short form tool 31 itttm tool #31 short form “iso and qs 9000: quality launch systems, supplier...

Short Form Tool 31

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Tool #31 Short Form“ISO and QS 9000: Quality Launch

Systems, Supplier Relationships Guiding Our Synchronous Future”

Topics

1. ISO/QS introduced and overviewed2. ISO requirements, focus, foundations3. General concerns, getting started4. New product development relationships5. Lean, six sigma, service relationships6. Tool applications………..

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ISO/QS Introduced And OverviewedISO, international standards organization• Focused on global marketplace, and at home• QS, domestic customer/supplier, automotive• How we do business, future, contract issues• Consistent standards, level playing field80% of ISO overlaps into QS standards• Automotive Industry Alliance Group (AIAG) • Key part of understanding, satisfying customers

ISO is about Baldridge, broad framework, TQM• Baldridge is through Commerce Department• American “push” for quality

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Baldridge basis, ISO, QS, relationships• Leadership, how we do business• Information and analysis• Strategic quality planning• Human resource development• Management of process quality, operations• Customer focus and satisfaction

ISO/QS Introduced And Overviewed

Standards do not measure quality…….• Organization identifies, defines, standards• Manages production per customer demands• Specifies, certifies quality, compliance• Organization certifies, contractually, customer

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Registrar selected similar to any supplier• Registrar, body such as Underwriters Lab• Reviews documentation system, quality manual• Do pre-assessment, preparatory work internal• Must understand business, be customer focused• Objective, willing, to work your calendar

ISO/QS Introduced And Overviewed

Process design, documentation routinely updated• Describes what we do, who is responsible• Describes how all is done, records, practices Time to be registered generally 6-12 months ++• Organization size, processes, preparedness• Startup costs, $15-25K, total easily twice this

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ISO Requirements, Focus, Foundations

Basic systems grew out of the 9000 framework• 9000 was a five part series, basic guidebook• 9001 was service, 9002 detailed production , and

9003 focused on inspection and testing• 9001, 9002, 9003 was audited by third party

More recent ISO developments are QS 9000• 20 elements describe standard, areas to comply• Totality of elements provide quality system• Documented quality manual, increasingly online

Assessment, internal, external audit, certification• Internal is to comply, may not certify, correct• External certification, desired, third party

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20 elements identified (cont.)• Control of inspection, measuring, test equipment• Inspection, test status• Control, non-conforming product• Corrective, preventive action• Handle, storage, packaging, delivery preservation• Control of quality records• Internal quality audits• Training• Servicing• Statistical techniques


20 elements identified• Management responsibility• Quality system• Contract review• Design control• Document, data control• Purchasing• Control of customer supplied product• Product identification, traceability• Process control• Inspection, testing

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Documentation Tools, Lean

Data Tools, Six Sigma

Service, Tools Manufacturing, Non- Manufacturing

Synchronous Tools, New Product Development

Project Team

Cultural Change And Continuous Improvement

Information Analysis,Communication Systems

Applied Research, Project Structure

Enhanced Problem Solving, Decision Making

Internal, External, E-commerce Relationships

Quality Management Systems (QMS)International Standards Organization (ISO)

Professional Outcomes, Growth, Knowledge

Technological Infrastructure

Industrial Technologists’ Toolkit For Technical Management


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Four levels of quality documentation…….• First level, quality manual, policies and objectives• Second level is Process descriptions, flowcharts• Third level, work instructions, step by step SOPs• Fourth, lowest level, charting form and records


Sector specific requirements, industry specific…..

