What Quality Systems Do You Need for Government Contracts

1
What Quality Systems Do You Need for Government
Contracts?

• Dr. Jim Patterson, C.P.M., A.P.P.
• Associate Professor of Management
• Western Illinois University Quad Cities
• May 7, 2009

2
What Does the U.S. Federal Government Require?

• MIL-Q-9858 (Quality System),MIL-I-45208A
  (Inspection System), and MIL-STD-44662
  (Calibration) are no longer required
• For all Government agencies, except NASA,
  offerors must reference ISO 90002008
  compliance
• However, you do not have to be third-party
  registered with ISO 90002008

3
What Does the U.S. Federal Government Require?

• Government QC organizations do not place specific
  criteria on contractors
• The contractor can define its own unique quality
  system requirements in its Quality System Plan
• The contractor is held accountable to its own
  quality system via Government compliance audits

4
What Does the U.S. Federal Government Require?

• Never assume that you understand what is being
  required in
• Section C (Description/Specifications/ Work
  Statement)
• Section D (Packaging and Marking) and/or
• Section E (Inspection and Acceptance)
• When in doubt, ask for additional clarification

5
What Does the U.S. Federal Government Require?

• You need to conduct a thorough and detailed
  evaluation of Sections C, D, and E requirements
  for confusing or conflicting terms
• This questioning does not mean that you are
  non-responsive
• It means that you have performed your due
  diligence

6
What Does the U.S. Federal Government Require?

• The reality is that the Government technical
  community, engineers, configuration managers, and
  quality assurance specialists do not interact
  with offerors until after the contract has been
  awarded

7
Generally-Accepted Quality Management Systems

• ISO 90002008
• Six Sigma
• Malcolm Baldrige National Quality Award (MBNQA)

8
ISO 90002008

• Is a generic quality management system (QMS)
• Provides a model to follow in setting up and
  operating the organizations management system
• i.e., what the organization does to manage its
  processes, or activities, so that its products or
  services meet the objectives it has set for itself

9
Benefits of ISO 90002008

• Improvement
• Provides foundation of good processes and systems
  ? better products and services
• Marketing
• Well-recognized quality standard
• Customer requirements
• Satisfies specific customer needs

10
ISO 90002008

• Based on Demings P-D-C-A cycle

11
ISO 90002008

• PLAN - establish objectives and make action plans
• DO implement your plans
• CHECK measure your results
• ACT correct and improve your plans and how you
  put them into practice

12
ISO 90002008Quality Management Principles

• Customer focus
• Leadership
• Involvement of people
• Process approach
• Systems approach to management
• Continual improvement
• Factual approach to decision making
• Mutually beneficial supplier relationships

13
ISO 90002008 Revision

• Companies currently certified to ISO 90002000
  can change their certification to the new ISO
  90002008 after a successful re-certification or
  surveillance audit
• ISO 90002008 is not expected to be revised again
  before 2015

14
ISO 90002008 Sections

• Quality Management System
• Management Responsibility
• Resource Management
• Product Realization
• Measurement, Analysis and Improvement

15
Section 1. Customer Focus

• Identify the process (or activities) needed for
  the QMS
• Determine the sequence and interaction of these
  processes
• Determine how these processes are effectively
  operated and controlled

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Section 1. Customer Focus

• Ensure that all information is available to
  support the operation and monitoring of these
  processes
• Measure, monitor, and analyze these processes
• Implement action necessary to correct the
  processes and achieve continual improvement

17
Section 2. Management Responsibility

• ISO 90002008 places great emphasis on top
  managements commitment to quality
• Requires a quality policy and quality objectives
• Reinforces the involvement of top management with
  customer requirements

18
Section 2. Management Responsibility

• Requires top management to establish
  responsibilities and authorities within the
  company
• Establishes an ISO 9000 management representative

19
Section 3. Resource Management

• Clarifies the requirement to determine and
  provide, in a timely manner, resources needed to
  implement and improve the processes of the QMS
  and to address customer satisfaction

20
Section 3. Resource Management

• Includes requirements for
• Employee training
• Physical facilities
• The work environment

21
Section 4. Product Realization

• That sequence of process and sub-processes
  required to achieve the product
• How the product is designed, produced, tested,
  handled, shipped, etc.
• Also applies to service providers

22
Section 4. Product Realization

• Emphasis is on how companies understand,
  communicate, and actually meet customer
  requirements
• Contains various requirements for the design of
  products and for the planning of processes,
  projects, and services

23
Section 5. Measurement, Analysis and Improvement

• Provides requirements for measurement and
  monitoring activities
• Helps the company determine whether it is not on
  track
• Includes internal audits
• Includes monitoring of customer perceptions

24
ISO 90002008sSources of Information

• National Standards Bodies
• www.iso.org/iso/about/iso_members.htm
• ISO website
• www.iso.org
• ISO/TC176 website
• www.tc176.org

