Quality management systems – Requirements 6 Planning 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes In Clause 9: the organization is required to consider risks and opportunities when determining what needs to be monitored, measured, analyzed and evaluated In Clause 4: the organization is required to determine risks that can affect its ability to meet objectives” In Clause 6: the organization is required to plan and take action to address risks and opportunities Risk The concept of “Risk” is emphasized in new edition of ISO 9001, especially when used in relation to function of organizational planning. Evaluation of risk; Planning for risk; What is acceptable? What is unacceptable? What is the probability? What is severity? How to avoid, mitigate or eliminate risk? Opportunities Encountered problems can be considered as an opportunity for improvement. Of course there are other ways to find opportunities. We can use special tools like SWOT analysis to list both opportunities and risks (see example in chapter 5). To implement requirements in clause 6.1 we can use different tools like SWOT for identification of risk and opportunities, FMEA to define actions to avoid, mitigate or eliminate risk or some other tool. In Clause 5: top management are required to commit to ensuring Clause 4 is followed In Clause 8: the organization is required to have processes which identify and address risk in its operations In Clause 10: the organization is required to improve by responding to changes in risk and opportunities

6.1 Inventive principles that address risk and risk based thinking There are several inventive principles in TRIZ that address risk and risk based thinking: #9 Preliminary Anti-action (failure analysis and prevention techniques); #10 Preliminary action (preparing in advance like preventive maintenance); #11 Beforehand Cushioning (prepare emergency beforehand to increase reliability of the system); #22 Blessing in Disguise (how to avoid, block or eliminate effects of harmful functions); #39 Inert Atmosphere (i.e. risk based audit); #40 Composite materials (dealing with risk using combination of different tools). One of very useful TRIZ tools is Anticipatory Failure Determination (AFD)which is a tool for analyzing, predicting and eliminating failures in systems, products, and processes.  References: Svetlana Visnepolschi, How to Deal with Failures (The Smart Way), 2008-2010 Ideation International Inc., http://whereinnovationbegins.net/afd/AFD-intro-20.pdf Stan Kaplan, Svetlana Visnepolschi, Boris Zlotin and Alla Zusman, New Tools for Failure and Risk Analysis Anticipatory Failure Determination (AFD) and the Theory of Scenario Structuring, Ideation International Inc. 2005, ISBN 1-928747-0-51, http://www.ideationtriz.com/new/materials/AFDNewToolsbook.pdf Philip B. Crosby explaining what should top management do for reliable organization

TRIZ tools for RISK management References: Svetlana Visnepolschi, How to Deal with Failures (The Smart Way), 2008-2010 Ideation International Inc., http://whereinnovationbegins.net/afd/AFD-intro-20.pdf Stan Kaplan, Svetlana Visnepolschi, Boris Zlotin and Alla Zusman, New Tools for Failure and Risk Analysis Anticipatory Failure Determination (AFD) and the Theory of Scenario Structuring, Ideation International Inc. 2005, ISBN 1-928747-0-51, http://www.ideationtriz.com/new/materials/AFDNewToolsbook.pdf Separate conflicting requirements using “SEPARATION PRINCIPLES” “TRIM” a system of unnecessary elements (less parts, higher reliability of a system) Use “Anticipatory Failure Determination “(AFD) tool to identify possible failure points in a system.

EXAMPLE: how to reduce risk of Alcohol related traffic fatalities Solution could be: DON’T DRINK AND DRIVE Example above shows how to use segmentation principles to separate causes of problem and how to identify which inventive principles can be used as sources for solution. Select separation between conditions principle These inventive principles have been used by inventors to solve similar problems.

6.2 Quality objectives and planning to achieve them We are going to show how QMS operates on strategic and operational level using PDCA approach. Each management level is using its’ own PDCA loop. Both loops are connected and synchronized by information exchange.

P D C A QMS Top management Process owners Plan: establish the objectives of the system and its processes, and the resources needed to deliver results in accordance with customers' requirements and the organization's policies;

P D C A QMS Top management Process owners Do: implement what was planned;

P D C A QMS Top management Process owners Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives and requirements and report the results;

P D C A QMS Top management Process owners Act: take actions to improve performance, as necessary.

Business plan with quality objectives QMS Top management Process owners 5.2 Quality policy 8.1 Target values P 6.1 and 6.2 Business plan with quality objectives 8.1 Action plan 6.1 Quality plan Actions FMEA, SWOT D Top management shall establish, implement and maintain a quality policy and establish quality objectives at relevant functions, levels and processes needed for the quality management system. C A

Business plan with quality objectives QMS Top management Process owners 5.2 Quality policy 8.1 Target values P 6.1 and 6.2 Business plan with quality objectives 8.1 Action plan 6.1 Quality plan Actions FMEA, SWOT D The organization shall plan actions to address these risks and opportunities. C A

P D C A QMS Top management Process owners Quality policy Target values 5.2 Quality policy 8.1 Target values P 6.1 and 6.2 Business plan with quality objectives 8.1 Action plan Actions 6.1 FMEA, SWOT Quality plan Managing organization according to Quality policy and objectives D 8.2 to 8.5 Operations as planned The organization shall plan, implement and control the processes needed to meet the requirements for the provision of products and services C A

P D C A QMS Top management Process owners Quality policy Target values 5.2 Quality policy 8.1 Target values P The organization shall implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met and control nonconforming output. 6.1 and 6.2 Business plan with quality objectives 10.2 8.1 Corrective actions Action plan Actions 6.1 FMEA, SWOT Quality plan 9.1.3 Managing organization according to Quality policy and objectives Analyzing data D 8.2 to 8.5 8.7 Operations as planned Control of nonconformities Check 8.6 Check Nonconformance C 9.2 Internal audits A Customers

P D C A QMS Top management Process owners Quality policy Target values 5.2 Quality policy 8.1 Target values P 6.1 and 6.2 Business plan with quality objectives 10.2 8.1 Corrective actions Action plan Top management shall review the organization's QMS, at planned Intervals. Actions 6.1 FMEA, SWOT 6.1 Quality plan 9.1.3 Managing organization according to Quality policy and objectives Analyzing data D 8.2 to 8.5 8.7 Operations as planned Control of nonconformities Check 8.6 Check Nonconformance C 9.2 Internal audits 9.3 Management review Analyzing results and action taking A Customers 9.3.3 9.1.2

P D C A QMS Top management Process owners Quality policy Target values 5.2 Quality policy 8.1 Target values P 6.1 and 6.2 Business plan with quality objectives 10.2 8.1 Corrective actions Action plan Actions 6.1 FMEA, SWOT Quality plan 9.1.3 Managing organization according to Quality policy and objectives Analyzing data D 8.2 to 8.5 8.7 Operations as planned Control of nonconformities Check 8.6 Check Nonconformance C 9.2 Internal audits 9.3 Management review Analyzing results and action taking A Customers 9.3.3 9.1.2

Practical example PLAN DO CHECK ACT Company owners Top management Process owners Project manager and experts Corrective & preventive actions Quality policy C Business plan with quality objectives A NOT OK PLAN Approval Targets Analysis of NC OK Approved business plan Process plan Action plan Work according to plan Work according to plan DO Work according to plan Non conformance Checking Checking Quarterly Checking monthly CHECK Prototype production (vendor) Audit report Auditing Non conformance C A Checking Analyzing results Monthly Quarterly Customer Annual report Non conformance ACT Annual management review Checking Customer satisfaction feedback Analysis of customer perception of quality