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
What are the regulations?
ISO 13485
ISO 9001:2000
AS/NZS 4815:2006
AS/NZS 4187:2003
AS/NZS 4187:DRAFT
ISO 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

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

8. 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.

9. 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

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

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

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

13. 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

14. TRACKING GOODS RECEIVED
Goods Received Note

15. 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

16. Record all NC incidents
NON-CONFORMANCE
Record all NC incidents

17. 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. The use of Non-Conformance data should be tabulated
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. 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

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