QMS automations and an organization’s ERP activities

In last month’s article I discussed how the effectivity of a Quality Management System (QMS) can be determined by first examining the actual practices and results of an organization’s management review and risk management activities because those two processes are the most significant manifestations of the ‘Plan-Do-Check-Act’ methodology encouraged by QMS standards like ISO 9000. In summary, risk management and the management review activities are really all about the organization pro-actively:

• identifying opportunities for business growth and improvement
• assessing, planning, prioritizing, and communicating awareness to the actions that will allow it to achieve its objectives

In this article I discuss what is an ‘e-QMS’ and its relationship to an organization’s Enterprise Resource Planning (ERP) activities and the continuous improvement journey thereof.

What is an ‘e-QMS’ and what is its relationship to the organization’s ERP?

The ‘electronic-QMS’ or ‘Enterprise-QMS’ is the software/system automations purposed with managing the quality concerns of an organization. Often is the case that e-QMS automations first appear in an organization’s ERP for its activities pertaining to compliance, auditing, and non-conformance incident management. However, since a ‘good’ QMS encompasses the control and assurance mechanisms used for all processes and their results, e-QMS automations will also interface with or expand the capabilities of many other of the organization’s ERP activities. 

What are the organization’s ERP activities?

‘ERP’ is the management of all the business activities conducted by the organization. Examples of those activities include the management of:

• sales orders
• marketing
• customer relationships
• supplier relationships
• employee recruitment, acquisition, and career development
• organizational knowledge and lessons learned
• projects
• bill of materials
• product life cycle
• material requirement planning
• purchasing and inbound inspection
• inventory management of raw materials
• manufacturing (e.g., build, repair) processes and resource planning and result tracking
• releasing, distribution, and warehousing of finished goods
• customer complaints
• product offering warranty programs
• customer service requests
• employee help desk requests
• non-conforming materials or services from suppliers
• facilities, assets, and equipment calibration and maintenance programs
• governance, risk, and compliance programs
• auditing programs
• environmental, health and safety incident programs
• accounting, financing, and invoicing
• business data analytics
• process documentation

Typically, organizations will use a collection of software/systems to store, analyze and report the data needed for successful management and improvement of its ERP activities. Also, it is likely that the ERP software/systems – whether developed or bought – will be deployed in stages especially as an organization matures its business tooling from ‘pen-and-paper’ based to ‘word processer and spreadsheet’ based and to well connected systems of ‘databases.’

How does an organization gain QMS automations in its ERP software/systems?

Obtaining process automations within any organization’s ERP ecosystem is hard to discuss in one (single) article. Furthermore, the automating or digitizing of any business process can be problematic especially in smaller to mid-sized companies as they transition from being a collection of standalone (siloed) departments to being more well-structured units of business operations composed of integrated functions and capabilities. 

So how does an organization go about gaining QMS automations? Well, a good starting point is a cost-benefit analysis. That cost-benefit analysis should take into consideration the:

• cost of the initial deployment of the automations. That will include the cost of the software/systems’:
  • installation and setup
  • integration with existing systems (or minimally the migration of data from them)
  • any necessary customization
  • transition/cut-over

• re-occurring costs for:
  • training staff how to use those automations
  • maintenance and service request fees of those automations (which, for e-QMS automations that are purchased, will include consideration of their (annual) subscription or licensing fees)

If an organization intends to buy its QMS automations then it should also consider the viability (e.g., reputation, credibility) of the vendor. For example, the organization may wish to limit itself to the assessment of vendors that are recommended to it by its own key customers and suppliers or the regulatory authorities with which it must comply. In this way symmetry with and integration of the ERP systems to those entities might go easier.

The relevant internal stakeholders must be involved at all stages of the effort to automate an organization’s QMS. For example, their awareness to the use-cases of the processes implicated and the dashboards for reporting process effectivity is essential to the success of any effort to automate. This is particularly so for e-QMS automation initiatives because:

• the organization’s ability to meets its objectives and to delight its customers and the regulatory authorities implicated is something that must be always maintained – especially so if the organization is already supporting previously delivered finished goods/services.
• 3^rd party suppliers of e-QMS capabilities, in recent years, have designed and built their offerings using the tooling from the more well-known vendors of other ERP tooling. As a specific example, Customer Relationship Management (CRM) is a topic that is well embraced by senior management at any point in an organization’s journey for sustainable success, so it helps if the e-QMS tooling is already well integrated and proven with that same CRM tooling.

What are the characteristics of a ‘good’ e-QMS?

A ‘good’ e-QMS is one that enables an organization to easily demonstrate regulatory compliance. Other characteristics of a ‘good’ e-QMS include its ability to provide the organization with improved:

• access to data analysis and insights/trends that enable the organization to reduce costs
• employee morale
• customer satisfaction
• product capability, quality, and brand

For example, a ‘good’ e-QMS will simplify an organization’s struggles with:

• obsolete or out-dated documentation, result templates or otherwise relevant information about business risks/opportunities, work-in-progress as well as finished good failures/defects
• connectivity between other (manual) business management systems
• ineffective quality objectives 
• ineffective quality control and assurance methods
• visibility and traceability into its supply chain
• productivity
• minimizing rework, waste, and scrap
• responsiveness
• operating margins
• product recalls and failure analysis

How do e-QMS software/software systems do that? The answer is that a ‘good’ e-QMS provides the mechanisms for governance to occur on every ERP activity in a real-time fashion. Also, and ideally, a ‘good’ e-QMS provides artificial intelligence and ‘what if’ simulation capabilities that allow an organization to more accurately pinpoint where problems exist, the possible root-causes of those problems, as well as what types of process or product changes might eliminate or at least significantly reduce those problems.

Summary and Conclusion

In summary, e-QMS automations are:

• an integral part of the ERP software/systems used by an organization. For example, e-QMS automations will enable an organization to more clearly define how it can reach its strategic, tactical, and operational objectives for improved process and product quality
• a competitive advantage because they provide the organization with real-time awareness to its management review activities as well as its areas/needs for improvement. For example, e-QMS automations will provide improved results in how people in the organization can detect and collaborate on the management of risks 

To conclude, a ‘good’ e-QMS software/system solution is one that:

• can integrate quickly with and is complimentary to the other automation tooling that exists within the organization’s ERP software/systems; e.g., e-QMS automations are designed and implemented to link with other ERP software/systems in a centralized way such that everyone is kept on the same page when collaborating on the identification or implementation of design changes or continuous improvements
• reduces likelihood of human-errors through improved process controls
• provides accurate, single point-of-truth, and real-time indications of the organization’s perception of customer satisfaction as well as to the actual progress staff are making on the work assigned to them
• scales easily as the organization grows
• accessible to all the intended users at every level of an organization; e.g., operates and secure for each device those users will use to interface with it

And now, a sneak peak into my next article

In my next article I will discuss the planning and management of an organization’s internal QMS audit program and some best practices thereof.