One of the first things I learned about quality management was that quality, cost and schedule were interrelated. My earliest mentors used the example of a 3-legged wooden stool to explain that, if any leg were shorter or longer than the other two, the stool would fall over.

If too much emphasis was placed upon on-time delivery, the business would sacrifice quality and lose money to expedite replacements for poor-quality product.

If too much emphasis was placed upon cost, cutting corners would lead to poor quality. This would cause missed delivery dates due to time needed for sorting, reworking, repairing, or replacing poor-quality product.

If too much emphasis was placed upon quality, the higher costs for materials might lead to lost profit or people might be so strict about making sure the product met every specification that product would be unable to ship on-time.

There are sophisticated models that talk about the cost of (poor) quality, like the Taguchi Loss Function1, and balance it against other key factors for society, for businesses and for customers. The American Society for Quality (ASQ) is a rich resource for Cost of Quality (COQ) information.2

As the years have passed, there have been arguments about other, equally important, factors to consider for business success. Each of these other factors are also interrelated and must be balanced against one another by business leaders. These have included safety, employee satisfaction, regulatory compliance, project scope, community support and environmental considerations. Factors surrounding the model were also added, like environments of managed risk and competitive environments.

When I step back and look at it all today, everything is really a quality. I do not mean everything looks like a nail because I happen to have a hammer. I mean that everything is made up of qualities and is a quality of something else… like atomic particles. So, for cost, not making a profit is a poor quality for a business, while staying within a budget is a high quality. For schedule, making it to market with a new product before a competitor is a high quality, while failing to ship product in time to meet a customer need is a poor quality. Cost and schedule are qualities.

So… what needs to be balanced? All of it, but what is balanced for one business may not be for another. Each business needs to define its own factors for success and understand the qualities for each of those factors, including those for cost and schedule.

Want more information about or help with optimizing quality-based cost and schedule performance for your organization? EMMA International can help! Contact us via our website, by phone at 248-987-4497, or by sending an email to:

1”Taguchi Loss Function”, from Wikipedia® Creative Commons, Attribution – ShareAlike License 3.0, last edited 10/05/2020, accessed 10/16/2022 via:

2”Quality Resources / Cost of Quality”, adapted from The ASQ Quality Improvement Pocket Guide: Basic History, Concepts, Tools, and Relationships, ASQ Quality Press, ©2022 American Society for Quality, accessed 10/16/2022 via:

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

Process Validation

Process Validation

All right, you have just gotten all of your paperwork together, submitted the right forms to the right people, set up your factory, hired and trained your staff; now it’s time to make the medical devices. The regulatory nonsense is over and done, right?
The Role of Management in Product Quality

The Role of Management in Product Quality

Depending on the factory, some production employees may find it surprising that management has an important role to play in a quality system.  21 CFR 820.20 mandates that “Management with executive responsibility shall establish objectives for, and commitment to, quality”.[1]  The Federal Government expects that management takes an active interest in improving the output of their company, at least in the case of medical device manufacturers.
Corrective and Preventive Action

Corrective and Preventive Action

In addition to helping manufacturers make better products, corrective and preventive actions are important because the process is legally required by the FDA when making medical devices for the US market.

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