576 Arch Pathol Lab Med—Vol 123, July 1999 Quality Systems—Hanson

The ‘‘P’s and Q’s’’ of Quality SystemsMargaret Hanson, PhD, MT(ASCP)SBB

● Quality improvement in blood collection centers hasbeen a priority of regulatory and accrediting agencies forthe past several years. The Food and Drug Administrationand the American Association of Blood Banks have devel-oped guidelines for quality assurance activities. Inspectionprograms have focused on evaluation of processes and howthey are controlled to assure the safety and efficacy ofblood components. A review of Food and Drug Adminis-tration enforcement actions shows that all such actions citesimilar deficiencies related to management control, per-sonnel training, error, and record management policies. Aquality program that includes management commitment tocompliance and continuous improvement, defined person-nel training, internal audit, and error management policiesprovides documented evidence to management and regu-latory agencies that operations are in control.

(Arch Pathol Lab Med. 1999;123:576–579)

For the past several years regulatory and accreditingagencies have promoted a systems approach to qual-

ity in blood banking. Both the Food and Drug Adminis-tration (FDA) and the American Association of BloodBanks (AABB) have developed quality assurance (QA)guidelines1,2 to assist blood centers and transfusion ser-vices in implementing and managing systems to assurethe quality of components and services. The College ofAmerican Pathologists, America’s Blood Centers, and oth-er organizations also support practices that assure contin-uous quality improvement in transfusion medicine.

The provision of safe and efficacious blood componentshas always been a priority for transfusion medicine pro-fessionals. To ensure that blood components meet estab-lished criteria, quality control measures have been widelyused. These measures usually monitor a specific function,such as daily evaluation of test reagents, but do not pro-vide an assessment of the entire process. To maintain aquality system, efforts must go beyond quality control.The systems approach to quality is a relatively new con-cept in transfusion medicine, so for most organizationsimplementation of a quality system requires shifting theirfocus from controlling quality through inspection of thefinal product to assuring quality by controlling the pro-cess. A quality management program that effectively in-corporates the components listed in Table 1 will help toassure that blood collection and processing functions arein control.3

Presented at the College of American Pathologists ConferenceXXXIII, Transfusion Medicine Performance Improvement, which wascosponsored with the American Association of Blood Banks, San Fran-cisco, Calif, August 20–22, 1998.

Reprints: Margaret Hanson, PhD, MT(ASCP)SBB, PO Box 244,Mound, MN 55364.

The AABB Accreditation Information Manual defines asystem as ‘‘a group of interrelated processes and its vari-ables, which include people, equipment, facilities and pro-cedures.’’ 4 A quality system is the organizational struc-ture, procedures, processes, and resources needed to im-plement quality management. A systems approach eval-uates the integration of multiple operations rather thanassessing each function separately. The FDA guidelines as-sist facilities in complying with Current Good Manufac-turing Practices (cGMP). These guidelines address all as-pects of operations and facilities and provide a guide forthe development, implementation, and management of aquality program. The AABB’s quality system essentials arebased on these specifications and provide additional guid-ance in implementing practices that assure quality andcompliance with cGMP.1

A systems approach begins with management’s com-mitment to quality (Table 2). Lacking a philosophy of qual-ity, it is difficult, if not impossible, to achieve a goal ofcompliance and continuous improvement. Managementmust focus on promoting an environment committed toquality and devoting the resources required.

Quality as an organizational priority should be specifi-cally stated in the vision and/or mission statement(s).Compliance and continuous improvement should be de-fined as critical success factors in the organization’s stra-tegic plan. Increased workloads require managers to jug-gle many priorities. Those that are clearly stated as criticalto the success of the organization will command more at-tention than those defined only casually. It is importantthat quality-related activities be recognized as good busi-ness practices as well as regulations with which the or-ganization must comply.

