Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Taran March @ Quality Digest
The Olympus CIX100 inspection system enables 21 CFR Part 11 compliance
Wade Schroeder
Gleaning best practices from regulatory standards
Adrian Hernandez
Current manufacturing oversight in the United States and overseas is hampered by staff shortages and limited funding
Del Williams
Tubular cable conveyors can be flushed with water, rinsed, and sanitized without disassembly
Jon Speer
How to do it in real time

More Features

FDA Compliance News
First trial module of learning tool focuses on ISO 9001 and is available now
Free education source for global medical device community
Good quality is adding an average of 11 percent to organizations’ revenue growth
Further enhances change management capabilities
Creates adaptive system for managing product development and post-market quality for devices with software elements
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains
An invite from Alcon Laboratories
Intended to harmonize domestic and international requirements
Pharma quality teams will have performance-oriented objectives as well as regulatory compliance goals

More News

Steve Arbogast

FDA Compliance

Quality Management Systems Are Not for Renegades

Quality requires structure.

Published: Tuesday, October 20, 2009 - 14:53

A quality management system is a framework of processes and procedures that are used to ensure that an organization can fulfill all tasks required to achieve its goals, strategies, and objectives.

The majority of businesses around the world have some sort of well-defined quality management system (QMS). The intent of most businesses with structured QMS is to ensure  that employees are following a formal approach to doing the work of the business, and that the organization knows how to manage change and achieve continual improvement. A typical quality management system may contain:

  • A definition of the goals, strategies, and objectives of the business
  • A clear statement of what business they are in, what the products and services are, what the market is, and to what types of customers the business intends to market and sell to
  • Strengths, weaknesses, opportunities, and threats
  • Business functions and a well-defined and related set of business processes and procedures
  • Organizational structure with clearly defined responsibilities
  • Monitoring and measuring approaches such as customer satisfaction measurement, etc.
  • Governance and control approaches
  • Methods for changing and improving the organization

There are still some businesses that do not have a well-defined, documented, and communicated QMS. We have to wonder how they do what they do, and we have to believe it's probably a “fly by the seat of your pants” type of organization. There are also businesses that have a QMS, but don’t use it, follow it, nor adhere to its intent and doctrine. So, the question is, why do they have a management system at all?

I know of one business that has a quality management system in place, but its management tends to ignore it, does not promote it, and does not use it to their advantage. Knowing this business as I do, it would appear that they have a QMS only to ensure the company maintains its ISO standards certifications. Staff within the organization has made it clear to me that management commits the staff and money to building and supporting the QMS, but when it comes to managing the business per the management system, management does not give the system any teeth.

Peter Drucker wrote in his 1973 book Management: Tasks, Responsibilities, Practices (Harper Paperbacks, 1993), “In modern society there is no other leadership group but managers. If the managers of our major institutions, and especially of business, do not take responsibility for the common good, no one else can or will.” If the management of the organization is not acting like leaders, setting direction, managing to the management system, then it is highly unlikely that the nonmanagers of the business will follow the management system. 

To the outsider, this business looks as if it uses its QMS, but in its day-to-day operations it's clear that the company does nothing but “firefighting.” Granted, the global economic downturn has challenged many businesses and their management; the economy has caused many organizations to become reactive vs. proactive. In doing so, many organizations are ignoring their management system, not following its processes and procedures, and thereby not managing the business per the management system. This probably means that their overall quality goals, strategies, and objectives are being satisfied at a greater cost than necessary. If the QMS is really being utilized using a continual improvement approach, the overall operation of the business could be done with less money and resources, and deliver higher customer satisfaction levels.

Quality management systems require the organization to commit resources to the management of the management system. This means there must be resources committed to the development and continual improvement of the QMS. Processes and procedures must be changed as the business goes through its normal evolution, and business and business process transformation plans become a necessity, not an option. The resources can be used to communicate and train operational staff on the defined processes and the expectations built within the process. There must be a set of business metrics and measurements so that the business can ascertain how well it is operating. These metrics may include financial data, but there will be many other metrics that permit the business to assess its levels of efficiency, effectiveness, and productivity. Most important, before the business can expect the operational levels of the organization to commit to a QMS—and do their work based on it—management must first be committed to it. People in the organization (leaders and operational staff) must be measured based on the management system. 

Management systems take on different forms and constructs, but the best-managed ones use modeling and management solutions. These solutions allow the management system owners to construct models reflecting business goals, strategies, and policies with associated and dependent processes and procedures. The solutions will allow for capture and tracking of customer and supplier requirements, and problems and satisfaction levels of customers and suppliers. Audits, findings, and corrective and preventive action tracking will also be included with such management solutions. The overall solution should have a repository that permits long-term storage of the overall QMS so that there is history and change control. Finally, it is important that the management solution permit publication of the management system so that everyone in the organization that has a need to know about the content of the QMS, does know of it and is using it regularly in the execution of their work. This publication support can come in different forms, but the most common and usable approach is to publish the QMS via HTML over the intranet or internet. 

Without adherence to a formalized quality management system, business management and staff are nothing but a bunch of renegades; i.e., individuals who reject structure or expected behavior. A business requires structure. A business defines the expected behavior through its management systems, its processes, and its procedures, and a business assesses how well it is doing by monitoring and measuring its functions and processes. If a business does not do these things, then what we have is a business that is likely doomed. Build your management system, use it, improve it, and gain competitive advantage. 

Discuss

About The Author

Steve Arbogast’s picture

Steve Arbogast

With more than 40 years of experience in managing both business and IT functions, Steve Arbogast specializes in defining, mapping, integrating and changing corporate processes, business management systems, and governance approaches, with a focus on aligning business goals and strategies with business operations. Arbogast utilizes his background in IT and business management to improve the overall strategies and operations of businesses in the pharmaceutical, computer, telecommunications, legal, petroleum, software sales, and insurance industries.

Arbogast manages the North American QualiWare business, and continues to provide professional services to a variety of enterprise customers.

Comments

Myers-Briggs Assessments

It has long seemed to me that we tend to react to quality systems in accordance with how we show up in a Myers-Briggs personality analysis (in which I am far from an expert). Some personality types will tend to fit naturally with a quality system approach, while for others it will be troublesome. I know that this kind of analysis only tells us what we are naturally comfortable with, and not what we are capable of, but it seems to me that those of us for whom this comes naturally need to find ways to make quality systems more worth the effort for those to whom it does not come naturally. This is not to say I have this fully thought out and ready for action -- more like just an idea.