Quality in EducationQuality in Education

Shelley O’Grady, M.S.Assistant ProfessorBiotechnology Department, Austin Community Collegesogrady@austincc.edu

Acknowledgements Acknowledgements This work was sponsored by South-

Central Region of Bio-link

Developing a quality system is a *team* effort

Contributors: ◦Bio-link◦Linnea Fletcher◦Trish Phelps◦Evelyn Goss◦Steven Spurlock◦Coe Vander Zee◦Students of BITC1402 Spring 2010

Teaching QualityTeaching 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 Teaching Quality: Austin Community College, Biotechnology DepartmentCollege, Biotechnology Department

Quality Course: Quality Assurance for the Biosciences

The Biotechnology Department offers a distance-learning course covering quality assurance principles and applications which is required of all Biotechnology degree plans

This class can also be taken as a Continuing Education course

Quality Assurance CourseQuality Assurance CourseThe 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 Teaching Quality: Quality in the classroomclassroom

Quality procedures built into the program:◦Quality manual◦Student & Faculty Handbooks:

departmental-specific policies & procedures

◦SOPs booklet – laboratory procedures◦QA/QC lab exercises in every course:

Maintaining Notebook, logbook Properly follow written protocols, & SOPs Filling out forms Creating SOPs, procedures, forms Equipment validation

Quality: Quality: Lead by ExampleLead by Example

Why bother with developing a quality system?

We’re already doing everything right!

If it ain’t broke…

Costs resources! ◦employee time, computers, money to

pay for auditors, standards and guidances

Quality: Quality: Benefits the Benefits the student!student!

Teach students about quality systems by immersing them in a quality system◦Learn by example◦Learn by doing

Added value for the student

Increased student satisfaction

Quality: Quality: Benefits Benefits educator!educator!

Build a better program◦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 Quality Management SystemsSystems

Quality Management Quality Management SystemsSystems

Quality does not happen by accident

A quality management system requires:◦Resources◦Planning◦Commitment

Seidman & Moore, 2009

Quality systems are customer-Quality systems are customer-oriented -oriented -

Who is the educator’s customer?Who is the educator’s customer?Customer: Student (the learner)

Product: Education service

Interested party:◦ Governing bodies (TSSB, SACS)◦ Local biotech community◦ Tax payers – local and federal◦ Parents◦ College staff

IWA 2:2007

Quality Management Quality Management SystemsSystemsMany different types of systems

◦Depends on type of product◦Depends on workplace◦Different consequences for a poor

product!

For example, pharmaceutical products follow cGMP regulations◦Bad product can result in death◦Government enforced

Voluntary systems, such as ISO9000 series

Seidman & Moore, 2009

International Organization International Organization for Standardizationfor Standardization

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:ISO:International Organization for International Organization for StandardizationStandardization

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 ISO: Quality Management PrinciplesPrinciples

1. Customer focus2. Visionary Leadership3. Involvement of people4. Process approach5. Systems approach to management6. Continual improvement7. Factual approach to decision

making8. Collaboration with partners

IWA 2:2007

Additional Principles to sustain Additional Principles to sustain successsuccess

1. Creating learner value◦ Satisfaction measures

2. Focusing on social value◦ How learners feel about ethics,

safety, environmental conservation3. Agility

◦ Address ever-changing education environment

4. Autonomy◦ Self-analysis

ISO 9001ISO 9001There 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 management4.Product realization & process

management5.Monitoring, analysis and improvement

http://www.iso.org/

http://www.iso.org/

ISO 9001:2008ISO 9001:2008Provides a set of standardized

requirements for a quality management system

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

Lays down what requirements your quality system must meet, but does not dictate how they should be met

ISO in EducationISO in Education

IWA 2:2007 provides guidelines for a quality management system in educational organizations based on ISO 9001:2000

http://www.iso.org/

International Workshop International Workshop AgreementAgreementIn order to respond to urgent

market requirements, ISO prepares documents through a workshop mechanism, external to its normal committee processes

Documents are published by ISO as International Workshop Agreements

Process Approach for Process Approach for Management SystemsManagement Systems

Process Approach for Process Approach for Management SystemsManagement Systems

The purpose of this approach is to enhance an organization’s effectiveness and efficiency in achieving its defined objectives

Enhancing customer satisfaction by meeting customer requirements!

http://www.iso.org/

What is a process?What is a process?“Set of interrelated or interacting

activities which transforms inputs into outputs”

Inputs and outputs may be tangible or intangible

Each process has customers and other interested parties who define the required outputs of the process

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 ProcessesTypical ProcessesProcesses for management of

organization◦Strategic planning, establishing policies,

setting objectives, ensuring resourcesProcesses for managing resources

◦Provide resources for quality objectives and desired outcomes

Realization Processes◦All processes that provide desired outcome

Measurement, analysis & improvement◦Measuring, monitoring, auditing,

improvement

http://www.iso.org/

Examples of process in Examples of process in educationeducationAccrediting and certifying programsAcquiring materials and other

resourcesAssessing performanceAllocating teaching loadEvaluating current curriculumDeveloping course materialEnsuring ISO 9001 requirements are

known, implemented & maintained

Process Approach for Process Approach for Management SystemsManagement Systems

Benefits to the process approach:1.Integration & alignment of processes 2.Focus effort on effectiveness & efficiency3.Transparency of operations 4.Lower costs through effective use of resources5.Improved, consistent and predictable results6.Focused and prioritized improvement

initiatives7.Encouragement of the involvement of people8.The clarification of responsibilities

http://www.iso.org/

Process GuidelinesProcess GuidelinesAll processes should be aligned

with the objectives & scope of the organization and should be designed to add value

