Creating Product and Process Control Systems

Transcript Creating Product and Process Control Systems

Product and Process Control Systems

Purpose

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.

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.

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.

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.

customer

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

External customers are a “cast of characters”

beyond your organization.

Agree on Common Definitions

internal

organization.

customer is one who is located within your 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

specific 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.

How Do CCRs Relate to KPCs

All…

KPC

Are…

CCR

Not all…

CCR

Are…

KPC

What Is a Key Characteristic?

KEY

characteristic is a product characteristic for which reasonably anticipated variation

significantly affect could

a product’s safety, compliance to government regulations, performance, or fit.

LSL

Std

USL LSL

KPC

USL

Taguchi Loss Function

Key Characteristic Concepts

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

Fit/Function Key Product Characteristics

A product characteristic for which reasonably anticipated variation could

significantly

affect: 

Customer outcomes

as: other than safety/compliance such – Fit – Function – Performance – Durability – Mounting or appearance – Ability to process or build the product

Fit / Function

Fit / Function Symbol

Standard Product Characteristics

Safety/Compliance Characteristics

A product characteristic for which reasonably anticipated variation could

significantly

affect:  

Product Safety Compliance with Governmental Standards and Regulations

– Emissions – Environmental Safety/Compliance Symbol

Fit / Function Standard Product Characteristics

Selecting KPCs and KCCs

Key Product Characteristics (KPCs)

process that are measurable

are

outputs from a

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.

Translate KPCs to Effective KCCs

1. Identify the exact step where each KPC is created 2. Determine what process characteristic(s) impact the KPC and how they affect KPCs a. May require studies (Design of Experiment, PFMEA) b. These are your Key Control Characteristics (KCC) 3. Determine how to measure those KCCs 4. Determine how repeatable and reproducible those measurements are (measurement system capability) 5. Determine your process capability 6. Develop your process control system

KCC KCC

7. Implement your process control system

KPC KCC KCC

Tools to Identify 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 Product-Process Control 12 .PPT

KPCs May Be…

         Dimensions Attributes Properties Engineering Specifications/Tests Usage Function/System Function Orientation Fit and Finish Feature for a Part  A Sub-assembly  A System Product-Process Control 13 .PPT

KCC Test

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.

Product and Process Control Systems

CONTROL SUBJECT

(Specific attribute or variable to be controlled)

ACTUATOR

(Adjusts the process)  

NOT OK



SENSOR

(Device and/or person measuring the control subject) 

UMPIRE

(Does control subject meet the standard?) 

STANDARD

(Specification, target value)  Product-Process Control 15 .PPT

OK End of One Cycle

Purpose

    To maintain a specific output of a process at it’s standard; To assume consistent production; To assure

stability

Choose Control Subjects Establish Measurement Establish Standards of Performance Measure Actual Performance Compare to the Standards Not OK?

Take Action on the Difference OK?

Choose Control Subjects

      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) All Rights Reserved, Juran Institute, Inc. Product-Process Control 16 .PPT

Go to supermarket Yes Long list of items?

Yes Get shopping cart Shop More than ten items?

Yes Go to any check-out Put groceries on conveyor Pay for groceries Leave store Product-Process Control 17 .PPT

No No Pick up basket

Process Map

Concept of Dominance

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.” All Rights Reserved, Juran Institute, Inc. Product-Process Control 18 .PPT

Dominant Variable

Setup Time Worker Component Information Product-Process Control 19 .PPT

Dominant Variables

Example Process Description Strategy

Sheet metal stamping Stable, reproducible over many cycles Precise set up, validation Metal cutting, visual inspection Pharmacist dispensing medication, carpenter Electrical appliance assembly, dispensing meals at a fast food restaurant Order entry, airline scheduling Change progressively Dynamic, changing according to the situation and skill of worker Input components to retain identity Dynamic information/decision stream Periodic evaluation or prediction of change, convenient adjustment Worker training, error proofing, periodic evaluation Control components within supplier organization System design for accurate, timely information All Rights Reserved, Juran Institute, Inc.

Dominant Variables

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.

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.

Establish Measurement

Choose Control Subjects Establish Measurement Establish Standards of Performance Measure Actual Performance Compare to the Standards Not OK?

Take Action on the Difference OK?

Product-Process Control 23 .PPT

Measurement

Unit of Measure

A defined amount through which one can evaluate a quality feature in numbers

Sensor

Product-Process Control 24 .PPT

Ideal Unit of Measure

Product-Process Control 25 .PPT

Types of Sensors

Technical Human

Establish Standards of Performance

Choose Control Subjects Establish Measurement Establish Standards of Performance Measure Actual Performance Compare to the Standards Not OK?

Take Action on the Difference OK?

Product-Process Control 27 .PPT

Criteria for Targets

Develop Checking Methods

What

will be checked

How

the checking will be done

When

it will be checked

Who

is responsible Product-Process Control 28 .PPT

Example: Baking a Cake

Process Indicator:

Oven Temperature

Temperature (What) Gauges read (How) Time (When) Checked by (Who)

300 degrees Thermometer 325 degrees Thermometer 11:40 a.m.

12:20 p.m.

A. Smith B. Jones Product-Process Control 29 .PPT

Measure Actual Performance

Choose Control Subjects Establish Measurement Establish Standards of Performance Measure Actual Performance Compare to the Standards Not OK?

Take Action on the Difference OK?

Compare to the Standards

Choose Control Subjects Establish Measurement Establish Standards of Performance Measure Actual Performance Compare to the Standards Not OK?

Take Action on the Difference OK?

Take Action on the Difference

Choose Control Subjects Establish Measurement Establish Standards of Performance Measure Actual Performance Compare to the Standards Not OK?

Take Action on the Difference OK?

Three Types of Actions

Troubleshooting

Product-Process Control 33 .PPT

Quality Planning Quality Improvement

Next Steps

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 All Rights Reserved, Juran Institute, Inc. Product-Process Control 34 .PPT

Process Control System (Business Process Framework)

Process Owner: Process Description: Flowchart Direct Process Customer: CCR: Date: Key Measurements Measuring and Monitoring Specs &/or Targets Measures (Tools) Where & Frequency Responsibility (Who) Contingency (Quick Fix) Remarks Product-Process Control 35 .PPT

Creating Product and Process Control Systems

Transcript Creating Product and Process Control Systems

Product and Process Control Systems

Purpose

Agree on Common Definitions

Agree on Common Definitions

How Do CCRs Relate to KPCs

All…

Are…

Not all…

Are…

What Is a Key Characteristic?

Key Characteristic Concepts

Fit/Function Key Product Characteristics

Safety/Compliance Characteristics

Selecting KPCs and KCCs

Translate KPCs to Effective KCCs

Tools to Identify KCCs

KPCs May Be…

KCC Test

Product and Process Control Systems

Choose Control Subjects

Process Map

Concept of Dominance

Dominant Variables

Dominant Variables

Dominant Variables

Establish Measurement

Measurement

Ideal Unit of Measure

Types of Sensors

Technical Human

Establish Standards of Performance

Criteria for Targets

Develop Checking Methods

Example: Baking a Cake

Process Indicator:

Oven Temperature

Measure Actual Performance

Compare to the Standards

Take Action on the Difference

Three Types of Actions

Next Steps

Process Control System (Business Process Framework)

Directory