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QUALITY TOOLS FOR CSSD PRODUCTION

QUALITY TOOLS FOR CSSD PRODUCTION. OVERVIEW. Quality Management Systems Non conformance analysis Benchmarking performance Continuous improvement. QUALITY MANAGEMENT SYSTEM. What is it?.

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QUALITY TOOLS FOR CSSD PRODUCTION

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  1. QUALITY TOOLS FOR CSSD PRODUCTION

  2. OVERVIEW • Quality Management Systems • Non conformance analysis • Benchmarking performance • Continuous improvement

  3. QUALITY MANAGEMENT SYSTEM What is it? A quality management system (QMS) is a collection of business policies, processes and procedures focused on achieving your quality policy and quality objectives.

  4. QUALITY MANAGEMENT SYSTEM What does that involve? Implementation of policy and procedures to meet the quality objectives of the business Overseeing all activities and tasks to ensure that they are performed correctly Control of process and product to ensure conformity Satisfying quality requirements - Patient Safety Complying to regulations

  5. QUALITY MANAGEMENT SYSTEM Who uses Quality Management Systems? Quality management systems at varied levels are used in all industries: Manufacturers Suppliers Hospitals & Medical Facilities

  6. QUALITY MANAGEMENT STANDARDS ISO 13485 ISO 9001:2000 AS/NZS 4815:2006 AS/NZS 4187:2003 AS/NZS 4187:DRAFT What are the regulations?

  7. QUALITY MANAGEMENT TOOLS Manual Traceability Systems Electronic Traceability Systems What tools are available?

  8. TRACEABILITY SYSTEMS What do they provide CSSD? Documented evidence at each stage of the sterile processing life cycle from receipt to point of use. Verification of history, location and sterile processing of all items processed through the CSSD.

  9. CLOSING THE LOOP Find the Missing Pieces Find the gaps in your current quality management system Fill them with a documented process

  10. ITEM TRACEABILITY Consumables Single use items Pre-sterile prosthesis Loan sets What about items from external sources?

  11. EXTERNAL SUPPLIERS Item Description Serial Number Lot / Batch Number Expiry Makes recall possible Use Quality Management Systems

  12. TRACKING GOODS RECEIVED Supplier Purchase Order Number Product Description Product Lot / Batch Number Qty / Unit of Measure Identify, record and trace raw materials.

  13. TRACKING GOODS RECEIVED Is the product fit for use? Report non-conformity Document product information Continue the traceability link from manufacture to patient contact Check for Quality Issues and Document

  14. TRACKING GOODS RECEIVED Goods Received Note

  15. TRACKING LOAN SETS Gather as much information as you can • Create a unique item code for each loan set • Check content and record appropriately • Take photos on receipt / document actual content • Store supplier documentation • Record any discrepancy and non-conformance

  16. NON-CONFORMANCE Record all NC incidents

  17. NON-CONFORMANCE The case of Non-Conformance • A closed loop quality system does not allow a label or item to escape • The label must go somewhere • - Patient Record or; • - Non Conformance Report • We must account for it, to prove it did not end up being used on a patient

  18. NON-CONFORMANCE REPORT • But why record it ? Isn’t that just spending time and money on something that is already defective? • Wrong! • You learn from your mistakes , but only if you know about them.

  19. NON CONFORMANCE REPORT Record the incident • The supplier of the goods in question must be informed that what was supplied was incorrect in some way • Return the goods with a simple report outlining the problem • This way the supplier can record the problem and take preventative action to stop a recurrence

  20. NON-CONFORMANCE REPORT

  21. BENCHMARKING Analyse the incident • This allows comparison of performance • Are we doing it any better than last month, last year etc • Objective proof that you are on the path to increased or decreased quality

  22. BENCHMARKING SYSTEM The use of Non-Conformance data should be tabulated

  23. COST OF NON-CONFORMANCE Errors = waste = inefficient use of resources • Increases to production costs • Wastage costs • Possible legal actions

  24. MANAGEMENT REVIEW • Periodically all Non conformance should be reviewed • This allows untoward trends to be identified • Asses cost of non-conformance • Corrective action, training etc can be implemented • Better service is attained

  25. SUMMARY • Assess your quality management tools and fill any gaps • Ensure closed loop traceability is in place • Implement Non conformance reports • Analyse non-conformance incidents • Focus on designing processes that promote quality, safety, and a great patient experience

  26. FOOD FOR THOUGHT If 99% were good enough, then… • 20 newborns lost at birth each month • Five minutes of unsafe water each month • One unsafe landing or takeoff at Sydney International every second day • One pack with unsterile or dirty instruments would go undetected every day in Australia Suddenly the quest for ZERO NONCONFORMITIES makes more sense

  27. THANK YOU Austmel Pty Ltd Established 1974 One Step Ahead! 1800 074 085 Web site: www.austmel.com

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