achieving accreditation: managing the process iafs...

Achieving Accreditation: Managing the Process

IAFS Workshop

Toronto, Canada

August 2017

Facilitators: Terry Mills & Ted Smith

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Achieving AccreditationAchieving AccreditationAchieving AccreditationAchieving AccreditationManaging the Process

Instructors: Terry Mills & Ted SmithGoals:

1. Introduction to the management strategy developed to help laboratories achieve either ISO/IEC 17020 or 17025 accreditation

2. Introduction to the dynamics of change management

3. Begin the process of developing an implementation plan for your laboratory

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While at her mother’s funeral, a girl met a guy. Though it was their first meeting, she thought he was amazing. She believed he was the man of her dreams, and fell in love with him instantly. She failed to ask him for his phone number.

A few days later she killed her sister.

What was her motive for killing her sister?

Measurement + Observer

A ≠ B

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The Quantum Enigma “Ultimate” reality is not confined to our perception of it • Observation plays a role in our perception of and description

of the existence of quantum particles• “particles” do not possess definite, deterministic qualities until

they are measured, the act of observation helps determine the reality that is perceived…

• Entanglement & Non-locality• Spatially separated systems can instantaneously influence one

another at both the quantum and macroscopic levels

�There is no real “world” apart from us; rather, the world unfolds in and through our choices and actions.

�The concept of “world” is like a mirror; empty in itself, it can only reflect to the giver the values it receives.

Ilia Delio, Making All Things New: Catholicity, Cosmology, Consciousness, 2015

�“We” negotiate reality….

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�The “reality” of A & B did not change but how I observed/perceived that reality did…

�ISO asks us to look at our organizational reality from a different perspective; using a different frame of reference…

�A different management model…values and practices…

�How we observe and measure determines the “reality” of our “system” …

�Appling a different set of values and practices changes our perception of our “system reality”“system reality”“system reality”“system reality”and the outcomes it produces…

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Definitions• Decision…a conclusion, resolution, settlement, commitment, determination, choice

reached after consideration…

a decision is executed and it takes resources to execute…

• Problem…an obstacle or difficulty in the path ahead that is a by-product of the process of decision making…

• Decisions create problems…

• Problem solving is not decision making; they

are not the same thing!

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MARSHALL UNIVERSITYFORENSIC SCIENCE CENTER

Ethics vs. Morals vs. Values

� the set of rules, principles, or ways of thinking that guide, or claim authority to guide, the actions of a particular group

� habits of life in regard to right and wrong conduct; tends to be associated with a narrower and more personal concept of values

Never let your sense of morals get in the way of doing what is right!Issac Asimov

MARSHALL UNIVERSITYFORENSIC SCIENCE CENTER

Values

� Every individual, group/organization, has a core set of personal, group, values.

� By definition there is no such thing as a “bad” value. The issue is not “good or bad” values but the ranking of values.

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Either in compliance or in non-compliance,

Cannot leave out parts because you don't like them or you do not want to change your existing management modelmanagement modelmanagement modelmanagement model

You must choose You must choose You must choose You must choose voluntarilyvoluntarilyvoluntarilyvoluntarily to comply with allto comply with allto comply with allto comply with all!

Driven by:

Government requirementsExpectations of customers

Business culture

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1) Customer Focus: meet/exceed customer requirements

2) Leadership: create unity of purpose and direction

3) Involvement of People: maximize organizational use of abilities

4) Process Approach: management of activities and resources

5) System Approach: management of interrelated processes

6) Continual Improvement: permanent objective

7) Factual Decision Making: measurement and data analysis

8) Mutually Beneficial Relationships: focus on creation of value

Credibility Is the Foundation of Leadership

ValuesValuesValuesValues are directly relevant to credibility.

To do what you say you will do—the behavioral definition of credibility—you must know what you want to do and how you want to behave.

That's what values help you to define.

ISO/IEC Standards help clarify and define values.

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Present Reality

Defined PathDefined PathDefined PathDefined Path

Course Correction

Learning

Feedback

ObjectiveObjectiveObjectiveObjective

� Momentum is something that you can control…

� Momentum is not simply a description, it's an aspiration. You aspire to sustain momentum, and you want to manage for momentum…

� Momentum isn't a mystery, it's a series of finite, specific activities…

� The basic challenges facing managers are the very things that allow them to sustain momentum…

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Decision Continuums

Structure, Performance, Culture, Political

Primary concern Primary concern Primary concern Primary concern –––– responsibility and resourcesresponsibility and resourcesresponsibility and resourcesresponsibility and resources

� Who does what?

� What resources are going to be allocated?

� How much time do you want to spend on an issue?

Focus: building and sustaining the capacity of your people to deliver on your agenda.

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PrimaryPrimaryPrimaryPrimary concernconcernconcernconcern –––– evaluationsevaluationsevaluationsevaluations areareareare conducted,conducted,conducted,conducted, progressprogressprogressprogress isisisismeasured,measured,measured,measured, andandandand feedbackfeedbackfeedbackfeedback isisisis givengivengivengiven

� How do you want to evaluate progress?

