Supplier verification

When carrying out subcontractor surveillance you will need a plan which indicates what you intend to do and when you intend to do it. You will also need to agree the plan with your subcontractor. If you intend witnessing certain tests, the subcontractor will need to give you advanced warning of its commencement so that you may attend (see also later in this chapter under Supplier verification at subcontractor s premises.)... 

The standard requires that the supplier identify resource requirements for management, performance of work, and verification activities and provide adequate resources. 

Generically there are two types of requirements defining requirements and verification requirements. Defining requirements specify the features and characteristics required of a product, process, or service. (Within the standard these are termed specified requirements.) These may be wholly specified by the customer or by the supplier or a mixture of the two. Verification requirements specify the requirements for verifying that the defining requirements have been achieved and again may be wholly specified by the customer or by the supplier or a mixture of the two. With verification requirements, how-... 

The standard requires the supplier to verify that changes are validated (including all subcontractor changes) and, when required by the customer, additional verification/ identification requirements shall be met. 

The standard requires the supplier to provide appropriate technical resources for tool and gage design, fabrication, and verification activities, establish a system for tooling management, and implement a system to tack and follow-up tooling management activities if any work is subcontracted. 

The standard requires the supplier to specify verification arrangements and the method of product release in the purchasing documents where it is proposed that purchased product is verified at the subcontractor s premises. 

The requirements pertain to your customer verifying product purchased by you either at your supplier or on your premises. Verification of purchased product is normally carried out by the supplier before or after receipt as part of the purchasing process but may also be carried out by the customer. However, due to the standard locating most of the inspection and test requirements in clause 4.10, the receipt inspection requirements are displaced. 

The standard requires the supplier to establish and maintain procedures for verification of customer supplied product provided for incorporation into the supplies or for related activities. 

The standard requires that any such product that is lost, damaged, or is otherwise unsuitable for use be recorded and reported to the customer and again advises the supplier that verification bp the supplier does not absolve the customer of the responsibility to provide acceptable product. 

The standard requires that the supplier ensures that incoming product is not used or processed (except in the circumstances described in 4.10.1.2) until it has been inspected or otherwise verified as conforming to specified requirements and requires that verification be in accordance with the quality plan or documented procedures. 

It would be considered prudent to prohibit the premature release of product if you did not have an adequate traceability system in place. If in fact any nonconformities in a component will be detected by the end product tests, it may be worth allowing production to commence without the receipt tests being available, in which case the tests will only be confidence checks and not verification checks. If only one product is received and released prior to verification one would think that, as the requirement applies prior to verification, there is no need to positively identify the product to permit recall because you would know where it was if you found it to be nonconforming. However, the nonconformity may have been reported to you by the supplier after delivery. The standard does not stipulate when and by whom the nonconformity may have been detected. If you lose the means of determining conformity by premature release, don t release the product until you have verified it is acceptable. 

Installation qualification involves performing checks to ensure that the correct equipment or system has been installed and/or connected, including all necessary controls, monitors, instrumentation, or ancillary services. These checks should include verification that relevant operator manuals or instructions have been received from the supplier and that any applicable calibration steps have been identified. 

Much information on the mode of operation and verification of performance of laboratory instruments is often available from manufacturers or suppliers in a form that is suitable for incorporation into an SOP. 

The laboratory shall define the characteristics of the materials, reagents and instrument to be purchased and evaluate the ability of the eligible suppliers to supply the required materials and/or services. The verification process that is, the process to ensure that the purchased products conform to the defined requirements shall be defined and the necessary resources, including persormel, shall be provided. 

Based on the verification process already defined, upon receipt of purchased material the laboratory inspects and verifies that the received materials conform to the purchase requirements. When the verification is made at the supplier s premises there is a need to make arrangements for such verification and for a definition of the method for the release of products. 

Standard reference material (SRM) for wavelength accuracy, stray light, resolution check, and photometric accuracy can be purchased from NIST. Certified reference materials (CRMs) which are traceable to NIST and recertification services can be purchased from instrument manufacturers and commercial vendors [12]. The cost of neutral-density filters and prefabricated standard solutions in sealed cuvettes can be substantial. When purchasing performance verification standards from a secondary supplier other than a national standard organizations such as NIST in the United States and National Physical Laboratory (NPL) in the United Kingdom, make sure that the traceability of the standards are available in the certificates. The traceability establishes the relationship of individual results to the national standard through an unbroken chain of comparisons. 

Verification by the supplier does not absolve the purchaser of the responsibility to provide an acceptable product. 

Where the organization or customer intends to perform verification at the supplier s premises, the organization states the intended verification arrangements and method of product release in the purchasing information. 

Difficulties are encountered with these mixtures as the concentration of some of the components gets into the 1-100 ppm (v/v) range. Reaction and adsorption become problems even for gases normally considered fairly nonreactive. One report (24) of two CO standards certified at 26 ppm and 41 ppm by the same supplier gave 51 ppm for the second one (25% error) with the instrument calibrated using the first one. Two conclusions come from this (a) at least one "certified" standard is wrong, and (b) even "certified standards should not be trusted implicitly without verification. 

Standards are available today in small pressurized cans that are extremely convenient to use with a gas-sampling valve for injection. Again supplier reliability with verification are a must. 

Task verification should be to the supplier s standard specifications or procedures. 

Design, development, and system build is normally a period of intense activity, in which a supplier will be involved in life-cycle activities and will need to provide a set of auditable design and development documentation to support the validation program. For this, the entire design and development process should be carried out to written and approved procedures, and all design, development, testing, and verification activities should be documented and approved in order to provide a level of computer system documentation that can be used to support the pharmaceutical manufacturer s life-cycle qualification activities. 

The supplier will normally apply GEP in covering the two parts of this contractual acceptance test, namely FAT and SAT. However, and if required by the pharmaceutical manufacturer, it should be possible to structure acceptance testing to include the enhanced level of verification, testing, and documentation that are necessary for the in situ qualification under the validation life cycle. 

For DQ (also referred to as enhanced design review) this means review of documented activities throughout the supplier s design, development, and build phases and can include FAT. This is followed by verification and testing of the computer system in its operating environment, under IQ, OQ, and PQ (see Fig. 2). 

An approved version of the validation plan should be available when a computer technology supplier or contract developer is being selected, and should be updated whenever project events or verification results require a change. An example of a project event would be a change in project scope. 

During the qualification of computer technology suppliers and developers, a site visit and inspection of the computing environment and related technology products is conducted. Information is collected through formal inspection of the defined practices, verification of supporting evidence, and interviews with key personnel. Information collected is compared to the defined acceptance criteria and verified before completion of the on-site visit. 

It is recommended that every complete replacement valve, either withdrawn from the stores or returned from a valve specialist, be inspected. New valves coming from an ASME or PED-approved SRV supplier should already be tagged and leaded and will most probably meet all code requirements without requiring further inspection. The only question is how transport could have affected the setting and operation of the valve. Careful verification of how the valve was packed and shipped is important. Therefore many users test all valves, regardless, before putting them on the system. 

The WRMs are binary mixtures of C02 in nitrogen for each one the concentration with its uncertainty are certified by the supplier. The comparison of WRMs with PRMs was carried out in the range 300 500 mol/mol. PRMs used were supplied by a COFRAC accredited laboratory and were gravimetrically prepared mixtures of C02 in nitrogen. Each cylinder is accompanied by a certificate of analysis which reports the concentration and its uncertainty as provided by the analytical verification of the mixture. 

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