How Have Quality Management Systems Evolved?

Events

The statistician W. Edwards Deming, one of the fathers of quality management theory and recipient of the National Medal of Technology in 1987. Public Domain. Via Wikimedia Commons.

Quality management systems and compliance or reporting systems might seem like a nightmare at first. Two gnarled nests of paperwork that are deeply intertwined yet notoriously difficult to maintain in good order seem like they should be handled by the usual suspects: a staff of regulatory and quality experts who are knowledgeable about navigating the labyrinthine details and quality experts who are often inscrutable to extensive licensing requirements.1

As entrepreneurs know, where there’s inefficiency, there’s opportunity. Connecting manufacturing quality systems, standardization, documentation and compliance is a way that many manufacturers are choosing to optimize key business metrics, reduce risk and up their returns. Unifying your QMS via software allows for document control, learning management, and regulatory control under one hood. The question remains: How is it possible to put all of these functions and more under the same hood without massively disrupting your operations?

What Were Good Quality Managment Solutions Of The Past?

Before answering the question of QMS unification with other thorny areas of manufacturing practice, let’s look at historical quality management systems so that there’s some context for how far the field has come since the early days.

It goes without saying that quality management has come a long way from the random sampling off of the production line as practiced in the early 20th century and the haphazard and unstandardized efforts of the mid century’s factories. There’s no reason to look that far back with any detail, except to mention that the mid-century period saw much of the important theoretical work for quality management systems.2 The main thrust for systematic quality management occurred in the 1980s, with centers of activity in the US and Japan.

There are two main parts to the huge improvements in quality management which have created the concept as it exists today.

Standardization of quality management practices like:

  • TQM
  • ISO90003
  • ISO140001
  • ISO19011
  • Six Sigma
  • Various software development standardization systems4

paired with mandates such as:

  • Object Oriented Quality Management5
  • GMP
  • GLP
  • Numerous parts of the 21 CFR regulations

are enough to make manufacturing in an environment of quality-improvement and quality-tracking under an umbrella of quality documentation the norm. Frighteningly, many aspects of the documentation and regulatory frameworks are based off of physical paper rather than digital document control. This makes unifying standardized quality management systems and their regulatory documentation very cumbersome.

There’s even more room for improvement, and manufacturers recognize that improvement in maintenance of quality control, regulatory compliance, and the tracking thereof are worth pursuing. In particular, software has grown to play a major role in coordinating between standardization, manufacturing data, documentation of that data, and regulatory reporting of compliance of data in light of the standardized procedures. These are huge issues for manufacturers, and they don’t need to be difficult to implement when the right software package is used. That begs the question: what will the software package that handles quality management system of the future do, and how?

What Will The Quality Management Systems Of The Future Look Like?

The QMS of the future will live up to the expectations of quality management from the past succinctly stated in the one of the original quality management systems practiced by the US Department of Defense: “Quality Management… is a strategy for continuously improving performance at every level, and in all areas of responsibility. It combines … management techniques, existing improvement efforts… under a disciplined structured focused on continuously improving all processes.”6  The difference between the origin of quality systems and the QMS that manufacturers today use is the new emphasis on software integration.

Software integration is a good thing, provided that all of the inputs of software are organized through a central hub to which they deliver intelligible outputs which can then affect change in the manufacturing environment. There’s no point in creating a software quality monitoring system that can’t correct quality issues–or at least identify them—any more. The QMS that the leading companies use will be more like dashboards for manufacturing than understandings of physical paper reports requiring human processing and information integration. Additionally, leading QMS will start to take over areas of manufacturing that are tightly related to document control, regulatory compliance and quality control– like learning management–and make them seamless parts of the manufacturing process.

In short, the QMS of the future will be powerful pieces of software which will massively improve business’ ability to scale their operations while maintaining the same quality standards and meeting the same regulatory guidelines. Importantly, these QMS will enable clean scaling without introducing additional personnel costs that are lost to administrative practices alone. Rather than worry about meta-information logistics and human power to process them, powerful QMS can easily fill the space–standards are maintained without additional intervention.  

Powerful QMS Improve Business Efficiencies

QMS aren’t magic, of course. Manufacturers will still need to keep tight control over their production pipeline, starting with elements which may be outside their control like raw material harvesting, processing, shipping, and other logistical concerns. New QMS can help here, too, but their power is limited to reporting whatever’s going on outside a manufacturer’s domain and helping manufacturers adapt to the changes–valuable additions to be sure. Why would any manufacturer settle for anything less than a software platform which can improve their profitability while maintaining quality and making their business easier to scale in response to demand? As it turns out, there’s a software package designed specifically for this purpose that manufacturers will find easy to deploy and start improving their processes immediately.

Contact us at BIOVIA to see how our QMS can help your company connect product quality to documentation, regulatory compliance and offer your business with a controllable manufacturing hub which keeps you informed about key quality metrics while handling the difficult parts without human intervention. Also be sure to tune into our webinar Evolution of a Quality Management System – What Comes Next, scheduled for November 30th.

  1. “Quality Engineer Certification CQE.” 2017, https://asq.org/cert/quality-engineer.
  2.  “Deming’s 14 Points.” http://asq.org/learn-about-quality/total-quality-management/overview/deming-points.html
  3. “Quality Management Principles.” 2015, https://www.iso.org/files/live/sites/isoorg/files/archive/pdf/en/pub100080.pdf
  4.  “Enterprise Quality Management Software Best Practices Guide.” 2012, http://www.lnsresearch.com/research-library/research-articles/Enterprise-Quality-Management-Software-Best-Practices-Guide
  5.  “Object Oriented Quality Management: A Management Model For Quality.” 2009, https://unstats.un.org/unsd/dnss/QAF_comments/Object%20Oriented%20Quality%20Management.pdf
  6. “Total Quality Management Master Plan.” 1988, http://www.dtic.mil/cgi-bin/GetTRDoc?Location=U2&doc=GetTRDoc.pdf&AD=ADA355612.