1 Implementation of an EHS Review/Approval Procedure for New Equipment and Processes David E. Downs, CIH, CSP President EHS Management Partners, Inc.
Copyright - EHS Management Partners, Inc 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
Copyright - EHS Management Partners, Inc 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
Copyright - EHS Management Partners, Inc 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”
Copyright - EHS Management Partners, Inc 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
Copyright - EHS Management Partners, Inc Review Process Development Consultant initially asked to “help out” with volume Liability Issues Challenges –Reasonable Comprehensiveness –Consistency –Responsiveness/Efficiency –Documentation –Business Integration
Copyright - EHS Management Partners, Inc 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
Copyright - EHS Management Partners, Inc 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
Copyright - EHS Management Partners, Inc Equipment Review Database Equipment Data
Copyright - EHS Management Partners, Inc Equipment Review Database Hazardous Chemicals
Copyright - EHS Management Partners, Inc Equipment Review Database Hazard Assessment Criteria
Copyright - EHS Management Partners, Inc Equipment Review Database Physical Hazards
Copyright - EHS Management Partners, Inc Equipment Review Database Ergonomic Assessment
Copyright - EHS Management Partners, Inc Equipment Review Database PPE Hazard Assessment
Copyright - EHS Management Partners, Inc 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
Copyright - EHS Management Partners, Inc Equipment Review Database Review Results Conditions Corrected Follow-up Checkbox
Copyright - EHS Management Partners, Inc Equipment Review Report
Copyright - EHS Management Partners, Inc Corrective Action Follow-up Requirements Corrective Action
Copyright - EHS Management Partners, Inc Process Results More comprehensive More consistent More efficient Better documented Better follow-up on required changes Integrated into process/equipment documentation
Copyright - EHS Management Partners, Inc 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
Copyright - EHS Management Partners, Inc 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