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Quality Risk Assessment — what it is and when you need it

Planned

Assesses risks to patient safety, product quality and data integrity, and defines the controls that mitigate them.

Who writes it
The quality function, with the joint carrying ownership.
When it appears
Design stage — How the solution will meet it.
What requires it
  • ICH Q9 — clause 4
  • EU GMP Annex 15 — clause 1.5
Traceability
Traces back to URS requirement IDs. Each acceptance criterion here should name the requirement it verifies.

What it must contain

  • Scope, system identification and the revision it applies to.
  • The responsibilities of each contributing function, and the approvers.
  • A traceability column linking every item back to the URS requirement it addresses.
  • Acceptance criteria or decision rules stated before execution.
  • Handling of deviations, and how they are dispositioned before approval.

Common mistakes

  • Writing it after the work, so it records what happened instead of governing it.
  • Acceptance criteria that are unmeasurable, or added once results are known.
  • Broken traceability — requirement IDs renumbered without updating this document.
  • Approvals collected from titles rather than from the functions that contributed.

Where it sits in the lifecycle

SpecifyWhat is needed, and why.DesignHow the solution will meet it.BuildFabrication and factory testing.InstallSite delivery and qualification.OperateRoutine production and control.SustainChange, review and requalificatio…Validation Master Plan — Sets out the site-wide validation policy, scope, responsibilities and acceptance philosophy that every individual qualification follows.VMPValidation Master PlanValidation Project Plan — Applies the master plan to one project: deliverables, sequence, roles and the qualification strategy for this system.VPPValidation Project PlanUser Requirement Specification — States what the system must do, in vendor-neutral terms, so design can be verified against requirements rather than against itself.URSUser Requirement SpecificationFunctional Specification — Describes the functions the supplier will provide to satisfy each user requirement.FSFunctional SpecificationDesign Specification — Records the technical design — hardware, materials, instrumentation and software architecture — that delivers the specified functions.DSDesign SpecificationConfiguration Specification — Captures every configurable parameter, recipe value and security setting applied to a configured product.Configuration Specificati…Captures every configurable p…GxP Impact Assessment — Determines whether the system has direct, indirect or no impact on product quality, and so how much qualification is warranted.GxP Impact AssessmentDetermines whether the system…Component Criticality Assessment — Identifies which components and instruments are critical to quality attributes, setting the scope of testing and calibration.Component Criticality Ass…Identifies which components a…Quality Risk Assessment — Assesses risks to patient safety, product quality and data integrity, and defines the controls that mitigate them.QRAQuality Risk AssessmentFailure Mode and Effects Analysis — Structured failure-mode analysis scoring severity, occurrence and detectability to prioritise design and test controls.FMEAFailure Mode and Effects Anal…Supplier Assessment and Audit Report — Evaluates the supplier's quality system and technical capability, and decides how much supplier documentation can be leveraged.Supplier Assessment and A…Evaluates the supplier's qual…Requirements Traceability Matrix — Links every user requirement to its design element and to the test that verifies it, and proves nothing was dropped.RTMRequirements Traceability Mat…Design Qualification — Documented verification that the proposed design meets the user requirements before purchase or fabrication is committed.DQDesign QualificationCommissioning Plan — Defines the engineering checks, setting to work and pre-qualification testing, and which of it may be leveraged into qualification.Commissioning PlanDefines the engineering check…Enhanced Design Review — Science- and risk-based review of the design against critical aspects, used to justify a leveraged verification approach.EDREnhanced Design ReviewFactory Acceptance Test protocol — Defines the tests run at the supplier's works before shipment, and the acceptance criteria each must meet.FATFactory Acceptance Test proto…Factory Acceptance Test report — Records the executed factory tests, deviations raised and the punch list carried to site.FAT reportFactory Acceptance Test reportSite Acceptance Test protocol — Defines the tests repeated or completed after delivery to confirm nothing was lost in transit and site services are correct.SATSite Acceptance Test protocolSite Acceptance Test report — Records executed site acceptance testing and the outstanding items before qualification begins.SAT reportSite Acceptance Test reportInstallation Qualification