The P s and Q s of Quality Systems

Margaret Hanson, PhD, MT(ASCP)SBB

Quality improvement in blood collection centers has

been a priority of regulatory and accrediting agencies for
the past several years. The Food and Drug Administration
and the American Association of Blood Banks have developed guidelines for quality assurance activities. Inspection
programs have focused on evaluation of processes and how
they are controlled to assure the safety and efficacy of
blood components. A review of Food and Drug Administration enforcement actions shows that all such actions cite
similar deficiencies related to management control, personnel training, error, and record management policies. A
quality program that includes management commitment to
compliance and continuous improvement, defined personnel training, internal audit, and error management policies
provides documented evidence to management and regulatory agencies that operations are in control.
(Arch Pathol Lab Med. 1999;123:576579)

or the past several years regulatory and accrediting

agencies have promoted a systems approach to quality in blood banking. Both the Food and Drug Administration (FDA) and the American Association of Blood
Banks (AABB) have developed quality assurance (QA)
guidelines1,2 to assist blood centers and transfusion services in implementing and managing systems to assure
the quality of components and services. The College of
American Pathologists, Americas Blood Centers, and other organizations also support practices that assure continuous quality improvement in transfusion medicine.
The provision of safe and efficacious blood components
has always been a priority for transfusion medicine professionals. To ensure that blood components meet established criteria, quality control measures have been widely
used. These measures usually monitor a specific function,
such as daily evaluation of test reagents, but do not provide an assessment of the entire process. To maintain a
quality system, efforts must go beyond quality control.
The systems approach to quality is a relatively new concept in transfusion medicine, so for most organizations
implementation of a quality system requires shifting their
focus from controlling quality through inspection of the
final product to assuring quality by controlling the process. A quality management program that effectively incorporates the components listed in Table 1 will help to
assure that blood collection and processing functions are
in control.3

Presented at the College of American Pathologists Conference

XXXIII, Transfusion Medicine Performance Improvement, which was
cosponsored with the American Association of Blood Banks, San Francisco, Calif, August 2022, 1998.
Reprints: Margaret Hanson, PhD, MT(ASCP)SBB, PO Box 244,
Mound, MN 55364.
576 Arch Pathol Lab MedVol 123, July 1999

The AABB Accreditation Information Manual defines a

system as a group of interrelated processes and its variables, which include people, equipment, facilities and procedures. 4 A quality system is the organizational structure, procedures, processes, and resources needed to implement quality management. A systems approach evaluates the integration of multiple operations rather than
assessing each function separately. The FDA guidelines assist facilities in complying with Current Good Manufacturing Practices (cGMP). These guidelines address all aspects of operations and facilities and provide a guide for
the development, implementation, and management of a
quality program. The AABBs quality system essentials are
based on these specifications and provide additional guidance in implementing practices that assure quality and
compliance with cGMP.1
A systems approach begins with managements commitment to quality (Table 2). Lacking a philosophy of quality, it is difficult, if not impossible, to achieve a goal of
compliance and continuous improvement. Management
must focus on promoting an environment committed to
quality and devoting the resources required.
Quality as an organizational priority should be specifically stated in the vision and/or mission statement(s).
Compliance and continuous improvement should be defined as critical success factors in the organizations strategic plan. Increased workloads require managers to juggle many priorities. Those that are clearly stated as critical
to the success of the organization will command more attention than those defined only casually. It is important
that quality-related activities be recognized as good business practices as well as regulations with which the organization must comply.
From a regulatory perspective, management commitment to quality and documented control over all functions
related to collection, processing, testing, labeling, storage,
and distribution of blood components are essential. A review of the FDA enforcement action citations indicates that
nearly all such actions identify deficiencies related to management control and oversight. The FDA requires documented evidence that processes are in control to assure
the safety, purity, potency, and efficacy of components.
This evidence includes defined lines of authority and responsibility. Table 3 summarizes organizational and management-related deficiencies cited in selected enforcement
actions initiated by the the FDA during the past several
years.
An organizations policies provide direction to management and staff and are a second critical component of a
quality system. Policies for compliance and continuous improvement should be based on sound QA principles, such
as establishing and measuring acceptability criteria, monitoring for and controlling change, and appropriate documentation. Quality and compliance should not be seen
as the responsibility only of personnel in the QA unit.
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Table 1. Quality Management Components

