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Implementation Of Quality Assurance Principles Into The Manufacturing Environment

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Title: implementation of quality assurance principles into the manufacturing environment Author: John Cachat Last modified by: IQS Created Date: 2/28/2008 6:38:33 PM – PowerPoint PPT presentation

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Title: Implementation Of Quality Assurance Principles Into The Manufacturing Environment


1
Implementation Of Quality Assurance Principles
Into The Manufacturing Environment
  • Presented by
  • John M. Cachat
  • Chairman and Founder, IQS, Inc.

2
Implementation Steps
  • QA vs QC vs QM
  • Quality Management Model
  • ROI Show Me the Money
  • Why Limit to Manufacturing?

3
ISO 9000 Definitions
  • Quality Control
  • The operational techniques and activities that
  • are used to fulfill requirements for quality
  • Quality Assurance
  • All those planned and systematic activities
  • implemented to provide adequate confidence
  • that an entity will fulfill requirements for
  • quality

4
Differences
Quality Control Quality Assurance
Product Process
Line function Staff function
Find defects Prevent defects
Reactive Proactive
5
Differences
Quality Control Quality Assurance
Testing Defining Process
Inspection Auditing Process
Product Checkpoints Training
SPC Information Systems
6
According to Dr. Joe Juran
  • QA Develops Plans To Ensure Quality For The
    Overall Organizational System
  • QC Inspects And Reports
  • The Same As Finance (QA) And Accounting (QC)

7
QA vs QC vs QM
  • QM Quality Management

FDA Regulated ISO13485 GMP
Aerospace AS9100
Automotive TS-16949
General ISO9000
8
Linking to Other Cool Stuff
  • Lean reduce waste
  • Six Sigma reduce variation
  • Operational Excellence
  • Business Process Improvement
  • Managing with Metrics
  • Non-Financial, Non-Inventory

9
Who Cares?
  • Poor Communication Results from Poor Definitions
  • QM is not a departmental responsibility
  • Top Management needs to understand that QM is a
    process approach that can solve existing business
    problems.
  • QM is not another project it is a means to
    reduce cost, reduce risk

10
Manufacturing Challenges
  • Multiple Market / Specs
  • One System Meet All
  • Entire Product Lifecycle
  • What Does A Single System Look Like?
  • How Do You Explain It?

11
Multiple Markets Multiple Specs
FDA Regulated ISO13485 GMP
Aerospace AS9100
Automotive TS-16949
General ISO9000
12
QM Quality Management
Impacts the Entire Product Lifecycle
  • Marketing / Sales
  • Engineering
  • Purchasing
  • Quality
  • Manufacturing
  • Human Resources
  • Finance / Accounting

Quality is Everyones Business
13
Manufacturing Process Flow
MANUFACTURING
  • INPUTS
  • Employees
  • Equipment
  • Gauging
  • Process Flows
  • Risk Analysis
  • Control Plans
  • Work Instructions
  • Blueprints / Specs
  • Raw Material / Parts
  • Change Requests

OUTPUT Product
14
The Research Has Been Done
  • 1980s - USAF Research Design A System That Does
    Everything Manufacturing Needs, But Do Not
    Overlap Accounting And Inventory Business
    Processes
  • 1990s American Society of Quality (ASQ)
    Technical Committee on Quality Management Systems

15
(No Transcript)
16
Reality Check
  • Make Sense?
  • Easy To Explain?
  • Too Busy Which Ones To Drop?
  • Impacts Entire Organization
  • Framework For Solving Problem, Achieving Goal,
    Satisfy A Need This Is NOT A Separate Project

17
Lesson Learned from ERP Point Solutions Dont Work
18
The Approach Pass the Test vs Learn
  • Pass the Test
  • We have to calibrate gages for ISO9000
  • Learn
  • We calibrate gages so that we do not reject good
    material or accept bad material

19
The Approach Pass the Test vs Learn
  • Pass The Test
  • Document What You Do Do What You Document
  • Learn
  • Documentation Is Used To Improve Communication

20
ROI Do The Math
  • What are your priorities?
  • Saving time
  • Reducing cost
  • Increasing compliance

21
ROI Do The Math
  • Most organizations are surprised to learn that
    quality initiatives have a huge and fast
    impact on time and cost reduction.
  • Surprised? Many think that quality costs money,
    when in reality poor quality increases expenses
    often caused by errors created in redundant and
    ad hoc work that is not tied to an overall
    process.
  • Reduce Costs by Improving Quality

22
ROI Do The Math
  • Most people think that quality costs money,
    well I will tell you, weve learned the hard
    way not having quality costs money. Building it
    right the first time is one of the few ways to
    save money and actually improve the company.
  • Fortune 100 CEO in CIO magazine

23
Conclusions
  • Effective Communication Requires Understanding QC
    vs QA vs QM
  • Reduce Costs by Improving Quality
  • Lean Quality Management Eliminate Waste
  • Do the Math ROI Calculator

24
ROI Do The Math
25
Conclusions
  • World Class Quality is a Organizational
    Challenge, Not a Manufacturing Challenge
  • Use Best In Class Business Models
  • Learning Approach Provides Long Term Benefits
  • Reduce Costs by Improving Quality
  • This is a framework for deployment, like ERP
    not another project
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