Quality Assurance

Quality assurance can be defined as "part of quality management focused on providing confidence that quality
requirements will be fulfilled." The confidence provided by quality assurance is twofold—internally to management
and externally to customers, government agencies, regulators, certifiers, and third parties. An alternate definition is
"all the planned and systematic activities implemented within the quality system that can be demonstrated to provide
confidence that a product or service will fulfill requirements for quality."

Quality Control
Quality control can be defined as "part of quality management focused on fulfilling quality requirements." While
quality assurance relates to how a process is performed or how a product is made, quality control is more the
inspection aspect of quality management. An alternate definition is "the operational techniques and activities used to
fulfill requirements for quality."

INDUSTRY PERSPECTIVES ON QA AND

QC
For some service organizations, the concept of quality control may be foreign because there is no tangible product
to inspect and control. The quality assurance function in a service organization may not include quality control of the
service but may include quality control of any products involved in providing the service.

A service may include products that are documents (such as a report, contract, or design) or tangible products (such
as a rental car or units of blood). It may be necessary to control product quality in a service organization to ensure
that the service meets customer requirements.

QA, QC, and Inspection

Inspection is the process of measuring, examining, and testing to gauge one or more characteristics of a product or
service and the comparison of these with specified requirements to determine conformity. Products, processes, and
various other results can be inspected to make sure that the object coming off a production line, or the service being
provided, is correct and meets specifications.

Quality Assurance and Audit Functions

Auditing is part of the quality assurance function. It is important to ensure quality because it is used to compare
actual conditions with requirements and to report those results to management.

In The Quality Audit: A Management Evaluation Tool (McGraw-Hill, 1988), Charles Mill wrote that auditing and
inspection are not interchangeable: “The auditor may use inspection techniques as an evaluation tool, but the audit
should not be involved in carrying out any verification activities leading to the actual acceptance or rejection of a
product or service. An audit should be involved with the evaluation of the process and controls covering the
production and verification activities.”

Formal management systems have evolved to direct and control organizations. There are quality management
systems (QMSs) as well as environmental or other management systems, and each of these systems may be
audited.

HISTORY OF QA AND QC
Quality has been defined as fitness for use, conformance to requirements, and the pursuit of excellence. Even
though the concept of quality has existed from early times, the study and definition of quality have been given
prominence only in the last century.

1920s: Quality Control

Following the Industrial Revolution and the rise of mass production, it became important to better define and control
the quality of products. Originally, the goal of quality was to ensure that engineering requirements were met in final
products. Later, as manufacturing processes became more complex, quality developed into a discipline for
controlling process variation as a means of producing quality products.
1950s: Quality Assurance and Auditing
The quality profession expanded to include the quality assurance and quality audit functions. The drivers of
independent verification of quality were primarily industries in which public health and safety were paramount.

QA AND QC RESOURCES
You can also search articles, case studies, and publications for quality assurance and quality control resources.

BENEFITS OF TOTAL
QUALITY MANAGEMENT
Note: Total quality management (TQM) as a term to describe an organization's quality policy and procedure has
fallen out of favor as international standards for quality management have been developed. Please see our series of
pages on quality management systems for more information.

Total quality management benefits and advantages:

 Strengthened competitive position

 Adaptability to changing or emerging market conditions and to environmental and other government
regulations
 Higher productivity
 Enhanced market image
 Elimination of defects and waste
 Reduced costs and better cost management
 Higher profitability
 Improved customer focus and satisfaction
 Increased customer loyalty and retention
 Increased job security
 Improved employee morale
 Enhanced shareholder and stakeholder value
 Improved and innovative processes
Quality and Reliability
Quality is defined as the degree to which a product or service meets customer requirements,
while reliability is defined as the probability that a system will perform its required function
without failure over time.
The reliability of a product is directly related to the quality of the product. A high-quality product is
typically more reliable. A low-quality product will invariably be of low reliability.
Quality, Reliability and Safety
Any product's three most important aspects are safety, quality and reliability. The term "safety" refers
to the absence of injury or damage caused by an object or substance. The term "reliability" refers to
the ability of a device or system to perform its intended functions in a predictable manner over time
(or quality over time). Finally, the term "quality" refers to the degree to which a device or system
meets customer requirements.
Safety and reliability are closely related concepts. If a product is designed to operate safely, it is likely
to be highly reliable.