� How do I measure output?

� How do I measure process?

� How do I get and give feedback?

FocusFocusFocusFocus:::: knowing when to take corrective action; findingthe right balance between making adjustments andmaintaining a sense of continuity

Primary concern- creating a group affiliation, “a culture” thatwill motivate people to get the job done; to go the distanceeven when times get tough

� How do I develop group cohesiveness?

� How do I foster a sense of commitment?

� How do I generate involvement?

� HowHowHowHow dodododo IIII getgetgetget totototo stopstopstopstop asking,asking,asking,asking, whywhywhywhy shouldshouldshouldshould IIII dodododo itititit;;;; And get themfocused on what needs to be done?

FocusFocusFocusFocus:::: totototo createcreatecreatecreate aaaa problemproblemproblemproblem----solvingsolvingsolvingsolving cultureculturecultureculture bybybyby fosteringfosteringfosteringfostering thethethetheindividualindividualindividualindividual identitiesidentitiesidentitiesidentities ofofofof thethethethe groupsgroupsgroupsgroups membersmembersmembersmembers

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PrimaryPrimaryPrimaryPrimary concernconcernconcernconcern – making sure that conflict is dealt withand that opposition is either challenged or incorporated.

� How do I maintain credibility?

� What dissent is surfacing?

� Who is supporting, opposing the initiative?

� How do I reinvigorate the vision?

FocusFocusFocusFocus:::: to sustain movement (mobilization) and the sensethat collectively, something of value can be achieved.

How well you manage manage manage manage will depend on:

� how you allocate resources,

� how you make corrections,

� how you maintain commitment, and

� how you deal with criticism.

StructureStructureStructureStructure

PerformancePerformancePerformancePerformance

CultureCultureCultureCulture

PoliticalPoliticalPoliticalPolitical

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Political competence to generate interest and support for your agenda

Managerial competence to keep people engaged and to deliver results

� The Fifth Discipline: The Art & Practice of The Learning Organization. The Fifth Discipline: The Art & Practice of The Learning Organization. The Fifth Discipline: The Art & Practice of The Learning Organization. The Fifth Discipline: The Art & Practice of The Learning Organization. Peter M. Senge, Crown Publishing Group. Kindle Edition, 2010

� The Human Side of Managing Human Innovation: A Collection of Readings. The Human Side of Managing Human Innovation: A Collection of Readings. The Human Side of Managing Human Innovation: A Collection of Readings. The Human Side of Managing Human Innovation: A Collection of Readings. Edited by Ralph Katz, Oxford University Press, 2004

� Developing and Agenda for Change. Developing and Agenda for Change. Developing and Agenda for Change. Developing and Agenda for Change. Samuel B. Bacharach, , , , eCornell, 2013

� Quantum Enigma : Physics Encounters ConsciousnessQuantum Enigma : Physics Encounters ConsciousnessQuantum Enigma : Physics Encounters ConsciousnessQuantum Enigma : Physics Encounters Consciousness. Bruce Rosenblum and Fred Kuttner, New York: Oxford University Press, 2006

� http://www.healthknowledge.org.uk/publichttp://www.healthknowledge.org.uk/publichttp://www.healthknowledge.org.uk/publichttp://www.healthknowledge.org.uk/public----healthhealthhealthhealth----textbook/organisationtextbook/organisationtextbook/organisationtextbook/organisation----management/5cmanagement/5cmanagement/5cmanagement/5c----managementmanagementmanagementmanagement----change/basicchange/basicchange/basicchange/basic----managementmanagementmanagementmanagement----models models models models #System_Theories#System_Theories#System_Theories#System_Theories

� the essential David Bohm. the essential David Bohm. the essential David Bohm. the essential David Bohm. Lee Nichol, ed. Routledge Publishing, 2003

� Why Your Innovation Leadership Training Will Fail, Why Your Innovation Leadership Training Will Fail, Why Your Innovation Leadership Training Will Fail, Why Your Innovation Leadership Training Will Fail, Henry Doss, Forbes, http://www.forbes.com, 2013

� Patterns Patterns Patterns Patterns –––– The Art, Soul, and Science of Beholding Nature. The Art, Soul, and Science of Beholding Nature. The Art, Soul, and Science of Beholding Nature. The Art, Soul, and Science of Beholding Nature. William C Graham, e-book, 2012

� Managing Product Management: Empowering Your Organization to Produce Managing Product Management: Empowering Your Organization to Produce Managing Product Management: Empowering Your Organization to Produce Managing Product Management: Empowering Your Organization to Produce Competitive Products and Brands. Competitive Products and Brands. Competitive Products and Brands. Competitive Products and Brands. Steven Haines, McGraw-Hill. Kindle Edition, 2011

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� The Human Side of Enterprise. The Human Side of Enterprise. The Human Side of Enterprise. The Human Side of Enterprise. Douglas McGregor, McGraw Hill, 1960

