Introduction to Laboratory Quality

Management Systems (QMS)

Tobin C. Guarnacci
Global Head of Quality IVI
Objectives

▪ Review History and purpose of Quality Management (QM)

▪ Understand Quality Management, Compliance and Shared Obligations
▪ Identify applicable laboratory regulations/accreditations requiring QM
implementation
▪ Understand the three (03) Phases of Laboratory Analysis and Impact to
Quality
▪ Understand organizational structure to support Quality Management
Systems (QMS)

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HISTORY
A Brief History of Quality Management

General Concepts of Quality Management are well established

and apply to multiple industries

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 A Brief History of Quality Management

WALTER A. SHEWHART

The father of statistical Quality who successfully brought together the

disciplines of statistics, engineering, and economics and became known
as the father of modern quality control.

https://asq.org/about-asq/honorary-members/shewhart

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 A Brief History of Quality Management

W. EDWARDS DEMING

Recognized for his role as adviser, consultant, author, and teacher to some of
the most influential businessmen, corporations, and scientific pioneers of
quality control, is the most widely known proponent of statistical quality
control. He has been described as a national folk hero in Japan, where he was
influential in the spectacular rise of Japanese industry after World War II; as a
curmudgeon; as the high prophet of quality control; as an imperious old man;
and as founder of the third wave of the Industrial Revolution.
https://asq.org/about-asq/honorary-members/deming

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 A Brief History of Quality Management

JOSEPH M. JURAN

"It is most important that top management be quality-minded. In the absence

of sincere manifestation of interest at the top, little will happen below."
— Joseph M. Juran
Juran emphasized the need for top management involvement, the Pareto
principle, the need for widespread training in quality, the definition of quality
as fitness for use, the project-by-project approach to quality improvement.
These are the ideas for which Juran was best known, and they are still widely
used today.
https://asq.org/about-asq/honorary-members/juran
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A Brief History of Quality Management

PHILIP CROSBY
The Guru of Quality Management
Philip B. Crosby was a legend in the discipline of quality. A noted
quality professional, consultant, and author, he is widely
recognized for promoting the concept of "zero defects" and for
defining quality as conformance to requirements.
https://asq.org/about-asq/honorary-members/crosby
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A Brief History of Quality Management

Robert W. Galvin
The 'inventor' of the Six Sigma process which is a method that
provides organizations tools to improve the capability of their
business processes. Defined by an increase in performance and
decrease in process variation helps lead to defect reduction and
improvement in profits, employee morale, and quality of products
or services.

https://asq.org/quality-resources/six-sigma
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A Brief History of Quality Management

History of Laboratory Regulations and Standards to Include Quality

Requirements:

➢ Clinical Laboratory Improvements Act (CLIA) - implemented in USA

in 1967 in response to poor quality of laboratory reports which arose
in the cytology laboratories that read PAP smears. In 1967, the
Clinical Laboratory Improvement Amendment was passed and the
first laboratory regulations were born.
➢ College of American Pathologists (CAP) – international
clinical/medical accreditation program. First CAP lab accreditation
was in the USA in 1964
➢ ISO15189 – Developed with support from CAP and initiated in 2003
supporting clinical/medical labs and accreditation
➢ ISO17025 – non-clinical/medical biological laboratory standards
defining basic laboratory systems that can be applied broadly to
various laboratory disciplines. Established 1999

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COMPLIANCE AND QUALITY
MANAGEMENT
COMPLIANCE AND QUALITY MANAGEMENT

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COMPLIANCE AND QUALITY MANAGEMENT

➢ Total Quality management (TQM) includes the design of

efficient monitoring tools and procedures for data
collection and processing, as well as the collection of
information that is essential to decision making, which
ensures laboratory reporting is accurate, reliable, and
timely.

➢ Compliance with the laboratory quality and accreditation

standards (e.g., ISO17025, ISO15189, CLSI and WHO)
ensures accuracy, reliability, and timeliness of the
reported test results and ensures the safety of patients is
protected.
Note: This also relates to laboratories involved with the humane treatment
of animal populations, as applicable.

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GCP COMPLIANCE AND QUALITY MANAGEMENT

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 GxP COMPLIANCE AND QUALITY MANAGEMENT

Quality Assurance (QA) and Quality Control (QC):

QA
Total Quality
Management

QC
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GCP COMPLIANCE AND QUALITY MANAGEMENT

Compliance is ensured through implementation of established

laboratory standards, defined process (e.g., SOPs) and
regulatory and accrediting organization requirements to include
(but not limited to) the following:

➢ ISO17025:2017 General requirements for the competence of testing and

calibration laboratories
➢ ISO 15189:2012 Medical laboratories — Requirements for quality and
competence
➢ Clinical Laboratory Standards Institute (CLSI) – Global Laboratory
Standards
➢ (WHO) Laboratory Quality Management System (based on ISO15189 and
CLSI)
➢ Country specific regulatory requirements (e.g., US CLIA 42CFR493)
➢ Laboratory Standard Operating Procedures

