Three forms of QMS noncompliance exist:
Failure to define procedure, such that it meets the intent of requirements
Failure to adhere to compliant procedure
Failure to obtain the results required by procedure and/or regulation
Regulation is law, enforced by a regulatory agency such as the FDA, formed or mandated to carry out the purpose or provisions of legislation. The intent of regulating industry that provides products used by the healthcare industry is simple… ensure patient safety. Companies operating within this regulated environment must build Quality Systems, comprised of processes that are documented in procedures, defined to be compliant with the applicable regulatory requirements. However, this is not enough. Simply writing procedures in such a way that they satisfy the evidentiary documentation that regulation was considered, does not ensure the underlying processes are both capable of being executed as defined, and effective in obtaining the intended result if properly executed.
To ensure patient safety, the system of processes that comprise a Quality System must enable/ensure the operations of the company to produce ‘quality’ product.
Definition of quality: The standard of process performance that will be ultimately be reflected in product quality, measured against the aggregate of Quality System processes, inclusive of the capability of people to execute those processes. Quality can be measured across three dimensions of performance:
Compliant to applicable regulation and standards
Effective in obtaining results
Efficient in operational execution
Although efficiency is not necessary for compliance, it is a dimension of quality, and is an expectation of internal stakeholders.
Ensuring compliance requires a comprehensive understanding of performance of the system of processes that comprise the Quality System. Quality management requires the measurement, monitoring, and improvement of the process constraints that inhibit the performance of the system. Management with Executive Responsibility (MER) must ensure the Quality System is compliant and effective. Responsible leadership will also ensure the Quality System is efficient.
QMS performance measurement must provide responsible management with the systemic understanding necessary to ensure control over the quality of the system, enabling the operations of the company to produce high quality product.