MID-HUDSON CHAPTER of APICS SEPTEMBER 13, 2017 ISO 9001:2015 TOP MANAGEMENT’S LEADERSHIP ROLE IN A PLANNED MANAGEMENT REVIEW DONALD M. COSTELLO DMC Services CELL: ( 475) 279-7115 CT PHONE: (203) 792-1421 dcostello66@comcast.net
FORMER PINSETTER
APICS MEETING “Review a roadmap to help enable top business managers to demonstrate their leadership commitment to deliver quality products and services in today’s competitive environment in a planned Management Review”
WINSTON CHURCHILL “A PESSIMIST SEES THE DIFFICULTY IN EVERY OPPORTUNITY; AN OPTIMIST SEES THE OPPORTUNITY IN EVERY DIFFICULTY.”
TODAY’S CHALLANGES • A new top management mindset - Take more responsibility, and leadership commitment for quality performance, and to • Join the competitive Global ISO 9001 Community Presented by DMC Services
TODAY’S CHALLANGES The ISO 9001:2015 Standard outlines basic and contemporary quality management principles in today’s competitive world Presented by DMC Services
“MANAGEMENT REVIEW” AS YOU SEE IT MY QUESTIONS & YOUR RESPONSES Presented by DMC Services
FIRST, LET’S ASK - How many work for ISO 9001 certified organizations? Presented by DMC Services
QUESTION 1 Does your organization conduct planned periodic Management Reviews to assess quality management performance? Presented by DMC Services
QUESTION 2 What quality performance topics does your organization review? Presented by DMC Services
QUESTION 3 Do you integrate your Management Review with other site/business or production meetings? Just don’t forget to include required MR “inputs” and “outputs” somewhere. Presented by DMC Services
TIP MAKE A CURRENT MANAGEMENT OR EXECUTIVE MEETING REQUIREMENTS MATRIX DOCUMENT Sample Matrix available upon request Presented by DMC Services
QUESTION 4 How often do you conduct your Management Reviews? Presented by DMC Services
QUESTION 5 What company leaders attend? Presented by DMC Services
QUESTION 6 Is it a formal meeting or an electronic meeting format? Presented by DMC Services
QUESTION 7 Use an “agenda” or preparation “checklist”? Presented by DMC Services
QUESTION 8 Does your top or senior manager(s) attend your Management Review? Presented by DMC Services
QUESTION 9 Are notes taken and follow-up actions assigned? Presented by DMC Services
BONUS “RBT” QUESTION 10 Does your organization review predetermined relevant business and process risks, consequences and opportunities during the Management Review(s)? Presented by DMC Services
EXTRA CREDIT QUESTION Should Finance or Accounting be included in your Management Review? Presented by DMC Services
LET’S REVIEW – A FEW MAIN DRIVERS OF “QUALITY MANAGEMENT” VERSESOLUTIONS.COM SURVEY (NOV 16, 2016) - • 41% - MEET CUSTOMER AND REGULATORY REQUIREMENTS • 27% - ISO STANDARDS • 22% - PRODUCT AND PROCESS IMPROVEMENTS • 10% - STRATEGIC DIRECTIONS FOR OPERATIONAL EFFICIENCY (E.G. REDUCE COSTS AND PRODUCT DEFECTS) Presented by DMC Services
