Análisis y Presentación Cláusula 7 de la ISO 9001

ISO 9000:2000 Clause 7 ISO 9000:2000 Clause 7 Product RealizationProduct Realization

Analysis and Analysis and ImplementationImplementation

a workshop presented bya workshop presented byJack WestJack West

&&Eduardo del RioEduardo del Rio

2Integrated process Integrated process managementmanagement

OutputInputActivity Activity Activity

Process

Control

Mechanism(resources)

3Consistent PairConsistent Pair of QMS of QMS StandardsStandards

ISO 9001 : QMS ISO 9001 : QMS -- RequirementsRequirements ISO 9004 : QMS ISO 9004 : QMS -- Guidance for Guidance for

performance improvement performance improvement

44

ISO 9004

ISO 9001

ISO 9004 perspective:Performance improvement

ISO 9001 perspective: Quality of product

Breadth

Depth

Res

ults

One Way to Think about the Relationship

5EffectiveQuality Management System

Efficient

Quality Management System

CompetitiveAdvantage

ISO 9001

TheBaseline

ISO 9004

Performance Improvement

Performance Excellence

The Bigger Picture: The Quality Hierarchy

Business Vision

From material developed by Joe Tsiakals

6The Consistent The Consistent TrioTrio

Consistent pairConsistent pair of QMS standardsof QMS standards ISO 9001 : QMS ISO 9001 : QMS -- RequirementsRequirements ISO 9004 : QMS ISO 9004 : QMS -- Guidance for performance Guidance for performance

improvement improvement

+ Compatible Fundamentals & Terminology+ Compatible Fundamentals & Terminology ISO 9000 : QMS ISO 9000 : QMS -- Fundamentals and Fundamentals and

Vocabulary Vocabulary

7TIME

UP

Is

good

Incremental ImprovementsOver Five Years

Five Years

Benchmark: Best in ClassPerformance

Breakthroughin 18 Months

Breakthrough Target:Be 5% Better than Benchmark

In 18 Months

18 Months

Continual Improvement: Continual Improvement: Incremental and BreakthroughIncremental and Breakthrough

8Continual Improvement: Incremental Continual Improvement: Incremental and Breakthroughand Breakthrough

Characteristics TendencyIncremental

ImprovementBreakthrough Improvement

People Involved People working in the process

Managers, engineers, consultants

Size of Changes Small incremental changes Big changes

Types of Changes Practices, procedures, equipment mods,

elimination/simplification of activities, process fool-

proofing

Technology, new equipment, major process upgrades, process re-engineering

Results Small improvements Large jumps in performance

Cost of Projects Low, generally included in operating budget

High, may involve capital investment

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Business BasicsBusiness Basics

Revenue - Cost = Profit

Better Quality Higher Revenue and Lower Cost

Better ProductsCustomer Satisfaction

Fewer RejectsLess ReturnsLess Problems

+ = Maybe YouGet a Bonus

Output matters: ScopeOutput matters: ScopeClauseClause RequirementRequirement

1.1 Scope1.1 Scope This International Standard specifies requirements for This International Standard specifies requirements for a quality management system where an a quality management system where an organizationorganization

a)a) needs to needs to demonstrate its ability to consistently demonstrate its ability to consistently provide product that meets provide product that meets customercustomerrequirementsrequirements, and , and

b)b) aims to enhance customer satisfaction through aims to enhance customer satisfaction through the effective application of the systemthe effective application of the system, including , including processes for continual improvement of the system processes for continual improvement of the system and the assurance of conformity to customer and and the assurance of conformity to customer and applicable regulatory requirements.applicable regulatory requirements.

20047 ISO20047 ISO

Output matters: Top managersOutput matters: Top managersClause 5Clause 55.25.2 Customer Customer

focusfocusTop management shall Top management shall ensure that customer ensure that customer

requirements are determined and are metrequirements are determined and are met with with the aim of enhancing customer satisfaction (see the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1).7.2.1 and 8.2.1).

5.3 Quality 5.3 Quality policypolicy

Quality policyQuality policyTop management shall ensure that the quality Top management shall ensure that the quality

policypolicyb)b) includes a includes a commitment to comply with commitment to comply with

requirements and continually improve the requirements and continually improve the effectiveness of the quality management effectiveness of the quality management systemsystem,,

5.6.35.6.3 Review Review

outputoutputThe output from the management review shall include The output from the management review shall include

any decisions and actions related toany decisions and actions related tob)b) improvement of product related to customer improvement of product related to customer

requirementsrequirements.. 2000 IS02000 IS0

Output matters: ResourcesOutput matters: ResourcesClause 6Clause 6

6.16.1 Provision Provision of resourcesof resources

The organization shall determine and provide the The organization shall determine and provide the resources neededresources needed

b)b) to enhance customer satisfaction by meeting to enhance customer satisfaction by meeting

customer requirements.customer requirements.

2000 ISO2000 ISO

Output matters: Product Output matters: Product realizationrealizationClause 7 cont.Clause 7 cont.