From a regulatory perspective, management commit-ment to quality and documented control over all functionsrelated to collection, processing, testing, labeling, storage,and distribution of blood components are essential. A re-view of the FDA enforcement action citations indicates thatnearly all such actions identify deficiencies related to man-agement control and oversight. The FDA requires docu-mented evidence that processes are in control to assurethe safety, purity, potency, and efficacy of components.This evidence includes defined lines of authority and re-sponsibility. Table 3 summarizes organizational and man-agement-related deficiencies cited in selected enforcementactions initiated by the the FDA during the past severalyears.

An organization’s policies provide direction to manage-ment and staff and are a second critical component of aquality system. Policies for compliance and continuous im-provement should be based on sound QA principles, suchas establishing and measuring acceptability criteria, mon-itoring for and controlling change, and appropriate doc-umentation. Quality and compliance should not be seenas the responsibility only of personnel in the QA unit.

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Table 1. Quality Management Components

Quality planQuality system essentials

Quality controlQuality assurance

Quality improvementQuality monitors

Table 2. Quality System Components

PhilosophyPriorityPolicies

ProcessesProcedures

People

Table 3. Management Deficiencies Cited by the Foodand Drug Administration

Defined structure and responsibilityManagement control of quality assurance and training

Defined reporting requirementsWritten program for quality

Defined responsibility for complianceSufficient staffing and supervision

Availability of medical staff

Table 4. Policy Issues Cited by the Food and DrugAdministration

Written quality assurance program for manufacturingfunctions

Inadequate planInadequate record reviewInadequate equipment maintenance/monitoring

Lack of written policies/procedures for:Internal auditsError managementRecords managementDonor suitabilityComputer systemsAdverse reactionsLook back

Table 5. The Food and Drug Administration CitationsRelated to Internal Audits

Failure to establish procedures and schedulesUse of standardized formsEvaluate all manufacturing systems

Processing, testing, packing, storage, distributionEstablish priorities for resolving deficienciesLack of management review

Table 6. The Food and Drug Administration CitationsRelated to Record Retention

Documentation of collection and processing stepsCompleteness and accuracy

Records readily located and accessibleSecurity

Procedures for component trackingNonconcurrent recording of information

Policies should confirm an organization-wide commitmentto compliance with regulations, standards, and industryguidelines. Personnel policies should define authority andresponsibilities in the areas of quality and compliance.Written policies should be made available to all personneland applied organization wide.

The FDA enforcement actions have included a numberof citations addressing QA policy (Table 4). Among thedeficiencies cited most often were failure to have a definedquality 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 per-formed by more than one person, that transforms inputsinto outputs.’’ 1 A quality system ensures that all parts ofthe process work together to produce the expected output.Elements of a process are linked, and changes in one areamay result in an unplanned and unexpected impact onother process components. Since components of a processmay cross departmental boundaries, processes must be

adequately defined so that critical steps are monitored andcontrolled appropriately. Graphic representation usingflowcharting or process mapping techniques allows iden-tification of process elements, critical control points, andinterrelationships or interactions between departments.Mapping also can be useful in identifying ways to im-prove the efficiency and/or effectiveness of a process.

Process control is the action taken to minimize variationin a process. It includes all steps from receipt of raw ma-terials to distribution of the final product and ensures thatprocesses, the output of which cannot be verified, consis-tently produce components that meet requirements.Where quality control tests result in the destruction of theproduct, as is the case with most blood components, it isessential that processes be controlled and monitored toassure the expected outcome. Validation of the process toverify that the actual outcome is consistent with the ex-pected, inclusion of controls where appropriate to docu-ment performance, and periodic monitoring to documentcompliance are all aspects of process control. Process con-trol is important to assure consistency and reproducibility,particularly where the same process is carried out at mul-tiple sites.

Standard operating procedures (SOPs) provide instruc-tions for performing a task and are the foundation of aneffective quality management program. SOPs define howa function is carried out to ensure consistency of practicebetween individuals and facilities within the organiza-tions. Written SOPs must be readily available to operationspersonnel. SOPs should include work instructions as wellas acceptability criteria, interpretative guidelines, and lim-its of performance. A document that provides guidance onthe development of SOPs also is important.