NEW 21 st CENTURY LEADERSHIP MINDSET TOP MANAGEMENT IS ACCOUNTABLE FOR THE EFFECTIVENESS OF THE QUALITY MANAGEMENT SYSTEM (QMS) AND ITS ALIGNMENT WITH THE COMPANY’S “STRATEGIC DIRECTION” Presented by DMC Services
7 NEW ISO 9001:2015 QUALITY MANAGEMENT PRINCIPLES • QMP 1 – CUSTOMER FOCUS • QMP 2 – LEADERSHIP • QMP 3 – ENGAGEMENT OF PEOPLE • QMP 4 – PROCESS APPROACH • QMP 5 – IMPROVEMENT • QMP 6 – EVIDENCE-BASED DECISION MAKING • QMP 7 – RELATIONSHIP MANAGEMENT (with other “interested parties”, e.g.suppliers) Presented by DMC Services
7 MALCOLM BALDRIGE QUALITY AWARD CRITERIA 1. LEADERSHIP 2. STRATEGIC PLANNING 3. CUSTOMER & MARKET FOCUS 4. PERFORMANCE MEASUREMENT 5. HUMAN RESOURCE DEVELOPMENT AND MANAGEMENT 6. PROCESS MANAGEMENT 7. BUSINESS RESULT Presented by DMC Services
KEY LEADERSHIP RESPONSIBILITIES • DEMONSTRATE LEADERSHIP COMMITMENT TO QUALITY & “STRATEGIC DIRECTION” • QMS COMMUNICATION TO OTHER PARTIES • CUSTOMER FOCUS • REVIEW RISKS AND OPPORTUNITIES • PROCESS APPROACH (ASSIGN RELEVANT PROCESS OWNERS & NECESSARY KPI CRITERIA) • PROFIT • OTHER, e.g. PROMOTE IMPROVEMENT, ETC. Presented by DMC Services
NEW LEADERSHIP EXPECTATIONS IN ISO 9001:2015 • 5.1.1 a) - TOP MANAGEMENT TO TAKE ACCOUNTABILITY FOR THE EFFECTIVENESS OF THE QMS • 5.1.1 b) - TOP MANAGEMENT ENSURE THAT THE QUALITY POLICY AND THE QUALITY OBJECTIVES ARE COMPATIBLE WITH THE CONTEXT AND STRATEGIC DIRECTION OF THE ORGANIZATION. (Con’t) Presented by DMC Services
NEW LEADERSHIP EXPECTATIONS IN ISO 9001:2015 • 5.1.1 c) - TOP MANAGEMENT TO INTEGRATE THE QMS INTO ITS BUSINESS PROCESSES. • 5.1.1 d) - TOP MANAGEMENT TO PROMOTE THE USE OF RISK-BASED THINKING. • 5.1.1 f) & g) - TOP MANAGEMENT TO COMMUNICATE THE IMPORTANCE OF EFFECTIVE QUALITY MANAGEMENT AND TO ENSURE THAT THE QMS ACHIEVES ITS INTENDED RESULTS. Presented by DMC Services
THEME OF PRESENTATION: ONE WAY TO MEET THE DEMONSTRATED LEADERSHIP COMMITMENT VIA A PLANNED AND PERIODIC MANAGEMENT REVIEW BY THE TOP MANAGER(S) FOR – – QMS EFFECTIVENESS – QMS ALIGNMENT WITH COMPANY’S “STRATEGIC DIRECTION” AND BUSINESS PROCESSES Presented by DMC Services
A BASIC MANAGEMENT REVIEW MAY TYPICALLY INCLUDE • HOW ARE WE DOING • CORRECTIVE ACTIONS • WHAT TO DO TO GET BETTER • REVIEW IDENTIFIED RISKS AND ANY CUSTOMER ISSUES • REVIEW RESOURCES • REVIEW “BUSINESS STRATEGY” AND POLICY • PREVIOUS ACTION ITEMS • MEET ISO REQUIREMENTS Presented by DMC Services
SUMMARY OF BASIC MANAGEMENT REVIEW EXPECTATIONS - FROM ISO 9001:2015, 9.3 1. PREVIOUS ACTIONS 2. RELEVANT CHANGES (INTERNAL & EXTERNAL-SUPPLIER ISSUES) 3. QMS PERFORMANCE ITEMS (NEXT SLIDE) 4. CONTINUAL IMPROVEMENT DECISIONS 5. DOCUMENT THE REVIEW Presented by DMC Services
MANAGEMENT REVIEW PERFORMANCE ITEMS (ISO 9001:2015, 9.3) 1. CUSTOMER SATISFACTION 2. QUALITY OBJECTIVES & POLICY 3. PROCESS KPIs 4. CARS/NCNs/SCARS 5. SUPPLIER DATA 6. AUDITS 7. QMS RELEVENT INTERNAL & EXTERNAL CHANGES Presented by DMC Services