7.3.67.3.6 Design Design and and development development validationvalidation

Design and development Design and development validation shall be validation shall be performedperformed in accordance with planned arrangements in accordance with planned arrangements (see 7.3.1) (see 7.3.1) to ensure that the resulting product is to ensure that the resulting product is capable of meeting the requirements for the capable of meeting the requirements for the specified applicationspecified application or intended use, where or intended use, where knownknown..

2000 ISO2000 ISO

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Clause 4Clause 4 Quality management system Quality management system 4.1 General requirements4.1 General requirements

Establish, implement, document, maintain, Establish, implement, document, maintain, and continually improve the QMS and continually improve the QMS processes; this includes:processes; this includes:

Defining their sequence and interactionsDefining their sequence and interactions Managing the QMS processesManaging the QMS processes Establishing criteria and methods to operate and control Establishing criteria and methods to operate and control

the QMS processesthe QMS processes Ensuring availability of information to operate and Ensuring availability of information to operate and

monitor the QMS processesmonitor the QMS processes Measuring, analyzing and continually improving the Measuring, analyzing and continually improving the

QMS processesQMS processes Provide for control of outsourced processesProvide for control of outsourced processes

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4.1 General Requirements4.1 General Requirements

EstablishEstablish

The organization shall...The organization shall...

DocumentDocumentImplementImplement

MaintainMaintainContinually ImproveContinually Improve

Quality Management

System

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Identify processesIdentify processes

Quality Quality Management Management

SystemSystem

17

Determine sequence & interactionDetermine sequence & interaction


SystemSystem

18

Determine methods to operate & Determine methods to operate & control processescontrol processes


SystemSystem

19

Ensure availability of Ensure availability of resources & informationresources & information

ResourcesResources


SystemSystem

20

Measure, monitor & Measure, monitor & analyze processesanalyze processes

Measure at key pointsMeasure at key points


SystemSystem

21

Chart the Basic Processes of the Chart the Basic Processes of the SystemSystem

Customer-Relationships Product design

Process Design &

ValidationProcurement

Production Operations

Information

Product

Measurement

and Analysis Management Review

Corrective Action and

Preventive Action

Delivery and Service

Data Management

Example Quality Management SystemRelationship Map

Records Management

There should be a relationship diagram of the overall system --

put it in the quality manual

Planning

&

Strategy

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Purpose Of Process Purpose Of Process ManagementManagementControlControl

Understand the Understand the processes and how processes and how they fit togetherthey fit together

Understand Understand relationship between relationship between response and response and independent process independent process variablesvariables

Control the processControl the process

YResponse Variable

Motion of the Car

Kid With the Control!

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5.4.15.4.1 Quality ObjectivesQuality Objectives Established at relevant Established at relevant

functions and levelsfunctions and levels Measurable Measurable Consistent with policyConsistent with policy

Clause 5 Clause 5 Management responsibilityManagement responsibility5.45.4 PlanningPlanning

5.4.25.4.2 Quality management Quality management system planningsystem planning

Top management must Top management must ensure QMS is planned ensure QMS is planned to meet clause 4.1to meet clause 4.1

Covers:Covers: processes of QMSprocesses of QMS resources neededresources needed continual improvement of continual improvement of

the QMSthe QMS

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5.4.25.4.2 Quality planning, Quality planning, continuedcontinued Planning shall ensure:Planning shall ensure:

change is controlledchange is controlled QMS integrity is maintained when QMS integrity is maintained when

changes are made to itchanges are made to it

Clause 5 Clause 5 Management responsibilityManagement responsibility

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Planning the QMS (Clause 4.1 & 5.4)Planning the QMS (Clause 4.1 & 5.4)

Planning

Quality management system planning (clauses 4.1 & 5.4)

Planning of quality management system (5.4.2)

Product realization planning (clause 7.1)

to meet quality objectives

to meet requirements given in clause 4.1

Change control of quality management system

Establishing quality objectives (5.4.1)

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Clause 7 Clause 7 Product realization Product realization

Figure 1 Model of a process-based quality management system

Resourcemanagement

Managementresponsibility

CONTINUAL IMPROVEMENT OFTHE QUALITY MANAGEMENT SYSTEM

CUSTOMER

REQURIEMENTS

CUSTOMER

SATISFACTIONMeasurement,analysis andimprovement

OutputProductInput

Key

Value adding activitiesInformation flow

Productrealization

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Clause 7Clause 7 Product realizationProduct realization

Clause 7 contains Clause 7 contains 7.1 Planning of product realization7.1 Planning of product realization 7.2 Customer7.2 Customer--related processesrelated processes 7.3 Design and development7.3 Design and development 7.4 Purchasing7.4 Purchasing 7.5 Production and service provision7.5 Production and service provision 7.6 Control of monitoring and measuring 7.6 Control of monitoring and measuring

devicesdevices

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Clause 7Clause 7 Product realizationProduct realization

Requirements similar to the 1994 Requirements similar to the 1994 edition, butedition, but