SOPs must comply with manufacturer’s instructions,FDA regulations, and AABB standards.4 Validation to ver-ify that an SOP produces the expected outcome and train-ing of personnel to perform a procedure appropriately arecritical steps in the SOP development and implementationprocess. Existing SOPs should be revised to reflectchanges in practice and reviewed periodically to assurethat they accurately describe the process. Among the SOP-related deficiencies noted in FDA enforcement actionswere failure to have an SOP, inadequate SOPs, SOPs notfollowed, and inconsistency of procedures performed atmultiple sites.

578 Arch Pathol Lab Med—Vol 123, July 1999 Quality Systems—Hanson

Table 7. The Food and Drug Administration Citationson Personnel Training

Standardized training planFocus on critical job elements

Ensure personnel perform tasks properlyProcedures to evaluate training effectivenessTraining conducted by qualified personnel

Annual competency reviewPlan for retraining as required

Document training in employee files

Table 8. Elements of a Quality System

PlanningProblem solving

ParticipationPerformance

Proactive approachProof

PatiencePreparation

Selection of the right people is another critical compo-nent of a quality system. Current position descriptionsspecifying qualifications and duties assist in the selectionof appropriate personnel and define authorities and re-sponsibilities. Position descriptions should specificallystate authority and responsibility for the quality of bloodcomponents and services and compliance with regula-tions.

Initially, personnel must be trained to perform job-re-lated tasks and should be provided training on cGMP,safety, and other job-related topics. A formal orientationprogram provides an opportunity to explain policies andprocedures, introduce the company’s quality philosophy,and provide an overview of cGMP. Personnel must be fa-miliar with these concepts so that they understand theirrole in assuring compliance with regulations and improv-ing quality.

A documented plan should be developed to define spe-cific training requirements for each position. The respon-sibility for training should be assigned to qualified indi-viduals and should be appropriately documented. Person-nel training files should contain a list of the procedureseach individual performs as well as documentation oftraining on those procedures. Training files should in-clude a statement of the individual’s competence to per-form tasks without immediate supervision as well as doc-umentation of cGMP, safety, and other training requiredby regulatory agencies or organization policies.

The FDA enforcement actions frequently cite a lack ofadequate training or adequate supervision. Other person-nel-related issues cited by the FDA are shown in Table 7.In some cases it is more likely to be failure to maintainadequate documentation of training rather than failure totrain.

Other elements of an effective quality management pro-gram are listed in Table 8. Planning for quality is essentialand preparation needs to take place on several levels. Aquality program that identifies the goals and objectives ofthe organization is essential for implementation of qualityinitiatives. While the AABB quality program and qualitysystem essentials provide a solid foundation for a qualityplan, other standards, such as International Organization

for Standardization 9000, provide an equally effectivemodel for a quality program.5

Effective communication between operating units en-sures that implementing a change in one area does notadversely affect operations in another. Effective planningincludes identification of the project scope, definition ofperformance goals, estimate of costs and required re-sources, and establishment of realistic timelines. Planningalso should include an analysis of where the project fitsin the organization’s priorities. Methods for monitoringand measuring progress also should be included in theproject plan.

Performance applies to many aspects of quality man-agement, including equipment, computer software, pro-cesses, and personnel. Performance measures provide doc-umentation that systems are in control. Equipment per-formance can be verified at installation using an appro-priate performance qualification procedure with definedacceptance criteria. Regular calibration of instruments as-sures consistent performance and may identify trends thatlead to early identification and resolution of equipmentproblems. Compliance with performance criteria for com-puter software can be verified through validation and test-ing. Validation of software should include tests designedto challenge the critical control points it monitors to verifythat the system performs as expected.

Performance criteria should be established for all posi-tions within the organization to guide personnel. Person-nel usually will perform in a manner consistent withmeeting defined expectations. Periodic assessment of per-sonnel provides assurance that individuals are competentto perform their assigned duties and are complying withestablished policies and procedures.

