vein into the bloodstream.

In addition, the manufacturing operator students are reminded that infants and the elderly have less protection against contaminants and are taught why.

Examples of contaminated baby formula are cited, versus similar contaminations affecting adults with less serious results. Learning the science behind the Injectable Manufacturing SOPs makes routine procedures come alive.

GetReskilled believe that understanding the “real science”, as CEO Creaner puts it, lessens the cultural taboos against bringing problems to the attention of superiors, because the operator can feel he is questioning the science, not the individual. So, education and training modules teach students how regulations, SOPs and cGMPs are based on to simple, good science.

Understanding how a drug’s chemistry works in the process, and how the equipment is used to protect that process – the temperatures, mixing, agitation, reaction times, are simplified and explained. “Understanding the real science leads to a clearer understanding of the Whys of GMP and fosters a quality culture,” says Creaner.

Consistency of Training Across Sites is Key

If your organization decides to embark on an operator training program, then consider this. Quality training consistency across geographic borders and between a company’s multiple sites, is important. With 90% of the medicines we ingest produced generically and 70% of those medicines also produced overseas (2), make sure the training you provide is consistent across your global organization, and is available in multiple languages.

Again, this sounds obvious, but your competitive advantage is lost if the GMP education is only available in English. A CMO who can show a web-based training program for its operators across its global organization with access to multiple languages will have a competitive advantage in the marketplace.

Risk Based Audits

Increased levels of scrutiny will be felt inside organizations, as Woodcock at FDA made no secret of the fact that she is dedicating higher levels of funding to the effort of audits, and is increasing staff. However, FDA is also quite clearly on a path to conduct more risk based audits.

There have been multiple meetings with industry to define the quality metrics necessary for consistent measurement of a risk based approach to measuring an organization’s quality culture.

While there is an ongoing debate on how to define a consistent measurement of company risk profiles, there seems little doubt that greater numbers of audits will be the result for those who cannot clearly demonstrate a quality culture, and show that it is imbedded deep inside their organizations.

If a quality culture can be clearly demonstrated, at all levels of an organization – from the operators who handle product at the shop floor and throughout an organization, it stands to reason that that organization’s risk profile will trend increasingly positive, leading to fewer audits.

Fewer audits mean measurable cost savings to an organization; just the cost difference between bi-annual audits and annual FDA audits alone is substantial. In addition, higher quality can mean commanding a better price in the market for an organization and products known to be consistently safe.

For a CMO going back to re-negotiate a contract with a client pharmaceutical company there is no question that their bargaining position will be stronger if the CMO organization has taken a proactive role in continuous quality improvement: developing, measuring and communicating their quality culture with its pool of potential clients.

At the ISPE annual meeting last year an official with the FDA was heard to comment that quality is absolutely cost effective, and can result in cost savings equal to 15%. So, while it may take investment up front, there are excellent commercial, market and operational reasons to consider investment in quality improvement and culture, including manufacturing floor training.

Manufacturing operator training is certainly not the only answer to embarking or tweaking your existing quality culture. Instead, it is a matter that clearly deserves attention, based on recent FDA-speak, and gives industry a chance to re-focus on manufacturing and cGMPs.

Commercially, there are clear reasons to become an early adopter and invest in operator learning. In short, focus on your manufacturing floor, because FDA is focusing there, in a big way.

If you head up a CMO or are the VP Manufacturing for a CMO, begin a discussion today about how to institute, measure, and demonstrate a learning program that encourages shop floor operators to go beyond the SOPs, to truly understand the Whys of cGMP.

(1) Food Safety News Obama Administration Seeks FDA Funding Increase for FSMA Implementation by Helena Bottemiller, April 11, 2013
(2) Janet Woodcock plenary speech, ISPE Annual Meeting, Washington DC, November 2013.