ISO 9001:2015 –how to use TRIZ for QMS design and

improvement

© 2015 Andrej Trebar

PDCA in ISO 9001:2015 Structure

4 Context of the organization

5 Leadership 6 Planning 7 Support 8 Operation9 Performance evaluation

10 Improvement

Understanding of the organization and its context

Expectations of interested parties

Scope of management system

QMS ind its processes

Leadership and commitment

Policy

Roles responsibilities and authorities

Actions to address risk and opportunity

Quality objectives

Planning of changes

Resources

Competence

Awarness

Communication

Documented information

Operations planning and control

Requirements for products and services

Design and development

Production and service provision

Monitoring, measurement, analysis and evaluation

Internal audit

Management review

General

Nonconformity and corrective action

Release of products and services

Control of nonconforming outputs

Continual improvement

PLAN DO CHECK ACT

Control of externally provided processes, products and services

Representation of the structure of ISO 9001:2015 Standard in the PDCA cycle

Quality Management System (4)

Support & Operation

(7,8)

Plan Do

CheckAct

Organization and its context

(4)

Customer requirements

Needs and expectations of

relevant Intersted

parties (4)

Leadership (5)

Planning (6)

Performance evaluation (9)

Improvement (10)

Customer satisfaction

Results of the QMS

Products and services

Reference: ISO 9001:2015 Figure 2

Which inventive principles are most effectiveQuality Management System (4)

Support & Operation

(7,8)

Plan Do

CheckAct

Organization and its context

(4)

Customer requirements

Needs and expectations of

relevant Intersted

parties (4)

Leadership (5)

Planning (6)

Performance evaluation (9)

Improvement (10)

Customer satisfaction

Results of the QMS

Products and services

6,19,20,24,26

1,2,4,5,9,10,15,16,22,23,24,33,37,39,40

All 40 inventive principles

7,8,13,15,17,18,21,22,27,29,30,31,35,36,38

12,14,15,,25,28,24,32,40

3,5,9,10,11,31,33,34,40

Reference: ISO 9001:2015 Figure 2

ContentsISO 9001:2015

0 Introduction

1 Scope

2 Normative references

3 Terms and definitions

4 Context of the organization

5 Leadership

6 Planning

7 Support

8 Operation

9 Performance evaluation

10 Improvement

Contents0 Introduction

0.1 General

0.2 Quality management principles

0.3 Process approach

0.4 Relationship with other management system standards

0.3 Process approach

P

Process owner is responsible for planning

and assuring results.

Risk based thinking is part of the process

approach!

0.3 Process approach

P D

People in process are executing planed

activities

0.3 Process approach

P D C

Results are checked before products and services are delivered

to customer.

0.3 Process approach

P D C

A

Customer internal or

externalIf any nonconformities in products, services or process are detected, they are

analyzed and corrective actions are performed to eliminate nonconformities.

feedback

0.3 Process approach

P D C

A

CustomerWe are monitoring customers’ perception

of the degree to which their needs and expectations have been fulfilled, and

acting upon the results in order to improve their satisfaction.

Customer satisfactionA

Productsand/or

services

feedback

feedback

0.3 Process approach

P D C

A

Customer

First of all customer requirements, needs and expectations are

gathered and analyzed.

Customers’ satisfactionA

Productsand/or

services

Requirements,needs and

expectationsA

feedback

feedback

feed forward

0.3 Process approach

P D C

A

Customer

Process owner shall align process goals to company

goals …

Customers’ satisfactionA

Productsand/or

services

Requirements,needs and

expectationsABusiness

plan

A

0.3 Process approach

P D C

A

Customer

… process owner shall ensure process to meet

applicable statutory and regulatory

Requirements, …

Customers’ satisfaction

Productsand/or

services

Requirements,needs and

expectationsABusiness

plan

Statutory &Regulatory

requirements

Requirementsof other processes A

0.3 Process approach

P D C

A

Customer

…… and coordinating

his/hers plans to plans of other processes.

Customers’ satisfaction

Productsand/or

services

Requirements,needs and

expectationsABusiness

plan

Statutory &Regulatory

requirements

Requirementsof other processes A

0.3 Process approach

P D C

A

Customer

Customers’ satisfaction

Productsand/or

services

Requirements,needs and

expectationsABusiness

plan

Statutory &Regulatory

requirements

Measurements of process effectiveness

Requirementsof other processes A

0.3 Process approach

P D C

A

Customer

Customers’ satisfaction

Productsand/or

services

Requirements,needs and

expectationsABusiness

plan

Statutory &Regulatory

requirements

Measurements of process effectiveness

Measurement of process efficiency

Resourcesplanned

Resourcesused

Goals planned Goals achieved

Requirementsof other processes A

0.3 Process approach

P D C

A

Customer

Customers’ satisfaction

Productsand/or

services

Requirements,needs and

expectationsABusiness

plan

Statutory &Regulatory

requirements

Measurements of process effectiveness

Measurement of process efficiency

Resourcesplanned

Resourcesused

Goals planned Goals achieved

NCR

CSI

Requirementsof other processes A

Using TRIZ to detect N.C.

P D C

A

Customer

Customers’ satisfaction

Productsand/or

services

Requirements,needs and

expectationsABusiness

plan

Statutory &Regulatory

requirements

Measurements of process effectiveness

Measurement of process efficiency

Resourcesplanned

Resourcesused

Goals planned Goals achieved

NCR

CSI

Nonconforming product is

produced here

Nonconforming product is not detected here

Improving speed and productivity

Improving features

Worsening features

Use 39×39 matrix for inventive principles

Using 39×39 matrixImproving features

Worsening features

#9 Speed

#39 Capacity / Productivity

#31 Harmful factors acting developed by an object

#37 Complexity of a control

2, 24, 35, 21

35, 22, 18, 39

3, 34, 27, 16

12, 17, 28, 24

Example: situation as-is

Metal chips are falling into the lathe.

Metal chips are jamming the lathe performing added value operation.

Metal chips are removed by operator. This is not value added operation.

Identification of free resources

GRAVITY

Gravity field is:• free,• reliable,• doesn’t need maintenance.

Gravity field can be used to remove metal chips from machine.

Using 39×39 contradiction matrixImproving

feature

Worsening feature

#9 Speed

#31 Harmful factors acting developed by an object

2, 24, 35, 21

Inventive principle

ActionRemove metal chips from the

system

Use gravity field to remove metal

chips

Change process – turn the lathe upside down

Skip manual removal of metal

chips

Example: situation to-be

Turn the lathe upside down.

Metal chips will be falling out of the system by gravity. This is effective use of gravity field (available for free) for removing metal chips.

Metal chips are collected periodically for recycling.