CEO: “I don’t want our quality management system to be a Rolls Royce.  I don’t even want a Cadillac. 

Quality Manager: “So… you want a Volkswagen-level QMS?”

CEO: “No.  I want a Yugo.”

In order to fully-understand that conversation, it is important to realize that there are popular views about the cost, performance and/or reliability of cars, namely, about a Rolls Royce, a Cadillac, a Volkswagen… and a Yugo, that can be related to quality management system (QMS) cost, effectiveness and/or sustainability.

Following are some popular views about the cars mentioned related to quality management systems, above. Substitute the descriptions of the cars for descriptions of a company’s QMS and you’ll realize what the CEO is actually asking for in the conversation.

A Rolls Royce is of “peerless quality” but costs “more than most of us make in a year, or several”.1 Such a QMS might cost more than the company’s annual revenues to implement and maintain.  The QMS would also probably do so much more than is required that it would be viewed as a burden upon the organization, at best. At worst, a nuisance to contend with.

A Cadillac is a luxury brand of automobile of above average cost but with average to low reliability ratings. It can cost more to fix (than other cars), no matter what the problem is.2 The cost for such a QMS might be viewed as an ‘investment’ toward achieving the company’s quality mission and objectives.

A Volkswagen has the benefit of embodying some of the best engineering in the world (that is, German engineering) while being affordable to purchase and maintain. Loyal Volkswagen drivers embody the philosophy that “A car that is treated well is a car that lasts.”3 This type of QMS might be just the right type to sustainably ensure most of the company’s quality objectives are achieved… while consistently ensuring regulatory compliance.

A Yugo has been called the “worst car in history”.  It was cheap to make and buy, but it failed every standard performance and safety test. Toyota could not even give a Yugo away with the purchase of one their other vehicles during one of their sales campaigns! The Yugo brand car finally died when the United Nations declared a trade embargo against the country (Serbia) that manufactured the parts.This type of QMS does no good, could actually cause more harm than good, and doesn’t even pretend to be adequate.

Need to right-size your Quality Management System? EMMA International and I can help! Contact us by phone at 248-987-4497 or by email at

1 “Rolls Royce” © 2022 CarBuzz, Inc.; retrieved on July 27, 2022, from

2 “Are Cadillacs Reliable?” © 2022; by David Ghanizadeh-Khoob, published May 4, 2022; retrieved on July 27, 2022, from

3 “Where does the huge VW fan base come from?”, June 25, 2015, © 2022 TrendMotors Volkswagen; retrieved on July 27, 2022, from,they%20follow%20their%20maintenance%20schedule.

4 “A Quick Look at the Yugo, the Worst Car in History” © 2018 by Jason Vuic for Car and Driver; retrieved on July 27, 2022, from

Diane Kulisek

Diane Kulisek

Ms. Kulisek serves as a Senior Quality Engineer and Senior Regulatory Affairs Specialist for EMMA International’s Technical Operations team. She has experience in technical writing, quality management systems, regulatory enforcement remediation, corrective and preventive action management, electronic data management systems, cybersecurity, and design controls for the medical device industry. Ms. Kulisek also has significant past experience in quality engineering and management for mass-produced consumer products, electronics, aerospace and commercial filtration industries. Ms. Kulisek holds a Master of Science in Engineering with a concentration in Civil, Industrial and Applied Mechanical Engineering Management from California State University, Northridge (CSUN) and a Bachelor of Arts in Biology with a concentration in Environmental Biology, also from CSUN. She also holds a Graduate Certificate in Program Management from West Coast University, a Lean Six Sigma Green Belt from Six Sigma Systems, Inc., and Certifications for multiple EU MDR and EU IVDR topics from Greenlight Guru. Ms. Kulisek maintained American Society for Quality Certifications for more than twenty consecutive years as a Quality Engineer (ASQ CQE) and as a Manager of Quality / Organizational Excellence (ASQ CMQ/OE).

More Resources

FDA’s Refusal to Accept Process

FDA’s Refusal to Accept Process

Before the submission of a 510(k) premarket notification, the purpose of which is to notify the FDA of the manufacturer’s intent to market a medical device,[i] there is a provision for acceptance review. This review serves as a method to assess whether a submission is administratively complete and includes all necessary information for FDA to determine substantial equivalence under section 513(i) of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 United States Code (U.S.C.) § 360c(i)). To establish substantial equivalence under this provision, FDA must find the same intended use as the predicate device and either have the same technological characteristics as the predicate device or appropriate clinical and scientific data necessary to establish that the device is safe and effective as the predicate device. If the Authority is unable to determine substantial equivalence due to insufficient information, it may request for additional information to make that determination. Therefore, as a part of the acceptance review, the FDA staff follows the acceptance checklist[ii] to ensure that the application is administratively complete. These administrative elements are identified as RTA items and are required to be presented. The purpose of conducting the acceptance review is for the Lead Reviewer to determine whether the 510(k) submission meets the minimum threshold of acceptability and should be accepted for substantive review.[iii]
Empowering Your Workforce through Kaizen

Empowering Your Workforce through Kaizen

Last week, I touched on the idea of involving and empowering all employees in the workplace through the corrective and preventive actions process by fostering taking initiative and a problem-solving (refer to blogpost ‘The Art of Addressing Non-Conformances in Operations’). To expand on this concept a bit further, we’re going to be looking at Kaizen–a continuous improvement strategy in which employees at all levels are also empowered to solve problems towards big gains.
FDA’s draft guidelines on Remote Regulatory Assessments (RRAs)

FDA’s draft guidelines on Remote Regulatory Assessments (RRAs)

The pandemic has been a challenging time for all industries including the Food and Drug Administration (FDA). The FDA had to alter the manner in which it conducted its operations. One set of tools adopted by the FDA in response to COVID-19 was the remote regulatory assessment (RRAs).

Ready to learn more about working with us?

Pin It on Pinterest

Share This