QUALITY TOOLS FOR CSSD PRODUCTION
OVERVIEW
Quality Management Systems
Non conformance analysis
Benchmarking performance
Continuous improvement
QUALITY MANAGEMENT SYSTEM
A quality management system (QMS) is a collection of business policies, processes and procedures focused on achieving your quality policy and quality objectives.
What is it?
QUALITY MANAGEMENT SYSTEM
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
What does that involve?
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
ISO 13485
ISO 9001:2000
AS/NZS 4815:2006
AS/NZS 4187:2003
AS/NZS 4187:DRAFT
What are the regulations?
QUALITY MANAGEMENT TOOLS
Manual Traceability Systems
Electronic Traceability Systems
What tools are available?
TRACEABILITY SYSTEMS
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.
What do they provide CSSD?
CLOSING THE LOOP
Find the gaps in your current quality management system
Fill them with a documented process
Find the Missing Pieces
ITEM TRACEABILITY
Consumables
Single use items
Pre-sterile prosthesis
Loan sets
What about items from external sources?
EXTERNAL SUPPLIERS
Item Description
Serial Number
Lot / Batch Number
Expiry
Makes recall possible
Use Quality Management Systems
TRACKING GOODS RECEIVED
Supplier
Purchase Order Number
Product Description
Product Lot / Batch Number
Qty / Unit of Measure
Identify, record and trace raw materials.
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
TRACKING GOODS RECEIVED
Goods Received Note
TRACKING LOAN SETS
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
Gather as much information as you can
NON-CONFORMANCE
Record all NC incidents
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
The case of Non-Conformance
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
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
Record the incident
NON-CONFORMANCE REPORT
BENCHMARKING
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
Analyse the incident
BENCHMARKING SYSTEM
The use of Non-Conformance data should be tabulated
COST OF NON-CONFORMANCE
Increases to production costs
Wastage costs
Possible legal actions
Errors = waste = inefficient use of resources
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
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
If 99% were good enough, then…
THANK YOU
Austmel Pty LtdEstablished 1974
One Step Ahead!
1800 074 085Web site: www.austmel.com