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Visit us [at www.sensum.eu](at www.sensum.eu).  \nContact us to get MS Excell document without the header.  \nLogo  \n\u003Cinsert company name>  \nRisk Assessment and Traceability matrix  \n\n| Project name |  |\n| --- | --- |\n| Project number |  |\n\n\n| Name | Function | Signature |\n| --- | --- | --- |\n|  | Qualification\u003Cbr>coordinator (author) |  |\n|  | Engineering |  |\n|  | HSE |  |\n|  | User Lead |  |\n\nTemplate document prepared by Sensum. Visit us [at www.sensum.eu](at www.sensum.eu).  \nContact us to get MS Excell document without the header.  \nDocument History  \n\n| Version | Date | Author | Changes |\n| --- | --- | --- | --- |\n| 1.0.0 | 25.05.2016 | John Doe | First version |\n\n\u003Cinsert project name> Template document prepared by Sensum. Visit us [at www.sensum.eu](at www.sensum.eu).  \nContact us to get MS Excell document without the header.  \nRisk Assessment and Traceability matrix  \n\n| Risk description |  |  |  | Evaluation\u003Cbr>/ |  |  |  |  |  | Traceability Matrix |  |  |\n| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |\n| \\# ID | Potential failure (risk description) | Potential cause for the failure | Effects of failure | HSE /\u003Cbr>Busine | erity\u003Cbr>(S) | urre\u003Cbr>nce | ction\u003Cbr>(D) | level\u003Cbr>(S*O* | Proposed actions | Affected URS | Installation verification\u003Cbr>(IQ test) | Functional verification\u003Cbr>(OQ test) |\n| 1 | General risks |  |  |  |  |  |  |  |  |  |  |  |\n| 1.1 | GMP Design / Construction | Use of wrong materials | Insufficient cleanability | GxP |  |  |  |  | Checking the material certificates in the scope of the IQ |  |  |  |\n| 1.2 |  |  |  |  |  |  |  |  |  |  |  |  |\n| 2 | Production and handling |  |  |  |  |  |  |  |  |  |  |  |\n| 2.1 | Improper feeding of\u003Cbr>products to system | Input container runs empty Malfunction of level sensor | Machine stops\u003Cbr>Filling system over-filled. Possible overspill of products. | GxP |  |  |  |  | Checking the sensors in the scope of the IQ |  |  |  |\n| 2.2 | Production reproducibility | Missing scales, inaccurate scales, inappropriate settings by operator | Impact to product quality | GxP |  |  |  |  | Checking the scales in the scope of the IQ\u003Cbr>Operator training |  |  |  |\n| 2.3 | Unsafe machine for the operator | Malfunction of safety sensors so operator can reach moving parts, while machine is operational | Possible injury | HSE |  |  |  |  | Checking the fail-safe design of sensors in the scope of the IQ |  |  |  |\n|  |  |  |  |  |  |  |  |  |  |  |  |  |\n| 3 | Cleaning |  |  |  |  |  |  |  |  |  |  |  |\n| 3.1 | Cleaning of parts in contact with product | Inappropriate cleaning procedure\u003Cbr>Inappropriate materials Improper execution of the construction\u003Cbr>Surface roughness does not comply with the specification Surface shows scratches and damages | Cross contamination Product contamination | GxP |  |  |  |  | Use of FDA compliant materials Disassembly and cleanability of individual components\u003Cbr>Use of recommended washing liquids Checking the cleaning instruction in the scope of the IQ\u003Cbr>Checking the training documentation in the scope of the IQ\u003Cbr>Training of operating personnel. Determine limits for cleaning validation. |  |  |  |\n|  |  |  |  |  |  |  |  |  |  |  |  |  |\n| 5 | Hardware and maintenance |  |  |  |  |  |  |  |  |  |  |  |\n| 5.1 | Safety devices malfunction | Improper installation of PE (earth potential) . Maschine running with open safetyguards.\u003Cbr>Defective safety devices | Operator safety endangered | HSE |  |  |  |  | Checking acc. to technical documentation in scope of the IQ.\u003Cbr>Checking PE (earth potential) |  |  |  |\n|  |  |  |  |  |  |  |  |  |  |  |  |  |\n| 6 | Software and 21 CFR Part 11 |  |  |  |  |  |  |  |  |  |  |  |\n| 6.1 | Production reports are not generated correctly | Software error | Data in the batch report is incorrect or missing | GxP |  |  |  |  | Checking report generation during the OQ |  |  |  |\n\n\u003Cinsert project name> Template document prepared by Sensum. Visit us [","cbCaihNNx6tLzYwC","https://ap.wps.com/l/cbCaihNNx6tLzYwC","pdf",90863,"English","# Risk Assessment and Traceability matrix\n## Document History\n## Risk description and traceability table\n## Risk evaluation (Severity/Occurrence/Detection)","[{\"question\":\"What information does the Risk Assessment and Traceability matrix capture?\",\"answer\":\"It captures risk descriptions, potential failure causes, effects of failure, evaluation ratings, proposed actions, affected URS, and verification placeholders for IQ and OQ.\"},{\"question\":\"How is the risk level calculated in the template?\",\"answer\":\"The template defines Severity (S), Occurrence (O), and Detection (D) on a 1–10 scale and calculates Risk level as S*O*D.\"},{\"question\":\"What verification activities are referenced for traceability?\",\"answer\":\"The matrix includes Installation verification (IQ test) and Functional verification (OQ test) fields for checking and confirming the proposed controls.\"}]","Risk Assessment and Traceability matrix - Template | PDF"]