•Production part approval, verification: (PPAP or PVP) new product, supply chain, issues

•Continuous improvement: all organization levels, functions defined, explained

•Production capabilities: cross functions, issues organizationally, relationally, delivery ability

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TS 16949 simplifies the previous 20 ISO elements to be more user friendly as five broad-based elements:• Quality management system: relationships and

sequences for all functions• Management responsibility: demonstrable

indications of top management commitment• Resource management: assuring that resources

are available to fulfill commitments• Product realization: understanding quality

objectives in product• Measurement, analysis and improvement:

data-based measures are used to improve


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Environmental 14000 standard helps all to assess environmental performance in five areas:• General requirements: requires establishment

of a system compliant with 14000• Environmental policy: top management led

environmental policy and commitment• Planning: procedures put in place to assure

appropriate environmental actions• Implementation and operation: environmental

management procedures, clearly documented• Management review: management’s scheduled

evaluations of systems, for improvement


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How we service, understand others, relationships• Managing organization, operating system• Paradigm shift in business accountability

Over 90 countries, workable, useful standards• Democratization, globalization • Contract language, how we communicate

Improved process linkages, efficiency• Teamwork, cooperation, flexibility, control• Improved ability of people to contribute• Decreased liability, increased reliability • Increased marketing abilities, advantages

General Concerns, Getting ISO Started

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Involve all, broader purposes, not in a vacuum• Empower all, understand processes, use, improve • Determine how current systems do ISO/QS• If not doing something by standards--why?• Evaluate costs, implications of not implementing

General Concerns, Getting ISO Started

Infrastructure, hardware, software, people• Persons who “champion” must handle change• Have broad expertise in processes, products• Evaluate, implement, standards, grow, together• Infrastructure must be satisfactorily in place

ISO increasingly becoming the base, umbrella……• Managing organization, operating system• Lean, six sigma, general improvement……..

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Launch systems for quality• Class I, new platform: first time customer• Class II, derivatives: based on existing work• Class III, tailoring: custom tailored work

Basic principles in launch procedures, strategic• Cross functions, self managed, flexible, plan• Synchronous production data, documentation• Facilities to capacity, market share, competitive

New Product Development Relationships

• Good “mix” of products in cycle• Some old, new launches, continuously improved

Product life cycle phases: Incubation, growth, maturity, saturation, decline……….

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Launch definitions, classifications, phases• Charter, vision, comparative advantage• Contract, management reviews• Customer led planning process (CLPP)• Program, leader, manager, sponsor defined• Design, development, prototyping phases• Managed introduction, 1st ship, stable

New Product Development RelationshipsNew product questions should include:• Are implementation costs offset by profits?• Product simplified? Improved? Safety impacted?• Should this be developed later, not now?• What is market, customer, long term strategy?• Compatibility with existing product, process?

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ISO/QS 9000, increasingly becoming base• As key management system, this has breadth and

scope to embody various other quality tools• ISO/QS are umbrella for all quality systems• Based on systemic analysis, many other tools and

quality methods can be pursued• If not used in this way, many duplicative systems

and sub systems can result• Basis for improvement is ISO/QS, but the system

must be designed for these purposes• Total quality system must facilitate kaizen, six

sigma, lean—all based around ISO/QS

Lean, Six Sigma, Service Relationships

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ISO/QS 9000, increasingly becoming base (cont.)• Each quality method requires data and

documentation to do improvement• ISO/QS are umbrella for collecting data,

documenting in ways to use for improvement• Cannot improve in absence of baseline data, well

documented, designed for systematic applications• Many other quality methods will come and go,

being brief buzz words……..• ISO/QS systems have lasting value, mature base

for total management, here to stay and enable many other quality methods


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Operation Versus Process

Operation Steps

Key Support Documentation

Using Capacity Determination For Building SOP's Through Kaizen

Capacity Determination As Basis For SOP's Through Kaizen.

