ISO 9001:2015 – how to use TRIZ for QMS design and improvement © 2015 Andrej Trebar Today Quality practitioners are placing considerable emphasis on achieving compliance with QMS standards (i.e. ISO 9001, EN 15224, ISO/TS16949, etc.) which is essential to ensure compatibility in the supply chain. TRIZ is a tool to improve creativity which is needed to help solve difficult problems or predict the future development of systems. Most often it is helpful in situations that present a serious threat to the organization’s survival (i.e. a competitor has better products or services at lower prices, the cost of materials is increasing faster than the prices of our products, or we could improve our market position if we could improve xxx). Predictions about the future form the bases upon which all decisions are made. Any improvement requires the prediction of evolution. This presentation will show how to use TRIZ for improving QMS for achieving better competitively of organizations. ISO 9001:2015 is the main reference used for this presentation. All other sources are given on individual slides on note pages.

PDCA in ISO 9001:2015 Structure PLAN DO CHECK ACT 4 Context of the organization 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance evaluation 10 Improvement Understanding of the organization and its context Leadership and commitment Actions to address risk and opportunity Resources Operations planning and control Monitoring, measurement, analysis and evaluation General Competence Nonconformity and corrective action Policy Quality objectives Awarness Requirements for products and services Expectations of interested parties Roles responsibilities and authorities Internal audit Communication Continual improvement Planning of changes Management review Design and development Documented information Scope of management system The slide above illustrates the clause structure of ISO 9001:2015 in more detail and in the context of the PDCA cycle – starting at clause 4. The following presentation is a brief commentary on those clauses including description of process approach and value definition of quality. Production and service provision Control of externally provided processes, products and services QMS ind its processes Release of products and services Control of nonconforming outputs

Representation of the structure of ISO 9001:2015 Standard in the PDCA cycle Quality Management System (4) Support & Operation (7,8) Plan Do Check Act 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 This diagram is published in ISO 9001:2015 showing structure of standard in PDCA cycle. We are going to use this diagram to show which inventive principles are effective in different clauses of ISO 9001 standard and phases of PDCA cycle. Reference: ISO 9001:2015 Figure 2

Which inventive principles are most effective Quality Management System (4) Support & Operation (7,8) Plan Do Check Act 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 12,14,15,,25,28,24,32,40 7,8,13,15,17,18,21,22,27,29,30,31,35,36,38 3,5,9,10,11,31,33,34,40 The “TRIZ crossover QMS” application was designed as a software tool to improve creative thinking for teams and individuals when designing QMS or improving processes and products and services. It has the role of being a creative booster encouraging users to select inventive principles for solutions and implement the right method for their implementation. Reference: TRIZ training kit, http://www.quality-assurance-solutions.com/TRIZ-training.html 1,2,4,5,9,10,15,16, 22,23,24,33,37,39,40 All 40 inventive principles Reference: ISO 9001:2015 Figure 2

Contents ISO 9001:2015 Introduction 1 Scope 2 Normative references 3 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 TRIZ techniques have been originally designed to be used for solving technical problems. Recently the use of TRIZ has been extended to business and management areas to help organizations to improve: business processes, business models, products and services, quality and productivity, Internal and external communication, competitiveness by improving value cost ratio, business strategies...

Contents Introduction 0.1 General 0.2 Quality management principles 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 Risk based thinking is part of the process approach! Process owner is responsible for planning and assuring results. P PDCA in process approach Requirements are given in ISO 9001:2015, clause 8.1 Operational planning and control.

People in process are executing planed activities 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 8.6 Release of products and services

Customer internal or external 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 D C feedback 8.7 Control of nonconforming outputs A

Customer satisfaction 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. Customer Products and/or services P D C feedback 9.1.2 Customer satisfaction The organization shall monitor customers‘ perceptions of the degree to which their needs and expectations have been fulfilled. A feedback Customer satisfaction A

0.3 Process approach A P D C A A First of all customer requirements, needs and expectations are gathered and analyzed. Customer Requirements, needs and expectations feed forward A Products and/or services P D C feedback 8.2.1 Customer communication (internal or external) Determination of requirements related to products and services. A feedback Customers’ satisfaction A

