Project Practitioners > What IS a Quality Management System, Anyway?

What IS a Quality Management System, Anyway?

By Matt Glei

For many years I worked in a regulated industry, medical devices.  In 1999, when I joined people to help create, I thought - wow, project management in non-regulated industries must be a lot easier!  Boy was I wrong!  In fact, I've since found that BECAUSE the medical device industry was regulated, there was more recognition of the need for formal project management, as well as more focus on creating processes that were repeatable and could be made efficient and effective.  This ultimately led to a requirement that various regulated industries have a Quality Management System [QMS] in place.

Many PM’s initial reaction to the statement “we need to have a quality system in place because blah, blah, blah.” Is “Yikes, they’re going to tell me how to do my job!”  In reality, especially if PMs join to help create a useful structure and processes, it can actually help, not hinder, getting projects accomplished.

A quality management system can be expressed as an organizational structure, procedures, processes and resources needed to implement quality management at a company or facility.  A number of industries are closely regulated and must have a quality system in place that complies with appropriate national or international regulations.  These industries include medical devices, drugs, automotive, aerospace, food, toys, and so on. 

Other, non-regulated companies have adopted more general quality standards (such as ISO 9000) as a way to both improve performance and quality, as well as differentiate themselves from other competitors in these industries.  Purchasing organizationsin regulated industries often require their suppliers or contractors to comply with various standards, even though the supplier is not being directly regulated.

The more general standards (such as the ISO 9000 series) require that a company provide the following:

  • a set of procedures that cover all key processes in the business;
  • monitoring processes to ensure they are effective;

  • keeping adequate records;
  • checking output for defects, with appropriate and corrective action where necessary;
  • regularly reviewing individual processes and the quality system itself for effectiveness; and
  • facilitating continual improvement

Specific industry regulations typically go beyond the above to add items such as complaint-handling, part traceability, risk management, etc., and differ based on the challenges of that industry (medical vs. automotive vs. aerospace have different concerns, although safety is common to all).

What is it like working under a quality system?  It means:

·        key processes have been thought through, designed and written down

·        monitoring people’s use of the processes to ensure they are being followed

·        evaluating the effectiveness of the process in achieving goals

·        making sure that the records required are being created, approved and stored

·        making sure the product or service is being checked for defects and if found, fixed

·        auditing processes and the entire system to evaluate effectiveness, and

·        improving individual processes and the entire system, continually.

The goal of all these systems is to have a repeatable process that is used by all, evaluating it and making it better.  Sounds simple?  Well, it IS as compared to making it up as you go along.  Just my opinion.

Matt Glei, PMP, CSM

Not all comments are posted. Posted comments are subject to editing for clarity and length.

Matt, I agree totally with monitoring and measuring quality. My struggle has recently been to find the balance between process and the ability to be flexible when required. In some cases process adds to bureaucracy, and removes any flexibility to handle outlying situations - ergo it hinders quality. Any quality system should not be a process for process sake only, but truly focus on results.

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