ISO 9001:2015 TOP MANAGEMENT’S LEADERSHIP ROLE IN A ... · iso 9001:2015 top management’s ... “production reviews ... the future as driven by iso 9001:2015 management review?

MID-HUDSON CHAPTER of APICSSEPTEMBER 13, 2017

ISO 9001:2015TOP MANAGEMENT’S

LEADERSHIP ROLE IN A PLANNEDMANAGEMENT REVIEW

DONALD M. COSTELLODMC Services

CELL: (475) 279-7115CT PHONE: (203) [email protected]

FORMER PINSETTER

APICS MEETING

“Review a roadmap to helpenable top business managers to

demonstrate their leadershipcommitment to deliver quality

products and services in today’scompetitive environment in a

planned Management Review”

WINSTON CHURCHILL

“A PESSIMIST SEES THEDIFFICULTY IN EVERY

OPPORTUNITY; ANOPTIMIST SEES THE

OPPORTUNITY IN EVERYDIFFICULTY.”

Presented by DMC Services

TODAY’S CHALLANGES

• A new top managementmindset - Take more

responsibility, and leadershipcommitment for quality

performance, and to• Join the competitive Global ISO

9001 Community


TODAY’S CHALLANGES

The ISO 9001:2015 Standardoutlines basic and

contemporary qualitymanagement principles intoday’s competitive world


“MANAGEMENTREVIEW” AS YOU SEE

IT

MY QUESTIONS & YOURRESPONSES


FIRST, LET’S ASK -

How many work for ISO 9001certified organizations?


QUESTION 1

Does your organizationconduct planned periodicManagement Reviews to

assess quality managementperformance?


QUESTION 2

What qualityperformance topics

does your organizationreview?


QUESTION 3

Do you integrate yourManagement Review with

other site/business orproduction meetings?

Just don’t forget to include requiredMR “inputs” and “outputs”somewhere.


TIP

MAKE A CURRENTMANAGEMENT OR EXECUTIVE

MEETING REQUIREMENTSMATRIX DOCUMENT

Sample Matrix available upon request


QUESTION 4

How often do youconduct your

Management Reviews?


QUESTION 5

What companyleaders attend?


QUESTION 6

Is it a formal meetingor an electronicmeeting format?


QUESTION 7

Use an “agenda” orpreparation“checklist”?


QUESTION 8

Does your top or seniormanager(s) attend yourManagement Review?


QUESTION 9

Are notes taken andfollow-up actions

assigned?


BONUS “RBT” QUESTION 10

Does your organizationreview predeterminedrelevant business and

process risks, consequencesand opportunities during the

Management Review(s)?


EXTRA CREDIT QUESTION

Should Finance orAccounting be included

in your ManagementReview?


LET’S REVIEW – A FEW MAINDRIVERS 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. REDUCECOSTS AND PRODUCT DEFECTS)


NEW 21st CENTURY LEADERSHIPMINDSET

TOP MANAGEMENT ISACCOUNTABLE FOR THE

EFFECTIVENESS OF THE QUALITYMANAGEMENT SYSTEM (QMS) AND

ITS ALIGNMENT WITH THECOMPANY’S “STRATEGIC

DIRECTION”


7 NEW ISO 9001:2015 QUALITYMANAGEMENT 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)


7 MALCOLM BALDRIGE QUALITYAWARD CRITERIA

1. LEADERSHIP2. STRATEGIC PLANNING3. CUSTOMER & MARKET FOCUS4. PERFORMANCE MEASUREMENT5. HUMAN RESOURCE DEVELOPMENT AND

MANAGEMENT6. PROCESS MANAGEMENT7. BUSINESS RESULT


KEY LEADERSHIP RESPONSIBILITIES

• DEMONSTRATE LEADERSHIP COMMITMENTTO QUALITY & “STRATEGIC DIRECTION”

• QMS COMMUNICATION TO OTHER PARTIES• CUSTOMER FOCUS• REVIEW RISKS AND OPPORTUNITIES• PROCESS APPROACH (ASSIGN RELEVANT

PROCESS OWNERS & NECESSARY KPICRITERIA)

• PROFIT• OTHER, e.g. PROMOTE IMPROVEMENT, ETC.


NEW LEADERSHIP EXPECTATIONSIN ISO 9001:2015

• 5.1.1 a) - TOP MANAGEMENT TO TAKEACCOUNTABILITY FOR THEEFFECTIVENESS OF THE QMS

• 5.1.1 b) - TOP MANAGEMENT ENSURETHAT THE QUALITY POLICY AND THEQUALITY OBJECTIVES ARECOMPATIBLE WITH THE CONTEXTAND STRATEGIC DIRECTION OF THEORGANIZATION.

