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“Taking Care of Business”

        Pharma Vaccines
Performance Improvement Project
         Northern Illinois University
 ETT 546 Training & Performance Technology
BGTW Consulting
“Our Team Members”
BGTW Consulting Team Strategy
•   Our Team’s Pharma Vaccines Case Study Findings

•   BGTW Performance Improvement Methods

•   BGTW Consulting & GMSM Learning Academies Project

      •   Analyzing (Performance Gaps and Root Cause)
      •   Designing (Quality Assurance and Training)
      •   Developing (Performance & instructional Goals)
      •   Implementing (Performance Interventions & Bargaining)
      •   Evaluating (Kirkpatrick's Five Levels)



Introduction
BGTW Consulting Team
   Determine your needs
      Define objectives
      Determine subject content
      Select participants
      Determine schedule
      Select facilities
      Select instructors
      Prepare multimedia training aids
      Evaluating the program


Our Objectives “Taking Care of Business”
   Goals alignment
      Accountability and Ownership
      Decision-making Capability
      Business management acumen
      Engagement-
       ◦ Supervisor
       ◦ Management
      Vaccine manufacturing



Pharma Vaccine Performance Gaps
 Process documentation
    LSS Implementation
    Organizational focus
    Existing Learning Resources




Pharma Vaccine Performance Gaps
Lewin’s Three-Step Change Management Model
 The BGTW Consultant’s Group intends to create a vision for
 change and then empowering employees of Pharma Vaccines to
 act as change agents to attain that vision. The empowered
 change management agent’s need plans that provide total
 Quality Assurance (QA) systems approach, are realistic, and are
 future oriented. For our work, we will be choosing Kurt Lewin’s
 3-step model for managing the change:


    Unfreeze Stage – Ensures a good project start.

    Move or “Change” Stage – Ensures a successful foundation for
     the work at hand.

    Freeze or “Refreeze” Stage – Ensures a proper ending.



Change Management
   Organization
      ◦ Build the capacity to creating opportunities
      ◦ Capitalize on market opportunities
      ◦ Define emerging market demands
     Teams
      ◦ Learn together
      ◦ Develop skills for thinking and acting
        effectively
     Individuals
      ◦ Continuous learning
      ◦ Rewards for learning


Successful Interventions
SUPPORTING                                          RESISTING
1.Win-Win    collaboration and bargaining training   1.Lack of accountability/responsibility (H)
across the organization (H)                          2.Organization does not accept or does not
2.Bargaining change management (M)                   use action learning to solve problems (M)
3.Recognition & Awards for employees                 3.Organization has no process in place to
4.Joint Union Partnership across the                 manage collective knowledge or create and
organization(H)                                      share knowledge (L)
5.Employee involvement collaboration (L)             4.Little value in place on learning or the
6.Correct training tools, material and information   learner as an integral part of the culture (H)
(H)                                                  5.Job aids are not used due to lack of
7.Flexibility across the organization (L)            knowledge or expertise (H)
8.Functional grouping across the floor (M)           6.Formal job descriptions unavailable or; at
9.External business drivers recognized (L)           best unspecific and unclear (M)
10.Sufficient resources (H)                          7.Breadth is nonexistent or seen as a play by
11.Ethics & Integrity recognized (L)                 management to increase productivity (L)
12.Company Values/Individual Values (H)              8.Quality effort are reactive and only as much
13.Team Norms (M)                                    as absolutely necessary (M)
14.Physical environment (H)                          9.No formal preventive maintenance program
15.Job Aids/References are accepted (H)              in place, organization operates on reactive
16.Allocation of functions (L)                       mode (M)
17.Processes & Procedures systematic (M)             10.Organization fosters conflict among
18.High visible structured programs with senior      members (L)
management involved (H)                              11.Problems solved by crisis (L)
19.Processes linked to systems, pride (L)            12.Hasty changes reactionary (M)




Force Field Analysis
BGTW Consulting Team
Five Levels of Evaluation
Build responsible QA and training teams
   ◦ Ensure overall training effectiveness
   ◦ Adopt training strategy for every department
     to ensure employees have solid
     understanding of business requirements

 Implement performance goals
   ◦ Build organizational capabilities
   ◦ Identify cultural changes to connect
     management and employees

 Implement Certification Plans (Four Plans)


Performance Team Strategies
Certification Plan One:
 ISO 9000 – Quality Principles

     Customer Focus
     Leadership
     Involvement of people
     Process approach
     System approach to management
     Continual improvement
     Factual approach
     Mutual relationships



Performance Team Strategies
Certification Plan Two:
Berkeley Management & Leadership Training

    Effective Leadership
    Leadership, influence and power in Organization
    Organizational communication strategies for
     managers
    Essentials of Management




