Our Commitment to Exceptional Quality
Transcript of Our Commitment to Exceptional Quality
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1 Proprietary & Confidential The world leader in serving science
Our Commitment to Exceptional QualityISO 18385:2016 & Beyond - HIDS 2016
Colin McEnaney – Senior Quality Manager Warrington Manufacturing Facility
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Introduction
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• Global manufacturing standard
• Aimed at reducing the risk of inadvertent contamination by manufacturers of
consumables and reagents
• Gives manufacturers the ability to label applicable products as “ISO18385
Forensic DNA Grade”
• Why is a standard needed?
• Measurement equipment is becoming more sensitive
• Forensic Labs are using more sensitive methods of analysis
• Identifying lower and lower amounts of DNA during investigations
• What will be the benefits for the customer
• Confidence in the product/manufacturer
• Increased confidence in your conclusion
• Reduction in wasted time/effort
What is ISO 18385? And Why is it needed?
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PROVEN
PROCESSES
CUTTING-EDGEFACILITIES
QUALITYMANUFACTURING
EXPERT
PERSONNEL
Thermo Fisher Journey to ISO18385
• Joint ENFSI / SWGDAM / BSAG Statement
2009
• PAS 377 : 2012
2012• ISO 18385
2016
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• Personnel at Thermo Fisher Manufacturing facility at Warrington are
• Well educated
• Well trained
• Assessed for competence in all aspects of the work flow
• Proud to be able to support the criminal justice system, wherever in the world
• Through the company’s 4-I values Innovation, Intensity, Integrity, Involvement
• A number of staff have been recruited from a Forensic Background
• Enabling a full understanding of the requirements of the work that is being
performed
Personnel
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Personnel
Beccy
Technical SupportLouise
Manufacturing Leader
Kim
Technical Support
Stacey
Quality Control Leader
Laura
Quality Control AnalystJo
Manufacturing
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• Quality Management System
• ISO 9001 – Since 1998
• ISO 13485 - Since 2010
• Support for development and compliance to PAS377:2012
• Gowning
• One way personnel flow
• Based on Risk assessment
• Elimination database
• In place since 2011
Processes
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• New Product Introductions
• Manufacturing involved during the early stages of development
• Ensuring products are designed and developed with manufacturing quality and
cleanliness at the fore front
• Including Risk Management of the supply chain
• Quality Management Systems regularly reviewed and audited
• Internal corporately
• External BSI
• Customers are openly invited to review
Concept Definition Development Manufacturing Confirmation Sales
Processes
Manufacturing Involvement throughout Design & Development
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• Investment in automation
• Designed to remove Human Touch Points
• Reducing risk of hDNA contamination
• Areas are designed and upgraded to ease cleaning
• Validated cleaning process
Facility
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• So when we reviewed we were confident in our ability to meet the requirements
• It would have been easy to stop there, label and hope we were right
• But we didn’t…..
• We enlisted an external, independent assessment – Kevin Sullivan
Assessment of Compliance
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• We are not going to stand still
• Compliance will be constantly assessed through internal audit program
• Any areas for further improvement are being followed up through the sites CAPA program
• Listen to you, the customer
• Expanded assessment program to other areas of business
• Sample collection
• Extraction kits
What's next
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Final Box Labelling
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Manufacturing
Manchester
Liverpool
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Warrington Manufacturing Facility
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Thank you!