Wording is more generic so as to ease Wording is more generic so as to ease application by all sectors and sizes of application by all sectors and sizes of organizationsorganizations

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Clause 7.1Clause 7.1 Planning of product Planning of product realizationrealization

Immediately focuses on processesImmediately focuses on processes Planning of realization processes Planning of realization processes

must be:must be: consistent with other requirements of the consistent with other requirements of the

organizationorganizations quality management systems quality management system documented in a form suitable to the documented in a form suitable to the

organizationorganizations operating methodss operating methods

7.1 covers all realization processes

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Clause 7.1Clause 7.1 Planning of product realization, Planning of product realization, continuedcontinued

In planning realization processes, the In planning realization processes, the organization must determine:organization must determine: quality objectives for the contract, project, or productquality objectives for the contract, project, or product need for processes and documentationneed for processes and documentation verification and validation activities and acceptance verification and validation activities and acceptance

criteriacriteria records required to provide confidence of process and records required to provide confidence of process and

product conformityproduct conformity Resources and facilities must be determined and Resources and facilities must be determined and

provided provided Note 2: may apply 7.3 to development of product Note 2: may apply 7.3 to development of product

realization realization processesprocesses

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Planning Product Realization (Clause Planning Product Realization (Clause 7.1)7.1)

Product realization planning (clause 7.1)

Planning

Quality management system planning (clauses 4.1 & 5.4)

Establish processes, documentation, and resources (7.1, 7.5.1)

Determine necessary records (7.1)

Define criteria for product acceptance and release (7.1, 7.3.3, 7.5.1)

Determine necessary inspection, test, verification & validation activities (7.1, 7.5.1, 8.1, 8.2.3, 8.2.4)

Determine quality objectives/requirements for product (7.1, 7.3.3)

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Planning the QMS (4.1, 5.4.1, & 5.42)

Planning Product Realization (7.1)

Quality Objectives Quality Manual Documented Procedures

Process PlanningActivity

Examples of Resulting Documents

Quality Plans for SpecificProducts or Projects

Work Instructions

Typical Planning OutputsTypical Planning Outputs

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Discussion GroupsDiscussion Groups

1.1. Form small groups of three to fiveForm small groups of three to five2.2. Discuss what can you do to improve the Discuss what can you do to improve the

planning processplanning process3.3. We will call on some to report to the We will call on some to report to the

whole groupwhole group

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Clause 7.2Clause 7.2 CustomerCustomer--related processesrelated processes7.2.1 Determination of requirements related to the 7.2.1 Determination of requirements related to the

productproduct completeness of requirements: availability, delivery, completeness of requirements: availability, delivery,

supportsupport requirements necessary but not specifiedrequirements necessary but not specified regulatory, and statutory obligationsregulatory, and statutory obligations

7.2.2 Review of requirements related to the product7.2.2 Review of requirements related to the product requirements clearly definedrequirements clearly defined confirm unwritten requirementsconfirm unwritten requirements verify differences from tenderverify differences from tender ensure ability to meet requirementsensure ability to meet requirements results of review and followresults of review and follow--up recordedup recorded

35

Clause 7.2Clause 7.2 CustomerCustomer--related processesrelated processes

7.2.3 Customer communication7.2.3 Customer communication implement implement arrangementsarrangements for customer for customer

communicationscommunications product informationproduct information enquiry/order handlingenquiry/order handling customer customer feedbackfeedback, including , including complaintscomplaints

36

Customer Customer satisfaction satisfaction

datadata

QualityQualityManagementManagement

SystemSystem

Management Management ReviewReview

8.2.1 Customer 8.2.1 Customer satisfactionsatisfaction

Use Use customer datacustomer data

37

AnalyzingAnalyzingMonitoringMonitoring

MeasuringMeasuring

ImprovingImproving

Customer Customer satisfaction satisfaction

datadata

Define how data are usedDefine how data are used

8.2.1 Customer satisfaction

38

One ApproachOne Approach Start by asking questions :Start by asking questions : What customer information do you What customer information do you

have?have? What customer information do you What customer information do you

want?want? Do you want your own internal Do you want your own internal

customer study capability?customer study capability? Do you want to selectively go to the Do you want to selectively go to the

outside for specific research projects?outside for specific research projects?

39

Examples of the Voice of the CustomerExamples of the Voice of the CustomerWant an ongoing process to gather, understand, and satisfy needs of customers.

Want an ongoing process to monitor and measure market trends.

Want a way to focus our sales force on the markets that have the greatest immediate potential.

Want to train our sales force so that they develop a market intelligence capability.

Want to monitor customer satisfaction to see if existing customers are experiencing dissatisfaction with existing products and services.

Want to develop capabilities so that we can meet ISO 9001:2000 Clause 8.2.1 on customer satisfaction and other related clauses.

Want to develop a robust survey process that can be handled internally.

Want to measure potential sources of customer dissatisfaction.

Want to understand how to write survey questions.

Want assistance in designing and administering a customer survey.

Want to train our sales force in gathering market intelligence followed by actual application of the training in the real world.

