ISO 9001:2015 TOP MANAGEMENTS LEADERSHIP ROLE IN A PLANNED - - PowerPoint PPT Presentation

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.”

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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

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TODAY’S CHALLANGES The ISO 9001:2015 Standard

• utlines basic and

contemporary quality management principles in today’s competitive world

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“MANAGEMENT REVIEW” AS YOU SEE IT MY QUESTIONS & YOUR RESPONSES

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FIRST, LET’S ASK -

How many work for ISO 9001 certified organizations?

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QUESTION 1

Does your organization conduct planned periodic Management Reviews to assess quality management performance?

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QUESTION 2

What quality performance topics does your organization review?

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QUESTION 3

Do you integrate your Management Review with

• ther site/business or

production meetings?

Just don’t forget to include required MR “inputs” and “outputs” somewhere.

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TIP

MAKE A CURRENT MANAGEMENT OR EXECUTIVE MEETING REQUIREMENTS MATRIX DOCUMENT

Sample Matrix available upon request

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QUESTION 4

How often do you conduct your Management Reviews?

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QUESTION 5

What company leaders attend?

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QUESTION 6

Is it a formal meeting

• r an electronic

meeting format?

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QUESTION 7

Use an “agenda” or preparation “checklist”?

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QUESTION 8

Does your top or senior manager(s) attend your Management Review?

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QUESTION 9

Are notes taken and follow-up actions assigned?

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BONUS “RBT” QUESTION 10

Does your organization review predetermined relevant business and process risks, consequences and opportunities during the Management Review(s)?

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EXTRA CREDIT QUESTION

Should Finance or Accounting be included in your Management Review?

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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)

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NEW 21st 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”

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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
• ther “interested parties”, e.g.suppliers)

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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

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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.

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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)

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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.

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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

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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

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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

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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

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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

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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

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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”

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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?

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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

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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.”

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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

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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

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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.)

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REFERENCE

“LEADING AND LAGGING INDICATORS CAN HELP YOU BUILD A SUSTAINABLE ORGANIZATION”, - Aug 18, 2017, AVETTA Whitepaper

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NEW “SMART LEADING INDICATOR MANAGEMENT REVIEW” FOCUS CONSIDER – CHANGES IN EXTERNAL AND INTERAL ISSUES THAT ARE RELEVANT TO THE

• ORGANIZATION. SUCH AS, FOR

EXAMPLE – (Next Slide)

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POSSIBLE SMART “LEADING INDICATOR” MANAGEMENT REVIEW* FOCUS RISK & OPPORTUNITY “RBT” FOCUS -

• E.G., DELL: CUSTOMER

SATISFACTION, DAYS OF SUPPLY IN INVENTORY

• E.G. DUANE, OR CROW-AMSAA

EXPECTED RELIABILITY GROWTH TEST MODEL PREDICTION STATUS

• EU DIRECTIVE & EMC DESIGN-RISK

PROGRESS (e.g. REACH/RoHS)

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POSSIBLE SMART “LEADING INDICATOR”* MANAGEMENT REVIEW* FOCUS (Con’t)

RISK & OPPORTUNITY “RBT” FOCUS -

• CONFLICT MINERALS REPORTING STATUS
• INVENTORY METRICS
• “EXPECTED VALUE” RISK MANAGEMENT

TOOL = (O+4*ML+P)/4

• CTPAT COMPLIANCE AND 3RD PARTY AUDIT

READINESS. Note: CTPAT means Customs Trade Partnership Against Terrorism, sponsored by the Custom Border Patrol regulatory body.

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KEEP IN MIND

• “RISK BASED THINKING” DOES

NOT REQUIRE USING “RISK MANAGEMENT” TECHNIQUES IN THE ISO 9001:2015 STANDARD

• RISK RECORDS AND REGISTERS

ARE NOT REQD BY THE STD.

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POSSIBLE SMART “LEADING” MANAGEMENT REVIEW* FOCUS (CON’T)

• e.g., SUBMIT ANNUAL HAZARDOUS

CHEMICAL INVENTORY-TIER II REPORT BY MARCH 1ST IF YOUR FACILITY USED OR STORED ANY LISTED EHS

– 40 CFR 355 Appendix A, in excess of 500 pounds (lb) or the threshold planning quantity, whichever is lower, or if your facility used or stored any

• ther hazardous substance in excess of 10,000 lb.

report.

• AND, FORM R (SECT 313)TRI REPORT JULY

1ST.

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“KEY” TAKE-AWAY

• “LEADERSHIP” COMMITMENT MAY BE

DEMONSTRATED, AS YOU SEE FIT, IN THE MANAGEMENT REVIEW.

• FORWARD-LEADING INDICATOR THINKING

TO MANAGE & MINIMIZE RISK

• DOCUMENT THE REVIEW AS EVIDENCE.
• MAY COMBINE WITH OTHER MEETINGS.
• DON’T FORGET TO COVER “INPUTS” &

“OUTPUTS” MIN REQUIREMENTS.

– OMNEX, Inc. reports “inputs” (9.3.2) a top major IATF 16949 automotive industry audit N/C (Aug 22, 2017)

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TAKE-AWAY NOTES

• THE REVISED ISO 9004

“GUIDELINES” VERSION IS DUE TO BE PUBLISHED IN 2018

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MANAGEMENT REVIEW PRESENTATION

Questions?

Contact Don Costello: dcostello66@comcast.net (475) 279-7115 cell (203) 792-1421 Connecticut

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OTHER DMC SERVICES BEST PRACTICE PRESENTATIONS

• ISO 14001 EMS & BENEFITS
• SAFETY PRACTICES IN THE WORKPLACE
• ENERGY MANAGEMENT COST REDUCTION
• HUMAN FACTORS & ERGONOMICS FOR

QUALITY

• ERGONOMICS TO IMPROVE HEALTH &

PROCESS EFFICIENCY

• EXPERIENCES WITH CHINA/JAPAN and

EUROPEAN MANUFACTURING CHALLENGES

• GAP AUDIT TO UNCOVER SHORTFALLS