|QA and pro soccer have a lot in common.|
Well, other than the bright lights.
by Beth Pedersen,
Marketing Communications, MasterControl
1979 was a pretty momentous year. The Sony Walkman made its debut, Michael Jackson released his breakthrough solo album, “Off the Wall,” and Margaret Thatcher became the first woman in history to be elected as the British prime minister (more on Thatcher in a minute). But anyone who works in quality will remember 1979 for another reason altogether: the introduction of the term “quality assurance” (QA) in FDA’s 21 CFR Part 58 (1), also recognized as the first Good Laboratory Practice (GLP) regulation. Incidentally, 1979 is also the year that Dr. Andrew Waddell, a seasoned QA pro and now director of the Scotland-based GxP consultancy TMQA, began his foray into the field. Waddell delivered the keynote presentation, titled “The Challenges Facing Today’s Quality Assurance,” at the 2016 Masters Conference, the annual event for MasterControl enterprise quality management software (EQMS) users in Europe. Drawing from his unique life experiences and 37-year tenure in QA, Waddell examined five lesser-known aspects of QA that challenge the relevance of a nearly 40-year-old regulation and point to an exciting new future of quality.
5 Things You Might Not Know About QA
1. Quality Assurance is Not Quality Control Waddell was a young teacher and researcher in human pathology at the University of Edinburgh when a series of events occurred that would change his career path forever. First, Thatcher (2) came to power in May 1979 and according to Waddell, her spending cuts made a career in medicine much less attractive. A month later, the FDA introduced GLP, at which time Waddell was invited by a major CRO to implement the brand new concept of QA.
As the regulated industry developed, the perception of QA morphed and a number of misconceptions arose around what QA is and what it isn’t – even among professional auditors. One such misconception was that QA and quality control (QC) are one and the same. By definition, “assurance” means providing confidence; in the case of QA, confidence that quality requirements will be fulfilled (3). QC, on the other hand, focuses on testing and providing evidence that quality requirements have, in fact, been met.
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To get the full details, please download your free white paper. “It’s a fundamental misunderstanding that QA is quality control,” Waddell said. “We’re not there to find things. Our job is to provide assurance and confidence that the quality requirements are being fulfilled.”
Audit is just one of the tools used in QA to provide this confidence (4).
2. Quality is Two-Dimensional
What is quality, other than an extremely good score in Scrabble? It turns out the answer is not so simple. While the perfect one-sentence definition of quality may not exist, Waddell explained that the literature supplies two classic definitions of quality:
Quality = compliance with clearly defined standards Quality = customer satisfaction (or delight) To illustrate the deficiencies of the first definition, Waddell humorously pointed to an example of concrete lifejackets. Here, the problem lies not with the end product itself but with the standard describing it. “Compliance with an incompetent standard is not quality,” Waddell explained. The second definition, while commonly used, also has its flaws. Waddell recounted a personal experience in which he once asked a tire shop in Scotland if he could pay a fraction of the price for tires, citing the company’s policy of 100 percent customer delight. While it would have delighted him to get the reduced price, it would have been poor business practice. The shop manager refused.
According to Waddell, both definitions are insufficient. “I’m not comfortable with either,” he said. “The reason is that quality is always two-dimensional: first of all, are we doing the right thing and secondly, are we doing it the right way.”
3. The “Development Spectrum” Should Dictate Which Regulations Apply
The development spectrum describes the innovation process from idea to marketed product. On one end of the spectrum is the “discovery” phase, where you form original ideas and explore endless possibilities. This phase is where “doing the right thing” occurs. It is your chance to decide what to create and which features will add value to the product.
On the other end of the spectrum is the “proof” phase, where precision is crucial and you are bound by the rigidities of satisfying regulations, safety requirements and customer expectations. Once you convert your bright idea into a product, you have to ensure it will work, or what Waddell refers to above as “doing things the right way.” Some companies, such as small, innovative startups, spend all of their time in the discovery phase as they develop new ideas and products; to these companies, quality means originality and brilliance. And yet, to sell their products, they must adhere to the same quality regulations as established companies with many products already on the market, companies whose definition of quality typically focus more on robustness and compliance. This poses a conundrum for many innovative companies because the regulations become increasingly difficult to apply. “The regulations are entirely about robustness, predictability, validity, etc. and life isn’t like that,” Waddell said. “Life is a spectrum, a journey, from the new idea through to the marketed product. At the same time, quality systems have got to reflect that as well.”