protocol — Verifies the system as installed matches the approved design: components, materials, utilities, drawings and calibration.IQInstallation Qualification pr…Installation Qualification report — Summarises IQ execution, deviations and the conclusion that installation is acceptable for OQ.IQ reportInstallation Qualification re…Operational Qualification protocol — Verifies the system operates as specified across its intended ranges, including alarms, interlocks and control functions.OQOperational Qualification pro…Operational Qualification report — Records OQ results and confirms operating ranges and controls perform to the acceptance criteria.OQ reportOperational Qualification rep…Performance Qualification protocol — Verifies the system performs reproducibly with the actual product or a representative surrogate under routine conditions.PQPerformance Qualification pro…Performance Qualification report — Records PQ execution and concludes on routine performance against the acceptance criteria.PQ reportPerformance Qualification rep…Requalification protocol — Defines the periodic or change-driven retesting needed to confirm a qualified system remains in its validated state.Requalification protocolDefines the periodic or chang…Periodic Review — Scheduled review of changes, deviations, maintenance and calibration to confirm continued fitness for use.Periodic ReviewScheduled review of changes, …Validation Summary Report — Consolidates every qualification deliverable, closes deviations and formally releases the system for GMP use.VSRValidation Summary ReportComputerised System Validation Plan — Defines the lifecycle, deliverables and testing strategy for a computerised system based on its GAMP category and risk.VPComputerised System Validatio…GAMP 5 Software Categorisation — Classifies the software (category 1, 3, 4 or 5) to set a proportionate validation effort.GAMP 5 Software Categoris…Classifies the software (cate…Data Integrity Assessment — Assesses each GxP record against ALCOA+ and identifies technical and procedural controls for gaps.Data Integrity AssessmentAssesses each GxP record agai…21 CFR Part 11 Assessment — Establishes which records and signatures are subject to Part 11 and whether the system's controls satisfy it.21 CFR Part 11 AssessmentEstablishes which records and…User Access Matrix — Defines roles, privileges and segregation of duties so no single user can both perform and approve a critical action.User Access MatrixDefines roles, privileges and…Audit Trail Review procedure — Sets who reviews which audit trail entries, how often, and what triggers an investigation.Audit Trail Review proced…Sets who reviews which audit …Backup and Restore qualification — Proves GxP data can be backed up and fully restored, with integrity and readability verified.Backup and Restore qualif…Proves GxP data can be backed…Disaster Recovery test protocol — Tests the documented business continuity arrangements for a prolonged system failure.DRDisaster Recovery test protoc…Data Migration protocol — Defines how legacy data is mapped, transferred and verified without loss of meaning or integrity.Data Migration protocolDefines how legacy data is ma…Data Migration report — Records the executed migration, reconciliation counts and any accepted differences.Data Migration reportRecords the executed migratio…System Retirement and Decommissioning Plan — Defines how a system is withdrawn while GxP records stay retrievable for their full retention period.System Retirement and Dec…Defines how a system is withd…Stage 1 Process Design report — Captures development knowledge, critical quality attributes and the process parameters that control them.Stage 1 Process Design re…Captures development knowledg…Process Performance Qualification protocol — Defines the commercial-scale batches, sampling plan and acceptance criteria that demonstrate a reproducible process.PPQProcess Performance Qualifica…Process Performance Qualification report — Reports PPQ batch data, statistical evaluation and the conclusion on commercial process capability.PPQ reportProcess Performance Qualifica…Continued Process Verification plan — Defines ongoing trending of parameters and attributes to show the process stays in a state of control.CPVContinued Process Verificatio…Hold Time study — Establishes how long in-process and bulk materials may be held without affecting quality.Hold Time studyEstablishes how long in-proce…Blend Uniformity study — Demonstrates the active is uniformly distributed through the blend and remains so to dosage unit.Blend Uniformity studyDemonstrates the active is un…Mixing study — Determines mixing time, speed and homogeneity criteria for liquid or semi-solid batches.Mixing studyDetermines mixing time, speed…Technology Transfer protocol — Defines the knowledge, materials and comparability testing required to move a process between sites or scales.TTTechnology Transfer protocolTechnology Transfer report — Concludes on comparability between sending and receiving unit and lists residual