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 ? 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
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: www.austmel.com