Assessment of new suppliers

Procedure Number CORP. 20, Assessment of New Suppliers Procedure New Suppliers... 

Procedures governing assessment of new suppliers, evaluations of raw materials, supplier audits, TSCA premanufacturing notification, waste management, and preparation of specifications, labels, and MSDSs. 

This procedure illustrates how a company might assess a new supplier and how the potential TSCA impact might be evaluated. Naming and responsibilities of functions will vary company by company. 

Software changes Assess software updates for compatibility with the existing software with particular emphasis on any changes made. In terms of system or standard software products, there is normally a bug fix list and details of new, modified, and removed features. Supplier s documentation should include an analysis of the impacts of the patch on their system, and this should be used by the customer to assess the extent of testing required to validate the patch implementation. These documents should be assessed to determine the effects of the change and any appropriate testing performed and incorporated into a validation dossier. 

This can be more complicated, since it will rely on the assessment of a company s potential ability, separate from the actual context of historical performance. Ideally any new supplier should be certificated to a national or international quality standard (e.g. ISO 9000), with an already audited and proven quality system. (During the 1990s many UK packaging companies have been independently certificated to the Pharmaceutical Supplier Codes of Practice, which are linked to ISO 9002.)... 

To obtain a realistic assessment, the method and detail of the purchaser s evaluation of a new supplier must be formalised, and the results documented. The opportunity must be taken to view the supplier under normal operating conditions, with the involvement of the relevant technical staff. Systems of working routines must be made available and the operation of quality systems defined. The supplier company should explain its organisation (line/functional disposition), its personnel training policy, and its philosophy and commitment to quality. 

While obtaining a certification of TSCA compliance from the supplier may be helpful, the best method is to ensure that the new supplier s material is in fact on the TSCA Inventory. The assessment to be made for new suppliers could be part of a general process change assessment. The important issue is to understand where process changes may occur in the company s processes, and to make certain those changes are adequately reviewed from a TSCA perspective. 

Avoid assessment of the new use (for instance because the assessment is not considered feasible or economical). In this case, the supplier and user must identify a solution that will satisfy the legal obligations. 

The selection of a supplier is just the start of the supplier-buyer relationship. Supplier relationship management (SRM) also includes the segmentation of suppliers, performance assessment, improvement of the relationship and collaboration to create new value (Procurement Strategy Council 2007, pp. 6-7). 

The digital I C considered for the project is new with respect to what is used in previous NPPs in Slovakia. For this reason there is no relevant operational experience from operating Slovak NPPs and the assessment of its reliability is based on the detailed reliability data from relevant suppliers. The reliability of the I C is assessed based on standard FMEA analysis, followed by a fault tree analysis for reliabihty estimation. The potential common failure modes are accounted for with suitable common cause factors substantiated with detailed analysis. Input data used for its evaluation are taken from the operational experience of the digital systems operating in other NPPs. Several conservative assumptions (e.g., input reliability data) are considered to ensure that the final result is a bounding estimation. 

The introduction of the EN ISO 13849-1 requires a probabilistic quantitative assessment of the safety-related functions of machine tools and it causes huge uncertainty for many manufacturers and suppliers of machine tools, because there is only very little experiences with this kind of assessment among small and medium enterprises (i.e. machine tool builders). Furthermore, the released and existing quantitative data are universal and have no plausible connection to the single machine tool concepts and components of the manufacturers. With the use of these universal parameters many concepts of safety-related functions wrongly seem to be inadequate to achieve the new requirements, which cause extra costs for the manufacturers. 

The Food Standards Code [10] is the main regulatory instrument which controls the quality of food, contaminant levels, approved additives, processing aids, sanitisers and disinfectants and these standards are performance based. If a chemical or a group of chemicals is covered by a food standard then they must only be used in food in accordance with the standard. However, if a chemical is not mentioned in a standard, then this does not preclude its use in food. For a new chemical not previously used in food production, it would be necessary for the supplier to undertake a detailed risk analysis of the product to demonstrate its safety and suitability. The assessment would need to consider both the toxicological profile of the chemical and the levels of human exposure that are likely to arise from residues in food. 

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