ISO 9001 2015 how to use TRIZ for

ISO 9001: 2015 – how to use TRIZ for QMS design and improvement © 2015 Andrej Trebar

PDCA in ISO 9001: 2015 Structure PLAN 4 Context of the organization Understanding of the organization and its context Expectations of interested parties Scope of management system QMS ind its processes 5 Leadership and commitment DO 6 Planning 7 Support Actions to address risk and opportunity Resources Quality objectives Awarness Competence Policy Roles responsibilities and authorities Planning of changes Communication Documented information 8 Operation CHECK 9 Performance evaluation Operations planning and control Requirements for products and services Design and development Production and service provision Release of products and services Control of nonconforming outputs Monitoring, measurement, analysis and evaluation Internal audit Management review Control of externally provided processes, products and services ACT 10 Improvement General Nonconformity and corrective action Continual improvement

Representation of the structure of ISO 9001: 2015 Standard in the PDCA cycle Quality Management System (4) Organization and its context (4) Support & Operation (7, 8) Plan Customer requirements Planning (6) Do Leadership (5) Act Needs and expectations of relevant Intersted parties (4) Performance evaluation (9) Check Customer satisfaction Results of the QMS Products and services Improvement (10) Reference: ISO 9001: 2015 Figure 2

Which inventive principles are most effective Quality Management System (4) Organization and its context (4) 12, 14, 15, , 25, 28, 24, 32, 40 Support & Operation (7, 8) Planning (6) Leadership (5) Act Needs and expectations of relevant Intersted parties (4) 7, 8, 13, 15, 17, 18, 21, 22, 27, 29, 30, 31, 35, 36, 38 Do 3, 5, 9, 10, 11, 33, 34, 40 Customer requirements 6, 19, 20, 24, 26 Performance evaluation (9) Check Customer satisfaction Results of the QMS Products and services 1, 2, 4, 5, 9, 10, 15, 16, 22, 23, 24, 33, 37, 39, 40 Improvement (10) All 40 inventive principles Reference: ISO 9001: 2015 Figure 2

Contents ISO 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

Contents 0 Introduction 0. 1 General 0. 2 Quality management principles 0. 3 Process approach 0. 4 Relationship with other management system standards

Risk based thinking is part of the process approach! 0. 3 Process approach Process owner is responsible for planning and assuring results. P

0. 3 Process approach People in process are executing planed activities P D

0. 3 Process approach Results are checked before products and services are delivered to customer. P D C

0. 3 Process approach Customer internal or external If any nonconformities in products, services or process are detected, they are analyzed and corrective actions are performed to eliminate nonconformities. P C D A feedback

0. 3 Process approach We 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. P C D A A Customer Products and/or services feedback Customer satisfaction

0. 3 Process approach First of all customer requirements, needs and expectations are gathered analyzed. Customer A P feed forward C D A A Requirements, needs and expectations Products and/or services feedback Customers’ satisfaction

0. 3 Process approach Customer Business plan Requirements, needs and expectations A P D C Products and/or services A Process owner shall align process goals to company goals … A Customers’ satisfaction

0. 3 Process approach Customer Business plan Statutory & Regulatory requirements Requirements, needs and expectations A P D C Products and/or services A … process owner shall ensure process to meet applicable statutory and regulatory Requirements, … A Customers’ satisfaction

0. 3 Process approach Customer Business plan Statutory & Regulatory requirements Requirements of other processes … … and coordinating his/hers plans to plans of other processes. Requirements, needs and expectations A P D C Products and/or services A A Customers’ satisfaction

0. 3 Process approach Measurements of process effectiveness Customer Business plan Statutory & Regulatory requirements Requirements of other processes Requirements, needs and expectations A P D C Products and/or services A A Customers’ satisfaction

0. 3 Process approach Measurements of process effectiveness Goals planned Business plan Statutory & Regulatory requirements Requirements of other processes Measurement of process efficiency Resources planned Goals achieved Customer Requirements, needs and expectations A Resources used P D C Products and/or services A A Customers’ satisfaction

0. 3 Process approach Measurements of process effectiveness Goals planned Business plan Statutory & Regulatory requirements Requirements of other processes Measurement of process efficiency Resources planned Goals achieved Customer Requirements, needs and expectations A Resources used P Products and/or services C D NCR A CSI A Customers’ satisfaction

Using TRIZ to detect N. C. Nonconforming Measurements of process effectiveness product is Goals planned Goals achieved produced here Resources planned Statutory & Regulatory requirements Requirements of other processes Improving features Customer Measurement of process efficiency Business plan Improving speed and productivity Requirements, Nonconforming needs and product is not expectations detected here A Resources used P Worsening features Products and/or services C D NCR A CSI A Customers’ satisfaction Use 39× 39 matrix for inventive principles

Using 39× 39 matrix Worsening features Improving features #31 Harmful factors acting developed by an object #37 Complexity of a control #9 Speed 2, 24, 35, 21 3, 34, 27, 16 #39 Capacity / Productivity 35, 22, 18, 39 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 matrix Worsening feature Improving feature #31 Harmful factors acting developed by an object #9 Speed 2, 24, 35, 21 Inventive principle Action Remove 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.