Vendor’s responsibility

At first glance, it may appear unnecessary to specify design parameters. This might appear to be the vendor s responsibility. While the vendor does take care of the basic design, there are optional areas where he... 

Vendor s Responsibility - Defines the terms of contractual commitments on the part of the vendor. 

Note Regardless of the generalized limits in 4.2.2, it shall be the vendor s responsibility to review the design limits of the equipment in the event that more stringent requirements are necessary. Defects that exceed the limits imposed in 4.2.2 shall be removed to meet the quality standards cited as defined by the inspection method specified. 

Both commercial and technical needs demand a clear distinction of technical responsibility between the purchaser and the vendor. Commercially, the precise definition of the vendor s responsibility assists the comparison of offers and the manageability of contracts, and is appreciated by vendors who wish to market quality. Definition of responsibility is always fundamental to quality management. 

Comments by N P Refinery on the Vendor s documents do not relieve him of his responsibility. 

Since the user knows best what the typical operating condition will be like in the laboratory, it is the user who should have the greatest input in formulating an acceptable PQ protocol. Although the vendor can certainly help provide resources, it is primarily the user s responsibility to finalize a PQ protocol that meets his/her needs and is acceptable to the company. 

Third, simple approaches constrain the relationship to be the same for all contexts. Jones and Sasser (1995) find that the customer satisfaction-customer loyalty relationship varies by industry, possibly because of differences in competitive environment. Bowman and Narayandas (2001, 2004) find that customer-specific factors such as the competitive context at a given customer account can occasion differential responsiveness. Accounting for heterogeneity in customer relationships and customer response to a vendor s strategies and tactics is a key theme of much recent research in management science. 

Our customer or our customer s representatives are afforded the right to verify at the source or upon receipt that the purchased product conforms to the specified requirements. Product verification by the customer does not absolve our operation of the responsibility to provide a fully acceptable product, nor does it preclude subsequent rejection. When our customer carries out product verification at a vendor s plant, such verification is used as evidence of effective quality control of the vendor. 

When selecting from a choice of software products, the director of pharmacy should consider the products vendors. The company s good reputation and its ability to provide referrals from former and existing clients are essential. Installation planning should be suitable for the organization s needs yet realistic for the vendor. While the vendor is responsible for system design, much of the installation, education, and training of employees will fall on the shoulders of the pharmacy department. 

While it is not the sponsor s responsibility to carry out the work, it is its responsibility to ensure it is done correctly and in accordance with the sponsor s standards and commitments to the regulatory agencies. It is critical to verify that vendors are meeting compliance and contractual obligations by performing an initial qualification audit and periodic monitoring audits. 

As a result of the audit, the vendor is responsible for developing a corrective action plan to address any weaknesses or deficiencies identified by the sponsor s auditors. It is the sponsor s responsibility to ensure that the corrective... 

Calibration checks are nsnally carried out on analyzers by injecting known samples into the sample conditioning systems. This mnst be determined for each type of analyzer by reference to the mannfacrnrer s handbook or by consnltation with the instrument vendor, and it mnst be agreed on with the cnstomer. Complex analyzer systems usually require specialist personnel from the analyzer mannfacmrer to assist in precalibration and commissioning and are generally ontside the scope of the installation contractor s responsibility and experience. 

As mentioned briefly, a recent contender to the hall of fame is the 5033, officially labeled a lOOV Push-Pull Voltage-Mode PWM controller, and released in 2003. Luckily, this analog vendor s datasheet only shows a Half-Bridge at work, and that we are aware is a good match for voltage-mode control. So I personally tend to think that marketing (alone) was responsible for this misleading push (or pull). 

Global sourcing. Multinational companies (and many local ones) source raw materials and manufactured goods from suppliers located around the world. For economic or cultural reasons, not all of these suppliers use products or processes that are sustainable - a situation that can compromise the ethics of purchasers and can reduce the vendor s ability to provide a consistent supply of high-quality products. Because it considers a supplier s sustainability when it begins developing business partnerships, 3M is more likely to build relationships with responsible and reliable vendors. 

From a regulatory point of view, computer systems must be validated. The user has the ultimate responsibility for validation but he can delegate some parts, for example validation during development, to the vendor. If he does this, the user should have some proof that his software has been validated at the vendor s site. Using software development practices... 

SDLC documentation underlies a strict approval process that is defined in the software vendor s SOPs and can be audited by customers and regulative organizations. Documents created under the SDLC are versioned and include either handwritten or electronic signatures for approval from the responsible departments. The approval also involves a member of the QA department that is independent of the project team. Different versions of documents may be created as full documents that is, the most recent version includes the entire documentation, or delta documents, that contain just changes with respect to the previous version. 

Employers should ensure that employment tests and other selection procedures are properly validated for the positions and purposes for which they are used. The test or selection procedure must be job-related and its results appropriate for the employer s purpose. While a test vendor s documentation supporting the validity of a test may be helpful, the employer is still responsible for ensuring that its tests are valid under UGESP. 

GM and UAW safety personnel had the responsibility to perform a safety Buy off on equipment at the vendor s place of business. Their purpose was to validate that the vendor was meeting the safety design specifications in the equipment being buUt. Implementation of this process drove compliance in the early design stages. 

Vendors will supply instructions for operation and maintenance of each system or piece of equipment. Plant personnel should make sure that the vendor s requirements are practicable and in line with established plant practices. All the relevant information then can be compiled for inclusion in a maintenance manual. The size of the plant and the nature of its organization will determine whether it is better to gather all maintenance information into a central comprehensive set of dedicated maintenance manuals or to file it by equipment item as part of the operating manuals. In either case, the plant must have clearly established lines of responsibility and well imderstood rules for performing certain types of work under permit (see Section 7.1.4). The maintenance information should cover the following ... 

The vendors are responsible for the Risk assessments of machinery. The reports from these assessments are part of the required documentation to issue a declaration of conformity with the machinery regulations. The contractor defines the documentation on risk assessments to be delivered by the vendors for review and verification. This includes the risk assessments for machinery and assemblies of machinery that are critical from a safety point of view (cf. NORSOK S-005 in Norsk Standard, 1999). 

In generaL it is process engineer s responsibility to specify process requirement of a compressor on a data sheet With the compressor process specification, a vendor is able to design or select a compressor to fit ihe need. Providing the compressor process specification is the first step to purchase a new compressor or to rate an existing compressor. 

Producers. The producers of databases are sometimes called database publishers because they make pubHc their databases. Some producers pubhsh hardcopy counterparts to databases and so are pubHshers in the traditional sense others pubHsh data only in electronic form. Database producers are responsible both for the deterrnination of content and for database production. Most producers offer their databases for lease or Hcense to private organisations or database vendors. Vendors offer database search services to the marketplace on a fee basis. An increasing number of producer/vendors such as Mead Data Central, U.S. National Library of Medicine, and DRI/McGraw-HiU. (formerly Data Resources), offer search services (batch or online) from their own databases as well as from the databases of other products. 

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. 

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