MANAGEMENT REVIEW PERFORMANCE ITEMS (Cont.) (ISO 9001:2015, 9.3) 8. RESOURCES 9. PERTINENT RISK ISSUES & OPPORTUNITIES 10. CONSIDER CONTINUAL IMPROVEMENT OPPORTUNITIES 11. MAKE QMS, OBJECTIVE METRIC, POLICY, SUPPLIER, RESOURCE, ETC. PERFORMANCE CHANGE DECISIONS 12. DOCUMENT IS AVAILABLE Presented by DMC Services
MANAGEMENT REVIEW PERFORMANCE ITEMS (Cont.) (ISO 9001:2015, 9.3) 13. INTERESTED PARTIES REVIEW (4.2) – OPPORTUNE TIME TO REVIEW INTERESTED PARTIES THAT ARE RELEVANT TO THE ORGANIZATION Presented by DMC Services
MANAGEMENT REVIEW TOOLS AND TIPS • MANAGEMENT REVIEW PREPARATION CHECKLIST – include required MR “inputs” and “outputs” • A NETWORK ELECTRONIC MANAGEMENT REVIEW WITH AUTOMATED RESPONSE CHECKLIST WITH PERFORMANCE ATTACHMENTS FOR TRAVELLING TOP MGRS • MAY CONDUCT “MINI” MANAGEMENT REVIEWS OR MELD INTO SCHEDULED “PRODUCTION REVIEWS” Presented by DMC Services
THE FUTURE AS DRIVEN BY ISO 9001:2015 MANAGEMENT REVIEW? • TOP MANAGEMENT TAILORED “DASHBOARDS” OR SCORECARDS TO MONITOR AND DRIVE STRATEGIC IMPROVEMENT INITIATIVES, and ASSESS “RISKS AND OPPORTUNITIES” • INCLUDE KEY LEAN (REMOVE WASTE) PROJECTS IN THEIR DASHBOARD TO MONITOR IMPROVEMENT STATUS, SUPPLIER and NEW TECHNOLOGICAL CHANGES (ref. next slide) • CONSIDER THIS A NEW WAVE, LEAN TYPE OF GEMBA WALK MODEL? Presented by DMC Services
DASHBOARD IDEA* CONSIDER MELDING A MANAGER’S “DASHBOARD” WITH KEY STRATEGIC AND MARKETING ELEMENTS OF ASQ.ORG’s “CUSTOMER JOURNEY MAPS” FOR “INTERESTED PARTY” CUSTOMERS Presented by DMC Services
THE FUTURE AS DRIVEN BY ISO 9001:2015 MANAGEMENT REVIEW? LEAN REFERENCE; “Update: Why "Lean Manufacturing" Does Not Guarantee Business Success”, Sept. 13, 2016 by Terence T. Burton • “The future (of Lean) is the cloud, big data, predictive and preventive business analytics, mobility, real time digital performance dashboards, instant digitized synchronization, and augmented reality supply chains.” Presented by DMC Services
THERANOS CASE STUDY • DID THERANOS CONDUCT A PROPER MANAGEMENT REVIEW TO EVALUATE THE RISKS OF ALLEGEDLY BYPASSING FULL LAB VERIFICATION OF THEIR NEW BLOOD TESTING MACHINE FOR WALGREENS? Re. Wall Street Journal , May 26, 2016 Presented by DMC Services
MORE PRODUCT RISK CASES • ISO registrar and CE Mark Notified Body TUV Rheinland fined 60m euros ($64m) in French court for its role in an international scandal involving defective breast implants-CE Mark certification issue (not ISO). • Takata airbag failures • Deepwater Horizon disaster • Samsung Note 7 cell phone battery fires • VW emission scandal Presented by DMC Services
NEW “SMART MANAGEMENT REVIEW”* FOCUS COULD INCLUDE - • “LEADING INDICATOR” (FUTURE DRIVEN) LEADERSHIP THINKING (i.e. RBT) VS USING ONLY “LAGGING INDICATORS” • SIMILAR TO FINANCIAL KPI’S, e.g. FORWARD P/E VS TRAILING P/E • RESOURCE TRAINING THINKING • “INVENTORY TURNS” (ALSO RBT) (Cont.) Presented by DMC Services
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