Glossary entry (derived from question below)
English term or phrase:
residual risk assessment vs. residual risk evaluation
Spanish translation:
Valoración del riesgo residual vs Evaluación del riesgo residual
Added to glossary by
VICTOR PRIETO
Aug 28, 2023 01:44
9 mos ago
40 viewers *
English term
Peru
15+ years in Technical-Scientific field
Native in: Spanish (Variants: Peruvian, Latin American)
Works in: English to Spanish, Spanish to English
residual risk assessment vs. residual risk evaluation
English to Spanish
Tech/Engineering
Engineering: Industrial
It seems that sometimes both have the same translation (Evaluación del Riesgo Residual), but they are two different steps in the process (differences detailed at the end)
Here is the context:
This Risk Management Document applies to the XXXXX medical device
Risk Management process steps documented:
1. Initial Risk Analysis
2. Initial Risk Evaluation
3. Risk Control
4. Residual Risk Assessment
5. Residual Risk Evaluation
6. Production and Post-production information
RESIDUAL RISK ASSESMENT includes an analysis of the risks level of ocurrence (before and after contro meassures) severity, and residual risk.
RESIDUAL RISK EVALUATION includes the Result of the residual risk evaluation (i.e. ACCEPTABLE, BROADLY ACCEPTABLE, etc.), and comments (e.g. comparisson of occurrence level form other documents)
Please I'll appreciate your help.
Here is the context:
This Risk Management Document applies to the XXXXX medical device
Risk Management process steps documented:
1. Initial Risk Analysis
2. Initial Risk Evaluation
3. Risk Control
4. Residual Risk Assessment
5. Residual Risk Evaluation
6. Production and Post-production information
RESIDUAL RISK ASSESMENT includes an analysis of the risks level of ocurrence (before and after contro meassures) severity, and residual risk.
RESIDUAL RISK EVALUATION includes the Result of the residual risk evaluation (i.e. ACCEPTABLE, BROADLY ACCEPTABLE, etc.), and comments (e.g. comparisson of occurrence level form other documents)
Please I'll appreciate your help.
Proposed translations
(Spanish)
References
| ISO 14971:2019 |
Tomasso
|
Change log
Aug 28, 2023 11:42: writeaway changed "Language pair" from "English" to "English to Spanish"
Proposed translations
2 days 12 hrs
Arturo Oswal Alva Mendiburu
Peru
Peru
Native in Spanish
Specializes in field
Peru
Spanish translator and subtitler
Native in: Spanish (Variants: Latin American, Peruvian) 
Works in: English to Spanish, Spanish to English, Spanish
Related KudoZ points
:
4
Selected
ponderación del riesgo residual vs calificación del riesgo residual
Ponderar, valorar, medir son también formas de análisis pero cuantitativa. En esta etapa se realiza algo parecido a lo que en seguridad se llama IPERC, n gestión documentaria le llaman Matriz de Evaluación de Riesgos. Tienes que medir. Lo que no se mide no se conoce.
En la calificación del riesgo ya no harás este paso, sino mas bien, vas a determinar, juzgar o definir que tan eficientes resultó tu medición, en términos de riesgo residual.
Hablando de Gestión Documentaria, parte de tu petición menciona estos conceptos:
ponderación del riesgo residual. Incluye un análisis del nivel de ocurrencia de los riesgos (antes y después de sus medidas de control), severidad y riesgo residual.
calificación del riesgo residual. Incluye el resultado de la medición (aceptable, bastante aceptable, no aceptable, etc.), y algunos comentarios (por ejemplo, comparaciones del nivel de ocurrencia con otros documentos).
En la calificación del riesgo ya no harás este paso, sino mas bien, vas a determinar, juzgar o definir que tan eficientes resultó tu medición, en términos de riesgo residual.
