Quality Management System (QMS) Refresher Training

Transcription

1 Quality Management System (QMS) Refresher Training Classifica(on 2: Foxhole Technology Employees Only RMD 022 QMS Refresher Training Course September 21, 2017 Version 1.0

2 The Resource Approach The Triad Reference Model Can Technology work well without People? And anymore, can People work well without Technology? Process It takes a Process to bring technology and people together to achieve anything Technology People The major determinant of cost and schedule - Quality - is reflected in the Triad Reference Model Process, Technology, and People Working Together to Achieve Quality. 1

3 The Premise of Process Management The quality of a product (or service ) is dictated by the quality of the processes used to acquire, develop, and maintain it. Improvement focuses on fixing the processes, and then examining the impact on the product. Institutionalized processes remain long after the people who defined them are gone. The collection and analysis of data should be used continuously in a continuous manner to improve performance. Well known Process Initiatives applied to manufacturing and systems engineering include: CMMI * ISO 9000 * Six Sigma 2

4 Motivations for Repeatable Processes Defined processes can promote use of technology and people to their best advantage. Disciplined use of processes facilitates evaluation, analysis, and improvement. Processes provide ways to work smarter, as opposed to harder. The promise behind a set of repeatable processes: If people leave or technology changes, the organization should be able to continue moving forward with minimal disruption. 3

5 Foxhole s ISO 9001:2015 QMS Foxhole s Quality Management System 4

6 Foxhole s QMS Foxhole s QMS (Quality Management System) Encompasses Two Dis=nct Models: ISO 9001:2015 CMMI Interna'onal Organiza'on Standards :2008 Cer'fica'on Earned in December of 2016) Transi'oning to ISO 9001:2015 version in 2017 Capability Maturity Model Integra'on Development Level 3 and Services Level 2 Appraisals Earned in 2015 Re-Cer'fica'on in 2018 Standards, Policies, Processes, and Procedures are Ingrained in Both Models Copyright 2011 Foxhole Technology 5

7 Definition of Terms Quality Management System (QMS) The Overarching Quality Processes Capability Maturity Model Integra=on (CMMI) Reference Model of Mature Prac'ces in a Specified Discipline used to Assess a Group s Capability to Perform that Discipline Process Engineering Group (PEG) Members Oversee the Process Architecture, Approvals, Manage Changes, and Priori'ze Changes Foxhole Quality Management Representa=ve (QMR) Responsible for Ensuring that Processes Needed for the QMS are Established, Implemented and Maintained Reports to Management on the Performance of the QMS and any Need for Improvement Plan and Coordinate Internal and External Audits 6

8 Why Our ISO Certification? Our ISO Cer=fica=on: Shows Foxhole s Commitment to Quality, to our Customers, and Shows our Willingness to Work Toward Improving Business and Company Efficiency Demonstrates the Existence of an Effec've QMS that Sa'sfies the Rigors of an Independent, External Audit Enhances Foxhole s Image in the Eyes of our Customers, our Employees, and our Shareholders Provides Foxhole with a Compe''ve Edge to our Organiza'on s Marke'ng 7

9 What is ISO 9001? ISO version 2015 is the Interna=onally Recognized Standards for the Quality Management System of a Business ISO 9001 is Applied to Processes that Create and Control Products and Services an Organiza'on Supplies to a Customer ISO 9001 Prescribes Systema'c Control of Ac'vi'es to Ensure that the Needs and Expecta'ons of Customers are Met ISO 9001 is Designed and Intended to Apply to Virtually any Product or Service, Made by any Process Anywhere in the World 8

10 Foxhole s Quality Policy Foxhole Achieves Customer Sa=sfac=on by: Delivering Op'mal Solu'ons to the Customer Striving to Exceed the Customer s Expecta'ons Recognizing our Defined Quality Objec'ves Pursuing Con'nual Improvements Every Foxhole Employee Should Be Able to State the Foxhole Quality Policy in Your Own Words when asked by an Auditor 9

11 Foxhole s Quality Policy It is the policy of Foxhole Technology, Inc. to maintain a quality system designed to meet the requirements of ISO9001:2015 in pursuit of its primary objec'ves. The Foxhole Technology Quality Manual defines our quality objec'ves and key procedures. In partnership with our staff, Foxhole Technology will provide all clients with an integrated set of services spanning from technological sophis'cated network and systems engineering consulta'on; full spectrum cyber opera'ons and security; and enterprise management to organiza'onally complex knowledge, risk and change management. Specifically, The Foxhole Technology Quality Policy will: Provide a properly resourced, high quality, modern, customer focused service. Ensure services are inclusive, and accessible, to all customers. Take an innova=ve, pro-ac=ve approach to the delivery and performance of a wide range of informa=on technology and organiza=onal services. Provide services appropriate to customer requirements in a =mely manner. Provide customers with all the services and support we have commized to do, and strive to exceed their expecta=ons. Con=nually improve the quality of our management system. Achieve and exceed the ISO 9001 minimal annual cer=fica=on requirements. Hire and retain the employees that meet and/or exceed the contractual requirements. Perform the work profitably to ensure Foxhole Technology con=nues to expand and mature. Develop and maintain strategic partnerships with key suppliers. Take all necessary steps to reduce and mi=gate program risk. It is the goal of Foxhole Technology to encourage ac've par'cipa'on of all employees in quality planning and con'nuous improvement to meet all quality, service and cost objec'ves. 10

