| Quality Management (QMS) |
Quality Execution (QES) |
| Program Overview |
| Stand alone system to establish, administer and report upon a quality program |
A system that directs and enforces quality processes; program is managed from a centralized enterprise system |
| Typically wider in scope and function, including comprehensive administration, planning and quality process establishment functionalities, including more in depth reporting capabilities, resulting in a longer deployment and implementation time |
Manufacturer will typically already have an enterprise-wide Quality program; implementation is therefore shorter, focused on establishing processes rather than designing the program |
| QMS reporting systems typically cover CAPA, Audits, Environmental Health & Safety (EHS), Governance Risk & Compliance, LIMS, Change Control, IT Service Management, Document Management, Human Resources Policy and Compliance Management and action item tracking; many of these reporting functions will overlap with ERP applications |
QES reporting will tend to be just focused on how well processes have been executed, typically including Quality Inspections and Quality Defects reports |
| As a separate system, will often include duplication of functionality of other enterprise systems, such as ERP |
Operates in tandem to an existing enterprise wide systems, such as ERP, providing incremental functionality |
| Synchronization with enterprise systems can be complex, due to high functionality overlap |
Tend to be complementary to existing systems sharing same master data source to facilitate an easier deployment |
| Largely an off-line application |
Primarily an on-line application, real-time links to operations down to shop floor |
| Well suited to run independantly at the plant level, or within a department |
Best to support global, enterprise-wide distributed deployment |
| Compliance and Governance Capabilities |
| Designed as a single system of record for regulatory or government policies; reconciliation issues may exist when dealing with multiple policies and practices by region or division |
Synchronized to a corporate standard, typically residing within an ERP system, to support a "single version of the truth" to support continuity across regions or divisions |
| Challenge to insure enterprise-wide execution of CAPA with supporting audit trail when multiple plant locations exist |
Non-conformance and CAPA actions are better executed across sites; strength is on executing and managing processes, so easier to document multi-site policy implementation and audit trails |
| What to Consider When Evaluating a Solution |
| Best if deploying at a single location with simple, manual processes without distributed manufacturing operations |
Best for manufacturers that already have a centralized enterprise planning system in place, such as ERP, to leverage the existing investment already committed, and to take advantage of the centralized visibilty already afforded by such a system |
| Multi-plant deployments where manufacturing operations are performed autonomously are also a good candidate for a complete QMS system, for ease of local management, without consideration for aggregation of results across muliple operating environments |
Global, distributed manufacturers concerned about consistency of quality performance, including consistent measurement of quality metrics, are well suited for a QES system whereby processes are best standardized with centralized visiblity |