actions.Technology Transfer reportConcludes on comparability be…Scale-up justification — Justifies the engineering basis for scaling a process and the parameters kept constant across scales.Scale-up justificationJustifies the engineering bas…Bracketing and Matrixing rationale — Justifies reduced testing across strengths, sizes or configurations using a defensible worst-case argument.Bracketing and Matrixing …Justifies reduced testing acr…Cleaning Validation Master Plan — Defines the site cleaning validation strategy: grouping, worst case selection, limits and revalidation triggers.CVMPCleaning Validation Master Pl…HBEL and PDE assessment — Establishes the health-based exposure limit for each product, derived by a qualified toxicologist.HBELHBEL and PDE assessmentMACO calculation — Converts the health-based limit into a maximum allowable carryover and a surface residue limit per equipment train.MACOMACO calculationCleaning Validation protocol — Defines the cleaning runs, sampling locations, analytical methods and acceptance criteria for a product-equipment pair.Cleaning Validation proto…Defines the cleaning runs, sa…Cleaning Validation report — Reports residue results against limits and concludes the cleaning procedure is effective and reproducible.Cleaning Validation reportReports residue results again…Swab and Rinse Recovery study — Establishes recovery factors for each surface material so sampling results can be corrected and defended.Swab and Rinse Recovery s…Establishes recovery factors …Dirty Hold Time study — Establishes the maximum time soiled equipment may stand before cleaning still succeeds.DHTDirty Hold Time studyClean Hold Time study — Establishes how long cleaned equipment stays acceptable before re-cleaning is required.CHTClean Hold Time studyCampaign Length justification — Justifies the number of consecutive batches run before full cleaning, with supporting residue and bioburden data.Campaign Length justifica…Justifies the number of conse…Contamination Control Strategy — Site-wide document linking every control — facility, process, personnel and monitoring — into a justified whole.CCSContamination Control StrategySteam Sterilisation validation — Demonstrates moist heat cycles deliver the required lethality to every load configuration.Steam Sterilisation valid…Demonstrates moist heat cycle…Dry Heat Sterilisation validation — Validates dry heat cycles for sterilisation and, where claimed, depyrogenation of glass components.Dry Heat Sterilisation va…Validates dry heat cycles for…Ethylene Oxide validation — Validates EO sterilisation cycles including residual limits and aeration.EOEthylene Oxide validationGamma Irradiation validation — Establishes and validates the sterilising dose for irradiated components or products.Gamma Irradiation validat…Establishes and validates the…Heat Distribution study — Maps temperature uniformity in the empty and loaded chamber and identifies the cold spot.Heat Distribution studyMaps temperature uniformity i…Heat Penetration study — Measures temperature achieved inside the load at worst-case positions to confirm lethality.Heat Penetration studyMeasures temperature achieved…F0 and Fh determination — Calculates delivered lethality for moist and dry heat cycles and compares it with the required minimum.F0 and Fh determinationCalculates delivered lethalit…Depyrogenation validation — Demonstrates at least a 3-log reduction of endotoxin on glass or component surfaces.Depyrogenation validationDemonstrates at least a 3-log…Aseptic Process Simulation (Media Fill) protocol — Defines the simulated fill, interventions and acceptance criteria that qualify the aseptic process and its operators.APSAseptic Process Simulation (M…Aseptic Process Simulation (Media Fill) report — Reports incubation results, interventions performed and the conclusion on aseptic capability.Aseptic Process Simulatio…Reports incubation results, i…Filter Bacterial Retention validation — Product-specific bacterial challenge proving the sterilising filter retains organisms under process conditions.Filter Bacterial Retentio…Product-specific bacterial ch…Filter Extractables and Compatibility study — Establishes that filter materials are compatible with the product and that extractables are within safe limits.Filter Extractables and C…Establishes that filter mater…Container Closure Integrity validation — Demonstrates the container-closure system maintains sterility over its shelf life.CCIContainer Closure Integrity v…VHP Cycle Development and validation — Develops and validates vaporised hydrogen peroxide decontamination cycles for isolators and rooms.VHPVHP Cycle Development and val…Sterility Test Method Suitability — Proves the sterility test method detects low levels of organisms in the presence of the product.Sterility Test Method Sui…Proves the sterility test met…Purified Water validation Phase 1 — Two to four weeks of intensive daily sampling at every point of use to develop and challenge operating procedures.PW Phase 1Purified Water validation Pha…Purified Water