“Quality, quality, quality.” You hear it all the time from your QA colleagues. There are so many forms to fill out, trainings to complete, procedures to read and follow, and internal audits 
to produce records for. Sometimes, it’s so overwhelming that we’re tempted to just tune it out.
That is, until we read an FDA Warning Letter like the one issued on November 24 to a Florida-based medical device company. The FDA cites 11 separate violations related to the company’s quality management system (QMS)…and its gaps.
Where is your organization on its blockchain journey?
| Answer | Total Number | Total % |
|---|---|---|
| Not yet started | 130 | 0.62 |
| Identifying use cases | 55 | 0.26 |
| Competing a POC | 9 | 0.04 |
| Building a prototype | 7 | 0.03 |
| Doing a pilot | 5 | 0.02 |
| Planning to scale | 3 | 0.01 |
| Total Responses: 209 of 428 (49%) |
Violations 9, 10, and 11 are related to failing to follow FDA-mandated reporting procedures for medical devices.
| Poll Results for What industry are you in? | ||
|---|---|---|
| Start Time: April 3, 2018 12:13:22 PM MDT | ||
| Total Responses: 222 of 428 (52%) | ||
| Results Summary | ||
| Answer | Total Number | Total % |
| Automotive | 7 | 0.03 |
| Energy and Utilities | 14 | 0.06 |
| Financial Services and Insurance | 47 | 0.21 |
| Healthcare and Life Sciences | 60 | 0.27 |
| Manufacturing | 14 | 0.06 |
| Retail | 22 | 0.1 |
| Other | 58 | 0.26 |
While some of the content of the letter might make you chuckle, like the President admitting to false advertising, the fact that they couldn’t produce their device risk assessment in English
(despite being U.S.-based), or the fact they’re 2.5 years late in reporting product complaints, the truth is that we’re all guilty of quality violations from time to time. Hopefully, not nearly as extreme as this particular company, but nobody’s perfect.
I propose that we use this Letter as a reminder to turn inward, take a look at ourselves, and make sure we’re genuinely doing all that we can to protect the public. Instead of tuning out quality, let’s crank up the volume.
For an assessment or a mock audit of your quality management system (QMS), contact us.