Want to receive new orders as a result of our market intelligence project.

Want to use customer data to increase market penetration.

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Methods of Gathering Methods of Gathering

Active

Receptive

Indirect

SurveysFocus groupsSite visitsInterviewsComplaintsWarranty costsAllowancesLettersArticlesTrade ShowsRepeat business

Sources of Customer Satisfaction Data

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Customer Ratings

R&D

Surveys

Complaints

Key Measures

Trade Shows

Sales Calls Articles

Often our customer data is like an incomplete puzzle

Credits & Returns

42

Customer Ratings

R&D

Surveys

Credits & Returns

Complaints

Key Measures Trade

Shows

Sales Calls

Articles

Get the pieces to fit together

43


1.1. Form small groups of three to fiveForm small groups of three to five2.2. Do you Do you reallyreally know your customersknow your customers

requirements, needs, wants? How well requirements, needs, wants? How well do you meet them?do you meet them?

3.3. What can you improve?What can you improve?4.4. We will call on some to report to the We will call on some to report to the


44

Clause 7.3Clause 7.3 Design and developmentDesign and development

Design and development planningDesign and development planning Design and development inputsDesign and development inputs Design and development outputsDesign and development outputs Design and development reviewDesign and development review Design and development verificationDesign and development verification Design and development validationDesign and development validation Control of design and development changesControl of design and development changes

45

Clause 7.3Clause 7.3 Design and development Design and development

7.3.1 Design and development planning 7.3.1 Design and development planning Requires determination of:Requires determination of:

stages of the processstages of the process required review, verification, and validations at required review, verification, and validations at

each stageeach stage responsibility and authority for these activitiesresponsibility and authority for these activities

Interfaces between groups involved must be Interfaces between groups involved must be managedmanaged

Project plans must be kept updatedProject plans must be kept updated

46


7.3.2 Design and development inputs7.3.2 Design and development inputs Define and document requirementsDefine and document requirements

functional/performancefunctional/performance regulatory/statutoryregulatory/statutory information from previous designsinformation from previous designs other essential requirementsother essential requirements

Review inputsReview inputs Resolve incomplete, ambiguous, or Resolve incomplete, ambiguous, or

conflicting requirementsconflicting requirements

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7.3.3 Design and development outputs7.3.3 Design and development outputs Document in a format that allows for Document in a format that allows for

comparison with input requirementscomparison with input requirements Output shall Output shall

meet input requirementsmeet input requirements relate to product acceptance criteriarelate to product acceptance criteria define characteristics essential to safe and proper define characteristics essential to safe and proper

useuse Approve output documents prior to releaseApprove output documents prior to release

48


7.3.4 Design and development review7.3.4 Design and development review Systematic review(s) at suitable stages in Systematic review(s) at suitable stages in

the design processthe design process evaluate ability to fulfill requirementsevaluate ability to fulfill requirements Identify problems & propose followIdentify problems & propose follow--upup

Include representatives of functions Include representatives of functions concerned with the designconcerned with the design

Record results of reviews and followRecord results of reviews and follow--upup

49


7.3.5 Design and development verification7.3.5 Design and development verification ensures design output conforms to ensures design output conforms to

requirementsrequirements record verification results and followrecord verification results and follow--upup

7.3.6 Design and development validation7.3.6 Design and development validation confirm product is capable of meeting the confirm product is capable of meeting the

intended use (examples: intended use (examples: pilot runpilot run or or testtest)) where practical, complete prior to product where practical, complete prior to product

releaserelease record validation results and followrecord validation results and follow--upup

50

Customer needs7.2.2

Design inputs7.3.2

Design process

phases and reviews

7.3.4

Design outputs 7.3.3

Design & Development Planning 7.3.1

Product

Design validation 7.3.6

Design verification 7.3.5

Risk analysis and preventive action

51

Use Appropriate Tools ISO 9004:2000 Use Appropriate Tools ISO 9004:2000 Clause 7.3.1Clause 7.3.1

Failure Modes and Effects analysisFailure Modes and Effects analysisFMEAFMEA

Fault tree analysisFault tree analysis Reliability predictionReliability prediction Relationship diagramsRelationship diagrams Ranking techniquesRanking techniques Simulation techniquesSimulation techniques

Many find FMEA the most powerful of these tools for preventing problems.

