Modern eQMS Technology

In the recent decades past, the utilization of sophisticated electronic quality management systems (eQMS) has operationally revolutionized many businesses by enabling them to move beyond the use of paper-based QMS systems. There is absolutely no doubt that the traditional pre-configured eQMS technology has provided a competitive edge for those businesses that had abandoned those antiquated paper-based QMS systems they previously used. That is all in the past now.

The evolution of eQMS solutions, however, has once again taken a technological leap forward, making the traditional eQMS offerings to now be considered as significantly outdated, in comparison. There now exists modern eQMS software, with no-code technology solutions, that enable any business process to be readily created and executed, not just a limited number of programmed and preconfigured compliance and Quality Management oriented workflow solution-sets.

This significant shift in eQMS technology offers a breakthrough opportunity that enables the holistic management of ‘quality’ for the entirety of the workflows that define the operations of the business, end to end. The capability to truly manage and address systemic level ‘quality’ issues and/or operational constraint can now be enabled by transitioning away from the soon to be antiquated eQMS systems. Modern eQMS technology solutions have the capability to manage the ‘quality’ of the entirety of your business operations, not just a limited number of workflow solution-sets that are traditionally deemed to be owned by the Quality group.

Management Responsibility & Control

Every business is uniquely different, yet still bound by the certain operational requirements:

Management Responsibility

The Establishment of Effective Processes: A company, any company, only succeeds when it defines and develops the capability (or capabilities) that are necessary to be successful. This occurs through defining the ‘standard work’ that must be done to create and deliver their product(s) and/or service(s) via:

Quality Planning?- The process of establishing the business process workflows and ‘quality’ requirements that are relevant to the success of business. (Plan)

Technology - Quality Management System (QMS): A ‘quality’ management tool used to establish (define, document, and implement) the business processes that are to be utilized within the business operations, designed to provide the operational capability to fulfill the mission of the Enterprise. A QMS is passive and simply defines the business processes that establish and enable operational capabilities, nothing more.

Efficient Execution - Skilled, trained, and competent people must execute that work in a manner that is efficiently effective in creating the product(s) and/or service(s) on behalf of the business.

Quality Control?- A ‘quality’ management method that is utilized to actively verify business process workflow requirements are met, to ensure the realization of the defined/desired outcome of the business process. (Do)

Quality System (QS) - The combination of skilled, trained, and competent people and their execution of the business process workflow components that are associated with their assigned role(s) within the established business processes. A QS is active; people executing process.

Management Control

Effective Management - The capability of verifying that the operational requirements of each of the business processes are met, and that operational objectives are consistently achieved.

Quality Assurance - The act of systemically verifying that the processes, products and/or services met their specified requirements, in achieving a defined/desired outcome. (Check)

Quality System Management (QSM) - A ‘quality’ management methodology that provides the capability to systemically verify the results created from each of the business processes. The intent is to ensure the QS (people + process) continues to cumulatively provide an effectively efficient outcome, within the network of operational capabilities required for operational success. Once a Quality System is operational, it must be actively measured and managed.

Efficient Management: The capability of managing the continual improvement of operational constraint that inhibits the performance and/or scalability of the business.

Quality Improvement?- The purposeful change of a business process workflow and/or requirements, to improve the confidence or reliability of the outcome. (Act)

Quality Management (QM) - A methodology that provides the capability to improve the results created from the system of business processes, by targeting systemic constraint. Once established, the only to sustain the ‘quality’ of an operational system is to systemically target operational constraint to improve operational capabilities and capacity.

Such a holistic approach to ‘quality’ management will yield the ability to:

1) identify and define the operational capabilities that are needed to realize the mission of the organization.

2) identify and define effective business processes that are required to enable each operational capability that is required for the success of the business.

3) establish the standard work documentation that defines the enabling business processes.

4) prepare the workforce to execute those business processes, such that they can efficiently create the results that matter to the organization.

5) measure the results obtained from the execution of each business process.

6) target constraint for business process improvement to create ‘bottom-line’ value and ROI, from improved efficacy and efficiency… The results that truly matter to the business!

Embracing Change

It is understandable that the transition away from the outdated preprogramed eQMS platforms will be difficult for some. Once adopted and adapted into the infrastructure of business organizations, it will take a methodical plan and a committed program to systematically replace an outdated eQMS technology platform. The good news is that only a handful of your business process workflows have been represented within those outdated preprogramed eQMS platforms.

Still, people can be slow to change when they have not yet been given a significant enough reason to change. Technology, however, doesn’t follow that same social construct. Technology replaced our once beloved eight track tape decks and record players with cassette and disc players, before transitioning to digital internet streaming. Just like that, essentially. Why? Why did so many significant iterations ‘music technology’ occur in such a relatively short period of time? That same innovation is now occurring with eQMS technology. Why? Let’s find out.

Considering the adoption of Modern eQMS Technology?

Organizations are held back when they cling to outdated preprogramed and/or preconfigured eQMS systems that supported how they did work in a substantially limited number of processes, when there were no other eQMS technology options in the not-so-distant past.

