Product-Stewardship-Management-Systems-Randy-Deskin.pdf

7/24/2019 Product-Stewardship-Management-Systems-Randy-Deskin.pdf

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Product StewardshipManagement

SystemsRandy Deskin, Ph.D., DABT, ERTDeskin Associates, LLC


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Product Safety to Stewardship - Evolution

Scope and complexity of Global Regulations Exploding Transition from Product Safety to Product Stewardship greatly broadened the

scope of knowledge required

Cross Functional Effectiveness complexity increased greatly

This evolution has created the need for a highly skilled PSRA organization

Governance- greater need for transparency

Greater involvement of value stream- up and down

Heightened public awareness of chemicals by public

Greater pressure to regulate and ban chemicals


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Shift from Product Safety Toward Sustainability

HazardCharacterization

CommunicateHazard

CustomerSafe Handling

ReduceEnvironmental

Footprint

Design Safer,Environmentally

Preferable Products

Product Safety Group

PS + BU + Customers

PS + BU + R&D +MFG + Customers + Stakeholders

Push Pull

Reactiv

e

Proactive

Sustainability

Product Stewardship

Product Safety

Shift requires PSRA employees with sound product, organizational,business and regulatory knowledge and excellent communication skills

The evolution from product safety to sustainability


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!""#!

$%&$!

Global Increase in Chemical Regulations

Proliferation of chemical regulations

barrier to global market entry


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AdvocacyDeterminethe impact

of developingregulations andproactively work

to positively influenceregulatory outcomes

ToxicologyConduct safety

evaluationsof products to

support productregistrationsand hazardassessment

RegulatoryObtain

global regulatoryapprovals andregistrationsfor productsin support ofBU initiatives

Stewardship/SustainabilityProactively work

with R&D andkey stakeholders

to promote productstewardship

and sustainabledevelopment

throughout theproduct lifecycle

HazardCommunication

Develop and evaluatehazard data needed

to protect humanhealth and

the environment.Communicate

information

through MSDSin a timely manner

To promote the protection of human health andthe environment and to ensure global product

regulatory compliance and safe handling ofproducts in a cost effective manner.

Product Stewardship

Cross Functional Effectiveness with Stakeholders is Essential

We all need to be Product Stewards


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Product Stewardship Vocabulary

TSCA

REACH

GHS

SDS

Physical Hazard

DSL

!"##$ &'#()*+",

!"#


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ProductStewardship

Product Stewardship

The cross-functional nature of Product Stewardship requires collaboration betweenall functional groups within an organization (Product Stewardship Society, 2014)

Recycling &Take-backprograms

ProductExposure &

RiskAssessment

ProductSafetyTesting

SustainableProductDesign/

Development

Banned/restricted

SubstancesManagement

DangerousGood

Transportation

Safety Data,Sheets,

Labels, & SafeHangling

Instructions

GlobalChemical &

ProductSafety

Regulations

Adverse Event

Recording&

ResponseCustomerInquires

MarketingClaims &

Declarations


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Stewardship Along the Value Chain

Raw Materials

Production

New Process

Regulated Shipments

TSCA

MSDS

Customer

ProductQuality

Product Packaging& MSDS

Solid waste

Label

Hazard Info

UltimateConsumer

Product useProduct life

DisposalUltimate Fate

New ProductDevelopment

Manufacturing / Supply Chain(incl Tolling / Distribution)

CommercializationR&D

Samples toCustomer

= Rep Process Gaps

Inventory

Label

Warehousing &Distribution

PSCFAMA

We Are All Product Stewards

Change effect (Regulatory)


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SWOT Analysis Organization

Opportunities

Becoming more proactive/Develop creativesolutions

Become more integrated with BUs

Leverage our database technology

Increase responsibilities to BUs/R&D/Man.

Develop career paths

Threats

Potential for employee burnoutand/or retention issues

Noncompliance/Fines

Inward focus decreases lack oforganizational effectiveness

Weaknesses

Lack of resources, bench strength& capacity; little redundancy

Lack of employee career pathand growth opportunities, Lack ofsuccession planning

Trend towards being reactive

Inward focus, lack of continuouscommunication with BUs/R&D/Man.

Lack of integration with BU X

Strengths (Competencies)

Knowledge of regulations & companyproducts

Experience & institutional knowledge

Efficient work processes (e.g., global issueshandled in one place; centralized)

Proficient problem solving

Strong network of outside resources

Core group of dedicated, hardworkingprofessionals


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Risk Map

LOW MEDIUM HIGH

PRIORITY

T

IMING

LongerTerm

Immediate

LI0

LL8 HL0

MI2 HI7

ML3


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Representative RACI(X)


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Product Stewardship Core Competenciesby Function


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Questionnaire

Total annual sales (USD)

Geographic breakdown of sales by region or country (percent)

Number of manufacturing facilities and their geographic distribution byregion or country

Number of major R&D centers and their geographic distribution by regionor country

Approximate number of active products irrespective of gradeor packaging

1. Company


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Questionnaire

2. PS Organizational Model

What are the biggest challenges you are facing in the product stewardshiparea?

What are the total number of FTE's engaged in Product Stewardship inyour company?

