The axiom “you can’t inspect quality into a product” is certainly well-founded. However, verification processes are usually part of the product design. Verification is one cog in the system to ensure that a company ships products that meet product requirements. Verification can prevent customer complaints and product recalls.
I have always considered verification as something we do for co-workers. I have learned from experience that people do not want to make non-conforming products. The verification process can help medtech manufacturers avoid the creation of such products by:
- Helping to prevent mistakes
- Giving people peace of mind by ensuring that someone “has their back”
- Increasing the level of collaboration and teamwork
- Counteracting the temptation to take shortcuts
- Enforcing accountability
- Patients expect superior quality from their medical devices, since they entrust their health to these products.
- Medtech manufacturers build their companies’ reputations and market share by producing high-quality products. Verification is a component of the product development processes that help medical devices meet customer and patient expectations.
- Stockholders and other investors back a company because of its products and/or services. Like patients, they expect high quality from medical products.
- Sales people depend daily on product quality. If the devices they sell do not meet quality expectations, sales people are negatively impacted.
- Distributors are impacted by product quality, and therefore benefit from verification activities as well. Distributors that dispense a non-conforming product risk tarnishing their reputations and increasing their operational costs, regardless of their role in manufacturing the device.
- Result in punitive actions to employees
- Lead to erroneously high “human error rates”
In my experience, verification is frequently a target of process improvement initiatives because the value that verification brings with it is often underestimated. Whenever I am involved in optimization, I always “check twice” before reducing or eliminating a verification process, as the value of avoiding mistakes is priceless.
Verification is not usually hailed for the service it provides; it is more often criticized for the defects and nonconformances that it misses. Don’t let this skewed perception lead to a reduction or elimination of verification processes. I understand that good design, automation, and strong validation activities can reduce the need and reliance on verification. And I am certainly not contending that verification is the most important issue. I am, however, emphasizing the importance of verification and the key role it plays in any quality management system. Think for a moment what the “plan, do, check (includes verification), act” cycle would be like without the “check” part. I would not want to work in an organization that uses this model because the negative impact of inadequate verification would be too high of a price for anyone to pay. Verification matters, and not just to those of us in the quality/regulatory roles. Verification matters to everyone involved with a company and its products and/or services.
James A. “Jim” Dunning’s consulting career began in 2001. He has provided quality and regulatory consulting services for various companies ranging from Fortune 500 medical device firms to startups. Dunning’s passion, however, lies with startups and small companies, especially those in regulatory distress. He has amassed significant experience in preparing 510(k) applications, developing complete Quality Management Systems, providing Quality System Training, and advising on quality, business, and leadership issues. Dunning is a senior member of the American Society for Quality (ASQ) and a member of the Regulatory Affairs Professional Society (RAPS). He can be reached at firstname.lastname@example.org.