Quality management systems Requirements 6 Planning 6 1

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 4: the organization is required to determine risks that can affect its ability to meet objectives” In Clause 5: top management are required to commit to ensuring Clause 4 is followed In Clause 6: the organization is required to plan and take action to address risks and opportunities In Clause 8: the organization is required to have processes which identify and address risk in its operations 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 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 Philip B. Crosby explaining what should top management do for reliable organization

TRIZ tools for RISK management • 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 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 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.

Top management P D C A QMS 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; Process owners

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

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

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

Top management QMS Process owners 5. 2 Quality policy P 8. 1 Target values 6. 1 and 6. 2 Business plan with quality objectives 8. 1 6. 1 Actions FMEA, SWOT D C A 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. Action plan Quality plan

Top management QMS Process owners 5. 2 Quality policy P 8. 1 Target values 6. 1 and 6. 2 Business plan with quality objectives 8. 1 6. 1 Actions FMEA, SWOT D C A The organization shall plan actions to address these risks and opportunities. Action plan Quality plan

Top management QMS Process owners 5. 2 Quality policy P 8. 1 Target values 6. 1 and 6. 2 Business plan with quality objectives 8. 1 6. 1 Actions D C A Managing organization according to Quality policy and objectives FMEA, SWOT Action plan Quality plan 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

Top management QMS Process owners 5. 2 Quality policy P D Target values 6. 1 and 6. 2 The organization shall implement Business planatwith planned arrangements, appropriatequality stages, objectives to verify that the product and service requirements have been met and Managing organization control nonconforming output. according to Quality policy and objectives Corrective 10. 2 actions 6. 1 Actions 9. 1. 3 FMEA, Analyzing SWOT data 8. 7 Control of nonconformities Check C 8. 1 Action plan Quality plan 8. 2 to 8. 5 Operations as planned Nonconformance 9. 2 8. 1 8. 6 Check Internal audits A Customers

QMS Top management Process owners 5. 2 Quality policy P D 8. 1 Target values 6. 1 and 6. 2 Business plan with quality objectives Corrective 10. 2 actions 6. 1 Top management shall 6. 1 Actions review the organization's 9. 1. 3 Managing organization FMEA, QMS, at planned Analyzing according to Quality policy SWOT data Intervals. Action plan Quality plan 8. 2 to 8. 5 and objectives 8. 7 Control of nonconformities Check Operations as planned 8. 6 Nonconformance C 9. 2 9. 3 A 9. 3. 3 8. 1 Management review Analyzing results and action taking Check Internal audits 9. 1. 2 Customers

QMS Top management Process owners 5. 2 Quality policy P D 8. 1 Target values 6. 1 and 6. 2 Business plan with quality objectives Managing organization according to Quality policy and objectives 8. 7 Control of nonconformities Check Management review Analyzing results and action taking Action plan Quality plan 8. 2 to 8. 5 8. 6 9. 2 9. 3 8. 1 Operations as planned Nonconformance C A 9. 3. 3 Corrective 10. 2 actions 6. 1 Actions 9. 1. 3 FMEA, Analyzing SWOT data Check Internal audits 9. 1. 2 Customers

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