Creating Product and Process Control Systems

Product and ProcessControl Systems

Product-Process Control * .PPT

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Product-Process Control * .PPTAssure that your companys products are meeting the needs of customers with regard to quality and that company suppliers are meeting internal company requirements.Validate and/or map the current processes for the selected products.Evaluate whether the current product and process controls that are in place are able to meet these needs.Identify optimized or new Critical to Quality Critical to Customer requirements for the vital few needs and assure that an effective process control system control plan is in place for the selected products and sub-components to assure customer and company needs are satisfied.Understand the relationship of CCRs (Critical Customer Requirements) to KPCs (Key Product/Process Characteristics) and the process to identify KCCs (Key Control Characteristics).Create small process control teams that will optimize existing or create Product and Process Control Systems for the selected products.Schedule time over the next few weeks to begin the process of improving the process controls and metrics defined in the control systems.

Purpose



Product-Process Control * .PPTAgree on Common DefinitionsThe purpose of an organization is to meet the needs of its customers at the lowest optimum cost. It creates products.

Products can be goods, services, or information. Products are produced by processes.

A process is a sequence of events or tasks that create an output: a product. A process includes everything involved at each step: people, techniques, equipment, materials, energy, facilities, etc.

A customer is one who receives the output of a process or any step in a process.

External customers are a cast of characters located beyond your organization.



Product-Process Control * .PPTAn internal customer is one who is located within your organization.

Meeting the needs of internal customers is a prerequisite for meeting the needs of external customers AS LONG AS IT DOES NOT SUB-OPTIMIZE the external customersManagement must meet both sets of needs.

Quality is measured by the extent to which the specific needs ofspecific customers are met.

Process outputs embody both product features and deficiencies.

Process variation is any change to the process that negatively impacts our ability to meet the needs of our customers.

Agree on Common Definitions



Product-Process Control * .PPTHow Do CCRs Relate to KPCsKPCCCRCCRKPC



Product-Process Control * .PPTA KEY characteristic is a product characteristic for which reasonably anticipated variation could significantly affect a products safety, compliance to government regulations, performance, or fit.LSLUSLUSLLSLStd.KPCTaguchi Loss FunctionWhat Is a Key Characteristic?




Two kinds of characteristics

ProductKey Product Characteristic (KPC)Safety / Compliance Fit / Function

ProcessKey Control Characteristic (KCC)

Control of a process characteristic will ensure that variation of a product characteristic is reducedKey Characteristic Concepts



Product-Process Control * .PPTA product characteristic for which reasonably anticipated variation could significantly affect:Customer outcomes other than safety/compliance such as:FitFunctionPerformance DurabilityMounting or appearanceAbility to process or build the product

Fit/Function Key Product Characteristics



Product-Process Control * .PPTA product characteristic for which reasonably anticipated variation could significantly affect:Product SafetyCompliance with Governmental Standards and RegulationsEmissionsEnvironmental

Safety/Compliance Characteristics



Product-Process Control * .PPTKey Product Characteristics (KPCs) are outputs from a process that are measurable on, within, or about the product itself. They are the outputs perceived by the customer.

Examples of Key Product Characteristics (KPCs):KPCs "On" The Product - Width, Thickness, Coating Adherence, Surface Cleanliness, Etc.KPCs "Within" The Product - Hardness, Density, Tensile Strength, Mass, Etc.KPCs "About" The Product - Performance, Weight, Etc.

Key Control Characteristics (KCCs) are inputs that affect the outputs (KPCs). They are unseen by the customer and are measurable only when they occur.

Selecting KPCs and KCCs



Product-Process Control * .PPTIdentify the exact step where each KPC is createdDetermine what process characteristic(s) impact the KPC and how they affect KPCsMay require studies (Design of Experiment, PFMEA)These are your Key Control Characteristics (KCC)Determine how to measure those KCCsDetermine how repeatable and reproducible those measurements are (measurement system capability)Determine your process capabilityDevelop your process control systemImplement your process control system

Translate KPCs to Effective KCCs



Product-Process Control * .PPTList of KPCsFMEA (Failure Mode and Effects Analysis)Process Capability StudiesProcess Flow DiagramsDOE (Design of Experiments)Process Control PlansCause-Effect DiagramsPareto Analysis

Tools to Identify KCCs



Product-Process Control * .PPTDimensionsAttributesPropertiesEngineering Specifications/TestsUsageFunction/System FunctionOrientationFit and FinishFeature for a PartA Sub-assemblyA System

KPCs May Be



Product-Process Control * .PPTThe following will determine if a process parameter is or is not a key control characteristic.

A Key Control Characteristic (KCC) is:A process parameter for which variation must be controlled around some target value to ensure that variation in a KPC is maintained around its target values during manufacturing and assembly. A process parameter for which reduction in variation will reduce the variation of a KPC.Directly traceable to a KPC.Particularly significant in ensuring a KPC achieves target value.Not specified on product drawing or product documentation.

