An effective quality management system (QMS) requires that everyone in the company has a good understanding of the reasons behind the system. This video takes a high level view of how the different pieces of a QMS fit together and what purpose that they serve in helping to satisfy your customers and improve the effectiveness of your company. Duotech Services’ Engineering Manager, Silas Gibbs, answers some common questions encountered over the past several years of successful AS9100 audits. See video presentation at: http://DuotechServices.com/Quality-Management-Why-Should-I-Care

1. Quality Management
Why should I care?

2. Key Terms
! Quality Management System (QMS)
! Document Control
! Configuration Management (CM)

3. Choices
! Systems:
! ISO 9000 series
! AS9100
! TS 16949
! ISO 13485
! Registrar (Certification Body)

4. Confused yet?

5. What does “quality” mean?

6. What does “quality” mean?

7. What problem is being solved?
! Customer Satisfaction
! Meet or exceed customer and
regulatory requirements
! Continual Improvement

8. What is the solution?
! Customized by each organization for its size, needs, objectives, products,
etc.
! Process Approach – a managed set of activities using resources to
transform inputs into outputs
! Meeting requirements
! Added value
! Performance/Effectiveness using objective measurements
! Accountability and trust through registration (certification)

9. QMS Process Model

10. Requirements of AS9100 (ISO9001)
! Quality Manual with documented procedures
! Documents/Records as necessary for effective planning and control of
processes
! Records provide evidence of QMS effectiveness and conformity to requirements

11. 4.2.3 Control of Documents
“A documented procedure shall be established to define the controls
needed”

12. Control of Documents
! Approve for adequacy prior to issue
! Review & Update as needed (re-approve)
! Changes and current revision identified
! Relevant versions available at point of use
! Documents remain legible and identifiable
! Control distribution of external origin documents
! Prevent unintended use of obsolete documents

13. Control of Records
! Legible
! Identifiable
! Retrievable

14. 7. PRODUCT REALIZATION
Key Processes

15. Planning
! Key aspects of the product (requirements, objectives)
! Project Management
! Risk Management
! Configuration Management
! Control of work transfers

16. Configuration Management
! Apply technical and administrative direction over the life cycle of a
product
! Configuration Items
! Product Configuration Information
! Documents a product’s configuration
! Identification
! Traceability
! Status in meeting requirements
! Accurate information
! Assign Responsibilities

17. Configuration Management Benefits
! Product attributes are defined – measurable performance parameters
provide common basis for buyer and seller
! Know basis for making changes – decisions are based on correct, current
information
! Product repeatability is enhanced
! Products are labeled and correlated with associated documentation –
data is available to avoid guesswork
! Proposed changes are identified and evaluated for impact prior to making
change decisions – downstream surprises are minimized

18. Potential Problems without CM
! Equipment failure due to incorrect part replacement
! Schedule delays & increased cost due to unanticipated changes
! Operation delays due to mismatches with support equipment
! Maintenance down-time and cost increase due to inconsistencies between
equipment and instructions

19. Customer-related processes
! Determination of requirements
! Requirements review
! Customer communication

20. Design and Development
! Planning
! Inputs
! Outputs
! Review
! Verification
! Validation
! Control of Changes

21. Product processes
! Purchasing
! Production and Service Provision
! Drawings, Parts Lists, Work Instructions, Tooling, Test Equipment
! Process Verification (FAI)
! Control of Measuring and Monitoring Equipment

22. Why care about QMS?
Eventually it is about pleasing the
customer, which results in benefit for
everyone in the company.

23. Presenter: Silas Gibbs Video of this presentation:
DuotechServices.com/Quality-Management-Why-Should-I-Care
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