Identify, Define, Coordinator

Identify Detailed Operations

Build Standard Procedures

Continuously Upgrade SOP

Update/ Revise SOP


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All organizations, units, provide service

•Service internal, external, cannot exist without serving •All are customers, suppliers, upstream and downstream•All work areas must serve others well•Good service, tell one-two, bad, tell six-eight•All rely on one another--need each other

Manufactured product, discreet, measurable

•Service not always physical, difficult to measure•General people functions, often ambiguous•Standards may not be readily established•Documentation required, synchronized, relates to QS/ISO


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Service functions are people functions•May need to educate customer•Use SOP, instructions•Juggle, synchronize, multiple demands

Did we satisfy the customer?•Deliver service to customer, but does customer accept?•Will we get customer repeat business?•Good service, tell one-two, bad, tell six-eight

Did the product perform as stated?•How do we improve product via better service?•Did we correct or simply adjust, patch, band aid?•Communications, marketing, sales, quality, technical staff


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Tool Applications…….

Tool 31 applications are:• OPCP, introduced, continuously built, not just at start• FMEA also introduced, built gradually, evolved• Documentation System Design, Communication, DSDC• ISOQSAOPP, designed to help set a plan for team• LVAOCA, broad based launch system design• All follow through, do and post, independently

Toolkit applications are a key part of the courseware• Located in separate folder of the CD• Provides the template for team portfolio• Each application s part of team project, portfolio• Designed to be done by all, each team member• First read long form, then short review, applications• Total contribution in application form is compiled• Portfolio is gradually evolved around applications

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Part Name: Process Location: OPCP Form Of

Supplier: Revision:

Other Pertinent General Information:

Process Description. Provide a written description of process in text format and a process flow chart depicting the same:

Tools For Manufacture/Production. Describe equipment required to produce the product, consistent with the flow chart above:

Process Parameters. Describe unique elements involved in processing the product which require additional explanation:

Product Characteristics. Describe all characteristics of the product, primarily as attributes or variables which are critical:

Class. Describe any codes or other unique identifiers per the specific industry or organization to help further distinguish the product:

Product/Process Specification. Provide specific measurable definitions for each product characteristic identified above:

Evaluation Method. Describe how specifications of characteristics are evaluated, what the measurement systems are:

Sample Size, Frequency of Inspection. Describe the sample, how it is derived, including devices used to inspect in a step by step manner:

Analysis Methods. Describe the methods and systems used to analyze the sampled data, such as statistical, experimental, and so on:

Reaction Program. Describe steps to be taken when product or process is found to be functioning inappropriately:

Ongoing Process Control Plan (OPCP)• Continuously built over entire course• Gradually evolved based on team, project growth • Becomes key part of team project, portfolio• Key ISO technical document for improvement• Partial form shown below, gradually addressed……..

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Failure Mode and Effects Analysis (FMEA)• Traditional FMEA, heavily oriented to manufacturing• Non-manufacturing failure-related issues apply as well• Ratings, analyses can lead to critical improvements• FMEA’s, built over entire course……..• A “user-friendly” form may be something like……..

Part Name/Service: Process/Service Location: FMEA Form Of

Supplier: Product, Process or Design FMEA, and Why? Revision:

Other Pertinent General Information, Particularly Oriented To Other Supportive Documentation And Data Attached:

Process Description. Provide a general written text description of the process, and detailed flow chart of same:

Product Description. Provide a general written text description of the product, and detailed step by step functioning of same:

Potential Failure Mode. Describe the general failure which has occurred or may occur, giving appropriate details to help all improve on same:

Key Characteristics. Describe key characteristics in product or process to be addressed to decrease likelihood of failure (rank order according to level of criticality, 1 being low and 10 being high):

Characteristic Ranking 1-10:

Potential Effects of Failure. Describe the general failure effects, particularly focused on implications for damage to surrounding environment

(provide a rating of severity where 1 is low and 10 is high):

Severity Rating 1-10:

Potential Causes of Failure. Describe general failure cause, particularly focused on process or product design which are implicated, with sufficient details to enable improvement. Also provide a occurrence of failure rating (1 = low and 10 = high):

Occurrence Failure 1-10:

Current Detection Control. Describe systems or methods of detecting failure which can lead to control of failure, including methods for same.