Performance Team Strategies
Certification Plan Three:
 New Jersey Institute of Technology (NJIT)

     Fundamentals for drug development cycles
     FDA requirements
     Methodologies / Regulations
     Technical aspects of facility design




Performance Team Strategies
Certification Plan Four:
 American Society for Quality

     Quality Systems
     Sterile and Non-sterile manufacturing systems
     Six levels of Cognitions
      ◦ Remember
      ◦ Understand
      ◦ Apply
      ◦ Analyze
      ◦ Evaluate
      ◦ Create



Performance Team Strategies
BGTW Consulting Team Schedule
Questions?
BGTW Consulting Team




       “Taking Care of Business”

Thank you!
Baekdal, T., Hansen, K. L., Todbjerg, L., Mikkelsen, H. (2006). Change management
   handbook: Handle change management projects more effectively. FINAL - 1 Edition
   2006 (English version). Retrieved from
   http://www.baekdal.com/downloads/changemanagement-en.pdf. September 29,
   2011.

Burnes, B. (2004). Kurt Lewin and complexity theories: Back to the future? Journal of
    Change Management, 4(4), 309-325. doi:10.1080/1469701042000303811

Burnes, B. (2009, December). Reflections: Ethics and organizational reflections – Time
    for a return to lewinian values. Journal of Change Management, 9(4), 359-381.
    doi:10.1080/14697010903360558

Certificate Program in Leadership and Management. (n.d.). Retrieved September 29,
    2011, from UC Berkeley Extension: http://extension.berkeley.edu/cert/mgt.html

Dick, W., Carey, L., Carey, J. O. (2005). The systematic design of instruction (Sixth
    ed.). Boston, MA: Pearson.

Kirkpatrick, D. L. (1998). The four levels: An overview. Ch. 3 in Evaluating Training
    Programs: The Four Levels, 3rd ed. San Francisco: Berrett-Koehler.

Kirkpatrick, D. L. (1998). Another look at evaluating training programs. Alexandria:
    American Society for Training & Development.


References
Kaufman, R., Keller, J., & Watkins, R. (1995). What works and what doesn't: Evaluation
    beyond Kirkpatrick. Performance & Instruction, 35, (2). 205-209.

Morrison, G. R., Kemp, J. E., & Ross, S. M. (2001). Chapter 10, The many faces of
   evaluation. In Designing Effective Instruction (3rd edition). New York: John Wiley &
   Sons.

NJIT: Adult Learner: Certificate in Pharmaceutical Manufacturing. (2011, July 7).
   Retrieved September 27, 2011, from New Jersey's Science & Technology University:
    http://adultlearner.njit.edu/programs/pharmaceuticalmanufacturing-cert.php

Pershing, J. (Ed.). (2006). Handbook of human performance technology (Third ed.).
    San Francisco, CA: Pfeiffer.

Pharmaceutical Good Manufacturing Practices Compliance Professional Certification
   Body of Knowledge. (n.d.). Retrieved September 27, 2011, from ASQ:
   http://asq.org/certification/pharmaceutical-gmp/bok.html

Phillips, J. (1997). Handbook of training evaluation and measurement methods
    (Improving Human Performance Series) 3rd Edition. Woburn, MA: Butterworth-
    Heinemann. Chapters 1 - 3.




References
Quality Management Principles. (n.d.). Retrieved September 29, 2011, from
   International Organization for Standards: International Standards for Business,
   Government and Society: http://www.iso.org/iso/qmp

Safety and Health Topics: Competent Persons. (n.d.). Retrieved September 27, 2011,
    from United States Department of Labor - OSHA:
    http://www.osha.gov/SLTC/competentperson/index.html

Standard Operating Procedure: GMP Training. (n.d.). Retrieved September 27, 2011,
   from GMP Quality Up: http://www.gmpqualityup.com/sample/QMS-095_sample.pdf

Sieloff, D. A. (1999). The bridge evaluation model. Performance Improvement, 38,
    (10). 14-18. International Society for Performance Improvement.

Van Tiem, D. M., Moseley, J. L., Dessinger, J. C. (2004). Fundamentals of performance
    technology: A guide to improving people, processes, and performance, 2nd Edition.
    Washington, DC: International Society for Performance Improvement.

Van Tiem, D. M., Moseley, J. L., Dessinger, J. C. (2004). Performance improvement
    interventions: Enhancing people, processes, and organizations through
    performance technology. 2nd Edition. Washington, DC: International Society for
    Performance Improvement




References
Ware P., & Bunce, D. (1995). Trainee characteristics and the outcomes of open learning.
  Personnel Psychology, 48, 347-375.

