ISO 9000 & AUDITS WORLD CONFERENCE
Forensic Pursuit of Process Liability
Presenter: William Allen Stimson, Systems Engineer, Charlottesville, VA, USA
Keywords: Management, Dysfunction, Liability
No process is perfect. Even the best of processes can provide a nonconforming product or service that leads to harm or injury of some sort. A random nonconformity, even though product liability may be at issue, can be defended from an engineering perspective. However, in the case of systemic process failure, the nonconformity of product or service may occur in large scale. Auto recalls are often good examples of process dysfunction and can be extremely expensive. Credit card security collapse, too, may be caused by process dysfunction and resolution can run into millions of dollars. Systemic process failure suggests and defines the notion of process liability. The theory of process liability is based on the reasoning that for every process a certain amount of variation is an integral part and is therefore a by-product of the process. If large scale nonconformity ensues, the performer is liable for resultant harm or injury and the process is at issue. Process liability comes about because systemic failure may affect the resolution of a tort suit. Systemic dysfunction implies misfeasance and possible malfeasance. A forensic audit of dysfunctional processes can determine the causes of systemic nonconformity and can assist the court in determining whether harm or a breach of contract has occurred. Courts now look beyond the defect of a product to a company’s quality assurance procedures to determine their ability to prevent and control risks. The purpose of this paper is to show that a process is nonconforming if one or more of its controls are nonconforming. If the nonconformity is systemic, there is a risk that the process will provide nonconforming output in large numbers. This risk is proportional to the delay in correcting the nonconformity. Hence, prolonged system dysfunction can lead to process liability. A process must be controllable and observable in order to be stable and capable. Misfeasance occurs when operational processes are changed without consideration of these properties. Examples of such change are the use of improper controls, waiver of product or process test and inspection, and substandard purchased parts, to name a few. A forensic investigation of process dysfunction is fundamentally an audit. You compare the descriptive system to the normative—what it is to what it should be. A reference standard is necessary to the comparison. The most commonly used such standard is ISO 9001 (2015) and is used in this paper as the normative reference for the forensic pursuit of process liability.