KCC Test



Product-Process Control * .PPTPurpose To maintain a specific output of a process at its standard;To assume consistent production;To assure stability;To prevent/correct departure from a specific standard

Product and Process Control Systems



Product-Process Control * .PPTIdentify major work processIdentify objective of the process Describe the work processIdentify customers of the processDiscover customer needs (Critical Customer Requirements)Select control subjects (KPCs and KCCs)

Choose Control Subjects



Product-Process Control * .PPTProcess Map



Product-Process Control * .PPTThe number of control subjects can be overwhelming.

Operating processes are influenced by many variables:Input materialsPhysical facilitiesHuman skillsEnvironmental conditions

Often one variable is more important than all the rest combined. Such a variable is said to be the dominant variable.

Concept of Dominance



Product-Process Control * .PPTDominant Variables

Dominant VariableExampleProcess DescriptionStrategySetupSheet metal stampingStable, reproducible over many cyclesPrecise set up, validationTimeMetal cutting, visual inspectionChange progressivelyPeriodic evaluation or prediction of change, convenient adjustmentWorkerPharmacist dispensing medication, carpenterDynamic, changing according to the situation and skill of workerWorker training, error proofing, periodic evaluationComponentElectrical appliance assembly, dispensing meals at a fast food restaurantInput components to retain identityControl components within supplier organizationInformationOrder entry, airline schedulingDynamic information/decision streamSystem design for accurate, timely information



Product-Process Control * .PPTDominant Process VariablesSet-up dominant: Some processes are highly stable, and their results can be reproduced over many cycles of operation. The design for control should provide the operating forces with the means for precise set-up and the means to validate it before operations begin. A common example is an operation or a printing process.Time-dominant: Here the process is known to change progressively with time, e.g., depletion of consumable supplies, heating up, length of an operation, wear of tools. The design for control should provide means for periodic evaluation of the effect of any progressive change, and for convenient readjustment.Component-dominant: Here the main variable is the quality of the input materials, sub-assemblies, and components. An example is the assembly of complex electronic or mechanical equipment, such as a computer. For the short run, it may be necessary to resort to inspection of materials from a supplier. For the long run, the design for control should be directed at supplier relations, including joint planning with suppliers to upgrade their inputs.Contd.Dominant Variables



Product-Process Control * .PPTWorker-dominant: In these processes, quality depends mainly on the skill and knack possessed by the workers. The skill trades and specialists are well-known examples. The design for control should emphasize aptitude testing of workers; training and certification; quality rating of workers; error-proofing to reduce worker errors.Information-dominant: Here the processes are of a job-shop nature, so that there is frequent change in what product is to be produced. As a result, the job information changes frequently, as in the case of a service department. The design for control should concentrate on providing an information system that can deliver accurate, up-to-date information on just how this job differs from its predecessors.Contd.Dominant Variables



Product-Process Control * .PPTEstablish MeasurementDevelop unit of measureDevelop sensor



Product-Process Control * .PPT98.698.6MeasurementUnit of MeasureA defined amount through which one can evaluate a quality feature in numbers

SensorA method or instrument that can make the measurement



Product-Process Control * .PPTIdeal Unit of MeasureIs understandableProvides an agreed-upon basis for decision-makingIs customer focusedApplies broadly



Product-Process Control * .PPTTechnicalHumanTypes of Sensors



Product-Process Control * .PPTEstablish Standards of PerformanceSet targetsDevelop control methodsSet checking criteria



Product-Process Control * .PPTCriteria for TargetsCustomer focusedAggressive and realisticHelp control the process



Product-Process Control * .PPTWhat will be checkedHow the checking will be doneWhen it will be checkedWho is responsibleDevelop Checking Methods



Product-Process Control * .PPTExample: Baking a Cake



Product-Process Control * .PPTMeasure Actual PerformanceCharter indicatorsDevelop detailed workInstructions



Product-Process Control * .PPTCompare to the StandardsQuality GoalsQuality Manual



Product-Process Control * .PPTTake Action on the DifferenceAnalyze processMake contingency plansTroubleshoot



Product-Process Control * .PPTQualityImprovementQuality PlanningTroubleshootingThree Types of Actions



Product-Process Control * .PPTWork in assigned teams to:Map assigned processes

Analyze processes for accuracy

Review the key processes to define CCRs, KPCs, and KCCs

Utilize a Process Control System Six Sigma Template to document Product and Process Control Systems for the assigned processes

Identify a plan to close the gaps if company and customer requirements are not met

Next Steps



Product-Process Control * .PPTProcess Control System (Business Process Framework)


Creating Product and Process Control Systems

Documents

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