12 Quality Management System Plan Do Check - Act Organiza'on and its Context (Sec 4) PLAN SUPPORT & OPERATION (Sec 7, 8) DO Customer Sa'sfac'on Customer Requirements PLANNING (Sec 6) LEADERSHIP (Sec 5) PERFORMANCE EVALUATION (Sec 9) Results of the QMS IMPROVEMENT (Sec 10) Expecta'ons of Interested Par'es (Sec 4) ACT CHECK Products & Services INPUTS OUTPUTS Copyright 2011 Foxhole Technology 11

13 Foxhole s Quality Management System The QMS Manual Describes the Foxhole Approach for Sa=sfying Each of the ISO 9001:2015 Requirements: Sec=on Title 1 Scope 2 References 3 Terms and Defini=ons 4 Context of the Organiza=on (Scope, Interested Par=es, Processes) 5 Leadership (Quality Policy, Customer Focus, Employee Roles & Responsibili=es) 6 Planning (Risks & Opportuni=es, Quality Objec=ves, Planning of Changes) 7 Support (Resources, Competence, Awareness, Communica=on) 8 Opera=on (Requirements, Design & Development, External Controls, Services Produc=on & Release) 9 Performance Evalua=on (Measurement & Analysis, Internal Audits, Management Reviews) 10 Improvement (Non-Conformity, Correc=ve Ac=on) 12

14 ACT ISO Section 4 - Context of the Organization Understanding the Organiza=on Framework that Iden'fies Internal and External Issues that Affect Foxhole Sets the Stage for what Foxhole does so that QMS Fulfills Stakeholder Needs Calls for Foxhole to Look at both Nega've (Risk) and Posi've (Opportunity) Factors Needs and Expecta=ons of Interested Par=es Iden'fies Groups that Foxhole will Touch, and What These Groups Expect from Us Develops External - Indirect (Customer) and Direct (Others Business ) Customers Expecta'ons from Foxhole Develops Internal Foxhole Expecta'ons (the Organiza'on, Sub-Contractors, etc.) Determining the Scope of the Quality Management System (QMS) Determines the Fence that Iden'fies and Defines the Processes that Foxhole will Develop and Use, Sets the Stage for Further Process Development Establishes Boundaries for Responsibili'es (Quality Manual) The QMS and Its Processes A Process: A Linked Series of Inputs, Outputs, Measurement, Transforma'on, Ownership Forces Accountability to Performance, and Con'nual Improvement Against Metrics Goals Uses Processes to Mi'gate Risks Copyright 2011 Foxhole Technology 13

15 ACT ISO Section 5 - Leadership General Responsibili=es of Management Leadership Ac've Foxhole Management Engagement, Not Passive Commitment Role Accountability to Quality Performance at Highest Levels of Foxhole Creates Ownership of Each Process in Foxhole s Quality Management System Leadership s Focus on the Customer Establishes and Measures Metrics for Customer Needs for Products and Services Creates Customer Sa'sfac'on Analysis of Foxhole Performance Develops and Delivers on Customer Requirements Quality Policy The Guiding Document that Drives Decisions for All QMS Ac'vi'es Shows what is Important to Foxhole Reinforces Foxhole effort toward Con'nual Improvement of All Requirements Organiza=onal Roles, Responsibili=es, and Authori=es Roles within the QMS System are Assigned, Communicated, and Understood Spells Out Responsibili'es and Authori'es for Foxhole Employees Con'ngency Plans in Place to Handle Changes and Maintain Con'nuity of Performance Copyright 2011 Foxhole Technology 14