52

Using Failure Mode and Effects AnalysisUsing Failure Mode and Effects Analysis

List each potential failure List each potential failure mode(smode(s) for each potential ) for each potential failurefailure

Describe failure mode for each potential effect that Describe failure mode for each potential effect that such a failure could havesuch a failure could have

Estimate (on a scale of 1 to 10 with 10 being worst) Estimate (on a scale of 1 to 10 with 10 being worst) severity, probability (or frequency) of occurrence, severity, probability (or frequency) of occurrence, detectabilitydetectability (ability to detect the potential cause and (ability to detect the potential cause and prevent the failure)prevent the failure)

Multiply rankings to give a risk priority number Multiply rankings to give a risk priority number (RPN)(RPN)

RPN is used to prioritize preventive actionsRPN is used to prioritize preventive actions

53


7.3.7 Control of design and 7.3.7 Control of design and development changesdevelopment changes

Identify, document and control changesIdentify, document and control changes Evaluate the effect of changes onEvaluate the effect of changes on

other parts of the product (e.g., other parts, other parts of the product (e.g., other parts, software)software)

delivered productsdelivered products Verify and validate the changes as Verify and validate the changes as

appropriateappropriate Record results of change review and Record results of change review and

subsequent actionssubsequent actions

54


1.1. Form small groups of three to fiveForm small groups of three to five2.2. Discuss what can you do to improve the Discuss what can you do to improve the

design and development process in your design and development process in your organizationsorganizations

3.3. We will call on some to report to the We will call on some to report to the whole groupwhole group

55

Clause 7.4Clause 7.4 PurchasingPurchasing

Purchasing processPurchasing process Purchasing informationPurchasing information Verification of purchased productVerification of purchased product

56

Clause 7.4 Clause 7.4 PurchasingPurchasing

7.4.1 Purchasing process7.4.1 Purchasing process Control to ensure purchased product conforms to Control to ensure purchased product conforms to

requirementsrequirements Type and extent of control to depend on effect on Type and extent of control to depend on effect on

subsequent processes and their outputsubsequent processes and their output Define supplier selection and periodic evaluation Define supplier selection and periodic evaluation

criteriacriteria Evaluate and select suppliers based on ability to Evaluate and select suppliers based on ability to

meet requirementsmeet requirements Record results of evaluations and followRecord results of evaluations and follow--upup

57


7.4.2 Purchasing information7.4.2 Purchasing information Purchasing documents must includePurchasing documents must include

approval/qualification requirements for approval/qualification requirements for product, procedures, processes, equipment, product, procedures, processes, equipment, and personneland personnel

quality management system requirementsquality management system requirements Ensure adequacy of purchase document Ensure adequacy of purchase document

requirements prior to their releaserequirements prior to their release

58


7.4.3 Verification of purchased product7.4.3 Verification of purchased product Identify and implement inspection or other Identify and implement inspection or other

activities to ensure product meets activities to ensure product meets requirementsrequirements

Provide for verification at the supplierProvide for verification at the suppliers s premises and for product releasepremises and for product release

59


1.1. Form small groups of three to fiveForm small groups of three to five2.2. What % of the cost of goods sold in your What % of the cost of goods sold in your

organization is purchased material? (In some organization is purchased material? (In some organizations it is over 50%!!)organizations it is over 50%!!)

3.3. What about What about outsourcedoutsourced processes?processes?4.4. Are the controls exercised over the purchasing Are the controls exercised over the purchasing

process in balance with the importance of process in balance with the importance of purchased material to quality perceptions of purchased material to quality perceptions of your products by your customers?your products by your customers?

5.5. We will call on some to report to the whole We will call on some to report to the whole groupgroup

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Clause 7.5Clause 7.5 Production and service provisionProduction and service provision

7.5.1 Control of production and service 7.5.1 Control of production and service provisionprovision

7.5.2 Validation of processes for production 7.5.2 Validation of processes for production and service provisionand service provision

7.5.3 Identification and traceability7.5.3 Identification and traceability 7.5.4 Customer property7.5.4 Customer property 7.5.5 Preservation of product7.5.5 Preservation of product

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7.5.1 Control of Production and service 7.5.1 Control of Production and service provisionprovision

Carry out production and service provision Carry out production and service provision under controlled conditions through:under controlled conditions through: availability of product/service specificationsavailability of product/service specifications availability of work instructions as neededavailability of work instructions as needed use of suitable equipmentuse of suitable equipment monitoring and measuring equipmentmonitoring and measuring equipment monitoring and measurementmonitoring and measurement release, delivery, and post delivery activitiesrelease, delivery, and post delivery activities

62

Clause 7.5Clause 7.5 Production and service Production and service provisionprovision

7.5.2 Validation of processes for 7.5.2 Validation of processes for production and service provisionproduction and service provision

Validate processes where output cannot Validate processes where output cannot be verified prior to deliverybe verified prior to delivery

Demonstrate production and service Demonstrate production and service processes can achieve planned resultsprocesses can achieve planned results

63


7.5.27.5.2 Validation of processes for Validation of processes for production and service provisionproduction and service provision(Continued)(Continued)

Define controls as applicable:Define controls as applicable: define criteria for review and approvaldefine criteria for review and approval qualification of process and/or equipmentqualification of process and/or equipment use of procedures and defined methodsuse of procedures and defined methods requirements for recordsrequirements for records rere--validationvalidation

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Use clause 7.1 note 2Use clause 7.1 note 2

Apply the notions for design and Apply the notions for design and development of products to the processes development of products to the processes for production and service provision for production and service provision processesprocesses

Conduct process design in parallel with Conduct process design in parallel with product designproduct design

