quality management - why should i care?

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Quality Management Why should I care?

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Quality Management Why should I care?

Key Terms

!  Quality Management System (QMS)

!  Document Control

!  Configuration Management (CM)

Choices

!  Systems:

!  ISO 9000 series

!  AS9100

!  TS 16949

!  ISO 13485

!  Registrar (Certification Body)

Confused yet?

What does “quality” mean?

What does “quality” mean?

What problem is being solved?

!  Customer Satisfaction

!  Meet or exceed customer and regulatory requirements

!  Continual Improvement

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)

QMS Process Model

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

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

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

Control of Records

!  Legible

!  Identifiable

!  Retrievable

7. PRODUCT REALIZATION Key Processes

Planning

!  Key aspects of the product (requirements, objectives)

!  Project Management

!  Risk Management

!  Configuration Management

!  Control of work transfers

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

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

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

Customer-related processes

!  Determination of requirements

!  Requirements review

!  Customer communication

Design and Development

!  Planning

!  Inputs

!  Outputs

!  Review

!  Verification

!  Validation

!  Control of Changes

Product processes

!  Purchasing

!  Production and Service Provision

!  Drawings, Parts Lists, Work Instructions, Tooling, Test Equipment

!  Process Verification (FAI)

!  Control of Measuring and Monitoring Equipment

Why care about QMS?

Eventually it is about pleasing the customer, which results in benefit for everyone in the company.

Presenter: Silas Gibbs Video of this presentation:

DuotechServices.com/Quality-Management-Why-Should-I-Care

Follow us on Twitter @DuotechServ