The use of software

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• The use of software
• to maintain the quality system
• in the Blood Bank in Iceland

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Ína Björg HjálmarsdóttirQuality managerThe
Blood BankThe University HospitalReykjavík,
Iceland
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The Blood BankReykjavík, Iceland

• Quality system according to ISO 9002
• ISO certification in May 2000

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Computer software

• Databyrån/ProSang - the Bood Bank system
• traceability of donors and blood units
• Lotus Notes - FOCAL solutions
• a part of the quality system

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Processes in the Blood Bank
Blood donor
Blood collection
Production of blood components
Blood components on stock
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What are some of the requirements of ISO 9002

• A quality manual and control of documents
• Training of personnel
• Control of non-conforming products
• Measurement and monitoring of processes
• Internal audits
• Improvement, corrective and preventive action

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A quality manual and control of documents
Blood donor
30 SOP
Blood collection
25 SOP
Production of blood components
Blood components on stock
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A quality manual and control of documents

• FOCAL Quality Handbook
• Electronic quality manual - no paper
• An up-to-date quality manual on every work
  station
• Control of documents according ISO is partly
  built in to the FOCAL system

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Training of personnel
Blood donor
8 workstations 14 employees
Blood collection
6 workstations 18 employees
Production of blood components
Blood components on stock
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Training of personnel

• Plan for training and a checklist for every
  workstation- FOCAL Quality Handbook
• Training of personnel- FOCAL Human Resources

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Measurement and monitoring of processes
Blood donor
Blood collection
Weight of units
Production of blood components
White blood cell count Red blood cell count
Blood components on stock
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Measurement and monitoring of processes

• FOCAL DOC - meeting minutes used to document
  the ability of processes to achieve planned
  results

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Control of nonconforming product
Blood donor
Donor with a new tatoo
Blood collection
A defect in the blood collection bag
Production of blood components
The red blood cell count is low
Blood components on stock
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Control of non-conforming products

• FOCAL Non-conformities
• What happened?
• What is decided according to that product?
• Is further action needed?
• Also used for customer complaints

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Internal audit
Blood donor
Blood collection
Production of blood components
Blood components on stock

• Are we doing what we say we are doing?

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Internal audit

• FOCAL Internal Audits
• A plan for internal audits each year
• Records on non-conformities
• Records on actions taken

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Improvement, corrective and preventive action
Blood donor
Blood collection
Production of blood components
Blood components on stock

• We can always do better

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Improvement, corrective and preventive action

• Projects in FOCAL DOC
• All written documents in the same place
• Pathways for projects
• Also used for validation of processes for
  production and service provision

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At last

• It is possible to have a quality system only on
  paper
• But software makes live easier!