(Con’t)


NEW LEADERSHIP EXPECTATIONSIN ISO 9001:2015

• 5.1.1 c) - TOP MANAGEMENT TO INTEGRATETHE QMS INTO ITS BUSINESS PROCESSES.

• 5.1.1 d) - TOP MANAGEMENT TO PROMOTETHE USE OF RISK-BASED THINKING.

• 5.1.1 f) & g) - TOP MANAGEMENT TOCOMMUNICATE THE IMPORTANCE OFEFFECTIVE QUALITY MANAGEMENT ANDTO ENSURE THAT THE QMS ACHIEVES ITSINTENDED RESULTS.


THEME OF PRESENTATION: ONEWAY TO MEET THE

DEMONSTRATED LEADERSHIPCOMMITMENT

VIA A PLANNED AND PERIODICMANAGEMENT REVIEW BY THETOP MANAGER(S) FOR –

– QMS EFFECTIVENESS– QMS ALIGNMENT WITH COMPANY’S

“STRATEGIC DIRECTION” ANDBUSINESS PROCESSES


A BASIC MANAGEMENT REVIEWMAY 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


SUMMARY OF BASIC MANAGEMENTREVIEW EXPECTATIONS - FROM ISO

9001:2015, 9.3

1. PREVIOUS ACTIONS2. RELEVANT CHANGES (INTERNAL &

EXTERNAL-SUPPLIER ISSUES)3. QMS PERFORMANCE ITEMS (NEXT

SLIDE)4. CONTINUAL IMPROVEMENT

DECISIONS5. DOCUMENT THE REVIEW


MANAGEMENT REVIEWPERFORMANCE ITEMS

(ISO 9001:2015, 9.3)1. CUSTOMER SATISFACTION2. QUALITY OBJECTIVES & POLICY3. PROCESS KPIs4. CARS/NCNs/SCARS5. SUPPLIER DATA6. AUDITS7. QMS RELEVENT INTERNAL &

EXTERNAL CHANGES


MANAGEMENT REVIEWPERFORMANCE ITEMS (Cont.)

(ISO 9001:2015, 9.3)8. RESOURCES9. PERTINENT RISK ISSUES &OPPORTUNITIES10. CONSIDER CONTINUALIMPROVEMENT OPPORTUNITIES11. MAKE QMS, OBJECTIVE METRIC,POLICY, SUPPLIER, RESOURCE, ETC.PERFORMANCE CHANGE DECISIONS12. DOCUMENT IS AVAILABLE


MANAGEMENT REVIEWPERFORMANCE ITEMS (Cont.)

(ISO 9001:2015, 9.3)13. INTERESTED PARTIES REVIEW(4.2) – OPPORTUNE TIME TO REVIEWINTERESTED PARTIES THAT ARERELEVANT TO THE ORGANIZATION


MANAGEMENT REVIEW TOOLSAND TIPS

• MANAGEMENT REVIEW PREPARATIONCHECKLIST

– include required MR “inputs” and “outputs”

• A NETWORK ELECTRONIC MANAGEMENTREVIEW WITH AUTOMATED RESPONSECHECKLIST WITH PERFORMANCEATTACHMENTS FOR TRAVELLING TOPMGRS

• MAY CONDUCT “MINI” MANAGEMENTREVIEWS OR MELD INTO SCHEDULED“PRODUCTION REVIEWS”


THE FUTURE AS DRIVEN BY ISO9001:2015 MANAGEMENT REVIEW?

• TOP MANAGEMENT TAILORED“DASHBOARDS” OR SCORECARDS TOMONITOR AND DRIVE STRATEGICIMPROVEMENT INITIATIVES, and ASSESS“RISKS AND OPPORTUNITIES”

• INCLUDE KEY LEAN (REMOVE WASTE)PROJECTS IN THEIR DASHBOARD TOMONITOR IMPROVEMENT STATUS,SUPPLIER and NEW TECHNOLOGICALCHANGES (ref. next slide)

• CONSIDER THIS A NEW WAVE, LEAN TYPEOF GEMBA WALK MODEL?