0.3 Process approach A P D C A A Customer Business plan Requirements, needs and expectations Business plan A Products and/or services P D C From ISO 9001:2015 Clause 0.3.1 General: Specific requirements considered essential to the adoption of a process approach are included in 4.4. The process approach involves the systematic definition and management of processes, and their interactions, so as to achieve the intended results in accordance with the quality policy and strategic direction of the organization (represented on figure above as “Business plan”). A Customers’ satisfaction Process owner shall align process goals to company goals … A

0.3 Process approach A P D C A A Customer Business plan Requirements, needs and expectations Business plan A Products and/or services Statutory & Regulatory requirements P D C See requirement ISO 9001:2015 in 4.2 Understanding the needs and expectations of interested parties. A Customers’ satisfaction … process owner shall ensure process to meet applicable statutory and regulatory Requirements, … A

0.3 Process approach A P D C A A Customer Business plan … Requirements, needs and expectations Business plan A Products and/or services Statutory & Regulatory requirements P D C Other processes (internal or external) can be considered as interested parties (see clause 4.2 Understanding the needs and expectations of interested parties). A Requirements of other processes Customers’ satisfaction A … … and coordinating his/hers plans to plans of other processes.

0.3 Process approach A P D C A A Measurements of process effectiveness Customer Requirements, needs and expectations Business plan A Products and/or services Statutory & Regulatory requirements P D C The effectiveness of the process lies in being able to provide the desired output as needed by the Organization (defined as a goal in Business plan) and its’ Customer (defined in customers requirements). (Are we doing the right things?) From the ISO 9’001:2015, clause 0.3.1: The application of the process approach in a quality management system enables: understanding and consistency in meeting requirements; b) the consideration of processes in terms of added value; c) the achievement of effective process performance; d) improvement of processes based on evaluation of data and information. A Requirements of other processes Customers’ satisfaction A

0.3 Process approach A P D C A A Measurements of process effectiveness Goals planned Goals achieved Customer Measurement of process efficiency Requirements, needs and expectations Business plan A Resources planned Resources used Products and/or services Statutory & Regulatory requirements P D C A process characteristic indicating the degree to which the process produces the required output at minimum resource cost. (Are we doing things right?) A Requirements of other processes Customers’ satisfaction A

0.3 Process approach A P D C A A Measurements of process effectiveness Goals planned Goals achieved Customer Measurement of process efficiency Requirements, needs and expectations Business plan A Resources planned Resources used Products and/or services Statutory & Regulatory requirements P D C NCR NCR – Non Conformance Request: Measuring how many NCR were issued and what was the cost of correcting nonconformity. SCI – Customer Satisfaction Index: How are our customers (internal and external) satisfied with result of our process. A Requirements of other processes CSI Customers’ satisfaction A

Using TRIZ to detect N.C. A P D C A A Worsening features Nonconforming product is produced here Worsening features Measurements of process effectiveness Goals planned Goals achieved Customer Measurement of process efficiency Nonconforming product is not detected here Requirements, needs and expectations Business plan A Resources planned Resources used Products and/or services Statutory & Regulatory requirements P D C NCR A Requirements of other processes CSI Customers’ satisfaction A Improving speed and productivity Improving features 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. To improve speed and productivity, operator is replaced by a robot. Metal chips that were generated by process are adverse factor jamming the system. Previously they were removed manually by operator, introducing robot they should be removed by some other means. 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. We are going to use Inventive problem solving procedure of TRIZ crossover QMS application. Firs step: Problem determination – described on previous page. Second step: Determination of system contradictions – improving the speed of process metal chips are clogging the lathe. Third step: Formulate an ideal solution – elimination of the harmful function (clogging) without introducing additional resources. Fourth step: Identify sources for solution – using inventive principles #2, 24, 35, 21 and gravitation field. Fifth step: Determine the “strength” of the solutions and choose the best one – turning lathe upside down. Sixth step: Predict the development of the system considered within the problem – use the same solution for other similar operations Seventh step: Analyze the solution process – the process change has enabled us to use gravity as free resource. Other proposed solutions were based on introducing mechanical approach to removing metal chips (based on brush, blowing and magnetic mechanism). 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 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 Action

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. To improve speed and productivity, operator is replaced by a robot. Metal chips that were generated by process are adverse factor jamming the system. Previously they were removed manually by operator should be removed by some other means. Reference: Jack Hipple, Using TRIZ to make systems more reliable, http://media.asq.org/103239/web.mp4 Metal chips are collected periodically for recycling.