Enterprise Quality Management [EQM]
 
   
   
The Challenge Related Regulations

The Challenge

Total Quality Management (TQM) is a management approach or strategy aimed at embedding awareness of quality in all organizational processes. It maintains that organizations must strive to continuously improve these processes by incorporating the knowledge and experiences of workers.

Quality management can be explained as the proposed action taken after finding out the difference or shortfall between the present condition and the expected level set by any quality standards. The proposed actions or the actual action carried out to fill the gap can be considered as quality management practice.

Although originally applied to manufacturing operations, TQM is now becoming recognized as a generic management tool, just as applicable in service and public sector organizations.

Enterprise Quality Management [EQM]

TQM is mainly concerned with continuous improvement in all work, from high level strategic planning and decision-making, to detailed execution of work elements on the shop floor. It stems from the belief that mistakes can be avoided and defects can be prevented.

Continuous improvement must deal not only with improving results, but more importantly with improving capabilities to produce better results in the future.

Among the most widely used tools for continuous improvement is a four-step quality model – the plan-do-check-act (PDCA) cycle:

  • Plan: Identify an opportunity and plan for change.
  • Do: Implement the change on a small scale.
  • Check: Use data to analyze the results of the change and determine whether it made a difference.
  • Act: If the change was successful, implement it on a wider scale and continuously assess your results. If the change did not work, begin the cycle again.

Organizations that may match or exceed the expectations of customers, should use systematic, planned and well structured processes that may contribute to improvement in quality and the quality management. A company or any business entity that doesn’t practice TQM may become non-competitive sooner or later and the chances of that company or business being driven out of the market is high.

Organizations today are discovering the realities of managing a fast-moving business in a permanent system of complex regulatory compliance. SOX, FDA, and a great number of other regulations are driving companies to implement sophisticated compliance frameworks with unprecedented levels of time, budget and resource.

Current and emerging trends suggest that the demands will most likely become tougher, more numerous and harder to apply within a fast-moving business environment.

However, effective compliance management will protect and enhance your brand and reputation by helping you avoid the adverse affects of non-compliance such as: litigation, fines, prosecution, and the risks, costs, liability, and damage to brand reputation associated with non-compliance.

Also, it’s important to focus not just on the immediate task at hand but also on how a business solution can support the organization throughout the full compliance lifecycle. A common cycle for process improvement activities that can be applied to any business improvement initiative is the classic PDCA Cycle stated above. Software solutions should be designed to support all phases of this cycle, from the planning stage to the correction phase.

The Solution

SoftExpert EQM is a suite of integrated web-based quality and compliance management applications that supports all phases of the PDCA Cycle and addresses the increasing complexity of efficiently and effectively managing your quality and compliance processes.

SoftExpert EQM Suite reduces the burden associated with operating a business in regulated industries. It helps organizations identify and harmonize overlapping regulatory demands – interdependencies that can’t be seen using spreadsheets – and enables transparency and visibility to stakeholders throughout the organization.

SoftExpert EQM Suite also increases efficiency while reducing costs for helping to drive success within any size organization, and will help in carrying out the management process with a quality punch.

Most important, SoftExpert EQM Suite is broadly consistent with international standards, such as ISO 9000, ISO 14000, ISO/IEC 17025, OHSAS 18000, FDA, among others.

Related Products

 

Related Regulations

AS/NZS 4360

FDA 21 CFR Part 11

FDA 21 CFR Part 820

ISO 14000

ISO 20000 (ITIL)

ISO 22000 (HACCP)

ISO 9000

ISO/IEC 17025

ISO/TS 16949

OHSAS 18000