Quality Governance vs the “Non-Value Added” Argument
- CJ Dash
- May 12
- 1 min read
Updated: May 14
Signs your Quality culture is undermining your QMS
“If it wasn’t documented, it didn’t happen.” Most companies echo this industry catch-phrase in an attempt to instill an oversimplified version of Quality culture. However, failure to integrate the Quality and Compliance principles that gave rise to this phrase not only lessens the message – but ultimately leads to the genesis of its own counter argument.
When offered as a rebuttal to Quality Governance strategies, the “non-value added” argument is a clear sign that foundational Quality and Compliance principles – and the associated source requirements – have been rejected internally.
Per EudraLex: “[…] The Quality Management System should include sufficient instructional detail [...] in addition to providing for sufficient recording of the various processes […] so that ongoing application of the requirements may be demonstrated.”
The requirement is clear. So what is this non-value added argument really about? Accountability. Competency. Avoidance.
The reality – it’s the cost of doing business in this industry.
A culture that perpetuates these arguments and behaviors actively erodes the processes put in place to establish operational controls and ensure adherence to regulatory requirements.
When left unchecked, this non-Quality culture turns arguments into gaps, gaps into deficiencies – and ultimately reduces Quality Governance into an anarchic collection of tribal rituals.
The erosion of Quality culture is easy to see:
Documentation is negotiable – often conceded as a paperwork exercise
Efficiency is weaponized – invoked selectively against Quality requirements
Processes are politicized – prioritizing influence over principles
When culture rejects Quality Governance principles, the QMS doesn’t become leaner – it becomes a liability.