Also provide a rating from 1-10 to indicate likelihood of occurrence ( where 1 = high and 10 = low):

Detection Control 1-10:

Risk Priority Number (RPN). Provide a RPN based on multiplying severity X occurrence X detection. RPN Calculated:

Recommended Action. Describe appropriate actions to be taken in process or product to alleviate failure, including area to take

action and when (if multiple actions are needed, add rows):

Responsible Area: When:


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Tool Applications…….ISO/QS Audit, Objective Prioritization Plan (ISOQSAOPP)• Preliminary plan, setup of assessments, work for team• Familiarize with ISO, auditing, all on same page, terms• Strategic planning, team level, change and improvement• Project 50% done when “problem” nailed down• “hot spots” focus, project objectives, gradually PPDPOA• Gantt from SDA form or template, for time, sequence• Partial form is shown……..

Organization Under Discussion: Current Operation: Location:

General Description Of Operations/Production Functions/Systems Being Assessed As An Internal Audit:

ISO/QS Element (TS 16949 2002—Others) Technical Function Description Audit Preliminary Information Actions, Recommendations For Change

(list each element separately for analysis/audit)

(describe technical function being audited) (How does function compare to standard) (explain anticipated necessary actions, changes)

Planning Statement Or Issue, Particularly As Associated With The Service Environment: Criticality Level: HML (H = 5; M = 3; L = 1)

Fac = Facility issues; Cost = Cost issues; Time = Time issues; Pers = Personnel issues

Objectives Prioritized, 5 Being Highest: Criticality HML

Fac Cost Time Pers

5, 4, 3, 2, 1

Problem Background: Resources? (Budget/Other Concerns)?

Task/Deliverable/Objective: Who Will Do? How Measured?

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Documentation System Design, Communication (DSDC)• Initial design, plan for how the team will work• Given that all work is about communications…….• Documentation is blackboard is critical• Must consider initially how this will happen, DSDC• DSDC provides opportunity to reflect on, discuss

Researcher Communication Method, Internal And External Customers:

Toolkit/Blackboard Design Element, How Does It Work?

How To Improve Professional Relationships, Communication?

1. 1. 1. 1.

Identify How The Systems’ Design You Are Advocating Can Assist IN Tieing Together PPDPOA, TPMSS, FACR, TRIRPA And Other Elements Of Team Problem Solving And Improvement:

Explain ISO/QS Characteristics And Other Necessary Entities To Be Possessed By Documentation And Communication Systems, Categorically, Particularly Focused On Service Functions:

Using The Template At The End Of The Applications Complete A Cause And Effect Diagram Indicating Issues And Opportunities For Systemic Documentation Relationships/Improvements, Particularly Focused On Service Functions:

Identify And Explain Why Your Organization Is Well Suited To The Documentation And Communication System Being Developed, Particularly Focused On Service Functions:

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Tool Applications…….Launch Value Analysis, Open Agenda, Corrective Action• Design of a plan for how team will do launch• Agenda is open over course to do corrective actions• Value analysis of each part in product determined• Consider initially how this will happen, follow through• LVAOACA provides opportunity to reflect on, discuss• Partial format is shown below……..

Identified Nature Of Product To Be Supplied, Specific Details:

Explain ISO/QS Characteristics (And Other Necessary Definitions) To Be Possessed By Launch Systems, Categorically:

Explain Potential Opportunities For improvement In Supplier Chain Systems:

Identify And Explain Why Your Organization Is Well Suited To Supply The Product Being Contracted:

Develop A Flow Chart, With Explanation, Of The Overall Launch System:

Current Product Cost: Target Production Cost: Current Sales Cost: Target Sales Cost: Other Costs or Functions:

Part/Component Function/Purpose

Value Rating (VR) (1-10)

PartCost (PC)

% Of CostTotal (TC%)

Value AddedWeight (VAW)

Alternatives to Add Value

Column Totals:

Value Analysis Summary Statement:

Open Agenda Topic/Issue/Activity When Started/Done/By Who?

Follow Up Details/Actions?

short form tool 31 itttm tool #31 short form “iso and qs 9000: quality launch systems, supplier...

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