� The Strengths and Weaknesses of Autocratic LeadershipThe Strengths and Weaknesses of Autocratic LeadershipThe Strengths and Weaknesses of Autocratic LeadershipThe Strengths and Weaknesses of Autocratic Leadership. http://www.legacee.com, 2014

� Advantages & Drawbacks of the Autocratic Leadership Style. Advantages & Drawbacks of the Autocratic Leadership Style. Advantages & Drawbacks of the Autocratic Leadership Style. Advantages & Drawbacks of the Autocratic Leadership Style. Eryn Travis , Demand Media, 2014

� Facilitative Leadership. Facilitative Leadership. Facilitative Leadership. Facilitative Leadership. Alasdair Smith, Facilitation Training Inc. (FTI), 2003

� The Art of Rhetoric. The Art of Rhetoric. The Art of Rhetoric. The Art of Rhetoric. Aristotle, 384-322 BC

� Leadership Strategies, Leadership Strategies, Leadership Strategies, Leadership Strategies, Larry Lashway, Research Roundup Research Roundup Research Roundup Research Roundup 13, 2 (Winter 1996-1997)

� Establishing Momentum: Managing Structure, Resources, and Performance. Establishing Momentum: Managing Structure, Resources, and Performance. Establishing Momentum: Managing Structure, Resources, and Performance. Establishing Momentum: Managing Structure, Resources, and Performance. Samuel B. Bacharach, , , , eCornell, 2013

� Sustaining Momentum: Motivating through Vision, Culture, and Political Agility. Sustaining Momentum: Motivating through Vision, Culture, and Political Agility. Sustaining Momentum: Motivating through Vision, Culture, and Political Agility. Sustaining Momentum: Motivating through Vision, Culture, and Political Agility. Samuel B. Bacharach, , , , eCornell, 2013

� Historical and Contemporary Theories of Management.Historical and Contemporary Theories of Management.Historical and Contemporary Theories of Management.Historical and Contemporary Theories of Management. Carter McNamara, Authenticity Consulting, LLC, managementmanagementmanagementmanagementhelp.org/managementmanagementmanagementmanagement/theoriestheoriestheoriestheories.htm , 2013

� Historical and Contemporary Theories of Management.Historical and Contemporary Theories of Management.Historical and Contemporary Theories of Management.Historical and Contemporary Theories of Management. www.saylor.org/.../BUS208-2.1, 2013

� The Leadership Challenge.The Leadership Challenge.The Leadership Challenge.The Leadership Challenge. James M. Kouzes and Barry Z. Posner, San Francisco, CA: Jossey-Bass Publishers, 1995

� Credibility: How Leaders Gain and Lose It, Why People Demand It. Credibility: How Leaders Gain and Lose It, Why People Demand It. Credibility: How Leaders Gain and Lose It, Why People Demand It. Credibility: How Leaders Gain and Lose It, Why People Demand It. James M. Kouzes & Barry Z. Posner, Wiley. Kindle Edition, 2011.

� Influence: Science and Practice. Influence: Science and Practice. Influence: Science and Practice. Influence: Science and Practice. Robert B. Cialdini, (5th Edition) Pearson HE, Inc., Kindle Edition, 2009

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Project Management

Ten (10) Ten (10) Ten (10) Ten (10) Strategic Strategic Strategic Strategic GoalsGoalsGoalsGoals

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� Initially define the desired scope of accreditation (flexible)◦ Specific activities

◦ Scope Guidance

BIOLOGYDNA-STR DNA-YSTR DNA-Mitochondrial DNA-SNP Body Fluid Identification Databasing

CHEMISTRYControlled SubstancesBotanical MaterialsGSRAlcohol, Blood and UrineAccelerants

� Design your general management system◦ Quality Manual

◦ General Quality Procedures

� 3 p’s

ILAC G19ILAC G19ILAC G19ILAC G19

Proof

+

PolicyPolicyPolicyPolicy

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Fit for Purpose

Method

EquipmentPeople

Reagents/

Supplies

Evidence

STRATEGIC GOAL #3

� Reduce all analysis or examination methods to writing and demonstrate their fitness for purpose fitness for purpose fitness for purpose fitness for purpose (validation)

� Implement the quality system as defined for at least three months

� Officially turn on the systemturn on the systemturn on the systemturn on the system

� Let it run

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� Successfully complete an external system test (Proficiency Test) of a validated analysis process in at least one activity for each general category of the desired scope before application sent

� Do an exhaustive internal audit of the system with “accrediting body perspective (ANAB)”trained internal auditors

� Feedback: how the system is functioning?

� Is it doing what we designed it to do?

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� Use the audit to identify and adjust the quality/technical systems as the standards require (make corrective actions, preventative actions, improvements)

� Use feedback to learn

� Correct course

� Do a “management” review of the system and develop a four-year proficiency testing plan

� Decision makers for system

� Is our system design effective?

� How do we need to adjust the system?