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GCP COMPLIANCE AND QUALITY MANAGEMENT

Compliance is ensured through implementation of established

laboratory standards, defined process (e.g., SOPs) and regulatory and
accrediting organization requirements to include (but not limited to)
the following:
LABORATORY LABORATORY APPLICABLE
DISCIPLINE CATEGORY INDUSTRY STANDARD OR GUIDANCE

Clinical/Medical Clinical/Medical • CLIA – 42 CFR 493 (US Mandated)

Laboratory Laboratory • CAP
• ISO15189
Bioanalytical (non- Non-clinical/medical •21 CFR 58 – Good Laboratory Practice for
human) Laboratory Nonclinical Laboratory Studies
•OECD – Principles of Good Laboratory
Practice and Compliance Monitoring
Bioanalytical (Human) Non-clinical/medical •No codified regulatory requirement exists to
Laboratory describe bioanalytical analysis of human
samples; however, Good Clinical Laboratory
Practice (GCLP) guidance is utilized by select
government organizations, e.g., WHO, US NIH,
etc.)
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QMS is supported by a System of Mutual Accountability

Regulatory
Authorities and Accrediting
Bodies

Laboratory Laboratory Quality

Management Oversight

Customers/Patients

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QMS is supported by a System of Mutual Accountability

Ensuring Laboratory Compliance to Regulations and

Standards is a shared responsibility by:

➢Regulators and Accrediting bodies, Lab Management and

Quality Oversight
➢ Responsibilities overlap – system of checks and balances
➢Each party is independently responsible for compliance
with Laboratory Executive Management holding
ultimate responsibility for implementation of quality
management systems
➢Failure in any of the shared responsibilities will impact
customer confidence and patient safety

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PHASES OF LABORATORY
ANALYSIS
Three (03) Phases of Laboratory Analysis and Impact to Quality

20 Source WHO
Three (03) Phases of Laboratory Analysis and Impact to Quality

The Path of Workflow of any laboratory (e.g., clinical/medical,

bioanalytical, etc.) is divided into three (03) phases of analysis:
➢ Pre-analytical/Pre-examination phase
➢ Analytical/Examination phase
➢ Post-analytical/Post-examination phase

Note: A failure of any one of these critical phases of clinical

laboratory testing can significantly affect the integrity of a
laboratory result.

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Three (03) Phases of Laboratory Analysis and Impact to Quality

Pre-analytical/Pre-examination phase
Represents all variables that can impact sample integrity prior to the
analysis/examination phase.

22 Source CLSI
Three (03) Phases of Laboratory Analysis and Impact to Quality

Analytical/examination phase
Represents all variables that can impact sample integrity and analysis during
the testing phase.

Source CLSI
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 Three (03) Phases of Laboratory Analysis and Impact to Quality

Post-analytical/post-examination phase
Represents all variables that can impact result reporting and follow-up.

Source CLSI
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Three (03) Phases of Laboratory Analysis and Impact to Quality

CLINICAL LABORATORY ANALYSIS PHASE VARIABLES IMPACTING PHASES OF ANALYSIS (i.e.,

Key Indicators)

Pre-analytical/Pre-examination phase • Specimen transport and environmental control of

shipping containers
• Specimen requisition and accessioning
• Analytical method and electronic system validation
• Phlebotomy and sample collection methods
• Sample storage
• Interfering substances
Analytical and Examination phase • Preparation of slides, solutions, calibrators, controls,
proficiency testing materials, reagents, stains, quality of
water and other materials used in testing
• Definition of reportable ranges for test results (i.e.,
normal values)
• References to manufacturer's test system instructions,
package inserts and operator manuals
• Identification of panic or alert values (as applicable)
Post-analytical and Post-examination phase • Report formatting (i.e., electronic or paper formats
which are associated with unique patient identifiers,
laboratory identifiers, identification of test reference
intervals and normal ranges)
• Review, approval and release of result reports and
corrected reports
• Verification of accurate and timely final report receipt
• Post-analysis sample storage and result retention.

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LABORATORY ORGANIZATIONAL
STRUCTURE
Organizational structure to Support Quality Management
Systems (QMS)

Organizational infrastructure is an essential element of a functional

QMS and the principal elements for a successful quality
management system are
➢ Top-Down Managerial commitment to quality
➢ Top-Down Managerial commitment to provide sufficient resources to
ensure implementation and on-going support
➢ Organizational structure must be developed to ensure that quality
goals of the organization are defined, implemented and met and that
the organization remains committed to defined quality goals ensuring
a state of continuous quality assurance

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Organizational structure to Support QMS

Executive management must ensure acquisition of an experienced

quality professional to support initial infrastructure development and
define short and long-term organizational and departmental goals.