It is absolutely imperative to understand that new and advanced eQMS technology have eclipsed the capabilities of the tired old technology solutions that provide only a limited number of pre-programed work process solutions that were somehow deemed to be processes used for “quality management”, citing processes such as CAPA, Document Management, Change Control, and Change Management, as examples. These are operational business processes. The Quality organization is only one of the many functional groups within the business operations. What about the business processes executed by all of the other functional groups? Shouldn’t they be managed with eQMS as well. Yes, they should.

These pre-programed eQMS solutions were developed with an extremely outdated management paradigm that the management of ‘quality’ is limited to a fixed number of discrete processes that are primarily reactive in nature. For example, one such outdated eQMS technology solution is described as offering “control over all quality related processes in one place”, without understanding that there is no such thing as “quality related processes”… Only work business processes that are built and managed for a ‘quality’ outcome to provide systemic results.

Outdated paradigms must be replaced with the basic concept of managing business process ‘quality’, for achieving the results that matter to the business.

Benefits of Modern eQMS Technology Solutions

There are many reasons to consider a modern and holistic approach to business operations ‘quality’ management, some of which are provided for your consideration, as follows:

1)??? A modern operational Quality ‘quality’ management framework can enable ALL of your business processes to be strategically managed, as one system, for unified business operations. There are no such things as ‘Quality processes’, only business process that are managed for a ‘quality’ outcome. Every business leader should ensure their business processes are systemically established and managed for a ‘quality’ outcome.

2)??? No-code eQMS software technology solution allows you to customize or build new apps, workflows, and reports with drag-and-drop, point-and-click technology. No programming skillsets and/or IT personnel are required. There now exists complete flexibility to create the operational Quality ‘quality’ management system capability that your business operations have been missing.

3)??? It is now possible to adopt preconfigured baseline or ‘secondary support’ business process workflows (Document Management and Control, CAPA, etc.) that have always been traditionally developed to support those ‘primary’ and ‘core’ business operations that are completely unique to your business. The difference, however, is that these baseline business processes can additionally and readily be further modified and better adapted for your specific business needs, to make your system work best for your internal stakeholders.

4)??? Automation of routine administrative tasks within a business process workflow is available, in support of process effectivity, through error reduction, and processes efficiency, resultant from eliminating the execution ‘que’ for these types of tasks that that exists within every business process workflow.

5)??? Worldwide, Federal and State regulatory requirements can be fully integrated into the associated and applicable business processes, any operational business process, with industry-specific and customizable solutions.

6)??? It is now possible to fully integrate industry applicable standards, such as the ISO standards, into the relevant and/or applicable operational business processes with industry-specific customizable eQMS solution-sets.

7)??? An integrated communications function, not based upon but inclusive of email, brings people, processes, and data into one collaborative platform that looks and feels like a simple chat application. All roles, even external roles, seamlessly communicate about the work being done within the business process itself.

8)??? Audits and inspections can be streamlined to reduce the audit and/or inspection cycle time. This better ensures that compliance with regulatory requirements that are maintained with the highest standards of ‘quality’. Audit time can also be reduced, so you can focus on the other more important aspects of your business, such as profitability.

9)??? Responsible operational management is enabled for establishing:

• a QMS to define business process content and the infrastructure (eQMS) to manage that content.
• a QS (people + process) because nothing happens without skilled, trained, and competent people who are deployed in numbers that are adequate to satisfy the volume of work defined for each operational business process.

10) True management control over business operations is enabled for:

• Quality System Management (QSM) - Once established, a Quality System must be professionally measured and managed, to verify and ensure the results that matter to the business are obtained for each business process within the operational system, and to identify systemic operational constraint. A data & analytics strategy can be deployed in conjunction with the technology that facilitates the level of reporting and review necessary to manage each individual business process. Additionally, due to the strategic design of measures, these individual results can be aggregated to achieve a systemic level of understanding for the identification and management of operational constraint. This is, by far, the most difficult operational management challenge that businesses face today.
• ?Quality Management (QM) - The planned, ongoing, and continual improvement of the systemic operational constraint. This is the only way to ensure business growth through operational capability and capacity.

11)?? ?A constant state of audit readiness is achieved, resultant from the execution of business operations that were established to be compliant, effective, and efficient in operational execution and outcome.

12)?? ?A culture of ‘quality’ will take hold, by simply running the business in a compliant, effective, and efficient manner.

13)?? A constant state of continual improvement will ensue, by targeting systemic constraint that ensures the business remains viable in regard to building upon the capability and creating new capacity for the sustained growth of the business.

14)?? A constant state of operational excellence (OpEx) is achieved as a result of combining strategic design with modern cutting-edge technology to execute and manage the ‘quality’ of business operations.

Time to Upgrade Your ‘quality’ Management Capability?

If your management of ‘quality’ isn’t inclusive of all of your operational business processes and/or if you are still using an outdated eQMS technology solution… It is time to upgrade your ‘quality’ management capability. We can help you with that.

To begin, just call. (844) 349-2272; or email: [email protected]; or visit. PQMcoach.com.