◦ Structure (resourcing)◦ Measurement (feedback loops)◦ Culture (morale, risk management)◦ Political (user dynamics)

Specific Inputs and Outputs

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� Make application to accrediting body (ANAB) for assessment

� Engage the external process

� Send the necessary documentation to initiate the review process:

�Quality Manual

�Technical Procedures

�Last internal audit and corrective actions

�Records of successful proficiency test completion

�4 year proficiency test plan

�Last management review

� Post assessment adjustment of the quality system as accrediting body (ANAB) requires

AccreditationAccreditationAccreditationAccreditation

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� TimeTimeTimeTime factor influences resource and manpower needs

� The dilemma most laboratories face…

Innovation vs Production

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� Simple questionnaire used to estimate time required to implement strategy…

� Initial Time ChecklistInitial Time ChecklistInitial Time ChecklistInitial Time Checklist

� 50% = 18 months50% = 18 months50% = 18 months50% = 18 months

� 25% = 2425% = 2425% = 2425% = 24----30 months30 months30 months30 months

� 75% = 875% = 875% = 875% = 8----10 months10 months10 months10 months

� Typical Time Frame ExampleTypical Time Frame ExampleTypical Time Frame ExampleTypical Time Frame Example

� Strategic Goal ExerciseStrategic Goal ExerciseStrategic Goal ExerciseStrategic Goal Exercise

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How well you manage manage manage manage will depend on:

� how you allocate resources, � how you make corrections, � how you maintain commitment, and� how you deal with criticism.





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Change ManagementChange ManagementChange ManagementChange Management

• 9001

• 17025

• 17020

2

} Management Philosophy/System (same)

+

Competency (fit for purpose) 1. Pattern creation2. Pattern recognition 3. Pattern comparison

Comparative Activity

InspectionQualitative

Analytical Activity

Análisis or CalibrationQuantitative

1702017025

Policy & Procedure}

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Present Reality

Transformation Process (Production)Transformation Process (Production)Transformation Process (Production)Transformation Process (Production)

Defined Path (specifications)Defined Path (specifications)Defined Path (specifications)Defined Path (specifications)

Course Correction (make decisions)Course Correction (make decisions)Course Correction (make decisions)Course Correction (make decisions)

Learning Learning Learning Learning

Feedback (monitoring)Feedback (monitoring)Feedback (monitoring)Feedback (monitoring)


ActualActualActualActual Path (records)Path (records)Path (records)Path (records)

Present Reality

Transformation Process – ISO Perspective

SpecificationsSpecificationsSpecificationsSpecifications

Making DecisionsMaking DecisionsMaking DecisionsMaking Decisions

LearningLearningLearningLearning

MonitoringMonitoringMonitoringMonitoring


1.1.1.1. AuditsAuditsAuditsAudits2.2.2.2. Performance Evaluations (PTs)Performance Evaluations (PTs)Performance Evaluations (PTs)Performance Evaluations (PTs)3.3.3.3. Management ReviewsManagement ReviewsManagement ReviewsManagement Reviews4.4.4.4. User CommunicationsUser CommunicationsUser CommunicationsUser Communications5.5.5.5. Analysis Controls Analysis Controls Analysis Controls Analysis Controls 6.6.6.6. Technical ReviewsTechnical ReviewsTechnical ReviewsTechnical Reviews7.7.7.7. Contract ReviewsContract ReviewsContract ReviewsContract Reviews8.8.8.8. Etc.Etc.Etc.Etc.

1. Policy1. Policy1. Policy1. Policy2. Procedure2. Procedure2. Procedure2. Procedure

1.1.1.1. Daily Process DecisionsDaily Process DecisionsDaily Process DecisionsDaily Process Decisions2.2.2.2. Corrective ActionsCorrective ActionsCorrective ActionsCorrective Actions3.3.3.3. Preventative ActionsPreventative ActionsPreventative ActionsPreventative Actions4.4.4.4. ImprovementsImprovementsImprovementsImprovements5.5.5.5. Etc.Etc.Etc.Etc.

Fit for PurposeFit for PurposeFit for PurposeFit for Purpose

Records Records Records Records (Proof)(Proof)(Proof)(Proof)

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Duality that creates a difficult situation:

FUNCTIONING EFFECTIVELY

vs.

INNOVATING EFFECTIVELY

Innovation Dilemma Innovation Dilemma Innovation Dilemma Innovation Dilemma

Why is it difficult?

Philosophy and Values of the Management Model generally requires a management

cultural shift

• Production (decisions put product first not bureaucracy first)

• Preventive (proactive not reactive)

• Empowering (decisions must be data driven and made by a “competent”

individuals)

• Administrative

• Quality

• Technical

• Impartiality (must be insulated from undo influences)

Do

CheckAct

Plan

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RapidRapidRapidRapid----Niche (Production) Niche (Production) Niche (Production) Niche (Production) Proactive Proactive Proactive Proactive

Static (Government) Static (Government) Static (Government) Static (Government) ReactiveReactiveReactiveReactive

� Static Organization (government)***

� Sprawling Organization

� Rapid-Niche Organization (laboratory)***

� Perpetual-Motion Organization

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� Operate at a relatively slow pace and with clear boundaries of operation; "bureaucratic."