Worthen, B. R, Sanders J. R., Fitzpatrick, J. L. (1997). Program evaluation: Alternative
  approaches and practical guidelines (Second Edition). New York: Addison, Wesley,
  Longman, Inc.




References

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BGTW Consulting Team Presentation

  • 1. “Taking Care of Business” Pharma Vaccines Performance Improvement Project Northern Illinois University ETT 546 Training & Performance Technology
  • 3. BGTW Consulting Team Strategy • Our Team’s Pharma Vaccines Case Study Findings • BGTW Performance Improvement Methods • BGTW Consulting & GMSM Learning Academies Project • Analyzing (Performance Gaps and Root Cause) • Designing (Quality Assurance and Training) • Developing (Performance & instructional Goals) • Implementing (Performance Interventions & Bargaining) • Evaluating (Kirkpatrick's Five Levels) Introduction BGTW Consulting Team
  • 4. Determine your needs  Define objectives  Determine subject content  Select participants  Determine schedule  Select facilities  Select instructors  Prepare multimedia training aids  Evaluating the program Our Objectives “Taking Care of Business”
  • 5. Goals alignment  Accountability and Ownership  Decision-making Capability  Business management acumen  Engagement- ◦ Supervisor ◦ Management  Vaccine manufacturing Pharma Vaccine Performance Gaps
  • 6.  Process documentation  LSS Implementation  Organizational focus  Existing Learning Resources Pharma Vaccine Performance Gaps
  • 7. Lewin’s Three-Step Change Management Model The BGTW Consultant’s Group intends to create a vision for change and then empowering employees of Pharma Vaccines to act as change agents to attain that vision. The empowered change management agent’s need plans that provide total Quality Assurance (QA) systems approach, are realistic, and are future oriented. For our work, we will be choosing Kurt Lewin’s 3-step model for managing the change:  Unfreeze Stage – Ensures a good project start.  Move or “Change” Stage – Ensures a successful foundation for the work at hand.  Freeze or “Refreeze” Stage – Ensures a proper ending. Change Management
  • 8. Organization ◦ Build the capacity to creating opportunities ◦ Capitalize on market opportunities ◦ Define emerging market demands  Teams ◦ Learn together ◦ Develop skills for thinking and acting effectively  Individuals ◦ Continuous learning ◦ Rewards for learning Successful Interventions
  • 9. SUPPORTING RESISTING 1.Win-Win collaboration and bargaining training 1.Lack of accountability/responsibility (H) across the organization (H) 2.Organization does not accept or does not 2.Bargaining change management (M) use action learning to solve problems (M) 3.Recognition & Awards for employees 3.Organization has no process in place to 4.Joint Union Partnership across the manage collective knowledge or create and organization(H) share knowledge (L) 5.Employee involvement collaboration (L) 4.Little value in place on learning or the 6.Correct training tools, material and information learner as an integral part of the culture (H) (H) 5.Job aids are not used due to lack of 7.Flexibility across the organization (L) knowledge or expertise (H) 8.Functional grouping across the floor (M) 6.Formal job descriptions unavailable or; at 9.External business drivers recognized (L) best unspecific and unclear (M) 10.Sufficient resources (H) 7.Breadth is nonexistent or seen as a play by 11.Ethics & Integrity recognized (L) management to increase productivity (L) 12.Company Values/Individual Values (H) 8.Quality effort are reactive and only as much 13.Team Norms (M) as absolutely necessary (M) 14.Physical environment (H) 9.No formal preventive maintenance program 15.Job Aids/References are accepted (H) in place, organization operates on reactive 16.Allocation of functions (L) mode (M) 17.Processes & Procedures systematic (M) 10.Organization fosters conflict among 18.High visible structured programs with senior members (L) management involved (H) 11.Problems solved by crisis (L) 19.Processes linked to systems, pride (L) 12.Hasty changes reactionary (M) Force Field Analysis
  • 10. BGTW Consulting Team Five Levels of Evaluation
  • 11. Build responsible QA and training teams ◦ Ensure overall training effectiveness ◦ Adopt training strategy for every department to ensure employees have solid understanding of business requirements Implement performance goals ◦ Build organizational capabilities ◦ Identify cultural changes to connect management and employees Implement Certification Plans (Four Plans) Performance Team Strategies
  • 12. Certification Plan One: ISO 9000 – Quality Principles  Customer Focus  Leadership  Involvement of people  Process approach  System approach to management  Continual improvement  Factual approach  Mutual relationships Performance Team Strategies