To which function does your product stewardship organization report? Do you use a centralized or decentralized model? Please describe

Do you use a regional or a global organization model? Please describe

Do you hire PS professionals from within and train or do you hireexternally?

On average, how long does it take to hire product stewardship talent?

What are the key Core Competencies you seek in new talent?

EACH and GHS Biggest issues

Also ~ 4 FTE/ B $ 1 Sales


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Questionnaire

3. Product Regulatory Compliance (focuses on the control

of chemical substance manufacturing, importing and salesexcluding REACH and Hazard Communication)

How many full-time equivalent (FTE) product regulatory compliance specialistsdo you employ internally ?

What is the geographic distribution of your product regulatory compliance

specialists and how is their work or areas of specialization allocated?

What are the educational backgrounds of your product regulatory compliancespecialists? Do they have any certifications?

Do your specialists receive on-going regulatory training or participate in tradeassociates to stay current?

Global organizational modelswith centralized PSRA


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Questionnaire

3. Product Regulatory Compliance (focuses on the control

of chemical substance manufacturing, importing and salesexcluding REACH and Hazard Communication)

What is their range of years experience in product regulatory compliance?Range of years tenure with your company?

Do you outsource any of your product regulatory compliance work?

If so, what type of work and at what approximate annual spend? What specific types of registrations are your product regulatory compliance

special responsible for? Approximately how many do they obtain per yearon average? How many are they currently working on?

Do your product regulatory compliance specialists routinely response tocustomer or business unit requests for regulatory information? If so,

approximately how many information requests do they respond to per year?

2 to 30 years of experience


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Questionnaire

4. Reach

How many full-time equivalent (FTE) REACH specialists do you employinternally?

Where are your REACH specialists physically located?

What are the educational backgrounds of your REACH specialists?Do they have any certifications?

Do your REACH specialists receive on-going regulatory training or participatein trade associates to stay current?

What is their range of years experience in REACH? Range of years tenurewith your company?

Do you outsource any of your REACH work? If so, what type of work and

at what approximate annual spend? What is your approximate number of Tier 4 chemical substances

(2018 registrations)?

Majority of REACH specialistslocated in the EU


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Questionnaire

5. Hazard Communication (Safety Data Sheets (SDS) and Labeling)

How many full-time equivalent (FTE) hazard communication specialistsdo you employ internally to author SDS?

What is the geographic distribution of your hazard communication specialistsand how is their work allocated? Is their SDS authoring work is done ona regional or global basis, i.e., do author based in the US only author

US format SDS or do they author for all formats?

What are the educational backgrounds of your hazard communicationspecialists? Do they have any certifications?

Do your specialists receive on-going regulatory training or participate intrade associates to stay current?

On the job training/experienceto B.S. degree


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Questionnaire


What is their range of years experience in hazard communication?Range of years tenure with your company?

To what degree in FTEs are they supported by specialists from outsidethe hazard communication group, e.g., toxicology, industrial hygiene,environmental, chemical control, etc.?

How many FTEs of non-professional level support are within the hazardcommunication group?

How many FTEs of technical IT type support from outside the hazardcommunication group do you rely on to use and maintain your hazardcommunication database system

Do you outsource any of your SDS preparation? If so, approximately howmany SDS per year and at what cost?

1 to 35 years of experience;median 5 to 10 years


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Questionnaire

How many different format SDS do you maintain? How many languages?

How many active SDS do you have (counting all formats and languagevariations)?

Approximately how many SDS do you publish per year?

What is your average turnaround time to author a single format/languageSDS for a new formulation? For an urgent rush request?

Of your active formulations, what is the approximate ratio of substancesversus mixtures?

What database system or other methods do you use to prepare and maintainSDS and labels?


Most companies ~ 30 formatsand 20- 30 languages


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Questionnaire

6. Toxicology

How many full-time equivalent (FTE) toxicologists do you employ internally?

Where are your toxicologists physically located?

What are the educational backgrounds of your toxicologists? Do they haveany certifications?

Do your toxicologist receive on-going training or participate in tradeassociations to stay current?

What is their range of years experience in industry? Range of years tenurewith your company?

Do you outsource any of your toxicology work? If so, what type of work and

at what approximate annual spend? How many REACH registrations are your toxicologists currently working on?

10 to 30 years experience


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Product Stewardship Organization QuestionnaireBenchmarking Major Takeaways

All have multi-national businesses and thousands of products

REACH and GHS appear to be a common major challenge for mostrespondents

Total number of FTEs appear somewhat comparable commensuratewith company size- 20 FTE/ B $5 Sales

Most respondents have some degree of a global organizational

model with centralized common work processes

Various core competencies sought by the respondents but almost allincluded technical skills.

All respondents except one mostly allocated resources intothe discrete functional areas of Product Regulatory Compliance,Hazard Communication, Toxicology and REACH with minimal overlap.

Respondents seemed to favor hiring from within.

Experience ranges varied widely across the respondents but almostall included highly experienced staff in each functional area.


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Reporting Structure of PSRA Organizations

EH&S60%

Operations14%

Legal10%

R&D10%Other

1%


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Randy Deskin, Ph.D., DABT, ERTDeskin Associates, LLC

[email protected]

Product-Stewardship-Management-Systems-Randy-Deskin.pdf

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