Manual of Biobank Quality Management

Preface
Acknowledgments
Contents
Abbreviations
1: Management of Biobanks
	1.1 Organizational Structure
		1.1.1 Organizational Structure of the Organization/Institution Under Which the Biobank Operates
		1.1.2 Organizational Chart of the Biobank
	1.2 Biobank´s Mission and Scope of Activity
	1.3 Biobank´s Objectives and Their Monitoring
	1.4 Communication
		1.4.1 External Communication
		1.4.2 Internal Communication
	References
2: Quality Management
	2.1 General Requirements
	2.2 Quality policy
	2.3 Setting Objectives
	2.4 Risk and Opportunity Management
		2.4.1 Identification of Risk and Opportunity
		2.4.2 Risk and Opportunity Assessment (Evaluation and Analysis)
		2.4.3 Reaction to Risk and Opportunity
		2.4.4 Monitoring of Risk and Opportunity
	References
3: Documentation and Records
	3.1 General Requirements
		3.1.1 Traceability of Documentation
		3.1.2 Readability of Documentation
		3.1.3 Availability of Documentation for Biobank Employees
		3.1.4 Confidentiality
		3.1.5 Supervision of Changes in Documentation
		3.1.6 Backup/Safety Copies of Documentation
	3.2 Implementing Documentation
		3.2.1 Responsibility for Dealing with Documentation
		3.2.2 Update and Withdrawal of Documentation
		3.2.3 Training After Documentation Updates
		3.2.4 Documentation Distribution
	3.3 Storage of QMS Documentation
		3.3.1 Records
	3.4 Verification of Documentation
		3.4.1 Periodic and Incidental Verification of Documentation
	References
4: Human Resources Management
	4.1 Human Resources Management Policy
	4.2 Biobank Employee Identification
	4.3 Admission of an Employee to the Biobank
		4.3.1 Scope of Initial Training
		4.3.2 On-the-Job Training
	4.4 Responsibility and Permissions of Key Personnel
	4.5 Biobank Personnel Training (Improvement Training)
	4.6 Verification of Biobank Employees´ Knowledge
	4.7 Training Documentation
	4.8 Termination of Employment
	References
5: Ethical and Legal Aspects
	5.1 Compliance with Ethical and Legal Requirements
	5.2 Ethical Advice and Approval
	5.3 Impartiality
		5.3.1 Impartiality Safeguarding
		5.3.2 Risks to Impartiality
		5.3.3 Transparency and Documentation
		5.3.4 Responsible Supervision
		5.3.5 Communication
	5.4 Confidentiality and Privacy
	5.5 Respect for Autonomy
		5.5.1 General Requirements
		5.5.2 Informed Consent
		5.5.3 Re-Contacting with Participants
		5.5.4 Right to Refuse Consent and Right to Withdraw Consent
		5.5.5 The Right to Know and Not to Know the Results
		5.5.6 Consent from Participants Who Are Not Capable to Give a Consent
	5.6 Sharing Material and Data
	5.7 Proprietary Rights and Commercialization
	References
6: Supplies, Materials Management
	6.1 Materials Receipt Rules
	6.2 Reception, Qualification, and Acceptance of Materials
	6.3 Qualification of Suppliers
	6.4 Handling of Materials Stored in Storage Space
	6.5 Handling of Materials Used in Daily Work
	References
7: Equipment
	7.1 Acceptance of the Equipment
		7.1.1 Device Acceptance Criteria
		7.1.2 Acceptance or Rejection of the Equipment
			7.1.2.1 Installation Qualification (IQ)
			7.1.2.2 Operational Qualification (OQ)
			7.1.2.3 Performance Qualification (PQ)
		7.1.3 Final Qualification Report (IQ, OQ, PQ)
	7.2 Rules for Supervision Over Equipment
	7.3 Recordings of Equipment Operation
		7.3.1 Key Parameters Defined Internally
		7.3.2 Parameters Verified/Actions Performed Directly by the User (User Maintenance)
		7.3.3 Parameters Verified/Actions Performed by an External Company
		7.3.4 Recordings From Maintenance, Cleaning of the Equipment
	7.4 Work with Equipment Outside the Supervision
	7.5 Requalification of Critical Equipment
	References
8: Traceability
	8.1 Traceability System
	8.2 Unique Identification of Biological Material
	References
9: Environmental and Staff Hygiene
	9.1 Personnel Hygiene and Safety
		9.1.1 Occupational Health and Safety
			9.1.1.1 Occupational Risk
			9.1.1.2 Periodic Examinations
			9.1.1.3 Personal Protective Equipment
			9.1.1.4 Handling of Clothing and Protective Equipment
		9.1.2 Chemical and Hazardous Substances
		9.1.3 Work with Potentially Infectious Material Derived from Humans
			9.1.3.1 The List of Employees Exposed to Biological Agents
			9.1.3.2 Occupational Exposure
			9.1.3.3 Disinfection
	9.2 Process Environment
		9.2.1 Environmental Conditions and Staff Hygiene
	9.3 Waste Management
	References
10: Biobanking Processes and Quality Control
	10.1 The Life Cycle of Biological Material and Critical Processes
		10.1.1 Acquisition of the Biological Material and Related Data
		10.1.2 Transport of Biological Materials and Associated Data
			10.1.2.1 Transport from and to the Biobank (Shipping)
			10.1.2.2 Transport Within the Biobank
		10.1.3 Reception, Qualification, and Acceptance of Biological Material and Associated Data for Inventory
		10.1.4 The Process of Handling of Biological Material and Associated Data
			10.1.4.1 Processing of Material and Data
			10.1.4.2 Storage of Material and Data
		10.1.5 Transport of Material and Data Within the Biobank
		10.1.6 Process of Withdrawing Biological Material and Associated Data
	10.2 Quality Control
	References
11: Deviations, Nonconforming Product/Data or Service
	11.1 Deviations/Nonconformities
	11.2 Corrective and Correction Actions
	11.3 Complaints
	11.4 Nonconforming Output/Service
		11.4.1 Identification of Nonconforming Products/Services and Accompanying Documentation
		11.4.2 Rejection of Nonconforming Product/Service
	References
12: Audits
	12.1 Internal Audit
	12.2 Auditor´s Competences and Qualifications
	References
13: Improvement
	13.1 Tools for Improving the Effectiveness of Biobank
	13.2 Management Review
		13.2.1 Conducting a Management Review
	References
14: Biobank Cooperation in the Scientific, Research, and Development Area
	14.1 General Requirements
	14.2 Sharing of Biological Material and Data for Research
	14.3 Cooperation Agreements
	14.4 Communication During Scientific Cooperation
		14.4.1 Informing About Irregularities in the Course of Research
	References
15: Safety and Security
	15.1 Security Procedures
	15.2 Biological Material Safety
	15.3 Information Security
	15.4 Basic Methods of Securing IT Infrastructure and Data Processing
		15.4.1 Awareness of the Functioning of the Biobank in the Organization
		15.4.2 General Principles for the Secure Exchange of Information
		15.4.3 Security of Processed Data
		15.4.4 Basic Methods of Securing Access to the Premises
		15.4.5 Operating Systems and Software
		15.4.6 Anti-virus Software
		15.4.7 User and Password Management
		15.4.8 LAN Network
		15.4.9 Emergency Power Supply
		15.4.10 Basic Features of the Biobank IT System
		15.4.11 Backups
		15.4.12 External Services Including Cloud Services
		15.4.13 Personnel
	References
Glossary