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 ISO 13485 is an International Organization for Standardization (ISO) standard, published in 2003, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices Currently Traybax meets AS/NZS 4187, quality standard for medical devices, ISO 9001 quality assurance and GS1 barcode standards

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

What do they provide CSSD? 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.

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

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

Use Quality Management Systems 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

Gather as much information as you can 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

Record all NC incidents NON-CONFORMANCE Record all NC incidents

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 ? 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.

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

The use of Non-Conformance data should be tabulated 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

If 99% were good enough, then… 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

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