Vendor approval

It is the responsibility of the quality assurance manager to develop the vendor approval system and maintain SOP compliance. 

After vendor approval, quality control or quality assurance will reduce the number of tests and inspections of incoming goods as agreed in the certification report, e.g., one out of ten batches. 

There are a few common misconceptions about MSDS management solutions. One size does not fit all, and cheaper is not better. It is important to remember that solution components do not need to be purchased and activated simultaneously, and that outsourced solutions will not eliminate the need for IT Support (critical to the vendor approval process and during many implementation phases) or back office and administrative support When considering a fuU-service program versus a do-it-yourself application, keep in mind that a host of vendors offer what appear to be less expensive alternatives. The hook is enticing, as reducing expenses is extremely attractive, especially in this economy. 

Effective specification control often can be estabUshed other than through requirements placed on the end use material, ie, the specification may beat on the taw materials, the process used to produce the material, or ancillary materials used in its processing. Related but supplementary techniques ate approved vendor Hsts, accredited testing laboratories, and pteptoduction acceptance tests. 

API again offers some help. API 671 covers the special purpose coupling as either a specification or guideline. It has been common practice for the compressor vendor to furnish the couplings. Most compressor vendors have no problem accepting this responsibility, while driver vendors sometimes prefer not to furnish them. In some compressor types, the coupling style will be somewhat influenced by the user. When torsionals become a major consideration, the vendor may have to make the choice based on system need. In all cases, the user should establish his right of approval if the vendor performs the selection. 

While the vendor may have been told that he is the successful bidder, he becomes the vendor when a contract is written and accepted by him. This is important because the clock is started at this time and all future dates will be referenced back to this date. This also is the date from which delivery is counted. The so-many-months-after-approval-of-draw-ings method is pretty obsolete. Drawings are reviewed, not approved. Vendor manufacture begins officially with the contract acceptance. 

Caution is advised on the name you give to this list of subcontractors. All have been assessed but all may not have been visited or used. Some organizations refer to it as an Approved Subcontractors List (ASL) or Approved Vendor List (AVL), but if you include unacceptable subcontractors you cannot call it an Approved Vendor List. If it is in paper form, two lists may be preferable. Some organizations use colored paper to distinguish between approved and unapproved subcontractors. If the data is stored electronically, the fields can be protected to prevent selection of unacceptable subcontractors. 

Prior to orders being placed the purchasing documents should be checked to verify that they are fit for their purpose. Again this requirement is appropriate to subcontracts but only if you submit your purchasing documents to your vendors. The extent to which you carry out this activity should be on the basis of risk and if you choose not to review and approve all purchasing documents, your procedures should provide the rationale for your decision. The standard does not require that the review and approval be documented. In some cases orders are produced using a computer and transmitted to the vendor directly without any evidence that the order has been reviewed or approved. The purchase order does not have to be the only purchasing document. If you enter pur-... 

Mention of a trademark, proprietary product or vendor does not constitute a guarantee or warranty of the product by the U. S. Department of Agriculture and does not Imply Its approval to the exclusion of other products or vendors that may also be suitable. 

Operational Qualification—The OQ is the protocol that verifies that the operation of the system meets the written and pre-approved performance and functional specifications established by the vendor within its required operating range. 

Referenced pnblieations, U.S. and SI, are listed in Appendix A. The U.S. pubhcations are the base documents. The corresponding international publications and standards may be acceptable as alternatives with the pnrchaser s approval. In all cases, the editions that are in effect at the time of the pnblication of this standard shall, to the extent specified herein, form a part of this standard. The applicability of changes in standards, codes, and specifications that occnr after the pnblication of this standard shall be mnmally agreed npon between the pnrchaser and the vendor. 

The conditions in the seal chamber required to maintain a stable film at the seal faces, including temperature, pressure, and flow, as well as provisions for assuring the adequacy of the design for sealing against atmospheric pressure when pumps are idle in vacuum service, shall be mutually agreed upon by the pump vendor and the seal manufacturer, approved by the purchaser, and noted on the data sheet. 

Note 1 The vendor shall notify the purchaser if the criteria for minimum temperature rise and velocity over heat exchange surfaces result in a conflict. The criterion for velocity over heat exchange surfaces is intended to minimize waterside fouling the criterion for minimum temperature rise is intended to minimize the use of cooling water. The purchaser will approve the final selection. 

When specified or if recommended by the vendor and approved by the purchaser, a pressure lubrication system shall be furnished to supply oil at a suitable pressure to the pump bearings, the driver, and any other driven equipment, including gears and continuously lubricated couplings. 

When a mechanical seal is specified, it shall be located at the cover plate to seal the vapor in the supply tank or vessel. Mechanical seals normally seal vapor however, they shall be designed to operate in liquid in the event of tank or vessel overfilling. With purchaser approval, the vendor may supply a seal pressurized by flush from the pump discharge or from an external source. External seal flush must be compatible with the liquid being pumped. The seal chamber shall have provisions for a high point vent. 

F.1.3 Piping configurations that produce loads greater than those allowed in F. 1.2 shall be mumally approved by the purchaser and the vendor. 

Where oil is supplied from a common system to two or more machines (such as a pump, a gear and a motor), the oil s characteristics shall be suitable for all equipment supplied. The vendor having unit responsibility shall obtain approval of the purchaser and the other equipment vendors for the oil selection. 

Because of the elevated iron concentration and low pH created by the ISOTEC process, regulatory approval may be required for some sites. The process can also create a temperature increase in the subsurface. According to the vendor, this increase can be as high as 10°C and lasts less than 24 hr. 

The vendor also claims that RadAway can effectively separate mixed waste—waste containing radioactive materials and hazardous solvents. This separation allows the solvent to be disposed of separately from the radioactive component, greatly reducing disposal costs. However, RadAway does not have regulatory approval for mixed waste. 

An example of this is the duloxetine antidepressant project at Eli Lilly. The company is bnying in the penultimate (next-to-last) step of the molecule. It was able to get FDA approval for this molecule as a semi-starting material. The requirement was divided among four suppliers. So it is easy for Lilly to play among four vendors at the same time and get very attractive prices. 

In the control of outsourced operations, the cGMP regulations require that the QU approve or reject products or services provided under a contract. Under current quality system models, the organization must follow a formal vendor qualification process to qualify outsource providers and verify through inspection or other appropriate means that the provider is capable of meeting the requirements of the organization. To comply with the regulation, these operations should be conducted by the QU. 

Quality purchasing is achieved through procurement from approved vendor sources. 

Vendors are selected on the basis of their ability to meet quality requirements. An approved vendor list is established and maintained. Only approved vendors are used. 

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