� Feedback in a static organization is often slow;

decision makers are remotedecision makers are remotedecision makers are remotedecision makers are remote

� The market is static market is static market is static market is static and poses no competition, or little.

Episodic ChangeEpisodic ChangeEpisodic ChangeEpisodic Change

� Change that occurs only from time to time; episodic change is driven by inertia and the inability of organizations to keep up.

� Change is infrequent, discontinuous, and intentional. Inertia creates tension.

� Triggers force changeTriggers force changeTriggers force changeTriggers force change…environment, legislation, performance, structure, new strategy, and characteristics of top managers

� Rarely venture out to incorporate products or services outside their existing industry.

� But within their industry, they are continuously looking to be responsive to the users But within their industry, they are continuously looking to be responsive to the users But within their industry, they are continuously looking to be responsive to the users But within their industry, they are continuously looking to be responsive to the users marketmarketmarketmarket and seem to perpetually search for the "next big thing.“

� Differentiation is derived from changes in the product produced, but not to the overall product market.

� Services and products are quick and are delivered to the customer with minimal delay.

Incremental ChangeIncremental ChangeIncremental ChangeIncremental Change

� Are always adjusting their product or service, are

predisposed towards incremental changeincremental changeincremental changeincremental change.

� Incremental change is defined, focused and occurs

continuously in the organization…

change is a way of lifechange is a way of lifechange is a way of lifechange is a way of life.

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Production (RapidProduction (RapidProduction (RapidProduction (Rapid----niche)niche)niche)niche)ProactiveProactiveProactiveProactive

Static (Government) Static (Government) Static (Government) Static (Government) ReactiveReactiveReactiveReactive

Main Types of SubsystemsMain Types of SubsystemsMain Types of SubsystemsMain Types of Subsystems

� Production Production Production Production ---- process & product process & product process & product process & product

� Supportive - production inputs are available - raw materialsraw materialsraw materialsraw materials

� Maintenance - social relations in the system - HR, training

� Adaptive - monitor the environment and generate responses (PR)

� Managerial - coordinate, adjust, control, and direct subsystems

1.1.1.1. Hire or train managers with the right skillsHire or train managers with the right skillsHire or train managers with the right skillsHire or train managers with the right skills

2.2.2.2. Enable Enable Enable Enable purchasingpurchasingpurchasingpurchasing control down to the operational control down to the operational control down to the operational control down to the operational product level (product level (product level (product level (validation drivenvalidation drivenvalidation drivenvalidation driven))))

3.3.3.3. Implement productImplement productImplement productImplement product----first decisionfirst decisionfirst decisionfirst decision----making processesmaking processesmaking processesmaking processes

4.4.4.4. Establish deep customer/user communicationEstablish deep customer/user communicationEstablish deep customer/user communicationEstablish deep customer/user communication

5.5.5.5. Collaborate across functional boundaries (Collaborate across functional boundaries (Collaborate across functional boundaries (Collaborate across functional boundaries (definition definition definition definition top managementtop managementtop managementtop management) ) ) )

6.6.6.6. Build the possibility of “innovation” into the Build the possibility of “innovation” into the Build the possibility of “innovation” into the Build the possibility of “innovation” into the standard workflow processstandard workflow processstandard workflow processstandard workflow process

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• Radical Innovation …. longer term, sporadic, nonlinear, and stochastic

(unpredictable), high risk

• Incremental Innovation …. is linear, more orderly with fewer organizational

and resource uncertainties

Types of InnovationTypes of InnovationTypes of InnovationTypes of Innovation

Google’s release of Gmail, heralded by many as

the best internet mail service, is an example of

such dedication to incremental innovation. When

Gmail launched it had a limited feature set but

did one thing very well, delivered emails. Unlike

competitors it was clean and easy to use with no

distracting flash ads and numerous interface

improvements. Over time Google released more

features and made the service better, faster, and

easier to use.

• Radical Innovation (significant system change) • Accreditation – Management Model

• DNA Analysis vs Serological

• Central Evidence Processing

• Robotics

• ACE-V

• New Instrument Technology

• Incremental Innovation• Routine Validations

• Accreditation Monitoring

• Upgraded Instrument Platform

• Procedural Improvements

Types of InnovationTypes of InnovationTypes of InnovationTypes of Innovation

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Equilibrium

Incremental innovation can be pushed down into the organization where the strategy is clear…

Radical innovation “management” must identify and remove

the restraining forces.

