Visits, supplier performing

Subcontractor/supplier performance will be evident from audit reports, surveillance visit reports, and receipt inspections carried out by you or the third party if one has been employed. You need to examine these documents for evidence that the subcontractor s quality system is controlling the quality of the products and services supplied. You can determine the effectiveness of these controls by periodic review of the subcontractor s performance what some firms call vendor rating . By collecting data on the performance of subcontractors/suppliers over a long period you can measure their effectiveness and rate them on a scale from excellent to poor. In such cases you should measure at least three characteristics quality, delivery, and service. Quality would be measured by the ratio of defective conforming products received delivery would be measured by the number of days early or late and service would be measured by the responsiveness to actions requested by you on scale of excellent to poor. The output of these reviews should be in the form of updates to the list of assessed subcontractors/suppliers. 

Even though full GMP compliance may begin later than receipt of raw materials, it is important to treat raw materials in a GMP compliant manner. Raw materials should be purchased only from suppliers approved by the Quality Unit. For raw materials whose quality is important to conformance of the excipient to compendial or specification requirements, or to performance expectations, the supplier approval process should be a combination of site visit and an evaluation of raw material quality. For other raw materials, it would be adequate to confirm that the raw material supplier can meet the purchasing specification. 

The first section is site qualification. Vendors selected to perform regulated work product will be evaluated for compliance with the appropriate s et of regulations. The results of the audit will be reviewed and the need for a site follow-up visit will be determined. Site qualification visits are generally performed on a cyclical basis at least once every 24 months is suggested unless the supplier becomes problematic. A continuous monitoring program is an essential component of a compliant vendor qualification program. 

Suppliers and potential suppliers are classified with respect to expected or known compliance with environmental and safety standards. In a first approach, this classification is performed according to their location in OECD countries or non-OECD countries, since the risk of noncompliance with environmental and safety standards is expected to be higher in non-OECD countries (Kranz and Sargasser, 2003). Products/producers assigned a C3 rating represent a potentially high risk and are therefore subjected to a particularly careful check. This means that BASF employees visit the supplier and carry out an EHS assessment to determine whether the supplier s plant operates according to Responsible Care standards. A company can only be included in our list of suppliers if its facilities meet our requirements. 

Supplier Involvement the CER states that Clariant requires suppliers to provide company information on quality and safety and environmental protection. We also make a brief evaluation of ESH performance in the course of our normal visits to a company, and this goes into the final assessment together with the supplier s own statement. 

EMS a yes score has been awarded since reference is made to a three-day review of Eastman s processes for managing HS E performance as part of the CMA s voluntary management systems verification programme. This included visits to two sites and interviews with employees, customers, suppliers, local neighbours and emergency responders. No reference is made to participation in any recognised EMS outside the USA. 

Including safety-related specifications in purchasing standards assists in attaining corporate goals for superior performance. There is great opportunity here for recognition and accomplishment by safety professionals. In a few companies, suppliers of equipment are not to ship the ordered items until visited by the purchaser s safety personnel, who are to sign off on acceptance. 

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