1. 1 Implementation of an EHS Review/Approval Procedure for New Equipment and Processes David E. Downs, CIH, CSP President EHS Management Partners, Inc.

2. Copyright - EHS Management Partners, Inc. - 19992 Context for the Development of an Equipment Review Process Context –Division of Rapidly Growing Medical Device Manufacturer 2000 employees; growing to 3000 over 2 years Operations - assembly, extrusion, metal finishing 7-8 facilities in local area One EHS Manager, one EHS staff, one Admin

3. Copyright - EHS Management Partners, Inc. - 19993 Context for the Development of an Equipment Review Process Internal Design and Construction of Manufacturing Equipment –Unique and innovative product line –Rapid growth in both depth and breath –5-10 new manufacturing devices released each week

4. Copyright - EHS Management Partners, Inc. - 19994 Context for the Development of an Equipment Review Process Initially began as a process for equipment documentation and conformance under ISO 9000 program Facilities requirements - power, water, space Sign-off by EHS Manager added as an “after-thought”

5. Copyright - EHS Management Partners, Inc. - 19995 Initial Implementation No structure to assessment Based on ability of EHS staff to recognize and resolve significant issues Lack of internal consistency No documentation of results Timing Issues –Responsiveness –Push-back on Findings

6. Copyright - EHS Management Partners, Inc. - 19996 Review Process Development Consultant initially asked to “help out” with volume Liability Issues Challenges –Reasonable Comprehensiveness –Consistency –Responsiveness/Efficiency –Documentation –Business Integration

7. Copyright - EHS Management Partners, Inc. - 19997 Equipment Review Process Design Developed a Format for Process Review –Addressed Full Range of EHS issues –Set up as a word processing form –Completed blank form in field –Entered data, printed results, sent documentation as follow-up Improvement, but not efficient

8. Copyright - EHS Management Partners, Inc. - 19998 Equipment Review Process Design Modified to a MS Access database Data entry at the time of review on portable computer Print Equipment Review Document on site with portable printer Document now incorporated into Equipment Documentation Package

9. Copyright - EHS Management Partners, Inc. - 19999 Equipment Review Database Equipment Data

10. Copyright - EHS Management Partners, Inc. - 199910 Equipment Review Database Hazardous Chemicals

11. Copyright - EHS Management Partners, Inc. - 199911 Equipment Review Database Hazard Assessment Criteria

12. Copyright - EHS Management Partners, Inc. - 199912 Equipment Review Database Physical Hazards

13. Copyright - EHS Management Partners, Inc. - 199913 Equipment Review Database Ergonomic Assessment

14. Copyright - EHS Management Partners, Inc. - 199914 Equipment Review Database PPE Hazard Assessment

15. Copyright - EHS Management Partners, Inc. - 199915 Equipment Review Database Evaluation Results Possible Review Outcomes –Released with no restrictions –Released with recommendations for improvement –Released on condition of correction of specified items –Not Released

16. Copyright - EHS Management Partners, Inc. - 199916 Equipment Review Database Review Results Conditions Corrected Follow-up Checkbox

17. Copyright - EHS Management Partners, Inc. - 199917 Equipment Review Report

18. Copyright - EHS Management Partners, Inc. - 199918 Corrective Action Follow-up Requirements Corrective Action

19. Copyright - EHS Management Partners, Inc. - 199919 Process Results More comprehensive More consistent More efficient Better documented Better follow-up on required changes Integrated into process/equipment documentation

20. Copyright - EHS Management Partners, Inc. - 199920 Additional Process Results Education of Engineers and Designers Involvement earlier in the development process Establishment of de facto standards Equipment Improvement over time Increased visibility and credibility of EHS function Now completely executed in-house

21. Copyright - EHS Management Partners, Inc. - 199921 Conclusions Being involved in the process of new equipment/process development is a critical EHS function Find a way to be an effective part of the process, not an addendum