1 implementation of an ehs review/approval procedure for new equipment and processes david e. downs,...
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Implementation of an EHS Review/Approval Procedure for New Equipment and Processes
David E. Downs, CIH, CSP
President
EHS Management Partners, Inc.
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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
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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
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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”
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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
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Review Process Development
• Consultant initially asked to “help out” with volume
• Liability Issues
• Challenges– Reasonable Comprehensiveness– Consistency– Responsiveness/Efficiency– Documentation– Business Integration
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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
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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
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Equipment Review DatabaseEquipment Data
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Equipment Review DatabaseHazardous Chemicals
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Equipment Review DatabaseHazard Assessment Criteria
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Equipment Review DatabasePhysical Hazards
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Equipment Review DatabaseErgonomic Assessment
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Equipment Review DatabasePPE Hazard Assessment
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Equipment Review DatabaseEvaluation Results
• Possible Review Outcomes– Released with no restrictions– Released with recommendations for
improvement– Released on condition of correction of specified
items– Not Released
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Equipment Review DatabaseReview Results
Conditions Corrected Follow-up Checkbox
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Equipment Review Report
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Corrective Action Follow-up
Requirements
CorrectiveAction
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Process Results
• More comprehensive
• More consistent
• More efficient
• Better documented
• Better follow-up on required changes
• Integrated into process/equipment documentation
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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
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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