The Quality Management BOK is currently under review for revision. Is it still important for a quality manager to be able to apply knowledge on organizational structures? How should this area of the BOK be changed?
I do believe that the quality manager/professional should has a knowledge on organizational structures in order to apply this knowledge as an enabler to enhance quality culture throughout organization, which lead for improving quality and achieving organization’s objectives.
That said, the bloom taxonomy of this needs to move up to at least synthesis. Categorize organizational designs and compare and contrast the effects of the management structures on an organization
Organizational structure, especially wrt to Quality, is critically important in Regulated industries. For example, FDA requires that the Top Quality Executive report directly to the CEO (or senior-most executive) to assure independence and autonomy from Design and Manufacturing. Some companies might have two distinct Quality organizations - one assigned to regulatory compliance, and the other to lead the Continuous Improvement efforts.
Robert Mitchell - can you provide written support for your statement that FDA requires the Top Quality Executive report directly to CEO within regulated industries? This has been a topic of conversation I have had recently, and I have not been able to find anything in writing to support this stance. Thank you!
Agree that Org Structure and its effect on performance is important for Quality Managers to understand. In the age of digital transformation, structures are becoming more network-based to keep up with the rapid changes and complexity of operations. In the networked environment, management practices need to become more focused on support (e.g., providing resources, coaching/mentoring) as the individuals in the networks take on greater accountability and responsibility for decisions and results. This is an important trend for Quality pros to understand and apply.
It is not correct to say "FDA requires that the Top Quality Executive report directly to the CEO (or senior-most executive) to assure independence and autonomy from Design and Manufacturing". FDA legally enforces that the "Quality Management System" must be executed per 21 CFR 820 with no conflicts in delivering the intended purpose to market where the risk outweighs the benefits of the product. It's interpreted on a case by case basis in court. However, ISO 13485 requires that the "head of quality" report to "an" executive of a company, not necessarily the top executive of the company. So while the discussion focuses on best practices that should be followed, the legal framework does not exist to support Quality if the "Executives" want to limit their expenses towards organizational structure in quality since the perception of quality is still a roadblock to their agenda.
Having said that, CMQ/OE adds no value in mentioning this beyond the scope of a "Manager of Quality" so it should limit to areas of influence they have responsibilities so it can actually be achieved. The certification's perception is for lower level management.
Lastly, ASQ needs to crack the manager ceiling and venture into "Executives" training so these discussions can be meaningfully implemented because the current chatter (same as the last two decades) has not moved the quality needle that goes beyond receptive leadership because we are too focused on certification/training revenue and membership retention. Unless we are just venting in our silos (misery loves company?) and using the same playbook to expect a different result (insanity?).