IAS eNews
How to Develop a Quality Management System
by Bernadette Rivera, M.S., Laborers AGC

Introduction

Development Strategy

Assemble Project TeamIn today’s highly competitive businessenvironment, forward-thinking organizations are more committed than everto continually refining their processes
and procedures to improve theirproducts and services. The development and implementation of a quality
management system (QMS) is perhaps the best way to demonstrate thiscommitment.

Once an organization has committed
to the development and implementation of a QMS, sound planning becomes a crucial element to theproject’s success. In fact, poor planning and inadequate resource allocation are often the primary causes ofimplementation failures. Organizations
can avoid these potential pitfalls byfollowing these key steps: establish aproject plan; assemble a project team;conduct a “gap analysis”; develop andimplement the system; and monitor
implementation.

The scope of the work that is required
to develop and implement a QMS willvary among organizations, but all will
require the right mix of people to get
the job done. Appointing a credibleand capable leader for the project(let’s call this person the “qualitychampion”) is an essential part of theprocess. An organization’s quality
champion is responsible for guiding
the quality team throughout the life of
the project. It is important to select anindividual who:

A quality management system provides organizations with the opportunity to increase their competitive
position by focusing improvement
efforts on those operational areas in
the most need of change. This in turnstreamlines operations, increases
efficiency and enables organizations
to provide higher quality products andmore effective services to theircustomers.
So why doesn’t every organization
implement a QMS? Very often, organizations shy away from implementing aquality management system because
the process is viewed as daunting. Not
only does it compel an organization totake a critical look at its current
business practices, analyze how wellthese are functioning and develop anorganization-wide documentation andmonitoring process, but such a system
also comes with the expectation ofimmediate and long-term culturalchange. Despite the significant
commitment needed to develop,
implement and maintain a QMS, thelong-term benefits to an organization
make such a system a worthwhile
endeavor and an essential element inensuring the organization’s long-termviability.

Project Planning
Careful planning and efficient management of the implementation are vital to
the success of any QMS project, as
this helps to control costs and avoid
extended timelines and the loss of key
personnel and general dissatisfaction
with the outcome. The following steps
should be considered when developing a QMS project plan:• Identify project tasks• Define milestones• Establish timelines• Develop a budget• Assign resources• Develop a strategy for monitoring
progress• Has a sound understanding of theorganization, particularly of its
culture and values• Understands the rationale behind
any new system implementation• Is able to undertake a comprehensive review of all business processes and begin to develop and introduce new policies and procedures• Can train staff to understand andhelp implement the system and tocontinuously identify areas ofimprovement.

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Gap Analysis
Before implementing a QMS, a thoroughanalysis should be completed to
profile the organization’s existing
business practices. Based on thefindings, the organization can determine what is already in place and whatneeds to be created. Basic elementsof a QMS, which should be taken into
consideration when conducting thegap analysis, include:• A quality manual, inclusive of theorganization’s mission and vision,quality policy, and structure• Standard Operating Procedures(SOPs) for every area of operation,
which address, at a minimum,
vendor manage ment, documents
and records control, benchmarking,corrective and preventive action andthe monitoring of customer satisfaction• Metrics that are designed to assess
the effectiveness of each majororganizational function and process• Regular internal audits that assessadherence to organizational procedures and determine the effectiveness of business operations

System Development andImplementation
The involvement of all personnel in thedevelopment and implementation of
the QMS, from the project’s onset, isessential to its ultimate success. This
involvement creates buy-in, helps toensure a better understanding of thesystem and guarantees all major
phases and facets of organizational
activities are captured. Working withdepartmental managers and theirstaff, the quality team should follow
the development and implementation
steps below:• Identify major functions• List related processes• Name related records• Develop SOPs
• Create metrics• Assign responsibility• Create and/or collect records• Conduct a procedures review withstaff (Process requirements andrelated documentation are clarified
and expectations established)• Gain review and approval byexecutive management• Train staff• Formally release the system documentation
Once these steps have been taken, theorganization is ready to “go live” with
its QMS. When that happens, little tono disruption of the day-to-day business activities should be experienced.
Of course, there will always be someminor issues that will need to beaddressed, but these should be
minimal and entirely manageable.

Monitoring
To ensure the strength and effectiveness of the QMS, ongoing internal
audits are critical. It is only throughsuch mechanisms thatinefficiencies are identified andaddressed. When conducting QMS
monitoring it is important to recognizethat the system in and of itself is not asilver bullet.
Having a team of trained internal
auditors who objectively review eacharea, document instances of noncompliance with established procedures
and make sound recommendations
for corrective actions is paramount tothe system’s ongoing success.

Conclusion
While all of the steps noted above
might seem like a lot of work, they are
the only means to assure that a QMS
will not become merely a document-generating system. Once a QMS
is deployed, periodic health checks inthe form of internal audits should
become a part of the organization’sroutine. There is an old adage thatsays the only constant is change. Thisis particularly true in today’s businessenvironment. Therefore, organizations
must constantly reassess the ability of
their QMS to capture key performanceand industry trends and guide efficiency improvements at all levels of theorganization.

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