1. Quality Management Systems in I/M programs Ken “Ozzy” Gadwah Director of Quality and Manufacturing 5/4/2016

2. Trivia #1 What municipality in the 48 contiguous states is largest in square miles?

3. Trivia #2 Can you guess who this is?

4. Quality Management Systems (QMS)  Provide a framework of process control to reduce random variations  The ISO 9001 standard defines how to create a QMS The areas we will focus on today are:  Risk Management  Continual Improvement  Improved Customer Satisfaction

5. Risk Management  Not every program requires a risk management plan, yet there are always risks that can affect the success of the program  Most organizations perform some level of risk management even if it’s not explicitly stated  An undocumented approach to risk management is in itself a risk for both the agency and the contractor as there are no controls in place

6. Risk Management  Risk-based thinking is essential for achieving an effective quality management system. The concept of risk-based thinking has been implicit in previous editions of ISO 9001  New to the ISO 9001-2015 Standard is concept of risk- based thinking  An organization needs to plan and implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the quality management system, achieving improved results and preventing negative effects

7. Risk Management

8. Continual Improvement  Although all contract deliverables may have been met is there an expectation that the contractor will seek to improve functionality and processes?  Are enhancements documented and monitored to ensure the desired improvement has been realized?  Are improvements transportable to other processes?  Is the cost for the improvement considered, is it worth the investment?

9. Continual Improvement  Need to be properly documented as an enhancement, when a bug or other issue is being resolved that is not recorded as a continual improvement  All aspects of the improvement need to be considered, i.e. does a software improvement require that the training process and one or more reports need to be updated?

10. Continual Improvement  Plan - Recognize an opportunity and plan a change.  Do - Test the change. Carry out a small-scale study, pilot or beta test.  Check - Review the test results from the Do phase, Are the benefits of the change substantiated?  Act - Take action based on what was learned in the check step: If the change did not work, go through the cycle again with a different plan. If it was successful, incorporate what was learned from the test into wider changes. Begin the cycle again.

11. Improved Customer Satisfaction  The goal of a Quality Management System is to provide a corporate culture where the end product or service meets requirements and satisfies the customer  Both Risk Management and Continual Improvement are areas that should help achieve this goal

12. Improved Customer Satisfaction  The Agency needs to be willing to share their level of satisfaction in a meaningful way  It’s understood that there will be both positive and negative feedback at times  The purpose of gauging the level of satisfaction leads back to Continual Improvement

13. In Closing  Quality is more than just calibration results and meeting service level agreements  Quality involves more than just the QA/QC staff  When a change is made (either to mitigate a risk or implement an improvement) there must be a review step to confirm that the intended results have been achieved