Qualification of subcontractors

The result of subcontractor qualification is a list of capable subcontractors that will be invited to bid for specific work. 

Drawings, process requirements, inspection instructions, and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment, and personnel. These requirements also apply to selection and control of subcontractors. Subcontractors include toll manufacturers and contract laboratories. 

Supervisors are responsible for the training, qualification, and performance of employees. They are required to review the qualifications of employees, subcontractors, visitors, and temporary employees in... 

A file in the name of each qualified contractor/subcontractor shall be maintained in the purchasing office awarding the qualification, with copies as appropriate at satellite or field buying offices. The file shall contain ... 

This would check the products, processes, or services to establish they are what the subcontractor claims them to be. Assessment of design and production capability may be carried out at this stage or be held until the pre-qualification stage when specific contracts are being considered. 

Pre-qualification is a process for selecting contractors for known future work. The design will have proceeded to a stage where an outline specification of the essential parameters has been developed. You know roughly what you want but not in detail. Pre-qualification is undertaken to select those subcontractors that can demonstrate they have the capability to meet your specific requirements on quality, quantity, price, and... 

Vendor support to validation—A common practice in BPC production is the subcontracting of certain chemical steps to outside suppliers. As is the case with subcontracted production for dosage forms, the owner of the NDA or DMF maintains responsibility for the validation of the process and must secure the cooperation of the subcontractor in the performance of any supportive qualification/validation activities. Agreement to this arrangement should be a precondition to the awarding of the contract to the supplier. 

This system of work leads to a major disjunction between safety and compensation. At law, employers are responsible for compensation and must carry workers compensation insurance. Thus the subcontracting firms carry the main costs of workers compensation. However, the principal contractor exercises close control over the subcontractors and even over their employees. In these circumstances the law imposes the primary responsibility for the safety of these workers on the principal contractor. (Subcontractors are responsible at law only to the extent that they exercise real control over the work process.) The result of these arrangements is that compensation costs cannot provide safety incentives so far as project management is concerned. Insofar as the principal contractor is safety conscious this must be for reasons other than the costs of compensation. By way of qualification, it should be noted that some industry leaders are now employing a greater proportion of the workers on site directly. Where this happens the disjunction will be correspondingly blurred. 

The tendency of contractors to cascade work to subcontractors without appropriate qualifications and controls ... 

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