A quality management system (QMS) is a collection of businesses policies, processes and procedures, focused on achieving your quality policy and quality objectives.

1. ALL YOU NEED
TO KNOW ABOUT
CENTRAL
STERILE SUPPLY
DEPARTMENT

2. Quality Tools
For CSSD
Production
Secrets to make a serious impact.
presented by: Talal Albudayri
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3. 02
Overview
QUALITY
MANAGEMENT
SYSTEM
NONE
CONFORMANCE
ANALYSIS
CONTINUOUS
IMPROVEMENT
BENCHMARKING
PERFORMANCE

4. WHA IS IT?
A quality management system (QMS) is a collection of businesses
policies, processes and procedures, focused on achieving your quality
policy and quality objectives.
Quality management
system
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5. 04
What does
that involve?
OVERSEEING ALL
ACTIVITIES AND
TASKS TO ENSURE
THAT THEY ARE
PERFORMED
CORRECTLY
COMPLYING TO
REGULATIONS
SATISFYING
QUALITY RE
REQUIREMENTS -
PATIENT SAFETY
CONTROL OF
PROCESS AND
PRODUCT TO
ENSURE
CONFIRMITY
IMPLEMENTATION
OF POLICY AND
PROCEDURE TO
MEET THE QUALITY
OBJECTIVES OF THE
BUSINESS

6. Manufactures Suppliers Hospitals and
medical facilities
Who uses quality management
system (QMS)?
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Quality management system at varied levels are used in all industries:

7. what are the
regulations?
ISO 13485
ISO 9001:2000
AS/NZS 4815:2006
AS/NZS 4187:2007
AS/NZS 4187:DRAFT
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8. 07
Manuel traceability systems
Electronic traceability systems
What tool are available?

9. 08
What do they provide to
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.

10. 09
Find the missing
pieces
Find the gabs in your current quality
management system.
Fill them with a documented process.

11. WHAT ABOUT ITEMS FROM
EXTERNAL SOURCES?
Consumables.
WHAT ABOUT ITEMS FROM
EXTERNAL SOURCES?
pre-sterile prosthesis.
WHAT ABOUT ITEMS FROM
EXTERNAL SOURCES?
Loan sets.
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WHAT ABOUT ITEMS FROM
EXTERNAL SOURCES?
Single used items.

12. 11
External suppliers.
use quality
management system
in:
Item description.. Serial number.. Lot / Batch number..
Expiry.. Makes recall possible.

13. SUPPLIER
QTY / UNIT OF
MEASURE
PRODUCT LOT /
BATCH NUMBER
PRODUCT
DESCRIPTION
PURCHASE ORDER
NUMBER
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Tracking goods received.
identify, record and trace
raw materials:

14. 13
Is the product fit for use?
Document product information.
Continue the traceability link from
manufacture to patient contact.
Check for quality issues
and documents
Report non-conformity.

15. Goods received note
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16. 15
Create a unique item code for each loan set.
Check content and record appropriately.
Take photo on receipt / document actual content.
Record any discrepancy and non-conformance.
Tracking loan sets.
gather as much
information as you can.

17. Record all NC incidents
NON-CONFORMANCE
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18. None-Conformance.
the case of non-conformance:
a closed loop quality system doesn’t 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 didn’t end
up being used on a patient.
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19. 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.
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20. 19
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 a
preventative action to stop a recurrence.
None-Conformance report.
record the incident:

21. 20
None-Conformance
report.
record the incident

22. 21
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.

23. 22
To use of Non-Conformance data
should be tabulated

24. 23
Increase the production of costs.
Wastage costs.
Possible legal action.
Cost of Non-Conformance
Error =Waste=infficient use of resources

25. 24
Management
review
CORRECTIVE
ACTION, TRAINING
ETC CAN BE
IMPLEMENTED
THIS ALLOWS
UNTOWARD
TRENDS TO BE
IDENTIFIED
PERIODICALLY ALL
NON-
CONFORMANCE
SHOULD BE
REVIEWED
ASSES COST OF
NON-
CONFORMANCE
BETTER SERVICE IS
ATTAINED

26. IMPLEMENT NON-CONFORMANCE
ANALYSE NON-CONFORMANCE
INCIDENTS
FOCUS ON DESIGNING PROCESSES
THAT PROMOTE QUALITY, SAFETY
AND A GREAT PATIENT EXPERIENCE
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Summary
ENSURE CLOSED LOOP
TRACEABILITY IS IN PLACE
ASSESS YOUR QUALITY MANAGEMENT
TOOLS AND FILL ANY GAPS.

27. Thank you!
PRESENTED BY: TALAL ALBUDAYRI