White Paper: Effective Quality System

Management

Author: Danielle DeLucy

Owner, ASA Training & Quality Consulting, LLC

In many Life Sciences companies, “quality” becomes a “buzz” word. In an industry which is
one of the most regulated in the world, quality should come first when a company wants to
be productive. If designed properly, quality management systems can help a company
achieve its compliance goals and its business goals. With regulations from FDA, EU and
others becoming more and more stringent, Companies must optimize resources to
effectively achieve their quality goals and find their optimal balance between cost and risk.

What does a quality management system consist of? A quality management system (QMS)
is a collection of business processes focused on achieving quality policy and quality
objectives to meet customer requirements. It is expressed as the organizational structure,
policies, procedures, processes and resources needed to implement quality management.

How did quality become such an important feature of our industry? The concept of quality
as we think of it now first emerged from the Industrial Revolution. Previously, goods had
been made from start to finish by the same person or team of people, with handcrafting and
tweaking the product to meet 'quality criteria’. Mass production brought huge teams of
people together to work on specific stages of production, where one person would not
necessarily complete a product from start to finish.

Application of statistical control came later as a result of World War II production methods,
and were advanced by the work done of W. Edwards Deming, a statistician, after whom the
Deming Prize for quality is named. Joseph M. Juran focused more on managing for quality.
The first edition of Juran's Quality Control Handbook was published in 1951. He also
developed the "Juran's trilogy," an approach to cross-functional management that is
composed of three managerial processes: quality planning, quality control and quality
improvement. These functions all play a vital role when evaluating quality. The quality
profession grew from simple control, to engineering, to systems engineering. Quality
control activities were predominant in the 1940s, 1950s and 1960s. The 1970s were an era
 White Paper: Effective Quality System
Management

of quality engineering, and the 1990s saw quality systems as an emerging field. Like
medicine, accounting, and engineering, quality has achieved status as a recognized
profession.

There are some inherent challenges when a company lacks a solid QMS. Companies that
produce products with rigorous quality requirements face numerous challenges associated
with meeting quality objectives. Organizations of all sizes and across all industries can
easily fall prey to quality issues without effective information controls as a core component
of their quality management systems. The result can range from organizational
inefficiencies and poorly allocated resources, to negative brand perception, lost revenue
and increased liability. Without a centralized and organization-wide approach to managing
their content, companies leave themselves vulnerable, because of the difficulty and
complexity of managing critical and sensitive information and processes that affect quality
and compliance.

Establishing a robust QMS in any industry is an important key to success. The greatest
resource of a quality company are its people, so strategies for managing both real and
perceived change, or concerns and attitudes, should be addressed during the initial
planning of the QMS. Be sure to include executive management in periodic updates and
progress checks along the way to implementation. A company requiring GMP and/or ISO
compliance must establish, document, implement and maintain a QMS, as well as maintain
its effectiveness in accordance with the required compliance standard. The following areas
should be included when launching your QMS:

Quality policy

Quality objectives

Quality manual

Organizational structure and responsibilities

Data management
 White Paper: Effective Quality System
Management

Processes - including purchasing

Product quality leading to Customer satisfaction

Continuous improvement, including Corrective And Preventive Action (CAPA)

Quality instruments

Control of document

In conclusion, GMP requirements (2l CFR parts 210 and 211), ISO standards and industry
best practices require pharmaceutical and biotechnology manufacturers, contract research
organizations and lab services organizations to implement reliable quality management
systems. FDA's Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP
Regulations (September 2006) calls for a "comprehensive quality systems (QS) model"
which integrates various aspects of the quality, manufacturing and risk management using
a holistic approach. Similar expectations are required of other national and international
regulatory bodies and health authorities. Using paper-based forms, disconnected systems
or manual processes to manage, track and report on quality issues and actions does not
provide effective solutions for implementing harmonized, integrated quality management
processes, which follow industry best practices.
White Paper: Effective Quality System
Management