Document dYOLG3XnVpEMNjOrRznYaDDB5

TO: Charlie Dutra Interoffice Communication FROM: DATE: SUBJ: T. G. Grumbles August 26, 1991 RECORD OF TRAINING T6k^BL ^ rf XF: fwr\^_____ ------- Attached are the training records and overheads used for the Product Liability Awareness and New Product Development Process training. dlj Attachment cc: P. D. Carrico-LCVCM, J. Ware-LCLAB VVV 000007572 SYNOPSIS OF PRODUCT LIABILITY/NEW PRODUCT DEVELOPMENT PROCESS TRAINING NEW PRODUCT DEVELOPMENT TRAINING An overview of the process and the specific items most applicable to the plants was presented. Manuals were distributed to appropriate supervisory personnel. PRODUCT LIABILITY AWARENESS TRAINING The intent of the training was to raise awareness on the issues of regulatory and product liability. The film ''When Products Harm" was shown and discussed. The differences in regulatory and product liability were reviewed. Product defects and how we manage them were discussed. The differences in regulatory and product liability were reviewed. Product defects and how we manage them were discussed. 8:15-9:45 10:00-11:30 1:30-2:30 Both Both New Product Development Only Instructor: Tom Grumbles vvv 000007573 L C.Cvj Leu j Lcuow^ io'.oo - ir-ao. Bor^roM, 1/KK.i Hlfe6.(NlS ........ _ ......... __,,_Lccf ______ Letup .Richard. Boeouj. ............ ____________ LccP bfJ/JS LtH-T ________ ._ L-CC.P David izdsb ___________ LCCP CoRL-ey . * 0.c^stA-sOfcr '>L(-X .......... .. 1<l<lP jLCCP ____ ____Lecs...... . -- /yet/is fJ 0*4/ 4 C'Cj^ !Rc/h {J)/h-*0 /rfooa . Vsku-sy l^CL^C.^- ^ k )t>Q VV. T^bAMco x/ot><SZY _ h/\jkr\c>r\ts r\^^liiryu i/C^ voi VJ C,tA^\ .... . . .................... M? _ LcciP ' -r* ................- VVV 0000G7574 L ci c?/Xcla&/Severn \ /2.c* trt i /i^ Y'tZ.j'll ` <Q\ K-q.M-i K^>J Ae^vH /V1M.5 fjATALIZ fY]lL,UtOAN \ i.a^7iv\e^" ^/;'<. Luinemon 'Didua^' 7amrex. 'f\ado-ytYic_ _ _ ^V/ 7~rc ia A , /"/"/,q,*T _,' L Cep LCCp . Cl/CJVV ......... <lG?P uluAb LC_cJ <t <= v<r>*t_ LcLAs .......LcL^S L- Cc-P \ <3i^ T'<`'J+2: /?,/ L <2 <^,P* /.ex/ vvv 000007575 Lcc?^Lcln&I L e\ic/v\ <\ 1 V'bo -2.' 5>> . "f ^ [) cx-( ^>4 Ktttrw. t.. r & o o Mil 4or.-U^^ D/^lI. M-ucc/~ t^-iL. VVV 0000075T6 LIABILITY REGULATORY CIVIL/CRIMINAL/ADMINISTRATIVE MINIMUM STANDARDS PRODUCT - DESIGN - MANUFACTURE^ - INHERENT WARNINGS VVV 000007577 6001FLP/TQG006.WP 8/21/91 DESIGN PRODUCT LIABILITY IS IT DESIGNED OR MEANT TO BE MANUFACTURED AS SAFE AS FEASIBLE (POSSIBLE)? MANUFACTURE WAS IT MADE ACCORDING TO DESIGN OR MANUFACTURING SPECIFICATIONS? IS QC IN-PLACE TO ASSURE THIS? INHERENT BASED ON PROPERTIES OF THE CHEMICAL OR PRODUCT. WARNINGS S001FLP/TQQ006.WP - LABELS AND MSDS'S VVv 000007578 PRODUCT LIABILITY WARNINGS LABELS ARE JUDGED ON THE FOLLOWING: 1. VISIBLE AND READABLE 2. STATEMENT OF HAZARD 3. CONVEYING LEVEL OF HAZARD 4. DESCRIPTION OF CONSEQUENCES OF HAZARD r" % 5. INSTRUCTIONS ON HOW TO AVOID HAZARD 6. INSTRUCTIONS ON WHAT TO DO IF HAZARD OCCURS VVV 00G007579 6001FLP/TGG006.WP *--------------- ------- PRODUCT LIABILITY IS IT UNFAIR? YES IS IT EXCESSIVE? OFTEN IS IT AVOIDABLE? NO IS IT MANAGEABLE? YES PREVENTION COSTS LESS THAN DEFENSE OOOOOT560 B60/g0l1/9R1J_YT_G_G_00_6_.W_P ^ Co m2 3 3 O Co vvv 000007581 THE WHOLE PROCESS IS TO ASSURE: