Charles Maurice de Talleyrand-Périgord was Napoleon's chief diplomat during the French Revolution. Talleyrand provided an apocryphal quote describing the Bourbons’ behavior after the abdication of Napoleon in making the insightful statement that “the Bourbon monarchy had learned nothing and forgotten nothing”. Due to their inability to change, the Bourbons gradually disappeared as the French Republics succeeded.
Within this era of unprecedented change in requirements leaders must forget how they previously viewed quality, and adopt a new paradigm regarding their Quality organization. Employees are individually accountable for the quality of their work; however, the leadership team is responsible to ensure a strong culture of quality exists within the organization. The Quality organization must be considered to have two primary responsibilities. The first responsibility is to support the organizations’ operations in utilizing the existing Quality System and, the second responsibility is to facilitate the continuous targeted improvement of the system’s constraints to better enable the effective and efficient operation of the organization.
A holistic solution is now required to enable your organization to make the transformation to being an organization that continually improves, and not just in terms of being compliant. Leaders must end the cycle of shortsighted compliance remediation in attempting to address the latest standard and/or regulation that has come due. It is very clear that these are all being harmonized towards the common goal of patient safety through a Quality System that ensures management control over the quality of the product provided to the market.
The quality of the products an organization provides to the market is a ‘reflection’ of the quality of operations. The quality of operations is a ‘reflection’ of the quality of the Quality Management System (QMS). When operating in a regulated environment, compliance is certainly required, however it is only one dimension of quality. Each process within a QMS must be designed to be capable of being executed such that it is compliant to applicable regulation and standards, effective in obtaining results, and efficient in operational execution. Producing high quality product in a manner that is compliant, effective and efficient will result in the achievement of sustainable success in the view of all stakeholders.
Compliance is basic, and it is not enough. Challenged organizations continue to hire “experts” who continually write compliant procedures that don’t work within the system, ironically resulting in the failure to be compliant in adherence and execution. They forget about the business because they are myopically focused upon compliance. They neglect the fact that the procedures they develop must properly define the processes utilized by real people to obtain the required results. They forget that the Quality System is a system of processes with defined sequence and interactions that provide inputs and outputs between themselves to enable the system to effectively work.
Pause… Think… Survive… Change… Thrive!
Leaders must adopt holistic solutions that enable the organization to transcend the focus on compliance, and focus on those that provide sustainable organizational success, resultant from efforts of transformational improvement towards becoming efficiently effective.
“Am I truly effective (doing the right thing) or am I merely efficient (doing things right)? Success requires being efficiently effective.” - Peter Drucker
Sustainable success begins with a complete understanding of the baseline performance of the current QMS, enabling the creation of a ‘roadmap’ necessary for planning and conducting QMS transformational improvement activities in a strategic and targeted manner. Leaders begin by becoming fully informed. This is resultant from measuring the baseline quality of an organizations’ people, process and product. This baseline measurement of QMS performance provides responsible management with the systemic understanding necessary to enable true management control over the quality of the management system. Once informed, management can responsibly act to ensure the ongoing capability of the company to conduct the transformational improvement required to become efficiently effective.
“A system must have an aim. A system must create something of value, in other words…results.” - W. Edwards Deming
Strategic and targeted QMS transformational improvement activities can only begin with a ‘plan’ that is resultant from a complete understanding of the baseline performance of the results the current Quality Management System provides.A baseline understanding of the quality of an organizations’ people, process and product provides us with the insight needed to target the constraints within the system.The objective is to transform these processes such that average people, who are well trained and competent, can execute and manage these processes to achieve efficiently effective results.It is better to get brilliant results from average people, managing brilliant processes within the Quality System, versus getting average (or worse) results from brilliant people who are doing their best to manage broken processes within the Quality System.Transformational improvement of the QMS to provide extraordinary results is attainable though this foundational concept and attention to the sequence and interaction (inputs & outputs) of the processes within the system.