25
ISO 90002008 Certification

• Refers to the issuing of written assurance by an
  independent external body that it has audited a
  management system and verified that it conforms
  to the requirements specified in the ISO
  90002008 standard
• A.k.a. as registration in North America

26
ISO 90002008 Revision

• ISO 90002008 now supersedes ISO 90002000
• Changes are primarily editorial
• Old ISO 90002000 certifications remain valid up
  to 13 Nov 2010
• New ISO 90002008 certifications are now being
  issued

27
ISO 90002008 Quality Manual

• Defines how each requirement of the ISO 90002008
  standard is applied at the company
• Is the de facto company specific version of the
  ISO 90002008 standard

28
ISO 90002008 Quality Manual

• Also required
• Quality procedures
• Quality policy
• Quality objectives
• Documentation for each area can be combined
  together to reduce administrative effort

29
Six Sigma

• A business improvement approach that seeks to
  find and eliminate causes of defects and errors
  in manufacturing and service processes
• Focuses on outputs that are critical to customers
  and a clear financial return for the organization

30
Core Philosophy of Six Sigma

• A change in the way of looking at your
  organization
• Think in terms of key business processes and
  customer requirements with a clear focus on
  overall strategic objectives

31
Core Philosophy of Six Sigma

• Focus on corporate sponsors responsible for
• Championing projects
• Support team activities
• Help to overcome resistance to change
• Obtain resources

32
Core Philosophy of Six Sigma

• Emphasize quantifiable measures as DFMO that can
  be applied to all parts of the organization
  (common metric)
• Ensure that appropriate metrics are identified
  early in the process
• Focus on business results, thereby providing
  incentives and accountability

33
Core Philosophy of Six Sigma

• Provide extensive training followed by project
  team deployment to
• Improve profitability
• Reduce non-value-adding activities
• Achieve cycle time reduction

34
Core Philosophy of Six Sigma

• Create highly qualified process improvement
  experts who can apply improvement tools and lead
  teams
• Green belts
• Black belts
• Master black belts
• Set stretch objectives for improvement ? zero
  defects

35
Six Sigma as a Quality Framework

• Owned by business leader champions
• Projects are truly cross-functional
• Focuses on a more rigorous and advanced set of
  statistical methods and a structured
  problem-solving methodology (DMAIC)
• Requires a verifiable ROI and a focus on the
  bottom line

36
DMAIC in Six Sigma

• D efine what is the problem?
• M easure how do we measure the internal
  processes that affect CTQs?
• A nalyze rigorous analysis
• I mprove create ideas to solve the defined
  problem
• C ontrol how to monitor and maintain the
  improvements

37
Six Sigma Technical Tools

• Elementary statistical tools
• Advanced statistical tools
• Product design and reliability
• Measurement and metrology
• Process control
• Process improvement
• Implementation and teamwork

38
Common Six Sigma Tools

• Define
• Project charter
• Cost of quality analysis
• Pareto analysis
• High-level process mapping

39
Common Six Sigma Tools

• Measure
• Check sheets
• Descriptive statistics
• Measurement system evaluation
• Process capability studies
• Benchmarking

40
Common Six Sigma Tools

• Analyze
• Detailed process mapping
• Statistical inference
• Cause-and-effect diagrams (Ishikawa)
• Failure mode and effects analysis (FMEA)
• Root-cause analysis

41
Common Six Sigma Tools

• Improve
• Design of experiments
• Mistake proofing (poka yoke)
• Lean production
• Deming cycle
• Seven management and planning tools

42
Common Six Sigma Tools

• Control
• Statistical process control (SPC)
• Standard operating procedures
• Gap analysis

43
Malcolm Baldrige National Quality Award (MBNQA)

• Established a framework for integrating total
  quality principles and practices in any
  organization
• Serves as the U.S. equivalent to Japans Deming
  Award
• Signed into law in 1987

44
Focus of the MBNQA

• Stimulate U.S. companies to improve quality and
  productivity
• Recognize the achievements of U.S. companies and
  provide an example
• Establish guidelines and criteria for companies
  to evaluate their own quality efforts
• Provide specific guidance for company improvement

45
MBNQA Criteria forPerformance Excellence

• Delivery of ever-improving value to customers,
  resulting in improved marketplace success
• Improvement of overall company performance and
  capabilities
• Organizational and personal learning

46
MBNQA Categories

• Leadership
• Strategic planning
• Customer and market focus
• Measurement, analysis, and knowledge management

• Human resource focus
• Process management
• Business results

47
Using the MBNQA

• Serves as a model for all types of businesses
• Not necessary to actually apply for the MBNQA
• Self-assessment
• Internal recognition programs
• Supplier recognition, certification, and
  development

48
Summary of Quality Programs

• No specific program is required for government
  contracts
• Specific business needs should directly influence
  the QMS developed
• Activities must be verified through an auditing
  process
• Improvement must be continual