Product Stewardship Management Systems. Randy Deskin, Ph.D., DABT, ERT Deskin Associates, LLC

Transcription

1 Product Stewardship Management Systems Randy Deskin, Ph.D., DABT, ERT Deskin Associates, LLC 1

2 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 2

3 Shift from Product Safety Toward Sustainability Hazard Characterization Communicate Hazard Product Safety Group Product Safety Customer Safe Handling Design Safer, Environmentally Preferable Products Reduce Environmental Footprint Reactive PS + BU + Customers Product Stewardship PS + BU + R&D +MFG + Customers + Stakeholders Sustainability Proactive Push Pull The evolution from product safety to sustainability Shift requires PSRA employees with sound product, organizational, business and regulatory knowledge and excellent communication skills 3

4 Global Increase in Chemical Regulations ACC, 2012 Proliferation of chemical regulations barrier to global market entry 4

5 Product Stewardship To promote the protection of human health and the environment and to ensure global product regulatory compliance and safe handling of products in a cost effective manner. We all need to be Product Stewards Regulatory Obtain global regulatory approvals and registrations for products in support of BU initiatives Hazard Communication Develop and evaluate hazard data needed to protect human health and the environment. Communicate information through MSDS in a timely manner Toxicology Conduct safety evaluations of products to support product registrations and hazard assessment Stewardship/ Sustainability Proactively work with R&D and key stakeholders to promote product stewardship and sustainable development throughout the product lifecycle Advocacy Determine the impact of developing regulations and proactively work to positively influence regulatory outcomes Cross Functional Effectiveness with Stakeholders is Essential 5

6 Product Stewardship Vocabulary REACH SDS TSCA GHS DSL EPA Physical Hazard Green chemistry 6

7 Product Stewardship Customer Inquires Global Chemical & Product Safety Regulations Adverse Event Recording & Response Safety Data, Sheets, Labels, & Safe Hangling Instructions Marketing Claims & Declarations Product Stewardship Dangerous Good Transportation Recycling & Take-back programs Product Exposure & Risk Assessment Product Safety Testing Banned/ restricted Substances Sustainable Management Product Design/ Development The cross-functional nature of Product Stewardship requires collaboration between all functional groups within an organization (Product Stewardship Society, 2014) 7

8 Stewardship Along the Value Chain R&D Manufacturing / Supply Chain (incl Tolling / Distribution) Commercialization Samples to Customer Raw Materials New Product Development Change effect (Regulatory) Production PSCF AMA Product Quality Customer Ultimate Consumer Product use Product life Disposal Ultimate Fate New Process Warehousing & Distribution ø TSCA Solid waste ø = Rep Process Gaps Inventory ø MSDS Regulated Shipments Product Packaging & MSDS Label We Are All Product Stewards Label Hazard Info 8

9 SWOT Analysis Organization Strengths (Competencies) Knowledge of regulations & company products Experience & institutional knowledge Efficient work processes (e.g., global issues handled in one place; centralized) Proficient problem solving Strong network of outside resources Core group of dedicated, hardworking professionals Weaknesses Lack of resources, bench strength & capacity; little redundancy Lack of employee career path and growth opportunities, Lack of succession planning Trend towards being reactive Inward focus, lack of continuous communication with BU s/r&d/man. Lack of integration with BU X Opportunities Becoming more proactive/develop creative solutions Become more integrated with BUs Leverage our database technology Increase responsibilities to BU s/r&d/man. Develop career paths Threats Potential for employee burnout and/or retention issues Noncompliance/Fines Inward focus decreases lack of organizational effectiveness 9

10 Risk Map TIMING Longer Term Immediate LI 0 MI 2 HI 7 LL 8 ML 3 HL 0 LOW MEDIUM HIGH PRIORITY 10

11 Representative RACI(X) 11

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13 Product Stewardship Core Competencies by Function 13

14 Questionnaire 1. Company Total annual sales (USD) Geographic breakdown of sales by region or country (percent) Number of manufacturing facilities and their geographic distribution by region or country Number of major R&D centers and their geographic distribution by region or country Approximate number of active products irrespective of grade or packaging 14

15 Questionnaire EACH and GHS Biggest issues 2. PS Organizational Model What are the biggest challenges you are facing in the product stewardship area? What are the total number of FTE's engaged in Product Stewardship in your company? Also ~ 4 FTE/ B $ 1 Sales 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 hire externally? On average, how long does it take to hire product stewardship talent? What are the key Core Competencies you seek in new talent? 15

16 Questionnaire 3. Product Regulatory Compliance (focuses on the control of chemical substance manufacturing, importing and sales excluding REACH and Hazard Communication) How many full-time equivalent (FTE) product regulatory compliance specialists do 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 compliance specialists? Do they have any certifications? Do your specialists receive on-going regulatory training or participate in trade associates to stay current? Global organizational models with centralized PSRA 16

17 Questionnaire 3. Product Regulatory Compliance (focuses on the control of chemical substance manufacturing, importing and sales excluding 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 year on average? How many are they currently working on? Do your product regulatory compliance specialists routinely response to customer 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 17

18 Questionnaire 4. Reach Majority of REACH specialists located in the EU How many full-time equivalent (FTE) REACH specialists do you employ internally? 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 participate in trade associates to stay current? What is their range of years experience in REACH? Range of years tenure with 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)? 18

19 Questionnaire 5. Hazard Communication (Safety Data Sheets (SDS) and Labeling) How many full-time equivalent (FTE) hazard communication specialists do you employ internally to author SDS? What is the geographic distribution of your hazard communication specialists and how is their work allocated? Is their SDS authoring work is done on a 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 communication specialists? Do they have any certifications? Do your specialists receive on-going regulatory training or participate in trade associates to stay current? On the job training/experience to B.S. degree 19

20 Questionnaire 1 to 35 years of experience; median 5 to 10 years 5. Hazard Communication (Safety Data Sheets (SDS) and Labeling) What is their range of years experience in hazard communication? Range of years tenure with your company? To what degree in FTE s are they supported by specialists from outside the hazard communication group, e.g., toxicology, industrial hygiene, environmental, chemical control, etc.? How many FTEs of non-professional level support are within the hazard communication group? How many FTEs of technical IT type support from outside the hazard communication group do you rely on to use and maintain your hazard communication database system Do you outsource any of your SDS preparation? If so, approximately how many SDS per year and at what cost? 20

21 Questionnaire Most companies ~ 30 formats and languages 5. Hazard Communication (Safety Data Sheets (SDS) and Labeling) How many different format SDS do you maintain? How many languages? How many active SDS do you have (counting all formats and language variations)? Approximately how many SDS do you publish per year? What is your average turnaround time to author a single format/language SDS for a new formulation? For an urgent rush request? Of your active formulations, what is the approximate ratio of substances versus mixtures? What database system or other methods do you use to prepare and maintain SDS and labels? 21

22 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 have any certifications? Do your toxicologist receive on-going training or participate in trade associations to stay current? What is their range of years experience in industry? Range of years tenure with 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 22

23 Product Stewardship Organization Questionnaire Benchmarking Major Takeaways All have multi-national businesses and thousands of products REACH and GHS appear to be a common major challenge for most respondents Total number of FTE s appear somewhat comparable commensurate with 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 all included technical skills. All respondents except one mostly allocated resources into the 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 almost all included highly experienced staff in each functional area. 23

24 Reporting Structure of PSRA Organizations EH&S 60% Other 1% R&D 10% Legal 10% Operations 14% 24

25 Randy Deskin, Ph.D., DABT, ERT Deskin Associates, LLC