Traybax Sterility Management System - SRACA QLD

Traybax Sterility Management System - SRACA QLD

QUALITY TOOLS FOR CSSD PRODUCTION OVERVIEW Quality Management Systems Non conformance analysis Benchmarking performance Continuous improvement

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.

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 QUALITY MANAGEMENT SYSTEM Who uses Quality Management Systems? Quality management systems at varied levels are used in all industries: Manufacturers Suppliers

Hospitals & Medical Facilities QUALITY MANAGEMENT STANDARDS What are the regulations? ISO 13485 ISO 9001:2000 AS/NZS 4815:2006 AS/NZS 4187:2003

AS/NZS 4187:DRAFT QUALITY MANAGEMENT TOOLS What tools are available? Manual Traceability Systems Electronic Traceability Systems

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. CLOSING THE LOOP Find the Missing Pieces Find the gaps in your

current quality management system Fill them with a documented process ITEM TRACEABILITY What about items from external sources? Consumables

Single use items Pre-sterile prosthesis Loan sets EXTERNAL SUPPLIERS Use Quality Management Systems Item Description Serial Number

Lot / Batch Number Expiry Makes recall possible TRACKING GOODS RECEIVED Identify, record and trace raw materials. Supplier Purchase Order Number

Product Description Product Lot / Batch Number Qty / Unit of Measure TRACKING GOODS RECEIVED Check for Quality Issues and Document Is the product fit for use? Report non-conformity

Document product information Continue the traceability link from manufacture to patient contact TRACKING GOODS RECEIVED Goods Received Note 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 nonconformance

NON-CONFORMANCE Record all NC incidents 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 NON-CONFORMANCE REPORT But why record it ? Isnt 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. 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

NON-CONFORMANCE REPORT 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 BENCHMARKING SYSTEM The use of Non-Conformance data should be tabulated COST OF NON-CONFORMANCE Errors = waste = inefficient use of resources Increases to production costs

Wastage costs Possible legal actions 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 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 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

THANK YOU Austmel Pty Ltd Established 1974 One Step Ahead! 1800 074 085 Web site:

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