Must mobilize senior leadership:

• Patronage … provide protection, resources, encouragement

• Provocateur … call to arms, voice of project, stimulate activity

• Shaper of Culture … shape organizational culture to make the innovation natural, accepted and valued; permission to bend, adjust, or change the existing “rules”

Imperatives

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Top Leadership approach:

� Leadership must relinquish control-task mentality for a monitor/redirect mentality

� Directive vs. facilitative leadership

� Accelerate project transition by gently but firmly encourage the “birdy” to leave the nest; it never thinks it is ready

Imperatives

• Right people:

� must be people that will dive the innovation with a high tolerance for risk, out-of-the box mentality

� cannot wait for them to emerge must recruit them; often they will be at odds with the existing organizational framework

� cross multifunctional core group … need both technical and broad thinking ability

� success is dependent on communication with the organization’s “mainstream”

� importance of influential advisors

Imperatives

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• Tinkering vs Overhauling

• Tinkerers prefer doing things the unit has already done before—just doing them a little better, a little more, a little faster, or a little more cost effectively.

• Overhaulers are intent on putting the unit or organization on a new trajectory with a radical, multidimensional, and fundamental change effort.

Types of Innovators

Change: Tinkering Overhauling

Incremental Radical

Low risk High risk

Surface Deep

Tinkering or overhauling is a strategic decision

• …assume that the future can be predicted and,

more importantly, controlled to minimize the risk of change…

• …attempt to identify the issues, problems, and variables to estimate likelyoutcomes and consequences of their decisions…

√ Focus on control

√ Define roles and responsibilities

√ Calculate likely outcomes

√ Centralize decision making

√ Proceed according to a predetermined plan

Planners

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• …assume that flexibility minimizes the risk of change…

• …approach change by learning from what others have done, then acting, and then reassessing before the next action…

√ Focus on perpetual adaptability

√ Rely on experience and knowledge

√ Decentralize decision making

√ Proceed by trial and error

Improvisers

Planning may be appropriate in terms of themedium and long run. But in the short run,to make planning work, you're going tohave to improvise.

Change Agenda Matrix

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• The more an agency tries to operate through “formal mechanisms” of existing organizationalprocedures, structure and controls the more the agency will drive out its ability to work with newtechnology, concepts and ideas!

• Informal organization designs/processes are needed to support innovation.

• Innovation is a dynamic process that goes beyond existing internal “boundaries;” not static like existingorganizational patterns.

• Need to overcome the communication bias (boundary driven) managers need to recognize these “strong” biases:

virtue and superiority of existing/own ideasdismissive of rival/new technologies as inferior/weaklimited group interaction with outside sourceslittle intentional exposure to new ideashomogeneity of group

Boundary Issues

• Majority Rules:

• Assume truth lies in numbers

• Fear of disapproval and rejection

• Extensive research indicates that when people are faced with a majority of others who agree on a particular attitude or judgment, they are likely to adopt the majority judgment.

• When faced with this situation people will view the issue from the majority perspective even if it is wrong!

• Also, if faced with a majority, people will search for information in a biased manner and will be unable to detect original solutions to problems.

Boundary Issues

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Given the boundary issues:

• Strong, well-identified executive sponsorship is required if the technology transfer is to be successful!

• The more radical the technology the stronger it must be!

Boundary Issues

• first idea …is that we tend to see resistance as part of the problem ofchange, and we focus on overcoming it rather than engaging it. Thistendency is the product of three compelling forces: cognitive biases, socialdynamics, and managerial missteps.

• second idea …is that resistance is a form of feedback and, as such, itprovides potentially valuable information that may not be available anyother way. By being willing to consider resistance as useful feedback,managers can reshape specific aspects of a change, thereby increasing thelikelihood of success.

Resistance - Two Ideas

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• Supporters are those individuals who continue to agree with youragenda and how it is being executed.

• Dissenters are those individuals who support your initiative, but mayquestion what you're doing and how you're going about doing it;they want to make some adjustments as you're moving along.

Managing Your Agenda

Managerially-competent leaders try to distinguish real dissent versus white noise.

Opponents, unlike dissenters, are likely to express stronger opposition aboutwhat you're doing and how you're getting there. While dissenters may makeoff-hand remarks and suggestions, opponents are more likely to challenge youdirectly and publicly in an adamant and continuous fashion. Their language ismore confrontational and reflects a stronger sense of urgency.

Managing Your Agenda

Resistors are those individuals who not only want to

challenge you, but actively sabotage where you're

going and how you're getting there. Resistors will

verge on obstruction, not only confronting you, but

actively blocking you.

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Momentum Framework

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Momentum: Tactics

Tactical Exercise

• “Implementing Radical Innovation in Mature Firms,” Richard Leifer, et al. in The Human Side of Managing Technological Innovation, 2004

• “Rules of Innovation,” Clayton Christensen, in The Human Side of Managing Technological Innovation, 2004

• “Examining Some Myths about New Product Winners,” Robert G. Cooper in The Human Side of Managing Technological Innovation, 2004

• “Organizational Issues in The Introduction of New Technologies,” Ralph Katz and Thomas Allen in The Human Side of Managing Technological Innovation, 2004

• “Managing Innovation,” Charlan Jeanne Nemeth in The Human Side of Managing Technical Innovation, 2004

• The Fifth Discipline: The Art & Practice of The Learning Organization. Peter M. Senge, Crown Publishing Group. Kindle Edition, 2010

• The Human Side of Managing Human Innovation: A collection of Readings, edited by Ralph Katz, Oxford University Press, 2004

• Negotiating Support and Buy In for Your Agenda. Samuel B. Bacharach, eCornell, 2014

• Leading & Managing Innovation: What Every Executive Team Must Know about Project, Program & Portfolio Management. Shane C. Archibald & Russell D. Archibald, Kindle Edition. 2013The ego bias.