Hablando de Gestión Documentaria, parte de tu petición menciona estos conceptos:
ponderación del riesgo residual. Incluye un análisis del nivel de ocurrencia de los riesgos (antes y después de sus medidas de control), severidad y riesgo residual.
calificación del riesgo residual. Incluye el resultado de la medición (aceptable, bastante aceptable, no aceptable, etc.), y algunos comentarios (por ejemplo, comparaciones del nivel de ocurrencia con otros documentos).
Note from asker:
| Gracias, sí, he optado por Valoración (similar a ponderación) de riesgo residual y a Evaluación (similar a calificación) ya que en la norma se encuentra como Evaluación Global de riesgo residual. Gracias. |
4 KudoZ points awarded for this answer.
1 hr
Taña Dalglish
Jamaica
Jamaica
Native in English
Specializes in field
Jamaica
Translating the Ideas Behind the Words
Native in: English (Variant: British)
Works in: Spanish to English, English to Spanish, French to English, and 2 more.
Related KudoZ points
:
36
Análisis del riesgo residual v evaluación del riesgo residual
Análisis del riesgo residual v evaluación del riesgo residual
Qué es la evaluación de riesgo residual?
El Riesgo Residual es el riesgo que persiste luego de la respuesta de la Dirección al Riesgo. Riesgo Inherente y Residual (cont.) La Evaluación del Riesgo se aplica primero al Riesgo Inherente. Una vez que se desarrollaron las respuestas a los riesgos, la Dirección considera el Riesgo Residual.
https://www.ccn-cert.cni.es/documentos-publicos/1789-magerit... (pág. 106)
Residual risk Riesgo residual
Risk Riesgo
Risk acceptance Aceptación de riesgos
Risk analysis Análisis de riesgos
Risk assessment Análisis de riesgos
Qué es la evaluación de riesgo residual?
El Riesgo Residual es el riesgo que persiste luego de la respuesta de la Dirección al Riesgo. Riesgo Inherente y Residual (cont.) La Evaluación del Riesgo se aplica primero al Riesgo Inherente. Una vez que se desarrollaron las respuestas a los riesgos, la Dirección considera el Riesgo Residual.
https://www.ccn-cert.cni.es/documentos-publicos/1789-magerit... (pág. 106)
Residual risk Riesgo residual
Risk Riesgo
Risk acceptance Aceptación de riesgos
Risk analysis Análisis de riesgos
Risk assessment Análisis de riesgos
Note from asker:
| Thank you for the reference. But now I have a new doubt. Risk Analysis = Risk assessment? |
| It is a good point, because we can take the previous steps as an analogy: 1. Initial Risk ANALYSIS 2. Initial Risk EVALUATION 3. 4. Residual Risk Assessment (Analysis) 5. Residual Risk EVALUATION |
| I decided to use: - Valoración de Riesgos Residuales (similar than Analysis) - Evaluación de Riesgos Residuales |
+1
9 hrs
Chris Ellison
Spain
Spain
Native in English
Works in field
Spain
Geology and environment specialist, PhD
Native in: English 
Works in: Spanish to English, Catalan to English, English
Identificación de riesgos residuales y Evaluación de riesgos residuales: resultados
This is a solution. My partner is a specialist in environmental risk assessments and he says they mean absolutely the same thing.
If not, another possibility would be:
Evaluación de riesgos residuales y Evaluación de riesgos residuales: resultados
but it depends on the content of the other chapters.
Best speak to the client and see if they agree to a slight name change as long as it fits the criteria.
HTH
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Note added at 9 hrs (2023-08-28 11:17:48 GMT)
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He's had another idea: evaluación y calculo del riesgo residual.
(In the answer there shouldn't be the ":resultados" I was playing with the answers to see which would fit best, sorry)
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Note added at 9 hrs (2023-08-28 11:18:51 GMT)
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Same for Initial, of course. x
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Note added at 9 hrs (2023-08-28 11:26:30 GMT)
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Look up ISO 31000 Gestión del riesgo. It shows the steps in risk assessment (its available in Spanish and English, which is handy). There's a diagram that shows the process: Identificación, Análisis y Valoración. The vocab is useful and you can use it as a ref when you talk to the client. :-)
If not, another possibility would be:
Evaluación de riesgos residuales y Evaluación de riesgos residuales: resultados
but it depends on the content of the other chapters.