validation Phase 2 — A further two to four weeks confirming consistent quality when the system runs to the finalised SOPs.PW Phase 2Purified Water validation Pha…Purified Water validation Phase 3 — One year of routine monitoring capturing seasonal variation in the feed water.PW Phase 3Purified Water validation Pha…WFI system validation — Qualifies water for injection generation, storage and distribution including endotoxin and microbial control.WFIWFI system validationPure Steam Quality qualification — Verifies non-condensable gases, dryness value and superheat against the published steam quality limits.Pure Steam Quality qualif…Verifies non-condensable gase…Compressed Air qualification — Qualifies particle, water and oil purity classes at each product-contact point of use.Compressed Air qualificat…Qualifies particle, water and…Process Gas qualification — Qualifies nitrogen, oxygen or other process gases for purity, filtration and point-of-use control.Process Gas qualificationQualifies nitrogen, oxygen or…HVAC qualification — Qualifies air changes, filter integrity, pressure cascade, temperature and humidity for each classified area.HVAC qualificationQualifies air changes, filter…Airflow Visualisation study — Smoke studies demonstrating unidirectional airflow is not disturbed by equipment or interventions.Airflow Visualisation stu…Smoke studies demonstrating u…Recovery Time study — Measures how quickly a classified room returns to its particle class after a challenge.Recovery Time studyMeasures how quickly a classi…Cleanroom Classification — Classifies each room at rest and in operation against the airborne particle limits.Cleanroom ClassificationClassifies each room at rest …Environmental Monitoring PQ — Establishes monitoring locations, frequencies and alert and action levels from risk assessment and initial data.EM PQEnvironmental Monitoring PQTemperature Mapping — Maps temperature and humidity distribution in chambers, cold rooms and warehouses, including door-open and power-loss cases.Temperature MappingMaps temperature and humidity…Analytical Method Validation — Demonstrates a method is specific, accurate, precise, linear and robust over its intended range.AMVAnalytical Method ValidationAnalytical Method Transfer — Proves the receiving laboratory can run a validated method with equivalent results.AMTAnalytical Method TransferCompendial Method Verification — Verifies a pharmacopoeial method performs correctly for the specific product matrix in this laboratory.Compendial Method Verific…Verifies a pharmacopoeial met…Instrument Qualification per USP <1058> — Qualifies laboratory instruments through the DQ, IQ, OQ and PQ stages appropriate to their group.AIQInstrument Qualification per …Reference Standard qualification — Establishes identity, purity and assigned value of in-house reference standards and their re-test interval.Reference Standard qualif…Establishes identity, purity …Shipping Lane qualification — Demonstrates a defined route, packaging and season combination keeps product within its labelled storage conditions.Shipping Lane qualificati…Demonstrates a defined route,…Packaging qualification — Qualifies primary and secondary packaging operations and materials against product protection requirements.Packaging qualificationQualifies primary and seconda…Transport Temperature Mapping — Maps temperature inside shipping containers and vehicles across worst-case duration and ambient extremes.Transport Temperature Map…Maps temperature inside shipp…Change Control — Evaluates, approves and records any change to a validated system before it is implemented.CCChange ControlDeviation report — Records a departure from an approved procedure or specification, its impact and its disposition.Deviation reportRecords a departure from an a…Corrective and Preventive Action — Defines the corrective and preventive actions arising from an investigation and verifies their effectiveness.CAPACorrective and Preventive Act…Investigation report — Documents root cause analysis for a deviation, out-of-specification result or complaint.Investigation reportDocuments root cause analysis…Standard Operating Procedure — Instructs staff how to perform a routine task consistently and in a compliant manner.SOPStandard Operating ProcedureMaster Batch Record — The approved manufacturing instruction from which every executed batch record is produced.MBRMaster Batch RecordElectronic Batch Record — The configured electronic equivalent of the batch record, with its own review-by-exception and audit trail controls.EBRElectronic Batch RecordProduct Quality Review — Annual review of batch data, deviations, changes and stability to confirm process and product consistency.PQRProduct Quality ReviewQuality Technical Agreement — Defines GMP responsibilities between contract giver and contract acceptor.QTAQuality Technical Agreement
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  • Connector lines show traceability back to URS requirement IDs.

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