A. TIMELY DEVELOPMENT OF DATA REQUIRED FOR HAZARD ASSESSMENTS AND REGULATORY CLASSIFICATIONS. B. TIME TO ASSIMILATE DATA INTO QUALITY AND COMPLIANT WARNING MATERIALS. C. IDENTIFICATION OF POTENTIAL BARRIERS TO PRODUCT DEVELOPMENT SUCH AS A LENGTHY PMN PROCESS, EXPENSE OF REQUIRED TOXICITY TESTING, REGULATORY ISSUES IN PLANT PRODUCTION, AND POSSIBLE UNACCEPTABLE PRODUCT LIABILITY RISKS. VVV 000007582 T0GCO5.WP 1^6/91 SIMPLIFIED NEW PRODUCT DEVELOPMENT PROCESS FLOW SECTION 1 Project Idea generates early lab work and initial customer samples SECTION 2 Customer interest and business area commitment generate scale-up work and consideration of health, safety, and regulatory concerns. Successful product candidate completed commercialization impact assessment and documentation. SECTION 3 AND 4 Commercial product remains up-to-date with changing volume, end use, and regulatory requirements. Determine TSCA Inventory Status (Step la, Appendix la) Determine Adequacy of Experimental MSDS and Labels (Step 1b) < < < o o oo o uC>O -> Develop Physical and Chemical Data (Step 2a, Appendix 2a) RevAiew Needs Regarding Product Toxicology Testing (Stepteb, Appendix 2b) Initial Review of End Use Regulatory Requirements (Step 2c) -> Complete and File PMN If Needed (Step 2d, Appendix 2d) Review Product Design (Inadvertent Contaminants, etc.) (Step 2e) Conduct Hazard Assessment (Step 2f, Appendix 21) Review Plant Impact (Step 2g, Appendix 2g) Develop Commercial MSDS and Label Test (Step 2h, Appendix 2h) --^ Assign Dot Classification for COEDS Entry (Step 21, Appendix 21) File Notice of Commencement to Manufacture (Step 3a, Appendix 3a) Review End Use Regulatory and Industry Standards (Step 3b) Add Appropriate Data to Other Company Literature (Technical Data Sheets, SAT Manual, etc.) (Step 3c) Add to Plant Hazard . Communication Program (Step 4a) Monitor Employees (Review Needed Changes) (Step 4b) ACTIONS, RESPONSMLTTY AND DOCUMENTATION FOR NEW PRODUCT DEVELOPMENT ACTION RESPONSI8UTY 1(a) Determination of TSCA Inventory Individual Researcher Status 1(b) Adequacy of Exp. MSDS and labels Researcher w/safety & health professional or R&D Toxicologist DOCUMENTATION Inventory Status Letter to new product file. Timing of transmittal is at discretion of the Product Manager or Supervisor Documentation of review* revised MSDS's & labels to new product file. Timing of transmittal is at discretion of the Product Manager or Supervisor. N01"E: Sample size may dictate that Step 2(i). DOT classification occur prior to sennple shipment. Review sequence step 2(i) prior to sample shipment. SAMPLE SENT - BUSINESS AREA COMMITMENT 2(a) Development of physical & chemical data Researcher Laboratory reports to new product file 2(b) Review of product toxicology testing needs Product Manager or Supervisor & VPSAG Request tetter from Product Manager or Supervisor and response letter from VPSAG 2(c) Initial end use regulatory review Individual Researcher. Biomedical and Env. Affairs, and Marketing Memo to new product file detailing review 2(d) Complete and file PMN if needed Individual Researcher Biomedical & Env. Affairs, and R&D Biological Technology Section Fie copies of PMN at location and in Biomedical and Env. Affairs 2(e) Product design review Manufacturing; R & 0 {inadvertent contaminants, etc.) Memo's to new product file on steps, results. 