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Customer needs7.2.2

Design inputs7.3.2

Design process

phases and reviews

7.3.4



Product




66

Customer needs7.2.2

Design inputs7.3.2

Design process

phases and reviews

7.3.4



Product&

Process




Additional considerations such as: Resources (capital, equipment, people) Process capability PFMEA

67

Analyze Process Data to Find and Analyze Process Data to Find and Act on OpportunitiesAct on OpportunitiesUse Simple Use Simple

Analytical ToolsAnalytical Tools

Effect

man

materials machinemethods

measurement

Ishikawa Cause and Effect Fishbone DiagramsIshikawa Cause and Effect Fishbone Diagrams

68

Analyze Data to Find and Act on Analyze Data to Find and Act on OpportunitiesOpportunitiesUse Simple Use Simple

Analytical ToolsAnalytical Tools

WrongViscosity

man

machinemethods

Training

Experience

Reactor age

Manual controls

Flow rate

Temperature settings

materials

Age of feedstock

Feed stockcontamination

measurement

Measurement capability

Gages out of calibration

69

Analyze Data to Find and Act on Analyze Data to Find and Act on OpportunitiesOpportunitiesUse Simple Analytical Use Simple Analytical

ToolsTools

YCustomer

Requirement

XProcess Variable

70


ToolsTools

X1Reactor

Temperature

X2FeedstockChemistry

(% Contaminant)

X3FlowRateGPM

YCustomer

Requirement

X iProcess Variable

Viscosity

71


ToolsTools

YCustomer

Requirement Viscosity

X 2FeedstockChemistry

(% Contaminant)

RangeCustomer

Needs

OurRange

(Tolerance)

New Range(Tolerance)

72


ToolsTools

YCustomer

Requirement Viscosity

X 3FlowRate

(GPM)

RangeCustomer

Needs

New Range

OurRange

(Tolerance)

73

Improvement Improvement Administrative Administrative

Distribution representing a reports delivery process > too many defects (unhappy customers) + mean too high (3.2 weeks): how to improve within the (green) limits?

Time to complete quarterly financial report (annual statistics)

Defects: Unacceptable to shareholders who expect report within 4 weeks max (voice of customers)

A

F

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q

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3

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2

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4

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5

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6

w

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Exceeds expectations unnecessarily

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Improvement Improvement -- Administrative Administrative

A

F

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q

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c

y

3

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k

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2

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B

2 possible improvements: 1) Mean A to B = Move the mean to the left

Remove defects

Reduce variability =

Process more robust =

Process under control

2) Curve A to Curve B = Reduce variations

Time to complete quarterly financial report (annual statistics)

75

Six SigmaSix Sigma(sigma):(sigma):

SStatisticaltatistical unit of measurement that defines the unit of measurement that defines the standard deviationstandard deviationof a population. (Definition: Point of inflection on the normaof a population. (Definition: Point of inflection on the normal curve.)l curve.)

MMeasure of variability easure of variability or spread of the data, that indicates how or spread of the data, that indicates how much of the data falls within the customersmuch of the data falls within the customers requirements. The requirements. The higher the process sigma, the more of the process outputs, produhigher the process sigma, the more of the process outputs, products cts and services, meet customersand services, meet customers requirements requirements or, the fewer the or, the fewer the defects. defects.

6 Sigma means the population is within the +/6 Sigma means the population is within the +/-- 6 x standard 6 x standard deviation limits deviation limits (*). (*). What is not within these limits is called What is not within these limits is called defectdefect..

1 6

* with 1.5 Sigma shift

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Three Basic Six Sigma MethodsThree Basic Six Sigma MethodsDMAICDMAIC The most common The most common

6 Sigma 6 Sigma To To improve an improve an

existing processexisting process Define > Measure > Define > Measure >

Analyse > Improve Analyse > Improve > Control> Control

Focuses on Focuses on real real problemsproblems directly directly related to the related to the bottombottom--lineline

Start realizing Start realizing results after results after 6 6 monthsmonths

DMEDI (DFSS)DMEDI (DFSS)Focuses on Focuses on

development of development of new new productsproducts, services, , services, processes, and processes, and plants that precisely plants that precisely meet customer meet customer current and future current and future needsneedsDefine > Measure > Define > Measure >

Explore > Develop > Explore > Develop > ImplementImplement

LEAN 6 SIGMALEAN 6 SIGMA An approach & set of An approach & set of

tools to tools to improve supply improve supply chain responsivenesschain responsiveness, , as a mix of lean as a mix of lean manufacturing (manufacturing (KanbanKanban, , 5S, JIT) and 6 Sigma5S, JIT) and 6 Sigma

5 principles5 principles: Value, : Value, Value stream, Flow, Value stream, Flow, Pull, PerfectionPull, Perfection

Reduction of lead, cycle Reduction of lead, cycle time, throughput, WIP, time, throughput, WIP, waste > waste > VelocityVelocity