Quality plan
Quality system essentials
Quality control
Quality assurance
Quality improvement
Quality monitors

Table 5. The Food and Drug Administration Citations

Related to Internal Audits
Failure to establish procedures and schedules
Use of standardized forms
Evaluate all manufacturing systems
Processing, testing, packing, storage, distribution
Establish priorities for resolving deficiencies
Lack of management review

Table 2. Quality System Components

Philosophy
Priority
Policies
Processes
Procedures
People

Table 3. Management Deficiencies Cited by the Food

and Drug Administration
Defined structure and responsibility
Management control of quality assurance and training
Defined reporting requirements
Written program for quality
Defined responsibility for compliance
Sufficient staffing and supervision
Availability of medical staff

Table 4. Policy Issues Cited by the Food and Drug

Administration
Written quality assurance program for manufacturing
functions
Inadequate plan
Inadequate record review
Inadequate equipment maintenance/monitoring
Lack of written policies/procedures for:
Internal audits
Error management
Records management
Donor suitability
Computer systems
Adverse reactions
Look back

Policies should confirm an organization-wide commitment

to compliance with regulations, standards, and industry
guidelines. Personnel policies should define authority and
responsibilities in the areas of quality and compliance.
Written policies should be made available to all personnel
and applied organization wide.
The FDA enforcement actions have included a number
of citations addressing QA policy (Table 4). Among the
deficiencies cited most often were failure to have a defined
quality program, lack of effective internal audits (Table 5),
and inadequate record retention practices (Table 6).
The Accreditation Information Manual defines a process as
a set of interrelated resources and activities, usually performed by more than one person, that transforms inputs
into outputs. 1 A quality system ensures that all parts of
the process work together to produce the expected output.
Elements of a process are linked, and changes in one area
may result in an unplanned and unexpected impact on
other process components. Since components of a process
may cross departmental boundaries, processes must be
Arch Pathol Lab MedVol 123, July 1999

Table 6. The Food and Drug Administration Citations

Related to Record Retention
Documentation of collection and processing steps
Completeness and accuracy
Records readily located and accessible
Security
Procedures for component tracking
Nonconcurrent recording of information

adequately defined so that critical steps are monitored and

controlled appropriately. Graphic representation using
flowcharting or process mapping techniques allows identification of process elements, critical control points, and
interrelationships or interactions between departments.
Mapping also can be useful in identifying ways to improve the efficiency and/or effectiveness of a process.
Process control is the action taken to minimize variation
in a process. It includes all steps from receipt of raw materials to distribution of the final product and ensures that
processes, the output of which cannot be verified, consistently produce components that meet requirements.
Where quality control tests result in the destruction of the
product, as is the case with most blood components, it is
essential that processes be controlled and monitored to
assure the expected outcome. Validation of the process to
verify that the actual outcome is consistent with the expected, inclusion of controls where appropriate to document performance, and periodic monitoring to document
compliance are all aspects of process control. Process control is important to assure consistency and reproducibility,
particularly where the same process is carried out at multiple sites.
Standard operating procedures (SOPs) provide instructions for performing a task and are the foundation of an
effective quality management program. SOPs define how
a function is carried out to ensure consistency of practice
between individuals and facilities within the organizations. Written SOPs must be readily available to operations
personnel. SOPs should include work instructions as well
as acceptability criteria, interpretative guidelines, and limits of performance. A document that provides guidance on
the development of SOPs also is important.
SOPs must comply with manufacturers instructions,
FDA regulations, and AABB standards.4 Validation to verify that an SOP produces the expected outcome and training of personnel to perform a procedure appropriately are
critical steps in the SOP development and implementation
process. Existing SOPs should be revised to reflect
changes in practice and reviewed periodically to assure
that they accurately describe the process. Among the SOPrelated deficiencies noted in FDA enforcement actions
were failure to have an SOP, inadequate SOPs, SOPs not
followed, and inconsistency of procedures performed at
multiple sites.
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Table 7. The Food and Drug Administration Citations

on Personnel Training
Standardized training plan
Focus on critical job elements
Ensure personnel perform tasks properly
Procedures to evaluate training effectiveness
Training conducted by qualified personnel
Annual competency review
Plan for retraining as required
Document training in employee files

