My last blog post on whether by outsourcing quality activities, a company can outsource the responsibility for quality generated a lot of interesting discussions. The feedback was consistent and generally answered the question with a resounding “NO”. However, the answer is based in more than just the principle of management with executive responsibility. Changing regulations and basic regulatory requirements are clear about the role of management responsibility.
The theme of increased responsibility is specifically a focus of upcoming changes within EU regulation. Effective September 1, 2017, the UK’s MHRA ushers in big changes for “virtual” and “own brand labelers.” BSI surmises the changes, “The MHRA guidance reinforces that the virtual manufacturer simply cannot refer to the quality management system (QMS) or the technical documentation held by the OEM, but should hold the full technical documentation which should be an output of their own QMS.” (Italics mine.) The virtual manufacturer is legally and solely responsible for the product regardless of subcontracted activities.
One commenter duly pointed out “In essence, all activities EXCEPT management responsibility can be outsourced. Even the Management Representative (defined in 21 CFR 820.20(b)(3) and ISO 13485:2016-5.5.2) can be contracted if needed, but they report to management.” Which is to say that a company can outsource quality activities to a significant extent, but the CEO cannot escape the fact that “the buck,” so to speak, stops with him or her. Executive responsibility cannot be outsourced. While consulting firms, contract manufacturers, or design houses can provide information needed to make informed decisions in a complex regulatory environment, the CEO remains responsible and accountable for the decision and more importantly the company’s products and reputation.
No doubt about it, CEO’s are in a tough spot when incorporating regulatory and quality requirements into company strategy. So what are some best practices that a CEO can implement to ensure compliance?
The CEO must Make Quality Make Sense™ by ensuring the three key factors are in place throughout their company: Leadership, Organization, and Culture.
Organization must have a structure designed to support and encourage quality. Teams must be purposefully designed for effectiveness and cross-functional accountability.
Culture must drive a desire and value for quality. Culture creates the environmental conditions for quality to flourish.
When these ingredients are combined, the quality policy and core values of your company become real and living. By Making Quality Make Sense™, a company realizes value and then Quality Makes $ense™. Only then will the company be able to maximize the value in quality and patient safety.
Lean RAQA Systems offers diagnostics and coaching tools to assess organizational needs for your company to maximize the value in quality.