Best speak to the client and see if they agree to a slight name change as long as it fits the criteria.
HTH
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Note added at 9 hrs (2023-08-28 11:17:48 GMT)
--------------------------------------------------
He's had another idea: evaluación y calculo del riesgo residual.
(In the answer there shouldn't be the ":resultados" I was playing with the answers to see which would fit best, sorry)
--------------------------------------------------
Note added at 9 hrs (2023-08-28 11:18:51 GMT)
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Same for Initial, of course. x
--------------------------------------------------
Note added at 9 hrs (2023-08-28 11:26:30 GMT)
--------------------------------------------------
Look up ISO 31000 Gestión del riesgo. It shows the steps in risk assessment (its available in Spanish and English, which is handy). There's a diagram that shows the process: Identificación, Análisis y Valoración. The vocab is useful and you can use it as a ref when you talk to the client. :-)
Peer comment(s):
| agree |
Juan Gil
: Identificación (se ven cuales son) y Evaluación (el nivel de cada uno de los identificados).
2 hrs
|
Reference comments
44 mins
Reference:
ISO 14971:2019
.iso.org/standard/72704 "his document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.
The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle.
They will SELL you information, can be bought in Spanish.
Cada dia todos quiren vender informacion, diarios,
--------------------------------------------------
Note added at 52 mins (2023-08-28 02:37:06 GMT)
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http://www.microkn.com/static/upload/file/20210118/161094817...
Informacion gratis, version en Ingles, psiblemente Aleman y Frances. Son 43 paginas.
The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.
The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle.
They will SELL you information, can be bought in Spanish.
Cada dia todos quiren vender informacion, diarios,
--------------------------------------------------
Note added at 52 mins (2023-08-28 02:37:06 GMT)
--------------------------------------------------
http://www.microkn.com/static/upload/file/20210118/161094817...
Informacion gratis, version en Ingles, psiblemente Aleman y Frances. Son 43 paginas.
Reference:
Note from asker:
| Thanks, it is a good reference. I don't find Residual Risk Assessment in that document, only Residual Risk Evaluation ("Evaluation of overall residual risk") |
Discussion
habría que disponer de más mimbres para adaptarlo con más seguridad, pero evaluación sugiere más la idea de calificación, con una escala, incluso.
An assessment is more subjective, based on opinion, professional judgement, experience, etc.
An evaluation is more objective, based on scores and measurable values.
1755, "action of appraising or valuing," from French évaluation, noun of action from évaluer "to find the value of," from é- "out" (see ex-) + valuer, from Latin valere "be strong, be well; be of value, be worth" (from PIE root *wal- "to be strong")
https://www.etymonline.com/word/evaluation
To be honest, I don't think one definition fits all uses. Education uses the two terms very differently from medicine.
- Residual Risk Assessment is more like Análisis /Valoración de Riesgos Residuales, (similar than Risk analysis and evaluation)
- Residual Risk Evaluation is more like "Evaluación de Riesgos Residuales" / "Evaluación de Aceptabilidad de Riesgos"
But there should be an standard technical name for it somewhere, or maybe it is a mistake.
The thing is that in that document only exist "Evaluación del Riesgo residual global" (Evaluación) and there is not other step before about residual risk assessment.
This text is badly written and confusing, but it seems that the assessment is quantitative, eg "there is a 50% risk of this occurring", while the evaluation is qualitative, eg "this risk is unacceptable".
If you agree with my interpretation, you could clarify this by saying "evaluación cuantitativa" and "evaluación cualitativa".
Septiembre 2020 Dispositivos médicos/productos sanitarios (MD) Aplicación de la gestión del riesgo a los MD (ISO 14971:2019) Esta norma ha sido elaborada por el comité técnico CTN 111 Aparatos y dispositivos médicos y quirúrgicos, cuya secretaría desempeña FENIN.