as of 2019 - 12 - 10
6 Qualification
6.A Official requirements and agency expectations
Summary
6.A.1 Principles of qualification
6.A.2 Legal framework and responsibilities
6.A.2.1 Qualification by Third Party
6.A.3 Documentation of qualification
6.A.4 Risk based approach
6.A.5 Design qualification (DQ)
6.A.6 Factory Acceptance Test/Site Acceptance Test (FAT/SAT)
6.A.7 Installation qualification (IQ)
6.A.8 Operational Qualification (OQ)
6.A.9 Performance Qualification (PQ)
6.A.10 Requalification
6.B Activities for the preparation of a qualification
Summary
6.B.1 The sequence of a qualification
6.B.2 Procurement procedures
6.B.2.1 Project start-up
6.B.2.2 Project development (planning)
6.B.2.3 Compilation of requirements
6.B.2.4 Bidding Phase
6.B.2.5 Detail planning
6.B.2.6 Design qualification
6.B.2.7 Technical acceptance testing (FAT, SAT) and qualification
6.B.2.8 Handover
6.B.3 Responsibilities
6.B.3.1 Overall responsibility
6.B.3.2 Project management
6.B.3.3 Responsibility of experts
6.B.4 Qualification team
6.B.5 Risk analysis
6.B.5.1 Significance of risk analysis for a qualification
6.B.5.2 Risk analysis in the equipment life cycle
6.B.5.3 Structure of a risk analysis
6.B.5.4 Evaluation of risks
6.B.5.5 Execution of a risk analysis
6.C Qualification documentation
Summary:
6.C.1 General requirements
6.C.1.1 Requirements on form
6.C.1.2 Content requirements
6.C.2 Validation and qualification master plan
6.C.2.1 Regulatory requirements
6.C.2.2 Contents of a QMP
6.C.2.3 Change Control
6.C.3 Structure of qualification documents
6.C.3.1 Qualification plans
6.C.3.2 Qualification test protocols
6.C.3.3 Qualification reports
6.C.4 Document structure of the qualification
6.C.4.1 Phase-specific, compact
6.C.4.2 Phase-specific, modular
6.C.4.3 Multi-phase, compact
6.C.4.4 Multi-phase, modular
6.C.5 Technical documentation
6.D Design Qualification (DQ)
Summary
6.D.1 Design qualification within the project schedule
6.D.2 Execution and documentation of design qualification
6.D.3 Risk analyses in the design phase
6.D.4 User Requirements Specification (URS)
6.D.4.1 Contents of the URS
6.D.4.2 Formal layout of a URS
6.D.4.3 Significance of the URS
6.D.5 Bidding process and offers
6.D.6 Conclusion of contract
6.D.7 Functional Design Specification (FDS)
6.D.7.1 Contents of an FDS
6.D.7.2 Checking the Functional Design Specification
6.D.7.3 Combined URS and FDS
6.D.8 Configuration specification
6.D.9 Trace matrix (proof of completeness)
6.D.10 DQ report
6.E Installation Qualification (IQ)
Summary
6.E.1 Purpose and content of an Installation Qualification
6.E.2 Technical documentation
6.E.3 Installation Qualification within the project schedule
6.E.4 Execution and documentation of the IQ
6.F Operational Qualification (OQ)
Summary
6.F.1 Purpose and Scope of an Operational Qualification
6.F.2 Operational Qualification in the Course of the Project
6.F.3 Execution and Documentation of an OQ
6.F.4 Example of an Operational Qualification of a Fluid Bed Dryer
6.G Performance Qualification (PQ)
Summary
6.G.1 Purpose and Scope of a Performance Qualification
6.G.2 Performance Qualification in the Course of the Project
6.G.3 Execution and Documentation of a PQ
6.G.4 Example of a Performance Qualification of a Filling Line
6.H Qualification by third party
Summary
6.H.1 Delegation and responsibility
6.H.2 Involvement of consultants in the qualification process
6.H.3 Outsourcing parts of the qualification exercise to engineering offices
6.H.4 Transfer of qualification activities to the supplier
6.I The qualification life cycle
Summary:
6.I.1 The life cycle concept and tools: an overview
6.I.1.1 Equipment documentation
6.I.1.2 Risk of failure
6.I.1.3 Maintenance
6.I.1.4 Exchanging like-for-like parts
6.I.2 Change control and (re-)qualification
6.I.2.1 Qualification of changes via change control
6.I.2.2 Re-qualification after major changes
6.I.3 Periodic review and periodic re-qualification
6.I.3.1 Periodic review
6.I.3.2 Periodic re-qualification
6.J Example SOP for the qualification of equipment and machinery
1 Area of application
2 Purpose
3 Scope
4 Definitions/abbreviations
5 Basic concepts
5.1 Regulatory fundamentals
5.2 Further applicable documents
6 Process description and responsibilities
6.1 Fundamentals
6.2 Qualification mandate
6.3 Classification of equipment into risk categories
6.4 Preparation of a qualification
6.5 Design Qualification and Functional Design Specification
6.6 Acceptance tests (FAT/SAT)
6.7 IQ/OQ/PQ Test plans
6.8 Equipment installation and Installation Qualification (IQ)
6.9 Equipment functional tests and Operational Qualification (OQ)
6.10 Performance Qualification (PQ)
6.11 Qualification report
6.12 Handover to the user
6.13 Re-qualification and review
6.14 Competencies and Responsibilities
7 Management and storage of documents
7.1 Documentation for equipment in Risk Category 1
7.2 Documentation for equipment in Risk Categories 2 and 3
8 Attachments
Attachment 1: Flow chart diagram
Attachment 2: Qualification Checklist
Attachment 3: FAT/SAT plan/protocol
6.K References
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