Product and Process Control Systems

Product and Process

Control Systems

All Rights Reserved, Juran Institute, Inc. Product-Process Control 2 .PPT

1. Assure that your company’s products are meeting the needs of customers with regard to quality and that company suppliers are meeting internal company requirements.

2. Validate and/or map the current processes for the selected products.3. Evaluate whether the current product and process controls that are in place

are able to meet these needs.4. 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.

5. Understand the relationship of CCRs (Critical Customer Requirements) to KPCs (Key Product/Process Characteristics) and the process to identify KCCs (Key Control Characteristics).

6. Create small process control teams that will optimize existing or create Product and Process Control Systems for the selected products.

7. Schedule time over the next few weeks to begin the process of improving the process controls and metrics defined in the control systems.

Purpose


Agree on Common Definitions

The 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.


An 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 customers

Management 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


All…Are…

Not all…Are…

How Do CCRs Relate to KPCs

KPCCCR

CCRKPC


A KEY characteristic is a product characteristic for which reasonably anticipated variation could significantly affect a product’s safety, compliance to government regulations, performance, or fit.

LSL USL USLLSLStd. KPC

Taguchi Loss Function

What Is a Key Characteristic?


1. Two kinds of characteristics

a. Product Key Product Characteristic (KPC)

– Safety / Compliance – Fit / Function

b. Process Key Control Characteristic (KCC)

2. Control of a process characteristic will ensure that variation of a product characteristic is reduced

Key Characteristic Concepts


A product characteristic for which reasonably anticipated variation could significantly affect: Customer outcomes other than safety/compliance such

as:– Fit– Function– Performance – Durability– Mounting or appearance– Ability to process or build

the productFit / Function

Standard Product Characteristics

Product Characteristic Pyramid

Fit / Function Symbol

Fit/Function Key Product Characteristics


A product characteristic for which reasonably anticipated variation could significantly affect: Product Safety Compliance with Governmental Standards and

Regulations– Emissions– Environmental

Fit / Function

Standard Product Characteristics

Product Characteristic Pyramid

Safety/ComplianceSymbol

Safety/Compliance Characteristics


Key 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


1. Identify the exact step where each KPC is created2. Determine what process characteristic(s) impact the KPC and

how they affect KPCsa. May require studies (Design of Experiment, PFMEA)b. These are your Key Control Characteristics (KCC)

3. Determine how to measure those KCCs4. Determine how repeatable and reproducible those

measurements are (measurement system capability)5. Determine your process capability6. Develop your process control system7. Implement your process control system KPC

KCCKCC

KCC KCC

Translate KPCs to Effective KCCs


List of KPCs FMEA (Failure Mode and Effects Analysis) Process Capability Studies Process Flow Diagrams DOE (Design of Experiments) Process Control Plans Cause-Effect Diagrams Pareto Analysis

Tools to Identify KCCs


Dimensions Attributes Properties Engineering Specifications/Tests Usage Function/System Function Orientation Fit and Finish Feature for a Part

A Sub-assembly A System

KPCs May Be…


The 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


Purpose

To maintain a specific output of a process at it’s standard;

To assume consistent production;

To assure stability; To prevent/correct departure

from a specific standard

CONTROL SUBJECT

(Specific attribute or variable to be

controlled)

SENSOR(Device and/or

person measuring the control subject)

STANDARD(Specification, target value)

ACTUATOR(Adjusts the

process)

UMPIRE(Does control

subject meet the standard?)

End of One Cycle

OK

NOT OK

Product and Process Control Systems


EstablishMeasurement

EstablishStandards ofPerformance

Measure ActualPerformance

Compare tothe Standards

Take Actionon the Difference

OK?

Not OK?

Choose ControlSubjects

Identify major work process

Identify objective of the process

Describe the work process

Identify customers of the process

Discover customer needs (Critical Customer Requirements)

Select control subjects (KPCs and KCCs)

Choose Control Subjects


YesLong list of

items?

Go to supermarket

Get shopping cart

Shop

More thanten items?

Leave store

Go to any check-out

Put grocerieson conveyor

Pay for groceries Receipt

No

No

Yes

Yes

Pick upbasket

Go toexpress

lane

Process Map


The number of control subjects can be overwhelming.

Operating processes are influenced by many variables: Input materials Physical facilities Human skills Environmental 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


Dominant Variables

Dominant Variable

Example Process Description

Strategy

Setup Sheet metal stamping Stable, reproducible over many cycles

Precise set up, validation

Time Metal cutting, visual inspection

Change progressively Periodic evaluation or prediction of change, convenient adjustment

Worker Pharmacist dispensing medication, carpenter

Dynamic, changing according to the situation and skill of worker

Worker training, error proofing, periodic evaluation

Component Electrical appliance assembly, dispensing meals at a fast food restaurant

Input components to retain identity

Control components within supplier organization

Information Order entry, airline scheduling

Dynamic information/decision stream

System design for accurate, timely information


Dominant Process Variables Set-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.

Cont’d.

Dominant Variables


Worker-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.

Cont’d.

Dominant Variables


Establish Measurement






OK?

Not OK?


Develop unit of measure Develop sensor


98.698.6

Measurement

Unit of MeasureA defined amount through which one can evaluate a quality feature in numbers

SensorA method or instrument that can make the measurement


Ideal Unit of Measure

Is understandable Provides an agreed-upon basis for

decision-making Is customer focused Applies broadly


Technical

Human

Types of Sensors







OK?

Not OK?


Establish Standards of Performance

Set targets Develop control methods Set checking criteria


Criteria for Targets

Customer focused Aggressive and realistic Help control the process


What will be checked

How the checking will be done

When it will be checked

Who is responsible

Develop Checking Methods


Temperature(What)

Gauges read(How)

Time(When)

Checked by(Who)

300 degrees Thermometer 11:40 a.m. A. Smith

325 degrees Thermometer 12:20 p.m. B. Jones

Process Indicator: Oven Temperature

Example: Baking a Cake







OK?

Not OK?


Measure Actual Performance

Charter indicators Develop detailed work Instructions


Compare to the Standards






OK?

Not OK?


Quality Goals Quality Manual


Take Action on the Difference






OK?

Not OK?


Analyze process Make contingency plans Troubleshoot


QualityImprovement

Quality Planning

Troubleshooting

Three Types of Actions


Work 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


Process Description:

Flowchart Measuring and Monitoring

Key Measurements

Specs &/or Targets

Measures (Tools)

Where & Frequency

Responsibility(Who)

Contingency (Quick Fix)

Remarks

Process Owner:

CCR:

Direct Process Customer: Date:

Process Control System (Business Process Framework)

Date post:	23-Feb-2016
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Product and Process Control Systems

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