• The Other Side of Innovation: Solving the Execution Challenge. Vijay Govindarajan & Chris Trimble, Harvard Business Review Press, Kindle Edition, 2010

Bibliography

8/3/2017

17

• Sustaining Momentum: Motivating through Vision, Culture, and Political Agility. Samuel B. Bacharach, eCornell, 2013

• Why Your Innovation Leadership Training Will Fail, Henry Doss, Forbes, http://www.forbes.com/, 2013.

• Switch: How to Change Things When Change Is Hard. Chip Heath, Dan Heath, Random House, Inc.. Kindle Edition, 2010.

• Innovation's Nine Critical Success Factors. Vijay Govindarajan, Harvard Business Review, July 5, 2011

• Developing and Agenda for Change. Samuel B. Bacharach, eCornell, 2013

• Managing Product Management: Empowering Your Organization to Produce Competitive Products and Brands. Steven Haines. McGraw-Hill. Kindle Edition, 2011

• Mapping the Political Terrain of Allies and Resistors. Samuel B. Bacharach, eCornell, 2013

• Stop Blaming Resistance to Change and Start Using It. Jeffrey D. Ford & Laurie W. Ford, Organizational Dynamics, Vol. 39, No. 1, 2010

• The Other Side of Innovation: Solving the Execution Challenge. Vijay Govindarajan & Chris Trimble, Harvard Business Review Press, 2010.

• Negotiating Support and Buy-In for Your Agenda. Samuel B. Bacharach, eCornell, 2014

• Credibility: How Leaders Gain and Lose It, Why People Demand It. James M. Kouzes & Barry Z. Posner, Wiley. Kindle Edition, 2011.

• Boundary Spanning Leadership: Six Practices for Solving Problems, Driving Innovation, and Transforming Organizations. Chris Ernst; Donna Chrobot-Mason, Kindle Edition, 2010.

Bibliography

EXERCISES

VALUES EXERCISE

Achieving Accreditation: Managing the Process IAFS Meeting August 2017 Page 1of 1

Accomplishment, Success Accountability Accuracy Adventure All for one & one for all Beauty Calm, quietude, peace Challenge Change Cleanliness, orderliness Collaboration Commitment Communication Community Competence Competition Concern for others Connection

Content over form Continuous improvement Cooperation Coordination Creativity Customer satisfaction Decisiveness Delight of being, joy Democracy Discipline Discovery Diversity Ease of Use Efficiency Equality Excellence Fairness Faith Faithfulness Family Family feeling Flair

Freedom Friendship Fun Global view Good will Goodness Gratitude Hard work Harmony Honesty Honor Improvement Independence Individuality Inner peace, calm, quietude Innovation Integrity Intensity Justice Knowledge Leadership Love, Romance Loyalty Maximum utilization (of time, resources) Meaning Merit Money Openness Patriotism Peace, Non-violence Perfection Personal Growth Pleasure Power Practicality Preservation Privacy Progress

Prosperity, Wealth Punctuality Quality of work Regularity Reliability Resourcefulness Respect for others Responsiveness Results-oriented Rule of Law Safety Satisfying others Security Self-givingness Self-reliance Self-thinking

Service (to others, society) Simplicity Skill Solving Problems Speed Spirit in life (using) Stability Standardization Status Strength

Succeed; A will to- Success, Achievement Systemization Teamwork Timeliness Tolerance Tradition Tranquility Trust Truth Unity Variety

Ranking 1. ____________________________________ 2. ____________________________________ 3. ____________________________________ 4. ____________________________________ 5. ____________________________________

Key 1 = 0k;

0 = Needs

work _____________ LABORATORY

Does the laboratory facility seem adequate?

Does the laboratory have its scope defined?

Have managerial and technical personnel?

Have a Quality Manual?

Manual addresses G19 requirements?

Have a Quality Manager?

Have the support of “top management? Willling to allocate resources for innovation?

Does the laboratory appear to be committed to “good” professional practice?

Is the laboratory willing to commit to compliance with the International Standard and to the

practice of continual improvement?

Do the laboratory have written technical procedures in each area of proposed scope of

accreditation?

Does the laboratory currently practice document control?

Does the laboratory have positive working relationship with its users?

Does the laboratory have procedures to perform scope anticipated activities off-site?

Does the laboratory do all of its own work? No sub-contract work?

Does the laboratory have the ability to timely acquire the supplies it needs?

Does the laboratory currently get formal feedback from its users?

Does the laboratory document corrective actions?

Does the laboratory create and retain records containing sufficient information to establish the

scientific foundation of it opinions?

