Quality in Education
Shelley O’Grady, M.S.
Assistant Professor
Biotechnology Department, Austin Community College
sogrady@austincc.edu
Acknowledgements
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This work was sponsored by South-Central
Region of Bio-link
Developing a quality system is a *team* effort
Contributors:
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Bio-link
Linnea Fletcher
Trish Phelps
Evelyn Goss
Steven Spurlock
Coe Vander Zee
Students of BITC1402 Spring 2010
Teaching Quality
It is the mission of the Biotechnology
Department to disseminate quality processes
throughout the department in a systematic
and conscientious program of
‘Leading by Example’
Teaching Quality: Austin Community College,
Biotechnology Department
Quality Course: Quality Assurance for the
Biosciences
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The Biotechnology Department offers a distancelearning course covering quality assurance
principles and applications which is required of all
Biotechnology degree plans
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This class can also be taken as a Continuing
Education course
Quality Assurance Course
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The learning objectives in this course include:
◦ Defining quality
◦ Regulations, Rules and Agencies as They Pertain to
Biotechnology
◦ Quality documentation and Quality Systems in the
Laboratory
◦ International Organization for Standardization
(ISO9000) system of quality
◦ FDA regulations to the biotechnology,
biopharmaceutical, & biomedical device industries
Teaching Quality: Quality in the classroom
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Quality procedures built into the program:
◦ Quality manual
◦ Student & Faculty Handbooks: departmentalspecific policies & procedures
◦ SOPs booklet – laboratory procedures
◦ QA/QC lab exercises in every course:
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Maintaining Notebook, logbook
Properly follow written protocols, & SOPs
Filling out forms
Creating SOPs, procedures, forms
Equipment validation
Quality: Lead by Example
Why bother with developing a quality system?
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We’re already doing everything right!
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If it ain’t broke…
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Costs resources!
◦ employee time, computers, money to pay for
auditors, standards and guidances
Quality: Benefits the student!
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Teach students about quality systems by
immersing them in a quality system
◦ Learn by example
◦ Learn by doing
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Added value for the student
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Increased student satisfaction
Quality: Benefits educator!
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Build a better program
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Organize, standardize program
Improve responsiveness to technology change
Demonstrate effective teaching
Assure greater consistency in curricula
Produce higher quality graduates
Improve cooperation between teachers and
administrators
Help with educational audits:
◦ Texas Skills Standards Board, Southern Association
of Colleges & Schools
Quality Management Systems
Quality Management Systems
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Quality does not happen by accident
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A quality management system requires:
◦ Resources
◦ Planning
◦ Commitment
Seidman & Moore, 2009
Quality systems are customer-oriented Who is the educator’s customer?
Customer: Student (the learner)
Product: Education service
Interested party:
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Governing bodies (TSSB, SACS)
Local biotech community
Tax payers – local and federal
Parents
College staff
IWA 2:2007
Quality Management Systems
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Many different types of systems
◦ Depends on type of product
◦ Depends on workplace
◦ Different consequences for a poor product!
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For example, pharmaceutical products
follow cGMP regulations
◦ Bad product can result in death
◦ Government enforced
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Voluntary systems, such as ISO9000 series
Seidman & Moore, 2009
International Organization for
Standardization
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Why did we choose ISO to model our QMS?
◦ Tried and tested method, effective results
◦ Local biotech community is ISO 9001
certified
◦ We teach ISO standards in the classroom
◦ Want to immerse the student in an ISO
environment
◦ We currently use process systems
◦ Flexibility in system
ISO:
International Organization for Standardization
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ISO9000 family of quality standards
represents an international consensus on
good quality management practices.
