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