Does the laboratory periodically do audits?

Does the laboratory have trained ISO auditors? (ABs perspective)

Does the laboratory have activity specific job descriptions?

Does the laboratory have an authorization process in place?

Does the laboratory have effective separation between neighboring areas in which there are

incompatible activities?

Does the laboratory have manageable evidence storage space?

Are measures taken to ensure housekeeping in the lab?

Does the laboratory have a documented training program?

Does the laboratory appear to be using use appropriate methods and procedures?

Does the laboratory appear to have adequate standard materials and reagents?

Have the laboratory's methods been validated?

Has the laboratory been furnished with all items of measurement and test equipment required

for its proposed testing schemes?

Is the laboratory's equipment capable of meeting basic testing requirements?

Does the laboratory have calibration and maintenance plans in place?

Does the laboratory currently do external system tests (proficiency tests)?

Does the laboratory have a safety requirements and guidelines in place?

Does the labatory have necessary legal licenses?

Does the laboratory use positive and negative controls? Are they in balance?

Do laboratory reports follow ISO guidelines (results vs interpretation; clarity)?

Does DNA report statistics? partials and mixtures?

Does the laboratory report uncertainty for critical measurements (weight/lengths)?

Uncertainty uses "process method"?

Technical case review being practiced?

Is evidence labeling permanent?

Tracks refence collections?

Total

Percent

TYPICAL TIME FRAME FOR A 50% VALUE


May 2016 – Jan 2017

Define its initial scope of accreditation Create a Quality Manual***** Reduce all quality and technical procedures to writing Begin solving “special issues” Begin training courses if required (Quality)

May 2016 – Jan 2017

Purchase required standard materials (weights, controls, measuring devices) Complete validations of all technical procedures Purchase external system tests for spring of 2017 (CTS proficiency tests) Begin educating “users” regarding the quality system and its requirements Solve any procurement issues (maintenance agreements, equipment calibration)

Sept – Nov 2016 Attend ANAB internal assessor training

Feb 1, 2017 Complete technical training requirements Implement ISO compliant quality management system

Feb – Apr 2017 Complete three-month compliance record required by ANAB Complete external proficiency tests

Apr - May 2017 Do an in-depth internal audit from AB's perspective of the quality system Identify opportunities for system improvement Begin corrective and preventative action process

June - July 2017 Complete corrective actions Do an in-depth management review of the system

August 31, 2017 Complete and submit the application for accreditation Complete the required four (4) year proficiency test plan

Oct – Dec 2017

Complete ANAB assessment Make necessary system adjustments post assessment Up load corrective actions into ANAB’s software system for approval Accreditation awarded

Strategic Action Items Exercise


Define its initial scope of accreditation Create a Quality Manual***** Reduce all quality and technical procedures to writing Begin solving “special issues” Begin training courses if required (Quality)

Purchase required standard materials (weights, controls, measuring devices) Complete validations of all technical procedures Purchase external system tests for spring of 2017 Begin educating “users” regarding the quality system and its requirements Solve any procurement issues (maintenance agreements, equipment calibration)

Attend ANAB internal assessor training

Complete technical training requirements Implement ISO compliant quality management system

Complete three-month compliance record required by ANAB Complete external proficiency tests

Do an in-depth internal audit from AB's perspective of the quality system Identify opportunities for system improvement Begin corrective and preventative action process

Complete corrective actions Do an in-depth management review of the system

Complete and submit the application for accreditation Complete the required four (4) year proficiency test plan

Complete ANAB assessment Make necessary system adjustments post assessment Up load corrective actions into ANAB’s software system for approval Accreditation awarded


Select Strategic Goal: Creation of Quality Manual

Structure

� Simple Execution or encourage dialogue? (individual / team?) � Who does what? (team/individual)? � What resources are going to be allocated? � How much time do I want to spend on an issue? � Potential blockages?

Resources … enough to facilitate…how will you periodically revisit the resource issue?

Performance

� How do I want to evaluate progress? Criteria… � How will I ensure the criteria are understood and agreed to by the work group? � Do I measure output/process/both? � How do I get and give feedback?

� Will I function primarily as a supervisor or as a mentor? � What factors are likely to influence my role?

Production vs innovation issues?

Culture

What measures will you need to take to achieve a team culture that is appropriately balanced between learning/self-reflection and the desire to act?

� How do I develop group cohesiveness, if team? Create and strengthen the connective bonds… � How do I foster a sense of commitment? � How do I generate involvement? � How do I get to stop asking, why should I do it; and get them focused on what needs to be

done? � Rewards and Recognitions…how…tactical milestones?

Political What specific strategies will I employ to address potential internal opposition to the initiative within my workgroup? How will I balance hard tactics of coercion with soft tactics of persuasion in dealing with dissenters, opponents, and resistors? What are the criteria by which I would dismiss a resistor from the work group?

� How do I establish credibility? � Who will likely be supporting, opposing the initiative? � How do I communicate the vision?

achieving accreditation: managing the process iafs...

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