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6. Drawing up functional specifications
The functional specification is a summary document whose aim is to express and prioritize the company's requirements for its production tool in terms of the results to be achieved. It is used to evaluate the solutions proposed by the design team or suppliers, in order to arrive at a well-founded choice. The functional specifications must be validated by the members of the qualification committee before moving on to the search for solutions.
Whatever the extent of the resources allocated to the design, production and operation of a tool, it will always present risks. The company's needs with regard to the tool must therefore be expressed not only in terms of quantitative production performance, but also in terms of quality and risk control for the company.
6.1 Risk...
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Drawing up functional specifications
Choice of solutions for tool design
Bibliography
Organizations
SARDELICES workshop, EPLEA Les Sardières, Bourg-en-Bresse.
Direction des services vétérinaires de l'Ain.
Île-de-France Regional Council.
Websites
http:// www.sartorius.com (equipment qualification)
Standards
Association Française de Normalisation (AFNOR).
- Analyse fonctionnelle. Caractéristiques fondamentales - NF X 50-100 - 12-96
- Vocabulaire du management de la valeur, de l'analyse de la valeur et de l'analyse fonctionnelle. Partie 1 (ég. x 50-150-1) - NF EN 1325-1 - 11-96
- Analyse de la valeur, analyse fonctionnelle. Expression fonctionnelle du besoin et cahier des charges fonctionnel - NF X 50-151...
Regulations
Arrêté du 8 juin 2006 relatif à l'agrément des établissements mettant sur le marché des produits d'origine animale ou des denrées contenant des produits d'origine animale (JO du 8 août 2006).
Hygiene package regulations (178/2002, 183/2005, 852 and 853/2005, 854/2004, 882/2004).
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