Purchasing standards audits

With respect to procedures to avoid bringing hazards into the workplace, does the audit system include an examination of the management practices for the design of the workplace, the work methods, and the environmental system, and the purchasing standards ... 

GLP regulations require QA personnel to inspect/audit each study conducted, but the extent to which QA personnel are involved in software development and the val-idation/verification process varies from company to company. In some companies, there is little or no QA involvement in these processes, whereas in others QA personnel are involved. QA personnel can provide assistance in the area of vendor audits for purchased software or can conduct inspections of in-house software development to ensure that internal procedures are being followed. QA personnel, who conduct in-process inspections and review the resulting data and validation report for accuracy, could provide inspection support during the validation and verification process. During system development and validation, properly trained QA personnel can provide the regulatory advice needed to ensure that the system will meet government standards. QA personnel become more familiar with the system(s) that will be used when they are involved early in the validation process. 

In negotiating to purchase raw materials, BASF uses a safety matrix to evaluate the dangers posed by their physical and chemical properties. Suppliers are also subject to environmental and safety audits by BASF employees to minimize pollution and to assure their use of safety standards are in accordance with Responsible Care. The company s environmental criteria are supplemented with minimum social standards that suppliers are expected to meet, including the prohibition of child labor and the use of forced or bonded workers. 

If standard software has been modified or new software has been developed on special request by a user, the vendor should be qualified through audits. This can be done through a detailed written questionnaire similar to the questions in Table 1 for smaller projects or through a detailed site audit (second party audit). Frequently the quality requirements are agreed upon before the programming is started as part of the purchase... 

The next example is of a Pre-Startup Review or a Process Hazards Audit held on a piece of purchased processing equipment, a Haake Rheocord Torque Rheometer and Laboratory Twin-screw Extruder. The organization responsible for this extruder has a standard checklist of eleven pages of items to be considered by the technical person or persons in charge of the equipment or process, before the review is held. Copies of the completed checklist are then sent to each committee member before the meeting for review. Generally, in a review of this type, the group will convene at the location of the equipment rather than in a conference room to go over the material provided. In this case, the committee consisted of ... 

CERTIFIED SUPPLIER An Approved Supplier who has been formally audited by the purchaser and who meets AS3901 or 3902 requirements and is so certified by Standards Australia (see also Approved Supplier). 

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