16 PLAN ISO Section 6 - Planning Risks and Opportuni=es ISO 9001:2015 Sets the Expecta'ons for Foxhole to Access, Apply, and Communicate Risk-Based Thinking Across the Organiza'on Line of Sight Between Foxhole Ac'ons and the Concept of Risk toward Interested Par'es Risk-Based Thinking Applies to Reducing Nega'ves (Risks) and Enhancing Posi'ves (Opportuni'es) Quality Objec=ves ISO 9001:2015 Requires the Selng of Measurable Organiza'onal Objec'ves Based on Both Posi've and Nega've Factors Objec'ves Align with Foxhole s Quality Policy, are Communicated, Updated, and Documented Accountability of Objec'ves Tied Back to Management that Established the Objec'ves Planning of Changes Covers New Programs, Business Situa'ons, and Rou'ne Changes in Management Changes Must be Planned, Communicated, and Carried Out Within the System Consequences of Change (Risk & Opportuni'es) Must be Understood Change Impact on Resources Needs to be Understood Before the Change Takes Place Plan Your Work Work Your Plan Copyright 2011 Foxhole Technology 15

17 DO ISO Section 7 - Support Resources Iden'fy People, Equipment, Infrastructure, Environmental Factors, Finances that Influence Dayto-Day Business Opera'ons Apply Internal/External Resources to Establish, Implement, Maintain, and Improve QMS Analyze Resources Against Risks (SWOT), Provide Resources to Sa'sfy Plans Competence Understand Project Performance Requirements Understand Competence Against Performance and Associated Risks of Non-Performance Based on Lack of Competence Hire Against Project Requirements Provide On the Job Competence Training as Needed Awareness Employees Need to Understand Foxhole s Quality Policy and its Associated Quality Objec'ves Objec'ves Must be Communicated to Internal and External Staff (Newslepers, etc.) Communica=on Determine: What to Communicate, When to do it, To Whom should the Communica'on go, How is the Communica'on to be Delivered, and Who will Deliver the Communica'on Documenta=on of Informa=on Determine what Documenta'on is Required within the QMS, How it will be Changed or Controlled, Where it will be Stored, and How it will be made Available to Foxhole Employees Copyright 2011 Foxhole Technology 16

18 DO ISO Section 8 - Operation Opera=onal Planning and Control Chronological Realiza'on of Product/Service for the Customer from Start to End of Life (Bid- No Bid, RFP, Requirements, Proposal, Award, Performance, Contract End of Life) Examine Risks, Determine Resources, Track Performance, Verify and Validate, Document Determine Processes to be Followed 8.2 Requirements for Products and Services Know and Understand Customer Requirements (RFP, PWS, SOW) Design, and Development for Products and Services Follow Design Plan, Input, Output, Review, Verifica'on, Valida'on, Changes & Approvals Control of Externally Provided Processes, Products, and Services Selec'on, Roles & Responsibili'es, Evalua'ons, Risks Associated with Non-Conformance Produc=on and Service Provision Control of Contract Condi'ons People, Infrastructure, Customer Property, Product Development Traceability, Measurement and Analysis, Audits on Performance Release of Products and Services Define and Document Ac'vi'es for Release of Product with Customer Control of Non-Conforming Outputs Separa'on Process for Product that does not meet Customer Requirements Iden'fy and Quaran'ne the Non-Conformity, Plan Ac'ons based on Associated Risks Copyright 2011 Foxhole Technology 17

19 CHECK ISO Section 9 Performance Evaluation Monitor, Measure, Analyze, and Evaluate the Organiza=on Iden'fy What Objec'ves are to be Measured, How They are Measured, and How Oqen They are to be Measured Evaluate Through Customer Percep'on Document Performance and Evalua'on Perform Internal Audits Periodic Checks on Performance Use Management Review to Evaluate and Act Evaluate Conformity to Expecta'ons Determine Sa'sfac'on of the Customer Examine Effec'veness of Risks Taken Conclude Need for Improvement and Gaps in Performance Objec'ves Copyright 2011 Foxhole Technology 18

20 CHECK ISO Section 10 - Improvement 10.1 General Improvement Ac'vi'es Around Improving a Service or Product Reducing Nega've Effects on Performance Non-Conformity and Correc=ve Ac=on Act on Failures to Meet Customer Requirements Handling Customer Complaints Responding, Evalua'ng, Implemen'ng Ac'ons, Reviewing Ac'ons Taken Apply Correc've Ac'ons Appropriate to the Level of Risk Involved Document Informa'on Ac'ons and Results of Ac'ons Taken Con=nual Improvement Strive to Make a Process Beper by Reducing the Nega'ves that may Surround it Analyze and Evaluate Conduct Trend Analysis Discuss at Management Review Mee'ngs Priori'ze Improvement Ac'vi'es Op'mize Resources - Time and Skills Keep it Simple No Overload of Projects Maximize Project Returns Take Appropriate Ac'ons Against Risk Copyright 2011 Foxhole Technology 19

21 Thank You Thanks for Viewing Proceed to the Evaluation Section of this FormSite Presentation to Evaluate This Training Deck. This Process program deck is a required training exercise for con'nued approval of CMMI Appraisals and ISO 9001 Cer'fica'ons. Thanks for par'cipa'ng! 20