Table 8. Elements of a Quality System

Planning
Problem solving
Participation
Performance
Proactive approach
Proof
Patience
Preparation

Selection of the right people is another critical component of a quality system. Current position descriptions
specifying qualifications and duties assist in the selection
of appropriate personnel and define authorities and responsibilities. Position descriptions should specifically
state authority and responsibility for the quality of blood
components and services and compliance with regulations.
Initially, personnel must be trained to perform job-related tasks and should be provided training on cGMP,
safety, and other job-related topics. A formal orientation
program provides an opportunity to explain policies and
procedures, introduce the companys quality philosophy,
and provide an overview of cGMP. Personnel must be familiar with these concepts so that they understand their
role in assuring compliance with regulations and improving quality.
A documented plan should be developed to define specific training requirements for each position. The responsibility for training should be assigned to qualified individuals and should be appropriately documented. Personnel training files should contain a list of the procedures
each individual performs as well as documentation of
training on those procedures. Training files should include a statement of the individuals competence to perform tasks without immediate supervision as well as documentation of cGMP, safety, and other training required
by regulatory agencies or organization policies.
The FDA enforcement actions frequently cite a lack of
adequate training or adequate supervision. Other personnel-related issues cited by the FDA are shown in Table 7.
In some cases it is more likely to be failure to maintain
adequate documentation of training rather than failure to
train.
Other elements of an effective quality management program are listed in Table 8. Planning for quality is essential
and preparation needs to take place on several levels. A
quality program that identifies the goals and objectives of
the organization is essential for implementation of quality
initiatives. While the AABB quality program and quality
system essentials provide a solid foundation for a quality
plan, other standards, such as International Organization
578 Arch Pathol Lab MedVol 123, July 1999

for Standardization 9000, provide an equally effective

model for a quality program.5
Effective communication between operating units ensures that implementing a change in one area does not
adversely affect operations in another. Effective planning
includes identification of the project scope, definition of
performance goals, estimate of costs and required resources, and establishment of realistic timelines. Planning
also should include an analysis of where the project fits
in the organizations priorities. Methods for monitoring
and measuring progress also should be included in the
project plan.
Performance applies to many aspects of quality management, including equipment, computer software, processes, and personnel. Performance measures provide documentation that systems are in control. Equipment performance can be verified at installation using an appropriate performance qualification procedure with defined
acceptance criteria. Regular calibration of instruments assures consistent performance and may identify trends that
lead to early identification and resolution of equipment
problems. Compliance with performance criteria for computer software can be verified through validation and testing. Validation of software should include tests designed
to challenge the critical control points it monitors to verify
that the system performs as expected.
Performance criteria should be established for all positions within the organization to guide personnel. Personnel usually will perform in a manner consistent with
meeting defined expectations. Periodic assessment of personnel provides assurance that individuals are competent
to perform their assigned duties and are complying with
established policies and procedures.
Prevention of errors, deviations, and variation is the key
to increased productivity and decreased cost. Problem
solving skills are an essential component of prevention.
The ability to identify problems or potential problem areas
is not sufficient. Organizations must be able to develop
and implement preventive action that effectively resolves
problems. Failure to thoroughly investigate errors, deviations, or variations may result in failure to identify an underlying cause that will lead to additional errors. Root
cause analysis allows an organization to develop and implement action that will effectively prevent recurrence.
Monitoring preventive action assures that the action taken
adequately and effectively addresses the problem.
Error management policies should focus on identifying
and resolving system problems rather than placing blame
or punishing personnel for making an error. Punitive error
management policies discourage error reporting, thereby
decreasing potential opportunities for improvement. A
comprehensive error management system is essential to
allow tracking of trends and to identify potential problem
areas before errors and/or accidents occur. It should be
promoted positively as a quality improvement tool rather
than as a measure of personnel performance. Table 9 summarizes FDA enforcement action citations related to error
management.
Proof of completion or documentation associated with
quality initiatives can be tedious and time-consuming;
however, it is critical to a quality management program.
Facilities should develop policies identifying what actions
need to be recorded and the appropriate documentation
method. Without appropriate documentation, there is no
way to prove that an action was taken or that the system
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Table 9. The Food and Drug Administration Citations

