Processes for Production and Service Provision

Validation of processes for production and service provision (contd.)... 

Sub-clause 7.5.1 control of production and seivice provision Sub-clause 7.5.2 validation of processes for production and service provision... 

VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION Clause — 4.9 ISO 9001 1994 Revision 0... 

Any process for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement, must be validated. Specihc consideration is given to the processes where deficiencies become apparent only after the product is in use or the service has been delivered... 

Production and service provision - Operate production and service provision under controlled conditions, maintain batch records, validation processes that cannct be verified, maintain identification and traceability of materials, address specific requirements for sterile products, provide suitable conditions for storage and distribution... 

The provision of goods and services (collectively, products) contributes to environmental impacts. Life cycle assessment (LCA) is a tool for comparing product options and for identifying opportunities for reducing related impacts. LCA provides insights that are complimentary to those of many regulatory and more site- or process-oriented risk and impact assessments. 

V.56. Documented procedures should provide for in-process, final, and in-service inspection carried out during all phases of testing, production, transport and maintenance against specified requirements. These procedures should include provision for measuring and test equipment used to be calibrated, adjusted and maintained at defined intervals. 

A tiered testing process will be phased in over a twenty year period, and is expected to cost industry approximately 2.5 billion, with an administrative staff of almost 200, to be paid for by a service fee levied on industry. Of major concern with HPPs is a fast track authorization provision for PBTs. As already noted in Sec. 24.3.4 above, HPP producers and importers must ensure accuracy of the definition of PBTs as (P-i-B-i-T)s or face the specter of across-the-board regulatory restrictions on their products due to exercise of the Precautionary Principle. 

One strategy that strengthens the acquisition process is the conditions-of-sale document. This multifaceted document integrates equipment specifications, performance, installation requirements, and follow-up services. The conditions-of-sale document ensures that negotiations are completed before a purchase order is delivered and each participant is in agreement about the product to be delivered. As a document of compliance, the conditions-of-sale document specifies the codes and standards having jurisdiction over that equipment. This may include provisions for future modification ofthe equipment, compliance with standards under development, compliance with national codes, and provision for software upgrades. 

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