Prevention of errors, deviations, and variation is the keyto increased productivity and decreased cost. Problemsolving skills are an essential component of prevention.The ability to identify problems or potential problem areasis not sufficient. Organizations must be able to developand implement preventive action that effectively resolvesproblems. Failure to thoroughly investigate errors, devia-tions, or variations may result in failure to identify an un-derlying cause that will lead to additional errors. Rootcause analysis allows an organization to develop and im-plement action that will effectively prevent recurrence.Monitoring preventive action assures that the action takenadequately and effectively addresses the problem.

Error management policies should focus on identifyingand resolving system problems rather than placing blameor punishing personnel for making an error. Punitive errormanagement policies discourage error reporting, therebydecreasing potential opportunities for improvement. Acomprehensive error management system is essential toallow tracking of trends and to identify potential problemareas before errors and/or accidents occur. It should bepromoted positively as a quality improvement tool ratherthan as a measure of personnel performance. Table 9 sum-marizes FDA enforcement action citations related to errormanagement.

Proof of completion or documentation associated withquality initiatives can be tedious and time-consuming;however, it is critical to a quality management program.Facilities should develop policies identifying what actionsneed to be recorded and the appropriate documentationmethod. Without appropriate documentation, there is noway to prove that an action was taken or that the system

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Table 9. The Food and Drug Administration CitationsRelated to Error Management

Written procedures for error review and resolutionAssigned responsibility for review and investigationPrompt, thorough review and investigation to identify

causeImplement corrective action: monitor and trackTimely reports to the Food and Drug AdministrationDocument errors due to system deficienciesRecall in compliance with lawTimely recall of unsuitable components

Table 10. Benefits of a Quality System

Public perceptionPatient expectations

Performance improvementProblem prevention

Purity, potency, and safety of componentsProductivity increased

Partnership between departmentsPersonnel satisfaction

was consistently in control. Documentation should includewhat action occurred, who was involved, and when it hap-pened. An interpretation of the outcome (eg, acceptable orunacceptable) also may be included. Documentationshould 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 thefinal product. Implementation of QA measures providesthe opportunity for an organization to be proactive ratherthan reactive in addressing quality issues. Participation ofall personnel in quality efforts is critical to the success ofa quality management program. When personnel are giv-en the opportunity to actively participate in process as-sessment and improvement activities, they are more likelyto understand and promote the benefits of quality initia-tives. Everyone must be held accountable for assuringquality.

The relationship between personnel responsible for QAand compliance activities and those primarily responsiblefor operations or ‘‘production’’ functions often is antago-nistic rather than cooperative. The challenge is to foster anenvironment in which partnering and participation arekey elements. Operations personnel must understand andappreciate the benefits of QA and compliance issues. Sim-ilarly, QA and compliance personnel must recognize andrespect the fact that other operations priorities may, attimes, be more important to the organization’s successthan QA issues.

Blood centers and hospitals as well as regulatory andaccrediting agencies must have patience when imple-

menting quality management systems. Regardless of howcomprehensive the QA program or how effectively an or-ganization identifies and corrects potential system prob-lems, there will always be room for improvement. Every-one must recognize this fact and set realistic expectations.Even where major deficiencies are identified, it takes timeto address all issues adequately and everything cannot bedone at the same time. Development of a plan to addressdeficiencies and prioritization of deficiencies on the basisof their potential impact on the safety of blood recipientsare important steps in continuous improvement.

Preparation is key to the success of a quality manage-ment program. A program that includes managementcommitment, effective training, regular audits of criticalfunctions to identify potential problems, implementationof effective corrective action, and establishment of priori-ties for improvement will not completely prevent errors ordeviations. It is, however, consistent with good businesspractices and benefits the organization in many ways (Ta-ble 10). An active quality management program also is aneffective way of assuring both management and externalinspectors that systems are in control.

References1. 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 Labo-

ratory Environment. Bethesda, Md: Abbott Quality Institute, American Associationof 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-Wes-ley Publishing Co; 1996.