Related to Error Management
Written procedures for error review and resolution
Assigned responsibility for review and investigation
Prompt, thorough review and investigation to identify
cause
Implement corrective action: monitor and track
Timely reports to the Food and Drug Administration
Document errors due to system deficiencies
Recall in compliance with law
Timely recall of unsuitable components

was consistently in control. Documentation should include

what action occurred, who was involved, and when it happened. An interpretation of the outcome (eg, acceptable or
unacceptable) also may be included. Documentation
should be completed at the time the activity is performed.
To be effective, quality needs to be built into the system;
it cannot be effectively achieved through inspection of the
final product. Implementation of QA measures provides
the opportunity for an organization to be proactive rather
than reactive in addressing quality issues. Participation of
all personnel in quality efforts is critical to the success of
a quality management program. When personnel are given the opportunity to actively participate in process assessment and improvement activities, they are more likely
to understand and promote the benefits of quality initiatives. Everyone must be held accountable for assuring
quality.
The relationship between personnel responsible for QA
and compliance activities and those primarily responsible
for operations or production functions often is antagonistic rather than cooperative. The challenge is to foster an
environment in which partnering and participation are
key elements. Operations personnel must understand and
appreciate the benefits of QA and compliance issues. Similarly, QA and compliance personnel must recognize and
respect the fact that other operations priorities may, at
times, be more important to the organizations success
than QA issues.
Blood centers and hospitals as well as regulatory and
accrediting agencies must have patience when imple-

Arch Pathol Lab MedVol 123, July 1999

Table 10. Benefits of a Quality System

Public perception
Patient expectations
Performance improvement
Problem prevention
Purity, potency, and safety of components
Productivity increased
Partnership between departments
Personnel satisfaction

menting quality management systems. Regardless of how

comprehensive the QA program or how effectively an organization identifies and corrects potential system problems, there will always be room for improvement. Everyone must recognize this fact and set realistic expectations.
Even where major deficiencies are identified, it takes time
to address all issues adequately and everything cannot be
done at the same time. Development of a plan to address
deficiencies and prioritization of deficiencies on the basis
of their potential impact on the safety of blood recipients
are important steps in continuous improvement.
Preparation is key to the success of a quality management program. A program that includes management
commitment, effective training, regular audits of critical
functions to identify potential problems, implementation
of effective corrective action, and establishment of priorities for improvement will not completely prevent errors or
deviations. It is, however, consistent with good business
practices and benefits the organization in many ways (Table 10). An active quality management program also is an
effective way of assuring both management and external
inspectors that systems are in control.
References
1. American Association of Blood Banks. Accreditation Information Manual.
1st ed. Bethesda, Md: American Association of Blood Banks; 1997.
2. Guidance for Quality Assurance in the Blood Bank. Rockville, Md: Center
for Biologics Evaluation and Research, Food and Drug Administration; 1995.
3. Navalainen DE, Callery MF. Quality Systems in the Blood Bank and Laboratory Environment. Bethesda, Md: Abbott Quality Institute, American Association
of Blood Banks; 1994.
4. Standards for Blood Banks and Transfusion Services. 18th ed. Bethesda, Md:
American Association of Blood Banks; 1997.
5. Paradis GW, Small F. Demystifying ISO 9000. Reading, Mass: Addison-Wesley Publishing Co; 1996.

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