Process effectiveness & efficiency is assessed through internal and external review processes

http://www.iso.org/

ISO 9001:2008 Standard on ISO 9001:2008 Standard on processesprocesses

“The organization shall establish, document, implement and maintain a quality

management system and continually improve its effectiveness”

a.Determine processes neededb.Determine sequence & interaction of

processesc. Determine criteria needed to keep operation

& control of process effectived.Ensure the availability of resources &

information needed to support operation & monitoring of processes

e.Monitor, measure & analyze processesf. Implement action to achieve planned results

& continual improvement of processeshttp://www.iso.org/

DocumentationDocumentationISO 9001:2008 allows an

organization flexibility in the way it chooses to document its quality management system

http://www.iso.org/

DocumentationDocumentation

Seidman & Moore, 2009

Objective of Objective of DocumentationDocumentationCornerstone of a quality systemWritten records that guide activities,

substantiate and prove what occurred

“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

"Prove it"

"Say what you do"

"Do what you say"

“Improve it”

Continuous Improvement

Innovation

"Unable to prove"Why?

"Corrective and Preventive Actions"

If it is not documented, it was not done!

http://interactive.snm.org/

Objective of Objective of DocumentationDocumentation

Documentation: ISO Documentation: ISO 9001:20089001:2008

Quality Management System shall include:1. Documented statements of a quality

policy & objectives2. A Quality Manual3. Documented procedures required by

standard4. Documents needed to ensure effective

planning, operation & control of processes

5. Records required by the standard

http://www.iso.org/

Quality Policy & Quality Policy & ObjectivesObjectivesQuality Policy communicates the

commitment to quality both internally & externally◦Understood, maintained &

implemented at all levels

Quality Objectives communicates how you will meet the commitment in the quality policy◦Should be measurable & relevant

http://www.iso.org/

Quality ManualQuality ManualDescribes the scope of the organization’s

quality management system and interaction of its educational and support processes

It should contain or reference all applicable documented procedures and other criteria upon which the quality management system is based:◦ Quality policy & objectives◦ description of the processes◦ Interaction of processes◦ Procedures◦ Instructions◦ Other documents (drafts, forms, records)

ISO: IWA 2

Other related QMS Other related QMS documentsdocumentsA few Biotechnology Education Related

examples:◦Department-specific Faculty Handbook◦Department-specific Student Handbook

◦Standard Operating Procedures◦Forms

Faculty & Student Faculty & Student HandbookHandbook

The most important reason to provide a handbook is to alleviate confusion on policies and procedures

K.L. Summerville, 2007

Important applications of a Important applications of a handbookhandbookA reference to departmental-specific policies

and procedures

A guideline to be used during orientation

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 Faculty & Student HandbooksHandbooksBe clear, concise, and consistent

Set a positive tone in the introduction and follow through with positivity throughout the manual

Let it serve as a *positive* tool for encouraging growth, improving morale, and aligning behavior with goals

K.L. Summerville, 2007

Standard Operating Standard Operating ProceduresProceduresInstruct personnel how to perform

a task

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 Sample SOP: Cleaning GlasswareGlassware

Data Collection: FormsData Collection: FormsSometimes 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

Seidman & Moore, 2009

Sample Form: Media Sample Form: Media Preparation FormPreparation Form

Developing your QMSDeveloping your QMS

Where to start?

This is a long-term process that should be realized in stages

http://www.iso.org/

Quality Management at your Quality Management at your CollegeCollege

1. Decide to implement a QMS2. Secure resources3. Establish a Quality representative or

team4. Preliminary audit5. Define quality plan - processes6. Realize processes7. Internal audit8. External audit (optional)9. Certification (optional)10.Improvement activities

Quality Systems in EducationQuality Systems in EducationExampleExample

ISO 9001:2008 certified:http://www.hollandcollege.com/quality/

ReferencesReferences1. http://www.iso.org/iso/home.html

i. Guidance on the concept and use of the process approach for management systems

ii. Guidance on the documentation requirements of ISO 9001:2008

2. http://www.fda.gov/3. http://www.hollandcollege.com/quality/4. http://interactive.snm.org/5. ISO IWA 2. Quality management systems – Guidelines

for the application of ISO 9001:2000 in education. 20076. Seidman & Moore, Basic Laboratory Methods for

Biotechnology: Textbook & Laboratory Reference, 2nd edition. 2009. Prentice Hall. ISBN: 0321570146

7. Kerry L. Summerville. Hospitality Employee Management and Supervision: Concepts and Practical Applications. 2007. Wiley. ISBN-10: 0471745227

8. Biotechnology Department, ACC. SOP Booklet. 6th edition. 2010

Thank you!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.

Email me! sogrady@gmail.com