4. Auditors Wear Many Hats
While an auditor’s job may seem clear-cut, his or her responsibilities are much more than meet the eye. In addition to performing their audit duties, auditors must serve in the following roles:
· Psychologist– Auditors spend a lot of time looking at the professional aspects of the audit, such as regulations, protocols, monitoring visit reports and data output. They also look closely at procedural aspects, like where is the audit going to be held, what tools to use and what information to gather. In Waddell’s experience, very seldom do audits go wrong because of professional or procedural issues, but more often because of the personal aspects. “When we’re dealing with people, we’re dealing with a huge range of personality types, and consequently an auditor has to be a chameleon and adapt his or her personality type to suit the situation of the auditee,” Waddell said.
· Technologist– With the onset of big data, conventional audit approaches have become ineffective because of the overwhelming amount of information available. “Too often, information, processes, systems and procedures are generated because we can generate them, rather than because we need them,” Waddell said. He encouraged the use of technology to tame the “paper mountain,” which will increase the demand for tech-savvy auditors.
· Evangelist– Risk management is not a new concept, but the latest evolution of the quality movement starting with the Quality Gurus, followed by Total Quality Management and Six Sigma. Waddell praised risk management, but warned against using it only as a tool to cut costs. “Risk management is a good thing, provided it’s used to apply resources smartly,” he said. “Traditional approaches to QA are very bad at that. We still spend a lot of time looking at output in a way that doesn’t give us value.” It is important to validate your risk assessment to ensure that it is serving its intended purpose, and auditors should help by leading by example.
5. Pro Soccer and QA Have a Lot in Common
Being a former professional soccer referee and current member of Scotland’s national soccer association, Waddell drew comparisons between his two parallel careers. There are many fundamental similarities, he said, as the purpose of both soccer refereeing and auditing is to compare reality with the requirements (e.g., the FIFA Laws of the Game or the FDA GLPs). But in professional soccer, it is recognized that not all pro soccer clubs are alike. Thus, the association implemented a tiered licensing structure which caters to the needs and level of each individual club. According to Waddell, there are some lessons that QA can learn from soccer. First, auditors in soccer don’t grade their findings on a minor/major/critical scale. Waddell wishes it was so in QA. “I spend more time arguing about whether it’s a major or a minor than whether it’s actually right or wrong,” he said about quality audits. “Energy is diverted from actually addressing things to arguing about grading.” Furthermore, in pro soccer, management is fully responsible for adhering to regulations and addressing audit findings. Auditors don’t recommend actions, rather, it is up to the club to be in compliance and correct any variances. Finally, reporting is quick and efficient. In soccer, audits follow a simple, expedited model of reporting findings, and these findings are presented at the closing meeting on the day of the audit. In the traditional GxP model, reporting can take weeks, due in part to the need for responses. Following the example of pro soccer, Waddell proposed a more variable compliance structure in QA, where companies can join at an “entry level” and work their way up as they become able to meet more demanding criteria. In 1979, when Waddell went from being a human pathologist to being one of the first GLP professionals, he read 21 CFR Part 58 and thought, “What kind of satanic ritual is this?” But he reconsidered after taking a closer look. “We didn’t need rules,” Waddell said. “Quality was in fact instinctive, and quality to us was exactly what GLP was about: making sure that the circumstances in which we did the work would ensure the validity and integrity of the data.” You can listen to a podcast of Waddell's entire presentation here.This year’s Masters Conference was held 11-12 May in Amsterdam, Netherlands. You can email email@example.com learn more, or visit the MasterControl News and Events page to view a list of upcoming events available to anyone in the quality and regulatory community.Dr. Andrew Waddell, director of TMQA, is an internationally recognized authority and trainer in research quality assurance (QA) with more than 30 years of experience in all aspects of quality management. He specializes in research and development QA systems and is a consultant and auditor across all “Good Practice” standards. He presents regularly on QA and auditing topics at international meetings.
Waddell founded TMQA, a leading international research QA organization, in 2001. Headquartered in Edinburgh, Scotland, and with an office in Bratislava, Slovakia, TMQA provides training, audit and consultancy in GCP, GLP, GMP, GVP and related standards. The company’s unique strengths are its depth of expertise and breadth of services, delivered by TMQA employees independent of consultants or contractors.
Among his accomplishments, Waddell is a former international soccer referee on FIFA’s elite list and is now a member of the Scottish Football Association’s Professional Game Board. He is also a member of the Advisory Board of the Scottish Lifesciences Association.
Beth Pedersen is a marketing communications specialist at the MasterControl headquarters in Salt Lake City, Utah. Her technical and marketing writing experience in the enterprise software space includes work for Microsoft, Novell, NetIQ, SUSE and Attachmate. She has a bachelor’s degree in life sciences communication from the University of Wisconsin-Madison and a master’s degree in digital design and communication from the IT University of Copenhagen. References: Read a related story: Quality by Design Part 1: You Can’t Design Something You Don’t Understand