◦ ISO standards are general and therefore
applicable to any company that makes a
product or service
◦ Voluntary
◦ Certification is not a compulsory requirement
http://www.iso.org/
ISO: Quality Management Principles
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Customer focus
Visionary Leadership
Involvement of people
Process approach
Systems approach to management
Continual improvement
Factual approach to decision making
Collaboration with partners
IWA 2:2007
Additional Principles to sustain success
Creating learner value
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Satisfaction measures
Focusing on social value
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How learners feel about ethics, safety,
environmental conservation
Agility
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Address ever-changing education
environment
Autonomy
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Self-analysis
ISO 9001
There are five sections in the standard that
specify activities that need to be considered
when implementing the system:
1. Overall
requirements for the quality
management system
2. Management responsibility, focus, policy,
planning and objectives
3. Resource management
4. Product realization & process management
5. Monitoring, analysis and improvement
http://www.iso.org/
http://www.iso.org/
ISO 9001:2008
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Provides a set of standardized requirements
for a quality management system
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Provides a tried & tested framework for
taking a systematic approach to managing the
organizations processes so that they
consistently turn out product that satisfies
the customers needs
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Lays down what requirements your quality
system must meet, but does not dictate how
they should be met
ISO in Education
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IWA 2:2007 provides guidelines for a quality
management system in educational
organizations based on ISO 9001:2000
http://www.iso.org/
International Workshop Agreement
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In order to respond to urgent market
requirements, ISO prepares documents
through a workshop mechanism, external
to its normal committee processes
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Documents are published by ISO as
International Workshop Agreements
Process Approach for
Management Systems
Process Approach for
Management Systems
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The purpose of this approach is to
enhance an organization’s effectiveness
and efficiency in achieving its defined
objectives
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Enhancing customer satisfaction by meeting
customer requirements!
http://www.iso.org/
What is a process?
“Set of interrelated or interacting activities which
transforms inputs into outputs”
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Inputs and outputs may be tangible or intangible
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Each process has customers and other interested
parties who define the required outputs of the
process
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A system should be used to gather data, provide
information about process performance then
analyzed to determine corrective action or
improvement
http://www.iso.org/
Typical Processes
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Processes for management of organization
◦ Strategic planning, establishing policies, setting
objectives, ensuring resources
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Processes for managing resources
◦ Provide resources for quality objectives and
desired outcomes
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Realization Processes
◦ All processes that provide desired outcome
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Measurement, analysis & improvement
◦ Measuring, monitoring, auditing, improvement
http://www.iso.org/
Examples of process in education
Accrediting and certifying programs
 Acquiring materials and other resources
 Assessing performance
 Allocating teaching load
 Evaluating current curriculum
 Developing course material
 Ensuring ISO 9001 requirements are
known, implemented & maintained
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Process Approach for
Management Systems
Benefits to the process approach:
1. Integration & alignment of processes
2. Focus effort on effectiveness & efficiency
3. Transparency of operations
4. Lower costs through effective use of resources
5. Improved, consistent and predictable results
6. Focused and prioritized improvement initiatives
7. Encouragement of the involvement of people
8. The clarification of responsibilities
http://www.iso.org/
Process Guidelines
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All processes should be aligned with the
objectives & scope of the organization
and should be designed to add value
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Process effectiveness & efficiency is
assessed through internal and external
review processes
http://www.iso.org/
ISO 9001:2008 Standard on processes
“The organization shall establish, document, implement
and maintain a quality management system and
continually improve its effectiveness”
Determine processes needed
b. Determine sequence & interaction of processes
c. Determine criteria needed to keep operation &
control of process effective
d. Ensure the availability of resources & information
needed to support operation & monitoring of
processes
e. Monitor, measure & analyze processes
f. Implement action to achieve planned results &
continual improvement of processes
a.
http://www.iso.org/
Documentation
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ISO 9001:2008 allows an organization
flexibility in the way it chooses to
document its quality management system
http://www.iso.org/
Documentation
Documents
Commitment
Quality
Manual
Data
collection
Directive
Handbooks
SOPs
Notebooks
Forms
Seidman & Moore, 2009
Objective of Documentation
Cornerstone of a quality system
 Written records that guide activities,
substantiate and prove what occurred
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“If it isn’t written down, it wasn’t done”
“Say what you do, do what you say, be able to
prove it, and improve it”
Seidman & Moore, 2009
Objective of Documentation
"Prove it"
“Improve it”
Continuous
Improvement
Innovation
"Unable to prove"
Why?