Can achieve results in Can achieve results in few weeksfew weeks

7 zeros7 zeros: Defects, : Defects, Excess, Set ups, Excess, Set ups, Breakdowns, Handling, Breakdowns, Handling, Lead times, SurgingLead times, Surging

Utilizes multiple tools and techniques including rigorous statistical methods

Sustains improvement over the long-term Disseminates improvement throughout the

organization Acts as an agent of change

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8.2.3 Monitoring and measurement of processes8.2.3 Monitoring and measurement of processes Apply suitable measures to processes as necessary Apply suitable measures to processes as necessary

to:to: meet customer requirementsmeet customer requirements demonstrate process continuing ability to satisfy its intended demonstrate process continuing ability to satisfy its intended

purposepurpose take appropriate correction and corrective action for take appropriate correction and corrective action for

nonconforming processes to ensure conforming productnonconforming processes to ensure conforming product Measures become an input to improve processesMeasures become an input to improve processes

Clause 8.2Clause 8.2 Monitoring and Monitoring and measurement measurement

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8.2.38.2.3 Monitoring and Monitoring and measurement of measurement of

processesprocesses Organization shall monitor & measure Organization shall monitor & measure

the QMS processesthe QMS processesDo processes achieve results?Do processes achieve results?Do they perform as intended?Do they perform as intended?

If not, then correct.If not, then correct.

Do our processes work?Do our processes work?

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8.2.4 Monitoring and measurement of 8.2.4 Monitoring and measurement of productproduct

Apply suitable measures to characteristics of Apply suitable measures to characteristics of products to verify the requirements for the products to verify the requirements for the product are metproduct are met

Maintain records to:Maintain records to: provide evidence of required measurement, monitoring, provide evidence of required measurement, monitoring,

and conformance and conformance indicate authority responsible for release of the product indicate authority responsible for release of the product

Release product only after all activities Release product only after all activities completedcompleted

Clause 8.2Clause 8.2 Monitoring and Monitoring and measurement measurement

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8.3 Control of nonconforming product8.3 Control of nonconforming product Identify and control nonconforming product to Identify and control nonconforming product to

prevent unintended use or deliveryprevent unintended use or delivery Deal with nonconforming product in one of three Deal with nonconforming product in one of three

ways:ways: eliminate the nonconformityeliminate the nonconformity authorize use under concession by relevant authorityauthorize use under concession by relevant authority take action to preclude original intended usetake action to preclude original intended use

Take appropriate action regarding consequences Take appropriate action regarding consequences of nonconformity found after product is delivered of nonconformity found after product is delivered or is in useor is in use

Clause 8 MClause 8 Measurement, analysis, easurement, analysis, and improvementand improvement

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7.5.37.5.3 Identification and traceabilityIdentification and traceability Suitable identification throughout Suitable identification throughout

production as appropriateproduction as appropriate Identify measuring and monitoring Identify measuring and monitoring

status of productstatus of product Record unique identification where Record unique identification where

traceability is requiredtraceability is required

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7.5.47.5.4 Customer propertyCustomer property Exercise care with customer property Exercise care with customer property

under the organizationunder the organizations controls control Identify, verify, protect and maintainIdentify, verify, protect and maintain Record and report loss or damage to customer Record and report loss or damage to customer

propertypropertyApplies to all customer property not just customer supplied product considerations include:

Customer provided product

Customer provided tooling, equipment and facilities

Customer provided intellectual property

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7.5.5 Preservation of product 7.5.5 Preservation of product Preserve conformity of product during Preserve conformity of product during

processing and delivery includingprocessing and delivery including identification identification handlinghandling packagingpackaging storagestorage protectionprotection

Control extends to constituent partsControl extends to constituent parts

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Clause 7.6Clause 7.6 Control of monitoring and Control of monitoring and measuring devicesmeasuring devices

Control, calibrate and maintain Control, calibrate and maintain measuring and monitoring measuring and monitoring devices used to assure devices used to assure conformance of product and conformance of product and service service

Measurement carried out in a Measurement carried out in a way consistent with way consistent with requirementsrequirements

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Clause 7.6Clause 7.6 Control of monitoring and Control of monitoring and measuring, measuring, continuedcontinued

Where applicable equipment must be:Where applicable equipment must be: Calibrated at intervals using traceable devices; Calibrated at intervals using traceable devices;

record calibration resultsrecord calibration results Adjusted as necessaryAdjusted as necessary Protected from damage and deteriorationProtected from damage and deterioration Identified to determine calibration statusIdentified to determine calibration status

Take action on equipment and product if Take action on equipment and product if equipment found not to conformequipment found not to conform

Confirm ability of monitoring and Confirm ability of monitoring and measurement software prior to usemeasurement software prior to use

ISO 10012 may be used as guidanceISO 10012 may be used as guidance

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Measurement AccuracyMeasurement AccuracyFour Four SituationsSituations

Centered & PreciseAccurateIndividual

Measurements

Centered But NotPrecise

Low Probability ofAccurate Individual

Measurement

PreciseBut Not CenteredLow Probability ofAccurate Individual

Measurement

Not PreciseAnd Not CenteredLow Probability ofAccurate Individual

Measurement

Target center is the actual value

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1.1. Form small groups of three to fiveForm small groups of three to five2.2. Are your product production and service Are your product production and service

provision processes provision processes consistently consistently delivering what the customer requires, delivering what the customer requires, needs, wants?needs, wants?