  • 13. Certification Plan Two: Berkeley Management & Leadership Training  Effective Leadership  Leadership, influence and power in Organization  Organizational communication strategies for managers  Essentials of Management Performance Team Strategies
  • 14. Certification Plan Three: New Jersey Institute of Technology (NJIT)  Fundamentals for drug development cycles  FDA requirements  Methodologies / Regulations  Technical aspects of facility design Performance Team Strategies
  • 15. Certification Plan Four: American Society for Quality  Quality Systems  Sterile and Non-sterile manufacturing systems  Six levels of Cognitions ◦ Remember ◦ Understand ◦ Apply ◦ Analyze ◦ Evaluate ◦ Create Performance Team Strategies
  • 18. BGTW Consulting Team “Taking Care of Business” Thank you!
  • 19. Baekdal, T., Hansen, K. L., Todbjerg, L., Mikkelsen, H. (2006). Change management handbook: Handle change management projects more effectively. FINAL - 1 Edition 2006 (English version). Retrieved from http://www.baekdal.com/downloads/changemanagement-en.pdf. September 29, 2011. Burnes, B. (2004). Kurt Lewin and complexity theories: Back to the future? Journal of Change Management, 4(4), 309-325. doi:10.1080/1469701042000303811 Burnes, B. (2009, December). Reflections: Ethics and organizational reflections – Time for a return to lewinian values. Journal of Change Management, 9(4), 359-381. doi:10.1080/14697010903360558 Certificate Program in Leadership and Management. (n.d.). Retrieved September 29, 2011, from UC Berkeley Extension: http://extension.berkeley.edu/cert/mgt.html Dick, W., Carey, L., Carey, J. O. (2005). The systematic design of instruction (Sixth ed.). Boston, MA: Pearson. Kirkpatrick, D. L. (1998). The four levels: An overview. Ch. 3 in Evaluating Training Programs: The Four Levels, 3rd ed. San Francisco: Berrett-Koehler. Kirkpatrick, D. L. (1998). Another look at evaluating training programs. Alexandria: American Society for Training & Development. References
  • 20. Kaufman, R., Keller, J., & Watkins, R. (1995). What works and what doesn't: Evaluation beyond Kirkpatrick. Performance & Instruction, 35, (2). 205-209. Morrison, G. R., Kemp, J. E., & Ross, S. M. (2001). Chapter 10, The many faces of evaluation. In Designing Effective Instruction (3rd edition). New York: John Wiley & Sons. NJIT: Adult Learner: Certificate in Pharmaceutical Manufacturing. (2011, July 7). Retrieved September 27, 2011, from New Jersey's Science & Technology University: http://adultlearner.njit.edu/programs/pharmaceuticalmanufacturing-cert.php Pershing, J. (Ed.). (2006). Handbook of human performance technology (Third ed.). San Francisco, CA: Pfeiffer. Pharmaceutical Good Manufacturing Practices Compliance Professional Certification Body of Knowledge. (n.d.). Retrieved September 27, 2011, from ASQ: http://asq.org/certification/pharmaceutical-gmp/bok.html Phillips, J. (1997). Handbook of training evaluation and measurement methods (Improving Human Performance Series) 3rd Edition. Woburn, MA: Butterworth- Heinemann. Chapters 1 - 3. References
  • 21. Quality Management Principles. (n.d.). Retrieved September 29, 2011, from International Organization for Standards: International Standards for Business, Government and Society: http://www.iso.org/iso/qmp Safety and Health Topics: Competent Persons. (n.d.). Retrieved September 27, 2011, from United States Department of Labor - OSHA: http://www.osha.gov/SLTC/competentperson/index.html Standard Operating Procedure: GMP Training. (n.d.). Retrieved September 27, 2011, from GMP Quality Up: http://www.gmpqualityup.com/sample/QMS-095_sample.pdf Sieloff, D. A. (1999). The bridge evaluation model. Performance Improvement, 38, (10). 14-18. International Society for Performance Improvement. Van Tiem, D. M., Moseley, J. L., Dessinger, J. C. (2004). Fundamentals of performance technology: A guide to improving people, processes, and performance, 2nd Edition. Washington, DC: International Society for Performance Improvement. Van Tiem, D. M., Moseley, J. L., Dessinger, J. C. (2004). Performance improvement interventions: Enhancing people, processes, and organizations through performance technology. 2nd Edition. Washington, DC: International Society for Performance Improvement References
  • 22. Ware P., & Bunce, D. (1995). Trainee characteristics and the outcomes of open learning. Personnel Psychology, 48, 347-375. Worthen, B. R, Sanders J. R., Fitzpatrick, J. L. (1997). Program evaluation: Alternative approaches and practical guidelines (Second Edition). New York: Addison, Wesley, Longman, Inc. References

Editor's Notes

  1. Bradley to slide 6
  2. Detail finding Pharm business case and finding
  3. Detail finding Pharm business case and finding
  4. Bettylynne’s
  5. Bettylynne
  6. Steve
  7. Larry