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Quality and Compliance: The Ogres Under the Bridge?

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The bridge from product inception and or production to the customer’s hands may seem like an amicable journey. The plan is followed and milestones attained. Then QA jumps out and growls that the product can’t be released due to a potential quality issue. The result: deadlines not met, revenue not realized and workplace harmony is destroyed. Sound familiar? Well you aren’t alone.

A 2014 survey of device manufactures conducted by Compliance-Alliance found that 27% of respondents categorized QA as a “necessary evil, a deterrent to revenue or a policeman who always says no.”

The View from the Villagers

In some cases, QA/RA is not included in the development process from the beginning. They then encounter an unacceptable issue near the introduction date. The product can’t be released until the issue is resolved. Everyone who has worked for months or years on the project is frustrated. On the other hand, if QA/RA are included from the beginning but are perceived as always saying no, that can also cause problems.

The focus should be on creating a strategic partnership. At the end of the day, everyone’s goal is to develop a safe and effective product in a cost efficient, compliant manner. The quality representative must demonstrate that they add value and make a contribution to the bottom line. Regardless of their role, everyone should be able to answer the question, “Does quality pay rather than cost?”

Building the Bridge


Getting support for quality throughout the organization can be difficult. Survey respondents were asked to provide insights into building collaboration. The suggestions included driving a culture of quality from the top down as a management responsibility. Others suggested training all staff on understanding regulatory requirements and how their jobs impact the quality of the product. Finally, building a partnership through open discussions that results in a solution that can be supported by all.

Bringing solutions to the debate is one way to build a relationship. Instead of saying, “We can’t do that.” Perhaps you can say, “We can’t do that, but we could do this…” QA/RA needs to take on an instructional role in explaining the reasons for a particular quality or regulatory decision. An issue shouldn’t escalate to a conflict that completely stalls progress.

Be the proponent for the concept that quality pays by reducing rework and improving throughput. This saves money for reinvestment for other improvements. Find ways to measure the savings of these improvements. It could be less scrap, less overtime, increased throughput and of course increased sales due to product availability and increased customer satisfaction.

Happily Ever After

Getting buy in from the top can drive the value proposition of quality. Show don’t tell is a better way to demonstrate what quality can do for them. Simple wins in the measurement of improvements can propel the organization to take on larger projects and fosters increased participation. To some extent the antagonism may continue like Beauty and the Beast, but we all know how that ended.


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