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Nonconforming Product Dispositions

French translation: (modes/types de) traitement/gestion des produits non conformes

14:14 Jun 6, 2023
English to French translations [PRO]
Medical - Medical (general) / FDA / medical devices
English term or phrase: Nonconforming Product Dispositions
Bonjour,

Je traduis un document faisant référence à des contenus de la FDA. Et je me demande s'il existe un terme utilisé dans l'industrie pour "dispositions". Le contexte est le suivant :

Typical Nonconforming Product Dispositions:
Return to Supplier
– When the reason for the nonconformance is the supplier
Scrap
– where you decide not to use the product
– destroy
Downgrade
– Reverting back to a safe and effective older version when there is a problem with an upgrade
Use as Is
– Use the Nonconformance as is when it does not
affect the safety and effectiveness of the final
product
– Example: Cosmetic defects that does not affect the performance of the product

Merci par avance !

Bonne journée.

Camille
C4mille
France
French translation:(modes/types de) traitement/gestion des produits non conformes
Explanation:

(4)Disposition
The term “disposition”, with respect to a product within the possession or control of an entity, means the removal of such product from the pharmaceutical distribution supply chain, which may include disposal or return of the product for disposal or other appropriate handling and other actions, such as retaining a sample of the product for further additional physical examination or laboratory analysis of the product by a manufacturer or regulatory or law enforcement agency.
https://www.law.cornell.edu/uscode/text/21/360eee#4

Disposition simply refers to how the nonconforming item is processed (rework, repair, scrap, etc.); corrective action refers to the actions taken to prevent the nonconformance from occurring again.
https://www.sciencedirect.com/topics/engineering/nonconformi...



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Note added at 1 day 1 hr (2023-06-07 15:37:46 GMT)
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On trouve des exemples de « gestion/traitement » en français dans le domaine médical :
https://www.chu-tours.fr/wp-content/uploads/2020/01/MP-proce...
https://www.bourgogne.synlab.fr/Media/PDF/SYNLABBourgogne/Pr...

On trouve aussi « maîtrise » (que j'ajouterais à l'intitulé de ma réponse si je le pouvais) : https://www.inspq.qc.ca/sites/default/files/lspq/forums/Docu...
https://www.idrrim.com/ressources/documents/10/6114-2018-08-...
Selected response from:

ph-b (X)
France
Local time: 09:31
Grading comment
2 KudoZ points were awarded for this answer



Summary of answers provided
4règlements concernant les produits non-conformes /la conformité des produits
Drmanu49
3 +1(modes/types de) traitement/gestion des produits non conformes
ph-b (X)


Discussion entries: 1





  

Answers


1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5
nonconforming product dispositions
règlements concernant les produits non-conformes /la conformité des produits


Explanation:
RÈGLEMENT (UE) 2019/ 1020 DU PARLEMENT EUROPÉEN ...
https://eur-lex.europa.eu › TXT › PDF
25
PDF
25 juin 2019 — sur la surveillance du marché et la conformité des produits, et modifiant la directive 2004/42/CE et les règlements (CE) no 765/2008 et (UE) ...

Dispositifs médicaux non conformes : quels sont les risques ?
Ecomundo.eu
https://ecomundo.eu › blog › dispositifs-medicaux-no...
14 déc. 2020 — Le nouveau règlement sur les dispositifs médicaux vise à améliorer la transparence du marché en Europe, la traçabilité des produits, et la ...

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Note added at 2 heures (2023-06-06 16:14:36 GMT)
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Description de la régulation de la promotion des produits ...
Haute Autorité de Santé
https://www.has-sante.fr › application › pdf › d...
PDF
1 janv. 2013 — REGLEMENTATION COMMUNE A TOUS LES PRODUITS DE SANTE. Tous les produits de santé sont soumis aux dispositions du code de la consommation qui.
11 pages


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Note added at 2 heures (2023-06-06 16:15:13 GMT)
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Réglementation
Haute Autorité de Santé
https://www.has-sante.fr › jcms › reglementation
Réglementation. Article HAS - Mis en ligne le 27 janv. 2015. L'accréditation des médecins et des équipes médicales est une démarche volontaire de gestion ...
Termes manquants : conformité ‎produits

Drmanu49
France
Local time: 09:31
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in FrenchFrench
PRO pts in category: 5457

Peer comments on this answer (and responses from the answerer)
disagree  Daryo: your references have nothing to do with the "disposition" as used in the ST
1 day 4 hrs
  -> I guess we don't read the same way!
agree  Lionel-N
5 days
  -> Thanks Lio!
Login to enter a peer comment (or grade)

1 hr   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
(modes/types de) traitement/gestion des produits non conformes


Explanation:

(4)Disposition
The term “disposition”, with respect to a product within the possession or control of an entity, means the removal of such product from the pharmaceutical distribution supply chain, which may include disposal or return of the product for disposal or other appropriate handling and other actions, such as retaining a sample of the product for further additional physical examination or laboratory analysis of the product by a manufacturer or regulatory or law enforcement agency.
https://www.law.cornell.edu/uscode/text/21/360eee#4

Disposition simply refers to how the nonconforming item is processed (rework, repair, scrap, etc.); corrective action refers to the actions taken to prevent the nonconformance from occurring again.
https://www.sciencedirect.com/topics/engineering/nonconformi...



--------------------------------------------------
Note added at 1 day 1 hr (2023-06-07 15:37:46 GMT)
--------------------------------------------------


On trouve des exemples de « gestion/traitement » en français dans le domaine médical :
https://www.chu-tours.fr/wp-content/uploads/2020/01/MP-proce...
https://www.bourgogne.synlab.fr/Media/PDF/SYNLABBourgogne/Pr...

On trouve aussi « maîtrise » (que j'ajouterais à l'intitulé de ma réponse si je le pouvais) : https://www.inspq.qc.ca/sites/default/files/lspq/forums/Docu...
https://www.idrrim.com/ressources/documents/10/6114-2018-08-...

ph-b (X)
France
Local time: 09:31
Native speaker of: French

Peer comments on this answer (and responses from the answerer)
agree  Daryo: "gestion des produits non conformes" would be the the nearest, although it avoids completely "disposition" (= comment disposer des produits non-conformes)
1 day 4 hrs
Login to enter a peer comment (or grade)



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