DASHBOARD IDEA*

CONSIDER MELDING A MANAGER’S“DASHBOARD” WITH KEY

STRATEGIC AND MARKETINGELEMENTS OF ASQ.ORG’s

“CUSTOMER JOURNEY MAPS” FOR“INTERESTED PARTY”

CUSTOMERS


THE FUTURE AS DRIVEN BY ISO9001:2015 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 performancedashboards, instant digitizedsynchronization, and augmented realitysupply chains.”


THERANOS CASE STUDY

• DID THERANOS CONDUCT A PROPERMANAGEMENT REVIEW TO EVALUATETHE RISKS OF ALLEGEDLYBYPASSING FULL LAB VERIFICATIONOF THEIR NEW BLOOD TESTINGMACHINE FOR WALGREENS?

Re. Wall Street Journal, May 26, 2016


MORE PRODUCT RISK CASES• ISO registrar and CE Mark Notified

Body TUV Rheinland fined 60m euros($64m) in French court for its role in aninternational scandal involvingdefective breast implants-CE Markcertification issue (not ISO).

• Takata airbag failures• Deepwater Horizon disaster• Samsung Note 7 cell phone battery fires• VW emission scandal


NEW “SMART MANAGEMENTREVIEW”* FOCUS COULD INCLUDE -

• “LEADING INDICATOR” (FUTUREDRIVEN) LEADERSHIP THINKING (i.e.RBT) VS USING ONLY “LAGGINGINDICATORS”

• SIMILAR TO FINANCIAL KPI’S, e.g.FORWARD P/E VS TRAILING P/E

• RESOURCE TRAINING THINKING• “INVENTORY TURNS” (ALSO RBT)

(Cont.)


REFERENCE

“LEADING AND LAGGING INDICATORSCAN HELP YOU BUILD A SUSTAINABLEORGANIZATION”, - Aug 18, 2017,AVETTA Whitepaper


NEW “SMART LEADINGINDICATOR MANAGEMENT

REVIEW” FOCUS

CONSIDER –CHANGES IN EXTERNAL AND INTERALISSUES THAT ARE RELEVANT TO THEORGANIZATION. SUCH AS, FOREXAMPLE – (Next Slide)


POSSIBLE SMART “LEADINGINDICATOR” MANAGEMENT REVIEW*

FOCUSRISK & OPPORTUNITY “RBT” FOCUS -• E.G., DELL: CUSTOMER

SATISFACTION, DAYS OF SUPPLY ININVENTORY

• E.G. DUANE, OR CROW-AMSAAEXPECTED RELIABILITY GROWTHTEST MODEL PREDICTION STATUS

• EU DIRECTIVE & EMC DESIGN-RISKPROGRESS (e.g. REACH/RoHS)


POSSIBLE SMART “LEADINGINDICATOR”* 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 bythe Custom Border Patrol regulatory body.


KEEP IN MIND

• “RISK BASED THINKING” DOESNOT REQUIRE USING “RISKMANAGEMENT” TECHNIQUES INTHE ISO 9001:2015 STANDARD

• RISK RECORDS AND REGISTERSARE NOT REQD BY THE STD.


POSSIBLE SMART “LEADING”MANAGEMENT REVIEW* FOCUS

(CON’T)

• e.g., SUBMIT ANNUAL HAZARDOUSCHEMICAL INVENTORY-TIER II REPORT BYMARCH 1ST IF YOUR FACILITY USED ORSTORED ANY LISTED EHS

– 40 CFR 355 Appendix A, in excess of 500 pounds(lb) or the threshold planning quantity, whicheveris lower, or if your facility used or stored anyother hazardous substance in excess of 10,000 lb.report.

• AND, FORM R (SECT 313)TRI REPORT JULY1ST.


“KEY” TAKE-AWAY• “LEADERSHIP” COMMITMENT MAY BE

DEMONSTRATED, AS YOU SEE FIT, IN THEMANAGEMENT REVIEW.

• FORWARD-LEADING INDICATOR THINKINGTO 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)


TAKE-AWAY NOTES

• THE REVISED ISO 9004“GUIDELINES” VERSION ISDUE TO BE PUBLISHED IN2018


MANAGEMENT REVIEWPRESENTATION

Questions?Contact Don Costello:

[email protected](475) 279-7115 cell(203) 792-1421 Connecticut


OTHER DMC SERVICES BESTPRACTICE 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 MANUFACTURINGCHALLENGES

• GAP AUDIT TO UNCOVER SHORTFALLS

Documents

ISO 9001:2015 TOP MANAGEMENT’S LEADERSHIP ROLE IN A ... · iso 9001:2015 top management’s ... “production reviews ... the future as driven by iso 9001:2015 management review?