2(0 Hazard assessment VPSAG. Biomedical & Env. Affairs Memo to new product file to include all regulatory classifications determined 2(9) Review of Plant imoact (If orocess Plant Engineering. Environmental ehanaes/modificatlons reauired) Coord., Safety Director Completed review checklist to new product file. 2(b) Development ot commercial MSDS and label text Biomedical & Env. Affairs Product Manager or Supervior written request, file documents & copy of MSDS and label text to new product file 2(0 DOT classification for COEDS entry Btomedteel & Env. Affairs COEDS entry form or request letter for ron-COEDS entnes COMMERCIAL PRODUCT SHIPPED Additional items needed for good business practice/liabilitv control. 3(a) File commencement to manufacture notice Manufacturing location (Env. Coord.) Copy to new product file 3(b) End use Regulatory/ Industry Standards Review R&D; Biomedical & Env, Affairs; Mkt. Dept. Memo of results to new product file 3(c) Addition of appropriate data to Product Manager other company literature (Tech Data Sheets, ST&S manual, etc.) Letter of transmittal to system managers IF NEW PRODUCT INVOLVES PLANT/PROCESS MODIFICATIONS VVV 000007 584 THEN THE FOLLOWING MUST BE ONE 4(a) Addition to plant hazard communication program m Employee monitoring Plant Safety Director Plant Safety Director Specific to each plant location Comply with OSHA regulatory requirements THE PRODUCT MANAGER OR PRODUCT SUPERVISOR FOR THE PRODUCT AREA IN WHICH THE NEW PRODUCT OR PRODUCT USE IS BEING DEVELOPED IS RESPONSIBLE FOR THE MANAGEMENT AND ADMINISTRATION OF THE NEW PRODUCT DEVELOPMENT PROCESS. ~ ' TGGOOS.WP i/ie/91 VVV 0000GT585 MULTIPLE EMPLOYEES OR DEPARTMENTS ARE RESPONSIBLE FOR GENERATING INFORMATION AND DOCUMENTATION FOR THIS PROCESS. AUTHORITY TO PROCEED WITH MANY OF THE STEPS ARE THE RESPONSIBILITY OF THE PRODUCT MANAGER OR SUPlIlVISOR. TGG0O5.WP m6/91 VVV 000007586 NEW PRODUCT NEW MOLECULE: ANY PRODUCT FOR WHICH A PREMANUFACTURE NOTIFICATION (PMN) WILL BE REQUIRED. NEW COMMERCIAL PRODUCT: ANY PRODUCT WHICH HAS NEVER BEEN "SOtfl,r BY VISTA EVEN IF A PMN IS NOT REQUIRED BECAUSE IT'S ALREADY ON THE INVENTORY. TGG005.WP 1/16/91 WV 000007587 MODIFIED COMMERCIAL PRODUCTS: "RELATIVELY MINOR" MODIFICATIONS IN PRODUCT DESIGN, SPECIFICATION OR EVEN COMMERCIAL NAME MAY NECESSITATE A REVISED HAZARD ASSESSMENT, CHANGE IN REGULATORY CLASSIFICATION OR ALLOWABLE USES. ANY COEDS CHANGE: THE COEDS ENTRY FORM IS THE FINAL CONTROL POINT BEFORE COMMERCIALIZATION. TGG005.WP 1/1M1 VVV 000007588 NEW USE: IF AN EXISTING PRODUCT IS BEING PUT INTO A NEW MARKET, OR END USE, THERE MAY BE REGULATORY CONSTRAINTS REGARDING PRODUCT QUALITY, MANUFACTURE, OR AN INCREASED LIABILITY RISK THAT WOULD REQUIRE ELEMENTS OF THE PROCESS TO BE APPLIED. RESEARCHER: IS DEFINED AS THE INITIATOR OF THE DEVELOPMENT WORK, OR THE PERSON THAT IS CLOSEST TO THE PRODUCTION OF THE INITIAL SAMPLES OR TEST RUN. TGG005.WP 1/18/91 VVV 000007539 WHEN TO INITIATE THE PROCESS THE DECISION TO BEGIN A NEW PRODUCT FILE AND COMMIT RESOURCES TO THE STEPS NECESSARY MUST BE GUIDED BY JUDGEMENT ON THE POTENTIAL FOR THE PRODUCT TO BE PUT IN COMMERCE. VVV OOOOGT59G