Quality in Education Shelley OGrady M S Assistant

Quality in Education Shelley O’Grady, M. S. Assistant Professor Biotechnology Department, Austin Community College sogrady@austincc. edu

Acknowledgements �This work was sponsored by South. Central Region of Bio-link �Developing effort Contributors: ◦ ◦ ◦ ◦ a quality system is a *team* Bio-link Linnea Fletcher Trish Phelps Evelyn Goss Steven Spurlock Coe Vander Zee Students of BITC 1402 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 �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 Course �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 (ISO 9000) system of quality ◦ FDA regulations to the biotechnology, biopharmaceutical, & biomedical device industries

Teaching Quality: Quality in the classroom �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: Lead by Example Why bother with developing a quality system? �We’re �If already doing everything right! it ain’t broke… �Costs resources! ◦ employee time, computers, money to pay for auditors, standards and guidances

Quality: Benefits the 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: Benefits 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 Systems

Quality Management Systems �Quality does not happen by accident �A quality management system requires: ◦ Resources ◦ Planning ◦ Commitment Seidman & Moore, 200

Quality systems are customeroriented 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 Systems �Many different types of systems ◦ Depends on type of product ◦ Depends on workplace ◦ Different consequences for a poor product! �For example, pharmaceutical products follow c. GMP regulations ◦ Bad product can result in death ◦ Government enforced �Voluntary series systems, such as ISO 9000 Seidman & Moore, 200

International Organization for 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: International Organization for Standardization �ISO 9000 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 1. 2. 3. 4. 5. 6. 7. 8. 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 1. ◦ Satisfaction measures Focusing on social value 2. ◦ How learners feel about ethics, safety, environmental conservation Agility 3. ◦ Address ever-changing education environment Autonomy 4. ◦ Self-analysis

ISO 9001 There are five sections in the standard that specify activities that need to be considered when implementing the system: 1. 2. 3. 4. 5. Overall requirements for the quality management system Management responsibility, focus, policy, planning and objectives Resource management Product realization & process management Monitoring, analysis and improvement http: //www. iso. org/

http: //www. iso. org/

ISO 9001: 2008 �Provides 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 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 Agreement �In 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 Management Systems

Process Approach for Management 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? “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 Processes �Processes for management of organization ◦ Strategic planning, establishing policies, setting objectives, ensuring resources �Processes 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 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

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 http: //www. iso. org/

Process Guidelines �All 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 processes “The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness” a. b. c. d. e. f. Determine processes needed Determine sequence & interaction of processes Determine criteria needed to keep operation & control of process effective Ensure the availability of resources & information needed to support operation & monitoring of processes Monitor, measure & analyze processes Implement action to achieve planned results & http: //www. iso. org/

Documentation �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, 200

Objective of Documentation �Cornerstone of a quality system �Written 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, 200

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 standardhttp: //www. iso. org/

Quality Policy & Objectives �Quality 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 Manual �Describes 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 ISO: IWA 2

Other related QMS documents �A few Biotechnology Education Related examples: ◦ Department-specific Faculty Handbook ◦ Department-specific Student Handbook ◦ Standard Operating Procedures ◦ Forms

Faculty & Student Handbook �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 �A 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 K. L. Summerville, 2007

Faculty & Student Handbooks �Be 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 Procedures �Instruct 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, 200

Sample SOP: Cleaning Glassware

Data Collection: Forms �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 Seidman & Moore, 200

Sample Form: Media Preparation Form

Developing 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 College Decide to implement a QMS Secure resources Establish a Quality representative or team 4. Preliminary audit 5. Define quality plan - processes 6. Realize processes 7. Internal audit 8. External audit (optional) 9. Certification (optional) 10. Improvement activities 1. 2. 3.

Quality Systems in Education Example ISO 9001: 2008 certified: http: //www. hollandcollege. com/quality/

References http: //www. iso. org/iso/home. html 1. i. ii. 2. 3. 4. 5. 6. 7. 8. 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, 2 nd edition. 2009. Prentice Hall. ISBN: 0321570146 Kerry L. Summerville. Hospitality Employee Management and Supervision: Concepts and Practical Applications. 2007. Wiley. ISBN-10: 0471745227 Biotechnology Department, ACC. SOP Booklet. 6 th 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. �Email me! sogrady@gmail. com