Basics of Quality Improvement

Quality improvement (QI) is a systematic, formal approach to the analysis of practice performance
and efforts to improve performance. A variety of approaches—or QI models—exist to help you collect
and analyze data and test change. While it’s important to choose a reputable QI model to guide your
efforts, it’s more important that you fully commit to using the QI process and good QI practices.

Benefits of QI

Understanding and properly implementing QI is essential to a well-functioning practice, and is

necessary for any practice interested in improving efficiency, patient safety, or clinical outcomes.

In addition, good QI practices and improved patient outcomes position your practice for success by:

 Helping you prepare for the transition to value-based payment models.

 Allowing you to participate in the public reporting of physician quality data.
 Giving you the opportunity to participate in the federal Quality Payment Program (QPP)
following one of two tracks: the Merit-based Incentive Payment System (MIPS) or
the Alternative Payment Model (APM).
 Equipping you with the skills necessary to apply for and complete national recognition
programs, such as National Committee for Quality Assurance’s (NCQA) Diabetes,
Heart/Stroke, and patient-centered medical home (PCMH)-recognition programs.
 Helping you earn Family Medicine Certification-Performance Improvement activity
credit (formerly Maintenance of Certification) requirements.

Quality Improvement Basics

The QI process is grounded in the following basic concepts:

 Establish a culture of quality in your practice. Your practice’s organization, processes, and

procedures should support and be integrated with your QI efforts. The culture of a practice—
attitudes, behaviors, and actions—reflect how passionately the practice team embraces
quality. The QI culture looks different for every practice, but may include establishing
dedicated QI teams, holding regular QI meetings, or creating policies around your QI goals.
 Determine and prioritize potential areas for improvement. You will need to identify and
understand the ways in which your practice could improve. Examine your patient population
(e.g., to identify barriers to care, frequently diagnosed chronic conditions, or groups of high-risk
patients) and your practice operations (e.g., to identify management issues such as low
morale, long patient wait times, or poor communication). Use established quality measures,
 such as those from the National Quality Forum, Agency for Healthcare Research and Quality,
and the Quality Payment Program to guide your efforts.
 Collect and analyze data. Data collection and analysis lie at the heart of quality improvement.
Your data will help you understand how well your systems work, identify potential areas for
improvement, set measurable goals, and monitor the effectiveness of change. It’s important to
collect baseline data before you begin a QI project, commit to regular data collection, carefully
analyze your results throughout the project, and make decisions based on your analysis.
 Communicate your results. Quality improvement efforts should be transparent to your staff,
physicians, and patients. Include the entire practice team and patients when planning and
implementating QI projects, and communicate your project needs, priorities, actions, and
results to everyone (patients included). When a project is successful, celebrate and
acknowledge that success.
 Commit to ongoing evaluation. Quality improvement is an ongoing process. A high-functioning
practice will strive to continually improve performance, revisit the effectiveness of
interventions, and regularly solicit patient and staff feedback.
 Spread your successes. Share lessons learned with others to support wide-scale, rapid 
improvement that benefits all patients and the health care industry as a whole.

Quality Improvement Models and Tools

Quality improvement models present a systematic, formal framework for establishing QI processes in your
practice. Examples of common QI models include the following:

 Model for Improvement (Plan-Do-Study-Act [PDSA] cycles): The Institute for Healthcare
Improvement’s Model for Improvement combines two popular QI models: Total Quality
Management (TQM) and Rapid-Cycle Improvement (RCI). The result is a framework that uses
PDSA cycles to test interventions on a small scale.
 Six Sigma: Six Sigma is a method of improvement that strives to decrease variation and
defects.
 Lean is an approach that drives out waste and improves efficiency in work processes so that
all work adds value.

Quality improvement tools are standalone strategies or processes that can help you better
understand, analyze, or communicate your QI efforts. Examples of QI tools include run charts,
process maps, and fishbone diagrams (ihi.org).