3.3. What about What about outsourcedoutsourced processes?processes?4.4. What needs to be improved?What needs to be improved?5.5. We will call on some to report to the We will call on some to report to the


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Quality management Quality management principlesprinciples

Customer focusCustomer focus LeadershipLeadership Involvement of peopleInvolvement of people Process approachProcess approach System approach to managementSystem approach to management Continual improvementContinual improvement Factual approach to decision makingFactual approach to decision making Mutually beneficial supplier relationshipMutually beneficial supplier relationship

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Quality management principlesQuality management principles

Customer FocusCustomer Focus

Organizations depend on their Organizations depend on their customers and therefore should customers and therefore should understand current and future understand current and future customer needs, should meet customer needs, should meet customer requirements, and strive to customer requirements, and strive to exceed customer expectations.exceed customer expectations.

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understanding the whole range of understanding the whole range of customer needs and expectations for customer needs and expectations for products, delivery, price, dependability, products, delivery, price, dependability, etc.etc.

measuring customer satisfaction and measuring customer satisfaction and acting on resultsacting on results

Customer Focus leads an organization to:Customer Focus leads an organization to:

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Some things to think aboutSome things to think about Have we identified the processes required for product Have we identified the processes required for product

realization?realization? Inputs and outputsInputs and outputs ActivitiesActivities MeasuresMeasures ControlsControls Etc.Etc.

Do we really have controlDo we really have controlare we managing all the are we managing all the realization processes and their interactions so that we realization processes and their interactions so that we meet requirements?meet requirements?

Is everything we do really focused on meeting customer Is everything we do really focused on meeting customer requirements, needs, wants?requirements, needs, wants?

ISO 9000:2000 Clause 7 Product RealizationAnalysis and ImplementationIntegrated process managementConsistent Pair of QMS StandardsThe Consistent TrioContinual Improvement: Incremental and BreakthroughContinual Improvement: Incremental and BreakthroughBusiness BasicsOutput matters: ScopeOutput matters: Top managersClause 5Output matters: ResourcesClause 6Output matters: Product realizationClause 7 cont.Clause 4 Quality management system 4.1 General requirements4.1 General RequirementsChart the Basic Processes of the SystemPurpose Of Process ManagementControlClause 5 Management responsibility5.4 PlanningClause 5 Management responsibilityPlanning the QMS (Clause 4.1 & 5.4)Clause 7 Product realization Clause 7 Product realizationClause 7 Product realizationClause 7.1 Planning of product realizationClause 7.1 Planning of product realization, continuedPlanning Product Realization (Clause 7.1)Typical Planning OutputsDiscussion GroupsClause 7.2 Customer-related processesClause 7.2 Customer-related processes8.2.1 Customer satisfaction8.2.1 Customer satisfactionOne ApproachExamples of the Voice of the CustomerDiscussion GroupsClause 7.3 Design and developmentClause 7.3 Design and development Clause 7.3 Design and development Clause 7.3 Design and development Clause 7.3 Design and development Clause 7.3 Design and developmentUse Appropriate Tools ISO 9004:2000 Clause 7.3.1Using Failure Mode and Effects AnalysisClause 7.3 Design and developmentDiscussion GroupsClause 7.4 PurchasingClause 7.4 PurchasingClause 7.4 PurchasingClause 7.4 PurchasingDiscussion GroupsClause 7.5 Production and service provisionClause 7.5 Production and service provisionClause 7.5 Production and service provisionClause 7.5 Production and service provisionUse clause 7.1 note 2Analyze Process Data to Find and Act on OpportunitiesUse Simple Analytical ToolsAnalyze Data to Find and Act on OpportunitiesUse Simple Analytical ToolsAnalyze Data to Find and Act on OpportunitiesUse Simple Analytical ToolsAnalyze Data to Find and Act on OpportunitiesUse Simple Analytical ToolsAnalyze Data to Find and Act on OpportunitiesUse Simple Analytical ToolsAnalyze Data to Find and Act on OpportunitiesUse Simple Analytical ToolsImprovement Administrative Improvement - Administrative Six SigmaThree Basic Six Sigma MethodsClause 8.2 Monitoring and measurement 8.2.3Monitoring and measurement of processesClause 8.2 Monitoring and measurement Clause 8 Measurement, analysis, and improvementClause 7.5 Production and service provisionClause 7.5 Production and service provisionClause 7.5 Production and service provisionClause 7.6 Control of monitoring and measuring devices Clause 7.6 Control of monitoring and measuring, continuedMeasurement AccuracyFour SituationsDiscussion GroupsQuality management principlesCustomer Focus leads an organization to:Some things to think about

Análisis y Presentación Cláusula 7 de la ISO 9001

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