Product verification

Where conformity assessment involves intervention of third party, that task is normally carried out by the notified body. The pressure equipment directive enables in addition the national authorities to authorise in their territory user inspectorates for the carrying out of conformity assessment procedures which relate to product verification. These inspectorates shall act exclusively on behalf of the group of which they are part. The placing on the market and putting into service of equipment which has undergone such assessment is however limited to the territory of the authorising Member State and to those Member States which have also proceeded to such authorisation. The equipment concerned shall therefore not bear the CE-marking. 

The quality of the product can be verified by you witnessing the final acceptance tests and inspections on the subcontractor s premises. (If you don t possess the necessary equipment or skill to carry out product verification, this method is an economic compromise and should yield as much confidence in the product as the previous methods. You do, however, need to recognize that your presence on the subcontractor s premises may affect the results. They may omit tests which are problematical or your presence may cause them to be particularly diligent, a stance which may not be maintained when you are not present.)... 

However, these requirements go further than merely controlling the devices used for measurement. They address the measurements themselves, the selection of the devices for measurement and also apply to devices which create product features, if they are used for product verification purposes. If you rely on jigs, tools, fixtures, templates, patterns, etc. to form shapes or other characteristics and have no other means of verifying the shape achieved, these devices become a means of verification. If you use software to control equipment, simulate the environment or operational conditions, or carry out tests and you rely on that software doing what it is supposed to do, without any separate means of checking the result, the quality of such software becomes critical to product verification. In fact the requirements apply to metrology as a whole rather than being limited to the equipment that is used to obtain the measurement and therefore a more appropriate title of the section would be Control of measurements . 

Devices that you use for product verification at all stages in the quality loop need to be controlled and this includes devices used for inspection and test on receipt of product, in-process, and final acceptance before release to the customer. It also includes devices used during design and development for determining product characteristics and for design verification. Some characteristics cannot be determined by calculation and need to be derived by experiment. In such cases the accuracy of devices you use must be con-... 

Knowing what devices are used for product verification purposes so that you can distinguish between controlled and uncontrolled devices - you will need to maintain a list of devices for this purpose. 

You may not need to know all these things about every device used for product verification but you should know most of them. This knowledge can be gained by controlling ... 

These are the measurements required to carry out product verification rather than the measurements to calibrate a measuring device. The measurements to be made should... 

This requirement hides an important provision. It not only applies to inspection, measuring, and test equipment but to the measurements that are performed with that equipment. Anywhere you intend performing product verification or monitoring processes you need to ensure that the environmental conditions are suitable. By environmental conditions is meant the temperature, pressure, humidity, vibration, lighting, cleanliness, dust, acoustic noise, etc. of the area in which such measurements are carried out. To avoid having to specify the conditions each time, you need to establish the ambient conditions and write this into your procedures. If anything other than ambient conditions prevail, you may need to assess whether the measuring devices will perform adequately in these conditions. If you need to discriminate between types of equipment, the ones most suitable should be specified in the verification procedures. 

If a quality record was intended to be any document generated or used by the quality system, the definition would surely have indicated this. If we decompose the definition further, requirements for quality are defined in ISO 8402 as the expression of the needs or their translation into a set of quantitatively stated requirements for the characteristics of an entity to enable its realization and examination. Clearly, such a requirement would be a contract, product specification, design requirement, etc. This implies that any product verification records are quality records, but it rules out any recorded information as being a quality record. 

Product verification requires inspection and testing programs to confirm that product meets the quality requirements. In PSM and ESH terms, the product is the management of environmental, health and safety issues and may be difficult to separate from measurement (Chapter 7) and Audit. 

This element addresses the quality (adherence to ESH/PSM standards and specifications) of purchased materials and equipment, in-process inspections, and final product verification. Methodologies, frequencies, and sample size or scope of inspections are all expected to be specified. 

Are the approved procedures for controlling the calibration of reference standards and measuring equipment available and used for product verification ... 

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. 

All relevant departments are provided with adequate resources and trained personnel for the activities related to product realization including inspection, test, monitoring of the design, production, installation, and servicing of the process and/or product. Verification and audit activities are carried out by personnel independent of those having direct responsibility for the work being performed. 

Production verification (PV) Documented verification that the integrated system performs as intended in its production environment. PV is the execution of selected Performance Qualification (PQ) tests in the production environment using production data. 

ISO TR 14253-2 (1998) Geometrical product specifications (GPS) - Inspection by measurement of work-pieces and measuring equipment -Part 2 Guide to the estimation of uncertainty in GPS measurement, in calibration of measuring equipment and in product verification. ISO, Geneva Kadis R (1998) Accred Qual Assur 3 237-241... 

NOTE For biological and biotechnological products, the following data are also required genetic development of the product, cell bank system, quality, origin and safety from viruses of the starting material, stcmdardisation of the bulk and finished product, verification of the method for viral inactivation and their validation. 

---