Process Management System Mental Model
In a business world with increasing externally imposed requirements, organizations struggle to manage risk associated with non-compliance while balancing multiple capabilities with specific (and sometimes apparently conflicting requirements) within the same process area. Assuring customer satisfaction, innovating into new market areas and meeting all regulatory requirements becomes a near sisyphean task. Companies find themselves in a tangle of poorly understood and occasionally conflicting requirements that confound their ability to comply and absolutely paralyze their ability to change.
Often, each capability (Quality, Product Stewardship, Environmental, and Safety to name a few), will independently create policies and procedures to meet their requirements with little or no knowledge of the other capabilities needs or involvement. Not only is this an inefficient use of time and resources, it creates significant liability risks due to conflicting guidance, causes frustration at the operations level and almost guarantees non compliance due to lack of the ability to understand all requirements in a clear and simple manner.
While the concern is complicated and the risk is real, the solution is actually quite simple. Requirements will continue to grow in a regulated environment, but each and every organization truly only has a finite number of macro processes. By clearly articulating each macro process in question and identifying the sub processes which support it, an organization can identify and optimize the key controls within the process required to effectively manage the risks associated with the requirements, while always keeping customer satisfaction at the fore front of the process.
This allows an organization to maintain a single process based management system which can meet the needs for quality, compliance and regulatory and eliminate the risk associated with contradictory guidance from different business capabilities. This also allows a single process to guide operations. Process assessments, are optimized to assess needs for all capabilities, and it assures the right knowledge is incorporated into the process for continuous improvement and change management. This allows the facility to spend more time manufacturing and less time dealing with compliance concerns.
The first step in initiating a process management system model is to identify what excellence looks like. This is your vision or overall goal of your management system (i.e. producing a finished good in such a way that it meets customer expectation and conforms to all internal and external process requirements to assure compliance). Once you have defined “what good looks like, the next step is to identify the key processes of the operation that help you meet that goal.
We then document the process clearly, identifying steps and decision points. At this point the subject matter experts in each capability can identify where in each process, key controls need to exist to assure we meet the needs of the requirements. This provides clear guidance to the operation sight and a comprehensive tool to assess compliance, identify gaps and build a foundation for cross functional continuous improvement without increasing risk in any single area.
Let’s use Raw Material Management, as an example and step through a simple case study.
From a quality perspective, the first step of raw material management is to define the needs of a given raw material to produce a finished good which meets the needs of the customer. This includes not only selecting the material in question, but the critical parameters that assure the raw material meets its needs.
From a product stewardship and regulatory perspective, the organization also needs to understand the raw material constituents for the new GHS regulations as well as identifying the materials involved and regulatory touch points such as TSCA, conflict minerals etc.
From an environmental perspective, the raw material must be evaluated against federal regulation, such as RMP, as well as facility specific permits (water, air etc.)
From a safety perspective, the raw material must be evaluated in the focus of OSHA regulations such as process safety management, dust explosivity and others.
The traditional approach would be to have 4 silo’d systems which may or may not have differing requirements. This would require 4 resources at the facility, 4 sets of procedures and 4 unique assessments to assure compliance.
Instead, by considering it as a single macro process of raw material management with several sub processes, we can focus on identifying and incorporating required key controls to assure compliance with all associated capabilities. In this case we know that the macro process of raw material management will have sub processes surrounding raw material definition, raw material and supplier qualification and raw material acceptance including how you manage non-conforming raw materials. These sub processes may begin at the Research and Development capability, to supplier selection with procurement, through qualification of both the specific material and supplier at a manufacturing facility including how facility manages acceptance to assure it meets the defined requirements and how it deals with off grade materials to assure they don’t get unintentionally incorporated in the finished product.
Once we accept this, by clearly articulating the process, key control points for all applicable requirements within the process can be clearly identified by the subject matter experts and expectations for success defined. This provides clear guidance to the operation sight and a comprehensive tool to assess compliance, identify gaps and build a foundation for cross functional continuous improvement without increasing risk in any single area.