The following are examples of quality management responsibilities:

✓ Monitor quality management system
✓ Ensure compliance
✓ Review critical laboratory documentation
✓ Conduct and coordinate audits (e.g., internal audits and vendor
qualifications)
✓ Investigate deficiencies and manage corrective and preventive
measures (CAPA)
✓ Inform decision makers

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Organizational structure to Support QMS

Ensure that QMS oversight is established as an objective process

without undue influence by the functional areas that are overseen by
quality, i.e., the organizational structure must be objective and
independent to ensure:

➢ The Quality Assurance (QA) Department is established with

direct line of reporting to executive Management
➢ QA Management must report to the highest-level executive in
the organization, such as the laboratory business unit head in a
hospital or the CEO of an organization.

Note: QA should not report to the Laboratory Director as this a

conflict of interest. QA should have authority by virtue of direct line
management to the head of the organization.

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Organizational structure to Support QMS

QMS implementation and development process:

➢ Define a Quality Policy which should be approved by executive

management
➢ Develop and Implement a Quality Manual to describe the basic
tenants of the quality management system to include (but not
limited to):
✓ Lines of communication between functional areas,
✓ Framework for meeting expectations related to Quality Manual defined system
requirements and
✓ Demonstration and definition of the organizations executive management
commitment to quality assurance and supporting quality operations and quality
systems.

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Organizational structure to Support QMS

QMS implementation and development process (cont):

➢ Ensure that quality oversight is established as an objective process without
undue influence by the functional areas that are overseen
➢ Implement and continuously improve the quality system (i.e., continuous
quality improvement)
➢ Establish quality systems to manage and support controlled document
development and implementation (e.g., Policies, manuals, SOPs, WI, etc.)
➢ Partner with the organization and provide leadership and mentoring
✓ Exercising responsible authority, while
providing motivation and vision.
✓ Build the team that is cohesive.
✓ Influencing and encouraging staff
to good performance
Note: Never enforce quality efforts by use of punitive actions as this will serve
only to demotivate and will negatively impact the QMS implementation and
sustainability

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Organizational structure to Support QMS

QMS must be adequately resourced and sufficient resources

identified through frequent assessment of quality infrastructure
through:
✓ Identification of financial requirements/budget planning
✓ Review Personnel needs:
▪ Staffing requirements
▪ Skills and training opportunities for personnel
✓ Facilities, equipment, supplies, computers

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QMS BUDGET

If you are designated as a quality assurance manager in a

peripheral hospital laboratory and if there is no quality
management system in place, what steps do you follow to
implement QMS?

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SUMMARY

Successful implementation of a quality management system

requires planning, management commitment, an understanding
of the benefits, engaging staff at all levels, setting realistic time
frames, and looking for ways to continually improve.

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QUESTIONS
CASE STUDY

If you are designated as a quality assurance manager in a

peripheral hospital laboratory and if there is no quality
management system in place, what steps do you follow to
implement QMS?

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Answer
1. Obtain top-down commitment from executive management (e.g., hospital
director).
2. Develop organizational chart defining line of authority and responsibility
(e.g.)

3. Perform a gap analysis using a checklist to evaluate the laboratory practice

Answer

4. Develop a work plan defining a task list of everything needs to be addressed e.g.

5. Form a team to develop quality management processes and procedures

6. Develop a quality policy
7. Develop quality manual and define content and objective
8. Develop of processes for controlling documents and records
Answer

9. Develop a program for nonconforming event management

10. Customer service and satisfaction program
11. Facilities and safety plans
12. Personnel programs
13. Purchasing and inventory programs
14. Equipment management plans.
15. Analysis and verification of QSE and path of workflow processes with the
development of procedures or instructions
16. Information management program
17. Continual improvement program
Answer

18. Monitor the effectiveness of the quality management system:

• Management review
• Internal audit
• Develop Quality indicators (IQC, stock out, equipment downtime,
EQA, external audit..)
References

➢ College of American Pathologists (CAP) - Laboratory General Checklists

Edition 06/17/2010 ( www.CAP.org) , Global search for CAP accredited
Laboratories / CAP History Timeline
➢ Title 42 US Code of Federal Regulations (CFR) 493 - Clinical Laboratories
Improvement Act Clinical of 1988 (CLIA)
http://www.access.gpo.gov/nara/cfr/waisidx_04/42cfr493_04.html
➢ International Standards of Operation (ISO) 15189:2012 and ISO17025:2017
- (www.ISO.org)
➢ 21 CFR 58 – Good Laboratory Practice for Nonclinical Laboratory Studies
http://ecfr.gpoaccess.gov/cgi/t/text/text-
idx?c=ecfr&rgn=div5&view=text&node=21:1.0.1.1.22&idno=21
➢ OCED – Principles of Good Laboratory Practice and Compliance Monitoring
http://www.oecd.org/officialdocuments/displaydocumentpdf/
➢ Laboratory Quality Management System (LQMS) training toolkit
https://www.who.int/ihr/training/laboratory_quality/introduction/en/
➢ CLSI. Quality management system: A model for laboratory services;
approved guidelines https://clsi.org/standards/products/quality-
management-systems/documents/qms01/

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Introduction to Laboratory Quality Management
Systems (QMS)

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