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Experiences of a Newly Accredited Laboratory. Barbara J. Baker, MPH Washington State Department of Agriculture Microbiology Laboratory. WSDA Laboratory Displaying Certificate. Who are we?. Microbiology Laboratory Program Manager Quality Assurance Officer Administrative Assistant
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Experiences of a Newly Accredited Laboratory Barbara J. Baker, MPH Washington State Department of Agriculture Microbiology Laboratory
Who are we? • Microbiology Laboratory • Program Manager • Quality Assurance Officer • Administrative Assistant • Technical Supervisor • 5 Microbiologists • 1.5 Laboratory Support Staff
Who are our Customers? • WSDA Food / Feed Safety Program • FDA • FERN MCAP • ISO • RRT • BSE
Food Testing • Routine RTE surveillance (including Retail Raw Milk products) • Environmental testing at Cheese and Retail Raw Milk Producers • Investigations / Outbreaks • FDA FERN – MCAP Laboratory
Dairy Testing • Regulatory testing for FDA • Laboratory certified by FDA-LQAB for testing dairy and water samples for NCIMS • FDA triennial on-site evaluations • 7 analysts are FDA-certified for dairy testing • Laboratory Evaluations of Industry Laboratories – 2 LEOs
Feed Testing • Test Ruminant Feed for Prohibited Materials • Test Animal Feed / Food Processing Waste for Pathogens
Steps to achieving ISO 17025:2005 • Based on your business, determine which accreditation body you want to work with – we use A2LA • Purchase and read the Standard for ISO 17025:2005 • Contract with an ISO 17025:2005 trainer to train all of your staff
Steps to achieving ISO 17025:2005 • Request assistance from your accrediting body on obtaining materials to help develop your Quality System – e.g., purchase the checklist • Research other laboratory’s Quality Manuals • Develop your Quality Manual • Policy Statement – what you intend to do • About 25-30 pages
Steps to achieving ISO 17025:2005 • Begin creating Procedures • Describe how to support your Laboratory’s policies • ~30 laboratory-wide system procedures you will need • Use the checklist to make sure you meet all the requirements • Start with your Document Control Procedure • Consider hiring an ISO 17025:2005 consultant to help you thru the process
Steps to achieving ISO 17025:2005 • Stay in touch with your accrediting organization to ensure you have all the pieces in place prior to applying for accreditation • This whole process can take as short as 1 year or as long as 5 years
Lessons Learned • Have a dedicated Quality Assurance position in your Laboratory • You are not alone – “don’t reinvent the wheel” • If you have the funds, hire a consultant to assist you • Do not put too many procedures under scope during the first year • It will make your Laboratory better and help you continuously improve • Be patient….
Contact Information Barbara Baker, Program Manager WSDA Microbiology Laboratory (360) 586-3645 bbaker@agr.wa.gov