"Do what you say"
"Corrective and
Preventive Actions"
"Say what you do"
If it is not documented, it was not done!
http://interactive.snm.org/
Documentation: ISO 9001:2008
Quality Management System shall include:
1. Documented statements of a quality policy &
objectives
2. A Quality Manual
3. Documented procedures required by
standard
4. Documents needed to ensure effective
planning, operation & control of processes
5. Records required by the standard
http://www.iso.org/
Quality Policy & Objectives
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Quality Policy communicates the
commitment to quality both internally &
externally
◦ Understood, maintained & implemented at all
levels
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Quality Objectives communicates how you
will meet the commitment in the quality
policy
◦ Should be measurable & relevant
http://www.iso.org/
Quality Manual
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Describes the scope of the organization’s quality
management system and interaction of its educational
and support processes
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It should contain or reference all applicable
documented procedures and other criteria upon
which the quality management system is based:
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Quality policy & objectives
description of the processes
Interaction of processes
Procedures
Instructions
Other documents (drafts, forms, records)
ISO: IWA 2
Other related QMS documents
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A few Biotechnology Education Related
examples:
◦ Department-specific Faculty Handbook
◦ Department-specific Student Handbook
◦ Standard Operating Procedures
◦ Forms
Faculty & Student Handbook
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The most important reason to provide a
handbook is to alleviate confusion on
policies and procedures
K.L. Summerville, 2007
Important applications of a handbook
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A reference to departmental-specific policies and
procedures
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A guideline to be used during orientation
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Create a positive learning climate
◦ Policies and procedures that are clearly explained
may prevent contentious issues from arising
◦ Encourage consistency of procedures and prevent
confusion over important department policies
◦ Provide a document of the department expectations
◦ Allow eager faculty & students to grow
professionally and to become successful
K.L. Summerville, 2007
Faculty & Student Handbooks
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Be clear, concise, and consistent
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Set a positive tone in the introduction and
follow through with positivity throughout
the manual
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Let it serve as a *positive* tool for
encouraging growth, improving morale, and
aligning behavior with goals
K.L. Summerville, 2007
Standard Operating Procedures
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Instruct personnel how to perform a task
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Importance:
◦ Provide consistency in the process
◦ Ensure task was performed correctly
◦ Help training in performing task
◦ Reduce possibility of error
Seidman & Moore, 2009
Sample SOP: Cleaning Glassware
Data Collection: Forms
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Sometimes associated with SOPs
Provide evidence a process was
performed and performed correctly
 Can monitor the process as it is being
performed
 Reminds personnel to record important
required information
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Seidman & Moore, 2009
Sample Form: Media Preparation Form
Developing your QMS
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Where to start?
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This is a long-term process that should be
realized in stages
http://www.iso.org/
Quality Management at your College
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Decide to implement a QMS
Secure resources
Establish a Quality representative or team
Preliminary audit
Define quality plan - processes
Realize processes
Internal audit
External audit (optional)
Certification (optional)
Improvement activities
Quality Systems in Education
Example
ISO 9001:2008 certified:
http://www.hollandcollege.com/quality/
References
http://www.iso.org/iso/home.html
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Guidance on the concept and use of the process approach for management
systems
Guidance on the documentation requirements of ISO 9001:2008
http://www.fda.gov/
http://www.hollandcollege.com/quality/
http://interactive.snm.org/
ISO IWA 2. Quality management systems – Guidelines for the
application of ISO 9001:2000 in education. 2007
Seidman & Moore, Basic Laboratory Methods for Biotechnology:
Textbook & Laboratory Reference, 2nd edition. 2009. Prentice Hall.
ISBN: 0321570146
Kerry L. Summerville. Hospitality Employee Management and
Supervision: Concepts and Practical Applications. 2007. Wiley. ISBN10: 0471745227
Biotechnology Department, ACC. SOP Booklet. 6th edition. 2010
Thank you!
If any of these documents I’ve discussed
are interesting or useful to you I’m happy
to share them with you.
 If you have ideas, suggestions, comments,
I’d love to hear them.
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Email me! sogrady@gmail.com